0A4F4F9BD490A749D5437F821CF06DF1
Decree No. 5,591, of November 22, 2005
http://www.planalto.gov.br/ccivil_03/_ato2004-2006/2005/Decreto/D5591.htm
http://leaux.net/URLS/ConvertAPI Text Files/1D8334D0C5444510765FF21C6B220010.en.txt
Examining the file media/Synopses/1D8334D0C5444510765FF21C6B220010.html:
This file was generated: 2020-07-15 04:11:29
| 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 crime:
(return to top)
p.(None): IV - keep a record of the individual monitoring of each activity or project under development involving GMOs and their derivatives;
p.(None): V - notify CTNBio, the registration and inspection bodies and entities and workers' entities the result of risk assessments to which they are subjected
p.(None): exposed persons, as well as any accident or incident that may cause the spread of biological agents;
p.(None): VI - investigate the occurrence of accidents and illnesses possibly related to GMOs and their derivatives and notify their conclusions and measures to the
p.(None): CTNBio.
p.(None): CHAPTER VII
p.(None): STEM CELL RESEARCH AND THERAPY
p.(None): HUMAN EMBIONARIES OBTAINED BY FERTILIZATION
p.(None): IN VITRO
p.(None): Art. 63. For research and therapy purposes, the use of embryonic stem cells obtained from human embryos produced by in vitro fertilization and
p.(None): not used in the respective procedure, provided the following conditions are met:
p.(None): I - are non-viable embryos; or
p.(None): II - frozen embryos are available.
p.(None): § 1 In any case, the consent of the parents is required.
p.(None): § 2 Research institutions and health services that carry out research or therapy with human embryonic stem cells must submit their projects to
p.(None): appreciation and approval of the respective research ethics committees, in the form of a resolution by the National Health Council.
p.(None): § 3 The sale of biological material referred to in this article is prohibited, and its practice implies the crime typi fi ed in art. 15 of Law No. 9,434, of 4
p.(None): February 1997.
p.(None): Article 64. It is the responsibility of the Ministry of Health to promote the survey and maintain an updated record of human embryos obtained by in vitro fertilization and not used in
p.(None): respective procedure.
p.(None): § 1 The institutions that carry out activities that involve freezing and storage of human embryos must inform, according to the specific norm
p.(None): which will establish deadlines, the necessary data for the identification of non-viable embryos produced in their establishments and of the available frozen embryos.
p.(None): § 2 The Ministry of Health will issue the rule referred to in § 1 within thirty days of the publication of this Decree.
p.(None): Article 65. The National Health Surveillance Agency - ANVISA will establish rules for procedures for the collection, processing, testing, storage,
p.(None): transport, quality control and use of human embryonic stem cells for the purposes of this Chapter.
p.(None): Art. 66. Parents who donate, for research or therapy purposes, human embryonic stem cells obtained in accordance with the provisions of this Chapter,
p.(None): must sign a Free and Informed Consent Form, according to a specific rule of the Ministry of Health.
p.(None): Art. 67. The use, in therapy, of human embryonic stem cells, observing art. 63, will be carried out in accordance with the guidelines of the Ministry of
p.(None): Health for the evaluation of new technologies.
p.(None): CHAPTER VIII
p.(None): CIVIL AND ADMINISTRATIVE RESPONSIBILITY
...
p.(None): Art. 77. If the infringer commits two or more infractions simultaneously, the sanctions imposed on each one will be applied cumulatively.
p.(None): Art. 78. In the case of a continuous infraction, characterized by the permanence of the action or omission initially punished, the respective penalty will be applied
p.(None): daily until its cause ceases, without prejudice to the immediate stoppage of the activity or the interdiction of the laboratory or the institution or company responsible.
p.(None): Art. 79. The registration and inspection bodies and entities may, regardless of the application of administrative sanctions, impose precautionary measures of
p.(None): seizure of products, suspension of product sales and embargoes of activities whenever there is an imminent risk of damage to human dignity, health
p.(None): human, animal and plant life and the environment.
p.(None): Section III
p.(None): Administrative Process
p.(None): Art. 80. Any person, noting the occurrence of administrative infraction, may direct representation to the competent inspection body or entity, for
p.(None): effect of the exercise of police power.
p.(None): Art. 81. Administrative infractions are investigated in a specific administrative process, ensuring the right to ample defense and the adversary.
p.(None): Art. 82. The competent authorities are competent to draw up an infraction notice, institute administrative proceedings and indicate the applicable penalties.
p.(None): of inspection provided for in art. 53.
p.(None): Art. 83. The supervisory authority will forward a copy of the infraction notice to CTNBio.
p.(None): Art. 84. When the infraction constitutes a crime or misdemeanor, or injury to the Public Treasury or the consumer, the supervisory authority will represent with the agency
p.(None): competent to determine administrative and penal responsibilities.
p.(None): Art. 85. The provisions of Law No. 9,784 of 1999 apply to this Decree, as appropriate.
p.(None): CHAPTER IX
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 86. CTNBio, in ninety days after its installation, will define:
p.(None): I - proposal for its internal regulations, to be submitted to the approval of the Minister of State for Science and Technology;
p.(None): II - the risk classes of GMOs;
p.(None): III - the levels of biosafety to be applied to GMOs and their derivatives, observing the GMO risk class.
p.(None): Single paragraph. Until the definition of the GMO risk classes by CTNBio, the table in the Annex to this Decree will be observed for classification purposes.
p.(None): Art. 87. The CNBS Executive Secretariat will submit, within ninety days, a proposal for internal regulations to the collegiate body.
p.(None): Art. 88. GMOs that have obtained a technical decision from CTNBio favorable to their commercial release until March 28, 2005 may be registered and
p.(None): commercialized, in compliance with CNBS Resolution No. 1, of May 27, 2005.
p.(None): Art. 89. The institutions that carry out activities regulated by this Decree must adapt to its provisions within one hundred and twenty days, counted from the
p.(None): publication.
