0A4F4F9BD490A749D5437F821CF06DF1
Gene Technology Act (2012)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10010826
http://leaux.net/URLS/ConvertAPI Text Files/EA8CABEABB90CFAC2D63299B4EE148C9.en.txt
Examining the file media/Synopses/EA8CABEABB90CFAC2D63299B4EE148C9.html:
This file was generated: 2020-07-14 06:28:48
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator illegal:
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p.(None): Section 100a (1) of the federal acts constitutes a criminal offense, constitutes an administrative offense and is subject to a fine of up to € 7,260.00.
p.(None): (4) Products within the meaning of Section 54 (1) that are placed on the market contrary to the provisions of this Federal Act are to be accepted by the authority
p.(None): confiscate; A notice of the confiscation must be issued within three days. The expiry of such products is in the administrative criminal proceedings
p.(None): pronounce; if the objective fact in the sense of the first sentence is present, then the expiration must be pronounced even if no specific person is concerned
p.(None): this administrative offense can be prosecuted or punished. The confiscation and the forfeiture have to take place regardless of whom
p.(None): Products belong.
p.(None): (5) The confiscation and the forfeiture within the meaning of paragraph 4 shall be omitted if the facts of paragraph 2 no. 2 are not realized and according to
p.(None): State of the art in science and technology there is no threat to security (Section 1 no. 1).
p.(None): (6) In the case of para. 2 no. 1, the administrative criminal authority can, in the decision declaring the expiry, order that the expired GMO from the
p.(None): these GMOs are to be harmlessly disposed of at the time of the illegal release or the costs of the harmless disposal are to be attributed to them
p.(None): has to wear.
p.(None): (7) The administrative criminal authority can lift the seizure upon request and refrain from forfeiture if the person concerned about this GMO at the time of the
p.(None): unlawful release ensures that the person who disposes of it can be harmlessly disposed of or otherwise used legally, if none
p.(None): Endangering security (§ 1 Z 1) is to be feared.
p.(None): References to other federal laws
p.(None): Section 110. (1) Insofar as other federal laws are referred to in this federal law, these are to be understood in their respectively applicable version.
p.(None): (2) This federal law does not affect the validity of other federal regulations.
p.(None): completion
p.(None): Section 111. The following are entrusted with the implementation of this federal law:
p.(None): 1. With regard to the ordinance to be issued pursuant to Section 8 of the Federal Minister of Health and Women in agreement with the Federal Minister of Agriculture
p.(None): and forestry, environment and water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and
p.(None): Culture,
p.(None): 2. With regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with § 12 and § 12a in agreement with the
p.(None): Federal Minister of Economics and Labor, the Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of
p.(None): Education, science and culture,
...
Political / Persecuted
Searching for indicator persecuted:
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p.(None): enable outgoing risks with regard to the required security measures,
p.(None): 5. Necessary changes or additions to the description of safety measures, measures for the harmless disposal of the GVM and if necessary
p.(None): accumulating biologically active nucleic acids, possible dangers of the waste and wastewater generated in the process used and information from
p.(None): Methods for the identification and detection of GVM,
p.(None): 6. necessary changes in the instruction of all persons involved in the work in the handling of the safety devices and
p.(None): Safety measures.
p.(None): B) Working with genetically modified plants and animals
p.(None): 1. First-time work with genetically modified plants or animals
p.(None): 1.1. All security levels:
p.(None): 1. Address of the plant, description of the parts of the plant and the greenhouse or of the plant that are relevant for working with GMOs and their safety
p.(None): Livestock farming,
p.(None): 2. Name of the operator and, if applicable, the project manager,
p.(None): 3. Name and qualification of the
p.(None): a) Biosafety Officer,
p.(None): b) Members of the Biosafety Committee,
p.(None): 4. Safety classification and summary presentation of the work that requires an assessment of the properties of the GMO with regard to the required
p.(None): Enable security measures,
p.(None): 5. Description of security measures and methods for the harmless elimination of the GMO as well as existing methods for
p.(None): Identification and proof of GMOs
p.(None): 6. Description of the planned change in the recipient organism in vertebrates,
p.(None): 7. when working with transgenic vertebrates by breaking the species limits, displaying the persecuted biomedical and developmental biology
p.(None): Aims.
p.(None): 2. Further work with genetically modified plants or animals
p.(None): 2.1. Further work with transgenic vertebrates of security level 1:
p.(None): 1. address of the facility,
p.(None): 2. date of receipt of the notification regarding the first work with transgenic vertebrates in this facility,
p.(None): 3. Description of the planned change in the recipient organism in vertebrates,
p.(None): 4. Presentation of the pursued biomedical and developmental goals of the work.
p.(None): 2.2. Further work with transgenic plants or animals, provided a security level 1 security level is not permitted:
p.(None): 1.Address of the plant and, if necessary, changes to the description of the parts of the plant which are relevant for working with GMOs and their safety,
p.(None): of the greenhouse or animal husbandry,
p.(None): 2. date of receipt of the notification regarding the first-time work with GMOs in this annex,
p.(None): 3. Name of the project manager,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Necessary changes or additions to the description of security measures, methods for the harmless elimination of the GMO, of
p.(None): Methods for the identification and detection of GMOs and measures to prevent accidents.
p.(None): Appendix 2
p.(None): To the Federal Ministry of
p.(None): Health and women
p.(None): Radetzkystrasse 2
p.(None): 1030 Vienna Date:
p.(None): Form for reporting genetic analyzes according to § 73
p.(None): 1. Setup
p.(None): 2. Observation period
p.(None): 3. Main reason for the examinations (multiple answers possible):
p.(None): humangenetische- / Family investigation
...
Political / Prosecuted
Searching for indicator prosecuted:
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p.(None): 43. who, contrary to the provision of Section 79g, provides information for purposes other than to enforce claims under IVa. Section used
p.(None): 44. violates the duty of confidentiality in accordance with Section 96,
p.(None): 45. contrary to the provisions of Section 101 (3) does not tolerate controls or sampling, fails to provide the necessary information or is responsible for the
p.(None): Does not provide the necessary aids or information for investigation and monitoring measures,
p.(None): 46. does not follow or oppose the provisional coercive measures ordered pursuant to Section 103 (1),
p.(None): 47. contrary to the provisions of section 108 (7), does not report that a clinical trial has been carried out for the purpose of somatic gene therapy.
p.(None): (3a) Whoever commits the provisions of one of the legal provisions listed in § 100a, unless the offense does not constitute the offense according to the in
p.(None): Section 100a (1) of the federal acts constitutes a criminal offense, constitutes an administrative offense and is subject to a fine of up to € 7,260.00.
p.(None): (4) Products within the meaning of Section 54 (1) that are placed on the market contrary to the provisions of this Federal Act are to be accepted by the authority
p.(None): confiscate; A notice of the confiscation must be issued within three days. The expiry of such products is in the administrative criminal proceedings
p.(None): pronounce; if the objective fact in the sense of the first sentence is present, then the expiration must be pronounced even if no specific person is concerned
p.(None): this administrative offense can be prosecuted or punished. The confiscation and the forfeiture have to take place regardless of whom
p.(None): Products belong.
p.(None): (5) The confiscation and the forfeiture within the meaning of paragraph 4 shall be omitted if the facts of paragraph 2 no. 2 are not realized and according to
p.(None): State of the art in science and technology there is no threat to security (Section 1 no. 1).
p.(None): (6) In the case of para. 2 no. 1, the administrative criminal authority can, in the decision declaring the expiry, order that the expired GMO from the
p.(None): these GMOs are to be harmlessly disposed of at the time of the illegal release or the costs of the harmless disposal are to be attributed to them
p.(None): has to wear.
p.(None): (7) The administrative criminal authority can lift the seizure upon request and refrain from forfeiture if the person concerned about this GMO at the time of the
p.(None): unlawful release ensures that the person who disposes of it can be harmlessly disposed of or otherwise used legally, if none
p.(None): Endangering security (§ 1 Z 1) is to be feared.
p.(None): References to other federal laws
p.(None): Section 110. (1) Insofar as other federal laws are referred to in this federal law, these are to be understood in their respectively applicable version.
p.(None): (2) This federal law does not affect the validity of other federal regulations.
p.(None): completion
p.(None): Section 111. The following are entrusted with the implementation of this federal law:
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Political / criminal
Searching for indicator criminal:
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p.(None): Section 95 External experts
p.(None): Section 96 duty of confidentiality
p.(None): Section 97 Rules of Procedure
p.(None): Section 98 office
p.(None): Section 99 Genetic engineering book (note: genetic engineering book, report on the application of genetic engineering)
p.(None): VI. Section - Authority and Controls
p.(None): (Note: Section VI - Competent Authority, Controls)
p.(None): Section 100 authority responsibility
p.(None): Section 100a Directly applicable community law
p.(None): Section 101 controls (note: controls, restoration of the environment)
p.(None): Section 101a Restoring the Environment
p.(None): Section 101b Measures in the event of a release without approval
p.(None): Section 101c Genetic Engineering Register
p.(None): Section 101d security documentation
p.(None): Section 101e Authorization to issue ordinances
p.(None): Section VII - Security Research
p.(None): Section 102 Security research
p.(None): Section VIII - Interim Measures
p.(None): Section 103 Provisional coercive measures
p.(None): IX. Section - Expiry of authorization
p.(None): Section 104 Expiry of authorization
p.(None): Section X - Confidentiality of data and data traffic
p.(None): Section 105 Confidentiality of data in the inception process
p.(None): Section 106 transmission of data
p.(None): XI. Section - International Exchange of Information
p.(None): (Note: Section XI)
p.(None): Section 107 Notification requirements to the European Commission
p.(None): XII. Section - Transitional, Penal, and Final Provisions
p.(None): Section 108 transitional provisions
p.(None): (Note: § 108a restriction of the authorization of GMOs - transitional provisions)
p.(None): Section 109 criminal provisions, confiscation, forfeiture
p.(None): Section 110 references to other federal laws
p.(None): Section 111 enforcement
p.(None): Section 112 Implementation notice
p.(None): § 113 Entry into force provisions
p.(None): (Note: § 113a
p.(None): Section 113b
p.(None): Section 113c
p.(None): § 113d
p.(None): Attachments 1 to 4)
p.(None): text
p.(None): I. SECTION
p.(None): General provisions
p.(None): Purpose of the law
p.(None): § 1. The aim of this federal law is
p.(None): 1. to protect human health including his offspring from harm that
p.(None): a) directly by interfering with the human genome, through genetic analyzes on humans or through effects of genetically modified
p.(None): Organisms on humans or
p.(None): b) can arise indirectly from the effects of genetically modified organisms on the environment, and
p.(None): protect the environment (especially the ecosystems) from harmful effects caused by genetically modified organisms and thereby a high level
p.(None): Ensure levels of security for people and the environment and
p.(None): 2. the applications of genetic engineering for the benefit of humans by establishing a legal framework for their research, development and use
p.(None): to promote.
p.(None): scope
p.(None): § 2. (1) This federal law applies to
p.(None): 1. genetic engineering systems;
p.(None): 2. Working with genetically modified organisms (GMOs);
p.(None): 3. releases of genetically modified organisms;
p.(None): 4. the placing on the market of products which consist of or contain genetically modified organisms;
p.(None): 5. the labeling of products which consist of or contain genetically modified organisms or parts thereof
...
p.(None): or other liable persons is at fault or otherwise caused. The same applies to the mutual replacement obligation. However, every person liable is liable
p.(None): Reason and scope only in accordance with the provisions applicable to him.
p.(None): information desk
p.(None): § 79f. (1) Are there circumstances that justify the assumption that damage caused by GMOs as a result of the genetic modification
p.(None): caused properties, the injured party has against each operator, whose activity according to § 79a locally and according to the type of GMO as
p.(None): Cause is generally considered, a right to information. The operator has the relevant aspects of his liability according to § 79a
p.(None): Activity, in particular on the GMOs produced, used, reproduced, stored, destroyed, disposed of or released and their
p.(None): Properties and effects to provide information. The operator is not entitled to information insofar as the operator states that the information can be used to assess whether and
p.(None): the extent to which the damage has been caused by the properties of this GMO caused by the genetic modification is not necessary.
p.(None): (2) The operator, whose liability has been asserted, has against every other operator, on whose activity the ones mentioned in paragraph 1
p.(None): Requirements apply, right to information according to paragraph 1.
p.(None): (3) There is no right to information insofar as the operator weighs all relevant interests by providing the information
p.(None): would be disproportionately burdened, in particular because of the expenses necessary for this, because of the criminal prosecution that could threaten him
p.(None): or because of the necessary disclosure of a business or company secret that is significantly more significant in relation to the damage.
p.(None): (4) The operator, who has been asked for information or his liability, is entitled to information against the injured party, insofar as this
p.(None): it is necessary to assess whether and to what extent the damage was caused by the injured party or other causer, and insofar as the
p.(None): The injured party would not be disproportionately burdened if all relevant interests were weighed up by providing the information.
p.(None): (5) Through extrajudicial negotiations for the provision of information and through a judicial procedure for the enforcement of the
p.(None): The right to information is inhibited from continuing the limitation of a claim under this section.
p.(None): Section 79g. (1) Information obtained in accordance with Section 79f may only be used to enforce claims under this section.
p.(None): (2) If business or trade secrets or the content of information according to § 79f are discussed in a judicial proceeding or evidence is provided
p.(None): the public is to be excluded at the request of one of the parties.
p.(None): Application of the ABGB
p.(None): Section 79h. (1) Unless otherwise specified in this section, the general civil code applies to the claims provided therein
p.(None): apply.
p.(None): (2) The operator is also liable in cases in which claims for compensation for damage caused by GMOs as a result of the genetic modification
...
p.(None): the environment is required, or if so provided by intergovernmental agreements.
p.(None): XI. SECTION
p.(None): Notification requirements to the European Commission
p.(None): § 107. The Federal Minister of Health and Women has the European Commission taking into account the provisions on confidentiality
p.(None): in accordance with section 105 and data traffic in accordance with section 106
p.(None): 1. As soon as possible to report all accidents when working with GMOs in a closed system and include details about the circumstances of the accident, the
p.(None): Identity and quantities of the GMOs released, the emergency measures applied and their effectiveness, as well as an analysis of the accident, including
p.(None): Provide recommendations to limit its impact and prevent similar accidents in the future,
p.(None): 2. At the end of each year, a summary report on work for approval in security levels 3 and 4 in
p.(None): closed systems, including the description, purpose and risks of the GMOs, and to be submitted every three years and at
p.(None): for the first time on June 5, 2003 a summary report on his experience with the application of the EC Directive 90/219 / EC in the version of the
p.(None): To transmit EC Directive 98/81 / EC,
p.(None): 3. communicate the official decisions in accordance with § 40,
p.(None): 4. after the end of each year, a short report on the control of the use of all those approved and placed on the market in accordance with Section 58 (5)
p.(None): To transmit products (section 54 (1)) and
p.(None): 5. to submit a report every three years, and for the first time on 1 September 1997, on the measures taken to implement Directive 90/220 / EEC.
p.(None): XII. SECTION
p.(None): Transitional, criminal and final provisions
p.(None): Transitional provisions
p.(None): Section 108. (1) At the time this Federal Act comes into force (Art. III Para. 1), work and series of work with GMOs in closed form are already taking place
p.(None): Systems are still permitted, subject to a later decision by the authority. The operators have this within twelve months from the entry into force
p.(None): Federal law to submit an application according to § 19 or an application according to § 20 to the authority.
p.(None): (2) Releases of GMOs that are already taking place at the time this Federal Act comes into force (Art. III Para. 1) are subject to a later one
p.(None): Authority decision still allowed. The operator must submit an application to the authority within twelve months of the entry into force of this federal law
p.(None): § 37 paragraph 2.
p.(None): (3) Anyone who places products on the market as a manufacturer or importer in accordance with Section 54 (1) at the time this Federal Act comes into force (Art. III (1)),
p.(None): subject to a later decision by the authority, it is still entitled to do so. He has the authority within eight months after its entry into force
p.(None): Federal law to submit an application pursuant to Section 55. If these are plant protection products, the application must be made to implement the
p.(None): Plant Protection Products Act, Federal Law Gazette No. 476/1990
...
p.(None): 41. contrary to the provisions of section 74, carries out somatic gene therapy on humans or uses cells for the production of embryos or
p.(None): somatic gene therapy contrary to the regulation of § 75 Abs. 1 carries out without being a doctor, or contrary to the regulation of § 75 Abs. 3 somatic
p.(None): Conducts gene therapy without a license or does not comply with the conditions and conditions specified in the license pursuant to Section 75 (3) or the
p.(None): Bans or requirements issued pursuant to Section 75 (4) are not observed or the doctor responsible for the implementation of somatic gene therapy
p.(None): Contrary to due diligence and notification obligations of § 77,
p.(None): 42. contrary to the provision of section 76, conducts a clinical trial for the purpose of somatic gene therapy without authorization,
p.(None): 43. who, contrary to the provision of Section 79g, provides information for purposes other than to enforce claims under IVa. Section used
p.(None): 44. violates the duty of confidentiality in accordance with Section 96,
p.(None): 45. contrary to the provisions of Section 101 (3) does not tolerate controls or sampling, fails to provide the necessary information or is responsible for the
p.(None): Does not provide the necessary aids or information for investigation and monitoring measures,
p.(None): 46. does not follow or oppose the provisional coercive measures ordered pursuant to Section 103 (1),
p.(None): 47. contrary to the provisions of section 108 (7), does not report that a clinical trial has been carried out for the purpose of somatic gene therapy.
p.(None): (3a) Whoever commits the provisions of one of the legal provisions listed in § 100a, unless the offense does not constitute the offense according to the in
p.(None): Section 100a (1) of the federal acts constitutes a criminal offense, constitutes an administrative offense and is subject to a fine of up to € 7,260.00.
p.(None): (4) Products within the meaning of Section 54 (1) that are placed on the market contrary to the provisions of this Federal Act are to be accepted by the authority
p.(None): confiscate; A notice of the confiscation must be issued within three days. The expiry of such products is in the administrative criminal proceedings
p.(None): pronounce; if the objective fact in the sense of the first sentence is present, then the expiration must be pronounced even if no specific person is concerned
p.(None): this administrative offense can be prosecuted or punished. The confiscation and the forfeiture have to take place regardless of whom
p.(None): Products belong.
p.(None): (5) The confiscation and the forfeiture within the meaning of paragraph 4 shall be omitted if the facts of paragraph 2 no. 2 are not realized and according to
p.(None): State of the art in science and technology there is no threat to security (Section 1 no. 1).
p.(None): (6) In the case of para. 2 no. 1, the administrative criminal authority can, in the decision declaring the expiry, order that the expired GMO from the
p.(None): these GMOs are to be harmlessly disposed of at the time of the illegal release or the costs of the harmless disposal are to be attributed to them
p.(None): has to wear.
p.(None): (7) The administrative criminal authority can lift the seizure upon request and refrain from forfeiture if the person concerned about this GMO at the time of the
p.(None): unlawful release ensures that the person who disposes of it can be harmlessly disposed of or otherwise used legally, if none
p.(None): Endangering security (§ 1 Z 1) is to be feared.
p.(None): References to other federal laws
p.(None): Section 110. (1) Insofar as other federal laws are referred to in this federal law, these are to be understood in their respectively applicable version.
p.(None): (2) This federal law does not affect the validity of other federal regulations.
p.(None): completion
p.(None): Section 111. The following are entrusted with the implementation of this federal law:
p.(None): 1. With regard to the ordinance to be issued pursuant to Section 8 of the Federal Minister of Health and Women in agreement with the Federal Minister of Agriculture
p.(None): and forestry, environment and water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and
p.(None): Culture,
p.(None): 2. With regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with § 12 and § 12a in agreement with the
p.(None): Federal Minister of Economics and Labor, the Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of
p.(None): Education, science and culture,
p.(None): 3. with regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with sections 17, 44 and 72 in agreement with the
...
Political / political affiliation
Searching for indicator party:
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p.(None): §6 security rating
p.(None): §7 assessment procedure
p.(None): §8 Authorization to issue regulations
p.(None): §9 Transgenic animals
p.(None): § 10 security measures
p.(None): § 11 accident, emergency plan
p.(None): Section 12 Authorization to issue regulations
p.(None): Section 12a Authorization to issue ordinances
p.(None): § 13 operator
p.(None): Section 14 Biosafety officer
p.(None): § 15 project manager
p.(None): Section 16 Committee for Biosafety
p.(None): Section 17 Authorization to issue regulations
p.(None): Section 18 Cooperation with other institutions
p.(None): § 19 Registration of work with GMOs
p.(None): Section 20 applications for approval for working with GMOs
p.(None): Section 21 Authorization to issue regulations
p.(None): Section 22 Official procedure
p.(None): Section 23 Official decision
p.(None): § 24 start of work
p.(None): § 25 inhibition of the deadline
p.(None): Section 26 Official procedure when working with transgenic animals
p.(None): Section 27 Official decision on working with transgenic animals
p.(None): § 28 hearing
p.(None): Section 29 Authorization to issue regulations
p.(None): § 30 due diligence, information and notification requirements
p.(None): Section 31 Change in safety equipment
p.(None): Section 32 Change of operator
p.(None): Section 33 Subsequent conditions (note: subsequent measures)
p.(None): Section 34 Obligation to record
p.(None): Section 35 Authorization to issue ordinances
p.(None): III. Section - GMO release and placing on the market
p.(None): Part A - Release of GMOs
p.(None): Section 36 level principle
p.(None): Section 37 Application for approval
p.(None): Section 38 Authorization to issue regulations
p.(None): Section 39 Official procedure
p.(None): Section 39a Party position
p.(None): Section 40 Official decision
p.(None): Section 41 Inhibition of the deadline
p.(None): Section 42 Simplified official procedure
p.(None): Section 43 hearing
p.(None): Section 44 Authorization to issue regulations
p.(None): § 45 security measures, due diligence, information and notification requirements
p.(None): Section 46 Report on the Results of the Release
p.(None): Section 46a Authorization to issue ordinances
p.(None): Section 47 Change of operator
p.(None): Section 48 Subsequent requirements
p.(None): Section 49 accident, emergency plan
p.(None): Section 50 Authorization to issue regulations
p.(None): § 51 controls
p.(None): Section 52 Duty to record
p.(None): Section 53 Authorization to issue ordinances
p.(None): Part B - Placing on the market
p.(None): Section 54
p.(None): Section 55 Applicants and application documents
p.(None): Section 56 Authorization to issue regulations
p.(None): § 57 due diligence
p.(None): Section 58 Official procedure and official decision
p.(None): Section 58a Content of the approval
p.(None): Section 58b Renewal of approval
p.(None): Section 58c Obligation to monitor
p.(None): Section 58d Authorization to issue ordinances
p.(None): Section 58e Change of approval
p.(None): Section 59 scope of authorization
p.(None): Section 60 Temporary prohibitions or restrictions
p.(None): Section 61 security measures
p.(None): § 62 packaging and labeling
p.(None): Section 62a Provision of GMOs for purposes other than placing them on the market
p.(None): Section 62b Authorization to issue ordinances
p.(None): Section 62c Unintentional presence of GMOs in other products
p.(None): Section 63 Social intolerance
p.(None): (Note: § 63a restriction of approval of GMOs)
p.(None): Section IV - Genetic Analysis and Gene Therapy in Humans
...
p.(None): order to provide further information on how to improve the application.
p.(None): (3) Before the decision to approve a release, except in the case of a simplified official procedure pursuant to Section 42, the authority has
p.(None): to carry out a hearing procedure in accordance with Section 43 and to obtain an expert opinion from the responsible scientific committee of the Genetic Engineering Commission.
p.(None): (4) The authority has submitted a summary of the application to the European Commission pursuant to Section 37 (2) lit. g within 30 days of receipt
p.(None): to transfer.
p.(None): (5) The authority has
p.(None): a) the Federal Ministry of Agriculture, Forestry, Environment and Water Management the receipt of the application (para. 1), the content of a request
p.(None): in accordance with paragraph 2 and the further information received on the basis of this request,
p.(None): b) to invite the Federal Ministry of Agriculture, Forestry, Environment and Water Management to the consultation procedure (§ 43) and
p.(None): c) the Federal Ministry of Agriculture, Forestry, Environment and Water Management their decisions (sections 40 and 48) and the reports and
p.(None): Notices of the operator (sections 45 (3), 46, 47 and 49 (2)) must be brought to your attention immediately.
p.(None): Note for the following provision
p.(None): Regarding para. 1: Appears through § 42 para. 1 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): party status
p.(None): Section 39a. (1) Party position in the official procedure for approval of a release, except for the release of animals and microorganisms
p.(None): related to medical applications
p.(None): 1. the applicant,
p.(None): 2. the municipality in whose local area of responsibility the release is to take place if it raises objections in accordance with § 43 Paragraphs 1 and 2
p.(None): Sent it to the authority in writing within the meaning of paragraph 2 below and explained it in more detail at the hearing,
p.(None): 3. if the property on which the release is to take place is at a municipal boundary, the municipalities adjacent to this property, if
p.(None): it submits objections, justified in accordance with Section 43, Paragraphs 1 and 2, in writing to the Authority in the sense of the following Paragraph 2 and further details at the hearing
p.(None): have explained
p.(None): 4. the owner of the property on which the release is to take place if he has written objections in accordance with § 43 paragraphs 1 and 2 of the
p.(None): Authority communicated and explained in more detail at the hearing and at the same time with his written objections the requirements for his
p.(None): Party position has demonstrated
p.(None): 5. the neighbors if they submit written objections to the authority in writing in accordance with section 43 subsection 1 and 2 within the meaning of the subsection 2 below and submit them
p.(None): the hearing was explained in more detail and, at the same time, with its written objections, the requirements for her party position were met
p.(None): to have. Neighbors are the owners of the land, which have a common border with the property on which the release is to take place,
p.(None): as well as persons who have leased these properties at the time of application and during the procedure, and persons who
p.(None): Time of the application and during the procedure legally and not only temporarily on one of these properties, as well
p.(None): 6. the federal state in whose area of responsibility the release should take place if there are justified objections within the meaning of section 43 (1) and (2)
p.(None): Submitted the following paragraph 2 in writing to the authority and explained in more detail at the hearing.
p.(None): (2) The municipalities in accordance with Paragraph 1 Numbers 2 and 3 are due to the party position they receive, each of them within the framework of the respective party according to § 43
p.(None): Paragraphs 1 and 2 raised objections, entitled to comply with legal requirements regarding security (§ 1 Z 1) within their respective local
p.(None): Area of responsibility serve to assert in the official procedure for approval of the release. The federal state according to paragraph 1 no. 6 is on the ground
p.(None): the party position it is entitled to within the scope of the objections raised by it according to § 43 Paragraph 1 and 2, compliance with
p.(None): Legislation that serves security (§ 1 Z 1) within its respective area of responsibility in the official procedure for approval of the
p.(None): Claim release. The owner of the property in accordance with paragraph 1 line 4 and its neighbors in accordance with paragraph 1 line 5, each of them within the framework of the
p.(None): Objections raised by him in accordance with § 43 Paragraphs 1 and 2 are entitled to comply with the legal provisions that ensure the security of his own
p.(None): Health and that of his offspring serve to assert a subjective public right in official proceedings, to take legal action
p.(None): and to lodge a complaint with the Administrative Court and the Constitutional Court.
p.(None): Official decision
p.(None): Section 40. (1) The authority must decide on applications pursuant to Section 37 (2) within 90 days of receipt of the application. Approval must be given if
p.(None): 1. It is ensured that the operator derives from the provisions of Part A of this section and the regulations based thereon
p.(None): Obligations for the intended release are fulfilled and this release is carried out according to the state of the art in science and technology,
p.(None): 2. It is guaranteed that the precautions necessary according to the state of the art in science and technology have been taken and therefore have adverse consequences for the
p.(None): Security (§ 1 Z 1) are not to be expected, and
p.(None): 3. the operator provides proof of liability insurance in accordance with section 79j (1) second or third sentence.
p.(None): (2) Insofar as this is necessary in the interest of security (§ 1 no. 1), the authority has the period within which a release may be carried out,
p.(None): to be limited in time or for the implementation and if necessary also for the monitoring after the implementation certain suitable conditions and requirements
p.(None): prescribe.
p.(None): (3) In its decision, the authority takes into account the need to use marker genes in GMOs, the resistance to human or
p.(None): impart antibiotics used in veterinary medicine and can have harmful effects on safety (§ 1 no. 1) in the event of releases up to
p.(None): December 31, 2008.
p.(None): (4) The authority has every decision in accordance with paragraphs 1 to 3 of the European Commission and the federal state in whose area of responsibility the
p.(None): Release should take place.
p.(None): (5) The Authority shall make publicly available information on any release approval on the Authority's website.
p.(None): Inhibition of the deadline
p.(None): § 41. (1) The notification of the result of the investigation to the applicant and the order to improve the application or the
p.(None): The associated documents and the hearing in accordance with section 43 inhibit the period in accordance with section 40 (1) until the applicant has received a statement or
p.(None): of improvement. The hearing pursuant to Section 43 will delay this period for a maximum of 30 days.
p.(None): (2) The notification of the result of the investigation to a party in accordance with Section 39a (1) lines 2 to 6 does not inhibit the period in accordance with Section 40 (1).
p.(None): Simplified official procedure
p.(None): Section 42. (1) The Federal Minister of Health and Women is authorized if sufficient with the release of certain GMOs in certain ecosystems
p.(None): Experience has been gathered, taking into account the state of the art in science and technology and safety (§ 1 no. 1) after consulting the
p.(None): competent scientific committee of the Genetic Engineering Commission to submit an application in accordance with Art. 7 of Directive 2001/18 / EC and to implement a
p.(None): Decision according to Art. 7 of Directive 2001/18 / EC by regulation in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the
p.(None): Implement simplified administrative procedures for the release of such GMOs that are comparable in terms of their safety.
p.(None): (2) The Federal Minister of Health and Women has an ordinance in accordance with paragraph 1 or the decision, a decision in accordance with Art. 7 of the Directive
p.(None): 2001/18 / EC not to be used to inform the European Commission.
p.(None): Note for the following provision
p.(None): Regarding para. 2: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): hearing
p.(None): Section 43. (1) The authority has in the Official Journal of the Wiener Zeitung, in two local daily newspapers and on the notice boards of the municipalities in accordance with Section 39a (1)
p.(None): Z 2 and 3 to announce at the expense of the operator that an application for the release of a GMO has been made, relevant documents to the authority (§ 100),
p.(None): all offices of the state governments and the municipalities in whose local area of responsibility GMOs are to be released during a
p.(None): Period of three weeks for public inspection and that everyone is at liberty to justify the authority within the period for which the information is available
p.(None): Submit objections in writing. The announcement includes persons who, in accordance with Section 39a (1) (4) and (5), are party to the further official procedure
p.(None): to obtain approval for the release, to point out that they have the party position by raising justified written objections
p.(None): can obtain at the same time the requirements for their party position and subsequent explanation of their objections at the hearing.
p.(None): (2) The authority shall schedule a hearing as part of the investigation; this hearing took place within three weeks from the end of the
p.(None): Deadline to be held. The hearing serves to discuss the objections submitted on time; the opponents have the opportunity to get closer
p.(None): To explain their objections. The authority has the right to this hearing to anyone who has submitted timely objections in writing
p.(None): load. This loading can be carried out in the announcement according to paragraph 1. The authority also has to load separately:
p.(None): a) the applicant in accordance with Section 39a (1) 1,
p.(None): b) the municipalities in accordance with Section 39a (1) 2 and 3 if they have raised objections in accordance with Section 1
p.(None): c) the owner of the property in accordance with Section 39a (1) no. 4,
p.(None): d) the neighbors in accordance with Section 39a (1) (5) if they raise objections in accordance with Section 1 and the requirements for their party status are met
p.(None): have demonstrated
p.(None): e) the federal state in accordance with section 39a (1) (6) if it has raised objections in accordance with section 1, and
p.(None): f) the members of the responsible scientific committee.
p.(None): statutory authorization
p.(None): § 44. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of the hearing
p.(None): is required, in agreement with the Federal Minister of Education, Science and Culture by ordinance, more detailed provisions on announcement and
p.(None): The course of the consultation process, the type and scope of the inspection of the application and the associated documents, with particular attention to the
p.(None): Confidentiality of data in accordance with Section 105, to determine the preparation and the course of the hearing.
p.(None): Security measures, due diligence, information and notification requirements
p.(None): Section 45. (1) Anyone who carries out a release has all that is necessary according to the state of the art in science and technology in the interest of safety (Section 1 no. 1)
p.(None): Take precautions and measures and - insofar as he is the operator - ensure that they are observed.
p.(None): (2) Even after approval of the release, the operator has all the facts and circumstances related to the release
p.(None): inform, which according to the state of the art in science and technology are suitable to endanger security (§ 1 Z 1).
p.(None): (3) The operator must immediately report facts and circumstances in accordance with paragraph 2 to the authority in writing.
p.(None): Release results report
...
p.(None): grant. The Federal Minister of Health and Women and the Federal Office for Safety in Health Care are also responsible for the scope of their responsibilities
p.(None): non-public part of the gene therapy register accessible.
p.(None): IVa. section
p.(None): Civil liability
p.(None): Personal injury and property damage
p.(None): Section 79a. (1) Is caused when working with GMOs (§ 4 Z 4) or when they are released (§ 4 Z 20) as a result of the genetic modification
p.(None): Characteristics of the organism A person has been killed, injured on the body or damaged in health or damaged a physical thing
p.(None): Operator (§ 4 Z 18) to compensate for the damage. The operator is liable for work and releases even if there is already a permit for the release
p.(None): or has been granted for placing on the market as long as the product (Section 54 (1)) has not yet been placed on the market in accordance with the approval.
p.(None): (2) The operator's liability also extends to damage caused by the properties of the GMO caused by the genetic modification
p.(None): Connection with its other dangerous properties.
p.(None): Environmental degradation
p.(None): Section 79b. Is the damage to a physical thing also a significant impairment of the environment (§ 101a para. 1) and is a restoration of the
p.(None): the previous state is not feasible by the liable operator or if the operator is not ready to restore it, the injured party also deserves it
p.(None): then the reimbursement of the costs of the restoration if these costs exceed the value of the damaged item. The victim can
p.(None): Demand recovery costs in advance, however, has an advance payment in excess of the value of the damaged item
p.(None): to be refunded if it does not restore the previous condition within a reasonable time.
p.(None): Disclaimer of liability
p.(None): Section 79c. The liability of the operator is excluded if the damage
p.(None): 1. through an act of war, similar hostilities, a civil war, an uprising or an extraordinary, inevitable and its consequences
p.(None): reasonably unavoidable natural event,
p.(None): 2. by a third party acting with the intention of causing damage and not participating in the activity pursuant to Section 79a despite compliance with all according to the type of activity
p.(None): security measures required in accordance with sections 10 and 45 or
p.(None): 3. in compliance with a legal regulation or a special official order or coercive measure
p.(None): has been caused.
p.(None): burden of proof
p.(None): Section 79d. If a GMO that was the subject of an activity pursuant to Section 79a is suitable for causing the damage in accordance with the circumstances of the individual case, then
p.(None): suspects that it caused the damage as a result of its properties caused by the genetic modification. The presumption is disproved if it is
p.(None): the operator believes that the damage was not caused by these properties or that it was caused in the sense of Section 79a (2).
p.(None): Liability, recourse and compensation for several operators
p.(None): Section 79e. (1) If several persons are liable according to this federal law or other legal provisions, they are liable insofar as the individual
p.(None): Do not let liability-related damage be distinguished, to the undivided hand. The same applies if several operators have a harmful activity
p.(None): have exercised one after the other and the damage attributable to the individual liability can not be distinguished. Every person liable is liable
p.(None): however, according to the reason and scope only in accordance with the provisions applicable to him.
p.(None): (2) If several persons are liable according to this federal law or other legal provisions, the obligation depends on each other
p.(None): for compensation and its scope depends on the circumstances of the individual case, in particular on the extent to which the damage is at least likely by one
p.(None): or other liable persons is at fault or otherwise caused. The same applies to the mutual replacement obligation. However, every person liable is liable
p.(None): Reason and scope only in accordance with the provisions applicable to him.
p.(None): information desk
p.(None): § 79f. (1) Are there circumstances that justify the assumption that damage caused by GMOs as a result of the genetic modification
p.(None): caused properties, the injured party has against each operator, whose activity according to § 79a locally and according to the type of GMO as
p.(None): Cause is generally considered, a right to information. The operator has the relevant aspects of his liability according to § 79a
p.(None): Activity, in particular on the GMOs produced, used, reproduced, stored, destroyed, disposed of or released and their
p.(None): Properties and effects to provide information. The operator is not entitled to information insofar as the operator states that the information can be used to assess whether and
p.(None): the extent to which the damage has been caused by the properties of this GMO caused by the genetic modification is not necessary.
p.(None): (2) The operator, whose liability has been asserted, has against every other operator, on whose activity the ones mentioned in paragraph 1
p.(None): Requirements apply, right to information according to paragraph 1.
p.(None): (3) There is no right to information insofar as the operator weighs all relevant interests by providing the information
p.(None): would be disproportionately burdened, in particular because of the expenses necessary for this, because of the criminal prosecution that could threaten him
p.(None): or because of the necessary disclosure of a business or company secret that is significantly more significant in relation to the damage.
p.(None): (4) The operator, who has been asked for information or his liability, is entitled to information against the injured party, insofar as this
p.(None): it is necessary to assess whether and to what extent the damage was caused by the injured party or other causer, and insofar as the
p.(None): The injured party would not be disproportionately burdened if all relevant interests were weighed up by providing the information.
p.(None): (5) Through extrajudicial negotiations for the provision of information and through a judicial procedure for the enforcement of the
p.(None): The right to information is inhibited from continuing the limitation of a claim under this section.
p.(None): Section 79g. (1) Information obtained in accordance with Section 79f may only be used to enforce claims under this section.
p.(None): (2) If business or trade secrets or the content of information according to § 79f are discussed in a judicial proceeding or evidence is provided
p.(None): the public is to be excluded at the request of one of the parties.
p.(None): Application of the ABGB
p.(None): Section 79h. (1) Unless otherwise specified in this section, the general civil code applies to the claims provided therein
p.(None): apply.
p.(None): (2) The operator is also liable in cases in which claims for compensation for damage caused by GMOs as a result of the genetic modification
p.(None): caused properties are to be assessed according to the general regulations of civil law, for the fault of the person,
p.(None): who cooperated with the will in the activity pursuant to Section 79a, insofar as this participation was the cause of the damage.
p.(None): (3) If the injured party or someone whose behavior he is responsible for is at fault, § 1304 ABGB shall apply mutatis mutandis.
p.(None): Other claims for compensation
p.(None): Section 79i. Provisions of the general civil code and other regulations, according to which damage to other extent or by others
p.(None): Persons who are to be replaced under this federal law remain unaffected.
p.(None): financial security
p.(None): Section 79j. (1) The operator of an activity pursuant to Section 79a has to a degree and to the extent that is customary in fair business dealings by entering into
p.(None): insurance or in any other suitable way to ensure that liability for damages according to this section can be fulfilled. Consists
p.(None): the activity in work with GMOs of security level 3 on a large scale or in the release of GMOs on a small scale (§ 36 Paragraph 1 No. 1), must
p.(None): in any case, this provision consists of liability insurance with an insurance sum of at least 712 200 euros for each damage event. Consists
p.(None): If you are working on GMOs of security level 4 or releasing GMOs to a large extent (Section 36 Paragraph 1 No. 2), this precaution must be taken
p.(None): at least in liability insurance with an insured sum of at least 4 069 700 euros for each damage event. The
p.(None): Liability insurance must be taken out with an insurer authorized to operate this insurance branch in Austria; on that must
p.(None): Austrian law must be applied. The competent body within the meaning of Section 158c (2) Insurance Contract Act 1958 is the authority under Section 100.
p.(None): (2) There is no obligation to provide cover if the federal government or a state is an operator.
p.(None): Claims against neighbors
...
p.(None): 1. for applications for approval as a genetically modified food and for applications for joint approval as a genetically modified food and
p.(None): Feed of the Federal Minister of Health and Women
p.(None): 2. the Federal Office for Food Security for applications for approval as genetically modified feed.
p.(None): Controls, restoration of the environment
p.(None): Section 101. (1) The organs of the authority are authorized in places where there is reason to believe that
p.(None): 1. work with GMOs is carried out,
p.(None): 2. GMOs are released,
p.(None): 3. products are placed on the market in accordance with section 54 (1),
p.(None): 4. genetic analyzes are carried out on humans in accordance with § 65 or the data obtained is processed and stored in an automated manner
p.(None): become, or
p.(None): 5. gene therapies are carried out on humans,
p.(None): To keep an eye on and for the purpose of checking compliance with the provisions of this federal law and those based on this federal law
p.(None): decrees and notices to be carried out, to inspect the records to be kept in accordance with sections 34 and 52, and
p.(None): Take samples to the extent necessary.
p.(None): (2) Except in the event of imminent danger, the review is during normal business or operating hours and with the involvement of a responsible person
p.(None): Employees. Care should be taken to ensure that any disruption or disability of the operator or anyone that is not absolutely necessary
p.(None): interference with third party rights that is not absolutely necessary is avoided.
p.(None): (3) The operator and anyone who places GMOs on the market must tolerate the controls and sampling to provide the necessary support
p.(None): to provide all information necessary for inspection and sampling and all aids necessary for the investigation and monitoring measures
p.(None): and to provide information, such as in particular probes - if available -, sequence information and the like.
p.(None): (4) In the event of a sample being taken, a cross-check should be carried out if possible. A request from the authority is available for the sample taken
p.(None): determining compensation in the amount of the material value to be paid by the federal government. Compensation does not apply if, on the basis of this sample, a specific person
p.(None): has been punished or if the authority determines by decision that - without a specific person being punished - the objective fact of a person
p.(None): Violation of this federal law has been implemented and the taking of the sample has contributed to the collection of this fact.
p.(None): (5) The authority may, insofar as economy, expediency and economy require it, carry out controls in accordance with paragraph 1 nos. 2 and 3
p.(None): including the control of compliance with the monitoring obligations in accordance with Section 58c, also external experts or expert institutions in accordance with
p.(None): All or part of their respective tasks. The Federal Environment Agency is particularly entitled to environmental control tasks
p.(None): take (Section 6 (4) of the Environmental Control Act).
...
p.(None): revoke the measures taken immediately.
p.(None): IX. SECTION
p.(None): The authorization expires
p.(None): Section 104. (1) The right to carry out a work or series of work with GMOs or a release expires three years after their expiry
p.(None): Registration or approval if the work or series of GMO or release work has not started within this period.
p.(None): (2) The authority may, upon request, extend the deadline in accordance with paragraph 1 for a significant reason by a maximum of one year if the security (§ 1 no. 1)
p.(None): the state of the art in science and technology is still guaranteed.
p.(None): X. SECTION
p.(None): Confidentiality of data and traffic
p.(None): Confidentiality of data in the inception process
p.(None): Section 105. (1) Data recognized by the authority as confidential shall not be made available to the public, even during the inception process.
p.(None): (2) Each applicant or operator can use the documents to be submitted by him under this Federal Act, provided that the documents contained therein
p.(None): information
p.(None): a) international relations and national defense,
p.(None): b) public security,
p.(None): c) Matters pending before the court or subject to, or subject to, preliminary proceedings (including disciplinary proceedings)
p.(None): The subject of preliminary proceedings are
p.(None): d) business and trade secrets including intellectual property,
p.(None): e) the confidentiality of personal data or files,
p.(None): f) documents that have been transmitted by a third party who was not legally obliged to do so,
p.(None): (g) information the disclosure of which would further increase the likelihood of environmental damage in the area concerned;
p.(None): touched, the data that are treated confidentially and thus should not be made available to the public even in the disclosure process. In
p.(None): In such cases, a verifiable justification must be given. After hearing the applicant or applicant, the authority decides which data as
p.(None): be recognized confidentially.
p.(None): (3) Under no circumstances may the following data be recognized as confidential:
p.(None): 1. General description of the GMO;
p.(None): 2. Name and address of the applicant or applicant;
p.(None): 3. a) Security level, containment measures and place of work with GMOs;
p.(None): b) purpose of release and place of release;
p.(None): 4. methods and plans for GMO monitoring and emergency response;
p.(None): 5. Assessment of the foreseeable effects, in particular the effects that are detrimental to safety (§ 1 no. 1).
p.(None): (4) The regulations according to paragraphs 1 to 3 on the confidentiality of data in the disclosure process also apply in relation to the others at the official level
p.(None): Procedure for authorizing a release involved.
p.(None): Transmission of data
p.(None): Section 106. The data to be disclosed to the authority in accordance with this federal law may be collected and processed by the authority. personal
p.(None): and confidential data may only be transmitted to
p.(None): 1. the departments of the federal and state governments, insofar as the data is for the recipient to enforce this federal law or other federal or
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p.(None): Violation of this federal law has been implemented and the taking of the sample has contributed to the collection of this fact.
p.(None): (5) The authority may, insofar as economy, expediency and economy require it, carry out controls in accordance with paragraph 1 nos. 2 and 3
p.(None): including the control of compliance with the monitoring obligations in accordance with Section 58c, also external experts or expert institutions in accordance with
p.(None): All or part of their respective tasks. The Federal Environment Agency is particularly entitled to environmental control tasks
p.(None): take (Section 6 (4) of the Environmental Control Act).
p.(None): (6) The assignment in accordance with Paragraph 5 and the dismissal must be made with notice. The assignment requires the approval of the representative. in the
p.(None): Notification of the commission are the local and factual scope of the control, the intended remuneration and that for the flawless implementation of the
p.(None): Control activities to determine the necessary conditions and requirements. No employment relationship is established through the assignment. The representative is at
p.(None): Instructions bound by the authority. A dismissal has to take place in particular if the agent does not or only insufficiently fulfills his tasks, or
p.(None): the requirements under which the order was placed no longer apply.
p.(None): Restoring the environment
p.(None): Section 101a. (1) When working with GMOs or when releasing them, the environment is affected by the properties of the GMOs, which are caused by genetic engineering changes
p.(None): are so significantly impaired that the security according to § 1 Z 1 is not guaranteed, the authority has the operator to that extent to restore the
p.(None): Environment or measures necessary to prevent further environmental damage. In the event of imminent danger, the authority has the
p.(None): take the necessary measures yourself (Section 103); the same applies if the operator cannot be determined or for legal or other reasons
p.(None): Is unable to carry out the necessary measures. The authority has to reimburse the operator for the costs incurred by it
p.(None): Impose measures.
p.(None): (2) If the rights of third parties are affected by measures in accordance with paragraph 1, these have such interference, in particular the use and access of
p.(None): Tolerate land to the extent that this proves to be absolutely necessary.
p.(None): (3) Anyone who takes measures in accordance with paragraph 1 of his property, his real rights, his obligatory rights of use or his rights of use in the sense
p.(None): of the Basic Law 1951, Federal Law Gazette No. 103, cannot be used in the manner or to the extent to which it is entitled on the basis of existing rights
p.(None): To compensate operators appropriately. If no agreement can be reached, the amount of the compensation must be determined by the authority,
p.(None): §§ 18 to 20a of the Federal Roads Act 1971, Federal Law Gazette No. 286, are to be applied analogously in the respectively applicable version. An appeal against that
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p.(None): Section 63 Social intolerance
p.(None): (Note: § 63a restriction of approval of GMOs)
p.(None): Section IV - Genetic Analysis and Gene Therapy in Humans
p.(None): Section 64 Prohibition of interventions in the genetic material of the human germline
p.(None): Section 65 Genetic analyzes in humans for medical purposes
p.(None): Section 66 Genetic analyzes in humans for scientific purposes and for training
p.(None): Section 67 Prohibition of collecting and using data from genetic analyzes for certain purposes (note: prohibition of the use of
p.(None): Genetic analysis data for specific purposes)
p.(None): Section 68 Performing genetic analyzes on humans for medical purposes - official procedure
p.(None): Section 68a Head of the facility and laboratory manager
p.(None): Section 69 Consent and advice
p.(None): Section 70 Inclusion of relatives
p.(None): Section 71 data protection (note: test results)
p.(None): Section 71a Documentation of the test results
p.(None): Section 72 Authorization to issue ordinances
p.(None): Section 73 Notification requirements
p.(None): Section 74 Somatic Gene Therapy
p.(None): Section 75 Institutions for the implementation of somatic gene therapy - official procedure (note: implementation of the somatic
p.(None): Gene Therapy - Official Procedure and Decision)
p.(None): Section 76 Clinical trials for the purpose of somatic gene therapy
p.(None): Section 77 due diligence and notification requirements
p.(None): Section 78 application of legal provisions
p.(None): (Note: § 78 reporting requirements)
p.(None): Section 79 Register
p.(None): IVa. Section - Civil liability
p.(None): Section 79a Personal injury and property damage
p.(None): Section 79b Impairment of the Environment
p.(None): Section 79c exclusion of liability
p.(None): Section 79d
p.(None): Section 79e liability, recourse and compensation for several operators
p.(None): §§ 79f, 79g information
p.(None): Section 79h Application of the ABGB
p.(None): Section 79i Other claims for compensation
p.(None): Section 79j
p.(None): Section 79k to Section 79m claims against neighbors
p.(None): Section V. - Genetic Engineering Commission and Genetic Engineering Book
p.(None): Section 80 Establishment of a genetic engineering commission
p.(None): Section 81 Composition of the Genetic Engineering Commission
p.(None): Section 82 Chairman
p.(None): Section 83 Decision-making
p.(None): Section 84 Duties of the commission
p.(None): Section 85 Standing Scientific Committees
p.(None): Section 86 Tasks and composition of the scientific committee for working with GMOs in a closed system
p.(None): Section 87 Tasks and composition of the scientific committee for releases and placing on the market
p.(None): Section 88 Tasks and composition of the scientific committee for gene analysis and gene therapy in humans
p.(None): Section 89 Right to nominate experts from scientific committees
p.(None): Section 90 Chair of the scientific committees
p.(None): Section 91 Decision-making in the scientific committees on applications and applications
p.(None): Section 92 deliberations of the commission and its scientific committees
p.(None): Section 93 Obligation to report
p.(None): Section 94 Members of the Commission and its scientific committees
p.(None): Section 95 External experts
p.(None): Section 96 duty of confidentiality
p.(None): Section 97 Rules of Procedure
p.(None): Section 98 office
p.(None): Section 99 Genetic engineering book (note: genetic engineering book, report on the application of genetic engineering)
p.(None): VI. Section - Authority and Controls
...
p.(None): of reporting obligations according to Section 73 (1) or Section 78a (1) (in particular history and final report) to be transferred to the register.
p.(None): (5) The registers must be updated continuously.
p.(None): (6) The published data must not contain any identifiable information about the persons treated. Everyone has access to the registers
p.(None): grant. The Federal Minister of Health and Women and the Federal Office for Safety in Health Care are also responsible for the scope of their responsibilities
p.(None): non-public part of the gene therapy register accessible.
p.(None): IVa. section
p.(None): Civil liability
p.(None): Personal injury and property damage
p.(None): Section 79a. (1) Is caused when working with GMOs (§ 4 Z 4) or when they are released (§ 4 Z 20) as a result of the genetic modification
p.(None): Characteristics of the organism A person has been killed, injured on the body or damaged in health or damaged a physical thing
p.(None): Operator (§ 4 Z 18) to compensate for the damage. The operator is liable for work and releases even if there is already a permit for the release
p.(None): or has been granted for placing on the market as long as the product (Section 54 (1)) has not yet been placed on the market in accordance with the approval.
p.(None): (2) The operator's liability also extends to damage caused by the properties of the GMO caused by the genetic modification
p.(None): Connection with its other dangerous properties.
p.(None): Environmental degradation
p.(None): Section 79b. Is the damage to a physical thing also a significant impairment of the environment (§ 101a para. 1) and is a restoration of the
p.(None): the previous state is not feasible by the liable operator or if the operator is not ready to restore it, the injured party also deserves it
p.(None): then the reimbursement of the costs of the restoration if these costs exceed the value of the damaged item. The victim can
p.(None): Demand recovery costs in advance, however, has an advance payment in excess of the value of the damaged item
p.(None): to be refunded if it does not restore the previous condition within a reasonable time.
p.(None): Disclaimer of liability
p.(None): Section 79c. The liability of the operator is excluded if the damage
p.(None): 1. through an act of war, similar hostilities, a civil war, an uprising or an extraordinary, inevitable and its consequences
p.(None): reasonably unavoidable natural event,
p.(None): 2. by a third party acting with the intention of causing damage and not participating in the activity pursuant to Section 79a despite compliance with all according to the type of activity
p.(None): security measures required in accordance with sections 10 and 45 or
p.(None): 3. in compliance with a legal regulation or a special official order or coercive measure
p.(None): has been caused.
p.(None): burden of proof
p.(None): Section 79d. If a GMO that was the subject of an activity pursuant to Section 79a is suitable for causing the damage in accordance with the circumstances of the individual case, then
p.(None): suspects that it caused the damage as a result of its properties caused by the genetic modification. The presumption is disproved if it is
...
p.(None): insurance or in any other suitable way to ensure that liability for damages according to this section can be fulfilled. Consists
p.(None): the activity in work with GMOs of security level 3 on a large scale or in the release of GMOs on a small scale (§ 36 Paragraph 1 No. 1), must
p.(None): in any case, this provision consists of liability insurance with an insurance sum of at least 712 200 euros for each damage event. Consists
p.(None): If you are working on GMOs of security level 4 or releasing GMOs to a large extent (Section 36 Paragraph 1 No. 2), this precaution must be taken
p.(None): at least in liability insurance with an insured sum of at least 4 069 700 euros for each damage event. The
p.(None): Liability insurance must be taken out with an insurer authorized to operate this insurance branch in Austria; on that must
p.(None): Austrian law must be applied. The competent body within the meaning of Section 158c (2) Insurance Contract Act 1958 is the authority under Section 100.
p.(None): (2) There is no obligation to provide cover if the federal government or a state is an operator.
p.(None): Claims against neighbors
p.(None): Section 79k. (1) The owner or beneficiary of an agricultural property can be a neighbor who is on his property
p.(None): Grows products within the meaning of section 54 (1) and is obliged to register in a register in accordance with section 101c (2) based on these products
p.(None): Prohibit actions if these actions exceed what is customary according to the local conditions and the use of the affected
p.(None): Affect property significantly. Such impairment exists in any case if the owner or the person entitled to use the products
p.(None): cannot place his property on the market due to the effects or not in the manner intended by him.
p.(None): (2) The neighbor who caused an influence in the sense of paragraph 1 is liable to the property owner or the person entitled to use it for the replacement of the
p.(None): this damage caused thereby, including the costs of restoring the environment (Section 79b).
p.(None): (3) If several neighbors have caused an influence in the sense of paragraph 1, each of them is only liable for its share in that
p.(None): Damage inflicted on property owners or beneficiaries. If the proportions cannot be determined, the neighbors are liable to the undivided hand.
p.(None): (4) Can the owner or beneficiary credibly demonstrate that a particular activity or omission of the neighbor according to the circumstances of the
p.(None): In individual cases it was suitable to bring about the influence in the sense of paragraph 1, it is assumed that this was caused by the activity or omission.
p.(None): This assumption is refuted if the neighbor believes it is likely that the influence does not result from it.
p.(None): (5) Provisions of the general civil code and other regulations on the prohibition of effects and compensation for damage
p.(None): stay untouched.
p.(None): § 79l. Non-contractual claims for compensation for damage caused by impacts within the meaning of § 79k are to be assessed according to the law of the state in which the
...
Health / Drug Usage
Searching for indicator influence:
(return to top)
p.(None): greatly reduce outside of the test area;
p.(None): 2. Attempt to a large extent, according to the state of the art in science and technology, to spread and multiply GMOs outside
p.(None): to monitor the test area.
p.(None): (2) If, according to the state of the art in science and technology, a risk to safety (§ 1 no. 1) can be excluded when certain GMOs are released,
p.(None): Authorization to request the release of this GMO, even if the stage according to Paragraph 1 No. 1 has not been passed.
p.(None): permit application
p.(None): Section 37. (1) Any release requires approval by the authority.
p.(None): (2) The operator must apply for approval of the release and attach the following information to the application:
p.(None): 1. those necessary to assess the immediate and late effects of the GMO or the combination of GMOs and their effects on safety (§ 1 Z 1)
p.(None): Information to the extent that it applies to the requested release. In cases where it is not technically possible or not necessary to provide information
p.(None): appears, this must be stated and justified. This information has including a description of the methods and bibliographical information
p.(None): to include these in particular:
p.(None): a) Name of the project and general information about the operator, the staff involved and their training;
p.(None): b) information about the GMO (s) and the genetic modification;
p.(None): c) information on the conditions of the release and the properties of the environment relevant to the release into which the GMO is released
p.(None): becomes;
p.(None): d) Information about the interactions between the GMO or GMOs and the environment, in particular about circumstances that affect survival and
p.(None): Influence propagation; Environmental impact,
p.(None): e) a monitoring plan, information on control measures, emergency plan and description of the planned disposal methods;
p.(None): f) place (s) of release;
p.(None): g) a summary of this information;
p.(None): 2. the safety assessment, i.e. a description and assessment of the intended release of the GMO or GMOs or the combination of GMOs
p.(None): expected impact on security (§ 1 Z 1). In the safety assessment, there are marker genes in GMOs that are resistant to human or
p.(None): Mediate veterinary antibiotics and can have harmful effects on safety (§ 1 Z 1), especially to
p.(None): consider.
p.(None): (3) In the application, data or results from the release of the same GMO or combination of GMOs that the applicant previously used must also be communicated
p.(None): or has applied for or undertaken outside Austria or is currently applying for or undertaking. In the application are also the locations of the
p.(None): to list the results of releases of relevant GMOs known from the literature.
p.(None): (4) The applicant can also refer to the data or results of previous applications by other applicants, provided that this is done in writing
p.(None): Have given consent.
p.(None): (5) If the release is changed in a way that can significantly change the risks to safety (§ 1 Z 1), or the operator either
p.(None): While the authority is reviewing the application or after its approval, new information is available on such risks, so is the applicant
p.(None): committed to immediately
p.(None): 1. to report this information to the authority,
p.(None): 2. review and adapt the measures listed in the application and
...
p.(None): in any case, this provision consists of liability insurance with an insurance sum of at least 712 200 euros for each damage event. Consists
p.(None): If you are working on GMOs of security level 4 or releasing GMOs to a large extent (Section 36 Paragraph 1 No. 2), this precaution must be taken
p.(None): at least in liability insurance with an insured sum of at least 4 069 700 euros for each damage event. The
p.(None): Liability insurance must be taken out with an insurer authorized to operate this insurance branch in Austria; on that must
p.(None): Austrian law must be applied. The competent body within the meaning of Section 158c (2) Insurance Contract Act 1958 is the authority under Section 100.
p.(None): (2) There is no obligation to provide cover if the federal government or a state is an operator.
p.(None): Claims against neighbors
p.(None): Section 79k. (1) The owner or beneficiary of an agricultural property can be a neighbor who is on his property
p.(None): Grows products within the meaning of section 54 (1) and is obliged to register in a register in accordance with section 101c (2) based on these products
p.(None): Prohibit actions if these actions exceed what is customary according to the local conditions and the use of the affected
p.(None): Affect property significantly. Such impairment exists in any case if the owner or the person entitled to use the products
p.(None): cannot place his property on the market due to the effects or not in the manner intended by him.
p.(None): (2) The neighbor who caused an influence in the sense of paragraph 1 is liable to the property owner or the person entitled to use it for the replacement of the
p.(None): this damage caused thereby, including the costs of restoring the environment (Section 79b).
p.(None): (3) If several neighbors have caused an influence in the sense of paragraph 1, each of them is only liable for its share in that
p.(None): Damage inflicted on property owners or beneficiaries. If the proportions cannot be determined, the neighbors are liable to the undivided hand.
p.(None): (4) Can the owner or beneficiary credibly demonstrate that a particular activity or omission of the neighbor according to the circumstances of the
p.(None): In individual cases it was suitable to bring about the influence in the sense of paragraph 1, it is assumed that this was caused by the activity or omission.
p.(None): This assumption is refuted if the neighbor believes it is likely that the influence does not result from it.
p.(None): (5) Provisions of the general civil code and other regulations on the prohibition of effects and compensation for damage
p.(None): stay untouched.
p.(None): § 79l. Non-contractual claims for compensation for damage caused by impacts within the meaning of § 79k are to be assessed according to the law of the state in which the
p.(None): Damage has occurred.
p.(None): § 79m. (1) The owner or beneficiary of an agriculturally used property has to file a lawsuit based on § 79k
p.(None): Paragraphs 1 and 2 to settle an arbitration board for amicable settlement, an application pursuant to Section 433 (1) of the Code of Civil Procedure, RGBl. № 113/1895
p.(None): or - if the neighbor agrees - to submit the dispute to a mediator. The action is admissible only if not within three at the latest
p.(None): An amicable settlement has been reached months after initiation of the arbitration process, from the time the application is received by the court or from the start of mediation.
p.(None): (2) Only one of a chamber of agriculture, a chamber of notaries, a chamber of lawyers or one comes as an arbitration board within the meaning of paragraph 1
p.(None): other corporation established under public law, as mediator only a mediator in the sense of the Civil Law Mediation Act, Federal Law Gazette I
p.(None): No. 29/2003.
p.(None): (3) Unless the parties agree otherwise, the costs of arbitration, judicial settlement or mediation are initially borne by the neighbor
p.(None): who has sought the amicable settlement. If no amicable settlement can be reached, these costs in the litigation are the same as pre-litigation costs
p.(None): to treat.
p.(None): (4) The plaintiff has to attach to the suit a confirmation from the arbitration board, the court or the mediator that no amicable settlement
p.(None): could be achieved.
p.(None): V. SECTION
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Searching for indicator substance:
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p.(None): Therapy is possible.
p.(None): (2) Relative examinations (§ 70) can be type 2, 3 or 4 examinations.
p.(None): Genetic analysis in humans for scientific purposes and for training
p.(None): Section 66. (1) Genetic analyzes in humans for scientific purposes and for training may only be carried out on de-identified samples.
p.(None): Non-genetic medical data that are to be linked to the genetic data of the same person must also be de-identified. The
p.(None): Allocation of this data to the respective sample donor may only take place in the facilities that have a valid consent (Art. 4 № 11 GDPR) of the
p.(None): data subject for this assignment.
p.(None): (2) Results from genetic analyzes in accordance with paragraph 1 may only be networked or published if they are ensured by suitable measures
p.(None): is that - apart from paragraph 1 - the sample donor cannot be determined.
p.(None): (3) The provisions of sections 2d (1) and (3) to (8), 2f (1) (6) and (3), (4), (6) and (7) and 2i (1), (2), (2) and (2k) of the Research Organization Act,
p.(None): BGBl. No. 341/1981, in the version of the Federal Law BGBl. I No. 31/2018, apply.
p.(None): Prohibition of using data from genetic analysis for certain purposes
p.(None): Section 67. (1) Employers and insurers including their agents and employees are prohibited from obtaining results from genetic analyzes of
p.(None): To collect, request, accept or otherwise exploit employees, jobseekers or policyholders or insurance applicants. Of
p.(None): This prohibition also includes the request for delivery and the acceptance of body substance for genetic analysis purposes.
p.(None): (2) Paragraph 1, 1st sentence does not apply to insurers, including their agents and employees, insofar as the results are from genetic analyzes of the type
p.(None): 1 deals with policyholders or policyholders and does not draw any conclusions from the results of genetic analyzes of type 2, 3 or 4
p.(None): possible are.
p.(None): Conducting genetic analysis on humans for medical purposes - Official procedure
p.(None): Section 68. (1) Genetic analyzes within the meaning of Section 65 (1) nos. 3 and 4 may only be carried out in approved facilities and only on
p.(None): Initiation of a specialist trained in human genetics / medical genetics or a treating or responsible for the indication area
p.(None): diagnosis specialist.
p.(None): (2) The approval is to be given by the head of the facility in which such genetic analyzes are intended to be carried out to the Federal Minister for
p.(None): Apply for health and women.
p.(None): (3) Approval is granted by the Federal Minister of Health and Women after consulting the responsible scientific committee - if necessary
p.(None): under the definition of suitable conditions and conditions - to be given if, due to the personnel and material equipment, the state of
p.(None): Science and technology appropriate execution of the genetic analyzes and the protection of the resulting genetic data according to § 71
p.(None): is ensured.
p.(None): (4) The Federal Minister of Health and Women must revoke the admission if the conditions for its granting are no longer met
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.(None): Water management.
p.(None): (4) The authority responsible for receiving applications in accordance with Articles 5, 17 and 27 of Regulation (EC) No 1829/2003
p.(None): 1. for applications for approval as a genetically modified food and for applications for joint approval as a genetically modified food and
p.(None): Feed of the Federal Minister of Health and Women
p.(None): 2. the Federal Office for Food Security for applications for approval as genetically modified feed.
p.(None): Controls, restoration of the environment
p.(None): Section 101. (1) The organs of the authority are authorized in places where there is reason to believe that
p.(None): 1. work with GMOs is carried out,
p.(None): 2. GMOs are released,
p.(None): 3. products are placed on the market in accordance with section 54 (1),
p.(None): 4. genetic analyzes are carried out on humans in accordance with § 65 or the data obtained is processed and stored in an automated manner
p.(None): become, or
p.(None): 5. gene therapies are carried out on humans,
p.(None): To keep an eye on and for the purpose of checking compliance with the provisions of this federal law and those based on this federal law
p.(None): decrees and notices to be carried out, to inspect the records to be kept in accordance with sections 34 and 52, and
p.(None): Take samples to the extent necessary.
p.(None): (2) Except in the event of imminent danger, the review is during normal business or operating hours and with the involvement of a responsible person
p.(None): Employees. Care should be taken to ensure that any disruption or disability of the operator or anyone that is not absolutely necessary
p.(None): interference with third party rights that is not absolutely necessary is avoided.
p.(None): (3) The operator and anyone who places GMOs on the market must tolerate the controls and sampling to provide the necessary support
p.(None): to provide all information necessary for inspection and sampling and all aids necessary for the investigation and monitoring measures
p.(None): and to provide information, such as in particular probes - if available -, sequence information and the like.
p.(None): (4) In the event of a sample being taken, a cross-check should be carried out if possible. A request from the authority is available for the sample taken
p.(None): determining compensation in the amount of the material value to be paid by the federal government. Compensation does not apply if, on the basis of this sample, a specific person
p.(None): has been punished or if the authority determines by decision that - without a specific person being punished - the objective fact of a person
p.(None): Violation of this federal law has been implemented and the taking of the sample has contributed to the collection of this fact.
p.(None): (5) The authority may, insofar as economy, expediency and economy require it, carry out controls in accordance with paragraph 1 nos. 2 and 3
p.(None): including the control of compliance with the monitoring obligations in accordance with Section 58c, also external experts or expert institutions in accordance with
p.(None): All or part of their respective tasks. The Federal Environment Agency is particularly entitled to environmental control tasks
p.(None): take (Section 6 (4) of the Environmental Control Act).