p.(None): Art. 90. The provisions of Law No. 7,802, of July 11, 1989, do not apply to GMOs and their derivatives, except for cases in which they are developed for
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None): activities with recombinant DNA / RNA techniques;
p.(None): XVIII - provide technical support to registration and inspection bodies and entities, in the exercise of their activities related to GMOs and their derivatives;
p.(None): XIX - disseminate in the Official Gazette of the Union, prior to the analysis, extracts of the claims and, subsequently, of the opinions of the processes submitted to it,
p.(None): as well as giving wide publicity in the Biosafety Information System - SIB to its agenda, processes in process, annual reports, minutes of meetings and
p.(None): other information about its activities, excluding confidential information, of commercial interest, pointed out by the applicant and so considered by him;
p.(None): XX - identify activities and products resulting from the use of GMOs and their derivatives that potentially cause degradation of the environment or that may
p.(None): cause risks to human health;
p.(None): XXI - reassess its technical decisions at the request of its members or by appeal by the registration and inspection bodies and entities, based on facts or
p.(None): new scientific knowledge, relevant to the biosafety of GMOs and their derivatives;
p.(None): XXII - to propose the carrying out of research and scientific studies in the field of biosafety of GMOs and their derivatives;
p.(None): XXIII - present a proposal for its internal regulations to the Minister of State for Science and Technology.
p.(None): Single paragraph. The reassessment referred to in item XXI of this article will be requested to the President of CTNBio in a petition that will contain the name and qualification of the
p.(None): requesting party, the reasoned statement with a description of the facts or a report of the new scientific knowledge that provided it and the request for a new decision regarding the
p.(None): biosafety of GMOs and their derivatives to which they refer.
p.(None): Section II
p.(None): Composition
p.(None): Art. 6 CTNBio, composed of full and alternate members, designated by the Minister of State for Science and Technology, will consist of twenty-seven
p.(None): Brazilian citizens of recognized technical competence, notorious performance and scientific knowledge, with an academic degree as a doctor and with outstanding professional activity
p.(None): in the areas of biosafety, biotechnology, biology, human and animal health or the environment, being:
p.(None): I - twelve specialists of notorious scientific and technical knowledge, in effective professional practice, being:
p.(None): a) three in the area of human health;
p.(None): b) three from the animal area;
p.(None): c) three from the plant area;
p.(None): d) three from the environmental area;
p.(None): II - one representative from each of the following bodies, appointed by the respective holders:
p.(None): a) Ministry of Science and Technology;
p.(None): b) Ministry of Agriculture, Livestock and Supply;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of the Environment;
p.(None): e) Ministry of Agrarian Development;
p.(None): f) Ministry of Development, Industry and Foreign Trade;
p.(None): g) Ministry of Defense;
p.(None): h) Ministry of Foreign Affairs;
p.(None): i) Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic;
p.(None): III - a consumer protection specialist, appointed by the Minister of State for Justice;
p.(None): IV - a specialist in the health field, appointed by the Minister of State for Health;
...
p.(None): § 1 Full and alternate members will participate in the sectoral subcommittees, and the distribution of the processes for analysis may be made to any of them.
p.(None): § 2 The operation and coordination of work in the sectoral and extraordinary subcommittees will be defined in the CTNBio internal regulations.
p.(None): Section IV
p.(None): Meetings and Resolutions
p.(None): Art. 18. The alternate member will have the right to speak and, in the absence of the respective holder, to vote in the deliberations.
p.(None): Art. 19. The CTNBio meeting may be installed with the presence of fourteen of its members, including at least one representative from each of the areas
p.(None): referred to in item I of art. 6th.
p.(None): Single paragraph. CTNBio's decisions will be taken with votes in favor of the absolute majority of its members, except in the commercial release processes
p.(None): GMOs and derivatives, for which the decision will be required to be taken with favorable votes from at least two thirds of the members.
p.(None): Art. 20. A member who:
p.(None): I - violate the provisions of art. 14;
p.(None): II - not attending three consecutive ordinary meetings of the CTNBio plenary, without justification.
p.(None): Art. 21. CTNBio will meet, on an ordinary basis, once a month and, extraordinarily, at any time, when convened by its President or by
p.(None): reasoned request signed by an absolute majority of its members.
p.(None): Single paragraph. The periodicity of ordinary meetings may, exceptionally, be changed by resolution of CTNBio.
p.(None): Art. 22. CTNBio meetings will be recorded, and the respective minutes, when deciding on requests, must contain a menu indicating the process number,
p.(None): interested party, object, motivation of the decision, possible divergence and result.
p.(None): Art. 23. The extracts of the claim must be published in the Official Gazette of the Union and in the SIB, at least thirty days in advance of being placed on the agenda, Art.
p.(None): except for urgent cases, which will be defined by the CTNBio President.
p.(None): Art. 24. Extracts of opinion and technical decisions must be published in the Federal Official Gazette.
p.(None): Single paragraph. The reasoned votes of each member must be included in the SIB.
p.(None): Art. 25. The bodies and entities that are part of the federal public administration may request participation in CTNBio meetings to deal with matters of their
p.(None): special interest, without voting rights.
p.(None): Single paragraph. The request to the CTNBio Executive Secretariat must be accompanied by justification that demonstrates the motivation and demonstrates the interest of the
p.(None): applicant in the biosafety of GMOs and their derivatives submitted to the decision of CTNBio.
p.(None): Art. 26. Representatives of the scientific community, the public sector and entities of the
p.(None): civil society without voting rights.
p.(None): Section V
p.(None): Proceedings of Processes
p.(None): Art. 27. The processes pertinent to the competences of CTNBio, dealt with in items IV, VIII, IX, XII, and XXI of art. 5, will obey the procedure defined in this
p.(None): Section.
p.(None): Art. 28. The application filed with the Executive Secretariat of CTNBio, after being assessed and duly instructed, will have its previous extract published in the Diário
...