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): Aims.
p.(None): 2. Further work with genetically modified plants or animals
p.(None): 2.1. Further work with transgenic vertebrates of security level 1:
p.(None): 1. address of the facility,
p.(None): 2. date of receipt of the notification regarding the first work with transgenic vertebrates in this facility,
p.(None): 3. Description of the planned change in the recipient organism in vertebrates,
p.(None): 4. Presentation of the pursued biomedical and developmental goals of the work.
p.(None): 2.2. Further work with transgenic plants or animals, provided a security level 1 security level is not permitted:
p.(None): 1.Address of the plant and, if necessary, changes to the description of the parts of the plant which are relevant for working with GMOs and their safety,
p.(None): of the greenhouse or animal husbandry,
p.(None): 2. date of receipt of the notification regarding the first-time work with GMOs in this annex,
p.(None): 3. Name of the project manager,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Necessary changes or additions to the description of security measures, methods for the harmless elimination of the GMO, of
p.(None): Methods for the identification and detection of GMOs and measures to prevent accidents.
p.(None): Appendix 2
p.(None): To the Federal Ministry of
p.(None): Health and women
p.(None): Radetzkystrasse 2
p.(None): 1030 Vienna Date:
p.(None): Form for reporting genetic analyzes according to § 73
p.(None): 1. Setup
p.(None): 2. Observation period
p.(None): 3. Main reason for the examinations (multiple answers possible):
p.(None): humangenetische- / Family investigation
p.(None): prenatal examination
p.(None): other:
p.(None): Attention: Please provide the following information separately for each test feature.
p.(None): Genetic analysis for the purpose of determining a predisposition to a disease, in particular the predisposition to an inherited disease or for determining
p.(None): a carrier status.
p.(None): A) Investigation characteristic (research question)
p.(None): B) Extent of this investigation during the observation period
p.(None): 1-50> 50-200> 200-1000> 1000
p.(None): C) Title of the test method (eg PCR), if applicable a quotation from the literature or a brief description of the method
p.(None): Proportion of positive findings in the observation period
p.(None): D) <0.1% 0.1-1%> 1-10%> 10-50%> 50%
p.(None): E) Confirmation of successful participation in the proficiency tests offered
p.(None): Appendix 3
p.(None): To the Federal Ministry of
p.(None): Health and women
p.(None): Radetzkystrasse 2
p.(None): 1030 Vienna Date:
p.(None): Form for reporting the start of a clinical trial for the purpose of somatic gene therapy in accordance with Section 79 GTG
p.(None): Facility:
p.(None): Clinical Trial Title:
p.(None): Date and transaction number of the notification:
p.(None): Start of clinical trial:
p.(None): Signature:
p.(None): Appendix 4
p.(None): To the Federal Ministry of
p.(None): Health and women
p.(None): Radetzkystrasse 2
p.(None): 1030 Vienna Date:
p.(None): Form for reporting the progress of a clinical trial for the purpose of somatic gene therapy in accordance with Section 79 GTG
p.(None): Facility:
p.(None): Date and transaction number of the notification:
p.(None): Clinical Trial Title:
p.(None): Course of the clinical trial:
p.(None): Number of people treated:
p.(None): Time of termination
p.(None): Signature:
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): 18. Operator: a natural or legal person or a partnership under commercial law or an acquisition company operating under their name
p.(None): operates a genetic engineering facility or works with GMOs or releases;
p.(None): 19. Biosafety measures: the application of measures or systems that are recognized according to the state of the art in science and technology
p.(None): exclude the ability of GMOs to reproduce or the transfer of genetically modified nucleic acid outside the place of use, or
p.(None): at least minimize;
p.(None): 20. Release (release): the deliberate application of GMOs, a combination of GMOs or a combination of GMOs with other organisms
p.(None): a closed system into the environment, unless this is permitted under a marketing authorization.
p.(None): 21. Placing on the market: the making available, for a fee or free of charge, to third parties of products which consist of or contain GMOs, as well as
p.(None): their shipment to the federal territory, insofar as these products
p.(None): a) are not intended to work with GMOs in genetic engineering plants or
p.(None): b) should not be the subject of a release requiring approval under this Federal Act or
p.(None): c) are not intended for scientific purposes, including clinical trials;
p.(None): 22. germline: the entirety of the cell sequence from which germ cells emerge and the germ cells themselves;
p.(None): 23. Genetic analysis: laboratory analysis that provides information about specific properties with regard to the number, structure or sequence of chromosomes, genes
p.(None): or DNA sections or of products of DNA and their specific chemical modifications, and thus according to the state of the art in science
p.(None): and technology statements about a carrier status, a disease risk, an existing illness or a course of illness or therapy on one
p.(None): Enables people.
p.(None): 24. Somatic gene therapy in humans: application of the targeted introduction of isolated expressible nucleic acids into somatic cells in humans,
p.(None): which leads to the expression of the introduced nucleic acids, or the use of such genetically modified outside the human organism
p.(None): somatic cells or cell assemblies in humans. A person treated with somatic gene therapy is not considered a GMO.
p.(None): The form chosen applies to both genders for all personal formulations.
p.(None): II. SECTION
p.(None): Working with genetically modified organisms in closed systems
p.(None): security levels
p.(None): § 5. Working with GMOs is divided into four security levels:
p.(None): 1. Security level 1 includes work in which, according to the state of the art in science and technology, there is no or only a negligible risk
p.(None): for security (§ 1 Z 1) is to be assumed.
p.(None): 2. Security level 2 includes work in which, according to the state of the art in science and technology, there is a low risk to security (§ 1 Z 1)
p.(None): is going out.
p.(None): 3. Security level 3 includes work in which, according to the state of the art in science and technology, a moderate risk to security (§ 1 Z 1)
p.(None): is going out.
p.(None): 4. Security level 4 includes work in which, according to the state of the art in science and technology, there is a high risk to security (§ 1 Z 1)
p.(None): is going out.
p.(None): security rating
p.(None): § 6. (1) Before starting any work with GMOs or work series, the operator has a safety classification for this work or work series
...
p.(None): of the original application, the adjustment of the geographical scope of the application or the application is based on the
p.(None): Directive 2001/18 / EC granted written consent and, if appropriate, by a decision in accordance with Art. 19 of Directive 2001/18 / EC and by a
p.(None): Decision on approval in accordance with Articles 7 and 19 of Regulation (EC) No. 1829/2003 implemented.
p.(None): (4) Should all or part of the federal territory be returned to the geographical scope of the approval / approval of which it was previously in accordance
p.(None): Paragraph 3 has been excluded, the Federal Minister of Health has made a request to the competent authority, the
p.(None): has given written consent in accordance with Directive 2001/18 / EC, or to the European Commission if the GMO according to Regulation (EC) № 1829/2003
p.(None): was allowed to judge.
p.(None): (5) Measures adopted under this provision do not affect the free movement of GMOs as or in products.
p.(None): IV. SECTION
p.(None): Genetic analysis and gene therapy in humans
p.(None): Prohibition of interference in the genetic material of the human germline
p.(None): Section 64. For interventions in the human germline, the prohibition of Section 9 (2) of the Reproductive Medicine Act applies, Federal Law Gazette No. 275/1992.
p.(None): Genetic analysis in humans for medical purposes
p.(None): Section 65. (1) Genetic analyzes on humans for medical purposes may only be carried out according to the state of the art in science and technology. she
p.(None): are divided into four types:
p.(None): 1. Type 1 is used to determine an existing illness, to prepare a therapy or to control a course of therapy and is based on statements
p.(None): about specific somatic changes in number, structure, sequence or their specific chemical modifications of chromosomes, genes or
p.(None): DNA segments
p.(None): 2. Type 2 is used to determine an existing disease that is based on a germline mutation
p.(None): 3. Type 3 is used to determine a predisposition to an illness, in particular the predisposition to a possibly emerging one
p.(None): genetic disease or determination of a carrier status, for which according to the state of the art in science and technology prophylaxis or
p.(None): Therapy is possible
p.(None): 4. Type 4 is used to determine a predisposition to an illness, in particular the predisposition to a potentially emerging one
p.(None): Genetically caused illness or determination of a carrier status, for which according to the state of the art in science and technology no prophylaxis or
p.(None): Therapy is possible.
p.(None): (2) Relative examinations (§ 70) can be type 2, 3 or 4 examinations.
p.(None): Genetic analysis in humans for scientific purposes and for training
p.(None): Section 66. (1) Genetic analyzes in humans for scientific purposes and for training may only be carried out on de-identified samples.
p.(None): Non-genetic medical data that are to be linked to the genetic data of the same person must also be de-identified. The
p.(None): Allocation of this data to the respective sample donor may only take place in the facilities that have a valid consent (Art. 4 № 11 GDPR) of the
p.(None): data subject for this assignment.
p.(None): (2) Results from genetic analyzes in accordance with paragraph 1 may only be networked or published if they are ensured by suitable measures
p.(None): is that - apart from paragraph 1 - the sample donor cannot be determined.
p.(None): (3) The provisions of sections 2d (1) and (3) to (8), 2f (1) (6) and (3), (4), (6) and (7) and 2i (1), (2), (2) and (2k) of the Research Organization Act,
p.(None): BGBl. No. 341/1981, in the version of the Federal Law BGBl. I No. 31/2018, apply.
p.(None): Prohibition of using data from genetic analysis for certain purposes
p.(None): Section 67. (1) Employers and insurers including their agents and employees are prohibited from obtaining results from genetic analyzes of
p.(None): To collect, request, accept or otherwise exploit employees, jobseekers or policyholders or insurance applicants. Of
...
p.(None): this genetic analysis is carried out by a specialist trained in human genetics / medical genetics or the specialist responsible for the indication area
p.(None): take place.
p.(None): (4) The advice after performing a genetic analysis in accordance with paragraph 1 must include the factual, comprehensive discussion of all test results
p.(None): and medical facts as well as possible medical, social and psychological consequences. If there is an appropriate disposition for one
p.(None): hereditary disease with serious physical, psychological and social effects also on the usefulness of an additional non-medical
p.(None): Advice in writing from a psychologist or psychotherapist or from a social worker. In addition, others can
p.(None): Advice centers and self-help groups are advised.
p.(None): (5) Consultations before and after a genetic analysis in accordance with paragraph 1 may not take place directly. The person seeking advice is already at the start of the
p.(None): Counseling interviews to indicate that he - at any time - even after consenting to genetic analysis or after advice has been given
p.(None): may not want to know the result of the analysis and the consequences that can be derived from it.
p.(None): (6) Counseling before and after a genetic analysis in accordance with paragraph 1 must be concluded with an individual advisory letter to the person seeking advice, in which
p.(None): the essential contents of the consultation are summarized in a generally understandable way.
p.(None): Involvement of relatives
p.(None): Section 70. The doctor who initiates the genetic analysis has
p.(None): 1. if the inclusion of relatives of the person under investigation is required to assess the result of a genetic analysis, or
p.(None): 2. if it can be assumed that there is a serious risk of illness of relatives of the person examined,
p.(None): to recommend the examined person to advise their relatives, who may be affected, on a human genetic examination and counseling.
p.(None): test results
p.(None): Section 71. (1) Anyone who carries out, initiates or processes the genetic data obtained from them has to keep this data secret
p.(None): hold.
p.(None): (2) Without prejudice to the provisions of Section 71a, personal data may only be transmitted regarding the documentation of the test results
p.(None): a) to persons who are directly concerned with the processing of the data in the facility in which they were collected,
p.(None): b) to the person examined,
p.(None): c) to the persons named in section 69 (2),
p.(None): d) the doctor who initiated the genetic analysis and the treating doctor,
p.(None): e) to other persons only if the examined person has expressly agreed to this in writing, with a written revocation of this
p.(None): Consent is possible at any time.
p.(None): (3) Unless otherwise stipulated in this federal law, the Data Protection Act (DSG), Federal Law Gazette I № 165/1999, remains
p.(None): Health Telematics Act 2012, Federal Law Gazette I No. 111/2012, as well as regulations that contain special confidentiality or reporting obligations, are not affected.
p.(None): (4) The examined person is to be informed of unexpected results that are of immediate clinical importance or for which they are specifically asked
p.(None): Has. This notification is to be designed in such a way that it does not refer to the examined person, especially if the examined person did not ask for it
p.(None): is troubling; in borderline cases this notification can be omitted entirely.
p.(None): Documentation of the test results
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): To ensure compliance. If the proficiency test was not offered at the time of admission to the institution (Section 68 (3)), he would regularly do so in
p.(None): to inquire with the authority no more than six months apart whether suitable round robin tests are already available.
p.(None): (4) If the laboratory manager leaves this function or his order is canceled by the manager of the facility, a new laboratory manager is immediately
p.(None): to order.
p.(None): (5) The head of the facility shall notify the authority of the resignation and each change of the laboratory head without undue delay, including that for the head of the
p.(None): The replacement person appointed to the facility must be notified in writing of the necessary evidence (para. 2).
p.(None): (6) The appointment of a laboratory manager increases the responsibility of the head of the facility for compliance with the provisions of this federal law
p.(None): and the administrative file based on it.
p.(None): Consent and advice
p.(None): Section 69. (1) A genetic analysis of type 2, 3 or 4, including a genetic analysis as part of a prenatal examination, may only be carried out after
p.(None): There is a written confirmation from the person to be examined that they have previously been through a human genetics / medical genetics
p.(None): trained specialist or a specialist responsible for the indication area has been informed about their nature, scope and significance and
p.(None): has consented to genetic analysis based on free knowledge based on this knowledge. These exams become prenatal
p.(None): carried out, the information and consent of the pregnant woman must also include the risks of the intended intervention.
p.(None): (2) The confirmation acc. Paragraph 1 granted
p.(None): 1. for an underage person, according to § 173 ABGB,
p.(None): 2. a legal guardian for a minor who is unable to make decisions and
p.(None): 3. for a person of legal age who is not able to make a decision, their legal representative (Section 1034 ABGB), in whose sphere of activity consent to
p.(None): medical treatment falls.
p.(None): (3) Before carrying out a genetic analysis in accordance with paragraph 1, the person to be examined and, if necessary, in accordance with paragraph 2 must have detailed advice
p.(None): authorized legal guardian or other legal representative about the nature, scope and significance of the analysis by the
p.(None): this genetic analysis is carried out by a specialist trained in human genetics / medical genetics or the specialist responsible for the indication area
p.(None): take place.
p.(None): (4) The advice after performing a genetic analysis in accordance with paragraph 1 must include the factual, comprehensive discussion of all test results
p.(None): and medical facts as well as possible medical, social and psychological consequences. If there is an appropriate disposition for one
p.(None): hereditary disease with serious physical, psychological and social effects also on the usefulness of an additional non-medical
p.(None): Advice in writing from a psychologist or psychotherapist or from a social worker. In addition, others can
p.(None): Advice centers and self-help groups are advised.
p.(None): (5) Consultations before and after a genetic analysis in accordance with paragraph 1 may not take place directly. The person seeking advice is already at the start of the
...
Health / injured
Searching for indicator injured:
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p.(None): to lead.
p.(None): (3) The name, address, homepage and area of activity of the institution must be recorded in the gene therapy register. The area of activity is by means of study title, name
p.(None): of the study director, and to describe the indication. The therapeutic genes and gene transfer systems used, as well as course and are for each gene therapy
p.(None): Show the final report separately in a non-public part of the register.
p.(None): (4) The Federal Minister of Health and Women has the data in accordance with paragraphs 2 and 3 taking into account any changes to be included
p.(None): of reporting obligations according to Section 73 (1) or Section 78a (1) (in particular history and final report) to be transferred to the register.
p.(None): (5) The registers must be updated continuously.
p.(None): (6) The published data must not contain any identifiable information about the persons treated. Everyone has access to the registers
p.(None): grant. The Federal Minister of Health and Women and the Federal Office for Safety in Health Care are also responsible for the scope of their responsibilities
p.(None): non-public part of the gene therapy register accessible.
p.(None): IVa. section
p.(None): Civil liability
p.(None): Personal injury and property damage
p.(None): Section 79a. (1) Is caused when working with GMOs (§ 4 Z 4) or when they are released (§ 4 Z 20) as a result of the genetic modification
p.(None): Characteristics of the organism A person has been killed, injured on the body or damaged in health or damaged a physical thing
p.(None): Operator (§ 4 Z 18) to compensate for the damage. The operator is liable for work and releases even if there is already a permit for the release
p.(None): or has been granted for placing on the market as long as the product (Section 54 (1)) has not yet been placed on the market in accordance with the approval.
p.(None): (2) The operator's liability also extends to damage caused by the properties of the GMO caused by the genetic modification
p.(None): Connection with its other dangerous properties.
p.(None): Environmental degradation
p.(None): Section 79b. Is the damage to a physical thing also a significant impairment of the environment (§ 101a para. 1) and is a restoration of the
p.(None): the previous state is not feasible by the liable operator or if the operator is not ready to restore it, the injured party also deserves it
p.(None): then the reimbursement of the costs of the restoration if these costs exceed the value of the damaged item. The victim can
p.(None): Demand recovery costs in advance, however, has an advance payment in excess of the value of the damaged item
p.(None): to be refunded if it does not restore the previous condition within a reasonable time.
p.(None): Disclaimer of liability
p.(None): Section 79c. The liability of the operator is excluded if the damage
p.(None): 1. through an act of war, similar hostilities, a civil war, an uprising or an extraordinary, inevitable and its consequences
p.(None): reasonably unavoidable natural event,
p.(None): 2. by a third party acting with the intention of causing damage and not participating in the activity pursuant to Section 79a despite compliance with all according to the type of activity
p.(None): security measures required in accordance with sections 10 and 45 or
p.(None): 3. in compliance with a legal regulation or a special official order or coercive measure
p.(None): has been caused.
p.(None): burden of proof
p.(None): Section 79d. If a GMO that was the subject of an activity pursuant to Section 79a is suitable for causing the damage in accordance with the circumstances of the individual case, then
p.(None): suspects that it caused the damage as a result of its properties caused by the genetic modification. The presumption is disproved if it is
p.(None): the operator believes that the damage was not caused by these properties or that it was caused in the sense of Section 79a (2).
p.(None): Liability, recourse and compensation for several operators
p.(None): Section 79e. (1) If several persons are liable according to this federal law or other legal provisions, they are liable insofar as the individual
p.(None): Do not let liability-related damage be distinguished, to the undivided hand. The same applies if several operators have a harmful activity
p.(None): have exercised one after the other and the damage attributable to the individual liability can not be distinguished. Every person liable is liable
p.(None): however, according to the reason and scope only in accordance with the provisions applicable to him.
p.(None): (2) If several persons are liable according to this federal law or other legal provisions, the obligation depends on each other
p.(None): for compensation and its scope depends on the circumstances of the individual case, in particular on the extent to which the damage is at least likely by one
p.(None): or other liable persons is at fault or otherwise caused. The same applies to the mutual replacement obligation. However, every person liable is liable
p.(None): Reason and scope only in accordance with the provisions applicable to him.
p.(None): information desk
p.(None): § 79f. (1) Are there circumstances that justify the assumption that damage caused by GMOs as a result of the genetic modification
p.(None): caused properties, the injured party has against each operator, whose activity according to § 79a locally and according to the type of GMO as
p.(None): Cause is generally considered, a right to information. The operator has the relevant aspects of his liability according to § 79a
p.(None): Activity, in particular on the GMOs produced, used, reproduced, stored, destroyed, disposed of or released and their
p.(None): Properties and effects to provide information. The operator is not entitled to information insofar as the operator states that the information can be used to assess whether and
p.(None): the extent to which the damage has been caused by the properties of this GMO caused by the genetic modification is not necessary.
p.(None): (2) The operator, whose liability has been asserted, has against every other operator, on whose activity the ones mentioned in paragraph 1
p.(None): Requirements apply, right to information according to paragraph 1.
p.(None): (3) There is no right to information insofar as the operator weighs all relevant interests by providing the information
p.(None): would be disproportionately burdened, in particular because of the expenses necessary for this, because of the criminal prosecution that could threaten him
p.(None): or because of the necessary disclosure of a business or company secret that is significantly more significant in relation to the damage.
p.(None): (4) The operator, who has been asked for information or his liability, is entitled to information against the injured party, insofar as this
p.(None): it is necessary to assess whether and to what extent the damage was caused by the injured party or other causer, and insofar as the
p.(None): The injured party would not be disproportionately burdened if all relevant interests were weighed up by providing the information.
p.(None): (5) Through extrajudicial negotiations for the provision of information and through a judicial procedure for the enforcement of the
p.(None): The right to information is inhibited from continuing the limitation of a claim under this section.
p.(None): Section 79g. (1) Information obtained in accordance with Section 79f may only be used to enforce claims under this section.
p.(None): (2) If business or trade secrets or the content of information according to § 79f are discussed in a judicial proceeding or evidence is provided
p.(None): the public is to be excluded at the request of one of the parties.
p.(None): Application of the ABGB
p.(None): Section 79h. (1) Unless otherwise specified in this section, the general civil code applies to the claims provided therein
p.(None): apply.
p.(None): (2) The operator is also liable in cases in which claims for compensation for damage caused by GMOs as a result of the genetic modification
p.(None): caused properties are to be assessed according to the general regulations of civil law, for the fault of the person,
p.(None): who cooperated with the will in the activity pursuant to Section 79a, insofar as this participation was the cause of the damage.
p.(None): (3) If the injured party or someone whose behavior he is responsible for is at fault, § 1304 ABGB shall apply mutatis mutandis.
p.(None): Other claims for compensation
p.(None): Section 79i. Provisions of the general civil code and other regulations, according to which damage to other extent or by others
p.(None): Persons who are to be replaced under this federal law remain unaffected.
p.(None): financial security
p.(None): Section 79j. (1) The operator of an activity pursuant to Section 79a has to a degree and to the extent that is customary in fair business dealings by entering into
p.(None): insurance or in any other suitable way to ensure that liability for damages according to this section can be fulfilled. Consists
p.(None): the activity in work with GMOs of security level 3 on a large scale or in the release of GMOs on a small scale (§ 36 Paragraph 1 No. 1), must
p.(None): in any case, this provision consists of liability insurance with an insurance sum of at least 712 200 euros for each damage event. Consists
p.(None): If you are working on GMOs of security level 4 or releasing GMOs to a large extent (Section 36 Paragraph 1 No. 2), this precaution must be taken
p.(None): at least in liability insurance with an insured sum of at least 4 069 700 euros for each damage event. The
p.(None): Liability insurance must be taken out with an insurer authorized to operate this insurance branch in Austria; on that must
p.(None): Austrian law must be applied. The competent body within the meaning of Section 158c (2) Insurance Contract Act 1958 is the authority under Section 100.
p.(None): (2) There is no obligation to provide cover if the federal government or a state is an operator.
p.(None): Claims against neighbors
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Social / Access to Social Goods
Searching for indicator access:
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p.(None): Announcing daily newspapers that an application for authorization to work with GMOs has been submitted, documents to the authority during
p.(None): within a period of six weeks for public inspection, a hearing is being held and that everyone is free to attend
p.(None): Attend hearing.
p.(None): (2) The authority shall have the hearing within the framework of the investigation procedure within three weeks of the end of the disclosure for public inspection
p.(None): perform. The authority has the public according to paragraph 1, as well as the members of the responsible scientific committee of the
p.(None): Genetic Engineering Commission, the operator and the members of the Biosafety Committee.
p.(None): (3) The hearing is public and serves to discuss the application and the associated documents. Everyone is allowed to ask questions and ask themselves
p.(None): to comment on the project.
p.(None): (4) Minutes of the public hearing must be drawn up.
p.(None): statutory authorization
p.(None): § 29. The Federal Minister of Health and Women, insofar as this is necessary in the interest of the expediency, speed and simplicity of the hearing,
p.(None): in agreement with the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture by ordinance
p.(None): Provisions regarding the announcement and the course of the consultation process, the type and scope of access to the application and the associated documents
p.(None): with particular attention to the confidentiality of data in accordance with § 105, to determine the schedule and the schedule of the hearing.
p.(None): Due diligence, information and notification requirements
p.(None): § 30. (1) Anyone who works with GMOs has all that is necessary according to the state of the art in science and technology in the interest of safety (§ 1 Z 1)
p.(None): Take precautions and measures.
p.(None): (2) Even after the start of work with GMOs, the operator has to deal with all facts and in connection with the execution of this work
p.(None): To inform circumstances which, according to the state of the art in science and technology, are likely to endanger security (Section 1 no. 1).
p.(None): (3) The operator has the facts and circumstances in accordance with paragraph 2 and the final cessation of all work with GMOs immediately in writing to the authority
p.(None): Report.
p.(None): Change in safety equipment
p.(None): § 31. The operator has any change in the security of the closed system, which according to the state of the art in science and technology
p.(None): Security (§ 1 Z 1) is likely to impair, to report to the authority in writing even after registration or after completion of the approval process.
p.(None): Change of operator
p.(None): § 32. A change in the person of the operator makes the permissibility of carrying out work with GMOs and the resulting ones
p.(None): Obligations not affected. The legal successor must immediately notify the authority of the change in writing.
p.(None): Subsequent measures
...
p.(None): Measures taken according to paragraph 1 and their justification. The authority complies with those in the Community procedure pursuant to Art. 30 Para
p.(None): 2001/18 / EG bound by these measures decisions of the European Commission or the Council.
p.(None): Safety measures
p.(None): Section 61. In cases of imminent danger to security (Section 1 (1)), the Federal Minister of Health and Women has the manufacturer or importer through
p.(None): To notify the public concerned about the risks posed by the products and about safety and elimination measures
p.(None): inform and, if necessary, request the return of these products.
p.(None): Packaging and labeling
p.(None): Section 62. (1) Products in accordance with Section 54 may only be placed on the market if their labeling and packaging comply with the approval requirements
p.(None): stipulated requirements. In any case, the marking must contain:
p.(None): 1. the commercial name of the product,
p.(None): 2. the express reference that the product contains genetically modified organisms (Section 58a (1) no. 6),
p.(None): 3. the exact name of the GMO (s), including the identification code (s) provided for the GMO in question,
p.(None): 4. Name and address of the person responsible for the placing on the market in the Community (manufacturer, importer or distributor) and
p.(None): 5. the reference to the registration of the product or the GMO (s) contained therein in the designated register of the European Commission
p.(None): in accordance with Art. 31 Para. 2 of Directive 2001/18 / EC including information about the possibility of access to this register.
p.(None): (2) The Federal Minister of Health and Women, insofar as this is with regard to the safe use of products in accordance with Section 54 (1) or therefrom
p.(None): manufactured products or to avoid misleading users and consumers, taking into account Annex IV of the
p.(None): Directive 2001/18 / EC or other Community labeling regulations referring to GMOs by regulation in agreement with the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of Economics and Labor for more detailed labeling regulations
p.(None): for products according to § 54 or products made from them.
p.(None): Provision of GMOs for purposes other than placing them on the market
p.(None): Section 62a. GMOs that are used to work with GMOs in a closed system, for a release or for scientific purposes including clinical trials
p.(None): must be provided on a label or in an accompanying document as a GMO.
p.(None): statutory authorization
p.(None): Section 62b. The Federal Minister of Health and Women has, insofar as this is necessary to ensure security (§ 1 Z 1) and under consideration
p.(None): Implementing provisions in accordance with Article 26 of Directive 2001/18 / EC after consulting the responsible scientific committee of the
p.(None): Genetic engineering commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the labeling of the according
p.(None): Section 62a of the GMO provided.
p.(None): Unintentional presence of GMOs in other products
...
p.(None): Consent is possible at any time.
p.(None): (3) Unless otherwise stipulated in this federal law, the Data Protection Act (DSG), Federal Law Gazette I № 165/1999, remains
p.(None): Health Telematics Act 2012, Federal Law Gazette I No. 111/2012, as well as regulations that contain special confidentiality or reporting obligations, are not affected.
p.(None): (4) The examined person is to be informed of unexpected results that are of immediate clinical importance or for which they are specifically asked
p.(None): Has. This notification is to be designed in such a way that it does not refer to the examined person, especially if the examined person did not ask for it
p.(None): is troubling; in borderline cases this notification can be omitted entirely.
p.(None): Documentation of the test results
p.(None): Section 71a. (1) Results from genetic analyzes of type 1 may in any case, results from genetic analyzes of types 2 and 3 only if the
p.(None): Patients who have not contradicted in writing are documented in medical reports and medical histories. The possibility of contradiction is in the
p.(None): Advice according to Section 69 (3).
p.(None): (2) Results from type 4 genetic analysis, as well as type 2 or 3 results when documented in medical reports and
p.(None): Medical records are not permitted because of the patient's objection, only in the institution in which they were collected and only on request
p.(None): processed by the attending doctor; they are to be kept or stored separately from other types of data and may only be saved by those persons
p.(None): are directly involved in the processing of the data in the facility and can only be accessed with a separate access option.
p.(None): statutory authorization
p.(None): § 72. (1) The Federal Minister of Health and Women has, if this is to ensure the proper implementation of genetic analyzes and of
p.(None): related advice is required, taking into account the current state of science and technology after consulting the
p.(None): responsible scientific committee of the genetic engineering commission by ordinance more detailed regulations on the personnel and material equipment of the
p.(None): Facilities according to § 68, including the qualification of the responsible laboratory manager according to § 68a, the initiation of the genetic analyzes according to § 68
p.(None): Paragraph 1, the information and advice to be issued in accordance with section 69, data protection in accordance with section 71 and the documentation of the test results in accordance with section 71a
p.(None): prescribe.
p.(None): (2) The Federal Minister of Health and Women has sufficient experience with safety according to the state of the art in science and technology (§ 1
p.(None): Z 1) certain genetic analyzes are available, after hearing the responsible scientific committee of the genetic engineering commission by ordinance
p.(None): more detailed provisions on the use of simplified official procedures for further applications for an application already approved in accordance with Section 68 (3)
p.(None): To establish the facility taking into account established methods and established indication areas. In deviation from Section 91, these procedures may include:
p.(None): official decision only with referral of the rapporteur, and provide for a shortening of the decision period to up to 30 days.
p.(None): Announcements
...
p.(None): To notify the authority immediately of any changes in the material and staffing of the approved hospital.
p.(None): register
p.(None): Section 79. (1) The Federal Minister of Health and Women must set up electronic registers in which all are permitted under this Federal Act
p.(None): 1. facilities for performing genetic analyzes (genetic analysis registers),
p.(None): 2. Somatic gene therapies on humans (gene therapy register) and
p.(None): 3. Proficiency tests offered (proficiency testing register)
p.(None): are recorded.
p.(None): (2) In the genetic analysis register, the name, address, homepage and the area of activity of the institution, which is structured according to the investigations carried out
p.(None): to lead.
p.(None): (3) The name, address, homepage and area of activity of the institution must be recorded in the gene therapy register. The area of activity is by means of study title, name
p.(None): of the study director, and to describe the indication. The therapeutic genes and gene transfer systems used, as well as course and are for each gene therapy
p.(None): Show the final report separately in a non-public part of the register.
p.(None): (4) The Federal Minister of Health and Women has the data in accordance with paragraphs 2 and 3 taking into account any changes to be included
p.(None): of reporting obligations according to Section 73 (1) or Section 78a (1) (in particular history and final report) to be transferred to the register.
p.(None): (5) The registers must be updated continuously.
p.(None): (6) The published data must not contain any identifiable information about the persons treated. Everyone has access to the registers
p.(None): grant. The Federal Minister of Health and Women and the Federal Office for Safety in Health Care are also responsible for the scope of their responsibilities
p.(None): non-public part of the gene therapy register accessible.
p.(None): IVa. section
p.(None): Civil liability
p.(None): Personal injury and property damage
p.(None): Section 79a. (1) Is caused when working with GMOs (§ 4 Z 4) or when they are released (§ 4 Z 20) as a result of the genetic modification
p.(None): Characteristics of the organism A person has been killed, injured on the body or damaged in health or damaged a physical thing
p.(None): Operator (§ 4 Z 18) to compensate for the damage. The operator is liable for work and releases even if there is already a permit for the release
p.(None): or has been granted for placing on the market as long as the product (Section 54 (1)) has not yet been placed on the market in accordance with the approval.
p.(None): (2) The operator's liability also extends to damage caused by the properties of the GMO caused by the genetic modification
p.(None): Connection with its other dangerous properties.
p.(None): Environmental degradation
p.(None): Section 79b. Is the damage to a physical thing also a significant impairment of the environment (§ 101a para. 1) and is a restoration of the
p.(None): the previous state is not feasible by the liable operator or if the operator is not ready to restore it, the injured party also deserves it
...
p.(None): Notification of the commission are the local and factual scope of the control, the intended remuneration and that for the flawless implementation of the
p.(None): Control activities to determine the necessary conditions and requirements. No employment relationship is established through the assignment. The representative is at
p.(None): Instructions bound by the authority. A dismissal has to take place in particular if the agent does not or only insufficiently fulfills his tasks, or
p.(None): the requirements under which the order was placed no longer apply.
p.(None): Restoring the environment
p.(None): Section 101a. (1) When working with GMOs or when releasing them, the environment is affected by the properties of the GMOs, which are caused by genetic engineering changes
p.(None): are so significantly impaired that the security according to § 1 Z 1 is not guaranteed, the authority has the operator to that extent to restore the
p.(None): Environment or measures necessary to prevent further environmental damage. In the event of imminent danger, the authority has the
p.(None): take the necessary measures yourself (Section 103); the same applies if the operator cannot be determined or for legal or other reasons
p.(None): Is unable to carry out the necessary measures. The authority has to reimburse the operator for the costs incurred by it
p.(None): Impose measures.
p.(None): (2) If the rights of third parties are affected by measures in accordance with paragraph 1, these have such interference, in particular the use and access of
p.(None): Tolerate land to the extent that this proves to be absolutely necessary.
p.(None): (3) Anyone who takes measures in accordance with paragraph 1 of his property, his real rights, his obligatory rights of use or his rights of use in the sense
p.(None): of the Basic Law 1951, Federal Law Gazette No. 103, cannot be used in the manner or to the extent to which it is entitled on the basis of existing rights
p.(None): To compensate operators appropriately. If no agreement can be reached, the amount of the compensation must be determined by the authority,
p.(None): §§ 18 to 20a of the Federal Roads Act 1971, Federal Law Gazette No. 286, are to be applied analogously in the respectively applicable version. An appeal against that
p.(None): Deciding on the amount of compensation is not permitted. However, the parties are free to do so within three months of issuing the decision
p.(None): To apply for a decision on the amount of compensation to the district court in whose district the environmental impact has occurred. With this
p.(None): Referral to the district court will invalidate the amount of the compensation.
p.(None): Measures in the event of release without authorization
p.(None): Section 101b. (1) If a release was carried out contrary to the provision of Section 37 (1) without prior approval, the authority has the person who
p.(None): this release has carried out the removal of the released GMOs as well as any other measures that are state of the art
p.(None): and technology to ensure security (§ 1 Z 1), to keep the spread of this GMO including its genetic material and to ensure the
p.(None): released GMOs are appropriate and necessary.
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Social / Age
Searching for indicator age:
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p.(None): to order.
p.(None): (5) The head of the facility shall notify the authority of the resignation and each change of the laboratory head without undue delay, including that for the head of the
p.(None): The replacement person appointed to the facility must be notified in writing of the necessary evidence (para. 2).
p.(None): (6) The appointment of a laboratory manager increases the responsibility of the head of the facility for compliance with the provisions of this federal law
p.(None): and the administrative file based on it.
p.(None): Consent and advice
p.(None): Section 69. (1) A genetic analysis of type 2, 3 or 4, including a genetic analysis as part of a prenatal examination, may only be carried out after
p.(None): There is a written confirmation from the person to be examined that they have previously been through a human genetics / medical genetics
p.(None): trained specialist or a specialist responsible for the indication area has been informed about their nature, scope and significance and
p.(None): has consented to genetic analysis based on free knowledge based on this knowledge. These exams become prenatal
p.(None): carried out, the information and consent of the pregnant woman must also include the risks of the intended intervention.
p.(None): (2) The confirmation acc. Paragraph 1 granted
p.(None): 1. for an underage person, according to § 173 ABGB,
p.(None): 2. a legal guardian for a minor who is unable to make decisions and
p.(None): 3. for a person of legal age who is not able to make a decision, their legal representative (Section 1034 ABGB), in whose sphere of activity consent to
p.(None): medical treatment falls.
p.(None): (3) Before carrying out a genetic analysis in accordance with paragraph 1, the person to be examined and, if necessary, in accordance with paragraph 2 must have detailed advice
p.(None): authorized legal guardian or other legal representative about the nature, scope and significance of the analysis by the
p.(None): this genetic analysis is carried out by a specialist trained in human genetics / medical genetics or the specialist responsible for the indication area
p.(None): take place.
p.(None): (4) The advice after performing a genetic analysis in accordance with paragraph 1 must include the factual, comprehensive discussion of all test results
p.(None): and medical facts as well as possible medical, social and psychological consequences. If there is an appropriate disposition for one
p.(None): hereditary disease with serious physical, psychological and social effects also on the usefulness of an additional non-medical
p.(None): Advice in writing from a psychologist or psychotherapist or from a social worker. In addition, others can
p.(None): Advice centers and self-help groups are advised.
p.(None): (5) Consultations before and after a genetic analysis in accordance with paragraph 1 may not take place directly. The person seeking advice is already at the start of the
p.(None): Counseling interviews to indicate that he - at any time - even after consenting to genetic analysis or after advice has been given
p.(None): may not want to know the result of the analysis and the consequences that can be derived from it.
p.(None): (6) Counseling before and after a genetic analysis in accordance with paragraph 1 must be concluded with an individual advisory letter to the person seeking advice, in which
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Social / Incarcerated
Searching for indicator liberty:
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p.(None): Decision according to Art. 7 of Directive 2001/18 / EC by regulation in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the
p.(None): Implement simplified administrative procedures for the release of such GMOs that are comparable in terms of their safety.
p.(None): (2) The Federal Minister of Health and Women has an ordinance in accordance with paragraph 1 or the decision, a decision in accordance with Art. 7 of the Directive
p.(None): 2001/18 / EC not to be used to inform the European Commission.
p.(None): Note for the following provision
p.(None): Regarding para. 2: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): hearing
p.(None): Section 43. (1) The authority has in the Official Journal of the Wiener Zeitung, in two local daily newspapers and on the notice boards of the municipalities in accordance with Section 39a (1)
p.(None): Z 2 and 3 to announce at the expense of the operator that an application for the release of a GMO has been made, relevant documents to the authority (§ 100),
p.(None): all offices of the state governments and the municipalities in whose local area of responsibility GMOs are to be released during a
p.(None): Period of three weeks for public inspection and that everyone is at liberty to justify the authority within the period for which the information is available
p.(None): Submit objections in writing. The announcement includes persons who, in accordance with Section 39a (1) (4) and (5), are party to the further official procedure
p.(None): to obtain approval for the release, to point out that they have the party position by raising justified written objections
p.(None): can obtain at the same time the requirements for their party position and subsequent explanation of their objections at the hearing.
p.(None): (2) The authority shall schedule a hearing as part of the investigation; this hearing took place within three weeks from the end of the
p.(None): Deadline to be held. The hearing serves to discuss the objections submitted on time; the opponents have the opportunity to get closer
p.(None): To explain their objections. The authority has the right to this hearing to anyone who has submitted timely objections in writing
p.(None): load. This loading can be carried out in the announcement according to paragraph 1. The authority also has to load separately:
p.(None): a) the applicant in accordance with Section 39a (1) 1,
p.(None): b) the municipalities in accordance with Section 39a (1) 2 and 3 if they have raised objections in accordance with Section 1
p.(None): c) the owner of the property in accordance with Section 39a (1) no. 4,
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Searching for indicator restricted:
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p.(None): Directive 2001/18 / EC or Regulation (EC) No. 1829/2003 that was submitted or issued before April 2, 2015, is adjusted.
p.(None): (2) If the registration or the application has not yet been decided and the applicant / applicant has 30 days from the submission of the request
p.(None): According to Paragraph 1, the adjustment of the geographical scope of its original application or application has not been confirmed
p.(None): adapt the geographical scope of the application or application accordingly. Written consent given in accordance with Directive 2001/18 / EC
p.(None): and, if appropriate, the decision in accordance with Article 19 of Directive 2001/18 / EC and the decision on authorization in accordance with Articles 7 and 19 of the
p.(None): Regulation (EC) № 1829/2003 then takes place on the basis of the geographical scope of the application adjusted by the applicant / applicant
p.(None): or the application.
p.(None): (3) If the approval has already been granted and the holder of the approval has the geographical within 30 days of the submission of the request in accordance with Paragraph 1
p.(None): If the scope of the approval is not confirmed, the approval will be changed accordingly. With a written consent in accordance with Directive 2001/18 / EC
p.(None): the competent authority that granted the original approval changes the European one in accordance with Regulation (EC) № 1829/2003
p.(None): Commission the decision on the approval or approval.
p.(None): (4) The provisions of paragraphs 1 to 3 do not affect the cultivation of any approved genetically modified seeds and
p.(None): Plant propagation material that has been lawfully grown before GMO cultivation has been restricted or prohibited.
p.(None): (5) Measures adopted under this provision do not affect the free movement of GMOs as or in products.
p.(None): Penal provisions, confiscation, forfeiture
p.(None): Section 109. (1) Unless the act forms part of an offense falling within the jurisdiction of the courts or according to others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to 36,300 euros
p.(None): 1. contrary to the prohibition of Section 67, employees, or job seekers, collects, requests, accepts or otherwise results of genetic analyzes
p.(None): recycled
p.(None): 2. contrary to the prohibition of Section 67, requests the results of genetic analyzes from policyholders or from policyholders,
p.(None): accepts or otherwise exploits.
p.(None): The attempt is punishable.
p.(None): (2) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are threatened with a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 21,800
p.(None): 1. contrary to the provision of section 37 subsection 1, carries out a release without prior approval,
p.(None): 2. contrary to the provisions of Section 54, places products on the market,
p.(None): 3. who, contrary to Section 79j Paragraph 1, second and third sentences, fails to take out liability insurance.
p.(None): (3) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 7,260
...
Social / Marital Status
Searching for indicator single:
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p.(None): (3) This Federal Act does not apply to the placing on the market and labeling of medicinal products within the meaning of Section 1 (1) and (2) 1 of the Medicinal Products Act and
p.(None): their subsequent use.
p.(None): (4) The use of GMOs in the context of a clinical trial to be approved according to § 75 for the purpose of somatic gene therapy is not considered
p.(None): Release in the sense of this federal law.
p.(None): principle
p.(None): § 3. The following principles must be observed when enforcing this federal law:
p.(None): 1. Working with GMOs, releases and placing GMOs on the market are only permitted if this does not result in the state of the art in science and technology
p.(None): adverse consequences for security (§ 1 Z 1) are to be expected (precautionary principle).
p.(None): 2. Research in the field of genetic engineering and the implementation of its results are not inappropriate considering safety (§ 1 Z 1)
p.(None): Impose restrictions (future principle).
p.(None): 3. The release of GMOs may only take place gradually, by gradually loosening the inclusion of the GMOs and only expanding their release
p.(None): if the assessment of the previous level shows that the subsequent level appears to be compatible with the precautionary principle
p.(None): (Steps principle).
p.(None): 4. The public must be involved in the enforcement in accordance with this federal law in order to ensure their information and participation
p.(None): (democratic principle).
p.(None): 5. In genetic analyzes and gene therapies in humans, care must be taken to protect human dignity; human responsibility
p.(None): account must be taken of animals, plants and the ecosystem (ethical principle).
p.(None): definitions
p.(None): § 4. For the purposes of this federal law:
p.(None): 1. Organisms: single or multicellular organisms or non-cellular reproductive biological units including viruses, viroids and under
p.(None): natural circumstances infectious and reproductive plasmids;
p.(None): 2. Microorganisms: microbial organisms and cultivated animal and plant cells;
p.(None): 3. Genetically modified organisms (GMOs): organisms whose genetic material has been modified as it is under natural conditions
p.(None): by crossing or natural recombination or other conventional breeding techniques. Procedure of genetic modification
p.(None): Materials in this sense are special
p.(None): a) DNA recombination techniques using vector systems,
p.(None): b) direct introduction of genetic information prepared outside the organism into an organism, including macro-injection,
p.(None): Microinjection, microencapsulation, electroporation or use of microprojectiles,
p.(None): c) cell fusion and hybridization processes, in which living cells are created with new combinations of genetic material that occur under natural
p.(None): Conditions do not occur, with the exception of the procedures mentioned in Section 2 (2) 5 and 6
p.(None): 4. Working with GMOs:
p.(None): a) the production, use and reproduction of genetically modified organisms, a series of work methodically and an indefinite number
p.(None): thematically related individual work with GMOs on a small scale of security level 2 with a longest possible duration of ten
p.(None): Years, unless approval has been given for their release or placing on the market,
p.(None): b) the storage, destruction or disposal as well as the internal transport of genetically modified organisms, as far as no approval
p.(None): for their release or placing on the market,
p.(None): c) a single work with GMOs according to lit. a and b also include an indefinite number of works with the same organisms and with essentially
p.(None): comparable inserts and vectors and consistent security measures;
p.(None): 5. In-house transport: Transport of GMOs at which
p.(None): (a) the same operator is the sender and recipient and
p.(None): b) which takes place inside the company premises or over a short distance outside the company premises in such a way that a permanent
p.(None): Monitoring of the transport process with operational security measures ready for use is guaranteed;
p.(None): 6. Genetic engineering facility: a locally bound facility that is used to carry out work with GMOs in one or more closed systems
p.(None): is determined;
p.(None): 7. Closed system: a system in which according to the requirements of the respective security level according to the state of the art and
p.(None): Technology required speci fi c organizational and technical security measures are applied to contact the GMO used
p.(None): with the population and the environment with the aim of preventing an uncontrolled multiplication of this GMO in the outside world, and to this
p.(None): Ways to achieve a high level of security for the population and the environment;
p.(None): 8. State of the art: the level of development of advanced technological processes based on the relevant scientific knowledge,
p.(None): Facilities, construction and operating methods;
p.(None): 9. Working on a small scale: Working with genetically modified microorganisms (GVM)
p.(None): a) Security level 1: up to 600 liters of culture volume
p.(None): b) security level 2: up to 100 liters of culture volume
p.(None): c) security levels 3 and 4: up to 10 liters of culture volume
p.(None): and working with genetically modified plants and animals;
p.(None): (Note: Z 10 repealed by Federal Law Gazette I No. 94/2002)
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Social / Occupation
Searching for indicator job:
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p.(None): Regulation (EC) № 1829/2003 then takes place on the basis of the geographical scope of the application adjusted by the applicant / applicant
p.(None): or the application.
p.(None): (3) If the approval has already been granted and the holder of the approval has the geographical within 30 days of the submission of the request in accordance with Paragraph 1
p.(None): If the scope of the approval is not confirmed, the approval will be changed accordingly. With a written consent in accordance with Directive 2001/18 / EC
p.(None): the competent authority that granted the original approval changes the European one in accordance with Regulation (EC) № 1829/2003
p.(None): Commission the decision on the approval or approval.
p.(None): (4) The provisions of paragraphs 1 to 3 do not affect the cultivation of any approved genetically modified seeds and
p.(None): Plant propagation material that has been lawfully grown before GMO cultivation has been restricted or prohibited.
p.(None): (5) Measures adopted under this provision do not affect the free movement of GMOs as or in products.
p.(None): Penal provisions, confiscation, forfeiture
p.(None): Section 109. (1) Unless the act forms part of an offense falling within the jurisdiction of the courts or according to others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to 36,300 euros
p.(None): 1. contrary to the prohibition of Section 67, employees, or job seekers, collects, requests, accepts or otherwise results of genetic analyzes
p.(None): recycled
p.(None): 2. contrary to the prohibition of Section 67, requests the results of genetic analyzes from policyholders or from policyholders,
p.(None): accepts or otherwise exploits.
p.(None): The attempt is punishable.
p.(None): (2) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are threatened with a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 21,800
p.(None): 1. contrary to the provision of section 37 subsection 1, carries out a release without prior approval,
p.(None): 2. contrary to the provisions of Section 54, places products on the market,
p.(None): 3. who, contrary to Section 79j Paragraph 1, second and third sentences, fails to take out liability insurance.
p.(None): (3) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 7,260
p.(None): 1. contrary to the provisions of § 6, fails to carry out a security classification, to record it in writing or to justify it,
p.(None): 2. contravenes the provisions of Section 11 (1) regarding the emergency plan or the on-call service,
p.(None): 3. The provisions of section 11 subsection 2, 3 or 5 relating to behavior in the event of an accident or as an operator contrary to the provisions of section 11 subsection 4 es
p.(None): fails to carry out a check,
p.(None): 4. contrary to an ordinance issued according to § 12, does not implement safety measures (Z 1) or does not meet requirements for genetic engineering systems (Z 2)
p.(None): Fulfills,
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Social / Police Officer
Searching for indicator officer:
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p.(None): BGBl. I No. 127/2005 (NR: GP XXII RV 1083 AB 1137 p. 125. BR: 7394 AB 7406 p. 727.)
p.(None): BGBl. I No. 13/2006 (NR: GP XXII RV 797 AB 823 S. 99. BR: 7230 AB 7232 S. 720.)
p.(None): [CELEX-No .: 31976L0768, 31989L0107, 31989L0398, 31989L0662, 31996L0023, 31997L0078, 31998L0083, 32000L0013, 32002L0046, 32004L0041]
p.(None): BGBl. I No. 111/2012 (NR: GP XXIV RV 1936 AB 1979 p. 179. BR: AB 8818 p. 815.)
p.(None): BGBl. I No. 114/2012 (NR: GP XXIV RV 2016 AB 2080 p. 185. BR: 8831 AB 8853 p. 816.)
p.(None): [CELEX No .: 32010L0063]
p.(None): BGBl. I No. 35/2015 (NR: GP XXV RV 445 AB 450 p. 59. BR: 9316 AB 9318 p. 838.)
p.(None): BGBl. I No. 92/2015 (NR: GP XXV RV 530 AB 744 p. 85. BR: AB 9430 p. 844.)
p.(None): [CELEX No .: 32015L0412]
p.(None): BGBl. I No. 126/2015 (VfGH)
p.(None): BGBl. I No. 112/2016 (NR: GP XXV RV 1336 AB 1378 p. 157. BR: AB 9706 p. 863.)
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 S. 23. BR: 9967 AB 9970 S. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): BGBl. I No. 59/2018 (NR: GP XXVI RV 191 AB 231 S. 36. BR: 10001 AB 10017 S. 883.)
p.(None): Preamble / Promulgatory
p.(None): TABLE OF CONTENTS
p.(None): Section I - General Provisions
p.(None): §1 aim of the law
p.(None): §2 scope
p.(None): §3 principles
p.(None): §4 Definitions
p.(None): Section II - Working with genetically modified organisms in closed systems
p.(None): §5 security levels
p.(None): §6 security rating
p.(None): §7 assessment procedure
p.(None): §8 Authorization to issue regulations
p.(None): §9 Transgenic animals
p.(None): § 10 security measures
p.(None): § 11 accident, emergency plan
p.(None): Section 12 Authorization to issue regulations
p.(None): Section 12a Authorization to issue ordinances
p.(None): § 13 operator
p.(None): Section 14 Biosafety officer
p.(None): § 15 project manager
p.(None): Section 16 Committee for Biosafety
p.(None): Section 17 Authorization to issue regulations
p.(None): Section 18 Cooperation with other institutions
p.(None): § 19 Registration of work with GMOs
p.(None): Section 20 applications for approval for working with GMOs
p.(None): Section 21 Authorization to issue regulations
p.(None): Section 22 Official procedure
p.(None): Section 23 Official decision
p.(None): § 24 start of work
p.(None): § 25 inhibition of the deadline
p.(None): Section 26 Official procedure when working with transgenic animals
p.(None): Section 27 Official decision on working with transgenic animals
p.(None): § 28 hearing
p.(None): Section 29 Authorization to issue regulations
p.(None): § 30 due diligence, information and notification requirements
p.(None): Section 31 Change in safety equipment
p.(None): Section 32 Change of operator
p.(None): Section 33 Subsequent conditions (note: subsequent measures)
p.(None): Section 34 Obligation to record
p.(None): Section 35 Authorization to issue ordinances
p.(None): III. Section - GMO release and placing on the market
p.(None): Part A - Release of GMOs
p.(None): Section 36 level principle
p.(None): Section 37 Application for approval
p.(None): Section 38 Authorization to issue regulations
p.(None): Section 39 Official procedure
p.(None): Section 39a Party position
p.(None): Section 40 Official decision
p.(None): Section 41 Inhibition of the deadline
p.(None): Section 42 Simplified official procedure
p.(None): Section 43 hearing
p.(None): Section 44 Authorization to issue regulations
p.(None): § 45 security measures, due diligence, information and notification requirements
p.(None): Section 46 Report on the Results of the Release
p.(None): Section 46a Authorization to issue ordinances
p.(None): Section 47 Change of operator
...
p.(None): special attention is paid to the type of work to be carried out with GMOs,
p.(None): 2. requirements for genetic engineering systems to prevent, limit and eliminate the effects of accidents,
p.(None): 3. about criteria for the security measures in rooms for keeping transgenic plants or animals,
p.(None): 4. general criteria for assessing the effectiveness of biological safety measures and
p.(None): 5. for the preparation and content of emergency plans
p.(None): and to provide examples of recognized host-vector systems.
p.(None): statutory authorization
p.(None): § 12a. (1) The Federal Minister for Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission
p.(None): by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and
p.(None): Work and the Federal Minister of Education, Science and Culture according to the state of the art in science and technology, taking into account Annex II Part C
p.(None): of Directive 90/219 / EEC on the use of genetically modified microorganisms in closed systems in the currently applicable version, types of
p.(None): List GMOs that are safe for human health and the environment.
p.(None): (2) Working with GMOs in closed systems, which only include types of GMOs that are included in this list
p.(None): not the requirements of sections II. and IVa.
p.(None): operator
p.(None): § 13. (1) According to the state of the art in science and technology, the operator has to take the necessary safety measures (§ 10) and to comply with them
p.(None): to care.
p.(None): (2) The operator has all questions of safety with the officer for biosafety (§ 14), the project manager (§ 15) and the committee
p.(None): advice on biosafety (§ 16).
p.(None): (3) By appointing a biosafety officer, a project manager or a biosafety committee, the
p.(None): Responsibility of the operator for compliance with the provisions of this federal law and the administrative acts based thereon are not affected.
p.(None): Biosafety Officer
p.(None): § 14. (1) The operator has a biosafety officer for each genetic engineering system and at least one representative with their
p.(None): Order consent and notify the local fire department immediately.
p.(None): (2) The Biosafety Officer and each deputy must have at least two years of practical experience working with GMOs such as
p.(None): they are mainly carried out in the plant, as well as sufficient knowledge in the field of measures to ensure safety (§ 1
p.(None): Z 1) dispose of threats from GMOs.
p.(None): (3) The biosafety officer and his deputy must be employed by the operator of the genetic engineering system
p.(None): or are mainly employed in the genetic engineering facility; at least one of them must work at security levels 3 or 4 in small
p.(None): Scale as well as at work in security levels 2, 3 or 4 on a large scale while working with GMOs present or at least reachable at short notice
p.(None): his. In the clinical area of the medical faculties there is an employment relationship with the officer for biosafety within the framework of the university
p.(None): Equal to the employment relationship with the operator, insofar as this is the sponsor of the hospital. Appointment of the representative for the biological
p.(None): In this case, security must be agreed with the respective clinic or institute board.
p.(None): (4) The Biosafety Officer has
p.(None): 1. a) regularly monitor compliance with the safety measures and the operator and the project manager via identified safety-relevant
p.(None): To inform defects immediately,
p.(None): b) review the emergency plan and, if necessary, propose it to the operator,
p.(None): c) Measures for the instruction and training of employees with regard to guaranteeing safety (§ 1 Z 1) against hazards from GMOs
p.(None): to propose to the operator and
p.(None): 2. keep written records of these activities and keep them ready for inspection by the authority.
p.(None): (5) The operator must support the biosafety officer in fulfilling his tasks, providing him with sufficient time during the
p.(None): To grant working hours and - if necessary - to provide auxiliary staff, further training opportunities, rooms, facilities and work equipment
p.(None): and to give him the opportunity to present suggestions and concerns to the project manager if there are differences of opinion.
p.(None): (6) If the biosafety officer leaves this function or if the operator cancels his order, one must be notified immediately
p.(None): appoint new biosafety officer; the same applies to his deputy, unless another deputy has been appointed.
p.(None): (7) The operator has the authority to withdraw and each change of the biosafety officer or one of his deputies
p.(None): to be announced immediately in writing, including the evidence required for the replacement person ordered by the operator (para. 2).
p.(None): (8) If, in the event of the appointment of a replacement person (para. 6), the authority determines on the basis of the evidence provided that the person appointed has the
p.(None): does not meet the requirements placed on them to request the operator within six weeks of the announcement of the replacement person, either
p.(None): (a) provide the outstanding evidence within a period not exceeding four weeks to be determined by the authority; or
p.(None): b) if a biosafety officer or a deputy is validly appointed for the genetic engineering system, in the event of a lack of qualification of the
p.(None): Proof of appropriate supplementary training within six months,
p.(None): otherwise the operator must order another suitable person.
p.(None): project Manager
p.(None): § 15. (1) The operator must appoint a project manager for each work with GMOs in security levels 2, 3 or 4 and for each work series. The
p.(None): Project managers must have sufficient practical experience working with GMOs, which they have been appointed to plan, manage and supervise, as well as
p.(None): have sufficient knowledge in the field of measures to ensure safety (§ 1 Z 1) against threats from GMOs.
p.(None): (2) The project manager is responsible for the planning, management and supervision of the work with GMOs for which he is appointed. He has for this work with GMOs or
p.(None): work rows
p.(None): 1. to propose a security classification (§ 6) to the operator,
p.(None): 2. The people involved in the work with GMOs about the safety measures to be applied, about the possible risks after the occurrence
p.(None): To inform accidents and about emergency measures and
p.(None): 3. to ensure compliance with the safety measures to be applied.
p.(None): (3) If the project manager leaves this function or if the operator cancels his order, a new project manager is to be assigned immediately
p.(None): to order.
p.(None): (4) The operator must inform the authority immediately of any change of project manager, including the evidence required for the replacement person (para. 1)
p.(None): to be announced in writing.
p.(None): (5) The appointment of a project manager in accordance with Paragraph 1 can be waived if working with GMOs only includes storage and internal
p.(None): Transport of GMOs includes.
p.(None): Biosafety Committee
p.(None): § 16. (1) The operator must set up a committee for biological safety for each genetic engineering system.
p.(None): (2) The Biosafety Committee consists of the biosafety officer of the facility and, if the facility only works in the
p.(None): be carried out on a small scale, from two additional members, and for all other work with GMOs from five additional members. If only in the plant
p.(None): Work on a small scale may be carried out, at least one member, otherwise two members, not in an employment relationship with the operator of the
p.(None): Plant. If large-scale GMO work is carried out in the facility, one of the members is the one responsible for the facility
p.(None): To send a works council or service committee from among the employees. For special questions, the Committee for Biological
p.(None): Security experts should be consulted. The members of the Committee for Biosafety are responsible for obtaining the items mentioned in para. 4 nos. 2 and 3
p.(None): Tasks regarding the content and the result of their activity are not bound by any instructions in their decision.
p.(None): (3) Each member of the Biosafety Committee must have knowledge of working with GMOs. If works in the plant
p.(None): To be carried out on a large scale, at least one member must also have knowledge in the field of security measures
p.(None): (§ 1 Z 1) against threats from GMOs. Overall, the members of the Biosafety Committee should be selected so that they jointly
p.(None): have the experience in the field of working with GMOs that enables them, the experience with working with GMOs that are mainly carried out in the plant,
p.(None): associated risks for security (§ 1 Z 1).
p.(None): (4) The Biosafety Committee has
p.(None): 1. the security measures required to ensure compliance with this Federal Act and the administrative acts based thereon to ensure that
p.(None): Safety (§ 1 Z 1) against threats from GMOs and these safety measures according to the state of the art in science and technology
...
p.(None): does not meet the requirements set, to request the operator, either within a period to be determined by the authority and not more than four weeks
p.(None): to provide outstanding evidence or, in the event of insufficient quali fi cation of the replacement person ordered, appropriate additional training within
p.(None): six months to prove, otherwise the operator has to appoint another suitable person. The assignment, a supplementary training within
p.(None): of six months is not permitted if the member to be replaced has been removed by the operator.
p.(None): (8) The appointment of a committee for biosafety in accordance with paragraph 1 can be waived if working with GMOs only involves storage and
p.(None): includes the internal transport of GMOs.
p.(None): statutory authorization
p.(None): § 17. The Federal Minister of Health and Women, insofar as this is necessary in the interest of security (§ 1 no. 1), according to the state of the art in science
p.(None): and technology and after hearing the responsible scientific committee of the genetic engineering commission by ordinance in agreement with the
p.(None): Federal Minister of Education, Science and Culture detailed provisions on the required experience in working with GMOs and knowledge
p.(None): in particular to adopt safety measures through which the biosafety officers, the project managers and the members of a committee
p.(None): for biological security.
p.(None): Cooperation with other institutions
p.(None): § 18. The Biosafety Officer, the Project Leader and the Biosafety Committee are required to perform their duties
p.(None): Advising the operator with the legal regulations for the protection of existing employees in the plant and with
p.(None): to work together with the officers appointed in this facility to perform environmental protection tasks.
p.(None): Registration of work with GMOs
p.(None): § 19. The operator has the implementation
p.(None): 1. first time working with GVM in a genetic engineering plant in security level 1,
p.(None): 2. first time working with GVM in a genetic engineering facility in security level 2,
p.(None): 3. further work with GVM in a genetic engineering facility in security level 2,
p.(None): 4. first-time work with transgenic plants or animals in a genetic engineering facility,
p.(None): 5. Further work with transgenic plants or animals in a genetic engineering facility, provided that a security classification of security level 1 is not
p.(None): is permissible, and
p.(None): 6. Further work with transgenic vertebrates in security level 1 in a genetic engineering facility
p.(None): Before starting work, register with the authority using the documents specified in Appendix 1. The registrations and the related ones
p.(None): Documents must be submitted in the original and in a copy.
p.(None): Permit applications for working with GMOs
p.(None): § 20. The operator has the authorization to carry out
p.(None): 1. Working with GVM in a genetic engineering system in security level 3 and
p.(None): 2. Working with GVM in a genetic engineering facility in security level 4
...
p.(None): Security (§ 1 Z 1) is likely to impair, to report to the authority in writing even after registration or after completion of the approval process.
p.(None): Change of operator
p.(None): § 32. A change in the person of the operator makes the permissibility of carrying out work with GMOs and the resulting ones
p.(None): Obligations not affected. The legal successor must immediately notify the authority of the change in writing.
p.(None): Subsequent measures
p.(None): § 33. After the granting of the permit, after the expiry of the prohibition period or after the start of the work, circumstances become known that are significant
p.(None): can adversely affect security (§ 1 Z 1), the authority, as far as this is necessary to keep the immediate dangers, under
p.(None): to preserve acquired rights as far as possible to prohibit additional suitable safety requirements, to restrict the work with GMOs
p.(None): or to temporarily suspend and order the harmless removal of GMOs.
p.(None): record keeping
p.(None): Section 34. (1) The operator must ensure that records are kept of all work with GMOs, kept and kept for inspection by the
p.(None): Authority.
p.(None): (2) Records of work in security levels 1 or 2 on a small scale can be kept in the form of laboratory records (laboratory journals)
p.(None): become. These records must contain the following information:
p.(None): 1. Name and address of the operator and location of the genetic engineering system;
p.(None): 2. Name of the project manager and biosafety officer;
p.(None): 3. designation of the respective work with GMOs;
p.(None): 4. Beginning, completion and safety classification of the work with GMOs or the work series with GMOs and their modification;
p.(None): 5. type of disposal of GMOs;
p.(None): 6. Information about accidents according to § 11 paragraph 2.
p.(None): (3) Other than the work with GMOs listed under paragraph 2 are to be recorded in separate records. In addition to those listed in paragraph 2
p.(None): For information, these records must contain the following information:
p.(None): 1. time of registration of work with GMOs or date and business number of the approval notice;
p.(None): 2. the names of the people directly involved in carrying out the work with GMOs;
p.(None): 3. Security and emergency measures taken.
p.(None): (4) Records of work in security levels 3 or 4 on a large scale must include a in addition to the information according to paragraphs 2 and 3
p.(None): Description of the process control and the devices and equipment used to control the safety measures.
p.(None): (5) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (6) Records of work in security levels 1 or 2 on a small scale must be at least three years after completion of the work or
p.(None): Work series are kept. All other records must be kept for at least five years after completing work with GMOs.
p.(None): statutory authorization
p.(None): § 35. The Federal Minister of Health and Women, insofar as this is in the interest of security (§ 1 Z 1) according to the state of the art in science and technology
...
p.(None): restrict or prohibit genetically modified organisms (GMOs) on their territory, OJ No.L 68 from 13.03. 2015, implemented.
p.(None): Entry into force of regulations
p.(None): Section 113. Section 71 (2) in the version of the Electronic Health Record Act, Federal Law Gazette I No. 111/2012, comes into force on January 1, 2013.
p.(None): Section 113a. Section 88 (2) 2 lit. a and § 97 GTG in the version of the Reproductive Medicine Law Amendment Act, BGBl. I. № 35/2015, occur with the
p.(None): Announcement in force the following day.
p.(None): Section 113b. Section 67 in the Federal Law Gazette I No. 112/2016 comes into force on 1 January 2017.
p.(None): Section 113c. Sections 66 Paragraphs 1 and 3, 71, 71a Paragraph 2, 106 and 109 Paragraph 3 Z 34 and 37 in the version of the 2nd Material Data Protection Adjustment Act,
p.(None): BGBl. I No. 37/2018, come into force on May 25, 2018.
p.(None): § 113d. Section 69 (2) and (3) in the version of the Federal Law Gazette I No. 59/2018 comes into force on July 1, 2018.
p.(None): Attachment 1
p.(None): Registration or application documents for working with GMOs in accordance with sections 19 and 20
p.(None): A) Working with genetically modified microorganisms (GVM)
p.(None): B) Working with genetically modified plants and animals
p.(None): A) Working with genetically modified microorganisms (GVM)
p.(None): 1. First time working with GVM
p.(None): 1.1. First time working with GVM on a small scale
p.(None): 1.1.1. Working at security level 1:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Description of safety measures and methods for the harmless disposal of the GVM.
p.(None): 1.1.2. Working at security level 2:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Description of security measures and methods for the harmless disposal of the GVM,
p.(None): 6. Information on accident prevention measures.
p.(None): 1.1.3. Working at security levels 3 and 4:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM and the one based on it
p.(None): Enable risks with regard to the required security measures,
p.(None): 5. Description of security measures and methods for the harmless disposal of GVM as well as methods for identification and for
p.(None): Proof of GVM,
p.(None): 6. Information about measures for accident prevention and the emergency plan according to § 11.
p.(None): 1.2. First-time work with GVM on a large scale
p.(None): 1.2.1. Working at security level 1:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and description of the process management, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Description of security measures and measures for the harmless disposal of the GVM as well as methods for identification and for
p.(None): Proof of GVM,
p.(None): 6. Information on accident prevention measures.
p.(None): 1.2.2. Working at security level 2:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Security classification and description of the process management, which an assessment of the properties of the GVM and the dangers emanating from it
p.(None): Allow for the necessary security measures,
p.(None): 5. Description of safety measures and measures for the harmless disposal of the GVM, possible dangers of the process used
p.(None): resulting waste and waste water as well as methods for the identification and detection of the GMM,
p.(None): 6. Information about measures for accident prevention and the emergency plan according to § 11.
p.(None): 1.2.3. Working at security levels 3 and 4:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and description of the process management, which an assessment of the properties of the GVM and the risks it poses in
p.(None): Allow for the necessary security measures,
p.(None): 5. Description of safety measures and measures for the harmless disposal of the GVM and any biologically active ones
p.(None): Nucleic acids, possible dangers of the waste and wastewater generated in the process used, as well as methods for identification and for
p.(None): Proof of GVM,
p.(None): 6. Information about the instruction of all persons involved in the work in the handling of the safety devices and safety measures,
p.(None): 7. external risks arising from the location of the plant,
p.(None): 8. Information about measures for accident prevention and the emergency plan according to § 11.
p.(None): 2. Further work
p.(None): 2.1. Further work on a small scale
p.(None): 2.1.1. Works or work series of security level 2:
p.(None): 1. Address of the plant and, if necessary, changes to the description of the parts of the plant that are relevant for working with GVM and its safety,
p.(None): 2. Date of receipt of the application or the date and business number of the approval notice regarding the first-time work with GVM
p.(None): or a higher security level in this facility, including the security rating of this initial work,
p.(None): 3. Name of the project manager,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Necessary changes or additions to the description of security measures and methods for the harmless elimination of the GVM and
p.(None): Accident prevention measures.
p.(None): 2.1.2. Working at security levels 3 and 4:
...
p.(None): Dangers of waste and wastewater arising from the process used and information on methods for identi fi cation and verification of
p.(None): GVM.
p.(None): 2.2.3. Working at security levels 3 and 4:
p.(None): 1. Address of the plant and, if necessary, changes to the description of the parts of the plant that are relevant for working with GVM and its safety,
p.(None): 2. Date and transaction number of the approval notice for the first work with GVM of this or a higher security level in this annex,
p.(None): including the security rating of this initial work,
p.(None): 3. Name of the project manager,
p.(None): 4. Security classification and description of changes in the process management, which is an assessment of the properties of the GVM and of them
p.(None): enable outgoing risks with regard to the required security measures,
p.(None): 5. Necessary changes or additions to the description of safety measures, measures for the harmless disposal of the GVM and if necessary
p.(None): accumulating biologically active nucleic acids, possible dangers of the waste and wastewater generated in the process used and information from
p.(None): Methods for the identification and detection of GVM,
p.(None): 6. necessary changes in the instruction of all persons involved in the work in the handling of the safety devices and
p.(None): Safety measures.
p.(None): B) Working with genetically modified plants and animals
p.(None): 1. First-time work with genetically modified plants or animals
p.(None): 1.1. All security levels:
p.(None): 1. Address of the plant, description of the parts of the plant and the greenhouse or of the plant that are relevant for working with GMOs and their safety
p.(None): Livestock farming,
p.(None): 2. Name of the operator and, if applicable, the project manager,
p.(None): 3. Name and qualification of the
p.(None): a) Biosafety Officer,
p.(None): b) Members of the Biosafety Committee,
p.(None): 4. Safety classification and summary presentation of the work that requires an assessment of the properties of the GMO with regard to the required
p.(None): Enable security measures,
p.(None): 5. Description of security measures and methods for the harmless elimination of the GMO as well as existing methods for
p.(None): Identification and proof of GMOs
p.(None): 6. Description of the planned change in the recipient organism in vertebrates,
p.(None): 7. when working with transgenic vertebrates by breaking the species limits, displaying the persecuted biomedical and developmental biology
p.(None): Aims.
p.(None): 2. Further work with genetically modified plants or animals
p.(None): 2.1. Further work with transgenic vertebrates of security level 1:
p.(None): 1. address of the facility,
p.(None): 2. date of receipt of the notification regarding the first work with transgenic vertebrates in this facility,
p.(None): 3. Description of the planned change in the recipient organism in vertebrates,
p.(None): 4. Presentation of the pursued biomedical and developmental goals of the work.
p.(None): 2.2. Further work with transgenic plants or animals, provided a security level 1 security level is not permitted:
p.(None): 1.Address of the plant and, if necessary, changes to the description of the parts of the plant which are relevant for working with GMOs and their safety,
p.(None): of the greenhouse or animal husbandry,
p.(None): 2. date of receipt of the notification regarding the first-time work with GMOs in this annex,
p.(None): 3. Name of the project manager,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
...
Social / Property Ownership
Searching for indicator property owner:
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p.(None): Liability insurance must be taken out with an insurer authorized to operate this insurance branch in Austria; on that must
p.(None): Austrian law must be applied. The competent body within the meaning of Section 158c (2) Insurance Contract Act 1958 is the authority under Section 100.
p.(None): (2) There is no obligation to provide cover if the federal government or a state is an operator.
p.(None): Claims against neighbors
p.(None): Section 79k. (1) The owner or beneficiary of an agricultural property can be a neighbor who is on his property
p.(None): Grows products within the meaning of section 54 (1) and is obliged to register in a register in accordance with section 101c (2) based on these products
p.(None): Prohibit actions if these actions exceed what is customary according to the local conditions and the use of the affected
p.(None): Affect property significantly. Such impairment exists in any case if the owner or the person entitled to use the products
p.(None): cannot place his property on the market due to the effects or not in the manner intended by him.
p.(None): (2) The neighbor who caused an influence in the sense of paragraph 1 is liable to the property owner or the person entitled to use it for the replacement of the
p.(None): this damage caused thereby, including the costs of restoring the environment (Section 79b).
p.(None): (3) If several neighbors have caused an influence in the sense of paragraph 1, each of them is only liable for its share in that
p.(None): Damage inflicted on property owners or beneficiaries. If the proportions cannot be determined, the neighbors are liable to the undivided hand.
p.(None): (4) Can the owner or beneficiary credibly demonstrate that a particular activity or omission of the neighbor according to the circumstances of the
p.(None): In individual cases it was suitable to bring about the influence in the sense of paragraph 1, it is assumed that this was caused by the activity or omission.
p.(None): This assumption is refuted if the neighbor believes it is likely that the influence does not result from it.
p.(None): (5) Provisions of the general civil code and other regulations on the prohibition of effects and compensation for damage
p.(None): stay untouched.
p.(None): § 79l. Non-contractual claims for compensation for damage caused by impacts within the meaning of § 79k are to be assessed according to the law of the state in which the
p.(None): Damage has occurred.
p.(None): § 79m. (1) The owner or beneficiary of an agriculturally used property has to file a lawsuit based on § 79k
p.(None): Paragraphs 1 and 2 to settle an arbitration board for amicable settlement, an application pursuant to Section 433 (1) of the Code of Civil Procedure, RGBl. № 113/1895
...
Searching for indicator home:
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p.(None): Home Contact Sitemap Imprint Deutsch
p.(None): [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query
p.(None): Federal law consolidated: Entire legal provision for genetic engineering law, version of the print version
p.(None): 02/18/2020
p.(None): Other formats:
p.(None): long Title
p.(None): Federal law, with the work with genetically modified organisms, the release and placing on the market of genetically modified organisms and
p.(None): the application of gene analysis and gene therapy to humans are regulated (Genetic Engineering Act - GTG)
p.(None): StF: BGBl.No. 510/1994 (NR: GP XVIII IA 732 / A AB 1730 p. 168. BR: AB 4827 p. 588.)
p.(None): [CELEX No .: 390L0219, 390L0220]
p.(None): modification
p.(None): BGBl. I No. 73/1998 (NR: GP XX AB 1112 p. 116. BR: 5663 AB 5667 p. 640.)
p.(None): BGBl. I No. 98/2001 (NR: GP XXI RV 621 AB 704 p. 75. BR: 6398 AB 6424 p. 679.)
p.(None): BGBl. I No. 94/2002 (NR: GP XXI RV 967 AB 1104 p. 104. BR: AB 6662 p. 688.)
p.(None): [CELEX No .: 398L0081]
p.(None): BGBl. I No. 73/2004 (NR: GP: XXII RV 510 AB 538 p. 67. BR: 7062 AB 7080 p. 711.)
p.(None): BGBl. I No. 126/2004 (NR: GP XXII RV 617 AB 630 p. 78. BR: 7139 p. 714.)
p.(None): [CELEX No .: 32001L0018]
p.(None): BGBl. I No. 127/2005 (NR: GP XXII RV 1083 AB 1137 p. 125. BR: 7394 AB 7406 p. 727.)
p.(None): BGBl. I No. 13/2006 (NR: GP XXII RV 797 AB 823 S. 99. BR: 7230 AB 7232 S. 720.)
p.(None): [CELEX-No .: 31976L0768, 31989L0107, 31989L0398, 31989L0662, 31996L0023, 31997L0078, 31998L0083, 32000L0013, 32002L0046, 32004L0041]
p.(None): BGBl. I No. 111/2012 (NR: GP XXIV RV 1936 AB 1979 p. 179. BR: AB 8818 p. 815.)
p.(None): BGBl. I No. 114/2012 (NR: GP XXIV RV 2016 AB 2080 p. 185. BR: 8831 AB 8853 p. 816.)
p.(None): [CELEX No .: 32010L0063]
p.(None): BGBl. I No. 35/2015 (NR: GP XXV RV 445 AB 450 p. 59. BR: 9316 AB 9318 p. 838.)
...
p.(None): and working with genetically modified plants and animals;
p.(None): (Note: Z 10 repealed by Federal Law Gazette I No. 94/2002)
p.(None): 11. Working on a large scale: all works with GVM other than those listed under Z 9;
p.(None): 12. Accident when working with GMOs in a closed system: any occurrence that is contaminated with or a significant, abusive or
p.(None): unintended multiplication of genetically modified organisms or organisms that are directly involved in working with GMOs outside
p.(None): of the closed system to an extent that, according to the state of the art, considering the quantity and the
p.(None): Properties of these organisms can lead to a risk to safety (§ 1 Z 1);
p.(None): 13. Accident in the course of releases: any unforeseen deviation from the planned test procedure, in which there is an increase in GMOs over the
p.(None): intended test area comes in such a way that it is according to the state of the art in consideration of the quantity and
p.(None): Properties of these organisms or their genetic material can endanger safety (Section 1 no. 1);
p.(None): 14. Vectors: carrier molecules and carrier microorganisms for inserting nucleic acid sequences into cells;
p.(None): 15. Transgenic animals: animals that are created by inserting one or more genes into the germ line or by deleting one or more genes from the germ line
p.(None): arise;
p.(None): 16. Applications of GMOs on animals: working with GMOs on animals;
p.(None): 17. Working with GVM for development purposes: Working at security level 3 on a large scale to develop or increase the e ffi ciency of
p.(None): Production process up to the market launch of the product or - if this precedes - until the first registration or approval of the
p.(None): Product at home or abroad;
p.(None): 18. Operator: a natural or legal person or a partnership under commercial law or an acquisition company operating under their name
p.(None): operates a genetic engineering facility or works with GMOs or releases;
p.(None): 19. Biosafety measures: the application of measures or systems that are recognized according to the state of the art in science and technology
p.(None): exclude the ability of GMOs to reproduce or the transfer of genetically modified nucleic acid outside the place of use, or
p.(None): at least minimize;
p.(None): 20. Release (release): the deliberate application of GMOs, a combination of GMOs or a combination of GMOs with other organisms
p.(None): a closed system into the environment, unless this is permitted under a marketing authorization.
p.(None): 21. Placing on the market: the making available, for a fee or free of charge, to third parties of products which consist of or contain GMOs, as well as
p.(None): their shipment to the federal territory, insofar as these products
p.(None): a) are not intended to work with GMOs in genetic engineering plants or
p.(None): b) should not be the subject of a release requiring approval under this Federal Act or
p.(None): c) are not intended for scientific purposes, including clinical trials;
p.(None): 22. germline: the entirety of the cell sequence from which germ cells emerge and the germ cells themselves;
p.(None): 23. Genetic analysis: laboratory analysis that provides information about specific properties with regard to the number, structure or sequence of chromosomes, genes
p.(None): or DNA sections or of products of DNA and their specific chemical modifications, and thus according to the state of the art in science
...