p.(None): Art. 38. In cases of commercial use, among other technical aspects of its analysis, the registration and inspection bodies, in the exercise of their duties in
p.(None): upon request by CTNBio, they will observe, regarding the biosafety aspects of GMOs and their derivatives, the technical decision of CTNBio.
p.(None): Art. 39. In the event of a favorable technical decision on biosafety within the scope of the research activity, CTNBio will send the respective process to the agencies and
p.(None): registration and inspection entities, for the exercise of their duties.
p.(None): Art. 40. CTNBio's technical decision must contain a summary of its technical basis, explain the security measures and restrictions on the use of GMOs and their
p.(None): derivatives and consider the particularities of the different regions of the country, with the objective of guiding and subsidizing registration and inspection bodies and entities, in the
p.(None): exercise of its duties.
p.(None): Art. 41. The derivative whose GMO has already been approved by CTNBio will not be submitted to analysis and issue of technical opinion by CTNBio.
p.(None): Art. 42. Individuals or legal entities involved in any of the phases of the agricultural production, commercialization or product transportation process
p.(None): genetically modified products that have been released for commercial use are exempted from presenting the CQB and constituting CIBio, unless
p.(None): contrary to CTNBio.
p.(None): Section VII
p.(None): Public Hearings
p.(None): Art. 43. CTNBio may hold public hearings, ensuring the participation of civil society, which will be required:
p.(None): I - by one of its members and approved by an absolute majority, in any event;
p.(None): II - by a party evidently interested in the subject matter of resolution and approved by an absolute majority, in the case of commercial release.
p.(None): Paragraph 1 CTNBio shall publish in the SIB and in the Federal Official Gazette, at least thirty days in advance, the summons for a public hearing, including the
p.(None): subject, date, time and place of work.
p.(None): § 2 The public hearing will be coordinated by the President of CTNBio who, after the objective presentation of the subject matter of the hearing, will open discussions with
p.(None): interested parties present.
p.(None): § 3 After the conclusion of the work of the public hearing, the manifestations, opinions, suggestions and documents will be available to those interested in the Secretariat-
p.(None): CTNBio Executive Board.
p.(None): Paragraph 4. For the purposes of item II of the caput of this article, the interested party is considered the applicant for the process or legal entity whose social objective is related
p.(None): to the areas provided for in the caput and in items III, VII and VIII of article 6.
p.(None): Section VIII
p.(None): General GMO Risk Classification Rules
p.(None): Art. 44. For the classification of GMOs according to risk classes, CTNBio must consider, among other criteria:
p.(None): I - general characteristics of the GMO;
p.(None): II - vector characteristics;
p.(None): III - characteristics of the insert;
p.(None): IV - characteristics of donor and recipient organisms;
p.(None): V - product of the gene expression of the inserted sequences;
p.(None): VI - proposed activity and the receiving environment of the GMO;
p.(None): VII - proposed use of the GMO;
p.(None): VIII - adverse effects of the GMO on human health and the environment.
p.(None): Section IX
p.(None): Quality Certificate in Biosafety
p.(None): Art. 45. The institution under public or private law that intends to carry out research in the laboratory, containment regime or field, as part of the process of
p.(None): obtaining GMOs or evaluating the biosafety of GMOs, which includes, in the experimental scope, the construction, cultivation, handling, transportation,
p.(None): transfer, import, export, storage, release into the environment and disposal of GMOs, must request, with CTNBio, the issuance of the CQB.
p.(None): § 1 CTNBio will establish the criteria and procedures for requesting, issuing, reviewing, extending, suspending and canceling CQB.
p.(None): § 2 CTNBio will send a copy of the CQB issuance process and its updates to the registration and inspection bodies.
p.(None): Art. 46. Public and private organizations, national and foreign, financing or sponsoring activities or projects referred to in the caput of art. 2nd,
...
Health / Drug Usage
Searching for indicator substance:
(return to top)
p.(None): XIII - non-viable embryos: those with genetic alterations confirmed by preimplantation diagnosis, according to specific norms established by the
p.(None): Ministry of Health, which had its development interrupted due to spontaneous absence of cleavage after a period longer than twenty-four hours from the
p.(None): in vitro fertilization, or with morphological changes that compromise the full development of the embryo;
p.(None): XIV - frozen embryos available: those frozen until March 28, 2005, after three years from the date of their
p.(None): freezing;
p.(None): XV - parents: end users of in vitro fertilization;
p.(None): XVI - registration and inspection bodies and entities: those referred to in the caput of art. 53;
p.(None): XVII - genetic technologies for use restriction: any human intervention process for the generation or multiplication of genetically modified plants
p.(None): to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at activating or deactivating genes related to
p.(None): plant fertility by external chemical inducers.
p.(None): § 1 The GMO category does not include the result of techniques that involve the direct introduction of hereditary material into an organism, provided that
p.(None): involve the use of recombinant DNA / RNA or GMO molecules, including in vitro fertilization, conjugation, transduction, transformation, polyploid induction and
p.(None): any other natural process.
p.(None): § 2 The category of GMO derivative does not include the pure, chemically defined substance obtained through biological processes and which does not contain GMOs,
p.(None): heterologous protein or recombinant DNA.
p.(None): CHAPTER II
p.(None): OF THE NATIONAL TECHNICAL COMMISSION ON BIOSAFETY
p.(None): Art. 4 CTNBio, member of the Ministry of Science and Technology, is a multidisciplinary collegiate body of an advisory and deliberative nature, to provide support
p.(None): technical and advisory services to the Federal Government in the formulation, updating and implementation of the National Biosafety Policy - GMO GNP and its
p.(None): derivatives, as well as in the establishment of technical safety standards and technical opinions regarding authorization for activities involving research and
p.(None): commercial use of GMOs and their derivatives, based on the assessment of their zoofitosanitary risk, to human health and to the environment.
p.(None): Single paragraph. CTNBio should monitor the development and technical and scientific progress in the areas of biosafety, biotechnology, bioethics and the like,
p.(None): with the objective of increasing its capacity to protect human health, animals and plants and the environment.
p.(None): Section I
p.(None): Assignments
p.(None): Art. 5 CTNBio is responsible for:
p.(None): I - establish rules for research with GMOs and their derivatives;
p.(None): II - establish rules regarding activities and projects related to GMOs and their derivatives;
p.(None): III - establish, within the scope of its competences, criteria for assessing and monitoring the risk of GMOs and their derivatives;
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): Brazilian citizens of recognized technical competence, notorious performance and scientific knowledge, with an academic degree as a doctor and with outstanding professional activity
p.(None): in the areas of biosafety, biotechnology, biology, human and animal health or the environment, being:
p.(None): I - twelve specialists of notorious scientific and technical knowledge, in effective professional practice, being:
p.(None): a) three in the area of human health;
p.(None): b) three from the animal area;
p.(None): c) three from the plant area;
p.(None): d) three from the environmental area;
p.(None): II - one representative from each of the following bodies, appointed by the respective holders:
p.(None): a) Ministry of Science and Technology;
p.(None): b) Ministry of Agriculture, Livestock and Supply;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of the Environment;
p.(None): e) Ministry of Agrarian Development;
p.(None): f) Ministry of Development, Industry and Foreign Trade;
p.(None): g) Ministry of Defense;
p.(None): h) Ministry of Foreign Affairs;
p.(None): i) Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic;
p.(None): III - a consumer protection specialist, appointed by the Minister of State for Justice;
p.(None): IV - a specialist in the health field, appointed by the Minister of State for Health;
p.(None): V - an expert on the environment, appointed by the Minister of State for the Environment;
p.(None): VI - a biotechnology specialist, appointed by the Minister of State for Agriculture, Livestock and Supply;
p.(None): VII - a specialist in family farming, appointed by the Minister of State for Agrarian Development;
p.(None): VIII - a specialist in occupational health, appointed by the Minister of State for Labor and Employment.
p.(None): Single paragraph. Each effective member will have an alternate, who will participate in the work in the absence of the holder.
p.(None): Art. 7 The specialists referred to in item I of art. 6th will be chosen from a triple list of members and alternates.
p.(None): Single paragraph. The Minister of State for Science and Technology will set up an ad hoc commission, made up of members external to CTNBio, representatives of
p.(None): scientific societies, the Brazilian Society for the Progress of Science - SBPC and the Brazilian Academy of Sciences - ABC, in charge of preparing the list
p.(None): the triple of which the caput of this article deals, within up to thirty days of its constitution.
p.(None): Art. 8 The representatives referred to in item II of art. 6, and their alternates, shall be appointed by the members of the respective bodies within thirty days from the date
p.(None): notice of the Minister of State for Science and Technology.
p.(None): Art. 9 The indication of the specialists dealt with in items III to VIII of art. 6th will be made by the respective Ministers of State, based on a triple list prepared
p.(None): civil society organizations with legal personality, whose social objective is compatible with the specialization provided for in those items, in
p.(None): procedure to be defined by the respective Ministries.
p.(None): Art. 10. Consultations with civil society organizations, for the purposes referred to in art. 9, must be held sixty days before the end of the mandate of the
p.(None): member to be replaced.
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.(None): Presidency of the Republic
p.(None): Civil House
p.(None): Sub-branch for Legal Affairs
p.(None): DECREE No. 5,591, OF NOVEMBER 22, 2005.
p.(None): Regulates provisions of Law No. 11,105, of March 24, 2005, which
p.(None): regulates items II, IV and V of § 1 of art. 225 of the Constitution, and gives other
p.(None): measures.
p.(None): THE PRESIDENT OF THE REPUBLIC, in the use of the powers conferred on him by art. 84, items IV and VI, item "a", of the Constitution, and in view of the provisions of Law
p.(None): 11,105, of March 24, 2005,
p.(None): DECREE:
p.(None): CHAPTER I
p.(None): PRELIMINARY AND GENERAL PROVISIONS
p.(None): Art. 1 This Decree regulates provisions of Law 11,105, of March 24, 2005, which establishes security rules and inspection mechanisms on
p.(None): construction, cultivation, production, handling, transport, transfer, import, export, storage, research, marketing,
p.(None): consumption, release into the environment and the disposal of genetically modified organisms - GMOs and their derivatives, with the guidelines of stimulating progress
p.(None): in the area of biosafety and biotechnology, the protection of human, animal and plant life and health, and the observance of the precautionary principle for protection
p.(None): of the environment, as well as rules for use upon authorization of embryonic stem cells obtained from human embryos produced by in vitro fertilization
p.(None): and not used in the respective procedure, for research and therapy purposes.
p.(None): Art. 2 The activities and projects involving GMOs and their derivatives, related to teaching with manipulation of living organisms, scientific research,
p.(None): technological development and industrial production are restricted to the scope of public or private entities, which will be responsible for
p.(None): precepts of Law No. 11,105, of 2005, of this Decree and of complementary norms, as well as for the eventual consequences or effects arising from its
p.(None): non-compliance.
p.(None): § 1 For the purposes of this Decree, activities and projects within the scope of an entity are considered to be carried out in its own facilities or under the responsibility of
p.(None): administrative, technical or scientific entity.
p.(None): § 2 The activities and projects referred to in this article are prohibited to individuals in autonomous and independent activities, even if they maintain a bond
p.(None): employment or any other with legal entities.
p.(None): Paragraph 3. Those interested in carrying out the activity provided for in this Decree must request authorization from the National Technical Commission on Biosafety - CTNBio, which
p.(None): will manifest within the period established in a specific rule.
p.(None): Art. 3 For the purposes of this Decree, it is considered:
p.(None): I - research activity: that carried out in the laboratory, containment regime or field, as part of the process of obtaining GMOs and their derivatives or of
p.(None): evaluation of the biosafety of GMOs and their derivatives, which includes, in the experimental scope, the construction, cultivation, handling, transport, transfer,
...