Searching for indicator property:
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p.(None): Section 62c Unintentional presence of GMOs in other products
p.(None): Section 63 Social intolerance
p.(None): (Note: § 63a restriction of approval of GMOs)
p.(None): Section IV - Genetic Analysis and Gene Therapy in Humans
p.(None): Section 64 Prohibition of interventions in the genetic material of the human germline
p.(None): Section 65 Genetic analyzes in humans for medical purposes
p.(None): Section 66 Genetic analyzes in humans for scientific purposes and for training
p.(None): Section 67 Prohibition of collecting and using data from genetic analyzes for certain purposes (note: prohibition of the use of
p.(None): Genetic analysis data for specific purposes)
p.(None): Section 68 Performing genetic analyzes on humans for medical purposes - official procedure
p.(None): Section 68a Head of the facility and laboratory manager
p.(None): Section 69 Consent and advice
p.(None): Section 70 Inclusion of relatives
p.(None): Section 71 data protection (note: test results)
p.(None): Section 71a Documentation of the test results
p.(None): Section 72 Authorization to issue ordinances
p.(None): Section 73 Notification requirements
p.(None): Section 74 Somatic Gene Therapy
p.(None): Section 75 Institutions for the implementation of somatic gene therapy - official procedure (note: implementation of the somatic
p.(None): Gene Therapy - Official Procedure and Decision)
p.(None): Section 76 Clinical trials for the purpose of somatic gene therapy
p.(None): Section 77 due diligence and notification requirements
p.(None): Section 78 application of legal provisions
p.(None): (Note: § 78 reporting requirements)
p.(None): Section 79 Register
p.(None): IVa. Section - Civil liability
p.(None): Section 79a Personal injury and property damage
p.(None): Section 79b Impairment of the Environment
p.(None): Section 79c exclusion of liability
p.(None): Section 79d
p.(None): Section 79e liability, recourse and compensation for several operators
p.(None): §§ 79f, 79g information
p.(None): Section 79h Application of the ABGB
p.(None): Section 79i Other claims for compensation
p.(None): Section 79j
p.(None): Section 79k to Section 79m claims against neighbors
p.(None): Section V. - Genetic Engineering Commission and Genetic Engineering Book
p.(None): Section 80 Establishment of a genetic engineering commission
p.(None): Section 81 Composition of the Genetic Engineering Commission
p.(None): Section 82 Chairman
p.(None): Section 83 Decision-making
p.(None): Section 84 Duties of the commission
p.(None): Section 85 Standing Scientific Committees
p.(None): Section 86 Tasks and composition of the scientific committee for working with GMOs in a closed system
p.(None): Section 87 Tasks and composition of the scientific committee for releases and placing on the market
p.(None): Section 88 Tasks and composition of the scientific committee for gene analysis and gene therapy in humans
p.(None): Section 89 Right to nominate experts from scientific committees
p.(None): Section 90 Chair of the scientific committees
p.(None): Section 91 Decision-making in the scientific committees on applications and applications
p.(None): Section 92 deliberations of the commission and its scientific committees
p.(None): Section 93 Obligation to report
p.(None): Section 94 Members of the Commission and its scientific committees
p.(None): Section 95 External experts
p.(None): Section 96 duty of confidentiality
p.(None): Section 97 Rules of Procedure
p.(None): Section 98 office
p.(None): Section 99 Genetic engineering book (note: genetic engineering book, report on the application of genetic engineering)
...
p.(None): to transfer.
p.(None): (5) The authority has
p.(None): a) the Federal Ministry of Agriculture, Forestry, Environment and Water Management the receipt of the application (para. 1), the content of a request
p.(None): in accordance with paragraph 2 and the further information received on the basis of this request,
p.(None): b) to invite the Federal Ministry of Agriculture, Forestry, Environment and Water Management to the consultation procedure (§ 43) and
p.(None): c) the Federal Ministry of Agriculture, Forestry, Environment and Water Management their decisions (sections 40 and 48) and the reports and
p.(None): Notices of the operator (sections 45 (3), 46, 47 and 49 (2)) must be brought to your attention immediately.
p.(None): Note for the following provision
p.(None): Regarding para. 1: Appears through § 42 para. 1 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): party status
p.(None): Section 39a. (1) Party position in the official procedure for approval of a release, except for the release of animals and microorganisms
p.(None): related to medical applications
p.(None): 1. the applicant,
p.(None): 2. the municipality in whose local area of responsibility the release is to take place if it raises objections in accordance with § 43 Paragraphs 1 and 2
p.(None): Sent it to the authority in writing within the meaning of paragraph 2 below and explained it in more detail at the hearing,
p.(None): 3. if the property on which the release is to take place is at a municipal boundary, the municipalities adjacent to this property, if
p.(None): it submits objections, justified in accordance with Section 43, Paragraphs 1 and 2, in writing to the Authority in the sense of the following Paragraph 2 and further details at the hearing
p.(None): have explained
p.(None): 4. the owner of the property on which the release is to take place if he has written objections in accordance with § 43 paragraphs 1 and 2 of the
p.(None): Authority communicated and explained in more detail at the hearing and at the same time with his written objections the requirements for his
p.(None): Party position has demonstrated
p.(None): 5. the neighbors if they submit written objections to the authority in writing in accordance with section 43 subsection 1 and 2 within the meaning of the subsection 2 below and submit them
p.(None): the hearing was explained in more detail and, at the same time, with its written objections, the requirements for her party position were met
p.(None): to have. Neighbors are the owners of the land, which have a common border with the property on which the release is to take place,
p.(None): as well as persons who have leased these properties at the time of application and during the procedure, and persons who
p.(None): Time of the application and during the procedure legally and not only temporarily on one of these properties, as well
p.(None): 6. the federal state in whose area of responsibility the release should take place if there are justified objections within the meaning of section 43 (1) and (2)
p.(None): Submitted the following paragraph 2 in writing to the authority and explained in more detail at the hearing.
p.(None): (2) The municipalities in accordance with Paragraph 1 Numbers 2 and 3 are due to the party position they receive, each of them within the framework of the respective party according to § 43
p.(None): Paragraphs 1 and 2 raised objections, entitled to comply with legal requirements regarding security (§ 1 Z 1) within their respective local
p.(None): Area of responsibility serve to assert in the official procedure for approval of the release. The federal state according to paragraph 1 no. 6 is on the ground
p.(None): the party position it is entitled to within the scope of the objections raised by it according to § 43 Paragraph 1 and 2, compliance with
p.(None): Legislation that serves security (§ 1 Z 1) within its respective area of responsibility in the official procedure for approval of the
p.(None): Claim release. The owner of the property in accordance with paragraph 1 line 4 and its neighbors in accordance with paragraph 1 line 5, each of them within the framework of the
p.(None): Objections raised by him in accordance with § 43 Paragraphs 1 and 2 are entitled to comply with the legal provisions that ensure the security of his own
p.(None): Health and that of his offspring serve to assert a subjective public right in official proceedings, to take legal action
p.(None): and to lodge a complaint with the Administrative Court and the Constitutional Court.
p.(None): Official decision
p.(None): Section 40. (1) The authority must decide on applications pursuant to Section 37 (2) within 90 days of receipt of the application. Approval must be given if
p.(None): 1. It is ensured that the operator derives from the provisions of Part A of this section and the regulations based thereon
p.(None): Obligations for the intended release are fulfilled and this release is carried out according to the state of the art in science and technology,
p.(None): 2. It is guaranteed that the precautions necessary according to the state of the art in science and technology have been taken and therefore have adverse consequences for the
p.(None): Security (§ 1 Z 1) are not to be expected, and
p.(None): 3. the operator provides proof of liability insurance in accordance with section 79j (1) second or third sentence.
p.(None): (2) Insofar as this is necessary in the interest of security (§ 1 no. 1), the authority has the period within which a release may be carried out,
p.(None): to be limited in time or for the implementation and if necessary also for the monitoring after the implementation certain suitable conditions and requirements
p.(None): prescribe.
...
p.(None): Period of three weeks for public inspection and that everyone is at liberty to justify the authority within the period for which the information is available
p.(None): Submit objections in writing. The announcement includes persons who, in accordance with Section 39a (1) (4) and (5), are party to the further official procedure
p.(None): to obtain approval for the release, to point out that they have the party position by raising justified written objections
p.(None): can obtain at the same time the requirements for their party position and subsequent explanation of their objections at the hearing.
p.(None): (2) The authority shall schedule a hearing as part of the investigation; this hearing took place within three weeks from the end of the
p.(None): Deadline to be held. The hearing serves to discuss the objections submitted on time; the opponents have the opportunity to get closer
p.(None): To explain their objections. The authority has the right to this hearing to anyone who has submitted timely objections in writing
p.(None): load. This loading can be carried out in the announcement according to paragraph 1. The authority also has to load separately:
p.(None): a) the applicant in accordance with Section 39a (1) 1,
p.(None): b) the municipalities in accordance with Section 39a (1) 2 and 3 if they have raised objections in accordance with Section 1
p.(None): c) the owner of the property in accordance with Section 39a (1) no. 4,
p.(None): d) the neighbors in accordance with Section 39a (1) (5) if they raise objections in accordance with Section 1 and the requirements for their party status are met
p.(None): have demonstrated
p.(None): e) the federal state in accordance with section 39a (1) (6) if it has raised objections in accordance with section 1, and
p.(None): f) the members of the responsible scientific committee.
p.(None): statutory authorization
p.(None): § 44. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of the hearing
p.(None): is required, in agreement with the Federal Minister of Education, Science and Culture by ordinance, more detailed provisions on announcement and
p.(None): The course of the consultation process, the type and scope of the inspection of the application and the associated documents, with particular attention to the
p.(None): Confidentiality of data in accordance with Section 105, to determine the preparation and the course of the hearing.
p.(None): Security measures, due diligence, information and notification requirements
p.(None): Section 45. (1) Anyone who carries out a release has all that is necessary according to the state of the art in science and technology in the interest of safety (Section 1 no. 1)
p.(None): Take precautions and measures and - insofar as he is the operator - ensure that they are observed.
p.(None): (2) Even after approval of the release, the operator has all the facts and circumstances related to the release
p.(None): inform, which according to the state of the art in science and technology are suitable to endanger security (§ 1 Z 1).
...
p.(None): 1. facilities for performing genetic analyzes (genetic analysis registers),
p.(None): 2. Somatic gene therapies on humans (gene therapy register) and
p.(None): 3. Proficiency tests offered (proficiency testing register)
p.(None): are recorded.
p.(None): (2) In the genetic analysis register, the name, address, homepage and the area of activity of the institution, which is structured according to the investigations carried out
p.(None): to lead.
p.(None): (3) The name, address, homepage and area of activity of the institution must be recorded in the gene therapy register. The area of activity is by means of study title, name
p.(None): of the study director, and to describe the indication. The therapeutic genes and gene transfer systems used, as well as course and are for each gene therapy
p.(None): Show the final report separately in a non-public part of the register.
p.(None): (4) The Federal Minister of Health and Women has the data in accordance with paragraphs 2 and 3 taking into account any changes to be included
p.(None): of reporting obligations according to Section 73 (1) or Section 78a (1) (in particular history and final report) to be transferred to the register.
p.(None): (5) The registers must be updated continuously.
p.(None): (6) The published data must not contain any identifiable information about the persons treated. Everyone has access to the registers
p.(None): grant. The Federal Minister of Health and Women and the Federal Office for Safety in Health Care are also responsible for the scope of their responsibilities
p.(None): non-public part of the gene therapy register accessible.
p.(None): IVa. section
p.(None): Civil liability
p.(None): Personal injury and property damage
p.(None): Section 79a. (1) Is caused when working with GMOs (§ 4 Z 4) or when they are released (§ 4 Z 20) as a result of the genetic modification
p.(None): Characteristics of the organism A person has been killed, injured on the body or damaged in health or damaged a physical thing
p.(None): Operator (§ 4 Z 18) to compensate for the damage. The operator is liable for work and releases even if there is already a permit for the release
p.(None): or has been granted for placing on the market as long as the product (Section 54 (1)) has not yet been placed on the market in accordance with the approval.
p.(None): (2) The operator's liability also extends to damage caused by the properties of the GMO caused by the genetic modification
p.(None): Connection with its other dangerous properties.
p.(None): Environmental degradation
p.(None): Section 79b. Is the damage to a physical thing also a significant impairment of the environment (§ 101a para. 1) and is a restoration of the
p.(None): the previous state is not feasible by the liable operator or if the operator is not ready to restore it, the injured party also deserves it
p.(None): then the reimbursement of the costs of the restoration if these costs exceed the value of the damaged item. The victim can
p.(None): Demand recovery costs in advance, however, has an advance payment in excess of the value of the damaged item
p.(None): to be refunded if it does not restore the previous condition within a reasonable time.
p.(None): Disclaimer of liability
p.(None): Section 79c. The liability of the operator is excluded if the damage
...
p.(None): Other claims for compensation
p.(None): Section 79i. Provisions of the general civil code and other regulations, according to which damage to other extent or by others
p.(None): Persons who are to be replaced under this federal law remain unaffected.
p.(None): financial security
p.(None): Section 79j. (1) The operator of an activity pursuant to Section 79a has to a degree and to the extent that is customary in fair business dealings by entering into
p.(None): insurance or in any other suitable way to ensure that liability for damages according to this section can be fulfilled. Consists
p.(None): the activity in work with GMOs of security level 3 on a large scale or in the release of GMOs on a small scale (§ 36 Paragraph 1 No. 1), must
p.(None): in any case, this provision consists of liability insurance with an insurance sum of at least 712 200 euros for each damage event. Consists
p.(None): If you are working on GMOs of security level 4 or releasing GMOs to a large extent (Section 36 Paragraph 1 No. 2), this precaution must be taken
p.(None): at least in liability insurance with an insured sum of at least 4 069 700 euros for each damage event. The
p.(None): Liability insurance must be taken out with an insurer authorized to operate this insurance branch in Austria; on that must
p.(None): Austrian law must be applied. The competent body within the meaning of Section 158c (2) Insurance Contract Act 1958 is the authority under Section 100.
p.(None): (2) There is no obligation to provide cover if the federal government or a state is an operator.
p.(None): Claims against neighbors
p.(None): Section 79k. (1) The owner or beneficiary of an agricultural property can be a neighbor who is on his property
p.(None): Grows products within the meaning of section 54 (1) and is obliged to register in a register in accordance with section 101c (2) based on these products
p.(None): Prohibit actions if these actions exceed what is customary according to the local conditions and the use of the affected
p.(None): Affect property significantly. Such impairment exists in any case if the owner or the person entitled to use the products
p.(None): cannot place his property on the market due to the effects or not in the manner intended by him.
p.(None): (2) The neighbor who caused an influence in the sense of paragraph 1 is liable to the property owner or the person entitled to use it for the replacement of the
p.(None): this damage caused thereby, including the costs of restoring the environment (Section 79b).
p.(None): (3) If several neighbors have caused an influence in the sense of paragraph 1, each of them is only liable for its share in that
p.(None): Damage inflicted on property owners or beneficiaries. If the proportions cannot be determined, the neighbors are liable to the undivided hand.
p.(None): (4) Can the owner or beneficiary credibly demonstrate that a particular activity or omission of the neighbor according to the circumstances of the
p.(None): In individual cases it was suitable to bring about the influence in the sense of paragraph 1, it is assumed that this was caused by the activity or omission.
p.(None): This assumption is refuted if the neighbor believes it is likely that the influence does not result from it.
p.(None): (5) Provisions of the general civil code and other regulations on the prohibition of effects and compensation for damage
p.(None): stay untouched.
p.(None): § 79l. Non-contractual claims for compensation for damage caused by impacts within the meaning of § 79k are to be assessed according to the law of the state in which the
p.(None): Damage has occurred.
p.(None): § 79m. (1) The owner or beneficiary of an agriculturally used property has to file a lawsuit based on § 79k
p.(None): Paragraphs 1 and 2 to settle an arbitration board for amicable settlement, an application pursuant to Section 433 (1) of the Code of Civil Procedure, RGBl. № 113/1895
p.(None): or - if the neighbor agrees - to submit the dispute to a mediator. The action is admissible only if not within three at the latest
p.(None): An amicable settlement has been reached months after initiation of the arbitration process, from the time the application is received by the court or from the start of mediation.
p.(None): (2) Only one of a chamber of agriculture, a chamber of notaries, a chamber of lawyers or one comes as an arbitration board within the meaning of paragraph 1
p.(None): other corporation established under public law, as mediator only a mediator in the sense of the Civil Law Mediation Act, Federal Law Gazette I
p.(None): No. 29/2003.
p.(None): (3) Unless the parties agree otherwise, the costs of arbitration, judicial settlement or mediation are initially borne by the neighbor
p.(None): who has sought the amicable settlement. If no amicable settlement can be reached, these costs in the litigation are the same as pre-litigation costs
p.(None): to treat.
p.(None): (4) The plaintiff has to attach to the suit a confirmation from the arbitration board, the court or the mediator that no amicable settlement
p.(None): could be achieved.
p.(None): V. SECTION
p.(None): Genetic engineering commission and genetic engineering book
p.(None): Establishment of a genetic engineering commission
p.(None): Section 80. For advice on all questions arising from the implementation of this law and for the preparation of the genetic engineering book, contact the
p.(None): Federal Ministry of Health and Women set up the Genetic Engineering Commission (commission) and its scientific committees.
...
p.(None): Instructions bound by the authority. A dismissal has to take place in particular if the agent does not or only insufficiently fulfills his tasks, or
p.(None): the requirements under which the order was placed no longer apply.
p.(None): Restoring the environment
p.(None): Section 101a. (1) When working with GMOs or when releasing them, the environment is affected by the properties of the GMOs, which are caused by genetic engineering changes
p.(None): are so significantly impaired that the security according to § 1 Z 1 is not guaranteed, the authority has the operator to that extent to restore the
p.(None): Environment or measures necessary to prevent further environmental damage. In the event of imminent danger, the authority has the
p.(None): take the necessary measures yourself (Section 103); the same applies if the operator cannot be determined or for legal or other reasons
p.(None): Is unable to carry out the necessary measures. The authority has to reimburse the operator for the costs incurred by it
p.(None): Impose measures.
p.(None): (2) If the rights of third parties are affected by measures in accordance with paragraph 1, these have such interference, in particular the use and access of
p.(None): Tolerate land to the extent that this proves to be absolutely necessary.
p.(None): (3) Anyone who takes measures in accordance with paragraph 1 of his property, his real rights, his obligatory rights of use or his rights of use in the sense
p.(None): of the Basic Law 1951, Federal Law Gazette No. 103, cannot be used in the manner or to the extent to which it is entitled on the basis of existing rights
p.(None): To compensate operators appropriately. If no agreement can be reached, the amount of the compensation must be determined by the authority,
p.(None): §§ 18 to 20a of the Federal Roads Act 1971, Federal Law Gazette No. 286, are to be applied analogously in the respectively applicable version. An appeal against that
p.(None): Deciding on the amount of compensation is not permitted. However, the parties are free to do so within three months of issuing the decision
p.(None): To apply for a decision on the amount of compensation to the district court in whose district the environmental impact has occurred. With this
p.(None): Referral to the district court will invalidate the amount of the compensation.
p.(None): Measures in the event of release without authorization
p.(None): Section 101b. (1) If a release was carried out contrary to the provision of Section 37 (1) without prior approval, the authority has the person who
p.(None): this release has carried out the removal of the released GMOs as well as any other measures that are state of the art
p.(None): and technology to ensure security (§ 1 Z 1), to keep the spread of this GMO including its genetic material and to ensure the
p.(None): released GMOs are appropriate and necessary.
p.(None): (2) The authority shall confiscate released GMOs without prior approval; Section 109 (4), second and third sentences apply to such
p.(None): To apply GMOs.
p.(None): Genetic Engineering register
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p.(None): (2) If the requirements for issuing a decision pursuant to Paragraph 1 no longer exist, the authority has the request with the decision
p.(None): revoke the measures taken immediately.
p.(None): IX. SECTION
p.(None): The authorization expires
p.(None): Section 104. (1) The right to carry out a work or series of work with GMOs or a release expires three years after their expiry
p.(None): Registration or approval if the work or series of GMO or release work has not started within this period.
p.(None): (2) The authority may, upon request, extend the deadline in accordance with paragraph 1 for a significant reason by a maximum of one year if the security (§ 1 no. 1)
p.(None): the state of the art in science and technology is still guaranteed.
p.(None): X. SECTION
p.(None): Confidentiality of data and traffic
p.(None): Confidentiality of data in the inception process
p.(None): Section 105. (1) Data recognized by the authority as confidential shall not be made available to the public, even during the inception process.
p.(None): (2) Each applicant or operator can use the documents to be submitted by him under this Federal Act, provided that the documents contained therein
p.(None): information
p.(None): a) international relations and national defense,
p.(None): b) public security,
p.(None): c) Matters pending before the court or subject to, or subject to, preliminary proceedings (including disciplinary proceedings)
p.(None): The subject of preliminary proceedings are
p.(None): d) business and trade secrets including intellectual property,
p.(None): e) the confidentiality of personal data or files,
p.(None): f) documents that have been transmitted by a third party who was not legally obliged to do so,
p.(None): (g) information the disclosure of which would further increase the likelihood of environmental damage in the area concerned;
p.(None): touched, the data that are treated confidentially and thus should not be made available to the public even in the disclosure process. In
p.(None): In such cases, a verifiable justification must be given. After hearing the applicant or applicant, the authority decides which data as
p.(None): be recognized confidentially.
p.(None): (3) Under no circumstances may the following data be recognized as confidential:
p.(None): 1. General description of the GMO;
p.(None): 2. Name and address of the applicant or applicant;
p.(None): 3. a) Security level, containment measures and place of work with GMOs;
p.(None): b) purpose of release and place of release;
p.(None): 4. methods and plans for GMO monitoring and emergency response;
p.(None): 5. Assessment of the foreseeable effects, in particular the effects that are detrimental to safety (§ 1 no. 1).
p.(None): (4) The regulations according to paragraphs 1 to 3 on the confidentiality of data in the disclosure process also apply in relation to the others at the official level
p.(None): Procedure for authorizing a release involved.
p.(None): Transmission of data
p.(None): Section 106. The data to be disclosed to the authority in accordance with this federal law may be collected and processed by the authority. personal
p.(None): and confidential data may only be transmitted to
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Social / Racial Minority
Searching for indicator minority:
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p.(None): to submit a reasoned opinion on the registration or the application in writing by the authority.
p.(None): (2) To prepare the opinion of the scientific committee, two selected according to the provisions of the rules of procedure
p.(None): Rapporteur made a proposal for the opinion to be delivered. The scientific committee decides by simple majority. The vote can also
p.(None): in writing; if no report is accepted in this way up to four days before the deadlines specified in Paragraph 1, the Chairman shall
p.(None): in any case to convene a meeting.
p.(None): (3) If the scientific committee does not adopt an opinion within the time limits specified in paragraph 1, the rapporteurs shall propose it
p.(None): and immediately present the minutes of the meeting to the authority.
p.(None): Consultation of the Commission and its scientific committees
p.(None): § 92. (1) The meetings of the commission and its scientific committees are to be scheduled by the chairman in such a way that the authority is legally responsible
p.(None): can perform the tasks assigned on time.
p.(None): (2) The meetings and votes of the Commission and its scientific committees are not public. The applicant or applicant can:
p.(None): Information can be loaded.
p.(None): (3) The results of the meetings are to be recorded in writing in a protocol; this must be the result of the vote, the reasoning, the
p.(None): Voting ratio and any minority votes at the request of the member remaining in the minority. The Scientific Committee
p.(None): no expert opinion accepted (section 91 (3)), the minutes also include statements made by individual members of the scientific committee on the
p.(None): Registration or the application to include.
p.(None): (4) The chairpersons of the scientific committees shall invite all members of their committee to meetings if the following
p.(None): Items to be advised or decided:
p.(None): 1. Preparation of sections of the genetic engineering book (§ 99),
p.(None): 2. Comments on draft regulations,
p.(None): 3rd activity report (Section 93 (1)),
p.(None): 4. Posting the representatives to the Genetic Engineering Commission (section 81 (1) 3).
p.(None): reporting requirements
p.(None): § 93. (1) The permanent scientific committees have to write to the Commission on March 1st of each year a report on the activity
p.(None): to transmit past calendar year.
p.(None): (2) The activity report has a summary of those in the reporting period
p.(None): 1. statements of the expert opinions important for safety (§ 1 Z 1),
p.(None): 2. Work carried out to prepare certain sections of the genetic engineering book and
p.(None): 3. treated technical problems
p.(None): to contain.
p.(None): (3) The standing scientific committees have given the Commission the part of the report on the applications that concerns their area of responsibility
p.(None): genetic engineering (Section 99 (5)).
p.(None): Members of the commission and its scientific committees
p.(None): § 94. (1) The term of office of a member or substitute member of the commission or a member of its scientific committees ends with
p.(None): 1. timing,
p.(None): 2nd death,
p.(None): 3. Removal via proposal of the nominating position (s),
p.(None): 4. Resignation of the member or substitute member or
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Social / Threat of Stigma
Searching for indicator threat:
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p.(None): Does not provide the necessary aids or information for investigation and monitoring measures,
p.(None): 46. does not follow or oppose the provisional coercive measures ordered pursuant to Section 103 (1),
p.(None): 47. contrary to the provisions of section 108 (7), does not report that a clinical trial has been carried out for the purpose of somatic gene therapy.
p.(None): (3a) Whoever commits the provisions of one of the legal provisions listed in § 100a, unless the offense does not constitute the offense according to the in
p.(None): Section 100a (1) of the federal acts constitutes a criminal offense, constitutes an administrative offense and is subject to a fine of up to € 7,260.00.
p.(None): (4) Products within the meaning of Section 54 (1) that are placed on the market contrary to the provisions of this Federal Act are to be accepted by the authority
p.(None): confiscate; A notice of the confiscation must be issued within three days. The expiry of such products is in the administrative criminal proceedings
p.(None): pronounce; if the objective fact in the sense of the first sentence is present, then the expiration must be pronounced even if no specific person is concerned
p.(None): this administrative offense can be prosecuted or punished. The confiscation and the forfeiture have to take place regardless of whom
p.(None): Products belong.
p.(None): (5) The confiscation and the forfeiture within the meaning of paragraph 4 shall be omitted if the facts of paragraph 2 no. 2 are not realized and according to
p.(None): State of the art in science and technology there is no threat to security (Section 1 no. 1).
p.(None): (6) In the case of para. 2 no. 1, the administrative criminal authority can, in the decision declaring the expiry, order that the expired GMO from the
p.(None): these GMOs are to be harmlessly disposed of at the time of the illegal release or the costs of the harmless disposal are to be attributed to them
p.(None): has to wear.
p.(None): (7) The administrative criminal authority can lift the seizure upon request and refrain from forfeiture if the person concerned about this GMO at the time of the
p.(None): unlawful release ensures that the person who disposes of it can be harmlessly disposed of or otherwise used legally, if none
p.(None): Endangering security (§ 1 Z 1) is to be feared.
p.(None): References to other federal laws
p.(None): Section 110. (1) Insofar as other federal laws are referred to in this federal law, these are to be understood in their respectively applicable version.
p.(None): (2) This federal law does not affect the validity of other federal regulations.
p.(None): completion
p.(None): Section 111. The following are entrusted with the implementation of this federal law:
p.(None): 1. With regard to the ordinance to be issued pursuant to Section 8 of the Federal Minister of Health and Women in agreement with the Federal Minister of Agriculture
p.(None): and forestry, environment and water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and
p.(None): Culture,
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Social / Trade Union Membership
Searching for indicator union:
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p.(None): and forestry (note: correct: Federal Minister of Agriculture, Forestry, Environment and Water Management), the Federal Minister of Economics and Labor and
p.(None): to determine the Federal Minister of Education, Science and Culture more detailed provisions on the content, type and form of the records in accordance with Section 52
p.(None): PART B
p.(None): marketing
p.(None): authorization
p.(None): Section 54. (1) The placing on the market of products consisting of or containing GMOs requires the approval of the authority; in this
p.(None): Approval is to indicate the intended use.
p.(None): (2) The placing on the market of an already approved product for a different use than that specified in the marketing authorization
p.(None): requires a separate approval.
p.(None): (3) According to this Federal Act, no authorization is required for placing products on the market
p.(None): 1. if products are used as intended for the manufacture of which the placing on the market has already been approved in accordance with this Federal Act
p.(None): become or have been
p.(None): 2. for products that fall within the scope of Regulation (EC) No. 1829/2003 on genetically modified food and feed.
p.(None): In these cases, sections 55 to 63 of this Federal Act, with the exception of section 62c (1), do not apply.
p.(None): (4) Without prejudice to Section 60, the authorization for placing on the market by the authority is equivalent to the authorization to place it on the market by the authorities
p.(None): of another member state of the European Union or the EEA in application of Directive 90/220 / EEC or Directive 2001/18 / EC.
p.(None): Applicants and application documents
p.(None): Section 55. (1) Anyone who, as a manufacturer or importer, wishes to place a product on the market within the meaning of Section 54 (1) has previously applied for approval from
p.(None): Placing on the market.
p.(None): (2) The application must contain the following information:
p.(None): 1. the information in accordance with § 37 Paragraph 2 No. 1, insofar as these are not only of importance for a specific release. This information must be provided by the
p.(None): Diversity of places of application of the product (§ 54 para. 1) take into account and information about within the framework of releases
p.(None): Data and results obtained regarding the effects of release or application of the product on safety (§ 1 Z 1)
p.(None): contain,
p.(None): 2. the name and a precise description of the product in terms of genetic engineering and corresponding to the state of the art
p.(None): changed special properties,
p.(None): 3. the name and address of the applicant or of the person established in the Community responsible for the placing on the market,
p.(None): 4. description of the intended use of the product and the planned spatial distribution,
p.(None): 5. conditions for placing on the market, including special conditions for the use and handling of the product,
p.(None): 6. The intended packaging and labeling on a label or in an accompanying document that at least meet the requirements of Section 62
p.(None): got to,
p.(None): 7. further specific information regarding the safe use of the product,
p.(None): 8. a proposal for the validity of the permit, which may not exceed 10 years,
p.(None): 9. a surveillance plan, including a proposal for the period for which the surveillance plan is to apply; this period can be different
p.(None): than the proposed period of approval,
...
p.(None): inform and, if necessary, offer to take back the products quickly and properly.
p.(None): Official procedure and official decision
p.(None): Section 58. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application as well as the attached documents
p.(None): Confirm receipt of receipt or otherwise in writing.
p.(None): (2) Before deciding whether to place the product on the market, the authority shall have an opinion from the responsible scientific committee of the
p.(None): GMO commission.
p.(None): (3) Insofar as this is necessary for the assessment of the approval requirements in accordance with Paragraph 4, the authority has to provide the applicant with a
p.(None): Justification to provide further information on how to improve the application.
p.(None): (4) The authority has a copy of the application and one without unnecessary postponement, but at the latest within 90 days of receipt of the application
p.(None): Assessment report to be drawn up in accordance with the guidelines set out in Annex VI to Directive 2001/18 / EC, together with a description of the conditions under which the
p.(None): Approval of the product is proposed to be forwarded to the European Commission if
p.(None): 1. the application is complete and
p.(None): 2. a) a release of the GMO contained in the product was approved in Austria within the meaning of this Federal Act or
p.(None): b) a release of the GMO contained in the product in another in accordance with Directive 90/220 / EEC or Directive 2001/18 / EC
p.(None): Member State of the European Union or the EEA or
p.(None): c) the applicant proves that the conditions for approval of the release (Section 40 (1) nos. 1 and 2) of the GMO contained in the product
p.(None): are given, and
p.(None): 3. according to the state of the art in science and technology, in particular on the basis of a positive safety assessment recorded in the assessment report
p.(None): the placing on the market of the product is not expected to have any adverse consequences for safety (Section 1 no. 1). It also takes that into account
p.(None): Requirement that marker genes in GMOs mediate resistance to antibiotics used in human or veterinary medicine and the harmful
p.(None): Can no longer have an impact on safety (§ 1 Z 1) in products that are placed on the market after December 31, 2004
p.(None): be used.
p.(None): (5) If one of the conditions specified in Paragraph 4 Nos. 1 to 3 does not exist, the authority has
p.(None): 1. to send the applicant her negative evaluation report immediately after its completion as part of the result of the investigation
p.(None): to transfer,
p.(None): 2. the European Commission no earlier than 15 days after the transmission in accordance with Z 1 and no later than 15 days after the deadline specified in Paragraph 4
p.(None): To submit the evaluation report and
p.(None): 3. to prohibit the placing on the market of the product immediately after the investigation has been completed.
p.(None): (6) In the event of a positive assessment in accordance with paragraph 4, the authority shall, within 30 days of the completion of the Community procedure in accordance with
p.(None): 15 and 18 of Directive 2001/18 / EC to grant approval if
p.(None): 1. Neither the European Commission nor a member state of the European Union raised a reasoned objection to the placing on the market
p.(None): have any open questions with the European Commission and the Member States concerned, or
p.(None): 2. in the event of an objection by the European Commission or a member state of the European Union after carrying out the procedure pursuant to
p.(None): Art. 30 (2) of Directive 2001/18 / EC a positive decision has been issued by the European Commission or the Council. Otherwise the authority
p.(None): to prohibit the placing on the market.
p.(None): (7) The notification of the result of the investigation to the applicant and the order to improve the application or the application documents
p.(None): inhibit the period according to paragraph 4 until the applicant receives the opinion or the improvement.
p.(None): (8) The authorization to place plant protection products on the market (Section 2 of the Plant Protection Products Act, Federal Law Gazette No. 476/1990) that contain or derive from GMOs
p.(None): such exist must be applied for at the authority responsible for the implementation of the Plant Protection Products Act; according to the procedure
p.(None): Plant Protection Products Act to decide on the application in accordance with paragraphs 1 to 7 and to apply sections 60 and 61. The approval according to § 8
p.(None): The Plant Protection Products Act replaces, within the scope of its validity, the authorization to place it on the market required by this Federal Act.
p.(None): Content of the approval
p.(None): Section 58a. (1) The conditions and conditions for the type and scope of the placing on the market and for the use of the product are in the authorization
...
p.(None): Renewal of approval
p.(None): Section 58b. (1) No later than nine months before the expiry of a license granted in accordance with Section 58 (6), the license holder can contact the
p.(None): Authority to submit an application for renewal of approval. This application must contain the following information and documents:
p.(None): 1. a copy of the notification of the original approval;
p.(None): 2. a report on the results of the monitoring carried out in accordance with Section 58c;
p.(None): 3. other new information which has become known with regard to the safety hazards arising from the product (§ 1 no. 1), and
p.(None): 4. Where appropriate, a proposal to change or add to the terms of the original approval, particularly with regard to the future one
p.(None): Monitoring and the limitation of the renewed approval.
p.(None): (2) Section 58 (1) to (3) apply mutatis mutandis.
p.(None): (3) After the application has been checked for completeness, the authority shall immediately send a copy to the European Commission
p.(None): Application and an assessment report prepared in accordance with Section 58 (4). In particular, this report must contain statements as to whether and under which
p.(None): Conditions the product should or should not remain on the market. The applicant must also be informed immediately.
p.(None): (4) In the event of a positive assessment in accordance with paragraph 3, the authority shall, within 30 days of the completion of the Community procedure in accordance with Art. 17
p.(None): of Directive 2001/18 / EC to renew the approval if
p.(None): 1. Neither the European Commission nor a member state of the European Union raised a reasoned objection to the placing on the market
p.(None): has or any open questions have been clarified with the European Commission and the Member States concerned, or
p.(None): 2. in the event of an objection from the European Commission or a Member State after carrying out the procedure pursuant to Article 30 (2) of the Directive
p.(None): 2001/18 / EG a positive decision of the European Commission or the Council has been made. Otherwise the authority has the further placing on the market
p.(None): Prohibit bringing the product.
p.(None): (5) The period of renewal of the authorization may be subject to a need to review the effects of the product
p.(None): limited to security (§ 1 Z 1). In principle, the time limit should not exceed 10 years, but it can be shorter in justified cases
p.(None): or be longer.
p.(None): (6) In the case of a negative evaluation report in accordance with paragraph 3, which also results from the Community law procedure in accordance with Article 17 of the Directive
p.(None): 2001/18 / EC is not invalidated, the authority must prohibit the further placing on the market of the product.
p.(None): (7) Until the final decision on an application in accordance with paragraph 1, the product may continue in accordance with the conditions of the original approval
p.(None): be placed on the market.
p.(None): (8) Section 58a applies mutatis mutandis.
p.(None): monitoring obligation
p.(None): Section 58c. (1) The license holder is responsible for carrying out a surveillance in accordance with the approval in Section 58a or, if applicable, in the
p.(None): Renewal of the approval according to § 58b prescribed monitoring plan and responsible for the corresponding reporting to the authority.
p.(None): The authority has to forward the reports to the European Commission and the other member states of the European Union. It has the results of
p.(None): Make surveillance accessible to the public on their website.
p.(None): (2) The authority can, based on the reports in accordance with paragraph 1, to avoid adverse consequences for security (§ 1 Z 1) within the scope of the approval
p.(None): or the renewal of the permit change the surveillance plan.
p.(None): statutory authorization
p.(None): Section 58d. The Federal Minister of Health and Women has, insofar as this is in order to clarify the monitoring obligations of the license holder and to
p.(None): Avoiding adverse effects on safety (§ 1 Z 1) is necessary, taking into account Annex VII of Directive 2001/18 / EC and the
p.(None): guidelines supplementing this appendix after consulting the responsible scientific committee of the genetic engineering commission in agreement with the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of Education, Science and Culture by ordinance
p.(None): to lay down further provisions for the preparation and implementation of the monitoring plan.
p.(None): Change of approval
p.(None): Section 58e. Does the authority receive new information after the approval in accordance with Section 58a or after a renewal of the approval in accordance with Section 58d
p.(None): Circumstances according to which the product authorized to be placed on the market could jeopardize safety (Section 1 (1)) will lead it within 60 days
p.(None): Information including any reasoned suggestions for a change or cancellation of the approval to the European Commission for the purpose
p.(None): Initiation of a procedure pursuant to Article 20 (3) of Directive 2001/18 / EC. According to the results of this procedure, the authority has the conditions
p.(None): change the approval or renewal of the approval or revoke the approval or renewal of the approval.
p.(None): scope of authorization
p.(None): Section 59. The supply and use of products (Section 54 (1)), the placing on the market of which is authorized in accordance with this Federal Act, requires in
p.(None): Within the scope of this approval, no further approval under this federal law.
p.(None): Temporary bans or restrictions
p.(None): Section 60. (1) Has the authority after granting a license or renewing a license based on new or additional information
p.(None): or based on a re-evaluation of existing information on the basis of new or additional scientific knowledge justified reason for
p.(None): The Federal Minister of Health and. Can assume that the product approved for placing on the market poses a risk to safety (§ 1 no. 1)
p.(None): Women after placing on the market the responsible scientific committee of the genetic engineering commission by regulation
p.(None): Temporarily restrict or prohibit the use of this product in Austria.
p.(None): (2) The Authority shall immediately inform the European Commission, the other Member States of the European Union and the public of the
p.(None): Measures taken according to paragraph 1 and their justification. The authority complies with those in the Community procedure pursuant to Art. 30 Para
p.(None): 2001/18 / EG bound by these measures decisions of the European Commission or the Council.
p.(None): Safety measures
p.(None): Section 61. In cases of imminent danger to security (Section 1 (1)), the Federal Minister of Health and Women has the manufacturer or importer through
p.(None): To notify the public concerned about the risks posed by the products and about safety and elimination measures
p.(None): inform and, if necessary, request the return of these products.
p.(None): Packaging and labeling
p.(None): Section 62. (1) Products in accordance with Section 54 may only be placed on the market if their labeling and packaging comply with the approval requirements
p.(None): stipulated requirements. In any case, the marking must contain:
p.(None): 1. the commercial name of the product,
p.(None): 2. the express reference that the product contains genetically modified organisms (Section 58a (1) no. 6),
p.(None): 3. the exact name of the GMO (s), including the identification code (s) provided for the GMO in question,
p.(None): 4. Name and address of the person responsible for the placing on the market in the Community (manufacturer, importer or distributor) and
p.(None): 5. the reference to the registration of the product or the GMO (s) contained therein in the designated register of the European Commission
p.(None): in accordance with Art. 31 Para. 2 of Directive 2001/18 / EC including information about the possibility of access to this register.
...
p.(None): (5) To determine that the presence of GMOs is unintentional or technically unavoidable, the person who places a product on the market or
p.(None): has demonstrated, at the request of the authority or the supervisory bodies, that appropriate measures have been taken to ensure the existence of the or
p.(None): to avoid GMOs.
p.(None): (6) The Federal Minister for Health and Women is authorized to implement implementing decisions in the regulatory committee procedure in accordance with
p.(None): Directive 2001/18 / EC or Regulation (EC) № 1829/2003, the threshold values specified in paragraphs 2 to 4 are taken into account by regulation
p.(None): to adapt security (§ 1 Z 1) to the state of the art in science and technology. With the coming into force of a regulation regulating this subject
p.(None): corresponding provisions of paragraphs 2 to 4 are invalid.
p.(None): (7) The analyzes to determine whether the threshold values in accordance with paragraphs 2 to 4 have been exceeded must be carried out according to procedures for the examination and sampling
p.(None): that have been published as national or international standards or by national or international working groups, preferably by the
p.(None): Community reference laboratory of the European Commission have been validated. If such procedures are not available, other methods may only be used
p.(None): if they are suitable for the application and have been validated for them in comparative studies.
p.(None): (8) Threshold values for the unintentional or technically unavoidable presence of GMOs in products according to seed law,
p.(None): food or feed law regulations or directly applicable European Union legislation
p.(None): not affected by paragraphs 2 to 6.
p.(None): Social intolerance
p.(None): Section 63. (1) Social intolerance of products according to Section 54 (1) exists if it can be assumed on the basis of factual bases that such
p.(None): Products could lead to an unbalanced burden on society or social groups, and if this burden for the
p.(None): Society appears unacceptable for economic, social or moral reasons.
p.(None): (2) The Federal Government shall, on the proposal of the Federal Minister for Health and Women, place such products on the commercial market in accordance with
p.(None): To prohibit section 54 (1) by ordinance, the placing of which on the market suggests a social intolerance.
p.(None): (3) After hearing the Genetic Engineering Commission, the Federal Minister for Health and Women must submit a proposal in accordance with paragraph 2 as soon as
p.(None): It is foreseeable that such products could be commercially placed on the Austrian market.
p.(None): Restriction of GMO approval
p.(None): Section 63a. (1) The Federal Minister of Health may, during the procedure for the authorization of a specific GMO in accordance with Directive 2001/18 / EC or the
p.(None): Regulation (EC) № 1829/2003 or during the renewal of a consent or authorization the applicant / applicant by way of European
p.(None): Commission to do so that the geographical scope of the written consent or approval is changed so that the federal territory
p.(None): is totally or partially excluded from cultivation.
p.(None): (2) The Federal Minister of Health has an appointment pursuant to Paragraph 1 no later than 45 days after forwarding the assessment report pursuant to Art. 14
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p.(None): to treat.
p.(None): (4) The plaintiff has to attach to the suit a confirmation from the arbitration board, the court or the mediator that no amicable settlement
p.(None): could be achieved.
p.(None): V. SECTION
p.(None): Genetic engineering commission and genetic engineering book
p.(None): Establishment of a genetic engineering commission
p.(None): Section 80. For advice on all questions arising from the implementation of this law and for the preparation of the genetic engineering book, contact the
p.(None): Federal Ministry of Health and Women set up the Genetic Engineering Commission (commission) and its scientific committees.
p.(None): Composition of the Genetic Engineering Commission
p.(None): Section 81. (1) The Commission must belong to:
p.(None): 1. The Commission must include:
p.(None): a) two representatives of the Federal Ministry of Health and Women, one of them an expert in women's affairs,
p.(None): b) two representatives of the Federal Ministry of Economics and Labor, one of them an expert in the field of employee protection,
p.(None): c) two representatives of the Federal Ministry of Agriculture, Forestry, Environment and Water Management, one each from the fields of agriculture and
p.(None): Environment,
p.(None): d) a representative of the Federal Ministry of Education, Science and Culture -
p.(None): the sending federal ministers have the right to propose.
p.(None): 2. a) a representative of the Federal Chamber of Labor,
p.(None): b) a representative of the Austrian Trade Union Confederation,
p.(None): c) a representative of the President's Conference of the Austrian Chambers of Agriculture,
p.(None): d) a representative of the Austrian Chamber of Commerce - the sending organizations have the right to propose;
p.(None): 3. one representative each of the scientific committees - the sending committees have the right to propose;
p.(None): 4. eight experts who have experience in the fields of microbiology, cell biology, virology, molecular biology, hygiene, ecology,
p.(None): Security technology and sociology. Each of the areas mentioned must be represented by at least one expert. At least five
p.(None): these experts must have worked with GMOs; the Austrian Academy of Sciences has the right to propose;
p.(None): 5. One expert each for questions of molecular biology on the proposal of the Austrian Chamber of Commerce and the Austrian one
p.(None): Federation of Trade Unions;
p.(None): 6. a) a representative of scientific philosophy - the Austrian Rectors' Conference has the right to propose,
p.(None): b) a representative of a theological faculty has the right to propose the theological faculties of Austria,
p.(None): c) a doctor - the three medical universities in Austria have the right to propose,
p.(None): d) a person familiar with environmental problems - the Federal Environment Agency has the right to propose,
p.(None): e) a representative to be proposed by the Austrian Working Group on Rehabilitation.
p.(None): (2) The members of the commission are from the Federal Minister of Health and Women on the basis of the proposals in accordance with paragraph 1 for a period of five years
p.(None): to order. A substitute member must be appointed for each member - also for five years; the right to propose exists in the same way as for the
p.(None): representing members.
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Social / Victim of Abuse
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p.(None): non-public part of the gene therapy register accessible.
p.(None): IVa. section
p.(None): Civil liability
p.(None): Personal injury and property damage
p.(None): Section 79a. (1) Is caused when working with GMOs (§ 4 Z 4) or when they are released (§ 4 Z 20) as a result of the genetic modification
p.(None): Characteristics of the organism A person has been killed, injured on the body or damaged in health or damaged a physical thing
p.(None): Operator (§ 4 Z 18) to compensate for the damage. The operator is liable for work and releases even if there is already a permit for the release
p.(None): or has been granted for placing on the market as long as the product (Section 54 (1)) has not yet been placed on the market in accordance with the approval.
p.(None): (2) The operator's liability also extends to damage caused by the properties of the GMO caused by the genetic modification
p.(None): Connection with its other dangerous properties.
p.(None): Environmental degradation
p.(None): Section 79b. Is the damage to a physical thing also a significant impairment of the environment (§ 101a para. 1) and is a restoration of the
p.(None): the previous state is not feasible by the liable operator or if the operator is not ready to restore it, the injured party also deserves it
p.(None): then the reimbursement of the costs of the restoration if these costs exceed the value of the damaged item. The victim can
p.(None): Demand recovery costs in advance, however, has an advance payment in excess of the value of the damaged item
p.(None): to be refunded if it does not restore the previous condition within a reasonable time.
p.(None): Disclaimer of liability
p.(None): Section 79c. The liability of the operator is excluded if the damage
p.(None): 1. through an act of war, similar hostilities, a civil war, an uprising or an extraordinary, inevitable and its consequences
p.(None): reasonably unavoidable natural event,
p.(None): 2. by a third party acting with the intention of causing damage and not participating in the activity pursuant to Section 79a despite compliance with all according to the type of activity
p.(None): security measures required in accordance with sections 10 and 45 or
p.(None): 3. in compliance with a legal regulation or a special official order or coercive measure
p.(None): has been caused.
p.(None): burden of proof
p.(None): Section 79d. If a GMO that was the subject of an activity pursuant to Section 79a is suitable for causing the damage in accordance with the circumstances of the individual case, then
p.(None): suspects that it caused the damage as a result of its properties caused by the genetic modification. The presumption is disproved if it is
p.(None): the operator believes that the damage was not caused by these properties or that it was caused in the sense of Section 79a (2).
p.(None): Liability, recourse and compensation for several operators
p.(None): Section 79e. (1) If several persons are liable according to this federal law or other legal provisions, they are liable insofar as the individual
p.(None): Do not let liability-related damage be distinguished, to the undivided hand. The same applies if several operators have a harmful activity
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Social / Women
Searching for indicator women:
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p.(None): no adverse consequences for security (§ 1 Z 1) are to be expected.
p.(None): (6) When using GMOs on animals, the safety classification of this work is based on the risk group of the GMO used
p.(None): Consideration of any biological safety measures envisaged.
p.(None): (7) If biological safety measures are used, they can be classified in a lower safety level than that of the GMO risk group
p.(None): corresponds if the biological safety measures reduce the risk.
p.(None): (8) The security classification must be recorded in writing and justified. In the case of working with GVM, the cultural volume of the planned one is also included
p.(None): To indicate work.
p.(None): Approval procedure
p.(None): § 7. (1) If there are doubts about the security level in which a certain work with GMOs can be classified, the security measures are the higher ones
p.(None): Security level apply, unless it is sufficiently proven in agreement with the authority that the application of less stringent measures
p.(None): is justified.
p.(None): (2) In the case of paragraph 1, the authority has ex officio or at the request of the operator after consulting the responsible scientific committee of the
p.(None): Genetic Engineering Commission to determine the security level of this work with GMOs in consideration of the provisions of § 6.
p.(None): statutory authorization
p.(None): § 8. The Federal Minister of Health and Women has to guarantee security (§ 1 2 1) according to the state of the art in science and technology
p.(None): Consideration of international guidelines and recommendations after consulting the responsible scientific committee of the genetic engineering commission
p.(None): Ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor
p.(None): and the Federal Minister of Education, Science and Culture
p.(None): 1. Establish criteria for the security classification and the allocation of donor and recipient organisms to risk groups and
p.(None): 2. To give examples of the assignment of donor and recipient organisms to risk groups.
p.(None): Transgenic animals
p.(None): § 9. (1) Work on the production of transgenic vertebrates, with which a breakthrough of the species boundaries is connected, and work with transgenic
p.(None): Vertebrates, which were produced by breaking the species boundaries, are only for the purposes of biomedicine and developmental research
p.(None): allowed.
p.(None): (2) A breach of the species limit within the meaning of paragraph 1 exists if the identity of the species of the recipient organism is taken into account
p.(None): Reproduction and in terms of the essential characteristics of its body structure, its physiological functions and its performance is not preserved.
p.(None): (3) There are doubts as to whether breakthrough of a work on the production of transgenic vertebrates or a work on transgenic vertebrates
p.(None): Is bound by the species limit, the authority has received a request from the operator after consulting the scientific committee for working with GMOs in the
...
p.(None): of the accident
p.(None): 1. the course of the accident,
p.(None): 2. the name, risk group and quantity of the GVM that has left,
p.(None): 3. all information necessary to assess the impact of the accident on public health and the environment,
p.(None): 4. the emergency measures taken and
p.(None): 5. the measures to eliminate the consequences of the accident
p.(None): to be communicated in writing.
p.(None): (3) When working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale, the authority is from
p.(None): notify the accident that has occurred immediately by telephone or fax. The operator has, if according to the state of science and technology
p.(None): a risk to the health of the employees or the residents of the genetic engineering plant is to be assumed by these persons immediately from the accident
p.(None): inform and recommend appropriate behavioral measures.
p.(None): (4) In the event of accidents in accordance with paragraph 3, the operator and, if necessary, the authority must carry out a monitoring (monitoring) of the effects of the accident on the
p.(None): Security (§ 1 Z 1) to perform.
p.(None): (5) In the event of accidents in accordance with paragraph 3, the local governor, the local administrative authority and the municipality are responsible
p.(None): communicate.
p.(None): statutory authorization
p.(None): § 12. The Federal Minister of Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission under
p.(None): Consideration of the principles mentioned in § 3 paragraphs 1 and 2 by ordinance in agreement with the Federal Minister of Agriculture and Forestry,
p.(None): Environment and Water Management, the Federal Minister of Economics and Labor and with the Federal Minister of Education, Science and Culture and according to the status
p.(None): of science and technology and taking into account relevant EU regulations and other international guidelines and recommendations
p.(None): provisions
p.(None): 1. About organizational and technical security measures when working with GMOs in closed systems that are appropriate for the respective security level
p.(None): special attention is paid to the type of work to be carried out with GMOs,
p.(None): 2. requirements for genetic engineering systems to prevent, limit and eliminate the effects of accidents,
p.(None): 3. about criteria for the security measures in rooms for keeping transgenic plants or animals,
p.(None): 4. general criteria for assessing the effectiveness of biological safety measures and
p.(None): 5. for the preparation and content of emergency plans
p.(None): and to provide examples of recognized host-vector systems.
p.(None): statutory authorization
p.(None): § 12a. (1) The Federal Minister for Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission
p.(None): by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and
p.(None): Work and the Federal Minister of Education, Science and Culture according to the state of the art in science and technology, taking into account Annex II Part C
p.(None): of Directive 90/219 / EEC on the use of genetically modified microorganisms in closed systems in the currently applicable version, types of
p.(None): List GMOs that are safe for human health and the environment.
p.(None): (2) Working with GMOs in closed systems, which only include types of GMOs that are included in this list
p.(None): not the requirements of sections II. and IVa.
p.(None): operator
p.(None): § 13. (1) According to the state of the art in science and technology, the operator has to take the necessary safety measures (§ 10) and to comply with them
p.(None): to care.
p.(None): (2) The operator has all questions of safety with the officer for biosafety (§ 14), the project manager (§ 15) and the committee
p.(None): advice on biosafety (§ 16).
p.(None): (3) By appointing a biosafety officer, a project manager or a biosafety committee, the
p.(None): Responsibility of the operator for compliance with the provisions of this federal law and the administrative acts based thereon are not affected.
p.(None): Biosafety Officer
p.(None): § 14. (1) The operator has a biosafety officer for each genetic engineering system and at least one representative with their
...
p.(None): Agreement with them to release the respective work with GMOs internally,
p.(None): 3. to check whether possible biological safety measures are applicable when working with GMOs, and
p.(None): 4. to prepare a protocol of his examinations according to Z 2 and 3 and, if necessary, of the release (Z 2).
p.(None): (5) If a member leaves the committee for biosafety, the operator must immediately appoint a suitable new member.
p.(None): (6) The operator shall immediately notify the authority of any change of one of the members of the Biosafety Committee, including those for the
p.(None): The person required to provide the replacement person with evidence (paragraph 3).
p.(None): (7) If the authority determines when ordering a replacement person on the basis of the evidence submitted that the person appointed has the right to them
p.(None): does not meet the requirements set, to request the operator, either within a period to be determined by the authority and not more than four weeks
p.(None): to provide outstanding evidence or, in the event of insufficient quali fi cation of the replacement person ordered, appropriate additional training within
p.(None): six months to prove, otherwise the operator has to appoint another suitable person. The assignment, a supplementary training within
p.(None): of six months is not permitted if the member to be replaced has been removed by the operator.
p.(None): (8) The appointment of a committee for biosafety in accordance with paragraph 1 can be waived if working with GMOs only involves storage and
p.(None): includes the internal transport of GMOs.
p.(None): statutory authorization
p.(None): § 17. The Federal Minister of Health and Women, insofar as this is necessary in the interest of security (§ 1 no. 1), according to the state of the art in science
p.(None): and technology and after hearing the responsible scientific committee of the genetic engineering commission by ordinance in agreement with the
p.(None): Federal Minister of Education, Science and Culture detailed provisions on the required experience in working with GMOs and knowledge
p.(None): in particular to adopt safety measures through which the biosafety officers, the project managers and the members of a committee
p.(None): for biological security.
p.(None): Cooperation with other institutions
p.(None): § 18. The Biosafety Officer, the Project Leader and the Biosafety Committee are required to perform their duties
p.(None): Advising the operator with the legal regulations for the protection of existing employees in the plant and with
p.(None): to work together with the officers appointed in this facility to perform environmental protection tasks.
p.(None): Registration of work with GMOs
p.(None): § 19. The operator has the implementation
p.(None): 1. first time working with GVM in a genetic engineering plant in security level 1,
p.(None): 2. first time working with GVM in a genetic engineering facility in security level 2,
p.(None): 3. further work with GVM in a genetic engineering facility in security level 2,
p.(None): 4. first-time work with transgenic plants or animals in a genetic engineering facility,
p.(None): 5. Further work with transgenic plants or animals in a genetic engineering facility, provided that a security classification of security level 1 is not
p.(None): is permissible, and
p.(None): 6. Further work with transgenic vertebrates in security level 1 in a genetic engineering facility
p.(None): Before starting work, register with the authority using the documents specified in Appendix 1. The registrations and the related ones
p.(None): Documents must be submitted in the original and in a copy.
p.(None): Permit applications for working with GMOs
p.(None): § 20. The operator has the authorization to carry out
p.(None): 1. Working with GVM in a genetic engineering system in security level 3 and
p.(None): 2. Working with GVM in a genetic engineering facility in security level 4
p.(None): to be submitted to the authority before starting work, following the documents specified in Appendix 1. The application and the related
p.(None): Documents must be submitted in the original and in a copy.
p.(None): statutory authorization
p.(None): § 21. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of a
p.(None): Procedure for examining a registration in accordance with § 19 or an application in accordance with § 20 and for assessing the requirements in accordance with § 23 is required at
p.(None): Consideration of the guarantee of security (§ 1 Z 1) and on the state of the art in science and after consulting the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Economics and Labor and the
p.(None): Federal Minister of Education, Science and Culture more detailed provisions on content, scope and form of the registration according to § 19 or the application according to
p.(None): Section 20 documents to be issued. The regulation may also require that these documents be used using the information provided by the authority
p.(None): The programs made available must be submitted on electronic data carriers.
p.(None): Official procedure
p.(None): § 22. (1) The authority has the applicant and applicant the receipt and date of receipt of the application or application and the attached
p.(None): Confirm documents immediately by means of an entry stamp or otherwise in writing.
p.(None): (2) The authority has the conformity of the application or the application with the provisions of this Federal Act and those based thereon
p.(None): Regulations, in particular the accuracy and completeness of the documents submitted, the accuracy of the security classification (§ 6) in a security level
p.(None): (§ 5) and, if necessary, the appropriateness of the safety measures (containment and other protective measures), the waste disposal measures
...
p.(None): Scope of application is the registration of work with transgenic animals required by this federal law.
p.(None): (2) The conduct of animal experiments in accordance with the Animal Experiments Act 2012 is prohibited if the requirements of Section 9 or
p.(None): Section 10 does not exist.
p.(None): hearing
p.(None): § 28. (1) The authority has in the cases of § 22 Paragraph 5 No. 2 in the official gazette of the Wiener Zeitung and in the editorial section of two widespread in the federal state
p.(None): Announcing daily newspapers that an application for authorization to work with GMOs has been submitted, documents to the authority during
p.(None): within a period of six weeks for public inspection, a hearing is being held and that everyone is free to attend
p.(None): Attend hearing.
p.(None): (2) The authority shall have the hearing within the framework of the investigation procedure within three weeks of the end of the disclosure for public inspection
p.(None): perform. The authority has the public according to paragraph 1, as well as the members of the responsible scientific committee of the
p.(None): Genetic Engineering Commission, the operator and the members of the Biosafety Committee.
p.(None): (3) The hearing is public and serves to discuss the application and the associated documents. Everyone is allowed to ask questions and ask themselves
p.(None): to comment on the project.
p.(None): (4) Minutes of the public hearing must be drawn up.
p.(None): statutory authorization
p.(None): § 29. The Federal Minister of Health and Women, insofar as this is necessary in the interest of the expediency, speed and simplicity of the hearing,
p.(None): in agreement with the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture by ordinance
p.(None): Provisions regarding the announcement and the course of the consultation process, the type and scope of access to the application and the associated documents
p.(None): with particular attention to the confidentiality of data in accordance with § 105, to determine the schedule and the schedule of the hearing.
p.(None): Due diligence, information and notification requirements
p.(None): § 30. (1) Anyone who works with GMOs has all that is necessary according to the state of the art in science and technology in the interest of safety (§ 1 Z 1)
p.(None): Take precautions and measures.
p.(None): (2) Even after the start of work with GMOs, the operator has to deal with all facts and in connection with the execution of this work
p.(None): To inform circumstances which, according to the state of the art in science and technology, are likely to endanger security (Section 1 no. 1).
p.(None): (3) The operator has the facts and circumstances in accordance with paragraph 2 and the final cessation of all work with GMOs immediately in writing to the authority
p.(None): Report.
p.(None): Change in safety equipment
p.(None): § 31. The operator has any change in the security of the closed system, which according to the state of the art in science and technology
p.(None): Security (§ 1 Z 1) is likely to impair, to report to the authority in writing even after registration or after completion of the approval process.
p.(None): Change of operator
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p.(None): 1. Name and address of the operator and location of the genetic engineering system;
p.(None): 2. Name of the project manager and biosafety officer;
p.(None): 3. designation of the respective work with GMOs;
p.(None): 4. Beginning, completion and safety classification of the work with GMOs or the work series with GMOs and their modification;
p.(None): 5. type of disposal of GMOs;
p.(None): 6. Information about accidents according to § 11 paragraph 2.
p.(None): (3) Other than the work with GMOs listed under paragraph 2 are to be recorded in separate records. In addition to those listed in paragraph 2
p.(None): For information, these records must contain the following information:
p.(None): 1. time of registration of work with GMOs or date and business number of the approval notice;
p.(None): 2. the names of the people directly involved in carrying out the work with GMOs;
p.(None): 3. Security and emergency measures taken.
p.(None): (4) Records of work in security levels 3 or 4 on a large scale must include a in addition to the information according to paragraphs 2 and 3
p.(None): Description of the process control and the devices and equipment used to control the safety measures.
p.(None): (5) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (6) Records of work in security levels 1 or 2 on a small scale must be at least three years after completion of the work or
p.(None): Work series are kept. All other records must be kept for at least five years after completing work with GMOs.
p.(None): statutory authorization
p.(None): § 35. The Federal Minister of Health and Women, insofar as this is in the interest of security (§ 1 Z 1) according to the state of the art in science and technology
p.(None): is necessary, after consulting the responsible scientific committee of the genetic engineering commission by regulation in agreement with the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the type and content of the
p.(None): To set records in accordance with § 34.
p.(None): III. SECTION
p.(None): Release of GMOs and placing products on the market
p.(None): PART A
p.(None): Release of GMOs
p.(None): stage principle
p.(None): Section 36. (1) The release of GMOs may only take place according to the step principle (Section 3 (3)). The following stages must be followed:
p.(None): 1. To a small extent, based on the state of the art in science and technology, unlimited distribution and multiplication of GMOs
p.(None): greatly reduce outside of the test area;
p.(None): 2. Attempt to a large extent, according to the state of the art in science and technology, to spread and multiply GMOs outside
p.(None): to monitor the test area.
p.(None): (2) If, according to the state of the art in science and technology, a risk to safety (§ 1 no. 1) can be excluded when certain GMOs are released,
p.(None): Authorization to request the release of this GMO, even if the stage according to Paragraph 1 No. 1 has not been passed.
p.(None): permit application
p.(None): Section 37. (1) Any release requires approval by the authority.
p.(None): (2) The operator must apply for approval of the release and attach the following information to the application:
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p.(None): Mediate veterinary antibiotics and can have harmful effects on safety (§ 1 Z 1), especially to
p.(None): consider.
p.(None): (3) In the application, data or results from the release of the same GMO or combination of GMOs that the applicant previously used must also be communicated
p.(None): or has applied for or undertaken outside Austria or is currently applying for or undertaking. In the application are also the locations of the
p.(None): to list the results of releases of relevant GMOs known from the literature.
p.(None): (4) The applicant can also refer to the data or results of previous applications by other applicants, provided that this is done in writing
p.(None): Have given consent.
p.(None): (5) If the release is changed in a way that can significantly change the risks to safety (§ 1 Z 1), or the operator either
p.(None): While the authority is reviewing the application or after its approval, new information is available on such risks, so is the applicant
p.(None): committed to immediately
p.(None): 1. to report this information to the authority,
p.(None): 2. review and adapt the measures listed in the application and
p.(None): 3. to take the necessary measures in the interest of security (§ 1 Z 1).
p.(None): (6) The applicant must immediately send a copy of the application (para. 2) and the notification (para. 5) to the Federal Ministry of Agriculture and Forestry,
p.(None): Environment and water management, which submits its opinion on this application to the authority.
p.(None): statutory authorization
p.(None): § 38. (1) The Federal Minister for Health and Women, insofar as this takes into account the expediency, speed and simplicity of a
p.(None): Procedure for examining an application in accordance with Section 37 Paragraphs 2 to 4, for the requirements of information exchange with the European Commission and for
p.(None): Assessment of the prerequisites in accordance with Section 40 (1) is necessary, taking into account safety (Section 1 (1)), the state of the art in science and technology
p.(None): and Community legislation relating to GMOs, in particular Annexes II and III to Directive 2001/18 / EC after consulting the
p.(None): responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture by ordinance
p.(None): Provisions on
p.(None): 1. The content, scope and form of the application in accordance with Section 37 (2) to (4) and the documents to be attached to it
p.(None): 2. the principles and methods to be used when preparing these application documents
p.(None): set. The regulation may also require that these documents be used using the programs provided by the authority
p.(None): to be presented on electronic data carriers.
p.(None): Note for the following provision
p.(None): Regarding para. 3: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): Official procedure
p.(None): Section 39. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application and the attached documents
...
p.(None): to be limited in time or for the implementation and if necessary also for the monitoring after the implementation certain suitable conditions and requirements
p.(None): prescribe.
p.(None): (3) In its decision, the authority takes into account the need to use marker genes in GMOs, the resistance to human or
p.(None): impart antibiotics used in veterinary medicine and can have harmful effects on safety (§ 1 no. 1) in the event of releases up to
p.(None): December 31, 2008.
p.(None): (4) The authority has every decision in accordance with paragraphs 1 to 3 of the European Commission and the federal state in whose area of responsibility the
p.(None): Release should take place.
p.(None): (5) The Authority shall make publicly available information on any release approval on the Authority's website.
p.(None): Inhibition of the deadline
p.(None): § 41. (1) The notification of the result of the investigation to the applicant and the order to improve the application or the
p.(None): The associated documents and the hearing in accordance with section 43 inhibit the period in accordance with section 40 (1) until the applicant has received a statement or
p.(None): of improvement. The hearing pursuant to Section 43 will delay this period for a maximum of 30 days.
p.(None): (2) The notification of the result of the investigation to a party in accordance with Section 39a (1) lines 2 to 6 does not inhibit the period in accordance with Section 40 (1).
p.(None): Simplified official procedure
p.(None): Section 42. (1) The Federal Minister of Health and Women is authorized if sufficient with the release of certain GMOs in certain ecosystems
p.(None): Experience has been gathered, taking into account the state of the art in science and technology and safety (§ 1 no. 1) after consulting the
p.(None): competent scientific committee of the Genetic Engineering Commission to submit an application in accordance with Art. 7 of Directive 2001/18 / EC and to implement a
p.(None): Decision according to Art. 7 of Directive 2001/18 / EC by regulation in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the
p.(None): Implement simplified administrative procedures for the release of such GMOs that are comparable in terms of their safety.
p.(None): (2) The Federal Minister of Health and Women has an ordinance in accordance with paragraph 1 or the decision, a decision in accordance with Art. 7 of the Directive
p.(None): 2001/18 / EC not to be used to inform the European Commission.
p.(None): Note for the following provision
p.(None): Regarding para. 2: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): hearing
p.(None): Section 43. (1) The authority has in the Official Journal of the Wiener Zeitung, in two local daily newspapers and on the notice boards of the municipalities in accordance with Section 39a (1)
p.(None): Z 2 and 3 to announce at the expense of the operator that an application for the release of a GMO has been made, relevant documents to the authority (§ 100),
p.(None): all offices of the state governments and the municipalities in whose local area of responsibility GMOs are to be released during a
p.(None): Period of three weeks for public inspection and that everyone is at liberty to justify the authority within the period for which the information is available
p.(None): Submit objections in writing. The announcement includes persons who, in accordance with Section 39a (1) (4) and (5), are party to the further official procedure
p.(None): to obtain approval for the release, to point out that they have the party position by raising justified written objections
p.(None): can obtain at the same time the requirements for their party position and subsequent explanation of their objections at the hearing.
p.(None): (2) The authority shall schedule a hearing as part of the investigation; this hearing took place within three weeks from the end of the
p.(None): Deadline to be held. The hearing serves to discuss the objections submitted on time; the opponents have the opportunity to get closer
p.(None): To explain their objections. The authority has the right to this hearing to anyone who has submitted timely objections in writing
p.(None): load. This loading can be carried out in the announcement according to paragraph 1. The authority also has to load separately:
p.(None): a) the applicant in accordance with Section 39a (1) 1,
p.(None): b) the municipalities in accordance with Section 39a (1) 2 and 3 if they have raised objections in accordance with Section 1
p.(None): c) the owner of the property in accordance with Section 39a (1) no. 4,
p.(None): d) the neighbors in accordance with Section 39a (1) (5) if they raise objections in accordance with Section 1 and the requirements for their party status are met
p.(None): have demonstrated
p.(None): e) the federal state in accordance with section 39a (1) (6) if it has raised objections in accordance with section 1, and
p.(None): f) the members of the responsible scientific committee.
p.(None): statutory authorization
p.(None): § 44. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of the hearing
p.(None): is required, in agreement with the Federal Minister of Education, Science and Culture by ordinance, more detailed provisions on announcement and
p.(None): The course of the consultation process, the type and scope of the inspection of the application and the associated documents, with particular attention to the
p.(None): Confidentiality of data in accordance with Section 105, to determine the preparation and the course of the hearing.
p.(None): Security measures, due diligence, information and notification requirements
p.(None): Section 45. (1) Anyone who carries out a release has all that is necessary according to the state of the art in science and technology in the interest of safety (Section 1 no. 1)
p.(None): Take precautions and measures and - insofar as he is the operator - ensure that they are observed.
p.(None): (2) Even after approval of the release, the operator has all the facts and circumstances related to the release
p.(None): inform, which according to the state of the art in science and technology are suitable to endanger security (§ 1 Z 1).
p.(None): (3) The operator must immediately report facts and circumstances in accordance with paragraph 2 to the authority in writing.
p.(None): Release results report
p.(None): Section 46. (1) After completion of the release, the operator has all in accordance with the deadlines and requirements of the authority specified in the approval notice
p.(None): Report the results of the release, which are decisive for its assessment with regard to safety (§ 1 no. 1). This may include products
p.(None): (Section 54 (1)), for which the operator intends due to the release to apply for approval of the in-
p.(None): To bring traffic.
p.(None): (2) The authority has the results of the release communicated in accordance with Paragraph 1 to the responsible scientific committee of the Genetic Engineering Commission
p.(None): and to inform the European Commission.
p.(None): statutory authorization
p.(None): Section 46a. The Federal Minister of Health and Women, taking into account Art. 10 of Directive 2001/18 / EC after consulting the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
p.(None): und Wasserwirtschaft, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture, more detailed provisions on
p.(None): Determine the content, scope and form of the notification in accordance with Section 46 (1).
p.(None): Change of operator
p.(None): § 47. A change in the person of the operator makes the permissibility of carrying out a release and the resulting
p.(None): Obligations not affected. The legal successor must immediately notify the authority of the change in writing.
p.(None): Subsequent editions
p.(None): Section 48. (1) If the release is intended or unintentionally changed after the approval has been granted in a manner that is significantly disadvantageous
p.(None): Could have an impact on security (§ 1 Z 1), or will become circumstances associated with such effects after the approval
p.(None): known, the authority has, insofar as this is necessary for the prevention of immediate dangers, with the greatest possible protection of acquired rights, additional
p.(None): to issue appropriate safety requirements, to restrict or prohibit the release, and to ensure the harmless removal of the released
p.(None): To order GMOs.
p.(None): (2) The authority shall make information on measures pursuant to Paragraph 1 available to the public on the website of the authority.