p.(None): derivatives for commercial purposes;
p.(None): III - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): IV - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): V - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying natural or synthetic DNA / RNA segments
p.(None): and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; the segments of
p.(None): Synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): VI - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): VII - genetically modified organism - GMO: an organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VIII - derived from GMOs: product obtained from GMOs and that does not have autonomous capacity for replication or that does not contain a viable form of GMOs;
p.(None): IX - human germ cell: mother cell responsible for the formation of gametes present in the female and male sex glands and their descendants
p.(None): direct in any degree of ploidy;
p.(None): X - in vitro fertilization: the fusion of gametes performed by any extracorporeal fertilization technique;
p.(None): XI - cloning: asexual reproduction process, artificially produced, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): XII - embryonic stem cells: embryo cells that have the ability to transform into cells of any tissue in an organism;
p.(None): XIII - non-viable embryos: those with genetic alterations confirmed by preimplantation diagnosis, according to specific norms established by the
p.(None): Ministry of Health, which had its development interrupted due to spontaneous absence of cleavage after a period longer than twenty-four hours from the
p.(None): in vitro fertilization, or with morphological changes that compromise the full development of the embryo;
p.(None): XIV - frozen embryos available: those frozen until March 28, 2005, after three years from the date of their
p.(None): freezing;
p.(None): XV - parents: end users of in vitro fertilization;
p.(None): XVI - registration and inspection bodies and entities: those referred to in the caput of art. 53;
p.(None): XVII - genetic technologies for use restriction: any human intervention process for the generation or multiplication of genetically modified plants
p.(None): to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at activating or deactivating genes related to
p.(None): plant fertility by external chemical inducers.
p.(None): § 1 The GMO category does not include the result of techniques that involve the direct introduction of hereditary material into an organism, provided that
p.(None): involve the use of recombinant DNA / RNA or GMO molecules, including in vitro fertilization, conjugation, transduction, transformation, polyploid induction and
p.(None): any other natural process.
...
p.(None): functioning will be established by CTNBio.
p.(None): Single paragraph. The institution referred to in the caput of this article will appoint a principal technician responsible for each specific project.
p.(None): Art. 62. CIBio is responsible, within the scope of each institution:
p.(None): I - keep workers and other members of the community informed, when they are likely to be affected by the activity, on issues related to
p.(None): health and safety, as well as on accident procedures;
p.(None): II - establish preventive and inspection programs to guarantee the functioning of the facilities under its responsibility, within the standards and norms of
p.(None): biosafety, defined by CTNBio;
p.(None): III - forward to CTNBio the documents whose relationship will be established by it, for the purposes of analysis, registration or authorization by the competent body, when
p.(None): fit;
p.(None): IV - keep a record of the individual monitoring of each activity or project under development involving GMOs and their derivatives;
p.(None): V - notify CTNBio, the registration and inspection bodies and entities and workers' entities the result of risk assessments to which they are subjected
p.(None): exposed persons, as well as any accident or incident that may cause the spread of biological agents;
p.(None): VI - investigate the occurrence of accidents and illnesses possibly related to GMOs and their derivatives and notify their conclusions and measures to the
p.(None): CTNBio.
p.(None): CHAPTER VII
p.(None): STEM CELL RESEARCH AND THERAPY
p.(None): HUMAN EMBIONARIES OBTAINED BY FERTILIZATION
p.(None): IN VITRO
p.(None): Art. 63. For research and therapy purposes, the use of embryonic stem cells obtained from human embryos produced by in vitro fertilization and
p.(None): not used in the respective procedure, provided the following conditions are met:
p.(None): I - are non-viable embryos; or
p.(None): II - frozen embryos are available.
p.(None): § 1 In any case, the consent of the parents is required.
p.(None): § 2 Research institutions and health services that carry out research or therapy with human embryonic stem cells must submit their projects to
p.(None): appreciation and approval of the respective research ethics committees, in the form of a resolution by the National Health Council.
p.(None): § 3 The sale of biological material referred to in this article is prohibited, and its practice implies the crime typi fi ed in art. 15 of Law No. 9,434, of 4
p.(None): February 1997.
p.(None): Article 64. It is the responsibility of the Ministry of Health to promote the survey and maintain an updated record of human embryos obtained by in vitro fertilization and not used in
p.(None): respective procedure.
p.(None): § 1 The institutions that carry out activities that involve freezing and storage of human embryos must inform, according to the specific norm
p.(None): which will establish deadlines, the necessary data for the identification of non-viable embryos produced in their establishments and of the available frozen embryos.
p.(None): § 2 The Ministry of Health will issue the rule referred to in § 1 within thirty days of the publication of this Decree.
p.(None): Article 65. The National Health Surveillance Agency - ANVISA will establish rules for procedures for the collection, processing, testing, storage,
p.(None): transport, quality control and use of human embryonic stem cells for the purposes of this Chapter.
p.(None): Art. 66. Parents who donate, for research or therapy purposes, human embryonic stem cells obtained in accordance with the provisions of this Chapter,
p.(None): must sign a Free and Informed Consent Form, according to a specific rule of the Ministry of Health.
p.(None): Art. 67. The use, in therapy, of human embryonic stem cells, observing art. 63, will be carried out in accordance with the guidelines of the Ministry of
p.(None): Health for the evaluation of new technologies.
p.(None): CHAPTER VIII
p.(None): CIVIL AND ADMINISTRATIVE RESPONSIBILITY
p.(None): Art. 68. Without prejudice to the application of the penalties provided for in Law No. 11,105, 2005, and in this Decree, those responsible for damage to the environment and third parties
p.(None): will be jointly and severally liable for their indemnity or full reparation, regardless of fault.