...
p.(None): 3. all information that is necessary for the assessment of the impact of the accident on safety (§ 1 Z 1),
p.(None): 4. the emergency measures taken, the procedures for monitoring the GMOs in the event of a proliferation outside the experimental area, and those in the
p.(None): Interest of security (§ 1 Z 1) necessary plans in the event of occurrence of undesirable effects
p.(None): to be communicated in writing.
p.(None): (3) In the case of accidents that can lead to an immediate risk to safety (Section 1 no. 1), the authority is also immediately informed of the accident that has occurred
p.(None): to be informed by telephone or fax. The operator has a risk to the health of, provided that it is state of the art in science and technology
p.(None): People must be assumed to inform them immediately of the accident and to recommend appropriate behavioral measures.
p.(None): (4) In the event of an accident, the operator and, if necessary, the authority must monitor the effects of the accident on safety (§ 1
p.(None): Z 1).
p.(None): (5) The authority has public information on every accident that has a significant impact on safety (§ 1 no. 1) on the website of the
p.(None): To make the authority accessible and to inform the federal state in whose area of responsibility the release took place of such an accident.
p.(None): statutory authorization
p.(None): Section 50. The Federal Minister of Health and Women may, as far as this is in the interest of security according to the state of the art in science and technology (Section 1 no. 1)
p.(None): is necessary, after hearing the responsible committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture
p.(None): and forestry (note: correct: Federal Minister of Agriculture, Forestry, Environment and Water Management) and the Federal Minister of Education,
p.(None): Science and culture issued more detailed regulations to prevent, limit and eliminate the effects of accidents caused by releases.
p.(None): controls
p.(None): § 51. The authority is entitled to inspect during and after the release both in the test area and in its vicinity, including under
p.(None): Take appropriate samples (§ 101).
p.(None): record keeping
p.(None): § 52. (1) The operator must ensure that accompanying records of the release carried out, kept and kept
p.(None): Inspection by the authority.
p.(None): (2) The records must contain the following information:
p.(None): 1. Name and address of the operator;
p.(None): 2. place of release;
p.(None): 3. Date and transaction number of the approval of the release;
p.(None): 4. Beginning and completion of the release;
p.(None): 5. Summary presentation of the release, which enables an assessment of the release with regard to the necessary safety measures;
p.(None): 6. the names of the persons directly involved in the execution of the work;
p.(None): 7. Deviations from the planned test procedure;
p.(None): 8. Disposal of GMOs.
p.(None): (3) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (4) The records must be kept at least ten years after the end of the release.
p.(None): statutory authorization
p.(None): Section 53. The Federal Minister of Health and Women, insofar as this is in the interest of security (Section 1 no. 1) according to the state of the art in science and technology
p.(None): is necessary after consulting the responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister of Agriculture
p.(None): and forestry (note: correct: Federal Minister of Agriculture, Forestry, Environment and Water Management), the Federal Minister of Economics and Labor and
p.(None): to determine the Federal Minister of Education, Science and Culture more detailed provisions on the content, type and form of the records in accordance with Section 52
p.(None): PART B
p.(None): marketing
p.(None): authorization
p.(None): Section 54. (1) The placing on the market of products consisting of or containing GMOs requires the approval of the authority; in this
p.(None): Approval is to indicate the intended use.
p.(None): (2) The placing on the market of an already approved product for a different use than that specified in the marketing authorization
p.(None): requires a separate approval.
p.(None): (3) According to this Federal Act, no authorization is required for placing products on the market
p.(None): 1. if products are used as intended for the manufacture of which the placing on the market has already been approved in accordance with this Federal Act
p.(None): become or have been
p.(None): 2. for products that fall within the scope of Regulation (EC) No. 1829/2003 on genetically modified food and feed.
p.(None): In these cases, sections 55 to 63 of this Federal Act, with the exception of section 62c (1), do not apply.
...
p.(None): 6. The intended packaging and labeling on a label or in an accompanying document that at least meet the requirements of Section 62
p.(None): got to,
p.(None): 7. further specific information regarding the safe use of the product,
p.(None): 8. a proposal for the validity of the permit, which may not exceed 10 years,
p.(None): 9. a surveillance plan, including a proposal for the period for which the surveillance plan is to apply; this period can be different
p.(None): than the proposed period of approval,
p.(None): 10. the safety assessment in accordance with Section 37 (2) 2,
p.(None): 11. a summary of the application.
p.(None): (3) In the application, data or results from the release of the same GMO or combination of GMOs that the applicant used to be must also be communicated
p.(None): has applied for or carried out within or outside Austria or is currently applying for or undertaking. In the application are also the locations of the
p.(None): cite literature results of releases of the relevant GMOs.
p.(None): (4) The applicant can also refer to the data or results of previous applications by other applicants, provided that this is done in writing
p.(None): Have given consent.
p.(None): (5) If according to the state of the art in science and technology based on the results of a release or on the basis of the safety assessment with the in-
p.(None): Placing the product on the market and the use of the product are not expected to have any adverse effects on safety (Section 1 (1))
p.(None): Conformity with Annex IV of Directive 2001/18 / EC on reasoned request by the applicant for the submission of speci fi c information in accordance with
p.(None): Abs. 2 Z 7 waive.
p.(None): statutory authorization
p.(None): § 56. (1) The Federal Minister of Health and Women has, insofar as this is in view of the expediency, speed and simplicity of the application process
p.(None): and for the assessment of safety (§ 1 Z 1) is necessary, after hearing the responsible scientific committee of the genetic engineering commission and in
p.(None): Agreement with the Federal Minister for Agriculture, Forestry, Environment and Water Management, the Federal Minister for Economy and Labor and the
p.(None): Federal Minister of Education, Science and Culture, taking into account the state of the art in science and technology and those referring to GMOs
p.(None): Community legislation, in particular Annexes II, III and IV to Directive 2001/18 / EC, through more detailed regulations on
p.(None): 1. Content, scope and form of the documents in accordance with § 55 Paragraph 2 and
p.(None): 2. the principles and methods to be used when compiling these documents
p.(None): set. The regulation may also require that these documents be used using the programs provided by the authority
p.(None): must be presented on electronic data carriers. "
p.(None): (2) By ordinance pursuant to Paragraph 1, first half sentence, taking into account a decision pursuant to Art. 16 of Directive 2001/18 / EC, for certain
p.(None): Types of products in derogation from the requirements according to § 55 Paragraph 2 more detailed provisions on the criteria and the application documents for the in-
p.(None): The placing on the market of these products should be determined if there is sufficient experience with the release and placing on the market of comparable GMOs
p.(None): and therefore adverse effects on security (§ 1 Z 1) are not expected. If these requirements are met, the Federal Minister for
p.(None): Health and women also authorized to make a corresponding application in accordance with Article 16 of Directive 2001/18 / EC.
p.(None): due diligence
p.(None): Section 57. Does the applicant or license holder have new ones during the examination of the application by the authority or after approval has been given
p.(None): The applicant has information immediately regarding the risks of the product for safety (§ 1 Z 1)
p.(None): 1. to review the information and documents submitted in accordance with Section 55 (2),
p.(None): 2. inform the authority in writing of this information and
p.(None): 3. to take the necessary measures for reasons of security (§ 1 no. 1), especially the affected public, in a suitable manner
p.(None): inform and, if necessary, offer to take back the products quickly and properly.
p.(None): Official procedure and official decision
p.(None): Section 58. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application as well as the attached documents
p.(None): Confirm receipt of receipt or otherwise in writing.
p.(None): (2) Before deciding whether to place the product on the market, the authority shall have an opinion from the responsible scientific committee of the
p.(None): GMO commission.
p.(None): (3) Insofar as this is necessary for the assessment of the approval requirements in accordance with Paragraph 4, the authority has to provide the applicant with a
p.(None): Justification to provide further information on how to improve the application.
...
p.(None): or be longer.
p.(None): (6) In the case of a negative evaluation report in accordance with paragraph 3, which also results from the Community law procedure in accordance with Article 17 of the Directive
p.(None): 2001/18 / EC is not invalidated, the authority must prohibit the further placing on the market of the product.
p.(None): (7) Until the final decision on an application in accordance with paragraph 1, the product may continue in accordance with the conditions of the original approval
p.(None): be placed on the market.
p.(None): (8) Section 58a applies mutatis mutandis.
p.(None): monitoring obligation
p.(None): Section 58c. (1) The license holder is responsible for carrying out a surveillance in accordance with the approval in Section 58a or, if applicable, in the
p.(None): Renewal of the approval according to § 58b prescribed monitoring plan and responsible for the corresponding reporting to the authority.
p.(None): The authority has to forward the reports to the European Commission and the other member states of the European Union. It has the results of
p.(None): Make surveillance accessible to the public on their website.
p.(None): (2) The authority can, based on the reports in accordance with paragraph 1, to avoid adverse consequences for security (§ 1 Z 1) within the scope of the approval
p.(None): or the renewal of the permit change the surveillance plan.
p.(None): statutory authorization
p.(None): Section 58d. The Federal Minister of Health and Women has, insofar as this is in order to clarify the monitoring obligations of the license holder and to
p.(None): Avoiding adverse effects on safety (§ 1 Z 1) is necessary, taking into account Annex VII of Directive 2001/18 / EC and the
p.(None): guidelines supplementing this appendix after consulting the responsible scientific committee of the genetic engineering commission in agreement with the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of Education, Science and Culture by ordinance
p.(None): to lay down further provisions for the preparation and implementation of the monitoring plan.
p.(None): Change of approval
p.(None): Section 58e. Does the authority receive new information after the approval in accordance with Section 58a or after a renewal of the approval in accordance with Section 58d
p.(None): Circumstances according to which the product authorized to be placed on the market could jeopardize safety (Section 1 (1)) will lead it within 60 days
p.(None): Information including any reasoned suggestions for a change or cancellation of the approval to the European Commission for the purpose
p.(None): Initiation of a procedure pursuant to Article 20 (3) of Directive 2001/18 / EC. According to the results of this procedure, the authority has the conditions
p.(None): change the approval or renewal of the approval or revoke the approval or renewal of the approval.
p.(None): scope of authorization
p.(None): Section 59. The supply and use of products (Section 54 (1)), the placing on the market of which is authorized in accordance with this Federal Act, requires in
p.(None): Within the scope of this approval, no further approval under this federal law.
p.(None): Temporary bans or restrictions
p.(None): Section 60. (1) Has the authority after granting a license or renewing a license based on new or additional information
p.(None): or based on a re-evaluation of existing information on the basis of new or additional scientific knowledge justified reason for
p.(None): The Federal Minister of Health and. Can assume that the product approved for placing on the market poses a risk to safety (§ 1 no. 1)
p.(None): Women after placing on the market the responsible scientific committee of the genetic engineering commission by regulation
p.(None): Temporarily restrict or prohibit the use of this product in Austria.
p.(None): (2) The Authority shall immediately inform the European Commission, the other Member States of the European Union and the public of the
p.(None): Measures taken according to paragraph 1 and their justification. The authority complies with those in the Community procedure pursuant to Art. 30 Para
p.(None): 2001/18 / EG bound by these measures decisions of the European Commission or the Council.
p.(None): Safety measures
p.(None): Section 61. In cases of imminent danger to security (Section 1 (1)), the Federal Minister of Health and Women has the manufacturer or importer through
p.(None): To notify the public concerned about the risks posed by the products and about safety and elimination measures
p.(None): inform and, if necessary, request the return of these products.
p.(None): Packaging and labeling
p.(None): Section 62. (1) Products in accordance with Section 54 may only be placed on the market if their labeling and packaging comply with the approval requirements
p.(None): stipulated requirements. In any case, the marking must contain:
p.(None): 1. the commercial name of the product,
p.(None): 2. the express reference that the product contains genetically modified organisms (Section 58a (1) no. 6),
p.(None): 3. the exact name of the GMO (s), including the identification code (s) provided for the GMO in question,
p.(None): 4. Name and address of the person responsible for the placing on the market in the Community (manufacturer, importer or distributor) and
p.(None): 5. the reference to the registration of the product or the GMO (s) contained therein in the designated register of the European Commission
p.(None): in accordance with Art. 31 Para. 2 of Directive 2001/18 / EC including information about the possibility of access to this register.
p.(None): (2) The Federal Minister of Health and Women, insofar as this is with regard to the safe use of products in accordance with Section 54 (1) or therefrom
p.(None): manufactured products or to avoid misleading users and consumers, taking into account Annex IV of the
p.(None): Directive 2001/18 / EC or other Community labeling regulations referring to GMOs by regulation in agreement with the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of Economics and Labor for more detailed labeling regulations
p.(None): for products according to § 54 or products made from them.
p.(None): Provision of GMOs for purposes other than placing them on the market
p.(None): Section 62a. GMOs that are used to work with GMOs in a closed system, for a release or for scientific purposes including clinical trials
p.(None): must be provided on a label or in an accompanying document as a GMO.
p.(None): statutory authorization
p.(None): Section 62b. The Federal Minister of Health and Women has, insofar as this is necessary to ensure security (§ 1 Z 1) and under consideration
p.(None): Implementing provisions in accordance with Article 26 of Directive 2001/18 / EC after consulting the responsible scientific committee of the
p.(None): Genetic engineering commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the labeling of the according
p.(None): Section 62a of the GMO provided.
p.(None): Unintentional presence of GMOs in other products
p.(None): Section 62c. (1) Anyone who places products on the market (Section 54 (1)) is obliged to take special care to ensure that, particularly in the case of sales,
p.(None): Transport, storage, use and processing a mixture of the GMOs contained in the products with goods that are not intended to be GMOs
p.(None): may contain is avoided.
p.(None): (2) The other provisions of III. Section relating to the release of GMOs and the placing on the market of products are traces on products
p.(None): contain a GMO not authorized in the EEA or a combination of such GMOs up to a threshold of 0.1%, if the
p.(None): Presence of the GMO (s) is unintentional or technically unavoidable.
p.(None): (3) Deviating from para. 2 is until April 18, 2007 on the placing on the market of a product that is for direct use as food or
p.(None): Feed or for processing and contains traces of a GMO not yet authorized in the EEA or a combination of such GMOs that III.
p.(None): Section of this Federal Law does not apply if
p.(None): 1. the proportion of such GMOs in the product does not exceed the threshold of 0.5%,
p.(None): 2. the presence of the GMO (s) is unintentional or technically unavoidable,
p.(None): 3. regarding the GMO (s) by the responsible scientific committee of the European Commission or by the European authority for
p.(None): Food safety a positive opinion was given before April 18, 2004,
p.(None): 4. a relevant application for authorization to place it on the market has not been rejected in the relevant Community procedure and
p.(None): 5. the detection methods for the GMO (s) are publicly available.
p.(None): (4) Section 62 does not apply to products that contain traces of GMOs authorized in the EEA, provided these products are for direct processing
p.(None): the proportion of such GMOs does not exceed a threshold of 0.9% and this proportion is unintentional or technically unavoidable.
p.(None): (5) To determine that the presence of GMOs is unintentional or technically unavoidable, the person who places a product on the market or
p.(None): has demonstrated, at the request of the authority or the supervisory bodies, that appropriate measures have been taken to ensure the existence of the or
p.(None): to avoid GMOs.
p.(None): (6) The Federal Minister for Health and Women is authorized to implement implementing decisions in the regulatory committee procedure in accordance with
p.(None): Directive 2001/18 / EC or Regulation (EC) № 1829/2003, the threshold values specified in paragraphs 2 to 4 are taken into account by regulation
p.(None): to adapt security (§ 1 Z 1) to the state of the art in science and technology. With the coming into force of a regulation regulating this subject
p.(None): corresponding provisions of paragraphs 2 to 4 are invalid.
p.(None): (7) The analyzes to determine whether the threshold values in accordance with paragraphs 2 to 4 have been exceeded must be carried out according to procedures for the examination and sampling
p.(None): that have been published as national or international standards or by national or international working groups, preferably by the
p.(None): Community reference laboratory of the European Commission have been validated. If such procedures are not available, other methods may only be used
p.(None): if they are suitable for the application and have been validated for them in comparative studies.
p.(None): (8) Threshold values for the unintentional or technically unavoidable presence of GMOs in products according to seed law,
p.(None): food or feed law regulations or directly applicable European Union legislation
p.(None): not affected by paragraphs 2 to 6.
p.(None): Social intolerance
p.(None): Section 63. (1) Social intolerance of products according to Section 54 (1) exists if it can be assumed on the basis of factual bases that such
p.(None): Products could lead to an unbalanced burden on society or social groups, and if this burden for the
p.(None): Society appears unacceptable for economic, social or moral reasons.
p.(None): (2) The Federal Government shall, on the proposal of the Federal Minister for Health and Women, place such products on the commercial market in accordance with
p.(None): To prohibit section 54 (1) by ordinance, the placing of which on the market suggests a social intolerance.
p.(None): (3) After hearing the Genetic Engineering Commission, the Federal Minister for Health and Women must submit a proposal in accordance with paragraph 2 as soon as
p.(None): It is foreseeable that such products could be commercially placed on the Austrian market.
p.(None): Restriction of GMO approval
p.(None): Section 63a. (1) The Federal Minister of Health may, during the procedure for the authorization of a specific GMO in accordance with Directive 2001/18 / EC or the
p.(None): Regulation (EC) № 1829/2003 or during the renewal of a consent or authorization the applicant / applicant by way of European
p.(None): Commission to do so that the geographical scope of the written consent or approval is changed so that the federal territory
p.(None): is totally or partially excluded from cultivation.
p.(None): (2) The Federal Minister of Health has an appointment pursuant to Paragraph 1 no later than 45 days after forwarding the assessment report pursuant to Art. 14
p.(None): Paragraph 2 of Directive 2001/18 / EC or after receipt of the opinion of the European Food Safety Authority in accordance with Art. 6 Paragraph 6 and Art. 18 Paragraph 6
p.(None): Regulation (EC) № 1829/2003 of the European Commission for forwarding to the applicant or applicant and the other Member States
p.(None): to transfer.
p.(None): (3) If there is no confirmation of the geographical scope of the original application or within 30 days of the submission of the request
p.(None): of the original application, the adjustment of the geographical scope of the application or the application is based on the
p.(None): Directive 2001/18 / EC granted written consent and, if appropriate, by a decision in accordance with Art. 19 of Directive 2001/18 / EC and by a
...
p.(None): BGBl. No. 341/1981, in the version of the Federal Law BGBl. I No. 31/2018, apply.
p.(None): Prohibition of using data from genetic analysis for certain purposes
p.(None): Section 67. (1) Employers and insurers including their agents and employees are prohibited from obtaining results from genetic analyzes of
p.(None): To collect, request, accept or otherwise exploit employees, jobseekers or policyholders or insurance applicants. Of
p.(None): This prohibition also includes the request for delivery and the acceptance of body substance for genetic analysis purposes.
p.(None): (2) Paragraph 1, 1st sentence does not apply to insurers, including their agents and employees, insofar as the results are from genetic analyzes of the type
p.(None): 1 deals with policyholders or policyholders and does not draw any conclusions from the results of genetic analyzes of type 2, 3 or 4
p.(None): possible are.
p.(None): Conducting genetic analysis on humans for medical purposes - Official procedure
p.(None): Section 68. (1) Genetic analyzes within the meaning of Section 65 (1) nos. 3 and 4 may only be carried out in approved facilities and only on
p.(None): Initiation of a specialist trained in human genetics / medical genetics or a treating or responsible for the indication area
p.(None): diagnosis specialist.
p.(None): (2) The approval is to be given by the head of the facility in which such genetic analyzes are intended to be carried out to the Federal Minister for
p.(None): Apply for health and women.
p.(None): (3) Approval is granted by the Federal Minister of Health and Women after consulting the responsible scientific committee - if necessary
p.(None): under the definition of suitable conditions and conditions - to be given if, due to the personnel and material equipment, the state of
p.(None): Science and technology appropriate execution of the genetic analyzes and the protection of the resulting genetic data according to § 71
p.(None): is ensured.
p.(None): (4) The Federal Minister of Health and Women must revoke the admission if the conditions for its granting are no longer met
p.(None): or if there are serious deficiencies, otherwise suitable requirements, combined with the order to be imposed, until the fulfillment of these requirements, no genetic requirements
p.(None): Conduct analyzes in accordance with section 65 (1) 3 or 4 more.
p.(None): Head of the facility and laboratory manager
p.(None): Section 68a. (1) The head of the facility must appoint a laboratory manager for each facility for performing genetic analyzes of type 2, 3 or 4.
p.(None): This may be the same as the head of the facility. The head of the facility has the laboratory head of the authority, including the person appointed for the person
p.(None): to provide the necessary evidence (para. 2) in writing.
p.(None): (2) The laboratory manager must
p.(None): 1. be a specialist in human genetics / medical genetics or for medical-chemical laboratory diagnostics, or
p.(None): 2. a university degree from a scientific subject, which includes training in molecular genetics or molecular biology, and
p.(None): have at least two years of experience in molecular genetic studies on humans, or
p.(None): 3. via specialist training that includes training in human genetics / medical genetics and at least two years of experience with
p.(None): molecular genetic studies in humans, or
p.(None): 4. If it is limited to genetic analyzes in the context of a special medical subject, the required for this special subject
p.(None): Specialist training and at least two years of experience in the field of molecular genetic testing in humans.
p.(None): (3) The laboratory manager is responsible for the ongoing instruction of the employees and the management and supervision of the implementation of the genetic analyzes. He has
...
p.(None): (3) Unless otherwise stipulated in this federal law, the Data Protection Act (DSG), Federal Law Gazette I № 165/1999, remains
p.(None): Health Telematics Act 2012, Federal Law Gazette I No. 111/2012, as well as regulations that contain special confidentiality or reporting obligations, are not affected.
p.(None): (4) The examined person is to be informed of unexpected results that are of immediate clinical importance or for which they are specifically asked
p.(None): Has. This notification is to be designed in such a way that it does not refer to the examined person, especially if the examined person did not ask for it
p.(None): is troubling; in borderline cases this notification can be omitted entirely.
p.(None): Documentation of the test results
p.(None): Section 71a. (1) Results from genetic analyzes of type 1 may in any case, results from genetic analyzes of types 2 and 3 only if the
p.(None): Patients who have not contradicted in writing are documented in medical reports and medical histories. The possibility of contradiction is in the
p.(None): Advice according to Section 69 (3).
p.(None): (2) Results from type 4 genetic analysis, as well as type 2 or 3 results when documented in medical reports and
p.(None): Medical records are not permitted because of the patient's objection, only in the institution in which they were collected and only on request
p.(None): processed by the attending doctor; they are to be kept or stored separately from other types of data and may only be saved by those persons
p.(None): are directly involved in the processing of the data in the facility and can only be accessed with a separate access option.
p.(None): statutory authorization
p.(None): § 72. (1) The Federal Minister of Health and Women has, if this is to ensure the proper implementation of genetic analyzes and of
p.(None): related advice is required, taking into account the current state of science and technology after consulting the
p.(None): responsible scientific committee of the genetic engineering commission by ordinance more detailed regulations on the personnel and material equipment of the
p.(None): Facilities according to § 68, including the qualification of the responsible laboratory manager according to § 68a, the initiation of the genetic analyzes according to § 68
p.(None): Paragraph 1, the information and advice to be issued in accordance with section 69, data protection in accordance with section 71 and the documentation of the test results in accordance with section 71a
p.(None): prescribe.
p.(None): (2) The Federal Minister of Health and Women has sufficient experience with safety according to the state of the art in science and technology (§ 1
p.(None): Z 1) certain genetic analyzes are available, after hearing the responsible scientific committee of the genetic engineering commission by ordinance
p.(None): more detailed provisions on the use of simplified official procedures for further applications for an application already approved in accordance with Section 68 (3)
p.(None): To establish the facility taking into account established methods and established indication areas. In deviation from Section 91, these procedures may include:
p.(None): official decision only with referral of the rapporteur, and provide for a shortening of the decision period to up to 30 days.
p.(None): Announcements
p.(None): Section 73. The head of a facility in accordance with Section 68 has the authority all essential with regard to the implementation of genetic analyzes of type 3 or 4
p.(None): Changes in the material and staffing of the approved facility immediately, as well as a summary of those in this facility
p.(None): genetic reports of type 3 or 4 carried out using the form (Appendix 2) for the past year, beginning on February 1, 2006.
p.(None): Somatic gene therapy
p.(None): § 74. Somatic gene therapy in humans may only be based on the state of the art in science and technology
p.(None): 1. for the purpose of therapy or the prevention of serious illnesses in humans or
p.(None): 2. to establish suitable procedures in the context of a clinical trial (§ 76)
p.(None): and only be carried out if, according to the state of the art in science and technology, it can be excluded that a change in the
p.(None): Genetic material of the germline takes place. According to the current state of science and technology, the risk of a change in the genetic material of the germ line is not complete
p.(None): to exclude, somatic gene therapy may only be used if this risk increases from that of the use of somatic gene therapy
p.(None): expected benefit for the health of this person is outweighed, and only for people who are certain to have no offspring; Cells of the
p.(None): The germline of a person treated in this way must not be used to produce embryos outside a woman's body.
p.(None): Implementation of somatic gene therapy - official procedure and decision
p.(None): Section 75. (1) Somatic gene therapy in humans may only be carried out by a doctor in a hospital and only after approval in accordance with paragraph 3
p.(None): be performed.
p.(None): (2) The approval must be obtained from the medical director of the hospital in which the use of somatic gene therapy is intended, together with the
p.(None): To apply for the head of the examination at the Federal Minister for Health and Women.
p.(None): (3) The approval is granted by the Federal Minister of Health and Women after consulting the responsible scientific committee of the
p.(None): Genetic Engineering Commission and the Advisory Council on Medicinal Products - insofar as the referral is provided for in the Medicinal Products Act due to the event and
p.(None): if necessary, stipulating requirements and conditions to be given if the requirements of § 74 are fulfilled and due to the personnel and
p.(None): factual equipment a state-of-the-art science and technology implementation of somatic gene therapy on humans and
p.(None): special protection of any genetic analysis data according to § 71 is ensured. If in the context of a clinical trial for the purpose of somatic
p.(None): If gene therapy is used on human GMOs, this approval is only to be granted if, as a result of the gene therapy carried out according to the state of
p.(None): Science and technology are not expected to have negative consequences for the safety (§ 1 no. 1) of spreading these GMOs into the environment.
p.(None): (4) The Federal Minister of Health and Women must revoke the approval if the conditions for its issuance are no longer met
p.(None): and in the event of serious deficiencies, appropriate conditions combined with the order to impose this gene therapy no longer until these requirements have been met
p.(None): perform.
p.(None): Clinical trials for the purpose of somatic gene therapy
p.(None): Section 76. The provisions of the Medicinal Products Act on clinical trials apply to clinical trials as part of somatic gene therapy on
p.(None): People with the proviso that such a clinical trial may only be carried out if it is approved in accordance with Section 75 exists.
p.(None): Due diligence and notification requirements
p.(None): Section 77. (1) The doctor responsible for the implementation of somatic gene therapy (Section 75 (1)) has continued after it has started until it is completed
p.(None): to inform about all facts and circumstances in connection with this gene therapy, which are according to the state of the art in science and technology
p.(None): are at risk of endangering the health of the person treated with this gene therapy or of the personnel involved in the gene therapy, or of the environment.
p.(None): He has chosen to assist a person with at least two years of experience in the field of security measures
p.(None): (§ 1 Z 1) to use, unless he himself has such experience.
p.(None): (2) The responsible doctor has to immediately inform the Federal Minister of Health and Women in writing or
p.(None): communicated by telex. The Federal Minister of Health and Women then dealt with the scientific committee for genetic
p.(None): Analyzes and gene therapy in humans according to the expected or already identified risk to the health of the somatic
p.(None): Gene therapy treated people to issue or carry out the necessary tasks to prevent this danger
p.(None): Restrict or prohibit gene therapy.
p.(None): Application of legislation
p.(None): Section 78. (1) The implementation of somatic gene therapy on humans is not subject to the regulations of II. And III. Section of this federal law.
p.(None): (2) A clinical trial conducted in accordance with this Federal Act is deemed to be a clinical trial in accordance with the Medicinal Products Act.
p.(None): Announcements
p.(None): Section 78a. (1) The doctor responsible for performing a somatic gene therapy (Section 75 (1)) has the actual start of a somatic
p.(None): Report gene therapy, its course, the number of people treated and the time of termination using the form (Annexes 3 and 4) to the authority.
p.(None): (2) The medical director of the hospital has all the essentials for the implementation of somatic gene therapy in humans
p.(None): To notify the authority immediately of any changes in the material and staffing of the approved hospital.
p.(None): register
p.(None): Section 79. (1) The Federal Minister of Health and Women must set up electronic registers in which all are permitted under this Federal Act
p.(None): 1. facilities for performing genetic analyzes (genetic analysis registers),
p.(None): 2. Somatic gene therapies on humans (gene therapy register) and
p.(None): 3. Proficiency tests offered (proficiency testing register)
p.(None): are recorded.
p.(None): (2) In the genetic analysis register, the name, address, homepage and the area of activity of the institution, which is structured according to the investigations carried out
p.(None): to lead.
p.(None): (3) The name, address, homepage and area of activity of the institution must be recorded in the gene therapy register. The area of activity is by means of study title, name
p.(None): of the study director, and to describe the indication. The therapeutic genes and gene transfer systems used, as well as course and are for each gene therapy
p.(None): Show the final report separately in a non-public part of the register.
p.(None): (4) The Federal Minister of Health and Women has the data in accordance with paragraphs 2 and 3 taking into account any changes to be included
p.(None): of reporting obligations according to Section 73 (1) or Section 78a (1) (in particular history and final report) to be transferred to the register.
p.(None): (5) The registers must be updated continuously.
p.(None): (6) The published data must not contain any identifiable information about the persons treated. Everyone has access to the registers
p.(None): grant. The Federal Minister of Health and Women and the Federal Office for Safety in Health Care are also responsible for the scope of their responsibilities
p.(None): non-public part of the gene therapy register accessible.
p.(None): IVa. section
p.(None): Civil liability
p.(None): Personal injury and property damage
p.(None): Section 79a. (1) Is caused when working with GMOs (§ 4 Z 4) or when they are released (§ 4 Z 20) as a result of the genetic modification
p.(None): Characteristics of the organism A person has been killed, injured on the body or damaged in health or damaged a physical thing
p.(None): Operator (§ 4 Z 18) to compensate for the damage. The operator is liable for work and releases even if there is already a permit for the release
p.(None): or has been granted for placing on the market as long as the product (Section 54 (1)) has not yet been placed on the market in accordance with the approval.
p.(None): (2) The operator's liability also extends to damage caused by the properties of the GMO caused by the genetic modification
p.(None): Connection with its other dangerous properties.
p.(None): Environmental degradation
p.(None): Section 79b. Is the damage to a physical thing also a significant impairment of the environment (§ 101a para. 1) and is a restoration of the
p.(None): the previous state is not feasible by the liable operator or if the operator is not ready to restore it, the injured party also deserves it
p.(None): then the reimbursement of the costs of the restoration if these costs exceed the value of the damaged item. The victim can
...
p.(None): § 79m. (1) The owner or beneficiary of an agriculturally used property has to file a lawsuit based on § 79k
p.(None): Paragraphs 1 and 2 to settle an arbitration board for amicable settlement, an application pursuant to Section 433 (1) of the Code of Civil Procedure, RGBl. № 113/1895
p.(None): or - if the neighbor agrees - to submit the dispute to a mediator. The action is admissible only if not within three at the latest
p.(None): An amicable settlement has been reached months after initiation of the arbitration process, from the time the application is received by the court or from the start of mediation.
p.(None): (2) Only one of a chamber of agriculture, a chamber of notaries, a chamber of lawyers or one comes as an arbitration board within the meaning of paragraph 1
p.(None): other corporation established under public law, as mediator only a mediator in the sense of the Civil Law Mediation Act, Federal Law Gazette I
p.(None): No. 29/2003.
p.(None): (3) Unless the parties agree otherwise, the costs of arbitration, judicial settlement or mediation are initially borne by the neighbor
p.(None): who has sought the amicable settlement. If no amicable settlement can be reached, these costs in the litigation are the same as pre-litigation costs
p.(None): to treat.
p.(None): (4) The plaintiff has to attach to the suit a confirmation from the arbitration board, the court or the mediator that no amicable settlement
p.(None): could be achieved.
p.(None): V. SECTION
p.(None): Genetic engineering commission and genetic engineering book
p.(None): Establishment of a genetic engineering commission
p.(None): Section 80. For advice on all questions arising from the implementation of this law and for the preparation of the genetic engineering book, contact the
p.(None): Federal Ministry of Health and Women set up the Genetic Engineering Commission (commission) and its scientific committees.
p.(None): Composition of the Genetic Engineering Commission
p.(None): Section 81. (1) The Commission must belong to:
p.(None): 1. The Commission must include:
p.(None): a) two representatives of the Federal Ministry of Health and Women, one of them an expert in women's affairs,
p.(None): b) two representatives of the Federal Ministry of Economics and Labor, one of them an expert in the field of employee protection,
p.(None): c) two representatives of the Federal Ministry of Agriculture, Forestry, Environment and Water Management, one each from the fields of agriculture and
p.(None): Environment,
p.(None): d) a representative of the Federal Ministry of Education, Science and Culture -
p.(None): the sending federal ministers have the right to propose.
p.(None): 2. a) a representative of the Federal Chamber of Labor,
p.(None): b) a representative of the Austrian Trade Union Confederation,
p.(None): c) a representative of the President's Conference of the Austrian Chambers of Agriculture,
p.(None): d) a representative of the Austrian Chamber of Commerce - the sending organizations have the right to propose;
p.(None): 3. one representative each of the scientific committees - the sending committees have the right to propose;
p.(None): 4. eight experts who have experience in the fields of microbiology, cell biology, virology, molecular biology, hygiene, ecology,
p.(None): Security technology and sociology. Each of the areas mentioned must be represented by at least one expert. At least five
p.(None): these experts must have worked with GMOs; the Austrian Academy of Sciences has the right to propose;
p.(None): 5. One expert each for questions of molecular biology on the proposal of the Austrian Chamber of Commerce and the Austrian one
p.(None): Federation of Trade Unions;
p.(None): 6. a) a representative of scientific philosophy - the Austrian Rectors' Conference has the right to propose,
p.(None): b) a representative of a theological faculty has the right to propose the theological faculties of Austria,
p.(None): c) a doctor - the three medical universities in Austria have the right to propose,
p.(None): d) a person familiar with environmental problems - the Federal Environment Agency has the right to propose,
p.(None): e) a representative to be proposed by the Austrian Working Group on Rehabilitation.
p.(None): (2) The members of the commission are from the Federal Minister of Health and Women on the basis of the proposals in accordance with paragraph 1 for a period of five years
p.(None): to order. A substitute member must be appointed for each member - also for five years; the right to propose exists in the same way as for the
p.(None): representing members.
p.(None): Chairman
p.(None): § 82. The chair of the commission is the representative of the Federal Ministry of Health and Women, the deputy chair is the representative
p.(None): of the Federal Ministry of Education, Science and Culture.
p.(None): decision-making
p.(None): § 83. (1) The commission has a quorum if at least half of the members entitled to vote, at least half of the members according to
p.(None): Section 81 (1) 3 to 6 is present.
p.(None): (2) All members of the commission with the exception of the chair have a casting vote. Substitute members only have such voting rights
p.(None): Prevention of the person they represent and when that person chairs it. The commission decides by simple majority. In the event of a tie
p.(None): the view that the chairman agrees with is accepted.
p.(None): Responsibilities of the commission
p.(None): § 84. The tasks of the commission are in particular
p.(None): 1. advising the authority on fundamental questions relating to the applications of genetic engineering, insofar as they are not within the scope of scientific work
p.(None): Committees fall
p.(None): 2. the passing of resolutions on proposed sections of the genetic engineering book in accordance with section 99 (3) and
p.(None): 3. the preparation of the report on the application of genetic engineering (Section 99 (5)).
p.(None): Standing scientific committees
p.(None): Section 85. (1) The Federal Minister for Health and Women has scientific committees of the Commission
p.(None): 1. a scientific committee for working with GMOs in a closed system,
p.(None): 2. a scientific committee on releases and placing on the market and
p.(None): 3. Establish a scientific committee for genetic analysis and gene therapy in humans.
p.(None): (2) The members of the scientific committees are approved by the Federal Minister of Health and Women on the basis of the proposals in accordance with Sections 86 to 89
p.(None): to be ordered for a period of five years. A replacement member must be appointed for each member - also for a period of five years; the nomination right for this consists of
p.(None): same way as for the members to be represented.
p.(None): Tasks and composition of the scientific committee for working with GMOs in a closed system
p.(None): Section 86. (1) The scientific committee for working with GMOs in a closed system is responsible for assessing registrations and applications for
p.(None): Working with GMOs in accordance with Section II, submitting opinions in the determination procedure in accordance with Sections 7, 9 (3), 10 (3) and 26 (2) and the
p.(None): Preparation of sections of the genetic engineering book and the submission of comments on draft regulations in accordance with this federal law
p.(None): Working with GMOs in a closed system.
p.(None): (2) This scientific committee must include:
p.(None): 1. one expert each from the areas
p.(None): a) molecular biology,
p.(None): b) molecular virology,
p.(None): c) molecular microbiology (nominated by the Federal Minister for Health and Women),
p.(None): d) hygiene (nominated by the Federal Minister of Economics and Labor),
p.(None): e) genetics,
p.(None): f) ecology, in particular microbial ecology (nominated by the Federal Minister of Agriculture, Forestry, Environment and Water Management);
p.(None): 2. In addition to the experts mentioned under Paragraph 1 (1), we are responsible for assessing registrations and applications relating to work
p.(None): a) with microorganisms: an expert in microbiology or virology,
p.(None): b) on a large scale: an expert in biotechnology (nominated by the Federal Minister of Economics and Labor) and an expert in security technology
p.(None): (nominated by the Federal Minister of Economics and Labor),
p.(None): c) with cell cultures: an expert in cell culture,
p.(None): d) with plants: an expert in plant physiology,
p.(None): e) with animals: consult an expert in zoology.
p.(None): Tasks and composition of the scientific committee for releases and placing on the market
p.(None): Section 87. (1) The scientific committee for releases and placing on the market is responsible for the assessment of applications for releases of GMOs into the
p.(None): Environment and applications for the placing on the market of products according to III. Section as well as the preparation of sections of the genetic engineering book and
p.(None): the submission of statements on draft regulations in accordance with this federal law regarding III. Section.
p.(None): (2) This scientific committee must include:
p.(None): 1. one expert each from the areas
p.(None): a) Molecular biology (nominated by the Federal Minister for Health and Women),
p.(None): b) Ecology (nominated by the Federal Minister of Agriculture, Forestry, Environment and Water Management) and that under § 81 para. 1 no. 6 lit. d called
p.(None): Member of the genetic engineering commission;
p.(None): 2. In addition to the experts mentioned under para. 2 no. 1, the release of
p.(None): a) Microorganisms: an expert in molecular microbiology (nominated by the Federal Minister of Economics and Labor), an expert in microbial ecology
p.(None): (nominated by the Federal Minister of Agriculture, Forestry, Environment and Water Management), an expert in plant or animal pathology (nominated by
p.(None): Federal Minister for Health and Women), an expert in environmental hygiene (nominated by the Federal Minister for Economic Affairs and Labor),
p.(None): b) Plants: one expert in plant genetics (nominated by the Federal Minister of Education, Science and Culture), one expert in plant breeding,
p.(None): Vegetation science, plant physiology, soil science, insect science, mycology and for population biology (each nominated by the Federal Minister for
p.(None): Agriculture, forestry, environment and water management) as well as an expert in plant pathology (nominated by the Federal Minister of Health and
p.(None): Women)
p.(None): c) Animals: an expert in animal genetics (nominated by the Federal Minister of Health and Women) and an expert in animal breeding and zoology (nominated
p.(None): to be consulted by the Federal Minister of Agriculture, Forestry, Environment and Water Management);
p.(None): 3. In addition to the experts mentioned under para. 2 nos. 1 and 2, the appraisal of applications includes the placing on the market of products
p.(None): an expert in toxicology (nominated by the Federal Minister for Health and Women) and an expert in quality assurance and
p.(None): Identification (nominated by the Federal Minister of Economics and Labor).
p.(None): (3) When assessing applications relating to releases and when preparing sections of the genetic engineering book and the submission of
p.(None): Comments on draft regulations in accordance with III. Section Part A of this federal law is a representative of the Federal Ministry of Agriculture and
p.(None): Involve forestry, environment and water management in an advisory capacity; this must be given the opportunity to comment on the Federal Ministry of
p.(None): Explain agriculture and forestry, the environment and water management (Section 37 (6)).
p.(None): Tasks and composition of the scientific committee for gene analysis and gene therapy in humans
p.(None): Section 88. (1) The Scientific Committee for Genetic Analysis and Gene Therapy on Humans is responsible for assessing applications in accordance with Section IV
p.(None): as well as the preparation of sections of the genetic engineering book and the submission of statements on draft regulations in accordance with section IV of this
p.(None): Federal law.
p.(None): (2) This scientific committee must include:
p.(None): 1. one expert each from the following areas:
p.(None): a) molecular biology,
p.(None): b) a doctor with knowledge in the field of molecular pathology (nominated by the three medical universities in Austria),
p.(None): c) two representatives of the Supreme Medical Council (nominated by the Council itself),
p.(None): d) Philosophy (nominated by the Austrian Rectors' Conference),
p.(None): e) Theology (nominated by the theological faculties of Austria);
p.(None): 2. In addition to the experts mentioned under Paragraph 3 No. 1, are also responsible for assessing applications for
p.(None): a) Genetic analyzes (Section 68 (2)): one expert each from the areas
p.(None): aa) Medical genetics (nominated by the three medical universities in Austria),
p.(None): bb) medical genetics (nominated by the Austrian Society for Human Genetics),
p.(None): cc) medical ethics (nominated by the three medical universities in Austria),
p.(None): dd) reproductive medicine (nominated by the three medical universities in Austria),
p.(None): ee) molecular genetic analysis,
p.(None): ff) Pediatrics and Adolescent Medicine (nominated by the three medical universities in Austria),
p.(None): gg) sociology,
p.(None): hh) social work (nominated by the Austrian Association for Rehabilitation),
p.(None): ii) data protection law and
p.(None): b) Gene therapies:
p.(None): aa) a doctor with knowledge of somatic gene therapy (nominated by the three medical universities in Austria) and
p.(None): bb) two of the five permanent members of the Drugs Advisory Board (nominated by the Advisory Board)
p.(None): contracting.
p.(None): Right to nominate experts from scientific committees
p.(None): § 89. (1) Unless otherwise stipulated in sections 86 to 88, the Austrian Academy of Sciences has the right to nominate the experts
p.(None): Sciences (ÖAW). The nomination takes place through the entire meeting of the Austrian Academy of Sciences based on a public call.
p.(None): (2) The Federal Minister of Health and Women and the Federal Ministers exercise their nomination rights on the basis of tripartite proposals. The creation
p.(None): These three suggestions are made by the overall meeting of the ÖAW on the basis of a public tender in the sense of the diversity of scientific
p.(None): Doctrine in agreement with the Fund for the Promotion of Scientific Research and the Austrian Research Promotion Agency
p.(None): mbH.
p.(None): (3) The President of the ÖAW has the positions to be filled in the scientific committees pursuant to Paragraphs 1 and 2 in the "Official Gazette of the Wiener Zeitung"
p.(None): to be publicly advertised. In addition, the President of the Austrian Academy of Sciences can change these positions in other ways, depending on the fi nancial coverage of the costs
p.(None): advertise appropriately. The application and proposal deadline must be at least three weeks.
p.(None): (4) Simultaneously with the submission of the nominations in accordance with paragraph 1 and the tripartite proposals in accordance with paragraph 2, the Federal Minister of Health and
p.(None): Women a list of all applications and tripartite proposals received on the basis of the public tender in accordance with Paragraph 3, as well as a reason for their
p.(None): Submit creation.
p.(None): (5) This list of all applications received on the basis of the public tender in accordance with paragraph 3, the nominations and tripartite proposals of the ÖAW
p.(None): as well as the reasons for their creation can be found in the appendix to the next report on the use of genetic engineering in accordance with Section 99 (5)
p.(None): publish.
p.(None): Chair of the scientific committees
p.(None): § 90. The Federal Minister of Health and Women has an employee of his Federal Ministry for each scientific committee
p.(None): Appoint chairperson; he has an advisory voice. If the Chairman is unable to attend, the Federal Minister of Health and Women has
p.(None): to ensure its representation.
p.(None): Decision-making in the scientific committees on applications and applications
p.(None): Section 91. (1) The competent scientific committee has the authority in the case of applications and applications for work with GMOs in accordance with Section II
p.(None): and in the case of applications for the release of GMOs into the environment and applications for the placing on the market of products in accordance with III. section
p.(None): within ten days of the referral by the authority, in cases where a hearing has to take place within ten days of the end of the hearing, and
p.(None): in the case of applications relating to genetic analysis and somatic gene therapy in humans in accordance with Section IV, at the latest within 20 days of referral
p.(None): to submit a reasoned opinion on the registration or the application in writing by the authority.
p.(None): (2) To prepare the opinion of the scientific committee, two selected according to the provisions of the rules of procedure
p.(None): Rapporteur made a proposal for the opinion to be delivered. The scientific committee decides by simple majority. The vote can also
p.(None): in writing; if no report is accepted in this way up to four days before the deadlines specified in Paragraph 1, the Chairman shall
p.(None): in any case to convene a meeting.
p.(None): (3) If the scientific committee does not adopt an opinion within the time limits specified in paragraph 1, the rapporteurs shall propose it
...
p.(None): no expert opinion accepted (section 91 (3)), the minutes also include statements made by individual members of the scientific committee on the
p.(None): Registration or the application to include.
p.(None): (4) The chairpersons of the scientific committees shall invite all members of their committee to meetings if the following
p.(None): Items to be advised or decided:
p.(None): 1. Preparation of sections of the genetic engineering book (§ 99),
p.(None): 2. Comments on draft regulations,
p.(None): 3rd activity report (Section 93 (1)),
p.(None): 4. Posting the representatives to the Genetic Engineering Commission (section 81 (1) 3).
p.(None): reporting requirements
p.(None): § 93. (1) The permanent scientific committees have to write to the Commission on March 1st of each year a report on the activity
p.(None): to transmit past calendar year.
p.(None): (2) The activity report has a summary of those in the reporting period
p.(None): 1. statements of the expert opinions important for safety (§ 1 Z 1),
p.(None): 2. Work carried out to prepare certain sections of the genetic engineering book and
p.(None): 3. treated technical problems
p.(None): to contain.
p.(None): (3) The standing scientific committees have given the Commission the part of the report on the applications that concerns their area of responsibility
p.(None): genetic engineering (Section 99 (5)).
p.(None): Members of the commission and its scientific committees
p.(None): § 94. (1) The term of office of a member or substitute member of the commission or a member of its scientific committees ends with
p.(None): 1. timing,
p.(None): 2nd death,
p.(None): 3. Removal via proposal of the nominating position (s),
p.(None): 4. Resignation of the member or substitute member or
p.(None): 5. Dismissal by the Federal Minister of Health and Women due to gross violation of the rules of procedure or the duty of confidentiality
p.(None): (§ 96).
p.(None): (2) The commission and its committees are quorate even if not all members have been nominated.
p.(None): (3) The work in the commission and in its scientific committees is voluntary. Any travel expenses are the members and
p.(None): Substitute members of the Commission and its scientific committees and the knowledgeable persons who are involved in accordance with Section 95 according to
p.(None): highest fee level of the travel fee regulation 1955, Federal Law Gazette No. 133.
p.(None): External experts
p.(None): Section 95. (1) The commission can work on individual general factual questions, its scientific committees can prepare certain
p.(None): Consult sections of the genetic engineering book on a case-by-case basis with knowledgeable people. The individual members of the scientific committees
p.(None): it is permitted to consult with individuals you trust in connection with the preparation of individual sections of the genetic engineering book,
p.(None): insofar as this is necessary to fulfill their tasks.
p.(None): 2. The Commission may, to the extent necessary to carry out its tasks, set up additional committees to advise on certain specific issues,
p.(None): the composition of which must be based on the subject to be treated.
p.(None): confidentiality
p.(None): Section 96. The members of the commission and its committees, as well as the competent persons and confidants consulted in accordance with section 95 (1)
p.(None): are about information and perceptions that they have acquired in this capacity - except for data that were or were accessible to the public
p.(None): are -, committed to secrecy for the duration of their term of office and also afterwards.
p.(None): Rules of Procedure
p.(None): § 97. The Federal Minister of Health must issue rules of procedure for the Commission and its scientific committees, which the
p.(None): Ensure that the tasks assigned to you are fulfilled. The rules of procedure have more detailed provisions, in particular on the convocation, the procedure, the
p.(None): Presence, representation and decision-making, as well as rules on incompatibility, must be approved by
p.(None): the Federal Minister of Health. This also applies to any change in the rules of procedure.
p.(None): office
p.(None): Section 98. For the day-to-day business of the Commission and its committees, there is an office at the Federal Ministry of Health and Women
p.(None): to set up. This must be managed by a legally qualified official.
p.(None): Genetic engineering book, report on the application of genetic engineering
p.(None): Section 99. (1) The Federal Minister for Health and Women is responsible for publishing the genetic engineering book. The Commission documents in the genetic engineering book
p.(None): the state of the art in science and technology for working with GMOs, for GMO releases and for placing products on the market, as well as for genetic engineering
p.(None): Analyzes and somatic gene therapy in humans.
p.(None): (2) The individual sections of the genetic engineering book are the responsibility of the relevant scientific committee for decision-making
p.(None): propose. A majority of two thirds of the votes cast is required in the scientific committees for such a proposal.
p.(None): (3) The Commission has individual sections of the genetic engineering book proposed by the relevant scientific committee with a simple majority
p.(None): to be accepted or rejected for further processing.
p.(None): (4) In execution of Sections 8, 12, 17, 21, 35, 38, 50, 53, 56 and 72, parts of the genetic engineering book can be issued as a regulation. These parts are in
p.(None): To publish the Federal Law Gazette. The Federal Minister of Health and Women can refrain from issuing regulations or from him
p.(None): Enforcement of the above-mentioned regulations if and insofar as the Genetic Engineering Book is sufficiently clear about the regulations contained therein
p.(None): Has created principles to be observed and the intended regulatory purpose is ensured by the genetic engineering book.
p.(None): (5) On the basis of the reports submitted to it by the standing scientific committees (Section 93 (3)), the Commission has three years
p.(None): Distances for the first time in 1998 - to produce a report that is a summary
p.(None): a) the work carried out in Austria with GMOs in closed systems,
p.(None): b) the release of GMOs and the placing on the market of products in Austria in accordance with III. Section and
p.(None): c) on general matters of genetic analyzes and gene therapies on humans carried out in Austria
p.(None): has to contain. The Commission has to assess and observe the developments observed with regard to compliance with the principles set out in § 3
p.(None): to examine and present the educational and research policy and economic consequences of the observed development for Austria. This
p.(None): Report is from the Federal Minister of Health and Women in agreement with the Federal Minister of Education, Science and Culture with an attached
p.(None): Present the measures they have taken to promote security research (Section 102) to the National Council.
p.(None): VI. SECTION
p.(None): Authority, controls
p.(None): authorities jurisdiction
p.(None): Section 100. (1) Authority within the meaning of this Act
p.(None): 1. With regard to working with GMOs in a closed system and the release of GMOs - insofar as these are in scientific universities or in
p.(None): scientific institutions of the federal government in its department or through them - the Federal Minister of Education, Science and Culture,
p.(None): 2. the Federal Minister for Health and Women.
p.(None): (2) The competent authority for the measures according to § 109 is the district administrative authority.
p.(None): (3) Without prejudice to the responsibilities under paragraph 1, the Federal Minister of Agriculture, Forestry, Environment and Water Management, insofar as this is the
p.(None): Perception of his competencies in the field of environmental protection and agricultural resource law is required in the
p.(None): Community law procedures in accordance with Directive 2001/18 / EC and Regulation (EC) № 1829/2003. The Federal Minister of Health
p.(None): and women has given the Federal Minister of Agriculture, Forestry, Environment and Water Management the necessary information obtained through these procedures
p.(None): Submit documents.
p.(None): Community law directly applicable
p.(None): § 100a. (1) The following legal provisions are to be implemented within the framework of this Federal Act:
p.(None): 1. Regulation (EC) No. 1946/2003 of July 15, 2003 on cross-border movements of genetically modified organisms
p.(None): 2. Regulation (EC) № 1829/2003 of September 22, 2003 on genetically modified food and feed, as far as it is not substances and
p.(None): Products that are placed on the market and controlled by the Food Safety and Consumer Protection Act - LMSVG or the
p.(None): Feed Act is regulated.
p.(None): 3. Regulation (EC) № 1830/2003 of September 22, 2003 on the traceability and labeling of genetically modified organisms and on
p.(None): the traceability of food and feed produced from genetically modified organisms and to amend the directive
p.(None): 2001/18 / EG, as far as it is not a matter or products, their placing on the market and control by the food safety and
p.(None): Consumer protection law - LMSVG, the feed law, the fertilizer law, the seed law, the plant law, the vine traffic law
p.(None): or the Forest Propagation Act is regulated.
p.(None): (2) Competent authority for the implementation of Regulation (EC) № 1946/2003 on cross-border movements of genetically modified
p.(None): Organisms are the authority according to § 100 paragraph 1. National contact point for contact with the secretariat of the Convention on Biosafety
p.(None): and the information point on biosafety in accordance with Articles 19 and 20 of the Protocol on Biosafety is the Federal Environment Agency.
p.(None): (3) The implementation of Regulation (EC) No. 1829/2003 on genetically modified food and feed is incumbent on
p.(None): 1. for substances and products that fall within the scope of the Food Safety and Consumer Protection Act - LMSVG, the Federal Minister
p.(None): for health and women
p.(None): 2. for substances and products that fall within the scope of the Feed Act, the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management.
p.(None): (4) The authority responsible for receiving applications in accordance with Articles 5, 17 and 27 of Regulation (EC) No 1829/2003
p.(None): 1. for applications for approval as a genetically modified food and for applications for joint approval as a genetically modified food and
p.(None): Feed of the Federal Minister of Health and Women
p.(None): 2. the Federal Office for Food Security for applications for approval as genetically modified feed.
p.(None): Controls, restoration of the environment
p.(None): Section 101. (1) The organs of the authority are authorized in places where there is reason to believe that
p.(None): 1. work with GMOs is carried out,
p.(None): 2. GMOs are released,
p.(None): 3. products are placed on the market in accordance with section 54 (1),
p.(None): 4. genetic analyzes are carried out on humans in accordance with § 65 or the data obtained is processed and stored in an automated manner
p.(None): become, or
p.(None): 5. gene therapies are carried out on humans,
p.(None): To keep an eye on and for the purpose of checking compliance with the provisions of this federal law and those based on this federal law
p.(None): decrees and notices to be carried out, to inspect the records to be kept in accordance with sections 34 and 52, and
p.(None): Take samples to the extent necessary.
p.(None): (2) Except in the event of imminent danger, the review is during normal business or operating hours and with the involvement of a responsible person
p.(None): Employees. Care should be taken to ensure that any disruption or disability of the operator or anyone that is not absolutely necessary
p.(None): interference with third party rights that is not absolutely necessary is avoided.
p.(None): (3) The operator and anyone who places GMOs on the market must tolerate the controls and sampling to provide the necessary support
p.(None): to provide all information necessary for inspection and sampling and all aids necessary for the investigation and monitoring measures
...
p.(None): §§ 18 to 20a of the Federal Roads Act 1971, Federal Law Gazette No. 286, are to be applied analogously in the respectively applicable version. An appeal against that
p.(None): Deciding on the amount of compensation is not permitted. However, the parties are free to do so within three months of issuing the decision
p.(None): To apply for a decision on the amount of compensation to the district court in whose district the environmental impact has occurred. With this
p.(None): Referral to the district court will invalidate the amount of the compensation.
p.(None): Measures in the event of release without authorization
p.(None): Section 101b. (1) If a release was carried out contrary to the provision of Section 37 (1) without prior approval, the authority has the person who
p.(None): this release has carried out the removal of the released GMOs as well as any other measures that are state of the art
p.(None): and technology to ensure security (§ 1 Z 1), to keep the spread of this GMO including its genetic material and to ensure the
p.(None): released GMOs are appropriate and necessary.
p.(None): (2) The authority shall confiscate released GMOs without prior approval; Section 109 (4), second and third sentences apply to such
p.(None): To apply GMOs.
p.(None): Genetic Engineering register
p.(None): Section 101c. (1) Products according to § 54 Paragraph 1 are immediately after the approval of their placing on the market under a consecutive number
p.(None): (Genetic engineering register number) in the register kept by the Federal Minister of Health and Women (genetic engineering register).
p.(None): (2) In the genetic engineering register are the date and scope of the authorization to place the product on the market, the information in accordance with Section 62 (1) and as required
p.(None): an ordinance pursuant to Section 101e (3) the locations of approved releases and data on the locations of the cultivation of marketed and
p.(None): registered genetically modified crops.
p.(None): (3) Anyone can inspect the genetic engineering register during office hours, make copies on the spot, or as required
p.(None): Have copies of the existing technical possibilities made at his own expense. The genetic engineering register is public to the Internet
p.(None): to make it accessible.
p.(None): (4) The determination and processing of data for the purpose of automation-supported maintenance of the genetic engineering register is permitted.
p.(None): safety documentation
p.(None): Section 101d. (1) The Federal Ministry of Health is responsible for checking the safety (Section 1 (1)) of products placed on the market in accordance with Section 54 (1)
p.(None): and women a documentation center on safety-related properties and for the identification of the GMOs contained in these products
p.(None): To set up information.
p.(None): (2) The information and information required for this are submitted to the documentation center with the application for marketing authorization from
p.(None): Products (Section 54 (1)). In any case, this information must contain:
p.(None): 1. description of the product and the GMOs contained therein,
p.(None): 2. Name and address of the license holder,
p.(None): 3. A description of the product corresponding to the state of the art in science and technology with regard to the genetic modification
p.(None): caused special properties,
p.(None): 4. Description of the expected types of use and the planned spatial distribution in Austria,
p.(None): 5. intended labeling,
p.(None): 6. Instructions and recommendations for storage and handling and a description of the resulting residues and their treatment as well as the
p.(None): Emergency plans and adequate information for the identification of the GMO (in particular introduced nucleotide sequences).
p.(None): statutory authorization
p.(None): Section 101e. (1) Insofar as this is necessary to ensure the control of the safety (§ 1 Z 1) of products according to § 54 paragraph 1, the Federal Minister
p.(None): for health and women after hearing the responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister
p.(None): for Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor and the Federal Minister of Science and Transport
p.(None): (Note: correct: Federal Minister of Education, Science and Culture) taking safety, expediency and completeness into account
p.(None): Information to be issued by ordinance for more detailed provisions on the content, scope and form of the information to be given to the authority in accordance with Section 57 no.
p.(None): (2) In addition, information must be included in the security documentation that the authority receives in accordance with Section 57 no. 2.
p.(None): (3) The Federal Minister of Health and Women, insofar as this is used to control the adverse effects of released GMOs and in traffic
p.(None): brought products (§ 54 para. 1) to the security (§ 1 Z 1) and for information to the public is necessary, after hearing the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
p.(None): and water management and the Federal Minister of Education, Science and Culture detailed regulations on the genetic engineering register and the therein
p.(None): data to be recorded and necessary reporting obligations, also with regard to the shared use of this data by federal and state authorities or with
p.(None): control bodies. This regulation may relate to the data on the places of cultivation for placing on the market
p.(None): Approved genetically modified crops may also be subject to the provincial governor's reporting obligation, insofar as this is due to federal or
p.(None): state law has such data; The entry into a register referred to in Section 79c (1) in accordance with Section 101c (2) is also supported by the
p.(None): official registration of this cultivation in a register kept according to state law regulations (state genetic engineering book) corresponded.
p.(None): VII. SECTION
p.(None): safety research
p.(None): Section 102. The federal ministers responsible in accordance with section 100 have, in accordance with the respective Federal Finance Act, taking into account the status of the
p.(None): Science to promote research in the field of safety in the applications of genetic engineering (interdisciplinary risk and safety research).
p.(None): VIII. SECTION
p.(None): Interim measures
...
p.(None): 3. a) Security level, containment measures and place of work with GMOs;
p.(None): b) purpose of release and place of release;
p.(None): 4. methods and plans for GMO monitoring and emergency response;
p.(None): 5. Assessment of the foreseeable effects, in particular the effects that are detrimental to safety (§ 1 no. 1).
p.(None): (4) The regulations according to paragraphs 1 to 3 on the confidentiality of data in the disclosure process also apply in relation to the others at the official level
p.(None): Procedure for authorizing a release involved.
p.(None): Transmission of data
p.(None): Section 106. The data to be disclosed to the authority in accordance with this federal law may be collected and processed by the authority. personal
p.(None): and confidential data may only be transmitted to
p.(None): 1. the departments of the federal and state governments, insofar as the data is for the recipient to enforce this federal law or other federal or
p.(None): state law provisions for the protection of human health or the environment form an essential prerequisite,
p.(None): 2. experts appointed by the authority, insofar as they require the data in order to complete this federal law,
p.(None): 3. the competent authorities of foreign countries, insofar as this is to avert a specific danger to the life or health of people or
p.(None): the environment is required, or if so provided by intergovernmental agreements.
p.(None): XI. SECTION
p.(None): Notification requirements to the European Commission
p.(None): § 107. The Federal Minister of Health and Women has the European Commission taking into account the provisions on confidentiality
p.(None): in accordance with section 105 and data traffic in accordance with section 106
p.(None): 1. As soon as possible to report all accidents when working with GMOs in a closed system and include details about the circumstances of the accident, the
p.(None): Identity and quantities of the GMOs released, the emergency measures applied and their effectiveness, as well as an analysis of the accident, including
p.(None): Provide recommendations to limit its impact and prevent similar accidents in the future,
p.(None): 2. At the end of each year, a summary report on work for approval in security levels 3 and 4 in
p.(None): closed systems, including the description, purpose and risks of the GMOs, and to be submitted every three years and at
p.(None): for the first time on June 5, 2003 a summary report on his experience with the application of the EC Directive 90/219 / EC in the version of the
p.(None): To transmit EC Directive 98/81 / EC,
p.(None): 3. communicate the official decisions in accordance with § 40,
p.(None): 4. after the end of each year, a short report on the control of the use of all those approved and placed on the market in accordance with Section 58 (5)
p.(None): To transmit products (section 54 (1)) and
p.(None): 5. to submit a report every three years, and for the first time on 1 September 1997, on the measures taken to implement Directive 90/220 / EEC.
p.(None): XII. SECTION
p.(None): Transitional, criminal and final provisions
p.(None): Transitional provisions
p.(None): Section 108. (1) At the time this Federal Act comes into force (Art. III Para. 1), work and series of work with GMOs in closed form are already taking place
...
p.(None): Products belong.
p.(None): (5) The confiscation and the forfeiture within the meaning of paragraph 4 shall be omitted if the facts of paragraph 2 no. 2 are not realized and according to
p.(None): State of the art in science and technology there is no threat to security (Section 1 no. 1).
p.(None): (6) In the case of para. 2 no. 1, the administrative criminal authority can, in the decision declaring the expiry, order that the expired GMO from the
p.(None): these GMOs are to be harmlessly disposed of at the time of the illegal release or the costs of the harmless disposal are to be attributed to them
p.(None): has to wear.
p.(None): (7) The administrative criminal authority can lift the seizure upon request and refrain from forfeiture if the person concerned about this GMO at the time of the
p.(None): unlawful release ensures that the person who disposes of it can be harmlessly disposed of or otherwise used legally, if none
p.(None): Endangering security (§ 1 Z 1) is to be feared.
p.(None): References to other federal laws
p.(None): Section 110. (1) Insofar as other federal laws are referred to in this federal law, these are to be understood in their respectively applicable version.
p.(None): (2) This federal law does not affect the validity of other federal regulations.
p.(None): completion
p.(None): Section 111. The following are entrusted with the implementation of this federal law:
p.(None): 1. With regard to the ordinance to be issued pursuant to Section 8 of the Federal Minister of Health and Women in agreement with the Federal Minister of Agriculture
p.(None): and forestry, environment and water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and
p.(None): Culture,
p.(None): 2. With regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with § 12 and § 12a in agreement with the
p.(None): Federal Minister of Economics and Labor, the Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of
p.(None): Education, science and culture,
p.(None): 3. with regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with sections 17, 44 and 72 in agreement with the
p.(None): Federal Minister of Education, Science and Culture,
p.(None): 4. With regard to the ordinances to be issued by the Federal Minister of Health and Women in accordance with Sections 21 and 29 in agreement with the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture,
p.(None): 5. With regard to the ordinance to be issued in accordance with Section 35 of the Federal Minister for Health and Women in agreement with the Federal Minister for
p.(None): Economy and Labor and the Federal Minister of Education, Science and Culture,
p.(None): 6. With regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with Sections 38, 42, 46a, 50, 53, 56 and 62b
p.(None): with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor and the Federal Minister
p.(None): for education, science and culture,
p.(None): 7. With regard to the ordinance to be issued pursuant to Section 62 (2) of the Federal Minister for Health and Women in agreement with the Federal Minister for
p.(None): Agriculture and forestry, environment and water management and the Federal Minister of Economics and Labor,
p.(None): 8. the Federal Government with regard to the ordinance to be issued pursuant to Section 63 (2),
p.(None): 9. with regard to Section 26 and Section 27 (2)
p.(None): a) Matters of higher education (Art. 14 para. 1 B-VG) of the Federal Minister of Education, Science and Culture,
p.(None): b) in matters of the scientific institutions of the Confederation (Art. 10 para. 1 no. 13 BVG) of the relevant scientific institution of the
p.(None): Federal minister responsible,
p.(None): (c) in matters of trade and industry (Art. 10 para. 1 no. 8 B-VG) of the Federal Minister of Economics and Labor,
p.(None): (d) in matters of health, veterinary and nutritional services, including food control (Art. 10 para. 1
p.(None): Z 12 B-VG) of the Federal Minister for Health and Women and
p.(None): (e) in matters relating to environmental protection measures,
p.(None): as far as the federal government is responsible according to Art. 10 Para. 1 Z 12 B-VG, as well as in matters of the Chemicals Act, Federal Law Gazette I № 53/1997, the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management,
p.(None): 10. with regard to sections 58 (8), 100a (4) (2) and 108 (3) last sentence, the Federal Minister of Agriculture, Forestry, Environment and Water Management,
p.(None): 11. with regard to IVa. Section of the Federal Minister of Justice, with regard to the task under Section 79j (1) last sentence but in accordance with Section 100 of the
p.(None): Federal Minister of Education, Science and Culture or the Federal Minister of Health and Women,
p.(None): 12. With regard to the nomination rights to the Genetic Engineering Commission and its committees, the ones mentioned in sections 81 (1), 86 (2) and 87 (2)
p.(None): Federal Minister,
p.(None): 13. With regard to Section 99 (4), the Federal Minister of Health and Women in agreement with those in accordance with those named there
p.(None): Authorization to issue ordinances to federal ministers authorized to consult,
p.(None): 14. With regard to the presentation of the report on the applications of genetic engineering in accordance with Section 99 (5) of the Federal Minister for Health and Women in
p.(None): Agreement with the Federal Minister of Education, Science and Culture,
p.(None): 15. the Federal Minister of Education with regard to the duties as an authority in accordance with section 100 (1) 1 and with regard to section 102 in conjunction with section 101 (1) 1;
p.(None): Science and culture,
p.(None): 16. With regard to the ordinance of the Federal Minister of Health and Women to be issued in accordance with Section 101e (3) in agreement with the Federal Minister
p.(None): for agriculture and forestry, environment and water management and the Federal Minister of Education, Science and Culture,
p.(None): 17. for the rest, the Federal Minister for Health and Women.
p.(None): implementation Note
p.(None): § 112. This federal law makes Directive 90/219 / EEC as amended by Directive 98/81 / EC and Directive 2001/18 / EC of the European
p.(None): Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and on the repeal of the directive
p.(None): 90/220 / EEC of the Council, OJ № L 106 of April 17, 2001, as amended by Regulations (EG) № 1829/2003 and (EG) № 1830/2003, OJ. № L 268 from
p.(None): October 18, 2003, as well as Directive (EU) 2015/412 amending Directive 2001/18 / EC on the possibility granted to the Member States to cultivate
p.(None): restrict or prohibit genetically modified organisms (GMOs) on their territory, OJ No.L 68 from 13.03. 2015, implemented.
p.(None): Entry into force of regulations
p.(None): Section 113. Section 71 (2) in the version of the Electronic Health Record Act, Federal Law Gazette I No. 111/2012, comes into force on January 1, 2013.
p.(None): Section 113a. Section 88 (2) 2 lit. a and § 97 GTG in the version of the Reproductive Medicine Law Amendment Act, BGBl. I. № 35/2015, occur with the
p.(None): Announcement in force the following day.
p.(None): Section 113b. Section 67 in the Federal Law Gazette I No. 112/2016 comes into force on 1 January 2017.
p.(None): Section 113c. Sections 66 Paragraphs 1 and 3, 71, 71a Paragraph 2, 106 and 109 Paragraph 3 Z 34 and 37 in the version of the 2nd Material Data Protection Adjustment Act,
p.(None): BGBl. I No. 37/2018, come into force on May 25, 2018.
p.(None): § 113d. Section 69 (2) and (3) in the version of the Federal Law Gazette I No. 59/2018 comes into force on July 1, 2018.
p.(None): Attachment 1
p.(None): Registration or application documents for working with GMOs in accordance with sections 19 and 20
p.(None): A) Working with genetically modified microorganisms (GVM)
...
p.(None): Identification and proof of GMOs
p.(None): 6. Description of the planned change in the recipient organism in vertebrates,
p.(None): 7. when working with transgenic vertebrates by breaking the species limits, displaying the persecuted biomedical and developmental biology
p.(None): Aims.
p.(None): 2. Further work with genetically modified plants or animals
p.(None): 2.1. Further work with transgenic vertebrates of security level 1:
p.(None): 1. address of the facility,
p.(None): 2. date of receipt of the notification regarding the first work with transgenic vertebrates in this facility,
p.(None): 3. Description of the planned change in the recipient organism in vertebrates,
p.(None): 4. Presentation of the pursued biomedical and developmental goals of the work.
p.(None): 2.2. Further work with transgenic plants or animals, provided a security level 1 security level is not permitted:
p.(None): 1.Address of the plant and, if necessary, changes to the description of the parts of the plant which are relevant for working with GMOs and their safety,
p.(None): of the greenhouse or animal husbandry,
p.(None): 2. date of receipt of the notification regarding the first-time work with GMOs in this annex,
p.(None): 3. Name of the project manager,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Necessary changes or additions to the description of security measures, methods for the harmless elimination of the GMO, of
p.(None): Methods for the identification and detection of GMOs and measures to prevent accidents.
p.(None): Appendix 2
p.(None): To the Federal Ministry of
p.(None): Health and women
p.(None): Radetzkystrasse 2
p.(None): 1030 Vienna Date:
p.(None): Form for reporting genetic analyzes according to § 73
p.(None): 1. Setup
p.(None): 2. Observation period
p.(None): 3. Main reason for the examinations (multiple answers possible):
p.(None): humangenetische- / Family investigation
p.(None): prenatal examination
p.(None): other:
p.(None): Attention: Please provide the following information separately for each test feature.
p.(None): Genetic analysis for the purpose of determining a predisposition to a disease, in particular the predisposition to an inherited disease or for determining
p.(None): a carrier status.
p.(None): A) Investigation characteristic (research question)
p.(None): B) Extent of this investigation during the observation period
p.(None): 1-50> 50-200> 200-1000> 1000
p.(None): C) Title of the test method (eg PCR), if applicable a quotation from the literature or a brief description of the method
p.(None): Proportion of positive findings in the observation period
p.(None): D) <0.1% 0.1-1%> 1-10%> 10-50%> 50%
p.(None): E) Confirmation of successful participation in the proficiency tests offered
p.(None): Appendix 3
p.(None): To the Federal Ministry of
p.(None): Health and women
p.(None): Radetzkystrasse 2
p.(None): 1030 Vienna Date:
p.(None): Form for reporting the start of a clinical trial for the purpose of somatic gene therapy in accordance with Section 79 GTG
p.(None): Facility:
p.(None): Clinical Trial Title:
p.(None): Date and transaction number of the notification:
p.(None): Start of clinical trial:
p.(None): Signature:
p.(None): Appendix 4
p.(None): To the Federal Ministry of
p.(None): Health and women
p.(None): Radetzkystrasse 2
p.(None): 1030 Vienna Date:
p.(None): Form for reporting the progress of a clinical trial for the purpose of somatic gene therapy in accordance with Section 79 GTG
p.(None): Facility:
p.(None): Date and transaction number of the notification:
p.(None): Clinical Trial Title:
p.(None): Course of the clinical trial:
p.(None): Number of people treated:
p.(None): Time of termination
p.(None): Signature:
p.(None): Article III
p.(None): Come into effect
p.(None): (1) With the exception of Article I V. Section Genetic Engineering Commission, this Federal Act shall enter into force on January 1, 1995.
p.(None): (2) Ordinances based on Article I of this Federal Act can be enacted from the day following its publication; they kick
p.(None): at the earliest at the time specified in paragraph 1.
p.(None): (3) Sections 26 and 27 in the version of the Animal Experimentation Law Amendment Act, Federal Law Gazette I No. 114/2012, come into force on January 1, 2013.
p.(None): Article II
p.(None): (Note: from BGBl. I No. 73/1998, §§ 43, 79a to 79j, 81, 85, 87, 89, 101e and 109, BGBl. No. 510/1994)
p.(None): (1) Sections 4, 39a, 41, 43, 58, 60, 81, 85, 87, 89, 101b to 101e, 105, 107, 109, with the exception of paragraph 2 line 3 and 111 line 19 in the version of the federal law
p.(None): BGBl. I No. 73/1998 come into force on July 1, 1998.
p.(None): (2) Sections 23, 40, 79a to 79j, 101a, 109 para. 2 no. 3 and 111 no. 13a in the version of the Federal Law BGBl. I No. 73/1998 come into force on October 1, 1998.
p.(None): (2a) Section 79j (1), Section 109 (1), Section 109 (2) and Section 109 (3) come into force on 1 January 2002 in the version of Federal Law BGBl. I No. 98/2001.
p.(None): (3) Sections 79a to 79j are for damage and Section 101a is not for damage to the environment caused before their entry into force
p.(None): apply.
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Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): (4) If the laboratory manager leaves this function or his order is canceled by the manager of the facility, a new laboratory manager is immediately
p.(None): to order.
p.(None): (5) The head of the facility shall notify the authority of the resignation and each change of the laboratory head without undue delay, including that for the head of the
p.(None): The replacement person appointed to the facility must be notified in writing of the necessary evidence (para. 2).
p.(None): (6) The appointment of a laboratory manager increases the responsibility of the head of the facility for compliance with the provisions of this federal law
p.(None): and the administrative file based on it.
p.(None): Consent and advice
p.(None): Section 69. (1) A genetic analysis of type 2, 3 or 4, including a genetic analysis as part of a prenatal examination, may only be carried out after
p.(None): There is a written confirmation from the person to be examined that they have previously been through a human genetics / medical genetics
p.(None): trained specialist or a specialist responsible for the indication area has been informed about their nature, scope and significance and
p.(None): has consented to genetic analysis based on free knowledge based on this knowledge. These exams become prenatal
p.(None): carried out, the information and consent of the pregnant woman must also include the risks of the intended intervention.
p.(None): (2) The confirmation acc. Paragraph 1 granted
p.(None): 1. for an underage person, according to § 173 ABGB,
p.(None): 2. a legal guardian for a minor who is unable to make decisions and
p.(None): 3. for a person of legal age who is not able to make a decision, their legal representative (Section 1034 ABGB), in whose sphere of activity consent to
p.(None): medical treatment falls.
p.(None): (3) Before carrying out a genetic analysis in accordance with paragraph 1, the person to be examined and, if necessary, in accordance with paragraph 2 must have detailed advice
p.(None): authorized legal guardian or other legal representative about the nature, scope and significance of the analysis by the
p.(None): this genetic analysis is carried out by a specialist trained in human genetics / medical genetics or the specialist responsible for the indication area
p.(None): take place.
p.(None): (4) The advice after performing a genetic analysis in accordance with paragraph 1 must include the factual, comprehensive discussion of all test results
p.(None): and medical facts as well as possible medical, social and psychological consequences. If there is an appropriate disposition for one
p.(None): hereditary disease with serious physical, psychological and social effects also on the usefulness of an additional non-medical
p.(None): Advice in writing from a psychologist or psychotherapist or from a social worker. In addition, others can
p.(None): Advice centers and self-help groups are advised.
p.(None): (5) Consultations before and after a genetic analysis in accordance with paragraph 1 may not take place directly. The person seeking advice is already at the start of the
p.(None): Counseling interviews to indicate that he - at any time - even after consenting to genetic analysis or after advice has been given
p.(None): may not want to know the result of the analysis and the consequences that can be derived from it.
...
Social / education
Searching for indicator education:
(return to top)
p.(None): corresponds if the biological safety measures reduce the risk.
p.(None): (8) The security classification must be recorded in writing and justified. In the case of working with GVM, the cultural volume of the planned one is also included
p.(None): To indicate work.
p.(None): Approval procedure
p.(None): § 7. (1) If there are doubts about the security level in which a certain work with GMOs can be classified, the security measures are the higher ones
p.(None): Security level apply, unless it is sufficiently proven in agreement with the authority that the application of less stringent measures
p.(None): is justified.
p.(None): (2) In the case of paragraph 1, the authority has ex officio or at the request of the operator after consulting the responsible scientific committee of the
p.(None): Genetic Engineering Commission to determine the security level of this work with GMOs in consideration of the provisions of § 6.
p.(None): statutory authorization
p.(None): § 8. The Federal Minister of Health and Women has to guarantee security (§ 1 2 1) according to the state of the art in science and technology
p.(None): Consideration of international guidelines and recommendations after consulting the responsible scientific committee of the genetic engineering commission
p.(None): Ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor
p.(None): and the Federal Minister of Education, Science and Culture
p.(None): 1. Establish criteria for the security classification and the allocation of donor and recipient organisms to risk groups and
p.(None): 2. To give examples of the assignment of donor and recipient organisms to risk groups.
p.(None): Transgenic animals
p.(None): § 9. (1) Work on the production of transgenic vertebrates, with which a breakthrough of the species boundaries is connected, and work with transgenic
p.(None): Vertebrates, which were produced by breaking the species boundaries, are only for the purposes of biomedicine and developmental research
p.(None): allowed.
p.(None): (2) A breach of the species limit within the meaning of paragraph 1 exists if the identity of the species of the recipient organism is taken into account
p.(None): Reproduction and in terms of the essential characteristics of its body structure, its physiological functions and its performance is not preserved.
p.(None): (3) There are doubts as to whether breakthrough of a work on the production of transgenic vertebrates or a work on transgenic vertebrates
p.(None): Is bound by the species limit, the authority has received a request from the operator after consulting the scientific committee for working with GMOs in the
p.(None): closed system (§ 86) with notice to determine whether this work involves a breach of the species limit.
p.(None): Safety measures
p.(None): § 10. (1) Working with GMOs may only be carried out in compliance with the state-of-the-art measures to guarantee the
p.(None): Security (§ 1 Z 1) against threats from GMOs.
p.(None): (2) In justified exceptional cases, individual organizational or technical security measures of a certain security level cannot
...
p.(None): 5. the measures to eliminate the consequences of the accident
p.(None): to be communicated in writing.
p.(None): (3) When working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale, the authority is from
p.(None): notify the accident that has occurred immediately by telephone or fax. The operator has, if according to the state of science and technology
p.(None): a risk to the health of the employees or the residents of the genetic engineering plant is to be assumed by these persons immediately from the accident
p.(None): inform and recommend appropriate behavioral measures.
p.(None): (4) In the event of accidents in accordance with paragraph 3, the operator and, if necessary, the authority must carry out a monitoring (monitoring) of the effects of the accident on the
p.(None): Security (§ 1 Z 1) to perform.
p.(None): (5) In the event of accidents in accordance with paragraph 3, the local governor, the local administrative authority and the municipality are responsible
p.(None): communicate.
p.(None): statutory authorization
p.(None): § 12. The Federal Minister of Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission under
p.(None): Consideration of the principles mentioned in § 3 paragraphs 1 and 2 by ordinance in agreement with the Federal Minister of Agriculture and Forestry,
p.(None): Environment and Water Management, the Federal Minister of Economics and Labor and with the Federal Minister of Education, Science and Culture and according to the status
p.(None): of science and technology and taking into account relevant EU regulations and other international guidelines and recommendations
p.(None): provisions
p.(None): 1. About organizational and technical security measures when working with GMOs in closed systems that are appropriate for the respective security level
p.(None): special attention is paid to the type of work to be carried out with GMOs,
p.(None): 2. requirements for genetic engineering systems to prevent, limit and eliminate the effects of accidents,
p.(None): 3. about criteria for the security measures in rooms for keeping transgenic plants or animals,
p.(None): 4. general criteria for assessing the effectiveness of biological safety measures and
p.(None): 5. for the preparation and content of emergency plans
p.(None): and to provide examples of recognized host-vector systems.
p.(None): statutory authorization
p.(None): § 12a. (1) The Federal Minister for Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission
p.(None): by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and
p.(None): Work and the Federal Minister of Education, Science and Culture according to the state of the art in science and technology, taking into account Annex II Part C
p.(None): of Directive 90/219 / EEC on the use of genetically modified microorganisms in closed systems in the currently applicable version, types of
p.(None): List GMOs that are safe for human health and the environment.
p.(None): (2) Working with GMOs in closed systems, which only include types of GMOs that are included in this list
p.(None): not the requirements of sections II. and IVa.
p.(None): operator
p.(None): § 13. (1) According to the state of the art in science and technology, the operator has to take the necessary safety measures (§ 10) and to comply with them
p.(None): to care.
p.(None): (2) The operator has all questions of safety with the officer for biosafety (§ 14), the project manager (§ 15) and the committee
p.(None): advice on biosafety (§ 16).
p.(None): (3) By appointing a biosafety officer, a project manager or a biosafety committee, the
p.(None): Responsibility of the operator for compliance with the provisions of this federal law and the administrative acts based thereon are not affected.
p.(None): Biosafety Officer
p.(None): § 14. (1) The operator has a biosafety officer for each genetic engineering system and at least one representative with their
p.(None): Order consent and notify the local fire department immediately.
p.(None): (2) The Biosafety Officer and each deputy must have at least two years of practical experience working with GMOs such as
...
p.(None): (6) The operator shall immediately notify the authority of any change of one of the members of the Biosafety Committee, including those for the
p.(None): The person required to provide the replacement person with evidence (paragraph 3).
p.(None): (7) If the authority determines when ordering a replacement person on the basis of the evidence submitted that the person appointed has the right to them
p.(None): does not meet the requirements set, to request the operator, either within a period to be determined by the authority and not more than four weeks
p.(None): to provide outstanding evidence or, in the event of insufficient quali fi cation of the replacement person ordered, appropriate additional training within
p.(None): six months to prove, otherwise the operator has to appoint another suitable person. The assignment, a supplementary training within
p.(None): of six months is not permitted if the member to be replaced has been removed by the operator.
p.(None): (8) The appointment of a committee for biosafety in accordance with paragraph 1 can be waived if working with GMOs only involves storage and
p.(None): includes the internal transport of GMOs.
p.(None): statutory authorization
p.(None): § 17. The Federal Minister of Health and Women, insofar as this is necessary in the interest of security (§ 1 no. 1), according to the state of the art in science
p.(None): and technology and after hearing the responsible scientific committee of the genetic engineering commission by ordinance in agreement with the
p.(None): Federal Minister of Education, Science and Culture detailed provisions on the required experience in working with GMOs and knowledge
p.(None): in particular to adopt safety measures through which the biosafety officers, the project managers and the members of a committee
p.(None): for biological security.
p.(None): Cooperation with other institutions
p.(None): § 18. The Biosafety Officer, the Project Leader and the Biosafety Committee are required to perform their duties
p.(None): Advising the operator with the legal regulations for the protection of existing employees in the plant and with
p.(None): to work together with the officers appointed in this facility to perform environmental protection tasks.
p.(None): Registration of work with GMOs
p.(None): § 19. The operator has the implementation
p.(None): 1. first time working with GVM in a genetic engineering plant in security level 1,
p.(None): 2. first time working with GVM in a genetic engineering facility in security level 2,
p.(None): 3. further work with GVM in a genetic engineering facility in security level 2,
p.(None): 4. first-time work with transgenic plants or animals in a genetic engineering facility,
p.(None): 5. Further work with transgenic plants or animals in a genetic engineering facility, provided that a security classification of security level 1 is not
p.(None): is permissible, and
p.(None): 6. Further work with transgenic vertebrates in security level 1 in a genetic engineering facility
p.(None): Before starting work, register with the authority using the documents specified in Appendix 1. The registrations and the related ones
p.(None): Documents must be submitted in the original and in a copy.
p.(None): Permit applications for working with GMOs
p.(None): § 20. The operator has the authorization to carry out
p.(None): 1. Working with GVM in a genetic engineering system in security level 3 and
p.(None): 2. Working with GVM in a genetic engineering facility in security level 4
p.(None): to be submitted to the authority before starting work, following the documents specified in Appendix 1. The application and the related
p.(None): Documents must be submitted in the original and in a copy.
p.(None): statutory authorization
p.(None): § 21. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of a
p.(None): Procedure for examining a registration in accordance with § 19 or an application in accordance with § 20 and for assessing the requirements in accordance with § 23 is required at
p.(None): Consideration of the guarantee of security (§ 1 Z 1) and on the state of the art in science and after consulting the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Economics and Labor and the
p.(None): Federal Minister of Education, Science and Culture more detailed provisions on content, scope and form of the registration according to § 19 or the application according to
p.(None): Section 20 documents to be issued. The regulation may also require that these documents be used using the information provided by the authority
p.(None): The programs made available must be submitted on electronic data carriers.
p.(None): Official procedure
p.(None): § 22. (1) The authority has the applicant and applicant the receipt and date of receipt of the application or application and the attached
p.(None): Confirm documents immediately by means of an entry stamp or otherwise in writing.
p.(None): (2) The authority has the conformity of the application or the application with the provisions of this Federal Act and those based thereon
p.(None): Regulations, in particular the accuracy and completeness of the documents submitted, the accuracy of the security classification (§ 6) in a security level
p.(None): (§ 5) and, if necessary, the appropriateness of the safety measures (containment and other protective measures), the waste disposal measures
p.(None): and contingency plans (§ 11).
p.(None): (3) Insofar as this is necessary to assess the requirements for working with GMOs according to § 23, the authority has the applicant or applicant
p.(None): order to provide additional information to improve registration or application.
p.(None): (4) Provided that the work is not started immediately after registration in accordance with Section 24, Paragraph 2, Paragraph 3, first sentence or Paragraph 4, second sentence
...
p.(None): Section 10 does not exist.
p.(None): hearing
p.(None): § 28. (1) The authority has in the cases of § 22 Paragraph 5 No. 2 in the official gazette of the Wiener Zeitung and in the editorial section of two widespread in the federal state
p.(None): Announcing daily newspapers that an application for authorization to work with GMOs has been submitted, documents to the authority during
p.(None): within a period of six weeks for public inspection, a hearing is being held and that everyone is free to attend
p.(None): Attend hearing.
p.(None): (2) The authority shall have the hearing within the framework of the investigation procedure within three weeks of the end of the disclosure for public inspection
p.(None): perform. The authority has the public according to paragraph 1, as well as the members of the responsible scientific committee of the
p.(None): Genetic Engineering Commission, the operator and the members of the Biosafety Committee.
p.(None): (3) The hearing is public and serves to discuss the application and the associated documents. Everyone is allowed to ask questions and ask themselves
p.(None): to comment on the project.
p.(None): (4) Minutes of the public hearing must be drawn up.
p.(None): statutory authorization
p.(None): § 29. The Federal Minister of Health and Women, insofar as this is necessary in the interest of the expediency, speed and simplicity of the hearing,
p.(None): in agreement with the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture by ordinance
p.(None): Provisions regarding the announcement and the course of the consultation process, the type and scope of access to the application and the associated documents
p.(None): with particular attention to the confidentiality of data in accordance with § 105, to determine the schedule and the schedule of the hearing.
p.(None): Due diligence, information and notification requirements
p.(None): § 30. (1) Anyone who works with GMOs has all that is necessary according to the state of the art in science and technology in the interest of safety (§ 1 Z 1)
p.(None): Take precautions and measures.
p.(None): (2) Even after the start of work with GMOs, the operator has to deal with all facts and in connection with the execution of this work
p.(None): To inform circumstances which, according to the state of the art in science and technology, are likely to endanger security (Section 1 no. 1).
p.(None): (3) The operator has the facts and circumstances in accordance with paragraph 2 and the final cessation of all work with GMOs immediately in writing to the authority
p.(None): Report.
p.(None): Change in safety equipment
p.(None): § 31. The operator has any change in the security of the closed system, which according to the state of the art in science and technology
p.(None): Security (§ 1 Z 1) is likely to impair, to report to the authority in writing even after registration or after completion of the approval process.
p.(None): Change of operator
p.(None): § 32. A change in the person of the operator makes the permissibility of carrying out work with GMOs and the resulting ones
...
p.(None): 5. type of disposal of GMOs;
p.(None): 6. Information about accidents according to § 11 paragraph 2.
p.(None): (3) Other than the work with GMOs listed under paragraph 2 are to be recorded in separate records. In addition to those listed in paragraph 2
p.(None): For information, these records must contain the following information:
p.(None): 1. time of registration of work with GMOs or date and business number of the approval notice;
p.(None): 2. the names of the people directly involved in carrying out the work with GMOs;
p.(None): 3. Security and emergency measures taken.
p.(None): (4) Records of work in security levels 3 or 4 on a large scale must include a in addition to the information according to paragraphs 2 and 3
p.(None): Description of the process control and the devices and equipment used to control the safety measures.
p.(None): (5) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (6) Records of work in security levels 1 or 2 on a small scale must be at least three years after completion of the work or
p.(None): Work series are kept. All other records must be kept for at least five years after completing work with GMOs.
p.(None): statutory authorization
p.(None): § 35. The Federal Minister of Health and Women, insofar as this is in the interest of security (§ 1 Z 1) according to the state of the art in science and technology
p.(None): is necessary, after consulting the responsible scientific committee of the genetic engineering commission by regulation in agreement with the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the type and content of the
p.(None): To set records in accordance with § 34.
p.(None): III. SECTION
p.(None): Release of GMOs and placing products on the market
p.(None): PART A
p.(None): Release of GMOs
p.(None): stage principle
p.(None): Section 36. (1) The release of GMOs may only take place according to the step principle (Section 3 (3)). The following stages must be followed:
p.(None): 1. To a small extent, based on the state of the art in science and technology, unlimited distribution and multiplication of GMOs
p.(None): greatly reduce outside of the test area;
p.(None): 2. Attempt to a large extent, according to the state of the art in science and technology, to spread and multiply GMOs outside
p.(None): to monitor the test area.
p.(None): (2) If, according to the state of the art in science and technology, a risk to safety (§ 1 no. 1) can be excluded when certain GMOs are released,
p.(None): Authorization to request the release of this GMO, even if the stage according to Paragraph 1 No. 1 has not been passed.
p.(None): permit application
p.(None): Section 37. (1) Any release requires approval by the authority.
p.(None): (2) The operator must apply for approval of the release and attach the following information to the application:
p.(None): 1. those necessary to assess the immediate and late effects of the GMO or the combination of GMOs and their effects on safety (§ 1 Z 1)
p.(None): Information to the extent that it applies to the requested release. In cases where it is not technically possible or not necessary to provide information
p.(None): appears, this must be stated and justified. This information has including a description of the methods and bibliographical information
p.(None): to include these in particular:
...
p.(None): While the authority is reviewing the application or after its approval, new information is available on such risks, so is the applicant
p.(None): committed to immediately
p.(None): 1. to report this information to the authority,
p.(None): 2. review and adapt the measures listed in the application and
p.(None): 3. to take the necessary measures in the interest of security (§ 1 Z 1).
p.(None): (6) The applicant must immediately send a copy of the application (para. 2) and the notification (para. 5) to the Federal Ministry of Agriculture and Forestry,
p.(None): Environment and water management, which submits its opinion on this application to the authority.
p.(None): statutory authorization
p.(None): § 38. (1) The Federal Minister for Health and Women, insofar as this takes into account the expediency, speed and simplicity of a
p.(None): Procedure for examining an application in accordance with Section 37 Paragraphs 2 to 4, for the requirements of information exchange with the European Commission and for
p.(None): Assessment of the prerequisites in accordance with Section 40 (1) is necessary, taking into account safety (Section 1 (1)), the state of the art in science and technology
p.(None): and Community legislation relating to GMOs, in particular Annexes II and III to Directive 2001/18 / EC after consulting the
p.(None): responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture by ordinance
p.(None): Provisions on
p.(None): 1. The content, scope and form of the application in accordance with Section 37 (2) to (4) and the documents to be attached to it
p.(None): 2. the principles and methods to be used when preparing these application documents
p.(None): set. The regulation may also require that these documents be used using the programs provided by the authority
p.(None): to be presented on electronic data carriers.
p.(None): Note for the following provision
p.(None): Regarding para. 3: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): Official procedure
p.(None): Section 39. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application and the attached documents
p.(None): Confirm receipt of receipt or otherwise in writing.
p.(None): (2) Insofar as this is necessary for assessing the requirements in accordance with Section 40 (1), the authority shall provide the applicant with a reason
p.(None): order to provide further information on how to improve the application.
p.(None): (3) Before the decision to approve a release, except in the case of a simplified official procedure pursuant to Section 42, the authority has
p.(None): to carry out a hearing procedure in accordance with Section 43 and to obtain an expert opinion from the responsible scientific committee of the Genetic Engineering Commission.
...
p.(None): Release should take place.
p.(None): (5) The Authority shall make publicly available information on any release approval on the Authority's website.
p.(None): Inhibition of the deadline
p.(None): § 41. (1) The notification of the result of the investigation to the applicant and the order to improve the application or the
p.(None): The associated documents and the hearing in accordance with section 43 inhibit the period in accordance with section 40 (1) until the applicant has received a statement or
p.(None): of improvement. The hearing pursuant to Section 43 will delay this period for a maximum of 30 days.
p.(None): (2) The notification of the result of the investigation to a party in accordance with Section 39a (1) lines 2 to 6 does not inhibit the period in accordance with Section 40 (1).
p.(None): Simplified official procedure
p.(None): Section 42. (1) The Federal Minister of Health and Women is authorized if sufficient with the release of certain GMOs in certain ecosystems
p.(None): Experience has been gathered, taking into account the state of the art in science and technology and safety (§ 1 no. 1) after consulting the
p.(None): competent scientific committee of the Genetic Engineering Commission to submit an application in accordance with Art. 7 of Directive 2001/18 / EC and to implement a
p.(None): Decision according to Art. 7 of Directive 2001/18 / EC by regulation in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the
p.(None): Implement simplified administrative procedures for the release of such GMOs that are comparable in terms of their safety.
p.(None): (2) The Federal Minister of Health and Women has an ordinance in accordance with paragraph 1 or the decision, a decision in accordance with Art. 7 of the Directive
p.(None): 2001/18 / EC not to be used to inform the European Commission.
p.(None): Note for the following provision
p.(None): Regarding para. 2: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): hearing
p.(None): Section 43. (1) The authority has in the Official Journal of the Wiener Zeitung, in two local daily newspapers and on the notice boards of the municipalities in accordance with Section 39a (1)
p.(None): Z 2 and 3 to announce at the expense of the operator that an application for the release of a GMO has been made, relevant documents to the authority (§ 100),
p.(None): all offices of the state governments and the municipalities in whose local area of responsibility GMOs are to be released during a
p.(None): Period of three weeks for public inspection and that everyone is at liberty to justify the authority within the period for which the information is available
p.(None): Submit objections in writing. The announcement includes persons who, in accordance with Section 39a (1) (4) and (5), are party to the further official procedure
...
p.(None): (2) The authority shall schedule a hearing as part of the investigation; this hearing took place within three weeks from the end of the
p.(None): Deadline to be held. The hearing serves to discuss the objections submitted on time; the opponents have the opportunity to get closer
p.(None): To explain their objections. The authority has the right to this hearing to anyone who has submitted timely objections in writing
p.(None): load. This loading can be carried out in the announcement according to paragraph 1. The authority also has to load separately:
p.(None): a) the applicant in accordance with Section 39a (1) 1,
p.(None): b) the municipalities in accordance with Section 39a (1) 2 and 3 if they have raised objections in accordance with Section 1
p.(None): c) the owner of the property in accordance with Section 39a (1) no. 4,
p.(None): d) the neighbors in accordance with Section 39a (1) (5) if they raise objections in accordance with Section 1 and the requirements for their party status are met
p.(None): have demonstrated
p.(None): e) the federal state in accordance with section 39a (1) (6) if it has raised objections in accordance with section 1, and
p.(None): f) the members of the responsible scientific committee.
p.(None): statutory authorization
p.(None): § 44. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of the hearing
p.(None): is required, in agreement with the Federal Minister of Education, Science and Culture by ordinance, more detailed provisions on announcement and
p.(None): The course of the consultation process, the type and scope of the inspection of the application and the associated documents, with particular attention to the
p.(None): Confidentiality of data in accordance with Section 105, to determine the preparation and the course of the hearing.
p.(None): Security measures, due diligence, information and notification requirements
p.(None): Section 45. (1) Anyone who carries out a release has all that is necessary according to the state of the art in science and technology in the interest of safety (Section 1 no. 1)
p.(None): Take precautions and measures and - insofar as he is the operator - ensure that they are observed.
p.(None): (2) Even after approval of the release, the operator has all the facts and circumstances related to the release
p.(None): inform, which according to the state of the art in science and technology are suitable to endanger security (§ 1 Z 1).
p.(None): (3) The operator must immediately report facts and circumstances in accordance with paragraph 2 to the authority in writing.
p.(None): Release results report
p.(None): Section 46. (1) After completion of the release, the operator has all in accordance with the deadlines and requirements of the authority specified in the approval notice
p.(None): Report the results of the release, which are decisive for its assessment with regard to safety (§ 1 no. 1). This may include products
p.(None): (Section 54 (1)), for which the operator intends due to the release to apply for approval of the in-
p.(None): To bring traffic.
p.(None): (2) The authority has the results of the release communicated in accordance with Paragraph 1 to the responsible scientific committee of the Genetic Engineering Commission
p.(None): and to inform the European Commission.
p.(None): statutory authorization
p.(None): Section 46a. The Federal Minister of Health and Women, taking into account Art. 10 of Directive 2001/18 / EC after consulting the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
p.(None): und Wasserwirtschaft, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture, more detailed provisions on
p.(None): Determine the content, scope and form of the notification in accordance with Section 46 (1).
p.(None): Change of operator
p.(None): § 47. A change in the person of the operator makes the permissibility of carrying out a release and the resulting
p.(None): Obligations not affected. The legal successor must immediately notify the authority of the change in writing.
p.(None): Subsequent editions
p.(None): Section 48. (1) If the release is intended or unintentionally changed after the approval has been granted in a manner that is significantly disadvantageous
p.(None): Could have an impact on security (§ 1 Z 1), or will become circumstances associated with such effects after the approval
p.(None): known, the authority has, insofar as this is necessary for the prevention of immediate dangers, with the greatest possible protection of acquired rights, additional
p.(None): to issue appropriate safety requirements, to restrict or prohibit the release, and to ensure the harmless removal of the released
p.(None): To order GMOs.
p.(None): (2) The authority shall make information on measures pursuant to Paragraph 1 available to the public on the website of the authority.
p.(None): Accident, emergency plan
p.(None): § 49. (1) Taking into account the respective release, the operator has all of the latest science and technology to prevent accidents
...
p.(None): to be communicated in writing.
p.(None): (3) In the case of accidents that can lead to an immediate risk to safety (Section 1 no. 1), the authority is also immediately informed of the accident that has occurred
p.(None): to be informed by telephone or fax. The operator has a risk to the health of, provided that it is state of the art in science and technology
p.(None): People must be assumed to inform them immediately of the accident and to recommend appropriate behavioral measures.
p.(None): (4) In the event of an accident, the operator and, if necessary, the authority must monitor the effects of the accident on safety (§ 1
p.(None): Z 1).
p.(None): (5) The authority has public information on every accident that has a significant impact on safety (§ 1 no. 1) on the website of the
p.(None): To make the authority accessible and to inform the federal state in whose area of responsibility the release took place of such an accident.
p.(None): statutory authorization
p.(None): Section 50. The Federal Minister of Health and Women may, as far as this is in the interest of security according to the state of the art in science and technology (Section 1 no. 1)
p.(None): is necessary, after hearing the responsible committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture
p.(None): and forestry (note: correct: Federal Minister of Agriculture, Forestry, Environment and Water Management) and the Federal Minister of Education,
p.(None): Science and culture issued more detailed regulations to prevent, limit and eliminate the effects of accidents caused by releases.
p.(None): controls
p.(None): § 51. The authority is entitled to inspect during and after the release both in the test area and in its vicinity, including under
p.(None): Take appropriate samples (§ 101).
p.(None): record keeping
p.(None): § 52. (1) The operator must ensure that accompanying records of the release carried out, kept and kept
p.(None): Inspection by the authority.
p.(None): (2) The records must contain the following information:
p.(None): 1. Name and address of the operator;
p.(None): 2. place of release;
p.(None): 3. Date and transaction number of the approval of the release;
p.(None): 4. Beginning and completion of the release;
p.(None): 5. Summary presentation of the release, which enables an assessment of the release with regard to the necessary safety measures;
p.(None): 6. the names of the persons directly involved in the execution of the work;
p.(None): 7. Deviations from the planned test procedure;
p.(None): 8. Disposal of GMOs.
p.(None): (3) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (4) The records must be kept at least ten years after the end of the release.
p.(None): statutory authorization
p.(None): Section 53. The Federal Minister of Health and Women, insofar as this is in the interest of security (Section 1 no. 1) according to the state of the art in science and technology
p.(None): is necessary after consulting the responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister of Agriculture
p.(None): and forestry (note: correct: Federal Minister of Agriculture, Forestry, Environment and Water Management), the Federal Minister of Economics and Labor and
p.(None): to determine the Federal Minister of Education, Science and Culture more detailed provisions on the content, type and form of the records in accordance with Section 52
p.(None): PART B
p.(None): marketing
p.(None): authorization
p.(None): Section 54. (1) The placing on the market of products consisting of or containing GMOs requires the approval of the authority; in this
p.(None): Approval is to indicate the intended use.
p.(None): (2) The placing on the market of an already approved product for a different use than that specified in the marketing authorization
p.(None): requires a separate approval.
p.(None): (3) According to this Federal Act, no authorization is required for placing products on the market
p.(None): 1. if products are used as intended for the manufacture of which the placing on the market has already been approved in accordance with this Federal Act
p.(None): become or have been
p.(None): 2. for products that fall within the scope of Regulation (EC) No. 1829/2003 on genetically modified food and feed.
p.(None): In these cases, sections 55 to 63 of this Federal Act, with the exception of section 62c (1), do not apply.
p.(None): (4) Without prejudice to Section 60, the authorization for placing on the market by the authority is equivalent to the authorization to place it on the market by the authorities
p.(None): of another member state of the European Union or the EEA in application of Directive 90/220 / EEC or Directive 2001/18 / EC.
p.(None): Applicants and application documents
p.(None): Section 55. (1) Anyone who, as a manufacturer or importer, wishes to place a product on the market within the meaning of Section 54 (1) has previously applied for approval from
p.(None): Placing on the market.
p.(None): (2) The application must contain the following information:
...
p.(None): than the proposed period of approval,
p.(None): 10. the safety assessment in accordance with Section 37 (2) 2,
p.(None): 11. a summary of the application.
p.(None): (3) In the application, data or results from the release of the same GMO or combination of GMOs that the applicant used to be must also be communicated
p.(None): has applied for or carried out within or outside Austria or is currently applying for or undertaking. In the application are also the locations of the
p.(None): cite literature results of releases of the relevant GMOs.
p.(None): (4) The applicant can also refer to the data or results of previous applications by other applicants, provided that this is done in writing
p.(None): Have given consent.
p.(None): (5) If according to the state of the art in science and technology based on the results of a release or on the basis of the safety assessment with the in-
p.(None): Placing the product on the market and the use of the product are not expected to have any adverse effects on safety (Section 1 (1))
p.(None): Conformity with Annex IV of Directive 2001/18 / EC on reasoned request by the applicant for the submission of speci fi c information in accordance with
p.(None): Abs. 2 Z 7 waive.
p.(None): statutory authorization
p.(None): § 56. (1) The Federal Minister of Health and Women has, insofar as this is in view of the expediency, speed and simplicity of the application process
p.(None): and for the assessment of safety (§ 1 Z 1) is necessary, after hearing the responsible scientific committee of the genetic engineering commission and in
p.(None): Agreement with the Federal Minister for Agriculture, Forestry, Environment and Water Management, the Federal Minister for Economy and Labor and the
p.(None): Federal Minister of Education, Science and Culture, taking into account the state of the art in science and technology and those referring to GMOs
p.(None): Community legislation, in particular Annexes II, III and IV to Directive 2001/18 / EC, through more detailed regulations on
p.(None): 1. Content, scope and form of the documents in accordance with § 55 Paragraph 2 and
p.(None): 2. the principles and methods to be used when compiling these documents
p.(None): set. The regulation may also require that these documents be used using the programs provided by the authority
p.(None): must be presented on electronic data carriers. "
p.(None): (2) By ordinance pursuant to Paragraph 1, first half sentence, taking into account a decision pursuant to Art. 16 of Directive 2001/18 / EC, for certain
p.(None): Types of products in derogation from the requirements according to § 55 Paragraph 2 more detailed provisions on the criteria and the application documents for the in-
p.(None): The placing on the market of these products should be determined if there is sufficient experience with the release and placing on the market of comparable GMOs
p.(None): and therefore adverse effects on security (§ 1 Z 1) are not expected. If these requirements are met, the Federal Minister for
p.(None): Health and women also authorized to make a corresponding application in accordance with Article 16 of Directive 2001/18 / EC.
p.(None): due diligence
p.(None): Section 57. Does the applicant or license holder have new ones during the examination of the application by the authority or after approval has been given
p.(None): The applicant has information immediately regarding the risks of the product for safety (§ 1 Z 1)
...
p.(None): be placed on the market.
p.(None): (8) Section 58a applies mutatis mutandis.
p.(None): monitoring obligation
p.(None): Section 58c. (1) The license holder is responsible for carrying out a surveillance in accordance with the approval in Section 58a or, if applicable, in the
p.(None): Renewal of the approval according to § 58b prescribed monitoring plan and responsible for the corresponding reporting to the authority.
p.(None): The authority has to forward the reports to the European Commission and the other member states of the European Union. It has the results of
p.(None): Make surveillance accessible to the public on their website.
p.(None): (2) The authority can, based on the reports in accordance with paragraph 1, to avoid adverse consequences for security (§ 1 Z 1) within the scope of the approval
p.(None): or the renewal of the permit change the surveillance plan.
p.(None): statutory authorization
p.(None): Section 58d. The Federal Minister of Health and Women has, insofar as this is in order to clarify the monitoring obligations of the license holder and to
p.(None): Avoiding adverse effects on safety (§ 1 Z 1) is necessary, taking into account Annex VII of Directive 2001/18 / EC and the
p.(None): guidelines supplementing this appendix after consulting the responsible scientific committee of the genetic engineering commission in agreement with the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of Education, Science and Culture by ordinance
p.(None): to lay down further provisions for the preparation and implementation of the monitoring plan.
p.(None): Change of approval
p.(None): Section 58e. Does the authority receive new information after the approval in accordance with Section 58a or after a renewal of the approval in accordance with Section 58d
p.(None): Circumstances according to which the product authorized to be placed on the market could jeopardize safety (Section 1 (1)) will lead it within 60 days
p.(None): Information including any reasoned suggestions for a change or cancellation of the approval to the European Commission for the purpose
p.(None): Initiation of a procedure pursuant to Article 20 (3) of Directive 2001/18 / EC. According to the results of this procedure, the authority has the conditions
p.(None): change the approval or renewal of the approval or revoke the approval or renewal of the approval.
p.(None): scope of authorization
p.(None): Section 59. The supply and use of products (Section 54 (1)), the placing on the market of which is authorized in accordance with this Federal Act, requires in
p.(None): Within the scope of this approval, no further approval under this federal law.
p.(None): Temporary bans or restrictions
p.(None): Section 60. (1) Has the authority after granting a license or renewing a license based on new or additional information
p.(None): or based on a re-evaluation of existing information on the basis of new or additional scientific knowledge justified reason for
p.(None): The Federal Minister of Health and. Can assume that the product approved for placing on the market poses a risk to safety (§ 1 no. 1)
...
p.(None): in accordance with Art. 31 Para. 2 of Directive 2001/18 / EC including information about the possibility of access to this register.
p.(None): (2) The Federal Minister of Health and Women, insofar as this is with regard to the safe use of products in accordance with Section 54 (1) or therefrom
p.(None): manufactured products or to avoid misleading users and consumers, taking into account Annex IV of the
p.(None): Directive 2001/18 / EC or other Community labeling regulations referring to GMOs by regulation in agreement with the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of Economics and Labor for more detailed labeling regulations
p.(None): for products according to § 54 or products made from them.
p.(None): Provision of GMOs for purposes other than placing them on the market
p.(None): Section 62a. GMOs that are used to work with GMOs in a closed system, for a release or for scientific purposes including clinical trials
p.(None): must be provided on a label or in an accompanying document as a GMO.
p.(None): statutory authorization
p.(None): Section 62b. The Federal Minister of Health and Women has, insofar as this is necessary to ensure security (§ 1 Z 1) and under consideration
p.(None): Implementing provisions in accordance with Article 26 of Directive 2001/18 / EC after consulting the responsible scientific committee of the
p.(None): Genetic engineering commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the labeling of the according
p.(None): Section 62a of the GMO provided.
p.(None): Unintentional presence of GMOs in other products
p.(None): Section 62c. (1) Anyone who places products on the market (Section 54 (1)) is obliged to take special care to ensure that, particularly in the case of sales,
p.(None): Transport, storage, use and processing a mixture of the GMOs contained in the products with goods that are not intended to be GMOs
p.(None): may contain is avoided.
p.(None): (2) The other provisions of III. Section relating to the release of GMOs and the placing on the market of products are traces on products
p.(None): contain a GMO not authorized in the EEA or a combination of such GMOs up to a threshold of 0.1%, if the
p.(None): Presence of the GMO (s) is unintentional or technically unavoidable.
p.(None): (3) Deviating from para. 2 is until April 18, 2007 on the placing on the market of a product that is for direct use as food or
p.(None): Feed or for processing and contains traces of a GMO not yet authorized in the EEA or a combination of such GMOs that III.
p.(None): Section of this Federal Law does not apply if
p.(None): 1. the proportion of such GMOs in the product does not exceed the threshold of 0.5%,
p.(None): 2. the presence of the GMO (s) is unintentional or technically unavoidable,
p.(None): 3. regarding the GMO (s) by the responsible scientific committee of the European Commission or by the European authority for
p.(None): Food safety a positive opinion was given before April 18, 2004,
p.(None): 4. a relevant application for authorization to place it on the market has not been rejected in the relevant Community procedure and
p.(None): 5. the detection methods for the GMO (s) are publicly available.
...
p.(None): No. 29/2003.
p.(None): (3) Unless the parties agree otherwise, the costs of arbitration, judicial settlement or mediation are initially borne by the neighbor
p.(None): who has sought the amicable settlement. If no amicable settlement can be reached, these costs in the litigation are the same as pre-litigation costs
p.(None): to treat.
p.(None): (4) The plaintiff has to attach to the suit a confirmation from the arbitration board, the court or the mediator that no amicable settlement
p.(None): could be achieved.
p.(None): V. SECTION
p.(None): Genetic engineering commission and genetic engineering book
p.(None): Establishment of a genetic engineering commission
p.(None): Section 80. For advice on all questions arising from the implementation of this law and for the preparation of the genetic engineering book, contact the
p.(None): Federal Ministry of Health and Women set up the Genetic Engineering Commission (commission) and its scientific committees.
p.(None): Composition of the Genetic Engineering Commission
p.(None): Section 81. (1) The Commission must belong to:
p.(None): 1. The Commission must include:
p.(None): a) two representatives of the Federal Ministry of Health and Women, one of them an expert in women's affairs,
p.(None): b) two representatives of the Federal Ministry of Economics and Labor, one of them an expert in the field of employee protection,
p.(None): c) two representatives of the Federal Ministry of Agriculture, Forestry, Environment and Water Management, one each from the fields of agriculture and
p.(None): Environment,
p.(None): d) a representative of the Federal Ministry of Education, Science and Culture -
p.(None): the sending federal ministers have the right to propose.
p.(None): 2. a) a representative of the Federal Chamber of Labor,
p.(None): b) a representative of the Austrian Trade Union Confederation,
p.(None): c) a representative of the President's Conference of the Austrian Chambers of Agriculture,
p.(None): d) a representative of the Austrian Chamber of Commerce - the sending organizations have the right to propose;
p.(None): 3. one representative each of the scientific committees - the sending committees have the right to propose;
p.(None): 4. eight experts who have experience in the fields of microbiology, cell biology, virology, molecular biology, hygiene, ecology,
p.(None): Security technology and sociology. Each of the areas mentioned must be represented by at least one expert. At least five
p.(None): these experts must have worked with GMOs; the Austrian Academy of Sciences has the right to propose;
p.(None): 5. One expert each for questions of molecular biology on the proposal of the Austrian Chamber of Commerce and the Austrian one
p.(None): Federation of Trade Unions;
p.(None): 6. a) a representative of scientific philosophy - the Austrian Rectors' Conference has the right to propose,
p.(None): b) a representative of a theological faculty has the right to propose the theological faculties of Austria,
p.(None): c) a doctor - the three medical universities in Austria have the right to propose,
p.(None): d) a person familiar with environmental problems - the Federal Environment Agency has the right to propose,
p.(None): e) a representative to be proposed by the Austrian Working Group on Rehabilitation.
p.(None): (2) The members of the commission are from the Federal Minister of Health and Women on the basis of the proposals in accordance with paragraph 1 for a period of five years
p.(None): to order. A substitute member must be appointed for each member - also for five years; the right to propose exists in the same way as for the
p.(None): representing members.
p.(None): Chairman
p.(None): § 82. The chair of the commission is the representative of the Federal Ministry of Health and Women, the deputy chair is the representative
p.(None): of the Federal Ministry of Education, Science and Culture.
p.(None): decision-making
p.(None): § 83. (1) The commission has a quorum if at least half of the members entitled to vote, at least half of the members according to
p.(None): Section 81 (1) 3 to 6 is present.
p.(None): (2) All members of the commission with the exception of the chair have a casting vote. Substitute members only have such voting rights
p.(None): Prevention of the person they represent and when that person chairs it. The commission decides by simple majority. In the event of a tie
p.(None): the view that the chairman agrees with is accepted.
p.(None): Responsibilities of the commission
p.(None): § 84. The tasks of the commission are in particular
p.(None): 1. advising the authority on fundamental questions relating to the applications of genetic engineering, insofar as they are not within the scope of scientific work
p.(None): Committees fall
p.(None): 2. the passing of resolutions on proposed sections of the genetic engineering book in accordance with section 99 (3) and
p.(None): 3. the preparation of the report on the application of genetic engineering (Section 99 (5)).
p.(None): Standing scientific committees
p.(None): Section 85. (1) The Federal Minister for Health and Women has scientific committees of the Commission
p.(None): 1. a scientific committee for working with GMOs in a closed system,
p.(None): 2. a scientific committee on releases and placing on the market and
p.(None): 3. Establish a scientific committee for genetic analysis and gene therapy in humans.
p.(None): (2) The members of the scientific committees are approved by the Federal Minister of Health and Women on the basis of the proposals in accordance with Sections 86 to 89
...
p.(None): d) with plants: an expert in plant physiology,
p.(None): e) with animals: consult an expert in zoology.
p.(None): Tasks and composition of the scientific committee for releases and placing on the market
p.(None): Section 87. (1) The scientific committee for releases and placing on the market is responsible for the assessment of applications for releases of GMOs into the
p.(None): Environment and applications for the placing on the market of products according to III. Section as well as the preparation of sections of the genetic engineering book and
p.(None): the submission of statements on draft regulations in accordance with this federal law regarding III. Section.
p.(None): (2) This scientific committee must include:
p.(None): 1. one expert each from the areas
p.(None): a) Molecular biology (nominated by the Federal Minister for Health and Women),
p.(None): b) Ecology (nominated by the Federal Minister of Agriculture, Forestry, Environment and Water Management) and that under § 81 para. 1 no. 6 lit. d called
p.(None): Member of the genetic engineering commission;
p.(None): 2. In addition to the experts mentioned under para. 2 no. 1, the release of
p.(None): a) Microorganisms: an expert in molecular microbiology (nominated by the Federal Minister of Economics and Labor), an expert in microbial ecology
p.(None): (nominated by the Federal Minister of Agriculture, Forestry, Environment and Water Management), an expert in plant or animal pathology (nominated by
p.(None): Federal Minister for Health and Women), an expert in environmental hygiene (nominated by the Federal Minister for Economic Affairs and Labor),
p.(None): b) Plants: one expert in plant genetics (nominated by the Federal Minister of Education, Science and Culture), one expert in plant breeding,
p.(None): Vegetation science, plant physiology, soil science, insect science, mycology and for population biology (each nominated by the Federal Minister for
p.(None): Agriculture, forestry, environment and water management) as well as an expert in plant pathology (nominated by the Federal Minister of Health and
p.(None): Women)
p.(None): c) Animals: an expert in animal genetics (nominated by the Federal Minister of Health and Women) and an expert in animal breeding and zoology (nominated
p.(None): to be consulted by the Federal Minister of Agriculture, Forestry, Environment and Water Management);
p.(None): 3. In addition to the experts mentioned under para. 2 nos. 1 and 2, the appraisal of applications includes the placing on the market of products
p.(None): an expert in toxicology (nominated by the Federal Minister for Health and Women) and an expert in quality assurance and
p.(None): Identification (nominated by the Federal Minister of Economics and Labor).
p.(None): (3) When assessing applications relating to releases and when preparing sections of the genetic engineering book and the submission of
p.(None): Comments on draft regulations in accordance with III. Section Part A of this federal law is a representative of the Federal Ministry of Agriculture and
p.(None): Involve forestry, environment and water management in an advisory capacity; this must be given the opportunity to comment on the Federal Ministry of
p.(None): Explain agriculture and forestry, the environment and water management (Section 37 (6)).
p.(None): Tasks and composition of the scientific committee for gene analysis and gene therapy in humans
...
p.(None): to be accepted or rejected for further processing.
p.(None): (4) In execution of Sections 8, 12, 17, 21, 35, 38, 50, 53, 56 and 72, parts of the genetic engineering book can be issued as a regulation. These parts are in
p.(None): To publish the Federal Law Gazette. The Federal Minister of Health and Women can refrain from issuing regulations or from him
p.(None): Enforcement of the above-mentioned regulations if and insofar as the Genetic Engineering Book is sufficiently clear about the regulations contained therein
p.(None): Has created principles to be observed and the intended regulatory purpose is ensured by the genetic engineering book.
p.(None): (5) On the basis of the reports submitted to it by the standing scientific committees (Section 93 (3)), the Commission has three years
p.(None): Distances for the first time in 1998 - to produce a report that is a summary
p.(None): a) the work carried out in Austria with GMOs in closed systems,
p.(None): b) the release of GMOs and the placing on the market of products in Austria in accordance with III. Section and
p.(None): c) on general matters of genetic analyzes and gene therapies on humans carried out in Austria
p.(None): has to contain. The Commission has to assess and observe the developments observed with regard to compliance with the principles set out in § 3
p.(None): to examine and present the educational and research policy and economic consequences of the observed development for Austria. This
p.(None): Report is from the Federal Minister of Health and Women in agreement with the Federal Minister of Education, Science and Culture with an attached
p.(None): Present the measures they have taken to promote security research (Section 102) to the National Council.
p.(None): VI. SECTION
p.(None): Authority, controls
p.(None): authorities jurisdiction
p.(None): Section 100. (1) Authority within the meaning of this Act
p.(None): 1. With regard to working with GMOs in a closed system and the release of GMOs - insofar as these are in scientific universities or in
p.(None): scientific institutions of the federal government in its department or through them - the Federal Minister of Education, Science and Culture,
p.(None): 2. the Federal Minister for Health and Women.
p.(None): (2) The competent authority for the measures according to § 109 is the district administrative authority.
p.(None): (3) Without prejudice to the responsibilities under paragraph 1, the Federal Minister of Agriculture, Forestry, Environment and Water Management, insofar as this is the
p.(None): Perception of his competencies in the field of environmental protection and agricultural resource law is required in the
p.(None): Community law procedures in accordance with Directive 2001/18 / EC and Regulation (EC) № 1829/2003. The Federal Minister of Health
p.(None): and women has given the Federal Minister of Agriculture, Forestry, Environment and Water Management the necessary information obtained through these procedures
p.(None): Submit documents.
p.(None): Community law directly applicable
p.(None): § 100a. (1) The following legal provisions are to be implemented within the framework of this Federal Act:
p.(None): 1. Regulation (EC) No. 1946/2003 of July 15, 2003 on cross-border movements of genetically modified organisms
p.(None): 2. Regulation (EC) № 1829/2003 of September 22, 2003 on genetically modified food and feed, as far as it is not substances and
p.(None): Products that are placed on the market and controlled by the Food Safety and Consumer Protection Act - LMSVG or the
p.(None): Feed Act is regulated.
p.(None): 3. Regulation (EC) № 1830/2003 of September 22, 2003 on the traceability and labeling of genetically modified organisms and on
...
p.(None): and women a documentation center on safety-related properties and for the identification of the GMOs contained in these products
p.(None): To set up information.
p.(None): (2) The information and information required for this are submitted to the documentation center with the application for marketing authorization from
p.(None): Products (Section 54 (1)). In any case, this information must contain:
p.(None): 1. description of the product and the GMOs contained therein,
p.(None): 2. Name and address of the license holder,
p.(None): 3. A description of the product corresponding to the state of the art in science and technology with regard to the genetic modification
p.(None): caused special properties,
p.(None): 4. Description of the expected types of use and the planned spatial distribution in Austria,
p.(None): 5. intended labeling,
p.(None): 6. Instructions and recommendations for storage and handling and a description of the resulting residues and their treatment as well as the
p.(None): Emergency plans and adequate information for the identification of the GMO (in particular introduced nucleotide sequences).
p.(None): statutory authorization
p.(None): Section 101e. (1) Insofar as this is necessary to ensure the control of the safety (§ 1 Z 1) of products according to § 54 paragraph 1, the Federal Minister
p.(None): for health and women after hearing the responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister
p.(None): for Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor and the Federal Minister of Science and Transport
p.(None): (Note: correct: Federal Minister of Education, Science and Culture) taking safety, expediency and completeness into account
p.(None): Information to be issued by ordinance for more detailed provisions on the content, scope and form of the information to be given to the authority in accordance with Section 57 no.
p.(None): (2) In addition, information must be included in the security documentation that the authority receives in accordance with Section 57 no. 2.
p.(None): (3) The Federal Minister of Health and Women, insofar as this is used to control the adverse effects of released GMOs and in traffic
p.(None): brought products (§ 54 para. 1) to the security (§ 1 Z 1) and for information to the public is necessary, after hearing the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
p.(None): and water management and the Federal Minister of Education, Science and Culture detailed regulations on the genetic engineering register and the therein
p.(None): data to be recorded and necessary reporting obligations, also with regard to the shared use of this data by federal and state authorities or with
p.(None): control bodies. This regulation may relate to the data on the places of cultivation for placing on the market
p.(None): Approved genetically modified crops may also be subject to the provincial governor's reporting obligation, insofar as this is due to federal or
p.(None): state law has such data; The entry into a register referred to in Section 79c (1) in accordance with Section 101c (2) is also supported by the
p.(None): official registration of this cultivation in a register kept according to state law regulations (state genetic engineering book) corresponded.
p.(None): VII. SECTION
p.(None): safety research
p.(None): Section 102. The federal ministers responsible in accordance with section 100 have, in accordance with the respective Federal Finance Act, taking into account the status of the
p.(None): Science to promote research in the field of safety in the applications of genetic engineering (interdisciplinary risk and safety research).
p.(None): VIII. SECTION
p.(None): Interim measures
p.(None): § 103. (1) Does the authority have reason to believe that immediate measures to prevent immediate threats to security (§ 1 Z 1)
p.(None): and location are required, it must take such measures, including the complete or partial decommissioning of, in accordance with the extent of the risk
p.(None): genetic engineering systems or the complete or partial cessation of work with GMOs, or releases of GMOs, even without previous
...
p.(None): (6) In the case of para. 2 no. 1, the administrative criminal authority can, in the decision declaring the expiry, order that the expired GMO from the
p.(None): these GMOs are to be harmlessly disposed of at the time of the illegal release or the costs of the harmless disposal are to be attributed to them
p.(None): has to wear.
p.(None): (7) The administrative criminal authority can lift the seizure upon request and refrain from forfeiture if the person concerned about this GMO at the time of the
p.(None): unlawful release ensures that the person who disposes of it can be harmlessly disposed of or otherwise used legally, if none
p.(None): Endangering security (§ 1 Z 1) is to be feared.
p.(None): References to other federal laws
p.(None): Section 110. (1) Insofar as other federal laws are referred to in this federal law, these are to be understood in their respectively applicable version.
p.(None): (2) This federal law does not affect the validity of other federal regulations.
p.(None): completion
p.(None): Section 111. The following are entrusted with the implementation of this federal law:
p.(None): 1. With regard to the ordinance to be issued pursuant to Section 8 of the Federal Minister of Health and Women in agreement with the Federal Minister of Agriculture
p.(None): and forestry, environment and water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and
p.(None): Culture,
p.(None): 2. With regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with § 12 and § 12a in agreement with the
p.(None): Federal Minister of Economics and Labor, the Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of
p.(None): Education, science and culture,
p.(None): 3. with regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with sections 17, 44 and 72 in agreement with the
p.(None): Federal Minister of Education, Science and Culture,
p.(None): 4. With regard to the ordinances to be issued by the Federal Minister of Health and Women in accordance with Sections 21 and 29 in agreement with the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture,
p.(None): 5. With regard to the ordinance to be issued in accordance with Section 35 of the Federal Minister for Health and Women in agreement with the Federal Minister for
p.(None): Economy and Labor and the Federal Minister of Education, Science and Culture,
p.(None): 6. With regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with Sections 38, 42, 46a, 50, 53, 56 and 62b
p.(None): with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor and the Federal Minister
p.(None): for education, science and culture,
p.(None): 7. With regard to the ordinance to be issued pursuant to Section 62 (2) of the Federal Minister for Health and Women in agreement with the Federal Minister for
p.(None): Agriculture and forestry, environment and water management and the Federal Minister of Economics and Labor,
p.(None): 8. the Federal Government with regard to the ordinance to be issued pursuant to Section 63 (2),
p.(None): 9. with regard to Section 26 and Section 27 (2)
p.(None): a) Matters of higher education (Art. 14 para. 1 B-VG) of the Federal Minister of Education, Science and Culture,
p.(None): b) in matters of the scientific institutions of the Confederation (Art. 10 para. 1 no. 13 BVG) of the relevant scientific institution of the
p.(None): Federal minister responsible,
p.(None): (c) in matters of trade and industry (Art. 10 para. 1 no. 8 B-VG) of the Federal Minister of Economics and Labor,
p.(None): (d) in matters of health, veterinary and nutritional services, including food control (Art. 10 para. 1
p.(None): Z 12 B-VG) of the Federal Minister for Health and Women and
p.(None): (e) in matters relating to environmental protection measures,
p.(None): as far as the federal government is responsible according to Art. 10 Para. 1 Z 12 B-VG, as well as in matters of the Chemicals Act, Federal Law Gazette I № 53/1997, the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management,
p.(None): 10. with regard to sections 58 (8), 100a (4) (2) and 108 (3) last sentence, the Federal Minister of Agriculture, Forestry, Environment and Water Management,
p.(None): 11. with regard to IVa. Section of the Federal Minister of Justice, with regard to the task under Section 79j (1) last sentence but in accordance with Section 100 of the
p.(None): Federal Minister of Education, Science and Culture or the Federal Minister of Health and Women,
p.(None): 12. With regard to the nomination rights to the Genetic Engineering Commission and its committees, the ones mentioned in sections 81 (1), 86 (2) and 87 (2)
p.(None): Federal Minister,
p.(None): 13. With regard to Section 99 (4), the Federal Minister of Health and Women in agreement with those in accordance with those named there
p.(None): Authorization to issue ordinances to federal ministers authorized to consult,
p.(None): 14. With regard to the presentation of the report on the applications of genetic engineering in accordance with Section 99 (5) of the Federal Minister for Health and Women in
p.(None): Agreement with the Federal Minister of Education, Science and Culture,
p.(None): 15. the Federal Minister of Education with regard to the duties as an authority in accordance with section 100 (1) 1 and with regard to section 102 in conjunction with section 101 (1) 1;
p.(None): Science and culture,
p.(None): 16. With regard to the ordinance of the Federal Minister of Health and Women to be issued in accordance with Section 101e (3) in agreement with the Federal Minister
p.(None): for agriculture and forestry, environment and water management and the Federal Minister of Education, Science and Culture,
p.(None): 17. for the rest, the Federal Minister for Health and Women.
p.(None): implementation Note
p.(None): § 112. This federal law makes Directive 90/219 / EEC as amended by Directive 98/81 / EC and Directive 2001/18 / EC of the European
p.(None): Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and on the repeal of the directive
p.(None): 90/220 / EEC of the Council, OJ № L 106 of April 17, 2001, as amended by Regulations (EG) № 1829/2003 and (EG) № 1830/2003, OJ. № L 268 from
p.(None): October 18, 2003, as well as Directive (EU) 2015/412 amending Directive 2001/18 / EC on the possibility granted to the Member States to cultivate
p.(None): restrict or prohibit genetically modified organisms (GMOs) on their territory, OJ No.L 68 from 13.03. 2015, implemented.
p.(None): Entry into force of regulations
p.(None): Section 113. Section 71 (2) in the version of the Electronic Health Record Act, Federal Law Gazette I No. 111/2012, comes into force on January 1, 2013.
p.(None): Section 113a. Section 88 (2) 2 lit. a and § 97 GTG in the version of the Reproductive Medicine Law Amendment Act, BGBl. I. № 35/2015, occur with the
p.(None): Announcement in force the following day.
p.(None): Section 113b. Section 67 in the Federal Law Gazette I No. 112/2016 comes into force on 1 January 2017.
p.(None): Section 113c. Sections 66 Paragraphs 1 and 3, 71, 71a Paragraph 2, 106 and 109 Paragraph 3 Z 34 and 37 in the version of the 2nd Material Data Protection Adjustment Act,
p.(None): BGBl. I No. 37/2018, come into force on May 25, 2018.
p.(None): § 113d. Section 69 (2) and (3) in the version of the Federal Law Gazette I No. 59/2018 comes into force on July 1, 2018.
p.(None): Attachment 1
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Searching for indicator educational:
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p.(None): (2) The individual sections of the genetic engineering book are the responsibility of the relevant scientific committee for decision-making
p.(None): propose. A majority of two thirds of the votes cast is required in the scientific committees for such a proposal.
p.(None): (3) The Commission has individual sections of the genetic engineering book proposed by the relevant scientific committee with a simple majority
p.(None): to be accepted or rejected for further processing.
p.(None): (4) In execution of Sections 8, 12, 17, 21, 35, 38, 50, 53, 56 and 72, parts of the genetic engineering book can be issued as a regulation. These parts are in
p.(None): To publish the Federal Law Gazette. The Federal Minister of Health and Women can refrain from issuing regulations or from him
p.(None): Enforcement of the above-mentioned regulations if and insofar as the Genetic Engineering Book is sufficiently clear about the regulations contained therein
p.(None): Has created principles to be observed and the intended regulatory purpose is ensured by the genetic engineering book.
p.(None): (5) On the basis of the reports submitted to it by the standing scientific committees (Section 93 (3)), the Commission has three years
p.(None): Distances for the first time in 1998 - to produce a report that is a summary
p.(None): a) the work carried out in Austria with GMOs in closed systems,
p.(None): b) the release of GMOs and the placing on the market of products in Austria in accordance with III. Section and
p.(None): c) on general matters of genetic analyzes and gene therapies on humans carried out in Austria
p.(None): has to contain. The Commission has to assess and observe the developments observed with regard to compliance with the principles set out in § 3
p.(None): to examine and present the educational and research policy and economic consequences of the observed development for Austria. This
p.(None): Report is from the Federal Minister of Health and Women in agreement with the Federal Minister of Education, Science and Culture with an attached
p.(None): Present the measures they have taken to promote security research (Section 102) to the National Council.
p.(None): VI. SECTION
p.(None): Authority, controls
p.(None): authorities jurisdiction
p.(None): Section 100. (1) Authority within the meaning of this Act
p.(None): 1. With regard to working with GMOs in a closed system and the release of GMOs - insofar as these are in scientific universities or in
p.(None): scientific institutions of the federal government in its department or through them - the Federal Minister of Education, Science and Culture,
p.(None): 2. the Federal Minister for Health and Women.
p.(None): (2) The competent authority for the measures according to § 109 is the district administrative authority.
p.(None): (3) Without prejudice to the responsibilities under paragraph 1, the Federal Minister of Agriculture, Forestry, Environment and Water Management, insofar as this is the
p.(None): Perception of his competencies in the field of environmental protection and agricultural resource law is required in the
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Social / employees
Searching for indicator employees:
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p.(None): Limiting the environment with the aim of preventing an uncontrolled multiplication of this GMO in the outside world; capable of reproduction under environmental conditions
p.(None): GMOs of risk groups 2 to 4 must be deactivated.
p.(None): Accident, emergency plan
p.(None): § 11. (1) The operator of a genetic engineering system
p.(None): 1. taking into account the respective work with GMOs, has all that is necessary according to the state of the art in science and technology to avoid accidents
p.(None): Take measures and therefore, in particular, take measures to minimize the risk and impact of accidents
p.(None): being held. When choosing measures, work with GVM in security levels 3 or 4 on a small scale or when working with GVM
p.(None): in security levels 2, 3 or 4 on a large scale possible internal sources of danger, such as incorrect processes, failure of
p.(None): Appropriate consideration of plant components or misconduct by personnel, external risks and possible interventions by unauthorized persons;
p.(None): 2. may only start work with GVM in security levels 3 or 4 on a small scale or in security levels 2, 3 or 4 on a large scale,
p.(None): if an emergency plan is available and has been submitted to the authority and the responsible fire department. The emergency plan has that in the event of an accident
p.(None): contain the necessary internal measures and safety instructions for the employees working there and for the fire brigade; the emergency plan is
p.(None): to connect a scheme for the notification process and for measures to deactivate leaked GVM. The emergency plan is the speci fi c one
p.(None): Adapt the type of work with GVM and the current state of science and technology. Another copy of the emergency plan is the
p.(None): District administrative authority to transmit; the emergency plan is also easily accessible for the fire brigade in the fire alarm center of the facility
p.(None): hang up;
p.(None): 3. has one for all work with GVM in security levels 3 or 4 on a small scale and security levels 2, 3 or 4 on a large scale
p.(None): to set up on-call duty who is present or at least short-term available while working with GVM and this with regard to the
p.(None): Train measures of the emergency plan;
p.(None): 4. has the first time working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale
p.(None): Residents at the latest six weeks from the start of work with GVM in a generally understandable form based on the state of the art in science and technology
p.(None): To inform technicians of necessary safety measures and behavior in the event of an accident; this information is off after three years
p.(None): Check the start of the work, update it if necessary and renew it vis-à-vis the public concerned, and afterwards in
p.(None): Repeat regular periods not exceeding five years.
p.(None): 5. has all work with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale
p.(None): genetic engineering plant employees once a year through instruction in the genetic engineering plant about the reduction in the event of an accident
p.(None): to inform adverse consequences for the safety (§ Z 1) necessary measures.
p.(None): (2) In accidents when working with GVM of security level 2 on a small scale and in accidents when working with transgenic plants and animals that are not of the
p.(None): Risk category 1 may be assigned to the course of the accident and the measures taken in the records in accordance with § 34 Paragraphs 1 and 2
p.(None): to log. About accidents when working with GVM in security levels 3 and 4 on a small scale and in security levels 2 to 4 on a large scale
p.(None): the operator informs the authority about the accident. The authority is hereby immediately by the operator, but at the latest within one month after entry
p.(None): of the accident
p.(None): 1. the course of the accident,
p.(None): 2. the name, risk group and quantity of the GVM that has left,
p.(None): 3. all information necessary to assess the impact of the accident on public health and the environment,
p.(None): 4. the emergency measures taken and
p.(None): 5. the measures to eliminate the consequences of the accident
p.(None): to be communicated in writing.
p.(None): (3) When working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale, the authority is from
p.(None): notify the accident that has occurred immediately by telephone or fax. The operator has, if according to the state of science and technology
p.(None): a risk to the health of the employees or the residents of the genetic engineering plant is to be assumed by these persons immediately from the accident
p.(None): inform and recommend appropriate behavioral measures.
p.(None): (4) In the event of accidents in accordance with paragraph 3, the operator and, if necessary, the authority must carry out a monitoring (monitoring) of the effects of the accident on the
p.(None): Security (§ 1 Z 1) to perform.
p.(None): (5) In the event of accidents in accordance with paragraph 3, the local governor, the local administrative authority and the municipality are responsible
p.(None): communicate.
p.(None): statutory authorization
p.(None): § 12. The Federal Minister of Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission under
p.(None): Consideration of the principles mentioned in § 3 paragraphs 1 and 2 by ordinance in agreement with the Federal Minister of Agriculture and Forestry,
p.(None): Environment and Water Management, the Federal Minister of Economics and Labor and with the Federal Minister of Education, Science and Culture and according to the status
p.(None): of science and technology and taking into account relevant EU regulations and other international guidelines and recommendations
p.(None): provisions
p.(None): 1. About organizational and technical security measures when working with GMOs in closed systems that are appropriate for the respective security level
p.(None): special attention is paid to the type of work to be carried out with GMOs,
p.(None): 2. requirements for genetic engineering systems to prevent, limit and eliminate the effects of accidents,
...
p.(None): (2) The Biosafety Officer and each deputy must have at least two years of practical experience working with GMOs such as
p.(None): they are mainly carried out in the plant, as well as sufficient knowledge in the field of measures to ensure safety (§ 1
p.(None): Z 1) dispose of threats from GMOs.
p.(None): (3) The biosafety officer and his deputy must be employed by the operator of the genetic engineering system
p.(None): or are mainly employed in the genetic engineering facility; at least one of them must work at security levels 3 or 4 in small
p.(None): Scale as well as at work in security levels 2, 3 or 4 on a large scale while working with GMOs present or at least reachable at short notice
p.(None): his. In the clinical area of the medical faculties there is an employment relationship with the officer for biosafety within the framework of the university
p.(None): Equal to the employment relationship with the operator, insofar as this is the sponsor of the hospital. Appointment of the representative for the biological
p.(None): In this case, security must be agreed with the respective clinic or institute board.
p.(None): (4) The Biosafety Officer has
p.(None): 1. a) regularly monitor compliance with the safety measures and the operator and the project manager via identified safety-relevant
p.(None): To inform defects immediately,
p.(None): b) review the emergency plan and, if necessary, propose it to the operator,
p.(None): c) Measures for the instruction and training of employees with regard to guaranteeing safety (§ 1 Z 1) against hazards from GMOs
p.(None): to propose to the operator and
p.(None): 2. keep written records of these activities and keep them ready for inspection by the authority.
p.(None): (5) The operator must support the biosafety officer in fulfilling his tasks, providing him with sufficient time during the
p.(None): To grant working hours and - if necessary - to provide auxiliary staff, further training opportunities, rooms, facilities and work equipment
p.(None): and to give him the opportunity to present suggestions and concerns to the project manager if there are differences of opinion.
p.(None): (6) If the biosafety officer leaves this function or if the operator cancels his order, one must be notified immediately
p.(None): appoint new biosafety officer; the same applies to his deputy, unless another deputy has been appointed.
p.(None): (7) The operator has the authority to withdraw and each change of the biosafety officer or one of his deputies
p.(None): to be announced immediately in writing, including the evidence required for the replacement person ordered by the operator (para. 2).
p.(None): (8) If, in the event of the appointment of a replacement person (para. 6), the authority determines on the basis of the evidence provided that the person appointed has the
p.(None): does not meet the requirements placed on them to request the operator within six weeks of the announcement of the replacement person, either
...
p.(None): work rows
p.(None): 1. to propose a security classification (§ 6) to the operator,
p.(None): 2. The people involved in the work with GMOs about the safety measures to be applied, about the possible risks after the occurrence
p.(None): To inform accidents and about emergency measures and
p.(None): 3. to ensure compliance with the safety measures to be applied.
p.(None): (3) If the project manager leaves this function or if the operator cancels his order, a new project manager is to be assigned immediately
p.(None): to order.
p.(None): (4) The operator must inform the authority immediately of any change of project manager, including the evidence required for the replacement person (para. 1)
p.(None): to be announced in writing.
p.(None): (5) The appointment of a project manager in accordance with Paragraph 1 can be waived if working with GMOs only includes storage and internal
p.(None): Transport of GMOs includes.
p.(None): Biosafety Committee
p.(None): § 16. (1) The operator must set up a committee for biological safety for each genetic engineering system.
p.(None): (2) The Biosafety Committee consists of the biosafety officer of the facility and, if the facility only works in the
p.(None): be carried out on a small scale, from two additional members, and for all other work with GMOs from five additional members. If only in the plant
p.(None): Work on a small scale may be carried out, at least one member, otherwise two members, not in an employment relationship with the operator of the
p.(None): Plant. If large-scale GMO work is carried out in the facility, one of the members is the one responsible for the facility
p.(None): To send a works council or service committee from among the employees. For special questions, the Committee for Biological
p.(None): Security experts should be consulted. The members of the Committee for Biosafety are responsible for obtaining the items mentioned in para. 4 nos. 2 and 3
p.(None): Tasks regarding the content and the result of their activity are not bound by any instructions in their decision.
p.(None): (3) Each member of the Biosafety Committee must have knowledge of working with GMOs. If works in the plant
p.(None): To be carried out on a large scale, at least one member must also have knowledge in the field of security measures
p.(None): (§ 1 Z 1) against threats from GMOs. Overall, the members of the Biosafety Committee should be selected so that they jointly
p.(None): have the experience in the field of working with GMOs that enables them, the experience with working with GMOs that are mainly carried out in the plant,
p.(None): associated risks for security (§ 1 Z 1).
p.(None): (4) The Biosafety Committee has
p.(None): 1. the security measures required to ensure compliance with this Federal Act and the administrative acts based thereon to ensure that
p.(None): Safety (§ 1 Z 1) against threats from GMOs and these safety measures according to the state of the art in science and technology
p.(None): Adapt the requirements of the work with GMOs carried out in the plant,
p.(None): 2. to check all safety classifications carried out by the operator and the proposed safety measures and in the case of his
p.(None): Agreement with them to release the respective work with GMOs internally,
p.(None): 3. to check whether possible biological safety measures are applicable when working with GMOs, and
p.(None): 4. to prepare a protocol of his examinations according to Z 2 and 3 and, if necessary, of the release (Z 2).
p.(None): (5) If a member leaves the committee for biosafety, the operator must immediately appoint a suitable new member.