p.(None): Section I
p.(None): Administrative Offenses
p.(None): Article 69. An administrative infraction is considered to be any action or omission that violates the rules provided for in Law No. 11,105, 2005, and in this Decree and other provisions
p.(None): relevant legal provisions, in particular:
p.(None): I - carry out an activity or project involving GMOs and their derivatives, related to teaching with manipulation of living organisms, scientific research,
p.(None): technological development and industrial production as an individual working independently;
p.(None): II - carry out research and commercial use of GMOs and their derivatives without authorization from CTNBio or in disagreement with the rules issued by it;
p.(None): III - fail to require the presentation of the CQB issued by CTNBio to legal entities that finance or sponsor activities and projects involving GMOs and their
p.(None): derivatives;
p.(None): IV - use, for research and therapy purposes, embryonic stem cells obtained from human embryos produced by in vitro fertilization without the consent of the
p.(None): parents;
p.(None): V - carry out research or therapy activities with human embryonic stem cells without approval from the respective research ethics committee, as
p.(None): norm of the National Health Council;
p.(None): VI - commercialize embryonic stem cells obtained from human embryos produced by in vitro fertilization;
p.(None): VII - use, for research and therapy purposes, embryonic stem cells obtained from human embryos produced by in vitro fertilization without meeting the
p.(None): provisions of Chapter VII;
p.(None): VIII - fail to keep a record of the individual monitoring of each activity or project under development involving GMOs and their derivatives;
p.(None): IX - perform genetic engineering on a living organism in disagreement with the rules of this Decree;
p.(None): X - carry out the in vitro handling of natural or recombinant DNA / RNA in disagreement with the rules provided for in this Decree;
p.(None): XI - carry out genetic engineering in human germ cell, human zygote and human embryo;
p.(None): XII - perform human cloning;
p.(None): XIII - destroy or dispose of GMOs and their by-products in the environment in disagreement with the rules established by CTNBio, by the agencies and entities of
p.(None): registration and inspection and in this Decree;
p.(None): XIV - release GMOs and their derivatives into the environment, within the scope of research activities, without the favorable technical decision of CTNBio, or in disagreement with the
p.(None): norms of this;
p.(None): XV - release GMOs and their derivatives into the environment, within the scope of commercial activity, without the licensing of the responsible environmental agency or entity, when
p.(None): CTNBio considers the activity as potentially causing environmental degradation;
p.(None): XVI - release GMOs and their derivatives into the environment, within the scope of commercial activity, without the approval of CNBS, when the process has been carried out by it
p.(None): avocado;
p.(None): XVII - use, commercialize, register, patent or license genetic technologies to restrict use;
p.(None): XVIII - leave the institution to send an investigation report of an accident occurred in the course of research and projects in the field of genetic engineering within the deadline
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): issues with which they have some professional or personal involvement, under penalty of loss of mandate.
p.(None): § 1 The CTNBio member, upon taking office, will sign a declaration of conduct, explaining any conflict of interest, in the form of the internal regulations.
p.(None): Paragraph 2. The CTNBio member must manifest his eventual impediment in the processes distributed to him for analysis, upon receipt, or, when
p.(None): is not the rapporteur, at the time of deliberations at subcommittee or plenary meetings.
p.(None): § 3º The CTNBio member or the one legitimized as interested may argue the impediment, under the terms of art. 9 of Law No. 9,784, of January 29, 1999.
p.(None): § 4 The impediment argument will be formalized in a reasoned and duly instructed petition, and will be decided by the CTNBio plenary.
p.(None): § 5 The technical decision in which the vote of a member declared impeded has been decisive for the outcome of the judgment is null.
p.(None): § 6 The CTNBio plenary, when deciding on the impediment, will issue a new technical decision, in which it will expressly regulate the object of the defective decision and the effects
p.(None): arising from it, since its publication.
p.(None): Art. 15. The President of CTNBio and his replacement will be appointed, among its members, by the Minister of State for Science and Technology, from a list
p.(None): triple voted by the plenary.
p.(None): Paragraph 1. The mandate of the President of CTNBio will be for two years, renewable for the same period.
p.(None): § 2 The CTNBio President is responsible for, among other duties to be defined in the internal regulations:
p.(None): I - represent CTNBio;
p.(None): II - preside over the CTNBio plenary meeting;
p.(None): III - delegate their duties;
p.(None): IV - determine the provision of information and grant access to documents, requested by the registration and inspection bodies.
p.(None): Section III
p.(None): Administrative Structure
p.(None): Art. 16. CTNBio will have an Executive Secretariat, with the Ministry of Science and Technology providing technical and administrative support.
p.(None): Single paragraph. It is incumbent upon the CTNBio Executive Secretariat, among other duties to be defined in the bylaws:
p.(None): I - provide technical and administrative support to CTNBio members;
p.(None): II - receive, instruct and process the requests submitted to CTNBio's decision;
p.(None): III - forward CTNBio's deliberations to the government agencies responsible for their implementation and provide the necessary publicity;
p.(None): IV - update the SIB.
p.(None): Art. 17. CTNBio will set up permanent sectoral subcommittees in the area of human health, animal, plant and environmental areas, and may
p.(None): set up extraordinary subcommittees, for prior analysis of the topics to be submitted to the plenary.
p.(None): § 1 Full and alternate members will participate in the sectoral subcommittees, and the distribution of the processes for analysis may be made to any of them.
p.(None): § 2 The operation and coordination of work in the sectoral and extraordinary subcommittees will be defined in the CTNBio internal regulations.
p.(None): Section IV
p.(None): Meetings and Resolutions
p.(None): Art. 18. The alternate member will have the right to speak and, in the absence of the respective holder, to vote in the deliberations.
p.(None): Art. 19. The CTNBio meeting may be installed with the presence of fourteen of its members, including at least one representative from each of the areas
p.(None): referred to in item I of art. 6th.
...
p.(None): Art. 33. The processes of commercial release of GMOs and their derivatives will be submitted to all permanent subcommittees.
p.(None): Art. 34. The draftsman of the opinion of subcommittees and the plenary shall consider, in addition to the proposers' reports, the existing scientific literature, as well as
p.(None): studies and other documents filed at public hearings or at CTNBio.
p.(None): Art. 35. CTNBio will adopt the necessary measures to protect confidential information, of commercial interest, indicated by the proponent and so on.
p.(None): considered, provided that no constitutionally guaranteed private or collective interests fall on that information.
p.(None): § 1 In order to safeguard the confidentiality referred to in the caput of this article, the applicant must address to the President of CTNBio an express request and
p.(None): reasoned, containing the specification of the information whose confidentiality it intends to protect.
p.(None): § 2 The request will be rejected by reasoned order, against which the plenary may appeal, in a procedure to be established in the bylaws
p.(None): CTNBio's internal system, guaranteeing the required confidentiality until the final decision to the contrary.
p.(None): § 3 The applicant may choose to withdraw from the case, if his request for secrecy has been definitively denied, in which case CTNBio will be prohibited from giving
p.(None): advertising the information subject to the intended confidentiality.
p.(None): Article 36. The registration and inspection bodies and entities will request access to certain confidential information, as long as it is indispensable for the exercise of their duties.
p.(None): functions, in a petition that will substantiate the request and indicate the agent who will have access to it.
p.(None): Section VI
p.(None): Technical Decision
p.(None): Art. 37. As for the biosafety aspects of GMOs and their derivatives, CTNBio's technical decision is binding on the other management bodies and entities.
p.(None): Art. 38. In cases of commercial use, among other technical aspects of its analysis, the registration and inspection bodies, in the exercise of their duties in
p.(None): upon request by CTNBio, they will observe, regarding the biosafety aspects of GMOs and their derivatives, the technical decision of CTNBio.
p.(None): Art. 39. In the event of a favorable technical decision on biosafety within the scope of the research activity, CTNBio will send the respective process to the agencies and
p.(None): registration and inspection entities, for the exercise of their duties.
p.(None): Art. 40. CTNBio's technical decision must contain a summary of its technical basis, explain the security measures and restrictions on the use of GMOs and their
p.(None): derivatives and consider the particularities of the different regions of the country, with the objective of guiding and subsidizing registration and inspection bodies and entities, in the
p.(None): exercise of its duties.
p.(None): Art. 41. The derivative whose GMO has already been approved by CTNBio will not be submitted to analysis and issue of technical opinion by CTNBio.
p.(None): Art. 42. Individuals or legal entities involved in any of the phases of the agricultural production, commercialization or product transportation process
p.(None): genetically modified products that have been released for commercial use are exempted from presenting the CQB and constituting CIBio, unless
p.(None): contrary to CTNBio.
p.(None): Section VII
p.(None): Public Hearings
p.(None): Art. 43. CTNBio may hold public hearings, ensuring the participation of civil society, which will be required:
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.(None): Civil House
p.(None): Sub-branch for Legal Affairs
p.(None): DECREE No. 5,591, OF NOVEMBER 22, 2005.
p.(None): Regulates provisions of Law No. 11,105, of March 24, 2005, which
p.(None): regulates items II, IV and V of § 1 of art. 225 of the Constitution, and gives other
p.(None): measures.
p.(None): THE PRESIDENT OF THE REPUBLIC, in the use of the powers conferred on him by art. 84, items IV and VI, item "a", of the Constitution, and in view of the provisions of Law
p.(None): 11,105, of March 24, 2005,
p.(None): DECREE:
p.(None): CHAPTER I
p.(None): PRELIMINARY AND GENERAL PROVISIONS
p.(None): Art. 1 This Decree regulates provisions of Law 11,105, of March 24, 2005, which establishes security rules and inspection mechanisms on
p.(None): construction, cultivation, production, handling, transport, transfer, import, export, storage, research, marketing,
p.(None): consumption, release into the environment and the disposal of genetically modified organisms - GMOs and their derivatives, with the guidelines of stimulating progress
p.(None): in the area of biosafety and biotechnology, the protection of human, animal and plant life and health, and the observance of the precautionary principle for protection
p.(None): of the environment, as well as rules for use upon authorization of embryonic stem cells obtained from human embryos produced by in vitro fertilization
p.(None): and not used in the respective procedure, for research and therapy purposes.
p.(None): Art. 2 The activities and projects involving GMOs and their derivatives, related to teaching with manipulation of living organisms, scientific research,
p.(None): technological development and industrial production are restricted to the scope of public or private entities, which will be responsible for
p.(None): precepts of Law No. 11,105, of 2005, of this Decree and of complementary norms, as well as for the eventual consequences or effects arising from its
p.(None): non-compliance.
p.(None): § 1 For the purposes of this Decree, activities and projects within the scope of an entity are considered to be carried out in its own facilities or under the responsibility of
p.(None): administrative, technical or scientific entity.
p.(None): § 2 The activities and projects referred to in this article are prohibited to individuals in autonomous and independent activities, even if they maintain a bond
p.(None): employment or any other with legal entities.
p.(None): Paragraph 3. Those interested in carrying out the activity provided for in this Decree must request authorization from the National Technical Commission on Biosafety - CTNBio, which
p.(None): will manifest within the period established in a specific rule.