...
p.(None): to provide outstanding evidence or, in the event of insufficient quali fi cation of the replacement person ordered, appropriate additional training within
p.(None): six months to prove, otherwise the operator has to appoint another suitable person. The assignment, a supplementary training within
p.(None): of six months is not permitted if the member to be replaced has been removed by the operator.
p.(None): (8) The appointment of a committee for biosafety in accordance with paragraph 1 can be waived if working with GMOs only involves storage and
p.(None): includes the internal transport of GMOs.
p.(None): statutory authorization
p.(None): § 17. The Federal Minister of Health and Women, insofar as this is necessary in the interest of security (§ 1 no. 1), according to the state of the art in science
p.(None): and technology and after hearing the responsible scientific committee of the genetic engineering commission by ordinance in agreement with the
p.(None): Federal Minister of Education, Science and Culture detailed provisions on the required experience in working with GMOs and knowledge
p.(None): in particular to adopt safety measures through which the biosafety officers, the project managers and the members of a committee
p.(None): for biological security.
p.(None): Cooperation with other institutions
p.(None): § 18. The Biosafety Officer, the Project Leader and the Biosafety Committee are required to perform their duties
p.(None): Advising the operator with the legal regulations for the protection of existing employees in the plant and with
p.(None): to work together with the officers appointed in this facility to perform environmental protection tasks.
p.(None): Registration of work with GMOs
p.(None): § 19. The operator has the implementation
p.(None): 1. first time working with GVM in a genetic engineering plant in security level 1,
p.(None): 2. first time working with GVM in a genetic engineering facility in security level 2,
p.(None): 3. further work with GVM in a genetic engineering facility in security level 2,
p.(None): 4. first-time work with transgenic plants or animals in a genetic engineering facility,
p.(None): 5. Further work with transgenic plants or animals in a genetic engineering facility, provided that a security classification of security level 1 is not
p.(None): is permissible, and
p.(None): 6. Further work with transgenic vertebrates in security level 1 in a genetic engineering facility
p.(None): Before starting work, register with the authority using the documents specified in Appendix 1. The registrations and the related ones
p.(None): Documents must be submitted in the original and in a copy.
p.(None): Permit applications for working with GMOs
p.(None): § 20. The operator has the authorization to carry out
p.(None): 1. Working with GVM in a genetic engineering system in security level 3 and
p.(None): 2. Working with GVM in a genetic engineering facility in security level 4
p.(None): to be submitted to the authority before starting work, following the documents specified in Appendix 1. The application and the related
p.(None): Documents must be submitted in the original and in a copy.
p.(None): statutory authorization
...
p.(None): Therapy is possible
p.(None): 4. Type 4 is used to determine a predisposition to an illness, in particular the predisposition to a potentially emerging one
p.(None): Genetically caused illness or determination of a carrier status, for which according to the state of the art in science and technology no prophylaxis or
p.(None): Therapy is possible.
p.(None): (2) Relative examinations (§ 70) can be type 2, 3 or 4 examinations.
p.(None): Genetic analysis in humans for scientific purposes and for training
p.(None): Section 66. (1) Genetic analyzes in humans for scientific purposes and for training may only be carried out on de-identified samples.
p.(None): Non-genetic medical data that are to be linked to the genetic data of the same person must also be de-identified. The
p.(None): Allocation of this data to the respective sample donor may only take place in the facilities that have a valid consent (Art. 4 № 11 GDPR) of the
p.(None): data subject for this assignment.
p.(None): (2) Results from genetic analyzes in accordance with paragraph 1 may only be networked or published if they are ensured by suitable measures
p.(None): is that - apart from paragraph 1 - the sample donor cannot be determined.
p.(None): (3) The provisions of sections 2d (1) and (3) to (8), 2f (1) (6) and (3), (4), (6) and (7) and 2i (1), (2), (2) and (2k) of the Research Organization Act,
p.(None): BGBl. No. 341/1981, in the version of the Federal Law BGBl. I No. 31/2018, apply.
p.(None): Prohibition of using data from genetic analysis for certain purposes
p.(None): Section 67. (1) Employers and insurers including their agents and employees are prohibited from obtaining results from genetic analyzes of
p.(None): To collect, request, accept or otherwise exploit employees, jobseekers or policyholders or insurance applicants. Of
p.(None): This prohibition also includes the request for delivery and the acceptance of body substance for genetic analysis purposes.
p.(None): (2) Paragraph 1, 1st sentence does not apply to insurers, including their agents and employees, insofar as the results are from genetic analyzes of the type
p.(None): 1 deals with policyholders or policyholders and does not draw any conclusions from the results of genetic analyzes of type 2, 3 or 4
p.(None): possible are.
p.(None): Conducting genetic analysis on humans for medical purposes - Official procedure
p.(None): Section 68. (1) Genetic analyzes within the meaning of Section 65 (1) nos. 3 and 4 may only be carried out in approved facilities and only on
p.(None): Initiation of a specialist trained in human genetics / medical genetics or a treating or responsible for the indication area
p.(None): diagnosis specialist.
p.(None): (2) The approval is to be given by the head of the facility in which such genetic analyzes are intended to be carried out to the Federal Minister for
p.(None): Apply for health and women.
p.(None): (3) Approval is granted by the Federal Minister of Health and Women after consulting the responsible scientific committee - if necessary
p.(None): under the definition of suitable conditions and conditions - to be given if, due to the personnel and material equipment, the state of
p.(None): Science and technology appropriate execution of the genetic analyzes and the protection of the resulting genetic data according to § 71
p.(None): is ensured.
p.(None): (4) The Federal Minister of Health and Women must revoke the admission if the conditions for its granting are no longer met
p.(None): or if there are serious deficiencies, otherwise suitable requirements, combined with the order to be imposed, until the fulfillment of these requirements, no genetic requirements
p.(None): Conduct analyzes in accordance with section 65 (1) 3 or 4 more.
p.(None): Head of the facility and laboratory manager
p.(None): Section 68a. (1) The head of the facility must appoint a laboratory manager for each facility for performing genetic analyzes of type 2, 3 or 4.
p.(None): This may be the same as the head of the facility. The head of the facility has the laboratory head of the authority, including the person appointed for the person
p.(None): to provide the necessary evidence (para. 2) in writing.
p.(None): (2) The laboratory manager must
p.(None): 1. be a specialist in human genetics / medical genetics or for medical-chemical laboratory diagnostics, or
p.(None): 2. a university degree from a scientific subject, which includes training in molecular genetics or molecular biology, and
p.(None): have at least two years of experience in molecular genetic studies on humans, or
p.(None): 3. via specialist training that includes training in human genetics / medical genetics and at least two years of experience with
p.(None): molecular genetic studies in humans, or
p.(None): 4. If it is limited to genetic analyzes in the context of a special medical subject, the required for this special subject
p.(None): Specialist training and at least two years of experience in the field of molecular genetic testing in humans.
p.(None): (3) The laboratory manager is responsible for the ongoing instruction of the employees and the management and supervision of the implementation of the genetic analyzes. He has
p.(None): to take the data protection and quality assurance measures suitable for the laboratory, in particular participation in proficiency tests, and for them
p.(None): To ensure compliance. If the proficiency test was not offered at the time of admission to the institution (Section 68 (3)), he would regularly do so in
p.(None): to inquire with the authority no more than six months apart whether suitable round robin tests are already available.
p.(None): (4) If the laboratory manager leaves this function or his order is canceled by the manager of the facility, a new laboratory manager is immediately
p.(None): to order.
p.(None): (5) The head of the facility shall notify the authority of the resignation and each change of the laboratory head without undue delay, including that for the head of the
p.(None): The replacement person appointed to the facility must be notified in writing of the necessary evidence (para. 2).
p.(None): (6) The appointment of a laboratory manager increases the responsibility of the head of the facility for compliance with the provisions of this federal law
p.(None): and the administrative file based on it.
p.(None): Consent and advice
p.(None): Section 69. (1) A genetic analysis of type 2, 3 or 4, including a genetic analysis as part of a prenatal examination, may only be carried out after
p.(None): There is a written confirmation from the person to be examined that they have previously been through a human genetics / medical genetics
p.(None): trained specialist or a specialist responsible for the indication area has been informed about their nature, scope and significance and
...
p.(None): 2. for substances and products that fall within the scope of the Feed Act, the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management.
p.(None): (4) The authority responsible for receiving applications in accordance with Articles 5, 17 and 27 of Regulation (EC) No 1829/2003
p.(None): 1. for applications for approval as a genetically modified food and for applications for joint approval as a genetically modified food and
p.(None): Feed of the Federal Minister of Health and Women
p.(None): 2. the Federal Office for Food Security for applications for approval as genetically modified feed.
p.(None): Controls, restoration of the environment
p.(None): Section 101. (1) The organs of the authority are authorized in places where there is reason to believe that
p.(None): 1. work with GMOs is carried out,
p.(None): 2. GMOs are released,
p.(None): 3. products are placed on the market in accordance with section 54 (1),
p.(None): 4. genetic analyzes are carried out on humans in accordance with § 65 or the data obtained is processed and stored in an automated manner
p.(None): become, or
p.(None): 5. gene therapies are carried out on humans,
p.(None): To keep an eye on and for the purpose of checking compliance with the provisions of this federal law and those based on this federal law
p.(None): decrees and notices to be carried out, to inspect the records to be kept in accordance with sections 34 and 52, and
p.(None): Take samples to the extent necessary.
p.(None): (2) Except in the event of imminent danger, the review is during normal business or operating hours and with the involvement of a responsible person
p.(None): Employees. Care should be taken to ensure that any disruption or disability of the operator or anyone that is not absolutely necessary
p.(None): interference with third party rights that is not absolutely necessary is avoided.
p.(None): (3) The operator and anyone who places GMOs on the market must tolerate the controls and sampling to provide the necessary support
p.(None): to provide all information necessary for inspection and sampling and all aids necessary for the investigation and monitoring measures
p.(None): and to provide information, such as in particular probes - if available -, sequence information and the like.
p.(None): (4) In the event of a sample being taken, a cross-check should be carried out if possible. A request from the authority is available for the sample taken
p.(None): determining compensation in the amount of the material value to be paid by the federal government. Compensation does not apply if, on the basis of this sample, a specific person
p.(None): has been punished or if the authority determines by decision that - without a specific person being punished - the objective fact of a person
p.(None): Violation of this federal law has been implemented and the taking of the sample has contributed to the collection of this fact.
p.(None): (5) The authority may, insofar as economy, expediency and economy require it, carry out controls in accordance with paragraph 1 nos. 2 and 3
p.(None): including the control of compliance with the monitoring obligations in accordance with Section 58c, also external experts or expert institutions in accordance with
...
p.(None): and, if appropriate, the decision in accordance with Article 19 of Directive 2001/18 / EC and the decision on authorization in accordance with Articles 7 and 19 of the
p.(None): Regulation (EC) № 1829/2003 then takes place on the basis of the geographical scope of the application adjusted by the applicant / applicant
p.(None): or the application.
p.(None): (3) If the approval has already been granted and the holder of the approval has the geographical within 30 days of the submission of the request in accordance with Paragraph 1
p.(None): If the scope of the approval is not confirmed, the approval will be changed accordingly. With a written consent in accordance with Directive 2001/18 / EC
p.(None): the competent authority that granted the original approval changes the European one in accordance with Regulation (EC) № 1829/2003
p.(None): Commission the decision on the approval or approval.
p.(None): (4) The provisions of paragraphs 1 to 3 do not affect the cultivation of any approved genetically modified seeds and
p.(None): Plant propagation material that has been lawfully grown before GMO cultivation has been restricted or prohibited.
p.(None): (5) Measures adopted under this provision do not affect the free movement of GMOs as or in products.
p.(None): Penal provisions, confiscation, forfeiture
p.(None): Section 109. (1) Unless the act forms part of an offense falling within the jurisdiction of the courts or according to others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to 36,300 euros
p.(None): 1. contrary to the prohibition of Section 67, employees, or job seekers, collects, requests, accepts or otherwise results of genetic analyzes
p.(None): recycled
p.(None): 2. contrary to the prohibition of Section 67, requests the results of genetic analyzes from policyholders or from policyholders,
p.(None): accepts or otherwise exploits.
p.(None): The attempt is punishable.
p.(None): (2) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are threatened with a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 21,800
p.(None): 1. contrary to the provision of section 37 subsection 1, carries out a release without prior approval,
p.(None): 2. contrary to the provisions of Section 54, places products on the market,
p.(None): 3. who, contrary to Section 79j Paragraph 1, second and third sentences, fails to take out liability insurance.
p.(None): (3) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 7,260
p.(None): 1. contrary to the provisions of § 6, fails to carry out a security classification, to record it in writing or to justify it,
p.(None): 2. contravenes the provisions of Section 11 (1) regarding the emergency plan or the on-call service,
p.(None): 3. The provisions of section 11 subsection 2, 3 or 5 relating to behavior in the event of an accident or as an operator contrary to the provisions of section 11 subsection 4 es
p.(None): fails to carry out a check,
p.(None): 4. contrary to an ordinance issued according to § 12, does not implement safety measures (Z 1) or does not meet requirements for genetic engineering systems (Z 2)
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Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): his. In the clinical area of the medical faculties there is an employment relationship with the officer for biosafety within the framework of the university
p.(None): Equal to the employment relationship with the operator, insofar as this is the sponsor of the hospital. Appointment of the representative for the biological
p.(None): In this case, security must be agreed with the respective clinic or institute board.
p.(None): (4) The Biosafety Officer has
p.(None): 1. a) regularly monitor compliance with the safety measures and the operator and the project manager via identified safety-relevant
p.(None): To inform defects immediately,
p.(None): b) review the emergency plan and, if necessary, propose it to the operator,
p.(None): c) Measures for the instruction and training of employees with regard to guaranteeing safety (§ 1 Z 1) against hazards from GMOs
p.(None): to propose to the operator and
p.(None): 2. keep written records of these activities and keep them ready for inspection by the authority.
p.(None): (5) The operator must support the biosafety officer in fulfilling his tasks, providing him with sufficient time during the
p.(None): To grant working hours and - if necessary - to provide auxiliary staff, further training opportunities, rooms, facilities and work equipment
p.(None): and to give him the opportunity to present suggestions and concerns to the project manager if there are differences of opinion.
p.(None): (6) If the biosafety officer leaves this function or if the operator cancels his order, one must be notified immediately
p.(None): appoint new biosafety officer; the same applies to his deputy, unless another deputy has been appointed.
p.(None): (7) The operator has the authority to withdraw and each change of the biosafety officer or one of his deputies
p.(None): to be announced immediately in writing, including the evidence required for the replacement person ordered by the operator (para. 2).
p.(None): (8) If, in the event of the appointment of a replacement person (para. 6), the authority determines on the basis of the evidence provided that the person appointed has the
p.(None): does not meet the requirements placed on them to request the operator within six weeks of the announcement of the replacement person, either
p.(None): (a) provide the outstanding evidence within a period not exceeding four weeks to be determined by the authority; or
p.(None): b) if a biosafety officer or a deputy is validly appointed for the genetic engineering system, in the event of a lack of qualification of the
p.(None): Proof of appropriate supplementary training within six months,
p.(None): otherwise the operator must order another suitable person.
p.(None): project Manager
p.(None): § 15. (1) The operator must appoint a project manager for each work with GMOs in security levels 2, 3 or 4 and for each work series. The
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p.(None): and contingency plans (§ 11).
p.(None): (3) Insofar as this is necessary to assess the requirements for working with GMOs according to § 23, the authority has the applicant or applicant
p.(None): order to provide additional information to improve registration or application.
p.(None): (4) Provided that the work is not started immediately after registration in accordance with Section 24, Paragraph 2, Paragraph 3, first sentence or Paragraph 4, second sentence
p.(None): the authority may, insofar as this is necessary in the interest of security (§ 1 Z 1),
p.(None): 1. impose on the applicant or applicant the conditions under which the intended work with GMOs is to be carried out, or the
p.(None): Change security rating and
p.(None): 2. order that this work with GMOs is only started or - if it is already being carried out - temporarily suspended until the
p.(None): Authority based on the additional information received in accordance with Paragraph 3 or the changed requirements or security classification of this work
p.(None): with GMO a decision in accordance with § 23 is made, or in the case of work with GMOs subject to notification in accordance with § 19 within 45 days of this order
p.(None): says that she takes note of the registration.
p.(None): (5) The authority has before the decision
p.(None): 1. about applications for approval of work with GMOs in security levels 3 and 4 and about registration of work with transgenic vertebrates
p.(None): for purposes other than biomedical or developmental research, if there is reason to believe that the species limit
p.(None): breached, an opinion from the responsible scientific committee of the genetic engineering commission is obtained and
p.(None): 2. on applications for the approval of work in security level 3 on a large scale, except work for development purposes, as well as on
p.(None): Applications for approval of initial work in security level 4 or further work in security level 4 on a large scale
p.(None): Conduct hearing procedures in accordance with § 28.
p.(None): Official decision
p.(None): Section 23. (1) Permission to carry out work with GMOs in accordance with Section 20 must be granted if
p.(None): 1. It is ensured that the operator, in particular with regard to the safety equipment of the genetic engineering system, resulting from the provisions
p.(None): This section and the resulting regulations for the intended work with GMOs are fulfilled and these
p.(None): Work carried out according to the state of the art in science and technology,
p.(None): 2. It is ensured that the precautions necessary for the required security level are taken according to the state of the art in science and technology
p.(None): therefore adverse consequences for security (§ 1 Z 1) are not expected, and
p.(None): 3. the operator provides proof of liability insurance in accordance with section 79j (1) second or third sentence.
p.(None): (2) The execution of work with GMOs in accordance with § 19 Z 1 or 2 in conjunction with § 24 Paragraph 1, § 19 Paragraph 3 in conjunction with § 24 Paragraph 3 second sentence, § 19
p.(None): Section 4 in conjunction with section 24 (4) first sentence and work with GMOs in accordance with section 20 must be prohibited if one or more of those mentioned in section 1
p.(None): Requirements are not met.
p.(None): (3) Insofar as this is necessary in the interest of safety (§ 1 no. 1), the authority has the period within which work with GMOs is carried out
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p.(None): Registration will be included if the authority has agreed to start work earlier. For the work mentioned in § 19 Z 5 and 6 this does not apply
p.(None): Cases, the waiting period, if the registration is accompanied by the protocol of the Committee for Biosafety about the release (§ 16 Paragraph 4 No. 4) and if
p.(None): §§ 26 and 27 do not apply to them.
p.(None): (5) The work mentioned in § 20 may not be started until it has been approved by the authority. The authority announced the application
p.(None): Approval of first-time work with GVM in security level 3 if there is already an approval for work with GVM in the same genetic engineering facility
p.(None): in security level 4, as well as the application for approval for further work with GVM in security level 3 in a genetic engineering facility
p.(None): to be decided within 45 days of receipt. Via the application for approval of first-time work with GVM in security level 3 or work with
p.(None): The authority has GVM in security level 4 in a genetic engineering facility, if the application is based on the protocol of the Committee for Biosafety
p.(None): approval (section 16 subsection 4 no.4) is enclosed, to be decided within 60 days, otherwise within 90 days.
p.(None): Inhibition of the deadline
p.(None): § 25. The running of the deadlines according to § 24 is inhibited by
p.(None): 1. the notification of the result of the investigation to the applicant or applicant until he receives his opinion,
p.(None): 2. the order to improve the registration or the application until a response from the applicant or applicant or the
p.(None): Improvement,
p.(None): 3. the implementation of a hearing procedure in accordance with § 28,
p.(None): 4. an expert opinion of the scientific committee of the genetic engineering commission according to §§ 86, 91 and 92 for a maximum of three
p.(None): Weeks if the authority carries out an assessment procedure in accordance with section 7, section 9 (3) or section 10 (3) or obtains an expert opinion in accordance with section 26.
p.(None): Official procedure when working with transgenic animals
p.(None): § 26. When working with GMOs, for which approval of animal testing is required according to the Animal Testing Act 2012, Federal Law Gazette I № 114/2012, the
p.(None): in accordance with Appendix 1 lit. B of this federal law to be submitted with the application for approval of the animal experiment. The after
p.(None): The authority responsible for animal testing law 2012 has to give an opinion of the responsible before the decision by the Federal Minister of Health
p.(None): scientific committee of the genetic engineering commission if
p.(None): 1. there are doubts about the classification of this work in security level 1 or
p.(None): 2. when working for purposes other than biomedical or development research, there is reason to believe that the
p.(None): Species boundary is breached.
p.(None): Official decision on working with transgenic animals
p.(None): § 27. (1) The registration or approval according to the Animal Experiments Act 2012 and the regulations based thereon replaces within the scope of their
p.(None): Scope of application is the registration of work with transgenic animals required by this federal law.
p.(None): (2) The conduct of animal experiments in accordance with the Animal Experiments Act 2012 is prohibited if the requirements of Section 9 or
p.(None): Section 10 does not exist.
p.(None): hearing
p.(None): § 28. (1) The authority has in the cases of § 22 Paragraph 5 No. 2 in the official gazette of the Wiener Zeitung and in the editorial section of two widespread in the federal state
p.(None): Announcing daily newspapers that an application for authorization to work with GMOs has been submitted, documents to the authority during
p.(None): within a period of six weeks for public inspection, a hearing is being held and that everyone is free to attend
p.(None): Attend hearing.
p.(None): (2) The authority shall have the hearing within the framework of the investigation procedure within three weeks of the end of the disclosure for public inspection
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p.(None): expected impact on security (§ 1 Z 1). In the safety assessment, there are marker genes in GMOs that are resistant to human or
p.(None): Mediate veterinary antibiotics and can have harmful effects on safety (§ 1 Z 1), especially to
p.(None): consider.
p.(None): (3) In the application, data or results from the release of the same GMO or combination of GMOs that the applicant previously used must also be communicated
p.(None): or has applied for or undertaken outside Austria or is currently applying for or undertaking. In the application are also the locations of the
p.(None): to list the results of releases of relevant GMOs known from the literature.
p.(None): (4) The applicant can also refer to the data or results of previous applications by other applicants, provided that this is done in writing
p.(None): Have given consent.
p.(None): (5) If the release is changed in a way that can significantly change the risks to safety (§ 1 Z 1), or the operator either
p.(None): While the authority is reviewing the application or after its approval, new information is available on such risks, so is the applicant
p.(None): committed to immediately
p.(None): 1. to report this information to the authority,
p.(None): 2. review and adapt the measures listed in the application and
p.(None): 3. to take the necessary measures in the interest of security (§ 1 Z 1).
p.(None): (6) The applicant must immediately send a copy of the application (para. 2) and the notification (para. 5) to the Federal Ministry of Agriculture and Forestry,
p.(None): Environment and water management, which submits its opinion on this application to the authority.
p.(None): statutory authorization
p.(None): § 38. (1) The Federal Minister for Health and Women, insofar as this takes into account the expediency, speed and simplicity of a
p.(None): Procedure for examining an application in accordance with Section 37 Paragraphs 2 to 4, for the requirements of information exchange with the European Commission and for
p.(None): Assessment of the prerequisites in accordance with Section 40 (1) is necessary, taking into account safety (Section 1 (1)), the state of the art in science and technology
p.(None): and Community legislation relating to GMOs, in particular Annexes II and III to Directive 2001/18 / EC after consulting the
p.(None): responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture by ordinance
p.(None): Provisions on
p.(None): 1. The content, scope and form of the application in accordance with Section 37 (2) to (4) and the documents to be attached to it
p.(None): 2. the principles and methods to be used when preparing these application documents
p.(None): set. The regulation may also require that these documents be used using the programs provided by the authority
p.(None): to be presented on electronic data carriers.
p.(None): Note for the following provision
p.(None): Regarding para. 3: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): Official procedure
p.(None): Section 39. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application and the attached documents
p.(None): Confirm receipt of receipt or otherwise in writing.
p.(None): (2) Insofar as this is necessary for assessing the requirements in accordance with Section 40 (1), the authority shall provide the applicant with a reason
p.(None): order to provide further information on how to improve the application.
p.(None): (3) Before the decision to approve a release, except in the case of a simplified official procedure pursuant to Section 42, the authority has
p.(None): to carry out a hearing procedure in accordance with Section 43 and to obtain an expert opinion from the responsible scientific committee of the Genetic Engineering Commission.
p.(None): (4) The authority has submitted a summary of the application to the European Commission pursuant to Section 37 (2) lit. g within 30 days of receipt
p.(None): to transfer.
p.(None): (5) The authority has
p.(None): a) the Federal Ministry of Agriculture, Forestry, Environment and Water Management the receipt of the application (para. 1), the content of a request
p.(None): in accordance with paragraph 2 and the further information received on the basis of this request,
p.(None): b) to invite the Federal Ministry of Agriculture, Forestry, Environment and Water Management to the consultation procedure (§ 43) and
p.(None): c) the Federal Ministry of Agriculture, Forestry, Environment and Water Management their decisions (sections 40 and 48) and the reports and
p.(None): Notices of the operator (sections 45 (3), 46, 47 and 49 (2)) must be brought to your attention immediately.
p.(None): Note for the following provision
p.(None): Regarding para. 1: Appears through § 42 para. 1 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): party status
p.(None): Section 39a. (1) Party position in the official procedure for approval of a release, except for the release of animals and microorganisms
p.(None): related to medical applications
p.(None): 1. the applicant,
p.(None): 2. the municipality in whose local area of responsibility the release is to take place if it raises objections in accordance with § 43 Paragraphs 1 and 2
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p.(None): The placing on the market of these products should be determined if there is sufficient experience with the release and placing on the market of comparable GMOs
p.(None): and therefore adverse effects on security (§ 1 Z 1) are not expected. If these requirements are met, the Federal Minister for
p.(None): Health and women also authorized to make a corresponding application in accordance with Article 16 of Directive 2001/18 / EC.
p.(None): due diligence
p.(None): Section 57. Does the applicant or license holder have new ones during the examination of the application by the authority or after approval has been given
p.(None): The applicant has information immediately regarding the risks of the product for safety (§ 1 Z 1)
p.(None): 1. to review the information and documents submitted in accordance with Section 55 (2),
p.(None): 2. inform the authority in writing of this information and
p.(None): 3. to take the necessary measures for reasons of security (§ 1 no. 1), especially the affected public, in a suitable manner
p.(None): inform and, if necessary, offer to take back the products quickly and properly.
p.(None): Official procedure and official decision
p.(None): Section 58. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application as well as the attached documents
p.(None): Confirm receipt of receipt or otherwise in writing.
p.(None): (2) Before deciding whether to place the product on the market, the authority shall have an opinion from the responsible scientific committee of the
p.(None): GMO commission.
p.(None): (3) Insofar as this is necessary for the assessment of the approval requirements in accordance with Paragraph 4, the authority has to provide the applicant with a
p.(None): Justification to provide further information on how to improve the application.
p.(None): (4) The authority has a copy of the application and one without unnecessary postponement, but at the latest within 90 days of receipt of the application
p.(None): Assessment report to be drawn up in accordance with the guidelines set out in Annex VI to Directive 2001/18 / EC, together with a description of the conditions under which the
p.(None): Approval of the product is proposed to be forwarded to the European Commission if
p.(None): 1. the application is complete and
p.(None): 2. a) a release of the GMO contained in the product was approved in Austria within the meaning of this Federal Act or
p.(None): b) a release of the GMO contained in the product in another in accordance with Directive 90/220 / EEC or Directive 2001/18 / EC
p.(None): Member State of the European Union or the EEA or
p.(None): c) the applicant proves that the conditions for approval of the release (Section 40 (1) nos. 1 and 2) of the GMO contained in the product
p.(None): are given, and
p.(None): 3. according to the state of the art in science and technology, in particular on the basis of a positive safety assessment recorded in the assessment report
p.(None): the placing on the market of the product is not expected to have any adverse consequences for safety (Section 1 no. 1). It also takes that into account
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p.(None): 1. to send the applicant her negative evaluation report immediately after its completion as part of the result of the investigation
p.(None): to transfer,
p.(None): 2. the European Commission no earlier than 15 days after the transmission in accordance with Z 1 and no later than 15 days after the deadline specified in Paragraph 4
p.(None): To submit the evaluation report and
p.(None): 3. to prohibit the placing on the market of the product immediately after the investigation has been completed.
p.(None): (6) In the event of a positive assessment in accordance with paragraph 4, the authority shall, within 30 days of the completion of the Community procedure in accordance with
p.(None): 15 and 18 of Directive 2001/18 / EC to grant approval if
p.(None): 1. Neither the European Commission nor a member state of the European Union raised a reasoned objection to the placing on the market
p.(None): have any open questions with the European Commission and the Member States concerned, or
p.(None): 2. in the event of an objection by the European Commission or a member state of the European Union after carrying out the procedure pursuant to
p.(None): Art. 30 (2) of Directive 2001/18 / EC a positive decision has been issued by the European Commission or the Council. Otherwise the authority
p.(None): to prohibit the placing on the market.
p.(None): (7) The notification of the result of the investigation to the applicant and the order to improve the application or the application documents
p.(None): inhibit the period according to paragraph 4 until the applicant receives the opinion or the improvement.
p.(None): (8) The authorization to place plant protection products on the market (Section 2 of the Plant Protection Products Act, Federal Law Gazette No. 476/1990) that contain or derive from GMOs
p.(None): such exist must be applied for at the authority responsible for the implementation of the Plant Protection Products Act; according to the procedure
p.(None): Plant Protection Products Act to decide on the application in accordance with paragraphs 1 to 7 and to apply sections 60 and 61. The approval according to § 8
p.(None): The Plant Protection Products Act replaces, within the scope of its validity, the authorization to place it on the market required by this Federal Act.
p.(None): Content of the approval
p.(None): Section 58a. (1) The conditions and conditions for the type and scope of the placing on the market and for the use of the product are in the authorization
p.(None): (Section 54 (1)), which is required according to the state of the art in science and technology in order to rule out adverse consequences for safety (Section 1 (1)).
p.(None): The approval must take into account any positive decision under Community law in accordance with Section 58 (6) (2), and in particular the following
p.(None): To contain components:
p.(None): 1. the scope of the permit;
p.(None): 2. the description of the identity of the GMO (s) to be placed on the market as an article and its specific identifier;
p.(None): 3. the period of validity required for a renewed review of the effects of the product on safety (§ 1 no. 1)
p.(None): Approval that must not exceed 10 years;
...
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the labeling of the according
p.(None): Section 62a of the GMO provided.
p.(None): Unintentional presence of GMOs in other products
p.(None): Section 62c. (1) Anyone who places products on the market (Section 54 (1)) is obliged to take special care to ensure that, particularly in the case of sales,
p.(None): Transport, storage, use and processing a mixture of the GMOs contained in the products with goods that are not intended to be GMOs
p.(None): may contain is avoided.
p.(None): (2) The other provisions of III. Section relating to the release of GMOs and the placing on the market of products are traces on products
p.(None): contain a GMO not authorized in the EEA or a combination of such GMOs up to a threshold of 0.1%, if the
p.(None): Presence of the GMO (s) is unintentional or technically unavoidable.
p.(None): (3) Deviating from para. 2 is until April 18, 2007 on the placing on the market of a product that is for direct use as food or
p.(None): Feed or for processing and contains traces of a GMO not yet authorized in the EEA or a combination of such GMOs that III.
p.(None): Section of this Federal Law does not apply if
p.(None): 1. the proportion of such GMOs in the product does not exceed the threshold of 0.5%,
p.(None): 2. the presence of the GMO (s) is unintentional or technically unavoidable,
p.(None): 3. regarding the GMO (s) by the responsible scientific committee of the European Commission or by the European authority for
p.(None): Food safety a positive opinion was given before April 18, 2004,
p.(None): 4. a relevant application for authorization to place it on the market has not been rejected in the relevant Community procedure and
p.(None): 5. the detection methods for the GMO (s) are publicly available.
p.(None): (4) Section 62 does not apply to products that contain traces of GMOs authorized in the EEA, provided these products are for direct processing
p.(None): the proportion of such GMOs does not exceed a threshold of 0.9% and this proportion is unintentional or technically unavoidable.
p.(None): (5) To determine that the presence of GMOs is unintentional or technically unavoidable, the person who places a product on the market or
p.(None): has demonstrated, at the request of the authority or the supervisory bodies, that appropriate measures have been taken to ensure the existence of the or
p.(None): to avoid GMOs.
p.(None): (6) The Federal Minister for Health and Women is authorized to implement implementing decisions in the regulatory committee procedure in accordance with
p.(None): Directive 2001/18 / EC or Regulation (EC) № 1829/2003, the threshold values specified in paragraphs 2 to 4 are taken into account by regulation
p.(None): to adapt security (§ 1 Z 1) to the state of the art in science and technology. With the coming into force of a regulation regulating this subject
p.(None): corresponding provisions of paragraphs 2 to 4 are invalid.
p.(None): (7) The analyzes to determine whether the threshold values in accordance with paragraphs 2 to 4 have been exceeded must be carried out according to procedures for the examination and sampling
p.(None): that have been published as national or international standards or by national or international working groups, preferably by the
...
p.(None): Products could lead to an unbalanced burden on society or social groups, and if this burden for the
p.(None): Society appears unacceptable for economic, social or moral reasons.
p.(None): (2) The Federal Government shall, on the proposal of the Federal Minister for Health and Women, place such products on the commercial market in accordance with
p.(None): To prohibit section 54 (1) by ordinance, the placing of which on the market suggests a social intolerance.
p.(None): (3) After hearing the Genetic Engineering Commission, the Federal Minister for Health and Women must submit a proposal in accordance with paragraph 2 as soon as
p.(None): It is foreseeable that such products could be commercially placed on the Austrian market.
p.(None): Restriction of GMO approval
p.(None): Section 63a. (1) The Federal Minister of Health may, during the procedure for the authorization of a specific GMO in accordance with Directive 2001/18 / EC or the
p.(None): Regulation (EC) № 1829/2003 or during the renewal of a consent or authorization the applicant / applicant by way of European
p.(None): Commission to do so that the geographical scope of the written consent or approval is changed so that the federal territory
p.(None): is totally or partially excluded from cultivation.
p.(None): (2) The Federal Minister of Health has an appointment pursuant to Paragraph 1 no later than 45 days after forwarding the assessment report pursuant to Art. 14
p.(None): Paragraph 2 of Directive 2001/18 / EC or after receipt of the opinion of the European Food Safety Authority in accordance with Art. 6 Paragraph 6 and Art. 18 Paragraph 6
p.(None): Regulation (EC) № 1829/2003 of the European Commission for forwarding to the applicant or applicant and the other Member States
p.(None): to transfer.
p.(None): (3) If there is no confirmation of the geographical scope of the original application or within 30 days of the submission of the request
p.(None): of the original application, the adjustment of the geographical scope of the application or the application is based on the
p.(None): Directive 2001/18 / EC granted written consent and, if appropriate, by a decision in accordance with Art. 19 of Directive 2001/18 / EC and by a
p.(None): Decision on approval in accordance with Articles 7 and 19 of Regulation (EC) No. 1829/2003 implemented.
p.(None): (4) Should all or part of the federal territory be returned to the geographical scope of the approval / approval of which it was previously in accordance
p.(None): Paragraph 3 has been excluded, the Federal Minister of Health has made a request to the competent authority, the
p.(None): has given written consent in accordance with Directive 2001/18 / EC, or to the European Commission if the GMO according to Regulation (EC) № 1829/2003
p.(None): was allowed to judge.
p.(None): (5) Measures adopted under this provision do not affect the free movement of GMOs as or in products.
p.(None): IV. SECTION
p.(None): Genetic analysis and gene therapy in humans
p.(None): Prohibition of interference in the genetic material of the human germline
...
p.(None): Submit creation.
p.(None): (5) This list of all applications received on the basis of the public tender in accordance with paragraph 3, the nominations and tripartite proposals of the ÖAW
p.(None): as well as the reasons for their creation can be found in the appendix to the next report on the use of genetic engineering in accordance with Section 99 (5)
p.(None): publish.
p.(None): Chair of the scientific committees
p.(None): § 90. The Federal Minister of Health and Women has an employee of his Federal Ministry for each scientific committee
p.(None): Appoint chairperson; he has an advisory voice. If the Chairman is unable to attend, the Federal Minister of Health and Women has
p.(None): to ensure its representation.
p.(None): Decision-making in the scientific committees on applications and applications
p.(None): Section 91. (1) The competent scientific committee has the authority in the case of applications and applications for work with GMOs in accordance with Section II
p.(None): and in the case of applications for the release of GMOs into the environment and applications for the placing on the market of products in accordance with III. section
p.(None): within ten days of the referral by the authority, in cases where a hearing has to take place within ten days of the end of the hearing, and
p.(None): in the case of applications relating to genetic analysis and somatic gene therapy in humans in accordance with Section IV, at the latest within 20 days of referral
p.(None): to submit a reasoned opinion on the registration or the application in writing by the authority.
p.(None): (2) To prepare the opinion of the scientific committee, two selected according to the provisions of the rules of procedure
p.(None): Rapporteur made a proposal for the opinion to be delivered. The scientific committee decides by simple majority. The vote can also
p.(None): in writing; if no report is accepted in this way up to four days before the deadlines specified in Paragraph 1, the Chairman shall
p.(None): in any case to convene a meeting.
p.(None): (3) If the scientific committee does not adopt an opinion within the time limits specified in paragraph 1, the rapporteurs shall propose it
p.(None): and immediately present the minutes of the meeting to the authority.
p.(None): Consultation of the Commission and its scientific committees
p.(None): § 92. (1) The meetings of the commission and its scientific committees are to be scheduled by the chairman in such a way that the authority is legally responsible
p.(None): can perform the tasks assigned on time.
p.(None): (2) The meetings and votes of the Commission and its scientific committees are not public. The applicant or applicant can:
p.(None): Information can be loaded.
p.(None): (3) The results of the meetings are to be recorded in writing in a protocol; this must be the result of the vote, the reasoning, the
p.(None): Voting ratio and any minority votes at the request of the member remaining in the minority. The Scientific Committee
p.(None): no expert opinion accepted (section 91 (3)), the minutes also include statements made by individual members of the scientific committee on the
p.(None): Registration or the application to include.
p.(None): (4) The chairpersons of the scientific committees shall invite all members of their committee to meetings if the following
p.(None): Items to be advised or decided:
p.(None): 1. Preparation of sections of the genetic engineering book (§ 99),
p.(None): 2. Comments on draft regulations,
p.(None): 3rd activity report (Section 93 (1)),
p.(None): 4. Posting the representatives to the Genetic Engineering Commission (section 81 (1) 3).
p.(None): reporting requirements
p.(None): § 93. (1) The permanent scientific committees have to write to the Commission on March 1st of each year a report on the activity
p.(None): to transmit past calendar year.
p.(None): (2) The activity report has a summary of those in the reporting period
p.(None): 1. statements of the expert opinions important for safety (§ 1 Z 1),
p.(None): 2. Work carried out to prepare certain sections of the genetic engineering book and
p.(None): 3. treated technical problems
p.(None): to contain.
p.(None): (3) The standing scientific committees have given the Commission the part of the report on the applications that concerns their area of responsibility
p.(None): genetic engineering (Section 99 (5)).
p.(None): Members of the commission and its scientific committees
p.(None): § 94. (1) The term of office of a member or substitute member of the commission or a member of its scientific committees ends with
p.(None): 1. timing,
p.(None): 2nd death,
p.(None): 3. Removal via proposal of the nominating position (s),
p.(None): 4. Resignation of the member or substitute member or
...
Searching for indicator philosophy:
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p.(None): b) two representatives of the Federal Ministry of Economics and Labor, one of them an expert in the field of employee protection,
p.(None): c) two representatives of the Federal Ministry of Agriculture, Forestry, Environment and Water Management, one each from the fields of agriculture and
p.(None): Environment,
p.(None): d) a representative of the Federal Ministry of Education, Science and Culture -
p.(None): the sending federal ministers have the right to propose.
p.(None): 2. a) a representative of the Federal Chamber of Labor,
p.(None): b) a representative of the Austrian Trade Union Confederation,
p.(None): c) a representative of the President's Conference of the Austrian Chambers of Agriculture,
p.(None): d) a representative of the Austrian Chamber of Commerce - the sending organizations have the right to propose;
p.(None): 3. one representative each of the scientific committees - the sending committees have the right to propose;
p.(None): 4. eight experts who have experience in the fields of microbiology, cell biology, virology, molecular biology, hygiene, ecology,
p.(None): Security technology and sociology. Each of the areas mentioned must be represented by at least one expert. At least five
p.(None): these experts must have worked with GMOs; the Austrian Academy of Sciences has the right to propose;
p.(None): 5. One expert each for questions of molecular biology on the proposal of the Austrian Chamber of Commerce and the Austrian one
p.(None): Federation of Trade Unions;
p.(None): 6. a) a representative of scientific philosophy - the Austrian Rectors' Conference has the right to propose,
p.(None): b) a representative of a theological faculty has the right to propose the theological faculties of Austria,
p.(None): c) a doctor - the three medical universities in Austria have the right to propose,
p.(None): d) a person familiar with environmental problems - the Federal Environment Agency has the right to propose,
p.(None): e) a representative to be proposed by the Austrian Working Group on Rehabilitation.
p.(None): (2) The members of the commission are from the Federal Minister of Health and Women on the basis of the proposals in accordance with paragraph 1 for a period of five years
p.(None): to order. A substitute member must be appointed for each member - also for five years; the right to propose exists in the same way as for the
p.(None): representing members.
p.(None): Chairman
p.(None): § 82. The chair of the commission is the representative of the Federal Ministry of Health and Women, the deputy chair is the representative
p.(None): of the Federal Ministry of Education, Science and Culture.
p.(None): decision-making
p.(None): § 83. (1) The commission has a quorum if at least half of the members entitled to vote, at least half of the members according to
p.(None): Section 81 (1) 3 to 6 is present.
p.(None): (2) All members of the commission with the exception of the chair have a casting vote. Substitute members only have such voting rights
p.(None): Prevention of the person they represent and when that person chairs it. The commission decides by simple majority. In the event of a tie
p.(None): the view that the chairman agrees with is accepted.
p.(None): Responsibilities of the commission
p.(None): § 84. The tasks of the commission are in particular
...
p.(None): an expert in toxicology (nominated by the Federal Minister for Health and Women) and an expert in quality assurance and
p.(None): Identification (nominated by the Federal Minister of Economics and Labor).
p.(None): (3) When assessing applications relating to releases and when preparing sections of the genetic engineering book and the submission of
p.(None): Comments on draft regulations in accordance with III. Section Part A of this federal law is a representative of the Federal Ministry of Agriculture and
p.(None): Involve forestry, environment and water management in an advisory capacity; this must be given the opportunity to comment on the Federal Ministry of
p.(None): Explain agriculture and forestry, the environment and water management (Section 37 (6)).
p.(None): Tasks and composition of the scientific committee for gene analysis and gene therapy in humans
p.(None): Section 88. (1) The Scientific Committee for Genetic Analysis and Gene Therapy on Humans is responsible for assessing applications in accordance with Section IV
p.(None): as well as the preparation of sections of the genetic engineering book and the submission of statements on draft regulations in accordance with section IV of this
p.(None): Federal law.
p.(None): (2) This scientific committee must include:
p.(None): 1. one expert each from the following areas:
p.(None): a) molecular biology,
p.(None): b) a doctor with knowledge in the field of molecular pathology (nominated by the three medical universities in Austria),
p.(None): c) two representatives of the Supreme Medical Council (nominated by the Council itself),
p.(None): d) Philosophy (nominated by the Austrian Rectors' Conference),
p.(None): e) Theology (nominated by the theological faculties of Austria);
p.(None): 2. In addition to the experts mentioned under Paragraph 3 No. 1, are also responsible for assessing applications for
p.(None): a) Genetic analyzes (Section 68 (2)): one expert each from the areas
p.(None): aa) Medical genetics (nominated by the three medical universities in Austria),
p.(None): bb) medical genetics (nominated by the Austrian Society for Human Genetics),
p.(None): cc) medical ethics (nominated by the three medical universities in Austria),
p.(None): dd) reproductive medicine (nominated by the three medical universities in Austria),
p.(None): ee) molecular genetic analysis,
p.(None): ff) Pediatrics and Adolescent Medicine (nominated by the three medical universities in Austria),
p.(None): gg) sociology,
p.(None): hh) social work (nominated by the Austrian Association for Rehabilitation),
p.(None): ii) data protection law and
p.(None): b) Gene therapies:
p.(None): aa) a doctor with knowledge of somatic gene therapy (nominated by the three medical universities in Austria) and
p.(None): bb) two of the five permanent members of the Drugs Advisory Board (nominated by the Advisory Board)
p.(None): contracting.
p.(None): Right to nominate experts from scientific committees
p.(None): § 89. (1) Unless otherwise stipulated in sections 86 to 88, the Austrian Academy of Sciences has the right to nominate the experts
p.(None): Sciences (ÖAW). The nomination takes place through the entire meeting of the Austrian Academy of Sciences based on a public call.
p.(None): (2) The Federal Minister of Health and Women and the Federal Ministers exercise their nomination rights on the basis of tripartite proposals. The creation
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): [CELEX No .: 398L0081]
p.(None): BGBl. I No. 73/2004 (NR: GP: XXII RV 510 AB 538 p. 67. BR: 7062 AB 7080 p. 711.)
p.(None): BGBl. I No. 126/2004 (NR: GP XXII RV 617 AB 630 p. 78. BR: 7139 p. 714.)
p.(None): [CELEX No .: 32001L0018]
p.(None): BGBl. I No. 127/2005 (NR: GP XXII RV 1083 AB 1137 p. 125. BR: 7394 AB 7406 p. 727.)
p.(None): BGBl. I No. 13/2006 (NR: GP XXII RV 797 AB 823 S. 99. BR: 7230 AB 7232 S. 720.)
p.(None): [CELEX-No .: 31976L0768, 31989L0107, 31989L0398, 31989L0662, 31996L0023, 31997L0078, 31998L0083, 32000L0013, 32002L0046, 32004L0041]
p.(None): BGBl. I No. 111/2012 (NR: GP XXIV RV 1936 AB 1979 p. 179. BR: AB 8818 p. 815.)
p.(None): BGBl. I No. 114/2012 (NR: GP XXIV RV 2016 AB 2080 p. 185. BR: 8831 AB 8853 p. 816.)
p.(None): [CELEX No .: 32010L0063]
p.(None): BGBl. I No. 35/2015 (NR: GP XXV RV 445 AB 450 p. 59. BR: 9316 AB 9318 p. 838.)
p.(None): BGBl. I No. 92/2015 (NR: GP XXV RV 530 AB 744 p. 85. BR: AB 9430 p. 844.)
p.(None): [CELEX No .: 32015L0412]
p.(None): BGBl. I No. 126/2015 (VfGH)
p.(None): BGBl. I No. 112/2016 (NR: GP XXV RV 1336 AB 1378 p. 157. BR: AB 9706 p. 863.)
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 S. 23. BR: 9967 AB 9970 S. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): BGBl. I No. 59/2018 (NR: GP XXVI RV 191 AB 231 S. 36. BR: 10001 AB 10017 S. 883.)
p.(None): Preamble / Promulgatory
p.(None): TABLE OF CONTENTS
p.(None): Section I - General Provisions
p.(None): §1 aim of the law
p.(None): §2 scope
p.(None): §3 principles
p.(None): §4 Definitions
p.(None): Section II - Working with genetically modified organisms in closed systems
p.(None): §5 security levels
p.(None): §6 security rating
p.(None): §7 assessment procedure
p.(None): §8 Authorization to issue regulations
p.(None): §9 Transgenic animals
p.(None): § 10 security measures
p.(None): § 11 accident, emergency plan
p.(None): Section 12 Authorization to issue regulations
p.(None): Section 12a Authorization to issue ordinances
p.(None): § 13 operator
p.(None): Section 14 Biosafety officer
p.(None): § 15 project manager
p.(None): Section 16 Committee for Biosafety
p.(None): Section 17 Authorization to issue regulations
p.(None): Section 18 Cooperation with other institutions
p.(None): § 19 Registration of work with GMOs
p.(None): Section 20 applications for approval for working with GMOs
p.(None): Section 21 Authorization to issue regulations
p.(None): Section 22 Official procedure
p.(None): Section 23 Official decision
p.(None): § 24 start of work
p.(None): § 25 inhibition of the deadline
p.(None): Section 26 Official procedure when working with transgenic animals
p.(None): Section 27 Official decision on working with transgenic animals
p.(None): § 28 hearing
p.(None): Section 29 Authorization to issue regulations
p.(None): § 30 due diligence, information and notification requirements
p.(None): Section 31 Change in safety equipment
p.(None): Section 32 Change of operator
p.(None): Section 33 Subsequent conditions (note: subsequent measures)
p.(None): Section 34 Obligation to record
p.(None): Section 35 Authorization to issue ordinances
p.(None): III. Section - GMO release and placing on the market
p.(None): Part A - Release of GMOs
p.(None): Section 36 level principle
p.(None): Section 37 Application for approval
p.(None): Section 38 Authorization to issue regulations
p.(None): Section 39 Official procedure
p.(None): Section 39a Party position
p.(None): Section 40 Official decision
p.(None): Section 41 Inhibition of the deadline
p.(None): Section 42 Simplified official procedure
p.(None): Section 43 hearing
p.(None): Section 44 Authorization to issue regulations
p.(None): § 45 security measures, due diligence, information and notification requirements
p.(None): Section 46 Report on the Results of the Release
p.(None): Section 46a Authorization to issue ordinances
p.(None): Section 47 Change of operator
p.(None): Section 48 Subsequent requirements
p.(None): Section 49 accident, emergency plan
p.(None): Section 50 Authorization to issue regulations
p.(None): § 51 controls
p.(None): Section 52 Duty to record
p.(None): Section 53 Authorization to issue ordinances
p.(None): Part B - Placing on the market
p.(None): Section 54
p.(None): Section 55 Applicants and application documents
p.(None): Section 56 Authorization to issue regulations
p.(None): § 57 due diligence
p.(None): Section 58 Official procedure and official decision
p.(None): Section 58a Content of the approval
p.(None): Section 58b Renewal of approval
p.(None): Section 58c Obligation to monitor
p.(None): Section 58d Authorization to issue ordinances
p.(None): Section 58e Change of approval
p.(None): Section 59 scope of authorization
p.(None): Section 60 Temporary prohibitions or restrictions
p.(None): Section 61 security measures
p.(None): § 62 packaging and labeling
p.(None): Section 62a Provision of GMOs for purposes other than placing them on the market
p.(None): Section 62b Authorization to issue ordinances
p.(None): Section 62c Unintentional presence of GMOs in other products
p.(None): Section 63 Social intolerance
p.(None): (Note: § 63a restriction of approval of GMOs)
p.(None): Section IV - Genetic Analysis and Gene Therapy in Humans
p.(None): Section 64 Prohibition of interventions in the genetic material of the human germline
p.(None): Section 65 Genetic analyzes in humans for medical purposes
p.(None): Section 66 Genetic analyzes in humans for scientific purposes and for training
p.(None): Section 67 Prohibition of collecting and using data from genetic analyzes for certain purposes (note: prohibition of the use of
p.(None): Genetic analysis data for specific purposes)
p.(None): Section 68 Performing genetic analyzes on humans for medical purposes - official procedure
p.(None): Section 68a Head of the facility and laboratory manager
...
p.(None): Is bound by the species limit, the authority has received a request from the operator after consulting the scientific committee for working with GMOs in the
p.(None): closed system (§ 86) with notice to determine whether this work involves a breach of the species limit.
p.(None): Safety measures
p.(None): § 10. (1) Working with GMOs may only be carried out in compliance with the state-of-the-art measures to guarantee the
p.(None): Security (§ 1 Z 1) against threats from GMOs.
p.(None): (2) In justified exceptional cases, individual organizational or technical security measures of a certain security level cannot
p.(None): applied or measures from two different security levels can be combined.
p.(None): (3) In the case of paragraph 2, the authority has, at the request of the operator, after consulting the responsible scientific committee, the
p.(None): Genetic Engineering Commission to determine the admissibility of these measures with a decision, if through their application according to the state of the art and
p.(None): Technology no adverse effects on security (§ 1 Z 1) are expected.
p.(None): (4) Waste water, waste and waste air from closed systems in which work with GMOs have been carried out are state of the art and
p.(None): Treat technology in such a way that, in accordance with the requirements of the respective security level, the contact of the GMO used with the population and the
p.(None): Limiting the environment with the aim of preventing an uncontrolled multiplication of this GMO in the outside world; capable of reproduction under environmental conditions
p.(None): GMOs of risk groups 2 to 4 must be deactivated.
p.(None): Accident, emergency plan
p.(None): § 11. (1) The operator of a genetic engineering system
p.(None): 1. taking into account the respective work with GMOs, has all that is necessary according to the state of the art in science and technology to avoid accidents
p.(None): Take measures and therefore, in particular, take measures to minimize the risk and impact of accidents
p.(None): being held. When choosing measures, work with GVM in security levels 3 or 4 on a small scale or when working with GVM
p.(None): in security levels 2, 3 or 4 on a large scale possible internal sources of danger, such as incorrect processes, failure of
p.(None): Appropriate consideration of plant components or misconduct by personnel, external risks and possible interventions by unauthorized persons;
p.(None): 2. may only start work with GVM in security levels 3 or 4 on a small scale or in security levels 2, 3 or 4 on a large scale,
p.(None): if an emergency plan is available and has been submitted to the authority and the responsible fire department. The emergency plan has that in the event of an accident
p.(None): contain the necessary internal measures and safety instructions for the employees working there and for the fire brigade; the emergency plan is
p.(None): to connect a scheme for the notification process and for measures to deactivate leaked GVM. The emergency plan is the speci fi c one
p.(None): Adapt the type of work with GVM and the current state of science and technology. Another copy of the emergency plan is the
p.(None): District administrative authority to transmit; the emergency plan is also easily accessible for the fire brigade in the fire alarm center of the facility
p.(None): hang up;
p.(None): 3. has one for all work with GVM in security levels 3 or 4 on a small scale and security levels 2, 3 or 4 on a large scale
p.(None): to set up on-call duty who is present or at least short-term available while working with GVM and this with regard to the
p.(None): Train measures of the emergency plan;
p.(None): 4. has the first time working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale
p.(None): Residents at the latest six weeks from the start of work with GVM in a generally understandable form based on the state of the art in science and technology
p.(None): To inform technicians of necessary safety measures and behavior in the event of an accident; this information is off after three years
p.(None): Check the start of the work, update it if necessary and renew it vis-à-vis the public concerned, and afterwards in
p.(None): Repeat regular periods not exceeding five years.
p.(None): 5. has all work with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale
p.(None): genetic engineering plant employees once a year through instruction in the genetic engineering plant about the reduction in the event of an accident
p.(None): to inform adverse consequences for the safety (§ Z 1) necessary measures.
p.(None): (2) In accidents when working with GVM of security level 2 on a small scale and in accidents when working with transgenic plants and animals that are not of the
p.(None): Risk category 1 may be assigned to the course of the accident and the measures taken in the records in accordance with § 34 Paragraphs 1 and 2
p.(None): to log. About accidents when working with GVM in security levels 3 and 4 on a small scale and in security levels 2 to 4 on a large scale
p.(None): the operator informs the authority about the accident. The authority is hereby immediately by the operator, but at the latest within one month after entry
p.(None): of the accident
p.(None): 1. the course of the accident,
p.(None): 2. the name, risk group and quantity of the GVM that has left,
p.(None): 3. all information necessary to assess the impact of the accident on public health and the environment,
p.(None): 4. the emergency measures taken and
p.(None): 5. the measures to eliminate the consequences of the accident
p.(None): to be communicated in writing.
p.(None): (3) When working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale, the authority is from
p.(None): notify the accident that has occurred immediately by telephone or fax. The operator has, if according to the state of science and technology
p.(None): a risk to the health of the employees or the residents of the genetic engineering plant is to be assumed by these persons immediately from the accident
p.(None): inform and recommend appropriate behavioral measures.
p.(None): (4) In the event of accidents in accordance with paragraph 3, the operator and, if necessary, the authority must carry out a monitoring (monitoring) of the effects of the accident on the
p.(None): Security (§ 1 Z 1) to perform.
p.(None): (5) In the event of accidents in accordance with paragraph 3, the local governor, the local administrative authority and the municipality are responsible
p.(None): communicate.
p.(None): statutory authorization
p.(None): § 12. The Federal Minister of Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission under
p.(None): Consideration of the principles mentioned in § 3 paragraphs 1 and 2 by ordinance in agreement with the Federal Minister of Agriculture and Forestry,
p.(None): Environment and Water Management, the Federal Minister of Economics and Labor and with the Federal Minister of Education, Science and Culture and according to the status
p.(None): of science and technology and taking into account relevant EU regulations and other international guidelines and recommendations
p.(None): provisions
p.(None): 1. About organizational and technical security measures when working with GMOs in closed systems that are appropriate for the respective security level
p.(None): special attention is paid to the type of work to be carried out with GMOs,
p.(None): 2. requirements for genetic engineering systems to prevent, limit and eliminate the effects of accidents,
p.(None): 3. about criteria for the security measures in rooms for keeping transgenic plants or animals,
p.(None): 4. general criteria for assessing the effectiveness of biological safety measures and
p.(None): 5. for the preparation and content of emergency plans
p.(None): and to provide examples of recognized host-vector systems.
p.(None): statutory authorization
p.(None): § 12a. (1) The Federal Minister for Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission
p.(None): by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and
p.(None): Work and the Federal Minister of Education, Science and Culture according to the state of the art in science and technology, taking into account Annex II Part C
p.(None): of Directive 90/219 / EEC on the use of genetically modified microorganisms in closed systems in the currently applicable version, types of
p.(None): List GMOs that are safe for human health and the environment.
p.(None): (2) Working with GMOs in closed systems, which only include types of GMOs that are included in this list
p.(None): not the requirements of sections II. and IVa.
p.(None): operator
p.(None): § 13. (1) According to the state of the art in science and technology, the operator has to take the necessary safety measures (§ 10) and to comply with them
p.(None): to care.
p.(None): (2) The operator has all questions of safety with the officer for biosafety (§ 14), the project manager (§ 15) and the committee
p.(None): advice on biosafety (§ 16).
p.(None): (3) By appointing a biosafety officer, a project manager or a biosafety committee, the
p.(None): Responsibility of the operator for compliance with the provisions of this federal law and the administrative acts based thereon are not affected.
p.(None): Biosafety Officer
...
p.(None): Order consent and notify the local fire department immediately.
p.(None): (2) The Biosafety Officer and each deputy must have at least two years of practical experience working with GMOs such as
p.(None): they are mainly carried out in the plant, as well as sufficient knowledge in the field of measures to ensure safety (§ 1
p.(None): Z 1) dispose of threats from GMOs.
p.(None): (3) The biosafety officer and his deputy must be employed by the operator of the genetic engineering system
p.(None): or are mainly employed in the genetic engineering facility; at least one of them must work at security levels 3 or 4 in small
p.(None): Scale as well as at work in security levels 2, 3 or 4 on a large scale while working with GMOs present or at least reachable at short notice
p.(None): his. In the clinical area of the medical faculties there is an employment relationship with the officer for biosafety within the framework of the university
p.(None): Equal to the employment relationship with the operator, insofar as this is the sponsor of the hospital. Appointment of the representative for the biological
p.(None): In this case, security must be agreed with the respective clinic or institute board.
p.(None): (4) The Biosafety Officer has
p.(None): 1. a) regularly monitor compliance with the safety measures and the operator and the project manager via identified safety-relevant
p.(None): To inform defects immediately,
p.(None): b) review the emergency plan and, if necessary, propose it to the operator,
p.(None): c) Measures for the instruction and training of employees with regard to guaranteeing safety (§ 1 Z 1) against hazards from GMOs
p.(None): to propose to the operator and
p.(None): 2. keep written records of these activities and keep them ready for inspection by the authority.
p.(None): (5) The operator must support the biosafety officer in fulfilling his tasks, providing him with sufficient time during the
p.(None): To grant working hours and - if necessary - to provide auxiliary staff, further training opportunities, rooms, facilities and work equipment
p.(None): and to give him the opportunity to present suggestions and concerns to the project manager if there are differences of opinion.
p.(None): (6) If the biosafety officer leaves this function or if the operator cancels his order, one must be notified immediately
p.(None): appoint new biosafety officer; the same applies to his deputy, unless another deputy has been appointed.
p.(None): (7) The operator has the authority to withdraw and each change of the biosafety officer or one of his deputies
p.(None): to be announced immediately in writing, including the evidence required for the replacement person ordered by the operator (para. 2).
p.(None): (8) If, in the event of the appointment of a replacement person (para. 6), the authority determines on the basis of the evidence provided that the person appointed has the
p.(None): does not meet the requirements placed on them to request the operator within six weeks of the announcement of the replacement person, either
p.(None): (a) provide the outstanding evidence within a period not exceeding four weeks to be determined by the authority; or
p.(None): b) if a biosafety officer or a deputy is validly appointed for the genetic engineering system, in the event of a lack of qualification of the
p.(None): Proof of appropriate supplementary training within six months,
p.(None): otherwise the operator must order another suitable person.
p.(None): project Manager
p.(None): § 15. (1) The operator must appoint a project manager for each work with GMOs in security levels 2, 3 or 4 and for each work series. The
p.(None): Project managers must have sufficient practical experience working with GMOs, which they have been appointed to plan, manage and supervise, as well as
p.(None): have sufficient knowledge in the field of measures to ensure safety (§ 1 Z 1) against threats from GMOs.
p.(None): (2) The project manager is responsible for the planning, management and supervision of the work with GMOs for which he is appointed. He has for this work with GMOs or
p.(None): work rows
p.(None): 1. to propose a security classification (§ 6) to the operator,
p.(None): 2. The people involved in the work with GMOs about the safety measures to be applied, about the possible risks after the occurrence
p.(None): To inform accidents and about emergency measures and
p.(None): 3. to ensure compliance with the safety measures to be applied.
p.(None): (3) If the project manager leaves this function or if the operator cancels his order, a new project manager is to be assigned immediately
p.(None): to order.
p.(None): (4) The operator must inform the authority immediately of any change of project manager, including the evidence required for the replacement person (para. 1)
p.(None): to be announced in writing.
p.(None): (5) The appointment of a project manager in accordance with Paragraph 1 can be waived if working with GMOs only includes storage and internal
p.(None): Transport of GMOs includes.
p.(None): Biosafety Committee
p.(None): § 16. (1) The operator must set up a committee for biological safety for each genetic engineering system.
p.(None): (2) The Biosafety Committee consists of the biosafety officer of the facility and, if the facility only works in the
p.(None): be carried out on a small scale, from two additional members, and for all other work with GMOs from five additional members. If only in the plant
p.(None): Work on a small scale may be carried out, at least one member, otherwise two members, not in an employment relationship with the operator of the
p.(None): Plant. If large-scale GMO work is carried out in the facility, one of the members is the one responsible for the facility
p.(None): To send a works council or service committee from among the employees. For special questions, the Committee for Biological
p.(None): Security experts should be consulted. The members of the Committee for Biosafety are responsible for obtaining the items mentioned in para. 4 nos. 2 and 3
...
p.(None): can adversely affect security (§ 1 Z 1), the authority, as far as this is necessary to keep the immediate dangers, under
p.(None): to preserve acquired rights as far as possible to prohibit additional suitable safety requirements, to restrict the work with GMOs
p.(None): or to temporarily suspend and order the harmless removal of GMOs.
p.(None): record keeping
p.(None): Section 34. (1) The operator must ensure that records are kept of all work with GMOs, kept and kept for inspection by the
p.(None): Authority.
p.(None): (2) Records of work in security levels 1 or 2 on a small scale can be kept in the form of laboratory records (laboratory journals)
p.(None): become. These records must contain the following information:
p.(None): 1. Name and address of the operator and location of the genetic engineering system;
p.(None): 2. Name of the project manager and biosafety officer;
p.(None): 3. designation of the respective work with GMOs;
p.(None): 4. Beginning, completion and safety classification of the work with GMOs or the work series with GMOs and their modification;
p.(None): 5. type of disposal of GMOs;
p.(None): 6. Information about accidents according to § 11 paragraph 2.
p.(None): (3) Other than the work with GMOs listed under paragraph 2 are to be recorded in separate records. In addition to those listed in paragraph 2
p.(None): For information, these records must contain the following information:
p.(None): 1. time of registration of work with GMOs or date and business number of the approval notice;
p.(None): 2. the names of the people directly involved in carrying out the work with GMOs;
p.(None): 3. Security and emergency measures taken.
p.(None): (4) Records of work in security levels 3 or 4 on a large scale must include a in addition to the information according to paragraphs 2 and 3
p.(None): Description of the process control and the devices and equipment used to control the safety measures.
p.(None): (5) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (6) Records of work in security levels 1 or 2 on a small scale must be at least three years after completion of the work or
p.(None): Work series are kept. All other records must be kept for at least five years after completing work with GMOs.
p.(None): statutory authorization
p.(None): § 35. The Federal Minister of Health and Women, insofar as this is in the interest of security (§ 1 Z 1) according to the state of the art in science and technology
p.(None): is necessary, after consulting the responsible scientific committee of the genetic engineering commission by regulation in agreement with the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the type and content of the
p.(None): To set records in accordance with § 34.
p.(None): III. SECTION
p.(None): Release of GMOs and placing products on the market
p.(None): PART A
p.(None): Release of GMOs
p.(None): stage principle
p.(None): Section 36. (1) The release of GMOs may only take place according to the step principle (Section 3 (3)). The following stages must be followed:
p.(None): 1. To a small extent, based on the state of the art in science and technology, unlimited distribution and multiplication of GMOs
...
p.(None): to monitor the test area.
p.(None): (2) If, according to the state of the art in science and technology, a risk to safety (§ 1 no. 1) can be excluded when certain GMOs are released,
p.(None): Authorization to request the release of this GMO, even if the stage according to Paragraph 1 No. 1 has not been passed.
p.(None): permit application
p.(None): Section 37. (1) Any release requires approval by the authority.
p.(None): (2) The operator must apply for approval of the release and attach the following information to the application:
p.(None): 1. those necessary to assess the immediate and late effects of the GMO or the combination of GMOs and their effects on safety (§ 1 Z 1)
p.(None): Information to the extent that it applies to the requested release. In cases where it is not technically possible or not necessary to provide information
p.(None): appears, this must be stated and justified. This information has including a description of the methods and bibliographical information
p.(None): to include these in particular:
p.(None): a) Name of the project and general information about the operator, the staff involved and their training;
p.(None): b) information about the GMO (s) and the genetic modification;
p.(None): c) information on the conditions of the release and the properties of the environment relevant to the release into which the GMO is released
p.(None): becomes;
p.(None): d) Information about the interactions between the GMO or GMOs and the environment, in particular about circumstances that affect survival and
p.(None): Influence propagation; Environmental impact,
p.(None): e) a monitoring plan, information on control measures, emergency plan and description of the planned disposal methods;
p.(None): f) place (s) of release;
p.(None): g) a summary of this information;
p.(None): 2. the safety assessment, i.e. a description and assessment of the intended release of the GMO or GMOs or the combination of GMOs
p.(None): expected impact on security (§ 1 Z 1). In the safety assessment, there are marker genes in GMOs that are resistant to human or
p.(None): Mediate veterinary antibiotics and can have harmful effects on safety (§ 1 Z 1), especially to
p.(None): consider.
p.(None): (3) In the application, data or results from the release of the same GMO or combination of GMOs that the applicant previously used must also be communicated
p.(None): or has applied for or undertaken outside Austria or is currently applying for or undertaking. In the application are also the locations of the
p.(None): to list the results of releases of relevant GMOs known from the literature.
p.(None): (4) The applicant can also refer to the data or results of previous applications by other applicants, provided that this is done in writing
p.(None): Have given consent.
p.(None): (5) If the release is changed in a way that can significantly change the risks to safety (§ 1 Z 1), or the operator either
p.(None): While the authority is reviewing the application or after its approval, new information is available on such risks, so is the applicant
p.(None): committed to immediately
p.(None): 1. to report this information to the authority,
p.(None): 2. review and adapt the measures listed in the application and
p.(None): 3. to take the necessary measures in the interest of security (§ 1 Z 1).
...
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
p.(None): und Wasserwirtschaft, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture, more detailed provisions on
p.(None): Determine the content, scope and form of the notification in accordance with Section 46 (1).
p.(None): Change of operator
p.(None): § 47. A change in the person of the operator makes the permissibility of carrying out a release and the resulting
p.(None): Obligations not affected. The legal successor must immediately notify the authority of the change in writing.
p.(None): Subsequent editions
p.(None): Section 48. (1) If the release is intended or unintentionally changed after the approval has been granted in a manner that is significantly disadvantageous
p.(None): Could have an impact on security (§ 1 Z 1), or will become circumstances associated with such effects after the approval
p.(None): known, the authority has, insofar as this is necessary for the prevention of immediate dangers, with the greatest possible protection of acquired rights, additional
p.(None): to issue appropriate safety requirements, to restrict or prohibit the release, and to ensure the harmless removal of the released
p.(None): To order GMOs.
p.(None): (2) The authority shall make information on measures pursuant to Paragraph 1 available to the public on the website of the authority.
p.(None): Accident, emergency plan
p.(None): § 49. (1) Taking into account the respective release, the operator has all of the latest science and technology to prevent accidents
p.(None): necessary measures to be taken, and therefore in particular all precautions to be taken that minimize the risk and effects of accidents
p.(None): be kept possible. When choosing the measures, possible sources of danger must be adequately taken into account.
p.(None): (2) The authority must be notified by the operator immediately, at the latest within 14 days after the occurrence of the accident
p.(None): 1. the course of the accident,
p.(None): 2. the name, risk group and quantities of the non-recoverable GMOs or their potentially dangerous products,
p.(None): 3. all information that is necessary for the assessment of the impact of the accident on safety (§ 1 Z 1),
p.(None): 4. the emergency measures taken, the procedures for monitoring the GMOs in the event of a proliferation outside the experimental area, and those in the
p.(None): Interest of security (§ 1 Z 1) necessary plans in the event of occurrence of undesirable effects
p.(None): to be communicated in writing.
p.(None): (3) In the case of accidents that can lead to an immediate risk to safety (Section 1 no. 1), the authority is also immediately informed of the accident that has occurred
p.(None): to be informed by telephone or fax. The operator has a risk to the health of, provided that it is state of the art in science and technology
p.(None): People must be assumed to inform them immediately of the accident and to recommend appropriate behavioral measures.
p.(None): (4) In the event of an accident, the operator and, if necessary, the authority must monitor the effects of the accident on safety (§ 1
p.(None): Z 1).
p.(None): (5) The authority has public information on every accident that has a significant impact on safety (§ 1 no. 1) on the website of the
p.(None): To make the authority accessible and to inform the federal state in whose area of responsibility the release took place of such an accident.
p.(None): statutory authorization
p.(None): Section 50. The Federal Minister of Health and Women may, as far as this is in the interest of security according to the state of the art in science and technology (Section 1 no. 1)
...
p.(None): registered genetically modified crops.
p.(None): (3) Anyone can inspect the genetic engineering register during office hours, make copies on the spot, or as required
p.(None): Have copies of the existing technical possibilities made at his own expense. The genetic engineering register is public to the Internet
p.(None): to make it accessible.
p.(None): (4) The determination and processing of data for the purpose of automation-supported maintenance of the genetic engineering register is permitted.
p.(None): safety documentation
p.(None): Section 101d. (1) The Federal Ministry of Health is responsible for checking the safety (Section 1 (1)) of products placed on the market in accordance with Section 54 (1)
p.(None): and women a documentation center on safety-related properties and for the identification of the GMOs contained in these products
p.(None): To set up information.
p.(None): (2) The information and information required for this are submitted to the documentation center with the application for marketing authorization from
p.(None): Products (Section 54 (1)). In any case, this information must contain:
p.(None): 1. description of the product and the GMOs contained therein,
p.(None): 2. Name and address of the license holder,
p.(None): 3. A description of the product corresponding to the state of the art in science and technology with regard to the genetic modification
p.(None): caused special properties,
p.(None): 4. Description of the expected types of use and the planned spatial distribution in Austria,
p.(None): 5. intended labeling,
p.(None): 6. Instructions and recommendations for storage and handling and a description of the resulting residues and their treatment as well as the
p.(None): Emergency plans and adequate information for the identification of the GMO (in particular introduced nucleotide sequences).
p.(None): statutory authorization
p.(None): Section 101e. (1) Insofar as this is necessary to ensure the control of the safety (§ 1 Z 1) of products according to § 54 paragraph 1, the Federal Minister
p.(None): for health and women after hearing the responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister
p.(None): for Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor and the Federal Minister of Science and Transport
p.(None): (Note: correct: Federal Minister of Education, Science and Culture) taking safety, expediency and completeness into account
p.(None): Information to be issued by ordinance for more detailed provisions on the content, scope and form of the information to be given to the authority in accordance with Section 57 no.
p.(None): (2) In addition, information must be included in the security documentation that the authority receives in accordance with Section 57 no. 2.
p.(None): (3) The Federal Minister of Health and Women, insofar as this is used to control the adverse effects of released GMOs and in traffic
p.(None): brought products (§ 54 para. 1) to the security (§ 1 Z 1) and for information to the public is necessary, after hearing the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
...
p.(None): (2) Each applicant or operator can use the documents to be submitted by him under this Federal Act, provided that the documents contained therein
p.(None): information
p.(None): a) international relations and national defense,
p.(None): b) public security,
p.(None): c) Matters pending before the court or subject to, or subject to, preliminary proceedings (including disciplinary proceedings)
p.(None): The subject of preliminary proceedings are
p.(None): d) business and trade secrets including intellectual property,
p.(None): e) the confidentiality of personal data or files,
p.(None): f) documents that have been transmitted by a third party who was not legally obliged to do so,
p.(None): (g) information the disclosure of which would further increase the likelihood of environmental damage in the area concerned;
p.(None): touched, the data that are treated confidentially and thus should not be made available to the public even in the disclosure process. In
p.(None): In such cases, a verifiable justification must be given. After hearing the applicant or applicant, the authority decides which data as
p.(None): be recognized confidentially.
p.(None): (3) Under no circumstances may the following data be recognized as confidential:
p.(None): 1. General description of the GMO;
p.(None): 2. Name and address of the applicant or applicant;
p.(None): 3. a) Security level, containment measures and place of work with GMOs;
p.(None): b) purpose of release and place of release;
p.(None): 4. methods and plans for GMO monitoring and emergency response;
p.(None): 5. Assessment of the foreseeable effects, in particular the effects that are detrimental to safety (§ 1 no. 1).
p.(None): (4) The regulations according to paragraphs 1 to 3 on the confidentiality of data in the disclosure process also apply in relation to the others at the official level
p.(None): Procedure for authorizing a release involved.
p.(None): Transmission of data
p.(None): Section 106. The data to be disclosed to the authority in accordance with this federal law may be collected and processed by the authority. personal
p.(None): and confidential data may only be transmitted to
p.(None): 1. the departments of the federal and state governments, insofar as the data is for the recipient to enforce this federal law or other federal or
p.(None): state law provisions for the protection of human health or the environment form an essential prerequisite,
p.(None): 2. experts appointed by the authority, insofar as they require the data in order to complete this federal law,
p.(None): 3. the competent authorities of foreign countries, insofar as this is to avert a specific danger to the life or health of people or
p.(None): the environment is required, or if so provided by intergovernmental agreements.
p.(None): XI. SECTION
p.(None): Notification requirements to the European Commission
p.(None): § 107. The Federal Minister of Health and Women has the European Commission taking into account the provisions on confidentiality
p.(None): in accordance with section 105 and data traffic in accordance with section 106
p.(None): 1. As soon as possible to report all accidents when working with GMOs in a closed system and include details about the circumstances of the accident, the
p.(None): Identity and quantities of the GMOs released, the emergency measures applied and their effectiveness, as well as an analysis of the accident, including
p.(None): Provide recommendations to limit its impact and prevent similar accidents in the future,
p.(None): 2. At the end of each year, a summary report on work for approval in security levels 3 and 4 in
p.(None): closed systems, including the description, purpose and risks of the GMOs, and to be submitted every three years and at
p.(None): for the first time on June 5, 2003 a summary report on his experience with the application of the EC Directive 90/219 / EC in the version of the
p.(None): To transmit EC Directive 98/81 / EC,
p.(None): 3. communicate the official decisions in accordance with § 40,
p.(None): 4. after the end of each year, a short report on the control of the use of all those approved and placed on the market in accordance with Section 58 (5)
p.(None): To transmit products (section 54 (1)) and
p.(None): 5. to submit a report every three years, and for the first time on 1 September 1997, on the measures taken to implement Directive 90/220 / EEC.
p.(None): XII. SECTION
p.(None): Transitional, criminal and final provisions
p.(None): Transitional provisions
p.(None): Section 108. (1) At the time this Federal Act comes into force (Art. III Para. 1), work and series of work with GMOs in closed form are already taking place
p.(None): Systems are still permitted, subject to a later decision by the authority. The operators have this within twelve months from the entry into force
p.(None): Federal law to submit an application according to § 19 or an application according to § 20 to the authority.
p.(None): (2) Releases of GMOs that are already taking place at the time this Federal Act comes into force (Art. III Para. 1) are subject to a later one
...
p.(None): Section 109. (1) Unless the act forms part of an offense falling within the jurisdiction of the courts or according to others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to 36,300 euros
p.(None): 1. contrary to the prohibition of Section 67, employees, or job seekers, collects, requests, accepts or otherwise results of genetic analyzes
p.(None): recycled
p.(None): 2. contrary to the prohibition of Section 67, requests the results of genetic analyzes from policyholders or from policyholders,
p.(None): accepts or otherwise exploits.
p.(None): The attempt is punishable.
p.(None): (2) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are threatened with a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 21,800
p.(None): 1. contrary to the provision of section 37 subsection 1, carries out a release without prior approval,
p.(None): 2. contrary to the provisions of Section 54, places products on the market,
p.(None): 3. who, contrary to Section 79j Paragraph 1, second and third sentences, fails to take out liability insurance.
p.(None): (3) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 7,260
p.(None): 1. contrary to the provisions of § 6, fails to carry out a security classification, to record it in writing or to justify it,
p.(None): 2. contravenes the provisions of Section 11 (1) regarding the emergency plan or the on-call service,
p.(None): 3. The provisions of section 11 subsection 2, 3 or 5 relating to behavior in the event of an accident or as an operator contrary to the provisions of section 11 subsection 4 es
p.(None): fails to carry out a check,
p.(None): 4. contrary to an ordinance issued according to § 12, does not implement safety measures (Z 1) or does not meet requirements for genetic engineering systems (Z 2)
p.(None): Fulfills,
p.(None): 5. contrary to the provisions of section 13 subsection 1, fails to take the necessary security measures or to ensure that they are observed,
p.(None): 6. contrary to the provisions of section 14 subsection 1, 6, 7 or 8, fails to find a suitable representative for biosafety or its
p.(None): To appoint or announce deputies,
p.(None): 7. contrary to the provisions of section 15 subsection 1, 3 or 4, fails to appoint or announce a project manager,
p.(None): 8. contrary to the provisions of section 16 subsection 1, 5, 6 or 7, fails to appoint the committee for biosafety or members of this committee
p.(None): or announce
p.(None): 9. contrary to the provisions of Section 19, works with GMOs without having registered them with the authority,
p.(None): 10. contrary to the provisions of section 20 or section 23 (2), works with GMOs without official approval,
p.(None): 11. contravenes an official order issued in accordance with section 22 (4) or a condition or condition issued in accordance with section 23 (3),
p.(None): 12. starts working with GVM or transgenic animals or plants earlier than permitted under Section 24,
p.(None): 13. fails to obtain information in accordance with section 30 (2) about circumstances which may endanger safety (section 1 (1)) or the obligation to report in accordance with section 30 (3)
p.(None): contravenes.
...
p.(None): Enable security measures,
p.(None): 5. Description of safety measures and methods for the harmless disposal of the GVM.
p.(None): 1.1.2. Working at security level 2:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Description of security measures and methods for the harmless disposal of the GVM,
p.(None): 6. Information on accident prevention measures.
p.(None): 1.1.3. Working at security levels 3 and 4:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM and the one based on it
p.(None): Enable risks with regard to the required security measures,
p.(None): 5. Description of security measures and methods for the harmless disposal of GVM as well as methods for identification and for
p.(None): Proof of GVM,
p.(None): 6. Information about measures for accident prevention and the emergency plan according to § 11.
p.(None): 1.2. First-time work with GVM on a large scale
p.(None): 1.2.1. Working at security level 1:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and description of the process management, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Description of security measures and measures for the harmless disposal of the GVM as well as methods for identification and for
p.(None): Proof of GVM,
p.(None): 6. Information on accident prevention measures.
p.(None): 1.2.2. Working at security level 2:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Security classification and description of the process management, which an assessment of the properties of the GVM and the dangers emanating from it
p.(None): Allow for the necessary security measures,
p.(None): 5. Description of safety measures and measures for the harmless disposal of the GVM, possible dangers of the process used
p.(None): resulting waste and waste water as well as methods for the identification and detection of the GMM,
p.(None): 6. Information about measures for accident prevention and the emergency plan according to § 11.
p.(None): 1.2.3. Working at security levels 3 and 4:
p.(None): 1. Address of the plant, description of the parts of the plant that are relevant for working with GVM and their safety,
p.(None): 2. Name of the operator and the project manager,
p.(None): 3. Name and qualification
p.(None): a) the Biosafety Officer,
p.(None): b) the members of the Biosafety Committee,
p.(None): 4. Safety classification and description of the process management, which an assessment of the properties of the GVM and the risks it poses in
p.(None): Allow for the necessary security measures,
p.(None): 5. Description of safety measures and measures for the harmless disposal of the GVM and any biologically active ones
p.(None): Nucleic acids, possible dangers of the waste and wastewater generated in the process used, as well as methods for identification and for
p.(None): Proof of GVM,
p.(None): 6. Information about the instruction of all persons involved in the work in the handling of the safety devices and safety measures,
p.(None): 7. external risks arising from the location of the plant,
p.(None): 8. Information about measures for accident prevention and the emergency plan according to § 11.
p.(None): 2. Further work
p.(None): 2.1. Further work on a small scale
p.(None): 2.1.1. Works or work series of security level 2:
p.(None): 1. Address of the plant and, if necessary, changes to the description of the parts of the plant that are relevant for working with GVM and its safety,
p.(None): 2. Date of receipt of the application or the date and business number of the approval notice regarding the first-time work with GVM
p.(None): or a higher security level in this facility, including the security rating of this initial work,
p.(None): 3. Name of the project manager,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM with regard to the required
p.(None): Enable security measures,
p.(None): 5. Necessary changes or additions to the description of security measures and methods for the harmless elimination of the GVM and
p.(None): Accident prevention measures.
p.(None): 2.1.2. Working at security levels 3 and 4:
p.(None): 1. Address of the plant and, if necessary, changes to the description of the parts of the plant that are relevant for the work and its safety,
p.(None): 2. The date and business number of the approval notice concern the first-time work with GVM in these security levels in this annex,
p.(None): including the security rating of this initial work,
p.(None): 3. Name of the project manager,
p.(None): 4. Safety classification and summary presentation of the work, which is an assessment of the properties of the GVM and the one based on it
p.(None): Enable risks with regard to the required security measures,
p.(None): 5. Necessary changes or additions to the description of security measures and methods for the harmless elimination of the GVM as well
p.(None): of methods for the identification and detection of the GVM and measures for accident prevention.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): Section 79c exclusion of liability
p.(None): Section 79d
p.(None): Section 79e liability, recourse and compensation for several operators
p.(None): §§ 79f, 79g information
p.(None): Section 79h Application of the ABGB
p.(None): Section 79i Other claims for compensation
p.(None): Section 79j
p.(None): Section 79k to Section 79m claims against neighbors
p.(None): Section V. - Genetic Engineering Commission and Genetic Engineering Book
p.(None): Section 80 Establishment of a genetic engineering commission
p.(None): Section 81 Composition of the Genetic Engineering Commission
p.(None): Section 82 Chairman
p.(None): Section 83 Decision-making
p.(None): Section 84 Duties of the commission
p.(None): Section 85 Standing Scientific Committees
p.(None): Section 86 Tasks and composition of the scientific committee for working with GMOs in a closed system
p.(None): Section 87 Tasks and composition of the scientific committee for releases and placing on the market
p.(None): Section 88 Tasks and composition of the scientific committee for gene analysis and gene therapy in humans
p.(None): Section 89 Right to nominate experts from scientific committees
p.(None): Section 90 Chair of the scientific committees
p.(None): Section 91 Decision-making in the scientific committees on applications and applications
p.(None): Section 92 deliberations of the commission and its scientific committees
p.(None): Section 93 Obligation to report
p.(None): Section 94 Members of the Commission and its scientific committees
p.(None): Section 95 External experts
p.(None): Section 96 duty of confidentiality
p.(None): Section 97 Rules of Procedure
p.(None): Section 98 office
p.(None): Section 99 Genetic engineering book (note: genetic engineering book, report on the application of genetic engineering)
p.(None): VI. Section - Authority and Controls
p.(None): (Note: Section VI - Competent Authority, Controls)
p.(None): Section 100 authority responsibility
p.(None): Section 100a Directly applicable community law
p.(None): Section 101 controls (note: controls, restoration of the environment)
p.(None): Section 101a Restoring the Environment
p.(None): Section 101b Measures in the event of a release without approval
p.(None): Section 101c Genetic Engineering Register
p.(None): Section 101d security documentation
p.(None): Section 101e Authorization to issue ordinances
p.(None): Section VII - Security Research
p.(None): Section 102 Security research
p.(None): Section VIII - Interim Measures
p.(None): Section 103 Provisional coercive measures
p.(None): IX. Section - Expiry of authorization
p.(None): Section 104 Expiry of authorization
p.(None): Section X - Confidentiality of data and data traffic
p.(None): Section 105 Confidentiality of data in the inception process
p.(None): Section 106 transmission of data
p.(None): XI. Section - International Exchange of Information
p.(None): (Note: Section XI)
p.(None): Section 107 Notification requirements to the European Commission
p.(None): XII. Section - Transitional, Penal, and Final Provisions
p.(None): Section 108 transitional provisions
p.(None): (Note: § 108a restriction of the authorization of GMOs - transitional provisions)
p.(None): Section 109 criminal provisions, confiscation, forfeiture
p.(None): Section 110 references to other federal laws
p.(None): Section 111 enforcement
p.(None): Section 112 Implementation notice
p.(None): § 113 Entry into force provisions
p.(None): (Note: § 113a
p.(None): Section 113b
p.(None): Section 113c
p.(None): § 113d
p.(None): Attachments 1 to 4)
p.(None): text
p.(None): I. SECTION
p.(None): General provisions
p.(None): Purpose of the law
p.(None): § 1. The aim of this federal law is
...
p.(None): represents.
p.(None): (5) Transgenic plants and animals may only be assigned to risk group 1 if according to the state of the art in science and technology
p.(None): an overall assessment of the donor and recipient organisms, the vector and the inserted nucleic acid sections under laboratory conditions
p.(None): Taking into account the security measures that may be envisaged, no pathogenic properties of the GMO for humans, animals and plants and
p.(None): no adverse consequences for security (§ 1 Z 1) are to be expected.
p.(None): (6) When using GMOs on animals, the safety classification of this work is based on the risk group of the GMO used
p.(None): Consideration of any biological safety measures envisaged.
p.(None): (7) If biological safety measures are used, they can be classified in a lower safety level than that of the GMO risk group
p.(None): corresponds if the biological safety measures reduce the risk.
p.(None): (8) The security classification must be recorded in writing and justified. In the case of working with GVM, the cultural volume of the planned one is also included
p.(None): To indicate work.
p.(None): Approval procedure
p.(None): § 7. (1) If there are doubts about the security level in which a certain work with GMOs can be classified, the security measures are the higher ones
p.(None): Security level apply, unless it is sufficiently proven in agreement with the authority that the application of less stringent measures
p.(None): is justified.
p.(None): (2) In the case of paragraph 1, the authority has ex officio or at the request of the operator after consulting the responsible scientific committee of the
p.(None): Genetic Engineering Commission to determine the security level of this work with GMOs in consideration of the provisions of § 6.
p.(None): statutory authorization
p.(None): § 8. The Federal Minister of Health and Women has to guarantee security (§ 1 2 1) according to the state of the art in science and technology
p.(None): Consideration of international guidelines and recommendations after consulting the responsible scientific committee of the genetic engineering commission
p.(None): Ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor
p.(None): and the Federal Minister of Education, Science and Culture
p.(None): 1. Establish criteria for the security classification and the allocation of donor and recipient organisms to risk groups and
p.(None): 2. To give examples of the assignment of donor and recipient organisms to risk groups.
p.(None): Transgenic animals
p.(None): § 9. (1) Work on the production of transgenic vertebrates, with which a breakthrough of the species boundaries is connected, and work with transgenic
p.(None): Vertebrates, which were produced by breaking the species boundaries, are only for the purposes of biomedicine and developmental research
p.(None): allowed.
p.(None): (2) A breach of the species limit within the meaning of paragraph 1 exists if the identity of the species of the recipient organism is taken into account
p.(None): Reproduction and in terms of the essential characteristics of its body structure, its physiological functions and its performance is not preserved.
p.(None): (3) There are doubts as to whether breakthrough of a work on the production of transgenic vertebrates or a work on transgenic vertebrates
p.(None): Is bound by the species limit, the authority has received a request from the operator after consulting the scientific committee for working with GMOs in the
p.(None): closed system (§ 86) with notice to determine whether this work involves a breach of the species limit.
p.(None): Safety measures
p.(None): § 10. (1) Working with GMOs may only be carried out in compliance with the state-of-the-art measures to guarantee the
p.(None): Security (§ 1 Z 1) against threats from GMOs.
p.(None): (2) In justified exceptional cases, individual organizational or technical security measures of a certain security level cannot
p.(None): applied or measures from two different security levels can be combined.
p.(None): (3) In the case of paragraph 2, the authority has, at the request of the operator, after consulting the responsible scientific committee, the
p.(None): Genetic Engineering Commission to determine the admissibility of these measures with a decision, if through their application according to the state of the art and
p.(None): Technology no adverse effects on security (§ 1 Z 1) are expected.
p.(None): (4) Waste water, waste and waste air from closed systems in which work with GMOs have been carried out are state of the art and
p.(None): Treat technology in such a way that, in accordance with the requirements of the respective security level, the contact of the GMO used with the population and the
p.(None): Limiting the environment with the aim of preventing an uncontrolled multiplication of this GMO in the outside world; capable of reproduction under environmental conditions
p.(None): GMOs of risk groups 2 to 4 must be deactivated.
p.(None): Accident, emergency plan
p.(None): § 11. (1) The operator of a genetic engineering system
p.(None): 1. taking into account the respective work with GMOs, has all that is necessary according to the state of the art in science and technology to avoid accidents
p.(None): Take measures and therefore, in particular, take measures to minimize the risk and impact of accidents
p.(None): being held. When choosing measures, work with GVM in security levels 3 or 4 on a small scale or when working with GVM
p.(None): in security levels 2, 3 or 4 on a large scale possible internal sources of danger, such as incorrect processes, failure of
p.(None): Appropriate consideration of plant components or misconduct by personnel, external risks and possible interventions by unauthorized persons;
p.(None): 2. may only start work with GVM in security levels 3 or 4 on a small scale or in security levels 2, 3 or 4 on a large scale,
p.(None): if an emergency plan is available and has been submitted to the authority and the responsible fire department. The emergency plan has that in the event of an accident
p.(None): contain the necessary internal measures and safety instructions for the employees working there and for the fire brigade; the emergency plan is
p.(None): to connect a scheme for the notification process and for measures to deactivate leaked GVM. The emergency plan is the speci fi c one
p.(None): Adapt the type of work with GVM and the current state of science and technology. Another copy of the emergency plan is the
p.(None): District administrative authority to transmit; the emergency plan is also easily accessible for the fire brigade in the fire alarm center of the facility
p.(None): hang up;
p.(None): 3. has one for all work with GVM in security levels 3 or 4 on a small scale and security levels 2, 3 or 4 on a large scale
p.(None): to set up on-call duty who is present or at least short-term available while working with GVM and this with regard to the
p.(None): Train measures of the emergency plan;
p.(None): 4. has the first time working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale
p.(None): Residents at the latest six weeks from the start of work with GVM in a generally understandable form based on the state of the art in science and technology
p.(None): To inform technicians of necessary safety measures and behavior in the event of an accident; this information is off after three years
p.(None): Check the start of the work, update it if necessary and renew it vis-à-vis the public concerned, and afterwards in
p.(None): Repeat regular periods not exceeding five years.
p.(None): 5. has all work with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale
p.(None): genetic engineering plant employees once a year through instruction in the genetic engineering plant about the reduction in the event of an accident
p.(None): to inform adverse consequences for the safety (§ Z 1) necessary measures.
p.(None): (2) In accidents when working with GVM of security level 2 on a small scale and in accidents when working with transgenic plants and animals that are not of the
p.(None): Risk category 1 may be assigned to the course of the accident and the measures taken in the records in accordance with § 34 Paragraphs 1 and 2
p.(None): to log. About accidents when working with GVM in security levels 3 and 4 on a small scale and in security levels 2 to 4 on a large scale
p.(None): the operator informs the authority about the accident. The authority is hereby immediately by the operator, but at the latest within one month after entry
p.(None): of the accident
p.(None): 1. the course of the accident,
p.(None): 2. the name, risk group and quantity of the GVM that has left,
p.(None): 3. all information necessary to assess the impact of the accident on public health and the environment,
p.(None): 4. the emergency measures taken and
p.(None): 5. the measures to eliminate the consequences of the accident
p.(None): to be communicated in writing.
p.(None): (3) When working with GVM in security level 4 on a small scale and in security levels 2, 3 or 4 on a large scale, the authority is from
p.(None): notify the accident that has occurred immediately by telephone or fax. The operator has, if according to the state of science and technology
p.(None): a risk to the health of the employees or the residents of the genetic engineering plant is to be assumed by these persons immediately from the accident
p.(None): inform and recommend appropriate behavioral measures.
p.(None): (4) In the event of accidents in accordance with paragraph 3, the operator and, if necessary, the authority must carry out a monitoring (monitoring) of the effects of the accident on the
p.(None): Security (§ 1 Z 1) to perform.
p.(None): (5) In the event of accidents in accordance with paragraph 3, the local governor, the local administrative authority and the municipality are responsible
p.(None): communicate.
p.(None): statutory authorization
p.(None): § 12. The Federal Minister of Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission under
p.(None): Consideration of the principles mentioned in § 3 paragraphs 1 and 2 by ordinance in agreement with the Federal Minister of Agriculture and Forestry,
p.(None): Environment and Water Management, the Federal Minister of Economics and Labor and with the Federal Minister of Education, Science and Culture and according to the status
p.(None): of science and technology and taking into account relevant EU regulations and other international guidelines and recommendations
p.(None): provisions
p.(None): 1. About organizational and technical security measures when working with GMOs in closed systems that are appropriate for the respective security level
p.(None): special attention is paid to the type of work to be carried out with GMOs,
p.(None): 2. requirements for genetic engineering systems to prevent, limit and eliminate the effects of accidents,
p.(None): 3. about criteria for the security measures in rooms for keeping transgenic plants or animals,
p.(None): 4. general criteria for assessing the effectiveness of biological safety measures and
p.(None): 5. for the preparation and content of emergency plans
p.(None): and to provide examples of recognized host-vector systems.
p.(None): statutory authorization
p.(None): § 12a. (1) The Federal Minister for Health and Women, after hearing the responsible scientific committee of the Genetic Engineering Commission
...
p.(None): they are mainly carried out in the plant, as well as sufficient knowledge in the field of measures to ensure safety (§ 1
p.(None): Z 1) dispose of threats from GMOs.
p.(None): (3) The biosafety officer and his deputy must be employed by the operator of the genetic engineering system
p.(None): or are mainly employed in the genetic engineering facility; at least one of them must work at security levels 3 or 4 in small
p.(None): Scale as well as at work in security levels 2, 3 or 4 on a large scale while working with GMOs present or at least reachable at short notice
p.(None): his. In the clinical area of the medical faculties there is an employment relationship with the officer for biosafety within the framework of the university
p.(None): Equal to the employment relationship with the operator, insofar as this is the sponsor of the hospital. Appointment of the representative for the biological
p.(None): In this case, security must be agreed with the respective clinic or institute board.
p.(None): (4) The Biosafety Officer has
p.(None): 1. a) regularly monitor compliance with the safety measures and the operator and the project manager via identified safety-relevant
p.(None): To inform defects immediately,
p.(None): b) review the emergency plan and, if necessary, propose it to the operator,
p.(None): c) Measures for the instruction and training of employees with regard to guaranteeing safety (§ 1 Z 1) against hazards from GMOs
p.(None): to propose to the operator and
p.(None): 2. keep written records of these activities and keep them ready for inspection by the authority.
p.(None): (5) The operator must support the biosafety officer in fulfilling his tasks, providing him with sufficient time during the
p.(None): To grant working hours and - if necessary - to provide auxiliary staff, further training opportunities, rooms, facilities and work equipment
p.(None): and to give him the opportunity to present suggestions and concerns to the project manager if there are differences of opinion.
p.(None): (6) If the biosafety officer leaves this function or if the operator cancels his order, one must be notified immediately
p.(None): appoint new biosafety officer; the same applies to his deputy, unless another deputy has been appointed.
p.(None): (7) The operator has the authority to withdraw and each change of the biosafety officer or one of his deputies
p.(None): to be announced immediately in writing, including the evidence required for the replacement person ordered by the operator (para. 2).
p.(None): (8) If, in the event of the appointment of a replacement person (para. 6), the authority determines on the basis of the evidence provided that the person appointed has the
p.(None): does not meet the requirements placed on them to request the operator within six weeks of the announcement of the replacement person, either
p.(None): (a) provide the outstanding evidence within a period not exceeding four weeks to be determined by the authority; or
p.(None): b) if a biosafety officer or a deputy is validly appointed for the genetic engineering system, in the event of a lack of qualification of the
p.(None): Proof of appropriate supplementary training within six months,
p.(None): otherwise the operator must order another suitable person.
p.(None): project Manager
p.(None): § 15. (1) The operator must appoint a project manager for each work with GMOs in security levels 2, 3 or 4 and for each work series. The
p.(None): Project managers must have sufficient practical experience working with GMOs, which they have been appointed to plan, manage and supervise, as well as
p.(None): have sufficient knowledge in the field of measures to ensure safety (§ 1 Z 1) against threats from GMOs.
p.(None): (2) The project manager is responsible for the planning, management and supervision of the work with GMOs for which he is appointed. He has for this work with GMOs or
p.(None): work rows
p.(None): 1. to propose a security classification (§ 6) to the operator,
p.(None): 2. The people involved in the work with GMOs about the safety measures to be applied, about the possible risks after the occurrence
p.(None): To inform accidents and about emergency measures and
p.(None): 3. to ensure compliance with the safety measures to be applied.
p.(None): (3) If the project manager leaves this function or if the operator cancels his order, a new project manager is to be assigned immediately
p.(None): to order.
p.(None): (4) The operator must inform the authority immediately of any change of project manager, including the evidence required for the replacement person (para. 1)
p.(None): to be announced in writing.
p.(None): (5) The appointment of a project manager in accordance with Paragraph 1 can be waived if working with GMOs only includes storage and internal
p.(None): Transport of GMOs includes.
p.(None): Biosafety Committee
p.(None): § 16. (1) The operator must set up a committee for biological safety for each genetic engineering system.
p.(None): (2) The Biosafety Committee consists of the biosafety officer of the facility and, if the facility only works in the
p.(None): be carried out on a small scale, from two additional members, and for all other work with GMOs from five additional members. If only in the plant
p.(None): Work on a small scale may be carried out, at least one member, otherwise two members, not in an employment relationship with the operator of the
p.(None): Plant. If large-scale GMO work is carried out in the facility, one of the members is the one responsible for the facility
p.(None): To send a works council or service committee from among the employees. For special questions, the Committee for Biological
p.(None): Security experts should be consulted. The members of the Committee for Biosafety are responsible for obtaining the items mentioned in para. 4 nos. 2 and 3
p.(None): Tasks regarding the content and the result of their activity are not bound by any instructions in their decision.
p.(None): (3) Each member of the Biosafety Committee must have knowledge of working with GMOs. If works in the plant
p.(None): To be carried out on a large scale, at least one member must also have knowledge in the field of security measures
p.(None): (§ 1 Z 1) against threats from GMOs. Overall, the members of the Biosafety Committee should be selected so that they jointly
p.(None): have the experience in the field of working with GMOs that enables them, the experience with working with GMOs that are mainly carried out in the plant,
p.(None): associated risks for security (§ 1 Z 1).
p.(None): (4) The Biosafety Committee has
p.(None): 1. the security measures required to ensure compliance with this Federal Act and the administrative acts based thereon to ensure that
p.(None): Safety (§ 1 Z 1) against threats from GMOs and these safety measures according to the state of the art in science and technology
p.(None): Adapt the requirements of the work with GMOs carried out in the plant,
p.(None): 2. to check all safety classifications carried out by the operator and the proposed safety measures and in the case of his
p.(None): Agreement with them to release the respective work with GMOs internally,
p.(None): 3. to check whether possible biological safety measures are applicable when working with GMOs, and
p.(None): 4. to prepare a protocol of his examinations according to Z 2 and 3 and, if necessary, of the release (Z 2).
p.(None): (5) If a member leaves the committee for biosafety, the operator must immediately appoint a suitable new member.
p.(None): (6) The operator shall immediately notify the authority of any change of one of the members of the Biosafety Committee, including those for the
p.(None): The person required to provide the replacement person with evidence (paragraph 3).
p.(None): (7) If the authority determines when ordering a replacement person on the basis of the evidence submitted that the person appointed has the right to them
p.(None): does not meet the requirements set, to request the operator, either within a period to be determined by the authority and not more than four weeks
p.(None): to provide outstanding evidence or, in the event of insufficient quali fi cation of the replacement person ordered, appropriate additional training within
p.(None): six months to prove, otherwise the operator has to appoint another suitable person. The assignment, a supplementary training within
p.(None): of six months is not permitted if the member to be replaced has been removed by the operator.
p.(None): (8) The appointment of a committee for biosafety in accordance with paragraph 1 can be waived if working with GMOs only involves storage and
p.(None): includes the internal transport of GMOs.
p.(None): statutory authorization
p.(None): § 17. The Federal Minister of Health and Women, insofar as this is necessary in the interest of security (§ 1 no. 1), according to the state of the art in science
p.(None): and technology and after hearing the responsible scientific committee of the genetic engineering commission by ordinance in agreement with the
p.(None): Federal Minister of Education, Science and Culture detailed provisions on the required experience in working with GMOs and knowledge
p.(None): in particular to adopt safety measures through which the biosafety officers, the project managers and the members of a committee
p.(None): for biological security.
p.(None): Cooperation with other institutions
p.(None): § 18. The Biosafety Officer, the Project Leader and the Biosafety Committee are required to perform their duties
p.(None): Advising the operator with the legal regulations for the protection of existing employees in the plant and with
p.(None): to work together with the officers appointed in this facility to perform environmental protection tasks.
p.(None): Registration of work with GMOs
p.(None): § 19. The operator has the implementation
p.(None): 1. first time working with GVM in a genetic engineering plant in security level 1,
p.(None): 2. first time working with GVM in a genetic engineering facility in security level 2,
p.(None): 3. further work with GVM in a genetic engineering facility in security level 2,
p.(None): 4. first-time work with transgenic plants or animals in a genetic engineering facility,
p.(None): 5. Further work with transgenic plants or animals in a genetic engineering facility, provided that a security classification of security level 1 is not
p.(None): is permissible, and
p.(None): 6. Further work with transgenic vertebrates in security level 1 in a genetic engineering facility
p.(None): Before starting work, register with the authority using the documents specified in Appendix 1. The registrations and the related ones
p.(None): Documents must be submitted in the original and in a copy.
p.(None): Permit applications for working with GMOs
p.(None): § 20. The operator has the authorization to carry out
p.(None): 1. Working with GVM in a genetic engineering system in security level 3 and
p.(None): 2. Working with GVM in a genetic engineering facility in security level 4
p.(None): to be submitted to the authority before starting work, following the documents specified in Appendix 1. The application and the related
p.(None): Documents must be submitted in the original and in a copy.
p.(None): statutory authorization
p.(None): § 21. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of a
p.(None): Procedure for examining a registration in accordance with § 19 or an application in accordance with § 20 and for assessing the requirements in accordance with § 23 is required at
p.(None): Consideration of the guarantee of security (§ 1 Z 1) and on the state of the art in science and after consulting the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Economics and Labor and the
p.(None): Federal Minister of Education, Science and Culture more detailed provisions on content, scope and form of the registration according to § 19 or the application according to
p.(None): Section 20 documents to be issued. The regulation may also require that these documents be used using the information provided by the authority
p.(None): The programs made available must be submitted on electronic data carriers.
p.(None): Official procedure
p.(None): § 22. (1) The authority has the applicant and applicant the receipt and date of receipt of the application or application and the attached
p.(None): Confirm documents immediately by means of an entry stamp or otherwise in writing.
p.(None): (2) The authority has the conformity of the application or the application with the provisions of this Federal Act and those based thereon
p.(None): Regulations, in particular the accuracy and completeness of the documents submitted, the accuracy of the security classification (§ 6) in a security level
p.(None): (§ 5) and, if necessary, the appropriateness of the safety measures (containment and other protective measures), the waste disposal measures
p.(None): and contingency plans (§ 11).
p.(None): (3) Insofar as this is necessary to assess the requirements for working with GMOs according to § 23, the authority has the applicant or applicant
p.(None): order to provide additional information to improve registration or application.
p.(None): (4) Provided that the work is not started immediately after registration in accordance with Section 24, Paragraph 2, Paragraph 3, first sentence or Paragraph 4, second sentence
p.(None): the authority may, insofar as this is necessary in the interest of security (§ 1 Z 1),
p.(None): 1. impose on the applicant or applicant the conditions under which the intended work with GMOs is to be carried out, or the
p.(None): Change security rating and
p.(None): 2. order that this work with GMOs is only started or - if it is already being carried out - temporarily suspended until the
p.(None): Authority based on the additional information received in accordance with Paragraph 3 or the changed requirements or security classification of this work
p.(None): with GMO a decision in accordance with § 23 is made, or in the case of work with GMOs subject to notification in accordance with § 19 within 45 days of this order
p.(None): says that she takes note of the registration.
p.(None): (5) The authority has before the decision
p.(None): 1. about applications for approval of work with GMOs in security levels 3 and 4 and about registration of work with transgenic vertebrates
p.(None): for purposes other than biomedical or developmental research, if there is reason to believe that the species limit
p.(None): breached, an opinion from the responsible scientific committee of the genetic engineering commission is obtained and
p.(None): 2. on applications for the approval of work in security level 3 on a large scale, except work for development purposes, as well as on
p.(None): Applications for approval of initial work in security level 4 or further work in security level 4 on a large scale
p.(None): Conduct hearing procedures in accordance with § 28.
p.(None): Official decision
p.(None): Section 23. (1) Permission to carry out work with GMOs in accordance with Section 20 must be granted if
p.(None): 1. It is ensured that the operator, in particular with regard to the safety equipment of the genetic engineering system, resulting from the provisions
p.(None): This section and the resulting regulations for the intended work with GMOs are fulfilled and these
p.(None): Work carried out according to the state of the art in science and technology,
p.(None): 2. It is ensured that the precautions necessary for the required security level are taken according to the state of the art in science and technology
p.(None): therefore adverse consequences for security (§ 1 Z 1) are not expected, and
p.(None): 3. the operator provides proof of liability insurance in accordance with section 79j (1) second or third sentence.
p.(None): (2) The execution of work with GMOs in accordance with § 19 Z 1 or 2 in conjunction with § 24 Paragraph 1, § 19 Paragraph 3 in conjunction with § 24 Paragraph 3 second sentence, § 19
p.(None): Section 4 in conjunction with section 24 (4) first sentence and work with GMOs in accordance with section 20 must be prohibited if one or more of those mentioned in section 1
p.(None): Requirements are not met.
p.(None): (3) Insofar as this is necessary in the interest of safety (§ 1 no. 1), the authority has the period within which work with GMOs is carried out
p.(None): may, for a limited period or for the execution of the work and for the parts relevant for the safety (§ 1 no. 1) of the genetic engineering system certain suitable
p.(None): To prescribe conditions or requirements.
p.(None): Start of work
p.(None): § 24. (1) The work mentioned in § 19 Z 1 and 2 may be started 45 days after registration, unless the authority within it
p.(None): Waiting period another decision is made pursuant to Section 23 (3). When registering the protocol of the Committee on Biosafety was made
p.(None): Approval (Section 16 Paragraph 4 No. 4) is enclosed, this work may be carried out 30 days after registration, provided that the authority has agreed to the earlier start of work,
p.(None): also be included before this waiting period expires.
p.(None): (2) The work mentioned in § 19 Z 1 and 2 may be started immediately after registration if the authority for work with GVM in a
p.(None): a higher security level in the same genetic engineering system has already taken note of a registration or has given a permit. Does the
p.(None): However, if the operator applies for the work specified in Section 19 (2) to have this work approved, the authority must do so within 45 days of receipt
p.(None): To decide.
p.(None): (3) The work mentioned in § 19 Z 3 may be started immediately after registration. However, the operator makes an application
p.(None): Approval of this work, the authority has to decide within 45 days after receipt of this application.
p.(None): (4) The work mentioned in § 19 Z 4, 5 and 6 may, if §§ 26 and 27 are not applicable to them, be started 30 days after their registration
p.(None): unless the authority makes another decision within this waiting period in accordance with section 23 (3); this work may be done earlier than 30 days after your
p.(None): Registration will be included if the authority has agreed to start work earlier. For the work mentioned in § 19 Z 5 and 6 this does not apply
p.(None): Cases, the waiting period, if the registration is accompanied by the protocol of the Committee for Biosafety about the release (§ 16 Paragraph 4 No. 4) and if
p.(None): §§ 26 and 27 do not apply to them.
p.(None): (5) The work mentioned in § 20 may not be started until it has been approved by the authority. The authority announced the application
p.(None): Approval of first-time work with GVM in security level 3 if there is already an approval for work with GVM in the same genetic engineering facility
p.(None): in security level 4, as well as the application for approval for further work with GVM in security level 3 in a genetic engineering facility
p.(None): to be decided within 45 days of receipt. Via the application for approval of first-time work with GVM in security level 3 or work with
p.(None): The authority has GVM in security level 4 in a genetic engineering facility, if the application is based on the protocol of the Committee for Biosafety
p.(None): approval (section 16 subsection 4 no.4) is enclosed, to be decided within 60 days, otherwise within 90 days.
p.(None): Inhibition of the deadline
p.(None): § 25. The running of the deadlines according to § 24 is inhibited by
p.(None): 1. the notification of the result of the investigation to the applicant or applicant until he receives his opinion,
p.(None): 2. the order to improve the registration or the application until a response from the applicant or applicant or the
p.(None): Improvement,
p.(None): 3. the implementation of a hearing procedure in accordance with § 28,
p.(None): 4. an expert opinion of the scientific committee of the genetic engineering commission according to §§ 86, 91 and 92 for a maximum of three
p.(None): Weeks if the authority carries out an assessment procedure in accordance with section 7, section 9 (3) or section 10 (3) or obtains an expert opinion in accordance with section 26.
p.(None): Official procedure when working with transgenic animals
p.(None): § 26. When working with GMOs, for which approval of animal testing is required according to the Animal Testing Act 2012, Federal Law Gazette I № 114/2012, the
p.(None): in accordance with Appendix 1 lit. B of this federal law to be submitted with the application for approval of the animal experiment. The after
...
p.(None): Take precautions and measures.
p.(None): (2) Even after the start of work with GMOs, the operator has to deal with all facts and in connection with the execution of this work
p.(None): To inform circumstances which, according to the state of the art in science and technology, are likely to endanger security (Section 1 no. 1).
p.(None): (3) The operator has the facts and circumstances in accordance with paragraph 2 and the final cessation of all work with GMOs immediately in writing to the authority
p.(None): Report.
p.(None): Change in safety equipment
p.(None): § 31. The operator has any change in the security of the closed system, which according to the state of the art in science and technology
p.(None): Security (§ 1 Z 1) is likely to impair, to report to the authority in writing even after registration or after completion of the approval process.
p.(None): Change of operator
p.(None): § 32. A change in the person of the operator makes the permissibility of carrying out work with GMOs and the resulting ones
p.(None): Obligations not affected. The legal successor must immediately notify the authority of the change in writing.
p.(None): Subsequent measures
p.(None): § 33. After the granting of the permit, after the expiry of the prohibition period or after the start of the work, circumstances become known that are significant
p.(None): can adversely affect security (§ 1 Z 1), the authority, as far as this is necessary to keep the immediate dangers, under
p.(None): to preserve acquired rights as far as possible to prohibit additional suitable safety requirements, to restrict the work with GMOs
p.(None): or to temporarily suspend and order the harmless removal of GMOs.
p.(None): record keeping
p.(None): Section 34. (1) The operator must ensure that records are kept of all work with GMOs, kept and kept for inspection by the
p.(None): Authority.
p.(None): (2) Records of work in security levels 1 or 2 on a small scale can be kept in the form of laboratory records (laboratory journals)
p.(None): become. These records must contain the following information:
p.(None): 1. Name and address of the operator and location of the genetic engineering system;
p.(None): 2. Name of the project manager and biosafety officer;
p.(None): 3. designation of the respective work with GMOs;
p.(None): 4. Beginning, completion and safety classification of the work with GMOs or the work series with GMOs and their modification;
p.(None): 5. type of disposal of GMOs;
p.(None): 6. Information about accidents according to § 11 paragraph 2.
p.(None): (3) Other than the work with GMOs listed under paragraph 2 are to be recorded in separate records. In addition to those listed in paragraph 2
p.(None): For information, these records must contain the following information:
p.(None): 1. time of registration of work with GMOs or date and business number of the approval notice;
p.(None): 2. the names of the people directly involved in carrying out the work with GMOs;
p.(None): 3. Security and emergency measures taken.
p.(None): (4) Records of work in security levels 3 or 4 on a large scale must include a in addition to the information according to paragraphs 2 and 3
p.(None): Description of the process control and the devices and equipment used to control the safety measures.
p.(None): (5) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (6) Records of work in security levels 1 or 2 on a small scale must be at least three years after completion of the work or
p.(None): Work series are kept. All other records must be kept for at least five years after completing work with GMOs.
p.(None): statutory authorization
p.(None): § 35. The Federal Minister of Health and Women, insofar as this is in the interest of security (§ 1 Z 1) according to the state of the art in science and technology
p.(None): is necessary, after consulting the responsible scientific committee of the genetic engineering commission by regulation in agreement with the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the type and content of the
p.(None): To set records in accordance with § 34.
p.(None): III. SECTION
p.(None): Release of GMOs and placing products on the market
p.(None): PART A
p.(None): Release of GMOs
p.(None): stage principle
p.(None): Section 36. (1) The release of GMOs may only take place according to the step principle (Section 3 (3)). The following stages must be followed:
p.(None): 1. To a small extent, based on the state of the art in science and technology, unlimited distribution and multiplication of GMOs
p.(None): greatly reduce outside of the test area;
p.(None): 2. Attempt to a large extent, according to the state of the art in science and technology, to spread and multiply GMOs outside
p.(None): to monitor the test area.
p.(None): (2) If, according to the state of the art in science and technology, a risk to safety (§ 1 no. 1) can be excluded when certain GMOs are released,
p.(None): Authorization to request the release of this GMO, even if the stage according to Paragraph 1 No. 1 has not been passed.
p.(None): permit application
p.(None): Section 37. (1) Any release requires approval by the authority.
p.(None): (2) The operator must apply for approval of the release and attach the following information to the application:
p.(None): 1. those necessary to assess the immediate and late effects of the GMO or the combination of GMOs and their effects on safety (§ 1 Z 1)
p.(None): Information to the extent that it applies to the requested release. In cases where it is not technically possible or not necessary to provide information
p.(None): appears, this must be stated and justified. This information has including a description of the methods and bibliographical information
p.(None): to include these in particular:
p.(None): a) Name of the project and general information about the operator, the staff involved and their training;
p.(None): b) information about the GMO (s) and the genetic modification;
p.(None): c) information on the conditions of the release and the properties of the environment relevant to the release into which the GMO is released
p.(None): becomes;
p.(None): d) Information about the interactions between the GMO or GMOs and the environment, in particular about circumstances that affect survival and
p.(None): Influence propagation; Environmental impact,
p.(None): e) a monitoring plan, information on control measures, emergency plan and description of the planned disposal methods;
p.(None): f) place (s) of release;
p.(None): g) a summary of this information;
p.(None): 2. the safety assessment, i.e. a description and assessment of the intended release of the GMO or GMOs or the combination of GMOs
p.(None): expected impact on security (§ 1 Z 1). In the safety assessment, there are marker genes in GMOs that are resistant to human or
p.(None): Mediate veterinary antibiotics and can have harmful effects on safety (§ 1 Z 1), especially to
p.(None): consider.
p.(None): (3) In the application, data or results from the release of the same GMO or combination of GMOs that the applicant previously used must also be communicated
p.(None): or has applied for or undertaken outside Austria or is currently applying for or undertaking. In the application are also the locations of the
p.(None): to list the results of releases of relevant GMOs known from the literature.
p.(None): (4) The applicant can also refer to the data or results of previous applications by other applicants, provided that this is done in writing
p.(None): Have given consent.
p.(None): (5) If the release is changed in a way that can significantly change the risks to safety (§ 1 Z 1), or the operator either
p.(None): While the authority is reviewing the application or after its approval, new information is available on such risks, so is the applicant
p.(None): committed to immediately
p.(None): 1. to report this information to the authority,
p.(None): 2. review and adapt the measures listed in the application and
p.(None): 3. to take the necessary measures in the interest of security (§ 1 Z 1).
p.(None): (6) The applicant must immediately send a copy of the application (para. 2) and the notification (para. 5) to the Federal Ministry of Agriculture and Forestry,
p.(None): Environment and water management, which submits its opinion on this application to the authority.
p.(None): statutory authorization
p.(None): § 38. (1) The Federal Minister for Health and Women, insofar as this takes into account the expediency, speed and simplicity of a
p.(None): Procedure for examining an application in accordance with Section 37 Paragraphs 2 to 4, for the requirements of information exchange with the European Commission and for
p.(None): Assessment of the prerequisites in accordance with Section 40 (1) is necessary, taking into account safety (Section 1 (1)), the state of the art in science and technology
p.(None): and Community legislation relating to GMOs, in particular Annexes II and III to Directive 2001/18 / EC after consulting the
p.(None): responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture by ordinance
p.(None): Provisions on
p.(None): 1. The content, scope and form of the application in accordance with Section 37 (2) to (4) and the documents to be attached to it
p.(None): 2. the principles and methods to be used when preparing these application documents
p.(None): set. The regulation may also require that these documents be used using the programs provided by the authority
p.(None): to be presented on electronic data carriers.
p.(None): Note for the following provision
p.(None): Regarding para. 3: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): Official procedure
p.(None): Section 39. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application and the attached documents
p.(None): Confirm receipt of receipt or otherwise in writing.
p.(None): (2) Insofar as this is necessary for assessing the requirements in accordance with Section 40 (1), the authority shall provide the applicant with a reason
p.(None): order to provide further information on how to improve the application.
p.(None): (3) Before the decision to approve a release, except in the case of a simplified official procedure pursuant to Section 42, the authority has
p.(None): to carry out a hearing procedure in accordance with Section 43 and to obtain an expert opinion from the responsible scientific committee of the Genetic Engineering Commission.
p.(None): (4) The authority has submitted a summary of the application to the European Commission pursuant to Section 37 (2) lit. g within 30 days of receipt
p.(None): to transfer.
p.(None): (5) The authority has
p.(None): a) the Federal Ministry of Agriculture, Forestry, Environment and Water Management the receipt of the application (para. 1), the content of a request
p.(None): in accordance with paragraph 2 and the further information received on the basis of this request,
p.(None): b) to invite the Federal Ministry of Agriculture, Forestry, Environment and Water Management to the consultation procedure (§ 43) and
p.(None): c) the Federal Ministry of Agriculture, Forestry, Environment and Water Management their decisions (sections 40 and 48) and the reports and
p.(None): Notices of the operator (sections 45 (3), 46, 47 and 49 (2)) must be brought to your attention immediately.
p.(None): Note for the following provision
p.(None): Regarding para. 1: Appears through § 42 para. 1 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): party status
p.(None): Section 39a. (1) Party position in the official procedure for approval of a release, except for the release of animals and microorganisms
p.(None): related to medical applications
p.(None): 1. the applicant,
p.(None): 2. the municipality in whose local area of responsibility the release is to take place if it raises objections in accordance with § 43 Paragraphs 1 and 2
p.(None): Sent it to the authority in writing within the meaning of paragraph 2 below and explained it in more detail at the hearing,
p.(None): 3. if the property on which the release is to take place is at a municipal boundary, the municipalities adjacent to this property, if
p.(None): it submits objections, justified in accordance with Section 43, Paragraphs 1 and 2, in writing to the Authority in the sense of the following Paragraph 2 and further details at the hearing
p.(None): have explained
p.(None): 4. the owner of the property on which the release is to take place if he has written objections in accordance with § 43 paragraphs 1 and 2 of the
p.(None): Authority communicated and explained in more detail at the hearing and at the same time with his written objections the requirements for his
p.(None): Party position has demonstrated
p.(None): 5. the neighbors if they submit written objections to the authority in writing in accordance with section 43 subsection 1 and 2 within the meaning of the subsection 2 below and submit them
p.(None): the hearing was explained in more detail and, at the same time, with its written objections, the requirements for her party position were met
p.(None): to have. Neighbors are the owners of the land, which have a common border with the property on which the release is to take place,
p.(None): as well as persons who have leased these properties at the time of application and during the procedure, and persons who
p.(None): Time of the application and during the procedure legally and not only temporarily on one of these properties, as well
p.(None): 6. the federal state in whose area of responsibility the release should take place if there are justified objections within the meaning of section 43 (1) and (2)
p.(None): Submitted the following paragraph 2 in writing to the authority and explained in more detail at the hearing.
p.(None): (2) The municipalities in accordance with Paragraph 1 Numbers 2 and 3 are due to the party position they receive, each of them within the framework of the respective party according to § 43
p.(None): Paragraphs 1 and 2 raised objections, entitled to comply with legal requirements regarding security (§ 1 Z 1) within their respective local
p.(None): Area of responsibility serve to assert in the official procedure for approval of the release. The federal state according to paragraph 1 no. 6 is on the ground
p.(None): the party position it is entitled to within the scope of the objections raised by it according to § 43 Paragraph 1 and 2, compliance with
p.(None): Legislation that serves security (§ 1 Z 1) within its respective area of responsibility in the official procedure for approval of the
p.(None): Claim release. The owner of the property in accordance with paragraph 1 line 4 and its neighbors in accordance with paragraph 1 line 5, each of them within the framework of the
p.(None): Objections raised by him in accordance with § 43 Paragraphs 1 and 2 are entitled to comply with the legal provisions that ensure the security of his own
p.(None): Health and that of his offspring serve to assert a subjective public right in official proceedings, to take legal action
p.(None): and to lodge a complaint with the Administrative Court and the Constitutional Court.
p.(None): Official decision
p.(None): Section 40. (1) The authority must decide on applications pursuant to Section 37 (2) within 90 days of receipt of the application. Approval must be given if
p.(None): 1. It is ensured that the operator derives from the provisions of Part A of this section and the regulations based thereon
p.(None): Obligations for the intended release are fulfilled and this release is carried out according to the state of the art in science and technology,
p.(None): 2. It is guaranteed that the precautions necessary according to the state of the art in science and technology have been taken and therefore have adverse consequences for the
p.(None): Security (§ 1 Z 1) are not to be expected, and
p.(None): 3. the operator provides proof of liability insurance in accordance with section 79j (1) second or third sentence.
p.(None): (2) Insofar as this is necessary in the interest of security (§ 1 no. 1), the authority has the period within which a release may be carried out,
p.(None): to be limited in time or for the implementation and if necessary also for the monitoring after the implementation certain suitable conditions and requirements
p.(None): prescribe.
p.(None): (3) In its decision, the authority takes into account the need to use marker genes in GMOs, the resistance to human or
p.(None): impart antibiotics used in veterinary medicine and can have harmful effects on safety (§ 1 no. 1) in the event of releases up to
p.(None): December 31, 2008.
p.(None): (4) The authority has every decision in accordance with paragraphs 1 to 3 of the European Commission and the federal state in whose area of responsibility the
p.(None): Release should take place.
p.(None): (5) The Authority shall make publicly available information on any release approval on the Authority's website.
p.(None): Inhibition of the deadline
p.(None): § 41. (1) The notification of the result of the investigation to the applicant and the order to improve the application or the
p.(None): The associated documents and the hearing in accordance with section 43 inhibit the period in accordance with section 40 (1) until the applicant has received a statement or
p.(None): of improvement. The hearing pursuant to Section 43 will delay this period for a maximum of 30 days.
p.(None): (2) The notification of the result of the investigation to a party in accordance with Section 39a (1) lines 2 to 6 does not inhibit the period in accordance with Section 40 (1).
p.(None): Simplified official procedure
p.(None): Section 42. (1) The Federal Minister of Health and Women is authorized if sufficient with the release of certain GMOs in certain ecosystems
p.(None): Experience has been gathered, taking into account the state of the art in science and technology and safety (§ 1 no. 1) after consulting the
p.(None): competent scientific committee of the Genetic Engineering Commission to submit an application in accordance with Art. 7 of Directive 2001/18 / EC and to implement a
p.(None): Decision according to Art. 7 of Directive 2001/18 / EC by regulation in agreement with the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the
p.(None): Implement simplified administrative procedures for the release of such GMOs that are comparable in terms of their safety.
p.(None): (2) The Federal Minister of Health and Women has an ordinance in accordance with paragraph 1 or the decision, a decision in accordance with Art. 7 of the Directive
p.(None): 2001/18 / EC not to be used to inform the European Commission.
p.(None): Note for the following provision
p.(None): Regarding para. 2: Appears through § 39 para. 2 AVG, Federal Law Gazette No. 51/1991, derogated in whole or in part since January 1, 1999, cf. Section 82 (7) AVG as amended by Federal Law Gazette I No. 158/1998.
p.(None): hearing
p.(None): Section 43. (1) The authority has in the Official Journal of the Wiener Zeitung, in two local daily newspapers and on the notice boards of the municipalities in accordance with Section 39a (1)
p.(None): Z 2 and 3 to announce at the expense of the operator that an application for the release of a GMO has been made, relevant documents to the authority (§ 100),
p.(None): all offices of the state governments and the municipalities in whose local area of responsibility GMOs are to be released during a
p.(None): Period of three weeks for public inspection and that everyone is at liberty to justify the authority within the period for which the information is available
p.(None): Submit objections in writing. The announcement includes persons who, in accordance with Section 39a (1) (4) and (5), are party to the further official procedure
p.(None): to obtain approval for the release, to point out that they have the party position by raising justified written objections
p.(None): can obtain at the same time the requirements for their party position and subsequent explanation of their objections at the hearing.
p.(None): (2) The authority shall schedule a hearing as part of the investigation; this hearing took place within three weeks from the end of the
p.(None): Deadline to be held. The hearing serves to discuss the objections submitted on time; the opponents have the opportunity to get closer
p.(None): To explain their objections. The authority has the right to this hearing to anyone who has submitted timely objections in writing
p.(None): load. This loading can be carried out in the announcement according to paragraph 1. The authority also has to load separately:
p.(None): a) the applicant in accordance with Section 39a (1) 1,
p.(None): b) the municipalities in accordance with Section 39a (1) 2 and 3 if they have raised objections in accordance with Section 1
p.(None): c) the owner of the property in accordance with Section 39a (1) no. 4,
p.(None): d) the neighbors in accordance with Section 39a (1) (5) if they raise objections in accordance with Section 1 and the requirements for their party status are met
p.(None): have demonstrated
p.(None): e) the federal state in accordance with section 39a (1) (6) if it has raised objections in accordance with section 1, and
p.(None): f) the members of the responsible scientific committee.
p.(None): statutory authorization
p.(None): § 44. The Federal Minister of Health and Women, insofar as this takes into account the expediency, speed and simplicity of the hearing
p.(None): is required, in agreement with the Federal Minister of Education, Science and Culture by ordinance, more detailed provisions on announcement and
p.(None): The course of the consultation process, the type and scope of the inspection of the application and the associated documents, with particular attention to the
p.(None): Confidentiality of data in accordance with Section 105, to determine the preparation and the course of the hearing.
p.(None): Security measures, due diligence, information and notification requirements
p.(None): Section 45. (1) Anyone who carries out a release has all that is necessary according to the state of the art in science and technology in the interest of safety (Section 1 no. 1)
p.(None): Take precautions and measures and - insofar as he is the operator - ensure that they are observed.
p.(None): (2) Even after approval of the release, the operator has all the facts and circumstances related to the release
p.(None): inform, which according to the state of the art in science and technology are suitable to endanger security (§ 1 Z 1).
p.(None): (3) The operator must immediately report facts and circumstances in accordance with paragraph 2 to the authority in writing.
p.(None): Release results report
p.(None): Section 46. (1) After completion of the release, the operator has all in accordance with the deadlines and requirements of the authority specified in the approval notice
p.(None): Report the results of the release, which are decisive for its assessment with regard to safety (§ 1 no. 1). This may include products
p.(None): (Section 54 (1)), for which the operator intends due to the release to apply for approval of the in-
p.(None): To bring traffic.
p.(None): (2) The authority has the results of the release communicated in accordance with Paragraph 1 to the responsible scientific committee of the Genetic Engineering Commission
p.(None): and to inform the European Commission.
p.(None): statutory authorization
p.(None): Section 46a. The Federal Minister of Health and Women, taking into account Art. 10 of Directive 2001/18 / EC after consulting the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
p.(None): und Wasserwirtschaft, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture, more detailed provisions on
p.(None): Determine the content, scope and form of the notification in accordance with Section 46 (1).
p.(None): Change of operator
p.(None): § 47. A change in the person of the operator makes the permissibility of carrying out a release and the resulting
p.(None): Obligations not affected. The legal successor must immediately notify the authority of the change in writing.
p.(None): Subsequent editions
p.(None): Section 48. (1) If the release is intended or unintentionally changed after the approval has been granted in a manner that is significantly disadvantageous
p.(None): Could have an impact on security (§ 1 Z 1), or will become circumstances associated with such effects after the approval
p.(None): known, the authority has, insofar as this is necessary for the prevention of immediate dangers, with the greatest possible protection of acquired rights, additional
p.(None): to issue appropriate safety requirements, to restrict or prohibit the release, and to ensure the harmless removal of the released
p.(None): To order GMOs.
p.(None): (2) The authority shall make information on measures pursuant to Paragraph 1 available to the public on the website of the authority.
p.(None): Accident, emergency plan
p.(None): § 49. (1) Taking into account the respective release, the operator has all of the latest science and technology to prevent accidents
p.(None): necessary measures to be taken, and therefore in particular all precautions to be taken that minimize the risk and effects of accidents
p.(None): be kept possible. When choosing the measures, possible sources of danger must be adequately taken into account.
p.(None): (2) The authority must be notified by the operator immediately, at the latest within 14 days after the occurrence of the accident
p.(None): 1. the course of the accident,
p.(None): 2. the name, risk group and quantities of the non-recoverable GMOs or their potentially dangerous products,
p.(None): 3. all information that is necessary for the assessment of the impact of the accident on safety (§ 1 Z 1),
p.(None): 4. the emergency measures taken, the procedures for monitoring the GMOs in the event of a proliferation outside the experimental area, and those in the
p.(None): Interest of security (§ 1 Z 1) necessary plans in the event of occurrence of undesirable effects
p.(None): to be communicated in writing.
p.(None): (3) In the case of accidents that can lead to an immediate risk to safety (Section 1 no. 1), the authority is also immediately informed of the accident that has occurred
p.(None): to be informed by telephone or fax. The operator has a risk to the health of, provided that it is state of the art in science and technology
p.(None): People must be assumed to inform them immediately of the accident and to recommend appropriate behavioral measures.
p.(None): (4) In the event of an accident, the operator and, if necessary, the authority must monitor the effects of the accident on safety (§ 1
p.(None): Z 1).
p.(None): (5) The authority has public information on every accident that has a significant impact on safety (§ 1 no. 1) on the website of the
p.(None): To make the authority accessible and to inform the federal state in whose area of responsibility the release took place of such an accident.
p.(None): statutory authorization
p.(None): Section 50. The Federal Minister of Health and Women may, as far as this is in the interest of security according to the state of the art in science and technology (Section 1 no. 1)
p.(None): is necessary, after hearing the responsible committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture
p.(None): and forestry (note: correct: Federal Minister of Agriculture, Forestry, Environment and Water Management) and the Federal Minister of Education,
p.(None): Science and culture issued more detailed regulations to prevent, limit and eliminate the effects of accidents caused by releases.
p.(None): controls
p.(None): § 51. The authority is entitled to inspect during and after the release both in the test area and in its vicinity, including under
p.(None): Take appropriate samples (§ 101).
p.(None): record keeping
p.(None): § 52. (1) The operator must ensure that accompanying records of the release carried out, kept and kept
p.(None): Inspection by the authority.
p.(None): (2) The records must contain the following information:
p.(None): 1. Name and address of the operator;
p.(None): 2. place of release;
p.(None): 3. Date and transaction number of the approval of the release;
p.(None): 4. Beginning and completion of the release;
p.(None): 5. Summary presentation of the release, which enables an assessment of the release with regard to the necessary safety measures;
p.(None): 6. the names of the persons directly involved in the execution of the work;
p.(None): 7. Deviations from the planned test procedure;
p.(None): 8. Disposal of GMOs.
p.(None): (3) The recordings may not be made unrecognizable by deletions or in any other way. The records will be added later
p.(None): changed, the date of the change and the name of the person making the change must be enclosed.
p.(None): (4) The records must be kept at least ten years after the end of the release.
p.(None): statutory authorization
p.(None): Section 53. The Federal Minister of Health and Women, insofar as this is in the interest of security (Section 1 no. 1) according to the state of the art in science and technology
p.(None): is necessary after consulting the responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister of Agriculture
p.(None): and forestry (note: correct: Federal Minister of Agriculture, Forestry, Environment and Water Management), the Federal Minister of Economics and Labor and
p.(None): to determine the Federal Minister of Education, Science and Culture more detailed provisions on the content, type and form of the records in accordance with Section 52
p.(None): PART B
p.(None): marketing
p.(None): authorization
p.(None): Section 54. (1) The placing on the market of products consisting of or containing GMOs requires the approval of the authority; in this
p.(None): Approval is to indicate the intended use.
p.(None): (2) The placing on the market of an already approved product for a different use than that specified in the marketing authorization
p.(None): requires a separate approval.
p.(None): (3) According to this Federal Act, no authorization is required for placing products on the market
p.(None): 1. if products are used as intended for the manufacture of which the placing on the market has already been approved in accordance with this Federal Act
p.(None): become or have been
p.(None): 2. for products that fall within the scope of Regulation (EC) No. 1829/2003 on genetically modified food and feed.
p.(None): In these cases, sections 55 to 63 of this Federal Act, with the exception of section 62c (1), do not apply.
p.(None): (4) Without prejudice to Section 60, the authorization for placing on the market by the authority is equivalent to the authorization to place it on the market by the authorities
p.(None): of another member state of the European Union or the EEA in application of Directive 90/220 / EEC or Directive 2001/18 / EC.
p.(None): Applicants and application documents
p.(None): Section 55. (1) Anyone who, as a manufacturer or importer, wishes to place a product on the market within the meaning of Section 54 (1) has previously applied for approval from
p.(None): Placing on the market.
p.(None): (2) The application must contain the following information:
p.(None): 1. the information in accordance with § 37 Paragraph 2 No. 1, insofar as these are not only of importance for a specific release. This information must be provided by the
p.(None): Diversity of places of application of the product (§ 54 para. 1) take into account and information about within the framework of releases
p.(None): Data and results obtained regarding the effects of release or application of the product on safety (§ 1 Z 1)
p.(None): contain,
p.(None): 2. the name and a precise description of the product in terms of genetic engineering and corresponding to the state of the art
p.(None): changed special properties,
p.(None): 3. the name and address of the applicant or of the person established in the Community responsible for the placing on the market,
p.(None): 4. description of the intended use of the product and the planned spatial distribution,
p.(None): 5. conditions for placing on the market, including special conditions for the use and handling of the product,
p.(None): 6. The intended packaging and labeling on a label or in an accompanying document that at least meet the requirements of Section 62
p.(None): got to,
p.(None): 7. further specific information regarding the safe use of the product,
p.(None): 8. a proposal for the validity of the permit, which may not exceed 10 years,
...
p.(None): Have given consent.
p.(None): (5) If according to the state of the art in science and technology based on the results of a release or on the basis of the safety assessment with the in-
p.(None): Placing the product on the market and the use of the product are not expected to have any adverse effects on safety (Section 1 (1))
p.(None): Conformity with Annex IV of Directive 2001/18 / EC on reasoned request by the applicant for the submission of speci fi c information in accordance with
p.(None): Abs. 2 Z 7 waive.
p.(None): statutory authorization
p.(None): § 56. (1) The Federal Minister of Health and Women has, insofar as this is in view of the expediency, speed and simplicity of the application process
p.(None): and for the assessment of safety (§ 1 Z 1) is necessary, after hearing the responsible scientific committee of the genetic engineering commission and in
p.(None): Agreement with the Federal Minister for Agriculture, Forestry, Environment and Water Management, the Federal Minister for Economy and Labor and the
p.(None): Federal Minister of Education, Science and Culture, taking into account the state of the art in science and technology and those referring to GMOs
p.(None): Community legislation, in particular Annexes II, III and IV to Directive 2001/18 / EC, through more detailed regulations on
p.(None): 1. Content, scope and form of the documents in accordance with § 55 Paragraph 2 and
p.(None): 2. the principles and methods to be used when compiling these documents
p.(None): set. The regulation may also require that these documents be used using the programs provided by the authority
p.(None): must be presented on electronic data carriers. "
p.(None): (2) By ordinance pursuant to Paragraph 1, first half sentence, taking into account a decision pursuant to Art. 16 of Directive 2001/18 / EC, for certain
p.(None): Types of products in derogation from the requirements according to § 55 Paragraph 2 more detailed provisions on the criteria and the application documents for the in-
p.(None): The placing on the market of these products should be determined if there is sufficient experience with the release and placing on the market of comparable GMOs
p.(None): and therefore adverse effects on security (§ 1 Z 1) are not expected. If these requirements are met, the Federal Minister for
p.(None): Health and women also authorized to make a corresponding application in accordance with Article 16 of Directive 2001/18 / EC.
p.(None): due diligence
p.(None): Section 57. Does the applicant or license holder have new ones during the examination of the application by the authority or after approval has been given
p.(None): The applicant has information immediately regarding the risks of the product for safety (§ 1 Z 1)
p.(None): 1. to review the information and documents submitted in accordance with Section 55 (2),
p.(None): 2. inform the authority in writing of this information and
p.(None): 3. to take the necessary measures for reasons of security (§ 1 no. 1), especially the affected public, in a suitable manner
p.(None): inform and, if necessary, offer to take back the products quickly and properly.
p.(None): Official procedure and official decision
p.(None): Section 58. (1) The authority must immediately notify the applicant of the receipt and date of receipt of the application as well as the attached documents
p.(None): Confirm receipt of receipt or otherwise in writing.
p.(None): (2) Before deciding whether to place the product on the market, the authority shall have an opinion from the responsible scientific committee of the
p.(None): GMO commission.
p.(None): (3) Insofar as this is necessary for the assessment of the approval requirements in accordance with Paragraph 4, the authority has to provide the applicant with a
p.(None): Justification to provide further information on how to improve the application.
p.(None): (4) The authority has a copy of the application and one without unnecessary postponement, but at the latest within 90 days of receipt of the application
p.(None): Assessment report to be drawn up in accordance with the guidelines set out in Annex VI to Directive 2001/18 / EC, together with a description of the conditions under which the
p.(None): Approval of the product is proposed to be forwarded to the European Commission if
p.(None): 1. the application is complete and
p.(None): 2. a) a release of the GMO contained in the product was approved in Austria within the meaning of this Federal Act or
p.(None): b) a release of the GMO contained in the product in another in accordance with Directive 90/220 / EEC or Directive 2001/18 / EC
p.(None): Member State of the European Union or the EEA or
p.(None): c) the applicant proves that the conditions for approval of the release (Section 40 (1) nos. 1 and 2) of the GMO contained in the product
p.(None): are given, and
p.(None): 3. according to the state of the art in science and technology, in particular on the basis of a positive safety assessment recorded in the assessment report
p.(None): the placing on the market of the product is not expected to have any adverse consequences for safety (Section 1 no. 1). It also takes that into account
p.(None): Requirement that marker genes in GMOs mediate resistance to antibiotics used in human or veterinary medicine and the harmful
p.(None): Can no longer have an impact on safety (§ 1 Z 1) in products that are placed on the market after December 31, 2004
p.(None): be used.
p.(None): (5) If one of the conditions specified in Paragraph 4 Nos. 1 to 3 does not exist, the authority has
p.(None): 1. to send the applicant her negative evaluation report immediately after its completion as part of the result of the investigation
p.(None): to transfer,
p.(None): 2. the European Commission no earlier than 15 days after the transmission in accordance with Z 1 and no later than 15 days after the deadline specified in Paragraph 4
p.(None): To submit the evaluation report and
p.(None): 3. to prohibit the placing on the market of the product immediately after the investigation has been completed.
p.(None): (6) In the event of a positive assessment in accordance with paragraph 4, the authority shall, within 30 days of the completion of the Community procedure in accordance with
p.(None): 15 and 18 of Directive 2001/18 / EC to grant approval if
p.(None): 1. Neither the European Commission nor a member state of the European Union raised a reasoned objection to the placing on the market
p.(None): have any open questions with the European Commission and the Member States concerned, or
p.(None): 2. in the event of an objection by the European Commission or a member state of the European Union after carrying out the procedure pursuant to
p.(None): Art. 30 (2) of Directive 2001/18 / EC a positive decision has been issued by the European Commission or the Council. Otherwise the authority
p.(None): to prohibit the placing on the market.
p.(None): (7) The notification of the result of the investigation to the applicant and the order to improve the application or the application documents
p.(None): inhibit the period according to paragraph 4 until the applicant receives the opinion or the improvement.
p.(None): (8) The authorization to place plant protection products on the market (Section 2 of the Plant Protection Products Act, Federal Law Gazette No. 476/1990) that contain or derive from GMOs
p.(None): such exist must be applied for at the authority responsible for the implementation of the Plant Protection Products Act; according to the procedure
p.(None): Plant Protection Products Act to decide on the application in accordance with paragraphs 1 to 7 and to apply sections 60 and 61. The approval according to § 8
p.(None): The Plant Protection Products Act replaces, within the scope of its validity, the authorization to place it on the market required by this Federal Act.
p.(None): Content of the approval
p.(None): Section 58a. (1) The conditions and conditions for the type and scope of the placing on the market and for the use of the product are in the authorization
p.(None): (Section 54 (1)), which is required according to the state of the art in science and technology in order to rule out adverse consequences for safety (Section 1 (1)).
p.(None): The approval must take into account any positive decision under Community law in accordance with Section 58 (6) (2), and in particular the following
p.(None): To contain components:
p.(None): 1. the scope of the permit;
p.(None): 2. the description of the identity of the GMO (s) to be placed on the market as an article and its specific identifier;
p.(None): 3. the period of validity required for a renewed review of the effects of the product on safety (§ 1 no. 1)
p.(None): Approval that must not exceed 10 years;
p.(None): 4. the conditions for placing the product on the market, including the specific conditions for use, handling and handling
p.(None): Packaging of the product, and the conditions for the protection of certain ecosystems / environmental conditions and / or geographical areas;
p.(None): 5. the indication that the applicant must provide the authority with control samples on request;
p.(None): 6. The mandatory labeling, the words "This product contains genetically modified organisms", on the label or in one
p.(None): Accompanying document must be provided;
p.(None): 7. Requirements related to surveillance, including the obligation to report to the competent authority the deadlines for the
p.(None): Monitoring plan and, if necessary, the obligations of persons who sell or use the product; for adequate information
p.(None): the authority, in particular, if the product is intended for cultivation, about the intended locations.
p.(None): (2) The authority shall provide the public with information about every marketing authorization (notification of approval) and about each
p.(None): make the decision under Community law available on the Authority's website in accordance with Section 58 (6).
p.(None): Renewal of approval
p.(None): Section 58b. (1) No later than nine months before the expiry of a license granted in accordance with Section 58 (6), the license holder can contact the
p.(None): Authority to submit an application for renewal of approval. This application must contain the following information and documents:
p.(None): 1. a copy of the notification of the original approval;
p.(None): 2. a report on the results of the monitoring carried out in accordance with Section 58c;
p.(None): 3. other new information which has become known with regard to the safety hazards arising from the product (§ 1 no. 1), and
p.(None): 4. Where appropriate, a proposal to change or add to the terms of the original approval, particularly with regard to the future one
p.(None): Monitoring and the limitation of the renewed approval.
p.(None): (2) Section 58 (1) to (3) apply mutatis mutandis.
p.(None): (3) After the application has been checked for completeness, the authority shall immediately send a copy to the European Commission
p.(None): Application and an assessment report prepared in accordance with Section 58 (4). In particular, this report must contain statements as to whether and under which
p.(None): Conditions the product should or should not remain on the market. The applicant must also be informed immediately.
p.(None): (4) In the event of a positive assessment in accordance with paragraph 3, the authority shall, within 30 days of the completion of the Community procedure in accordance with Art. 17
p.(None): of Directive 2001/18 / EC to renew the approval if
p.(None): 1. Neither the European Commission nor a member state of the European Union raised a reasoned objection to the placing on the market
p.(None): has or any open questions have been clarified with the European Commission and the Member States concerned, or
p.(None): 2. in the event of an objection from the European Commission or a Member State after carrying out the procedure pursuant to Article 30 (2) of the Directive
p.(None): 2001/18 / EG a positive decision of the European Commission or the Council has been made. Otherwise the authority has the further placing on the market
p.(None): Prohibit bringing the product.
p.(None): (5) The period of renewal of the authorization may be subject to a need to review the effects of the product
p.(None): limited to security (§ 1 Z 1). In principle, the time limit should not exceed 10 years, but it can be shorter in justified cases
p.(None): or be longer.
p.(None): (6) In the case of a negative evaluation report in accordance with paragraph 3, which also results from the Community law procedure in accordance with Article 17 of the Directive
p.(None): 2001/18 / EC is not invalidated, the authority must prohibit the further placing on the market of the product.
p.(None): (7) Until the final decision on an application in accordance with paragraph 1, the product may continue in accordance with the conditions of the original approval
p.(None): be placed on the market.
p.(None): (8) Section 58a applies mutatis mutandis.
p.(None): monitoring obligation
p.(None): Section 58c. (1) The license holder is responsible for carrying out a surveillance in accordance with the approval in Section 58a or, if applicable, in the
p.(None): Renewal of the approval according to § 58b prescribed monitoring plan and responsible for the corresponding reporting to the authority.
p.(None): The authority has to forward the reports to the European Commission and the other member states of the European Union. It has the results of
p.(None): Make surveillance accessible to the public on their website.
p.(None): (2) The authority can, based on the reports in accordance with paragraph 1, to avoid adverse consequences for security (§ 1 Z 1) within the scope of the approval
p.(None): or the renewal of the permit change the surveillance plan.
p.(None): statutory authorization
p.(None): Section 58d. The Federal Minister of Health and Women has, insofar as this is in order to clarify the monitoring obligations of the license holder and to
p.(None): Avoiding adverse effects on safety (§ 1 Z 1) is necessary, taking into account Annex VII of Directive 2001/18 / EC and the
p.(None): guidelines supplementing this appendix after consulting the responsible scientific committee of the genetic engineering commission in agreement with the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of Education, Science and Culture by ordinance
p.(None): to lay down further provisions for the preparation and implementation of the monitoring plan.
p.(None): Change of approval
p.(None): Section 58e. Does the authority receive new information after the approval in accordance with Section 58a or after a renewal of the approval in accordance with Section 58d
p.(None): Circumstances according to which the product authorized to be placed on the market could jeopardize safety (Section 1 (1)) will lead it within 60 days
p.(None): Information including any reasoned suggestions for a change or cancellation of the approval to the European Commission for the purpose
p.(None): Initiation of a procedure pursuant to Article 20 (3) of Directive 2001/18 / EC. According to the results of this procedure, the authority has the conditions
p.(None): change the approval or renewal of the approval or revoke the approval or renewal of the approval.
p.(None): scope of authorization
p.(None): Section 59. The supply and use of products (Section 54 (1)), the placing on the market of which is authorized in accordance with this Federal Act, requires in
p.(None): Within the scope of this approval, no further approval under this federal law.
p.(None): Temporary bans or restrictions
p.(None): Section 60. (1) Has the authority after granting a license or renewing a license based on new or additional information
p.(None): or based on a re-evaluation of existing information on the basis of new or additional scientific knowledge justified reason for
p.(None): The Federal Minister of Health and. Can assume that the product approved for placing on the market poses a risk to safety (§ 1 no. 1)
p.(None): Women after placing on the market the responsible scientific committee of the genetic engineering commission by regulation
p.(None): Temporarily restrict or prohibit the use of this product in Austria.
p.(None): (2) The Authority shall immediately inform the European Commission, the other Member States of the European Union and the public of the
p.(None): Measures taken according to paragraph 1 and their justification. The authority complies with those in the Community procedure pursuant to Art. 30 Para
p.(None): 2001/18 / EG bound by these measures decisions of the European Commission or the Council.
p.(None): Safety measures
p.(None): Section 61. In cases of imminent danger to security (Section 1 (1)), the Federal Minister of Health and Women has the manufacturer or importer through
p.(None): To notify the public concerned about the risks posed by the products and about safety and elimination measures
p.(None): inform and, if necessary, request the return of these products.
p.(None): Packaging and labeling
p.(None): Section 62. (1) Products in accordance with Section 54 may only be placed on the market if their labeling and packaging comply with the approval requirements
p.(None): stipulated requirements. In any case, the marking must contain:
p.(None): 1. the commercial name of the product,
p.(None): 2. the express reference that the product contains genetically modified organisms (Section 58a (1) no. 6),
p.(None): 3. the exact name of the GMO (s), including the identification code (s) provided for the GMO in question,
p.(None): 4. Name and address of the person responsible for the placing on the market in the Community (manufacturer, importer or distributor) and
p.(None): 5. the reference to the registration of the product or the GMO (s) contained therein in the designated register of the European Commission
p.(None): in accordance with Art. 31 Para. 2 of Directive 2001/18 / EC including information about the possibility of access to this register.
p.(None): (2) The Federal Minister of Health and Women, insofar as this is with regard to the safe use of products in accordance with Section 54 (1) or therefrom
...
p.(None): Genetic engineering commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry, Environment and Water Management, the
p.(None): Federal Minister of Economics and Labor and the Federal Minister of Education, Science and Culture more detailed provisions on the labeling of the according
p.(None): Section 62a of the GMO provided.
p.(None): Unintentional presence of GMOs in other products
p.(None): Section 62c. (1) Anyone who places products on the market (Section 54 (1)) is obliged to take special care to ensure that, particularly in the case of sales,
p.(None): Transport, storage, use and processing a mixture of the GMOs contained in the products with goods that are not intended to be GMOs
p.(None): may contain is avoided.
p.(None): (2) The other provisions of III. Section relating to the release of GMOs and the placing on the market of products are traces on products
p.(None): contain a GMO not authorized in the EEA or a combination of such GMOs up to a threshold of 0.1%, if the
p.(None): Presence of the GMO (s) is unintentional or technically unavoidable.
p.(None): (3) Deviating from para. 2 is until April 18, 2007 on the placing on the market of a product that is for direct use as food or
p.(None): Feed or for processing and contains traces of a GMO not yet authorized in the EEA or a combination of such GMOs that III.
p.(None): Section of this Federal Law does not apply if
p.(None): 1. the proportion of such GMOs in the product does not exceed the threshold of 0.5%,
p.(None): 2. the presence of the GMO (s) is unintentional or technically unavoidable,
p.(None): 3. regarding the GMO (s) by the responsible scientific committee of the European Commission or by the European authority for
p.(None): Food safety a positive opinion was given before April 18, 2004,
p.(None): 4. a relevant application for authorization to place it on the market has not been rejected in the relevant Community procedure and
p.(None): 5. the detection methods for the GMO (s) are publicly available.
p.(None): (4) Section 62 does not apply to products that contain traces of GMOs authorized in the EEA, provided these products are for direct processing
p.(None): the proportion of such GMOs does not exceed a threshold of 0.9% and this proportion is unintentional or technically unavoidable.
p.(None): (5) To determine that the presence of GMOs is unintentional or technically unavoidable, the person who places a product on the market or
p.(None): has demonstrated, at the request of the authority or the supervisory bodies, that appropriate measures have been taken to ensure the existence of the or
p.(None): to avoid GMOs.
p.(None): (6) The Federal Minister for Health and Women is authorized to implement implementing decisions in the regulatory committee procedure in accordance with
p.(None): Directive 2001/18 / EC or Regulation (EC) № 1829/2003, the threshold values specified in paragraphs 2 to 4 are taken into account by regulation
p.(None): to adapt security (§ 1 Z 1) to the state of the art in science and technology. With the coming into force of a regulation regulating this subject
p.(None): corresponding provisions of paragraphs 2 to 4 are invalid.
p.(None): (7) The analyzes to determine whether the threshold values in accordance with paragraphs 2 to 4 have been exceeded must be carried out according to procedures for the examination and sampling
p.(None): that have been published as national or international standards or by national or international working groups, preferably by the
p.(None): Community reference laboratory of the European Commission have been validated. If such procedures are not available, other methods may only be used
p.(None): if they are suitable for the application and have been validated for them in comparative studies.
p.(None): (8) Threshold values for the unintentional or technically unavoidable presence of GMOs in products according to seed law,
p.(None): food or feed law regulations or directly applicable European Union legislation
p.(None): not affected by paragraphs 2 to 6.
p.(None): Social intolerance
p.(None): Section 63. (1) Social intolerance of products according to Section 54 (1) exists if it can be assumed on the basis of factual bases that such
p.(None): Products could lead to an unbalanced burden on society or social groups, and if this burden for the
p.(None): Society appears unacceptable for economic, social or moral reasons.
p.(None): (2) The Federal Government shall, on the proposal of the Federal Minister for Health and Women, place such products on the commercial market in accordance with
p.(None): To prohibit section 54 (1) by ordinance, the placing of which on the market suggests a social intolerance.
p.(None): (3) After hearing the Genetic Engineering Commission, the Federal Minister for Health and Women must submit a proposal in accordance with paragraph 2 as soon as
p.(None): It is foreseeable that such products could be commercially placed on the Austrian market.
p.(None): Restriction of GMO approval
p.(None): Section 63a. (1) The Federal Minister of Health may, during the procedure for the authorization of a specific GMO in accordance with Directive 2001/18 / EC or the
p.(None): Regulation (EC) № 1829/2003 or during the renewal of a consent or authorization the applicant / applicant by way of European
p.(None): Commission to do so that the geographical scope of the written consent or approval is changed so that the federal territory
p.(None): is totally or partially excluded from cultivation.
p.(None): (2) The Federal Minister of Health has an appointment pursuant to Paragraph 1 no later than 45 days after forwarding the assessment report pursuant to Art. 14
p.(None): Paragraph 2 of Directive 2001/18 / EC or after receipt of the opinion of the European Food Safety Authority in accordance with Art. 6 Paragraph 6 and Art. 18 Paragraph 6
p.(None): Regulation (EC) № 1829/2003 of the European Commission for forwarding to the applicant or applicant and the other Member States
p.(None): to transfer.
p.(None): (3) If there is no confirmation of the geographical scope of the original application or within 30 days of the submission of the request
p.(None): of the original application, the adjustment of the geographical scope of the application or the application is based on the
p.(None): Directive 2001/18 / EC granted written consent and, if appropriate, by a decision in accordance with Art. 19 of Directive 2001/18 / EC and by a
p.(None): Decision on approval in accordance with Articles 7 and 19 of Regulation (EC) No. 1829/2003 implemented.
p.(None): (4) Should all or part of the federal territory be returned to the geographical scope of the approval / approval of which it was previously in accordance
p.(None): Paragraph 3 has been excluded, the Federal Minister of Health has made a request to the competent authority, the
p.(None): has given written consent in accordance with Directive 2001/18 / EC, or to the European Commission if the GMO according to Regulation (EC) № 1829/2003
p.(None): was allowed to judge.
p.(None): (5) Measures adopted under this provision do not affect the free movement of GMOs as or in products.
p.(None): IV. SECTION
p.(None): Genetic analysis and gene therapy in humans
p.(None): Prohibition of interference in the genetic material of the human germline
p.(None): Section 64. For interventions in the human germline, the prohibition of Section 9 (2) of the Reproductive Medicine Act applies, Federal Law Gazette No. 275/1992.
p.(None): Genetic analysis in humans for medical purposes
p.(None): Section 65. (1) Genetic analyzes on humans for medical purposes may only be carried out according to the state of the art in science and technology. she
p.(None): are divided into four types:
p.(None): 1. Type 1 is used to determine an existing illness, to prepare a therapy or to control a course of therapy and is based on statements
p.(None): about specific somatic changes in number, structure, sequence or their specific chemical modifications of chromosomes, genes or
p.(None): DNA segments
p.(None): 2. Type 2 is used to determine an existing disease that is based on a germline mutation
p.(None): 3. Type 3 is used to determine a predisposition to an illness, in particular the predisposition to a possibly emerging one
p.(None): genetic disease or determination of a carrier status, for which according to the state of the art in science and technology prophylaxis or
p.(None): Therapy is possible
...
p.(None): Initiation of a specialist trained in human genetics / medical genetics or a treating or responsible for the indication area
p.(None): diagnosis specialist.
p.(None): (2) The approval is to be given by the head of the facility in which such genetic analyzes are intended to be carried out to the Federal Minister for
p.(None): Apply for health and women.
p.(None): (3) Approval is granted by the Federal Minister of Health and Women after consulting the responsible scientific committee - if necessary
p.(None): under the definition of suitable conditions and conditions - to be given if, due to the personnel and material equipment, the state of
p.(None): Science and technology appropriate execution of the genetic analyzes and the protection of the resulting genetic data according to § 71
p.(None): is ensured.
p.(None): (4) The Federal Minister of Health and Women must revoke the admission if the conditions for its granting are no longer met
p.(None): or if there are serious deficiencies, otherwise suitable requirements, combined with the order to be imposed, until the fulfillment of these requirements, no genetic requirements
p.(None): Conduct analyzes in accordance with section 65 (1) 3 or 4 more.
p.(None): Head of the facility and laboratory manager
p.(None): Section 68a. (1) The head of the facility must appoint a laboratory manager for each facility for performing genetic analyzes of type 2, 3 or 4.
p.(None): This may be the same as the head of the facility. The head of the facility has the laboratory head of the authority, including the person appointed for the person
p.(None): to provide the necessary evidence (para. 2) in writing.
p.(None): (2) The laboratory manager must
p.(None): 1. be a specialist in human genetics / medical genetics or for medical-chemical laboratory diagnostics, or
p.(None): 2. a university degree from a scientific subject, which includes training in molecular genetics or molecular biology, and
p.(None): have at least two years of experience in molecular genetic studies on humans, or
p.(None): 3. via specialist training that includes training in human genetics / medical genetics and at least two years of experience with
p.(None): molecular genetic studies in humans, or
p.(None): 4. If it is limited to genetic analyzes in the context of a special medical subject, the required for this special subject
p.(None): Specialist training and at least two years of experience in the field of molecular genetic testing in humans.
p.(None): (3) The laboratory manager is responsible for the ongoing instruction of the employees and the management and supervision of the implementation of the genetic analyzes. He has
p.(None): to take the data protection and quality assurance measures suitable for the laboratory, in particular participation in proficiency tests, and for them
p.(None): To ensure compliance. If the proficiency test was not offered at the time of admission to the institution (Section 68 (3)), he would regularly do so in
p.(None): to inquire with the authority no more than six months apart whether suitable round robin tests are already available.
p.(None): (4) If the laboratory manager leaves this function or his order is canceled by the manager of the facility, a new laboratory manager is immediately
p.(None): to order.
p.(None): (5) The head of the facility shall notify the authority of the resignation and each change of the laboratory head without undue delay, including that for the head of the
p.(None): The replacement person appointed to the facility must be notified in writing of the necessary evidence (para. 2).
p.(None): (6) The appointment of a laboratory manager increases the responsibility of the head of the facility for compliance with the provisions of this federal law
p.(None): and the administrative file based on it.
p.(None): Consent and advice
p.(None): Section 69. (1) A genetic analysis of type 2, 3 or 4, including a genetic analysis as part of a prenatal examination, may only be carried out after
p.(None): There is a written confirmation from the person to be examined that they have previously been through a human genetics / medical genetics
p.(None): trained specialist or a specialist responsible for the indication area has been informed about their nature, scope and significance and
p.(None): has consented to genetic analysis based on free knowledge based on this knowledge. These exams become prenatal
p.(None): carried out, the information and consent of the pregnant woman must also include the risks of the intended intervention.
p.(None): (2) The confirmation acc. Paragraph 1 granted
p.(None): 1. for an underage person, according to § 173 ABGB,
p.(None): 2. a legal guardian for a minor who is unable to make decisions and
p.(None): 3. for a person of legal age who is not able to make a decision, their legal representative (Section 1034 ABGB), in whose sphere of activity consent to
p.(None): medical treatment falls.
...
p.(None): related advice is required, taking into account the current state of science and technology after consulting the
p.(None): responsible scientific committee of the genetic engineering commission by ordinance more detailed regulations on the personnel and material equipment of the
p.(None): Facilities according to § 68, including the qualification of the responsible laboratory manager according to § 68a, the initiation of the genetic analyzes according to § 68
p.(None): Paragraph 1, the information and advice to be issued in accordance with section 69, data protection in accordance with section 71 and the documentation of the test results in accordance with section 71a
p.(None): prescribe.
p.(None): (2) The Federal Minister of Health and Women has sufficient experience with safety according to the state of the art in science and technology (§ 1
p.(None): Z 1) certain genetic analyzes are available, after hearing the responsible scientific committee of the genetic engineering commission by ordinance
p.(None): more detailed provisions on the use of simplified official procedures for further applications for an application already approved in accordance with Section 68 (3)
p.(None): To establish the facility taking into account established methods and established indication areas. In deviation from Section 91, these procedures may include:
p.(None): official decision only with referral of the rapporteur, and provide for a shortening of the decision period to up to 30 days.
p.(None): Announcements
p.(None): Section 73. The head of a facility in accordance with Section 68 has the authority all essential with regard to the implementation of genetic analyzes of type 3 or 4
p.(None): Changes in the material and staffing of the approved facility immediately, as well as a summary of those in this facility
p.(None): genetic reports of type 3 or 4 carried out using the form (Appendix 2) for the past year, beginning on February 1, 2006.
p.(None): Somatic gene therapy
p.(None): § 74. Somatic gene therapy in humans may only be based on the state of the art in science and technology
p.(None): 1. for the purpose of therapy or the prevention of serious illnesses in humans or
p.(None): 2. to establish suitable procedures in the context of a clinical trial (§ 76)
p.(None): and only be carried out if, according to the state of the art in science and technology, it can be excluded that a change in the
p.(None): Genetic material of the germline takes place. According to the current state of science and technology, the risk of a change in the genetic material of the germ line is not complete
p.(None): to exclude, somatic gene therapy may only be used if this risk increases from that of the use of somatic gene therapy
p.(None): expected benefit for the health of this person is outweighed, and only for people who are certain to have no offspring; Cells of the
p.(None): The germline of a person treated in this way must not be used to produce embryos outside a woman's body.
p.(None): Implementation of somatic gene therapy - official procedure and decision
p.(None): Section 75. (1) Somatic gene therapy in humans may only be carried out by a doctor in a hospital and only after approval in accordance with paragraph 3
p.(None): be performed.
p.(None): (2) The approval must be obtained from the medical director of the hospital in which the use of somatic gene therapy is intended, together with the
...
p.(None): are at risk of endangering the health of the person treated with this gene therapy or of the personnel involved in the gene therapy, or of the environment.
p.(None): He has chosen to assist a person with at least two years of experience in the field of security measures
p.(None): (§ 1 Z 1) to use, unless he himself has such experience.
p.(None): (2) The responsible doctor has to immediately inform the Federal Minister of Health and Women in writing or
p.(None): communicated by telex. The Federal Minister of Health and Women then dealt with the scientific committee for genetic
p.(None): Analyzes and gene therapy in humans according to the expected or already identified risk to the health of the somatic
p.(None): Gene therapy treated people to issue or carry out the necessary tasks to prevent this danger
p.(None): Restrict or prohibit gene therapy.
p.(None): Application of legislation
p.(None): Section 78. (1) The implementation of somatic gene therapy on humans is not subject to the regulations of II. And III. Section of this federal law.
p.(None): (2) A clinical trial conducted in accordance with this Federal Act is deemed to be a clinical trial in accordance with the Medicinal Products Act.
p.(None): Announcements
p.(None): Section 78a. (1) The doctor responsible for performing a somatic gene therapy (Section 75 (1)) has the actual start of a somatic
p.(None): Report gene therapy, its course, the number of people treated and the time of termination using the form (Annexes 3 and 4) to the authority.
p.(None): (2) The medical director of the hospital has all the essentials for the implementation of somatic gene therapy in humans
p.(None): To notify the authority immediately of any changes in the material and staffing of the approved hospital.
p.(None): register
p.(None): Section 79. (1) The Federal Minister of Health and Women must set up electronic registers in which all are permitted under this Federal Act
p.(None): 1. facilities for performing genetic analyzes (genetic analysis registers),
p.(None): 2. Somatic gene therapies on humans (gene therapy register) and
p.(None): 3. Proficiency tests offered (proficiency testing register)
p.(None): are recorded.
p.(None): (2) In the genetic analysis register, the name, address, homepage and the area of activity of the institution, which is structured according to the investigations carried out
p.(None): to lead.
p.(None): (3) The name, address, homepage and area of activity of the institution must be recorded in the gene therapy register. The area of activity is by means of study title, name
p.(None): of the study director, and to describe the indication. The therapeutic genes and gene transfer systems used, as well as course and are for each gene therapy
p.(None): Show the final report separately in a non-public part of the register.
p.(None): (4) The Federal Minister of Health and Women has the data in accordance with paragraphs 2 and 3 taking into account any changes to be included
p.(None): of reporting obligations according to Section 73 (1) or Section 78a (1) (in particular history and final report) to be transferred to the register.
p.(None): (5) The registers must be updated continuously.
p.(None): (6) The published data must not contain any identifiable information about the persons treated. Everyone has access to the registers
...
p.(None): who cooperated with the will in the activity pursuant to Section 79a, insofar as this participation was the cause of the damage.
p.(None): (3) If the injured party or someone whose behavior he is responsible for is at fault, § 1304 ABGB shall apply mutatis mutandis.
p.(None): Other claims for compensation
p.(None): Section 79i. Provisions of the general civil code and other regulations, according to which damage to other extent or by others
p.(None): Persons who are to be replaced under this federal law remain unaffected.
p.(None): financial security
p.(None): Section 79j. (1) The operator of an activity pursuant to Section 79a has to a degree and to the extent that is customary in fair business dealings by entering into
p.(None): insurance or in any other suitable way to ensure that liability for damages according to this section can be fulfilled. Consists
p.(None): the activity in work with GMOs of security level 3 on a large scale or in the release of GMOs on a small scale (§ 36 Paragraph 1 No. 1), must
p.(None): in any case, this provision consists of liability insurance with an insurance sum of at least 712 200 euros for each damage event. Consists
p.(None): If you are working on GMOs of security level 4 or releasing GMOs to a large extent (Section 36 Paragraph 1 No. 2), this precaution must be taken
p.(None): at least in liability insurance with an insured sum of at least 4 069 700 euros for each damage event. The
p.(None): Liability insurance must be taken out with an insurer authorized to operate this insurance branch in Austria; on that must
p.(None): Austrian law must be applied. The competent body within the meaning of Section 158c (2) Insurance Contract Act 1958 is the authority under Section 100.
p.(None): (2) There is no obligation to provide cover if the federal government or a state is an operator.
p.(None): Claims against neighbors
p.(None): Section 79k. (1) The owner or beneficiary of an agricultural property can be a neighbor who is on his property
p.(None): Grows products within the meaning of section 54 (1) and is obliged to register in a register in accordance with section 101c (2) based on these products
p.(None): Prohibit actions if these actions exceed what is customary according to the local conditions and the use of the affected
p.(None): Affect property significantly. Such impairment exists in any case if the owner or the person entitled to use the products
p.(None): cannot place his property on the market due to the effects or not in the manner intended by him.
p.(None): (2) The neighbor who caused an influence in the sense of paragraph 1 is liable to the property owner or the person entitled to use it for the replacement of the
p.(None): this damage caused thereby, including the costs of restoring the environment (Section 79b).
p.(None): (3) If several neighbors have caused an influence in the sense of paragraph 1, each of them is only liable for its share in that
p.(None): Damage inflicted on property owners or beneficiaries. If the proportions cannot be determined, the neighbors are liable to the undivided hand.
...
p.(None): c) a doctor - the three medical universities in Austria have the right to propose,
p.(None): d) a person familiar with environmental problems - the Federal Environment Agency has the right to propose,
p.(None): e) a representative to be proposed by the Austrian Working Group on Rehabilitation.
p.(None): (2) The members of the commission are from the Federal Minister of Health and Women on the basis of the proposals in accordance with paragraph 1 for a period of five years
p.(None): to order. A substitute member must be appointed for each member - also for five years; the right to propose exists in the same way as for the
p.(None): representing members.
p.(None): Chairman
p.(None): § 82. The chair of the commission is the representative of the Federal Ministry of Health and Women, the deputy chair is the representative
p.(None): of the Federal Ministry of Education, Science and Culture.
p.(None): decision-making
p.(None): § 83. (1) The commission has a quorum if at least half of the members entitled to vote, at least half of the members according to
p.(None): Section 81 (1) 3 to 6 is present.
p.(None): (2) All members of the commission with the exception of the chair have a casting vote. Substitute members only have such voting rights
p.(None): Prevention of the person they represent and when that person chairs it. The commission decides by simple majority. In the event of a tie
p.(None): the view that the chairman agrees with is accepted.
p.(None): Responsibilities of the commission
p.(None): § 84. The tasks of the commission are in particular
p.(None): 1. advising the authority on fundamental questions relating to the applications of genetic engineering, insofar as they are not within the scope of scientific work
p.(None): Committees fall
p.(None): 2. the passing of resolutions on proposed sections of the genetic engineering book in accordance with section 99 (3) and
p.(None): 3. the preparation of the report on the application of genetic engineering (Section 99 (5)).
p.(None): Standing scientific committees
p.(None): Section 85. (1) The Federal Minister for Health and Women has scientific committees of the Commission
p.(None): 1. a scientific committee for working with GMOs in a closed system,
p.(None): 2. a scientific committee on releases and placing on the market and
p.(None): 3. Establish a scientific committee for genetic analysis and gene therapy in humans.
p.(None): (2) The members of the scientific committees are approved by the Federal Minister of Health and Women on the basis of the proposals in accordance with Sections 86 to 89
p.(None): to be ordered for a period of five years. A replacement member must be appointed for each member - also for a period of five years; the nomination right for this consists of
p.(None): same way as for the members to be represented.
p.(None): Tasks and composition of the scientific committee for working with GMOs in a closed system
p.(None): Section 86. (1) The scientific committee for working with GMOs in a closed system is responsible for assessing registrations and applications for
p.(None): Working with GMOs in accordance with Section II, submitting opinions in the determination procedure in accordance with Sections 7, 9 (3), 10 (3) and 26 (2) and the
p.(None): Preparation of sections of the genetic engineering book and the submission of comments on draft regulations in accordance with this federal law
...
p.(None): to be publicly advertised. In addition, the President of the Austrian Academy of Sciences can change these positions in other ways, depending on the fi nancial coverage of the costs
p.(None): advertise appropriately. The application and proposal deadline must be at least three weeks.
p.(None): (4) Simultaneously with the submission of the nominations in accordance with paragraph 1 and the tripartite proposals in accordance with paragraph 2, the Federal Minister of Health and
p.(None): Women a list of all applications and tripartite proposals received on the basis of the public tender in accordance with Paragraph 3, as well as a reason for their
p.(None): Submit creation.
p.(None): (5) This list of all applications received on the basis of the public tender in accordance with paragraph 3, the nominations and tripartite proposals of the ÖAW
p.(None): as well as the reasons for their creation can be found in the appendix to the next report on the use of genetic engineering in accordance with Section 99 (5)
p.(None): publish.
p.(None): Chair of the scientific committees
p.(None): § 90. The Federal Minister of Health and Women has an employee of his Federal Ministry for each scientific committee
p.(None): Appoint chairperson; he has an advisory voice. If the Chairman is unable to attend, the Federal Minister of Health and Women has
p.(None): to ensure its representation.
p.(None): Decision-making in the scientific committees on applications and applications
p.(None): Section 91. (1) The competent scientific committee has the authority in the case of applications and applications for work with GMOs in accordance with Section II
p.(None): and in the case of applications for the release of GMOs into the environment and applications for the placing on the market of products in accordance with III. section
p.(None): within ten days of the referral by the authority, in cases where a hearing has to take place within ten days of the end of the hearing, and
p.(None): in the case of applications relating to genetic analysis and somatic gene therapy in humans in accordance with Section IV, at the latest within 20 days of referral
p.(None): to submit a reasoned opinion on the registration or the application in writing by the authority.
p.(None): (2) To prepare the opinion of the scientific committee, two selected according to the provisions of the rules of procedure
p.(None): Rapporteur made a proposal for the opinion to be delivered. The scientific committee decides by simple majority. The vote can also
p.(None): in writing; if no report is accepted in this way up to four days before the deadlines specified in Paragraph 1, the Chairman shall
p.(None): in any case to convene a meeting.
p.(None): (3) If the scientific committee does not adopt an opinion within the time limits specified in paragraph 1, the rapporteurs shall propose it
p.(None): and immediately present the minutes of the meeting to the authority.
p.(None): Consultation of the Commission and its scientific committees
p.(None): § 92. (1) The meetings of the commission and its scientific committees are to be scheduled by the chairman in such a way that the authority is legally responsible
p.(None): can perform the tasks assigned on time.
p.(None): (2) The meetings and votes of the Commission and its scientific committees are not public. The applicant or applicant can:
p.(None): Information can be loaded.
p.(None): (3) The results of the meetings are to be recorded in writing in a protocol; this must be the result of the vote, the reasoning, the
p.(None): Voting ratio and any minority votes at the request of the member remaining in the minority. The Scientific Committee
p.(None): no expert opinion accepted (section 91 (3)), the minutes also include statements made by individual members of the scientific committee on the
p.(None): Registration or the application to include.
p.(None): (4) The chairpersons of the scientific committees shall invite all members of their committee to meetings if the following
p.(None): Items to be advised or decided:
p.(None): 1. Preparation of sections of the genetic engineering book (§ 99),
p.(None): 2. Comments on draft regulations,
p.(None): 3rd activity report (Section 93 (1)),
p.(None): 4. Posting the representatives to the Genetic Engineering Commission (section 81 (1) 3).
p.(None): reporting requirements
p.(None): § 93. (1) The permanent scientific committees have to write to the Commission on March 1st of each year a report on the activity
p.(None): to transmit past calendar year.
p.(None): (2) The activity report has a summary of those in the reporting period
p.(None): 1. statements of the expert opinions important for safety (§ 1 Z 1),
p.(None): 2. Work carried out to prepare certain sections of the genetic engineering book and
p.(None): 3. treated technical problems
p.(None): to contain.
...
p.(None): To publish the Federal Law Gazette. The Federal Minister of Health and Women can refrain from issuing regulations or from him
p.(None): Enforcement of the above-mentioned regulations if and insofar as the Genetic Engineering Book is sufficiently clear about the regulations contained therein
p.(None): Has created principles to be observed and the intended regulatory purpose is ensured by the genetic engineering book.
p.(None): (5) On the basis of the reports submitted to it by the standing scientific committees (Section 93 (3)), the Commission has three years
p.(None): Distances for the first time in 1998 - to produce a report that is a summary
p.(None): a) the work carried out in Austria with GMOs in closed systems,
p.(None): b) the release of GMOs and the placing on the market of products in Austria in accordance with III. Section and
p.(None): c) on general matters of genetic analyzes and gene therapies on humans carried out in Austria
p.(None): has to contain. The Commission has to assess and observe the developments observed with regard to compliance with the principles set out in § 3
p.(None): to examine and present the educational and research policy and economic consequences of the observed development for Austria. This
p.(None): Report is from the Federal Minister of Health and Women in agreement with the Federal Minister of Education, Science and Culture with an attached
p.(None): Present the measures they have taken to promote security research (Section 102) to the National Council.
p.(None): VI. SECTION
p.(None): Authority, controls
p.(None): authorities jurisdiction
p.(None): Section 100. (1) Authority within the meaning of this Act
p.(None): 1. With regard to working with GMOs in a closed system and the release of GMOs - insofar as these are in scientific universities or in
p.(None): scientific institutions of the federal government in its department or through them - the Federal Minister of Education, Science and Culture,
p.(None): 2. the Federal Minister for Health and Women.
p.(None): (2) The competent authority for the measures according to § 109 is the district administrative authority.
p.(None): (3) Without prejudice to the responsibilities under paragraph 1, the Federal Minister of Agriculture, Forestry, Environment and Water Management, insofar as this is the
p.(None): Perception of his competencies in the field of environmental protection and agricultural resource law is required in the
p.(None): Community law procedures in accordance with Directive 2001/18 / EC and Regulation (EC) № 1829/2003. The Federal Minister of Health
p.(None): and women has given the Federal Minister of Agriculture, Forestry, Environment and Water Management the necessary information obtained through these procedures
p.(None): Submit documents.
p.(None): Community law directly applicable
p.(None): § 100a. (1) The following legal provisions are to be implemented within the framework of this Federal Act:
p.(None): 1. Regulation (EC) No. 1946/2003 of July 15, 2003 on cross-border movements of genetically modified organisms
p.(None): 2. Regulation (EC) № 1829/2003 of September 22, 2003 on genetically modified food and feed, as far as it is not substances and
p.(None): Products that are placed on the market and controlled by the Food Safety and Consumer Protection Act - LMSVG or the
p.(None): Feed Act is regulated.
p.(None): 3. Regulation (EC) № 1830/2003 of September 22, 2003 on the traceability and labeling of genetically modified organisms and on
p.(None): the traceability of food and feed produced from genetically modified organisms and to amend the directive
p.(None): 2001/18 / EG, as far as it is not a matter or products, their placing on the market and control by the food safety and
p.(None): Consumer protection law - LMSVG, the feed law, the fertilizer law, the seed law, the plant law, the vine traffic law
p.(None): or the Forest Propagation Act is regulated.
p.(None): (2) Competent authority for the implementation of Regulation (EC) № 1946/2003 on cross-border movements of genetically modified
p.(None): Organisms are the authority according to § 100 paragraph 1. National contact point for contact with the secretariat of the Convention on Biosafety
p.(None): and the information point on biosafety in accordance with Articles 19 and 20 of the Protocol on Biosafety is the Federal Environment Agency.
p.(None): (3) The implementation of Regulation (EC) No. 1829/2003 on genetically modified food and feed is incumbent on
p.(None): 1. for substances and products that fall within the scope of the Food Safety and Consumer Protection Act - LMSVG, the Federal Minister
p.(None): for health and women
p.(None): 2. for substances and products that fall within the scope of the Feed Act, the Federal Minister of Agriculture, Forestry, Environment and
p.(None): Water management.
p.(None): (4) The authority responsible for receiving applications in accordance with Articles 5, 17 and 27 of Regulation (EC) No 1829/2003
p.(None): 1. for applications for approval as a genetically modified food and for applications for joint approval as a genetically modified food and
p.(None): Feed of the Federal Minister of Health and Women
p.(None): 2. the Federal Office for Food Security for applications for approval as genetically modified feed.
p.(None): Controls, restoration of the environment
p.(None): Section 101. (1) The organs of the authority are authorized in places where there is reason to believe that
p.(None): 1. work with GMOs is carried out,
p.(None): 2. GMOs are released,
p.(None): 3. products are placed on the market in accordance with section 54 (1),
p.(None): 4. genetic analyzes are carried out on humans in accordance with § 65 or the data obtained is processed and stored in an automated manner
p.(None): become, or
p.(None): 5. gene therapies are carried out on humans,
p.(None): To keep an eye on and for the purpose of checking compliance with the provisions of this federal law and those based on this federal law
p.(None): decrees and notices to be carried out, to inspect the records to be kept in accordance with sections 34 and 52, and
p.(None): Take samples to the extent necessary.
p.(None): (2) Except in the event of imminent danger, the review is during normal business or operating hours and with the involvement of a responsible person
p.(None): Employees. Care should be taken to ensure that any disruption or disability of the operator or anyone that is not absolutely necessary
p.(None): interference with third party rights that is not absolutely necessary is avoided.
p.(None): (3) The operator and anyone who places GMOs on the market must tolerate the controls and sampling to provide the necessary support
p.(None): to provide all information necessary for inspection and sampling and all aids necessary for the investigation and monitoring measures
p.(None): and to provide information, such as in particular probes - if available -, sequence information and the like.
p.(None): (4) In the event of a sample being taken, a cross-check should be carried out if possible. A request from the authority is available for the sample taken
p.(None): determining compensation in the amount of the material value to be paid by the federal government. Compensation does not apply if, on the basis of this sample, a specific person
p.(None): has been punished or if the authority determines by decision that - without a specific person being punished - the objective fact of a person
p.(None): Violation of this federal law has been implemented and the taking of the sample has contributed to the collection of this fact.
p.(None): (5) The authority may, insofar as economy, expediency and economy require it, carry out controls in accordance with paragraph 1 nos. 2 and 3
p.(None): including the control of compliance with the monitoring obligations in accordance with Section 58c, also external experts or expert institutions in accordance with
p.(None): All or part of their respective tasks. The Federal Environment Agency is particularly entitled to environmental control tasks
p.(None): take (Section 6 (4) of the Environmental Control Act).
p.(None): (6) The assignment in accordance with Paragraph 5 and the dismissal must be made with notice. The assignment requires the approval of the representative. in the
p.(None): Notification of the commission are the local and factual scope of the control, the intended remuneration and that for the flawless implementation of the
p.(None): Control activities to determine the necessary conditions and requirements. No employment relationship is established through the assignment. The representative is at
p.(None): Instructions bound by the authority. A dismissal has to take place in particular if the agent does not or only insufficiently fulfills his tasks, or
p.(None): the requirements under which the order was placed no longer apply.
p.(None): Restoring the environment
p.(None): Section 101a. (1) When working with GMOs or when releasing them, the environment is affected by the properties of the GMOs, which are caused by genetic engineering changes
p.(None): are so significantly impaired that the security according to § 1 Z 1 is not guaranteed, the authority has the operator to that extent to restore the
p.(None): Environment or measures necessary to prevent further environmental damage. In the event of imminent danger, the authority has the
p.(None): take the necessary measures yourself (Section 103); the same applies if the operator cannot be determined or for legal or other reasons
p.(None): Is unable to carry out the necessary measures. The authority has to reimburse the operator for the costs incurred by it
p.(None): Impose measures.
p.(None): (2) If the rights of third parties are affected by measures in accordance with paragraph 1, these have such interference, in particular the use and access of
p.(None): Tolerate land to the extent that this proves to be absolutely necessary.
p.(None): (3) Anyone who takes measures in accordance with paragraph 1 of his property, his real rights, his obligatory rights of use or his rights of use in the sense
p.(None): of the Basic Law 1951, Federal Law Gazette No. 103, cannot be used in the manner or to the extent to which it is entitled on the basis of existing rights
p.(None): To compensate operators appropriately. If no agreement can be reached, the amount of the compensation must be determined by the authority,
p.(None): §§ 18 to 20a of the Federal Roads Act 1971, Federal Law Gazette No. 286, are to be applied analogously in the respectively applicable version. An appeal against that
p.(None): Deciding on the amount of compensation is not permitted. However, the parties are free to do so within three months of issuing the decision
p.(None): To apply for a decision on the amount of compensation to the district court in whose district the environmental impact has occurred. With this
p.(None): Referral to the district court will invalidate the amount of the compensation.
p.(None): Measures in the event of release without authorization
p.(None): Section 101b. (1) If a release was carried out contrary to the provision of Section 37 (1) without prior approval, the authority has the person who
p.(None): this release has carried out the removal of the released GMOs as well as any other measures that are state of the art
p.(None): and technology to ensure security (§ 1 Z 1), to keep the spread of this GMO including its genetic material and to ensure the
p.(None): released GMOs are appropriate and necessary.
p.(None): (2) The authority shall confiscate released GMOs without prior approval; Section 109 (4), second and third sentences apply to such
p.(None): To apply GMOs.
p.(None): Genetic Engineering register
p.(None): Section 101c. (1) Products according to § 54 Paragraph 1 are immediately after the approval of their placing on the market under a consecutive number
p.(None): (Genetic engineering register number) in the register kept by the Federal Minister of Health and Women (genetic engineering register).
p.(None): (2) In the genetic engineering register are the date and scope of the authorization to place the product on the market, the information in accordance with Section 62 (1) and as required
p.(None): an ordinance pursuant to Section 101e (3) the locations of approved releases and data on the locations of the cultivation of marketed and
p.(None): registered genetically modified crops.
p.(None): (3) Anyone can inspect the genetic engineering register during office hours, make copies on the spot, or as required
p.(None): Have copies of the existing technical possibilities made at his own expense. The genetic engineering register is public to the Internet
p.(None): to make it accessible.
p.(None): (4) The determination and processing of data for the purpose of automation-supported maintenance of the genetic engineering register is permitted.
p.(None): safety documentation
p.(None): Section 101d. (1) The Federal Ministry of Health is responsible for checking the safety (Section 1 (1)) of products placed on the market in accordance with Section 54 (1)
p.(None): and women a documentation center on safety-related properties and for the identification of the GMOs contained in these products
p.(None): To set up information.
p.(None): (2) The information and information required for this are submitted to the documentation center with the application for marketing authorization from
p.(None): Products (Section 54 (1)). In any case, this information must contain:
p.(None): 1. description of the product and the GMOs contained therein,
p.(None): 2. Name and address of the license holder,
p.(None): 3. A description of the product corresponding to the state of the art in science and technology with regard to the genetic modification
p.(None): caused special properties,
p.(None): 4. Description of the expected types of use and the planned spatial distribution in Austria,
p.(None): 5. intended labeling,
p.(None): 6. Instructions and recommendations for storage and handling and a description of the resulting residues and their treatment as well as the
p.(None): Emergency plans and adequate information for the identification of the GMO (in particular introduced nucleotide sequences).
p.(None): statutory authorization
p.(None): Section 101e. (1) Insofar as this is necessary to ensure the control of the safety (§ 1 Z 1) of products according to § 54 paragraph 1, the Federal Minister
p.(None): for health and women after hearing the responsible scientific committee of the genetic engineering commission in agreement with the Federal Minister
p.(None): for Agriculture, Forestry, Environment and Water Management, the Federal Minister of Economics and Labor and the Federal Minister of Science and Transport
p.(None): (Note: correct: Federal Minister of Education, Science and Culture) taking safety, expediency and completeness into account
p.(None): Information to be issued by ordinance for more detailed provisions on the content, scope and form of the information to be given to the authority in accordance with Section 57 no.
p.(None): (2) In addition, information must be included in the security documentation that the authority receives in accordance with Section 57 no. 2.
p.(None): (3) The Federal Minister of Health and Women, insofar as this is used to control the adverse effects of released GMOs and in traffic
p.(None): brought products (§ 54 para. 1) to the security (§ 1 Z 1) and for information to the public is necessary, after hearing the responsible
p.(None): Scientific Committee of the Genetic Engineering Commission by ordinance in agreement with the Federal Minister of Agriculture, Forestry and Environment
p.(None): and water management and the Federal Minister of Education, Science and Culture detailed regulations on the genetic engineering register and the therein
p.(None): data to be recorded and necessary reporting obligations, also with regard to the shared use of this data by federal and state authorities or with
p.(None): control bodies. This regulation may relate to the data on the places of cultivation for placing on the market
p.(None): Approved genetically modified crops may also be subject to the provincial governor's reporting obligation, insofar as this is due to federal or
p.(None): state law has such data; The entry into a register referred to in Section 79c (1) in accordance with Section 101c (2) is also supported by the
p.(None): official registration of this cultivation in a register kept according to state law regulations (state genetic engineering book) corresponded.
p.(None): VII. SECTION
p.(None): safety research
p.(None): Section 102. The federal ministers responsible in accordance with section 100 have, in accordance with the respective Federal Finance Act, taking into account the status of the
p.(None): Science to promote research in the field of safety in the applications of genetic engineering (interdisciplinary risk and safety research).
p.(None): VIII. SECTION
p.(None): Interim measures
p.(None): § 103. (1) Does the authority have reason to believe that immediate measures to prevent immediate threats to security (§ 1 Z 1)
p.(None): and location are required, it must take such measures, including the complete or partial decommissioning of, in accordance with the extent of the risk
p.(None): genetic engineering systems or the complete or partial cessation of work with GMOs, or releases of GMOs, even without previous
p.(None): Procedures and prior to issuing a notice on the spot; however, written notification of this must be issued within two weeks,
p.(None): otherwise the measure taken is regarded as canceled. The notice is immediately enforceable. The notice is also deemed to have been issued if it is addressed to the
p.(None): Delivery point (Section 4 Delivery Act) has been addressed, but has been returned to the authority due to non-delivery according to Section 19 of the Delivery Act.
p.(None): (2) If the requirements for issuing a decision pursuant to Paragraph 1 no longer exist, the authority has the request with the decision
p.(None): revoke the measures taken immediately.
p.(None): IX. SECTION
p.(None): The authorization expires
p.(None): Section 104. (1) The right to carry out a work or series of work with GMOs or a release expires three years after their expiry
p.(None): Registration or approval if the work or series of GMO or release work has not started within this period.
p.(None): (2) The authority may, upon request, extend the deadline in accordance with paragraph 1 for a significant reason by a maximum of one year if the security (§ 1 no. 1)
p.(None): the state of the art in science and technology is still guaranteed.
p.(None): X. SECTION
p.(None): Confidentiality of data and traffic
p.(None): Confidentiality of data in the inception process
p.(None): Section 105. (1) Data recognized by the authority as confidential shall not be made available to the public, even during the inception process.
p.(None): (2) Each applicant or operator can use the documents to be submitted by him under this Federal Act, provided that the documents contained therein
p.(None): information
p.(None): a) international relations and national defense,
p.(None): b) public security,
p.(None): c) Matters pending before the court or subject to, or subject to, preliminary proceedings (including disciplinary proceedings)
p.(None): The subject of preliminary proceedings are
p.(None): d) business and trade secrets including intellectual property,
p.(None): e) the confidentiality of personal data or files,
p.(None): f) documents that have been transmitted by a third party who was not legally obliged to do so,
p.(None): (g) information the disclosure of which would further increase the likelihood of environmental damage in the area concerned;
p.(None): touched, the data that are treated confidentially and thus should not be made available to the public even in the disclosure process. In
p.(None): In such cases, a verifiable justification must be given. After hearing the applicant or applicant, the authority decides which data as
p.(None): be recognized confidentially.
p.(None): (3) Under no circumstances may the following data be recognized as confidential:
p.(None): 1. General description of the GMO;
p.(None): 2. Name and address of the applicant or applicant;
p.(None): 3. a) Security level, containment measures and place of work with GMOs;
p.(None): b) purpose of release and place of release;
p.(None): 4. methods and plans for GMO monitoring and emergency response;
p.(None): 5. Assessment of the foreseeable effects, in particular the effects that are detrimental to safety (§ 1 no. 1).
p.(None): (4) The regulations according to paragraphs 1 to 3 on the confidentiality of data in the disclosure process also apply in relation to the others at the official level
p.(None): Procedure for authorizing a release involved.
p.(None): Transmission of data
p.(None): Section 106. The data to be disclosed to the authority in accordance with this federal law may be collected and processed by the authority. personal
p.(None): and confidential data may only be transmitted to
p.(None): 1. the departments of the federal and state governments, insofar as the data is for the recipient to enforce this federal law or other federal or
p.(None): state law provisions for the protection of human health or the environment form an essential prerequisite,
p.(None): 2. experts appointed by the authority, insofar as they require the data in order to complete this federal law,
p.(None): 3. the competent authorities of foreign countries, insofar as this is to avert a specific danger to the life or health of people or
p.(None): the environment is required, or if so provided by intergovernmental agreements.
p.(None): XI. SECTION
p.(None): Notification requirements to the European Commission
p.(None): § 107. The Federal Minister of Health and Women has the European Commission taking into account the provisions on confidentiality
p.(None): in accordance with section 105 and data traffic in accordance with section 106
p.(None): 1. As soon as possible to report all accidents when working with GMOs in a closed system and include details about the circumstances of the accident, the
p.(None): Identity and quantities of the GMOs released, the emergency measures applied and their effectiveness, as well as an analysis of the accident, including
p.(None): Provide recommendations to limit its impact and prevent similar accidents in the future,
p.(None): 2. At the end of each year, a summary report on work for approval in security levels 3 and 4 in
p.(None): closed systems, including the description, purpose and risks of the GMOs, and to be submitted every three years and at
p.(None): for the first time on June 5, 2003 a summary report on his experience with the application of the EC Directive 90/219 / EC in the version of the
p.(None): To transmit EC Directive 98/81 / EC,
p.(None): 3. communicate the official decisions in accordance with § 40,
p.(None): 4. after the end of each year, a short report on the control of the use of all those approved and placed on the market in accordance with Section 58 (5)
p.(None): To transmit products (section 54 (1)) and
p.(None): 5. to submit a report every three years, and for the first time on 1 September 1997, on the measures taken to implement Directive 90/220 / EEC.
p.(None): XII. SECTION
p.(None): Transitional, criminal and final provisions
p.(None): Transitional provisions
p.(None): Section 108. (1) At the time this Federal Act comes into force (Art. III Para. 1), work and series of work with GMOs in closed form are already taking place
p.(None): Systems are still permitted, subject to a later decision by the authority. The operators have this within twelve months from the entry into force
p.(None): Federal law to submit an application according to § 19 or an application according to § 20 to the authority.
p.(None): (2) Releases of GMOs that are already taking place at the time this Federal Act comes into force (Art. III Para. 1) are subject to a later one
p.(None): Authority decision still allowed. The operator must submit an application to the authority within twelve months of the entry into force of this federal law
p.(None): § 37 paragraph 2.
p.(None): (3) Anyone who places products on the market as a manufacturer or importer in accordance with Section 54 (1) at the time this Federal Act comes into force (Art. III (1)),
p.(None): subject to a later decision by the authority, it is still entitled to do so. He has the authority within eight months after its entry into force
p.(None): Federal law to submit an application pursuant to Section 55. If these are plant protection products, the application must be made to implement the
p.(None): Plant Protection Products Act, Federal Law Gazette No. 476/1990
p.(None): (4) Institutions in which, at the time this Federal Act comes into force (Art. III Para. 1), genetic analyzes within the meaning of Section 65 Paragraph 1 No. 1
p.(None): subject to a later decision by the authority. The head of such an institution has within
p.(None): to submit an application pursuant to Section 68 (2) to the authority twelve months after the entry into force of this Federal Act (Art. III (1)).
p.(None): (5) A hospital in which somatic gene therapies were carried out on humans at the time this Federal Act came into force (Art. III Para. 1)
p.(None): subject to a later decision by the authority. The medical directors of these hospitals have within twelve
p.(None): Months after the entry into force of this federal law, to submit an application to the authority pursuant to Section 75 (2)
p.(None): (6) If the registrations or applications in accordance with paragraphs 1 to 5 are not submitted or are not submitted on time, the authorizations expire after the expiry of the
p.(None): each specified period.
p.(None): (7) Clinical trials for the purpose of somatic gene therapy that had already begun at the time this federal law came into force (Art. III Para. 1)
p.(None): are still permitted until they are terminated. Those who conduct such clinical trials have this fact within twelve months of the entry into force
p.(None): Federal law to report to the authority in writing.
p.(None): Restrictions on the authorization of GMOs - transitional provisions
p.(None): Section 108a. (1) From April 2, 2015 to October 3, 2015, the Federal Minister of Health can register the applicant / applicant by means of the European
p.(None): Commission to request that the geographical scope of a registration or an application or an authorization, which according to the
p.(None): Directive 2001/18 / EC or Regulation (EC) No. 1829/2003 that was submitted or issued before April 2, 2015, is adjusted.
p.(None): (2) If the registration or the application has not yet been decided and the applicant / applicant has 30 days from the submission of the request
p.(None): According to Paragraph 1, the adjustment of the geographical scope of its original application or application has not been confirmed
p.(None): adapt the geographical scope of the application or application accordingly. Written consent given in accordance with Directive 2001/18 / EC
p.(None): and, if appropriate, the decision in accordance with Article 19 of Directive 2001/18 / EC and the decision on authorization in accordance with Articles 7 and 19 of the
p.(None): Regulation (EC) № 1829/2003 then takes place on the basis of the geographical scope of the application adjusted by the applicant / applicant
p.(None): or the application.
p.(None): (3) If the approval has already been granted and the holder of the approval has the geographical within 30 days of the submission of the request in accordance with Paragraph 1
p.(None): If the scope of the approval is not confirmed, the approval will be changed accordingly. With a written consent in accordance with Directive 2001/18 / EC
p.(None): the competent authority that granted the original approval changes the European one in accordance with Regulation (EC) № 1829/2003
p.(None): Commission the decision on the approval or approval.
p.(None): (4) The provisions of paragraphs 1 to 3 do not affect the cultivation of any approved genetically modified seeds and
p.(None): Plant propagation material that has been lawfully grown before GMO cultivation has been restricted or prohibited.
p.(None): (5) Measures adopted under this provision do not affect the free movement of GMOs as or in products.
p.(None): Penal provisions, confiscation, forfeiture
p.(None): Section 109. (1) Unless the act forms part of an offense falling within the jurisdiction of the courts or according to others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to 36,300 euros
p.(None): 1. contrary to the prohibition of Section 67, employees, or job seekers, collects, requests, accepts or otherwise results of genetic analyzes
p.(None): recycled
p.(None): 2. contrary to the prohibition of Section 67, requests the results of genetic analyzes from policyholders or from policyholders,
p.(None): accepts or otherwise exploits.
p.(None): The attempt is punishable.
p.(None): (2) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are threatened with a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 21,800
p.(None): 1. contrary to the provision of section 37 subsection 1, carries out a release without prior approval,
p.(None): 2. contrary to the provisions of Section 54, places products on the market,
p.(None): 3. who, contrary to Section 79j Paragraph 1, second and third sentences, fails to take out liability insurance.
p.(None): (3) Unless the offense constitutes an offense falling within the jurisdiction of the courts or after others
p.(None): Administrative penalties are subject to a more severe penalty, commits an administrative offense and is punished with a fine of up to EUR 7,260
p.(None): 1. contrary to the provisions of § 6, fails to carry out a security classification, to record it in writing or to justify it,
p.(None): 2. contravenes the provisions of Section 11 (1) regarding the emergency plan or the on-call service,
p.(None): 3. The provisions of section 11 subsection 2, 3 or 5 relating to behavior in the event of an accident or as an operator contrary to the provisions of section 11 subsection 4 es
p.(None): fails to carry out a check,
p.(None): 4. contrary to an ordinance issued according to § 12, does not implement safety measures (Z 1) or does not meet requirements for genetic engineering systems (Z 2)
p.(None): Fulfills,
p.(None): 5. contrary to the provisions of section 13 subsection 1, fails to take the necessary security measures or to ensure that they are observed,
p.(None): 6. contrary to the provisions of section 14 subsection 1, 6, 7 or 8, fails to find a suitable representative for biosafety or its
p.(None): To appoint or announce deputies,
p.(None): 7. contrary to the provisions of section 15 subsection 1, 3 or 4, fails to appoint or announce a project manager,
p.(None): 8. contrary to the provisions of section 16 subsection 1, 5, 6 or 7, fails to appoint the committee for biosafety or members of this committee
p.(None): or announce
p.(None): 9. contrary to the provisions of Section 19, works with GMOs without having registered them with the authority,
p.(None): 10. contrary to the provisions of section 20 or section 23 (2), works with GMOs without official approval,
p.(None): 11. contravenes an official order issued in accordance with section 22 (4) or a condition or condition issued in accordance with section 23 (3),
p.(None): 12. starts working with GVM or transgenic animals or plants earlier than permitted under Section 24,
p.(None): 13. fails to obtain information in accordance with section 30 (2) about circumstances which may endanger safety (section 1 (1)) or the obligation to report in accordance with section 30 (3)
p.(None): contravenes.
p.(None): 14. contrary to the provisions of Section 31, fails to notify the authority of changes to the security equipment
p.(None): 15. As legal successor, contrary to the provisions of section 32 or section 47, the authority does not change the person of the operator
p.(None): announce
p.(None): 16. contravenes the conditions, orders, restrictions or prohibitions issued pursuant to Section 33,
p.(None): 17. does not fulfill the recording obligations according to §§ 34 or 35,
p.(None): 18. contrary to the provisions of section 37 subsection 5, fails to report new information to the authority or the measures prescribed here
p.(None): perform,
p.(None): 19. contravenes the conditions or requirements stipulated in Section 40 (2),
p.(None): 20. contrary to the provisions of Section 45 (1) fails to take the necessary security measures or to ensure that they are observed,
p.(None): 21. fails to obtain information about circumstances in accordance with section 45 (2) or to report these circumstances to the authority in accordance with section 45 (3),
p.(None): 22. contrary to the provisions of Section 46, does not disclose the results of the release or the data on long-term effects,
p.(None): 23. contravenes the conditions, orders, restrictions or prohibitions issued pursuant to Section 48,
p.(None): 24. contravenes the provisions of section 49 (1) or section 50 regarding measures to prevent accidents,
p.(None): 25. contravenes the provisions of section 49 subsection 2, 3 or 4 or section 50 regarding behavior in or after an accident,
p.(None): 26. does not meet the recording obligations pursuant to Section 52,
p.(None): 27. contrary to the provision of section 57, fails to check the information and documents submitted to the authority by new information
p.(None): or to inform the authority thereof or to take the necessary measures for security reasons (§ 1 Z 1),
p.(None): 28. does not comply with the conditions and requirements stipulated in section 58a (1) and section 58b or the monitoring obligations in accordance with section 58c.
p.(None): 29. contravenes the restrictions, restrictions or prohibitions issued pursuant to Section 60 Paragraph 1 or 2,
p.(None): 30. contravenes the orders issued by decision in accordance with Section 61,
p.(None): 31. contravenes the provisions of Section 62 on the packaging and labeling of products,
p.(None): 32. contravenes an ordinance issued pursuant to Section 63 (2),
p.(None): 33. genetic analyzes of humans for medical purposes contrary to the provisions of section 65 and section 68 subsection 1 of those not permitted for this purpose
p.(None): Facilities or if the requirements and conditions laid down in the admission pursuant to Section 68 (3) are not complied with or contrary to one pursuant to Section 68
p.(None): (4) orders genetic tests on humans before fulfilling the requirements,
p.(None): 34. carries out genetic analyzes on humans for scientific purposes or for training contrary to the provisions of section 66 (1) or their
p.(None): Results published or networked contrary to the provisions of Section 66 (2),
p.(None): 35. as laboratory manager contravenes the provisions of Section 68a (3) on participation in proficiency testing, or as head of the institution against
p.(None): Obligation to notify Section 68a (5) violates
p.(None): 36. arranges genetic analyzes within the meaning of section 69 (1) without ensuring the consent and advice provided there,
p.(None): 37. violates the provisions of Section 71,
p.(None): 38. contravenes the provisions of Section 71a on the documentation of the test results,
...
p.(None): Conducts gene therapy without a license or does not comply with the conditions and conditions specified in the license pursuant to Section 75 (3) or the
p.(None): Bans or requirements issued pursuant to Section 75 (4) are not observed or the doctor responsible for the implementation of somatic gene therapy
p.(None): Contrary to due diligence and notification obligations of § 77,
p.(None): 42. contrary to the provision of section 76, conducts a clinical trial for the purpose of somatic gene therapy without authorization,
p.(None): 43. who, contrary to the provision of Section 79g, provides information for purposes other than to enforce claims under IVa. Section used
p.(None): 44. violates the duty of confidentiality in accordance with Section 96,
p.(None): 45. contrary to the provisions of Section 101 (3) does not tolerate controls or sampling, fails to provide the necessary information or is responsible for the
p.(None): Does not provide the necessary aids or information for investigation and monitoring measures,
p.(None): 46. does not follow or oppose the provisional coercive measures ordered pursuant to Section 103 (1),
p.(None): 47. contrary to the provisions of section 108 (7), does not report that a clinical trial has been carried out for the purpose of somatic gene therapy.
p.(None): (3a) Whoever commits the provisions of one of the legal provisions listed in § 100a, unless the offense does not constitute the offense according to the in
p.(None): Section 100a (1) of the federal acts constitutes a criminal offense, constitutes an administrative offense and is subject to a fine of up to € 7,260.00.
p.(None): (4) Products within the meaning of Section 54 (1) that are placed on the market contrary to the provisions of this Federal Act are to be accepted by the authority
p.(None): confiscate; A notice of the confiscation must be issued within three days. The expiry of such products is in the administrative criminal proceedings
p.(None): pronounce; if the objective fact in the sense of the first sentence is present, then the expiration must be pronounced even if no specific person is concerned
p.(None): this administrative offense can be prosecuted or punished. The confiscation and the forfeiture have to take place regardless of whom
p.(None): Products belong.
p.(None): (5) The confiscation and the forfeiture within the meaning of paragraph 4 shall be omitted if the facts of paragraph 2 no. 2 are not realized and according to
p.(None): State of the art in science and technology there is no threat to security (Section 1 no. 1).
p.(None): (6) In the case of para. 2 no. 1, the administrative criminal authority can, in the decision declaring the expiry, order that the expired GMO from the
p.(None): these GMOs are to be harmlessly disposed of at the time of the illegal release or the costs of the harmless disposal are to be attributed to them
p.(None): has to wear.
p.(None): (7) The administrative criminal authority can lift the seizure upon request and refrain from forfeiture if the person concerned about this GMO at the time of the
p.(None): unlawful release ensures that the person who disposes of it can be harmlessly disposed of or otherwise used legally, if none
p.(None): Endangering security (§ 1 Z 1) is to be feared.
p.(None): References to other federal laws
p.(None): Section 110. (1) Insofar as other federal laws are referred to in this federal law, these are to be understood in their respectively applicable version.
p.(None): (2) This federal law does not affect the validity of other federal regulations.
p.(None): completion
p.(None): Section 111. The following are entrusted with the implementation of this federal law:
p.(None): 1. With regard to the ordinance to be issued pursuant to Section 8 of the Federal Minister of Health and Women in agreement with the Federal Minister of Agriculture
p.(None): and forestry, environment and water management, the Federal Minister of Economics and Labor and the Federal Minister of Education, Science and
p.(None): Culture,
p.(None): 2. With regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with § 12 and § 12a in agreement with the
p.(None): Federal Minister of Economics and Labor, the Federal Minister of Agriculture, Forestry, Environment and Water Management and the Federal Minister of
p.(None): Education, science and culture,
p.(None): 3. with regard to the ordinances of the Federal Minister of Health and Women to be issued in accordance with sections 17, 44 and 72 in agreement with the
...
p.(None): as far as the federal government is responsible according to Art. 10 Para. 1 Z 12 B-VG, as well as in matters of the Chemicals Act, Federal Law Gazette I № 53/1997, the
p.(None): Federal Minister of Agriculture, Forestry, Environment and Water Management,
p.(None): 10. with regard to sections 58 (8), 100a (4) (2) and 108 (3) last sentence, the Federal Minister of Agriculture, Forestry, Environment and Water Management,
p.(None): 11. with regard to IVa. Section of the Federal Minister of Justice, with regard to the task under Section 79j (1) last sentence but in accordance with Section 100 of the
p.(None): Federal Minister of Education, Science and Culture or the Federal Minister of Health and Women,
p.(None): 12. With regard to the nomination rights to the Genetic Engineering Commission and its committees, the ones mentioned in sections 81 (1), 86 (2) and 87 (2)
p.(None): Federal Minister,
p.(None): 13. With regard to Section 99 (4), the Federal Minister of Health and Women in agreement with those in accordance with those named there
p.(None): Authorization to issue ordinances to federal ministers authorized to consult,
p.(None): 14. With regard to the presentation of the report on the applications of genetic engineering in accordance with Section 99 (5) of the Federal Minister for Health and Women in
p.(None): Agreement with the Federal Minister of Education, Science and Culture,
p.(None): 15. the Federal Minister of Education with regard to the duties as an authority in accordance with section 100 (1) 1 and with regard to section 102 in conjunction with section 101 (1) 1;
p.(None): Science and culture,
p.(None): 16. With regard to the ordinance of the Federal Minister of Health and Women to be issued in accordance with Section 101e (3) in agreement with the Federal Minister
p.(None): for agriculture and forestry, environment and water management and the Federal Minister of Education, Science and Culture,
p.(None): 17. for the rest, the Federal Minister for Health and Women.
p.(None): implementation Note
p.(None): § 112. This federal law makes Directive 90/219 / EEC as amended by Directive 98/81 / EC and Directive 2001/18 / EC of the European
p.(None): Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and on the repeal of the directive
p.(None): 90/220 / EEC of the Council, OJ № L 106 of April 17, 2001, as amended by Regulations (EG) № 1829/2003 and (EG) № 1830/2003, OJ. № L 268 from
p.(None): October 18, 2003, as well as Directive (EU) 2015/412 amending Directive 2001/18 / EC on the possibility granted to the Member States to cultivate
p.(None): restrict or prohibit genetically modified organisms (GMOs) on their territory, OJ No.L 68 from 13.03. 2015, implemented.
p.(None): Entry into force of regulations
p.(None): Section 113. Section 71 (2) in the version of the Electronic Health Record Act, Federal Law Gazette I No. 111/2012, comes into force on January 1, 2013.
p.(None): Section 113a. Section 88 (2) 2 lit. a and § 97 GTG in the version of the Reproductive Medicine Law Amendment Act, BGBl. I. № 35/2015, occur with the
p.(None): Announcement in force the following day.
...
Orphaned Trigger Words
p.(None): Ensure levels of security for people and the environment and
p.(None): 2. the applications of genetic engineering for the benefit of humans by establishing a legal framework for their research, development and use
p.(None): to promote.
p.(None): scope
p.(None): § 2. (1) This federal law applies to
p.(None): 1. genetic engineering systems;
p.(None): 2. Working with genetically modified organisms (GMOs);
p.(None): 3. releases of genetically modified organisms;
p.(None): 4. the placing on the market of products which consist of or contain genetically modified organisms;
p.(None): 5. the labeling of products which consist of or contain genetically modified organisms or parts thereof
p.(None): were obtained with the exception of products isolated from genetically modified organisms, their parts or their culture supernatants
p.(None): were;
p.(None): 6. genetic analysis and gene therapy in humans.
p.(None): (2) Unless you work with genetically modified organisms or with genetically modified nucleic acid, this federal law does not apply to
p.(None): Works that do not lead to genetically modified organisms, such as in particular
p.(None): 1. In vitro fertilization,
p.(None): 2. conjugation, transduction, transformation or any other natural process,
p.(None): 3. polyploidy induction and elimination of chromosomes,
p.(None): 4. method of undirected mutagenesis,
p.(None): 5. Cell and protoplast fusion of plant cells, and fusion of protoplasts of microorganisms, insofar as the resulting organisms also
p.(None): conventional breeding techniques can be generated
p.(None): 6. Generation of somatic-human or somatic-animal hybridoma cells, unless it is a project of release or of
p.(None): Placing on the market,
p.(None): 7. Self-cloning of non-pathogenic, naturally occurring microorganisms that meet the criteria of risk group 1, provided that it is not a
p.(None): Release or placing on the market. Self-cloning also means cloning with similar recipients and
p.(None): Donor organisms that are carried out using defined, well-characterized vectors.
p.(None): (3) This Federal Act does not apply to the placing on the market and labeling of medicinal products within the meaning of Section 1 (1) and (2) 1 of the Medicinal Products Act and
p.(None): their subsequent use.
p.(None): (4) The use of GMOs in the context of a clinical trial to be approved according to § 75 for the purpose of somatic gene therapy is not considered
p.(None): Release in the sense of this federal law.
p.(None): principle
p.(None): § 3. The following principles must be observed when enforcing this federal law:
p.(None): 1. Working with GMOs, releases and placing GMOs on the market are only permitted if this does not result in the state of the art in science and technology
p.(None): adverse consequences for security (§ 1 Z 1) are to be expected (precautionary principle).
p.(None): 2. Research in the field of genetic engineering and the implementation of its results are not inappropriate considering safety (§ 1 Z 1)
p.(None): Impose restrictions (future principle).
p.(None): 3. The release of GMOs may only take place gradually, by gradually loosening the inclusion of the GMOs and only expanding their release
p.(None): if the assessment of the previous level shows that the subsequent level appears to be compatible with the precautionary principle
p.(None): (Steps principle).
p.(None): 4. The public must be involved in the enforcement in accordance with this federal law in order to ensure their information and participation
p.(None): (democratic principle).
p.(None): 5. In genetic analyzes and gene therapies in humans, care must be taken to protect human dignity; human responsibility
...
p.(None): Enables people.
p.(None): 24. Somatic gene therapy in humans: application of the targeted introduction of isolated expressible nucleic acids into somatic cells in humans,
p.(None): which leads to the expression of the introduced nucleic acids, or the use of such genetically modified outside the human organism
p.(None): somatic cells or cell assemblies in humans. A person treated with somatic gene therapy is not considered a GMO.
p.(None): The form chosen applies to both genders for all personal formulations.
p.(None): II. SECTION
p.(None): Working with genetically modified organisms in closed systems
p.(None): security levels
p.(None): § 5. Working with GMOs is divided into four security levels:
p.(None): 1. Security level 1 includes work in which, according to the state of the art in science and technology, there is no or only a negligible risk
p.(None): for security (§ 1 Z 1) is to be assumed.
p.(None): 2. Security level 2 includes work in which, according to the state of the art in science and technology, there is a low risk to security (§ 1 Z 1)
p.(None): is going out.
p.(None): 3. Security level 3 includes work in which, according to the state of the art in science and technology, a moderate risk to security (§ 1 Z 1)
p.(None): is going out.
p.(None): 4. Security level 4 includes work in which, according to the state of the art in science and technology, there is a high risk to security (§ 1 Z 1)
p.(None): is going out.
p.(None): security rating
p.(None): § 6. (1) Before starting any work with GMOs or work series, the operator has a safety classification for this work or work series
p.(None): Consideration of the risk group of this GMO in the case of the production of GMOs also of the donor and recipient organisms - and the intended ones
p.(None): Security measures and the planned disposal of waste and waste water.
p.(None): (2) The assignment of a GMO to a risk group has on the basis of an overall assessment of the security (§ 1 Z 1) according to the status of
p.(None): Science and technology have significant properties
p.(None): 1. the donor and recipient organisms used,
p.(None): 2. the vectors used,
p.(None): 3. the inserted foreign nucleic acid segments,
p.(None): 4. the GMO produced or used and
p.(None): 5. the gene products formed by this GMO on the basis of the newly inserted nucleic acid segments.
p.(None): (3) A GVM may be assigned to risk group 1 if it takes into account the state of the art in science and technology
p.(None): 1. the recipient microorganism is not expected to cause disease in humans, animals or plants,
p.(None): 2. the properties of the vector and the insert are such that they do not provide the GVM with a phenotype that is expected to be associated with
p.(None): Humans, animals or plants cause disease, or which is expected to have a harmful effect on the location at most
p.(None): affected environment and
p.(None): 3. The GVM is not expected to cause disease in humans, animals or plants and is not expected to be harmful
p.(None): Has an impact on the environment that may be affected by the location,
p.(None): whereby animals and plants are to be understood as organisms and location-related animals and plants.
p.(None): (4) GMMs that do not meet the requirements according to paragraph 3 for an assignment to risk group 1 are to be assigned to risk groups 2, 3 or 4, each
p.(None): depending on whether, according to the state of the art in science and technology, the respective GVM has a low, a moderate or a high risk for security (§ 1 no.
p.(None): represents.
p.(None): (5) Transgenic plants and animals may only be assigned to risk group 1 if according to the state of the art in science and technology
p.(None): an overall assessment of the donor and recipient organisms, the vector and the inserted nucleic acid sections under laboratory conditions
p.(None): Taking into account the security measures that may be envisaged, no pathogenic properties of the GMO for humans, animals and plants and
p.(None): no adverse consequences for security (§ 1 Z 1) are to be expected.
p.(None): (6) When using GMOs on animals, the safety classification of this work is based on the risk group of the GMO used
p.(None): Consideration of any biological safety measures envisaged.
p.(None): (7) If biological safety measures are used, they can be classified in a lower safety level than that of the GMO risk group
p.(None): corresponds if the biological safety measures reduce the risk.
p.(None): (8) The security classification must be recorded in writing and justified. In the case of working with GVM, the cultural volume of the planned one is also included
p.(None): To indicate work.
p.(None): Approval procedure
p.(None): § 7. (1) If there are doubts about the security level in which a certain work with GMOs can be classified, the security measures are the higher ones
...
p.(None): 28. does not comply with the conditions and requirements stipulated in section 58a (1) and section 58b or the monitoring obligations in accordance with section 58c.
p.(None): 29. contravenes the restrictions, restrictions or prohibitions issued pursuant to Section 60 Paragraph 1 or 2,
p.(None): 30. contravenes the orders issued by decision in accordance with Section 61,
p.(None): 31. contravenes the provisions of Section 62 on the packaging and labeling of products,
p.(None): 32. contravenes an ordinance issued pursuant to Section 63 (2),
p.(None): 33. genetic analyzes of humans for medical purposes contrary to the provisions of section 65 and section 68 subsection 1 of those not permitted for this purpose
p.(None): Facilities or if the requirements and conditions laid down in the admission pursuant to Section 68 (3) are not complied with or contrary to one pursuant to Section 68
p.(None): (4) orders genetic tests on humans before fulfilling the requirements,
p.(None): 34. carries out genetic analyzes on humans for scientific purposes or for training contrary to the provisions of section 66 (1) or their
p.(None): Results published or networked contrary to the provisions of Section 66 (2),
p.(None): 35. as laboratory manager contravenes the provisions of Section 68a (3) on participation in proficiency testing, or as head of the institution against
p.(None): Obligation to notify Section 68a (5) violates
p.(None): 36. arranges genetic analyzes within the meaning of section 69 (1) without ensuring the consent and advice provided there,
p.(None): 37. violates the provisions of Section 71,
p.(None): 38. contravenes the provisions of Section 71a on the documentation of the test results,
p.(None): 39. the regulations issued in accordance with section 72 (1) on the equipment of facilities, the initiation of genetic analyzes, data protection or
p.(None): contravenes the documentation of the test results,
p.(None): 40. as head of the institution violates the reporting requirements of Section 73,
p.(None): 41. contrary to the provisions of section 74, carries out somatic gene therapy on humans or uses cells for the production of embryos or
p.(None): somatic gene therapy contrary to the regulation of § 75 Abs. 1 carries out without being a doctor, or contrary to the regulation of § 75 Abs. 3 somatic
p.(None): Conducts gene therapy without a license or does not comply with the conditions and conditions specified in the license pursuant to Section 75 (3) or the
p.(None): Bans or requirements issued pursuant to Section 75 (4) are not observed or the doctor responsible for the implementation of somatic gene therapy
p.(None): Contrary to due diligence and notification obligations of § 77,
p.(None): 42. contrary to the provision of section 76, conducts a clinical trial for the purpose of somatic gene therapy without authorization,
p.(None): 43. who, contrary to the provision of Section 79g, provides information for purposes other than to enforce claims under IVa. Section used
p.(None): 44. violates the duty of confidentiality in accordance with Section 96,
p.(None): 45. contrary to the provisions of Section 101 (3) does not tolerate controls or sampling, fails to provide the necessary information or is responsible for the
p.(None): Does not provide the necessary aids or information for investigation and monitoring measures,
p.(None): 46. does not follow or oppose the provisional coercive measures ordered pursuant to Section 103 (1),
p.(None): 47. contrary to the provisions of section 108 (7), does not report that a clinical trial has been carried out for the purpose of somatic gene therapy.
p.(None): (3a) Whoever commits the provisions of one of the legal provisions listed in § 100a, unless the offense does not constitute the offense according to the in
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| criminal | criminal |
| disability | Mentally Disabled |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| home | Property Ownership |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| influence | Drug Usage |
| injured | injured |
| job | Occupation |
| liberty | Incarcerated |
| minor | Youth/Minors |
| minority | Racial Minority |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| persecuted | Persecuted |
| philosophy | philosophical differences/differences of opinion |
| pregnant | Pregnant |
| property | Property Ownership |
| property owner | Property Ownership |
| prosecuted | Prosecuted |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| victim | Victim of Abuse |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| education | ['educational'] |
| educational | ['education'] |
| home | ['propertyXowner', 'property'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| influence | ['substance'] |
| liberty | ['restricted'] |
| opinion | ['philosophy'] |
| philosophy | ['opinion'] |
| property | ['propertyXowner', 'home'] |
| property owner | ['home', 'property'] |
| restricted | ['liberty'] |
| substance | ['influence'] |
Trigger Words
capacity
consent
cultural
ethics
exploit
harm
justice
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input