p.(None): Art. 3 For the purposes of this Decree, it is considered:
p.(None): I - research activity: that carried out in the laboratory, containment regime or field, as part of the process of obtaining GMOs and their derivatives or of
p.(None): evaluation of the biosafety of GMOs and their derivatives, which includes, in the experimental scope, the construction, cultivation, handling, transport, transfer,
p.(None): import, export, storage, release into the environment and disposal of GMOs and their derivatives;
p.(None): II - activity for commercial use of GMOs and their derivatives: that which does not fit as a research activity, and which deals with cultivation, production, handling,
p.(None): transport, transfer, commercialization, import, export, storage, consumption, release and disposal of GMOs and their
p.(None): derivatives for commercial purposes;
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): transport, transfer, commercialization, import, export, storage, consumption, release and disposal of GMOs and their
p.(None): derivatives for commercial purposes;
p.(None): III - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): IV - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): V - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying natural or synthetic DNA / RNA segments
p.(None): and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; the segments of
p.(None): Synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): VI - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): VII - genetically modified organism - GMO: an organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VIII - derived from GMOs: product obtained from GMOs and that does not have autonomous capacity for replication or that does not contain a viable form of GMOs;
p.(None): IX - human germ cell: mother cell responsible for the formation of gametes present in the female and male sex glands and their descendants
p.(None): direct in any degree of ploidy;
p.(None): X - in vitro fertilization: the fusion of gametes performed by any extracorporeal fertilization technique;
p.(None): XI - cloning: asexual reproduction process, artificially produced, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): XII - embryonic stem cells: embryo cells that have the ability to transform into cells of any tissue in an organism;
p.(None): XIII - non-viable embryos: those with genetic alterations confirmed by preimplantation diagnosis, according to specific norms established by the
p.(None): Ministry of Health, which had its development interrupted due to spontaneous absence of cleavage after a period longer than twenty-four hours from the
p.(None): in vitro fertilization, or with morphological changes that compromise the full development of the embryo;
p.(None): XIV - frozen embryos available: those frozen until March 28, 2005, after three years from the date of their
p.(None): freezing;
p.(None): XV - parents: end users of in vitro fertilization;
p.(None): XVI - registration and inspection bodies and entities: those referred to in the caput of art. 53;
p.(None): XVII - genetic technologies for use restriction: any human intervention process for the generation or multiplication of genetically modified plants
p.(None): to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at activating or deactivating genes related to
p.(None): plant fertility by external chemical inducers.
p.(None): § 1 The GMO category does not include the result of techniques that involve the direct introduction of hereditary material into an organism, provided that
p.(None): involve the use of recombinant DNA / RNA or GMO molecules, including in vitro fertilization, conjugation, transduction, transformation, polyploid induction and
p.(None): any other natural process.
p.(None): § 2 The category of GMO derivative does not include the pure, chemically defined substance obtained through biological processes and which does not contain GMOs,
p.(None): heterologous protein or recombinant DNA.
p.(None): CHAPTER II
p.(None): OF THE NATIONAL TECHNICAL COMMISSION ON BIOSAFETY
p.(None): Art. 4 CTNBio, member of the Ministry of Science and Technology, is a multidisciplinary collegiate body of an advisory and deliberative nature, to provide support
p.(None): technical and advisory services to the Federal Government in the formulation, updating and implementation of the National Biosafety Policy - GMO GNP and its
p.(None): derivatives, as well as in the establishment of technical safety standards and technical opinions regarding authorization for activities involving research and
p.(None): commercial use of GMOs and their derivatives, based on the assessment of their zoofitosanitary risk, to human health and to the environment.
p.(None): Single paragraph. CTNBio should monitor the development and technical and scientific progress in the areas of biosafety, biotechnology, bioethics and the like,
p.(None): with the objective of increasing its capacity to protect human health, animals and plants and the environment.
p.(None): Section I
p.(None): Assignments
p.(None): Art. 5 CTNBio is responsible for:
p.(None): I - establish rules for research with GMOs and their derivatives;
p.(None): II - establish rules regarding activities and projects related to GMOs and their derivatives;
p.(None): III - establish, within the scope of its competences, criteria for assessing and monitoring the risk of GMOs and their derivatives;
p.(None): IV - proceed with the analysis of the risk assessment, case by case, in relation to activities and projects involving GMOs and their derivatives;
p.(None): V - establish the functioning mechanisms of the Internal Biosafety Commissions - CIBio, within the scope of each institution that dedicates itself to teaching,
p.(None): scientific research, technological development and industrial production involving GMOs and their derivatives;
p.(None): VI - establish requirements related to biosafety for authorization to operate a laboratory, institution or company that will develop activities
p.(None): related to GMOs and their derivatives;
p.(None): VII - relate to institutions focused on the biosafety of GMOs and their derivatives, at national and international levels;
p.(None): VIII - authorize, register and monitor research activities with GMOs and their derivatives, under the terms of the legislation in force;
p.(None): IX - authorize the importation of GMOs and their derivatives for research activities;
...
p.(None): XVI - issue resolutions, of a normative nature, on matters within its competence;
p.(None): XVII - provide technical support to the competent bodies in the process of prevention and investigation of accidents and illnesses, verified in the course of projects and
p.(None): activities with recombinant DNA / RNA techniques;
p.(None): XVIII - provide technical support to registration and inspection bodies and entities, in the exercise of their activities related to GMOs and their derivatives;
p.(None): XIX - disseminate in the Official Gazette of the Union, prior to the analysis, extracts of the claims and, subsequently, of the opinions of the processes submitted to it,
p.(None): as well as giving wide publicity in the Biosafety Information System - SIB to its agenda, processes in process, annual reports, minutes of meetings and
p.(None): other information about its activities, excluding confidential information, of commercial interest, pointed out by the applicant and so considered by him;
p.(None): XX - identify activities and products resulting from the use of GMOs and their derivatives that potentially cause degradation of the environment or that may
p.(None): cause risks to human health;
p.(None): XXI - reassess its technical decisions at the request of its members or by appeal by the registration and inspection bodies and entities, based on facts or
p.(None): new scientific knowledge, relevant to the biosafety of GMOs and their derivatives;
p.(None): XXII - to propose the carrying out of research and scientific studies in the field of biosafety of GMOs and their derivatives;
p.(None): XXIII - present a proposal for its internal regulations to the Minister of State for Science and Technology.
p.(None): Single paragraph. The reassessment referred to in item XXI of this article will be requested to the President of CTNBio in a petition that will contain the name and qualification of the
p.(None): requesting party, the reasoned statement with a description of the facts or a report of the new scientific knowledge that provided it and the request for a new decision regarding the
p.(None): biosafety of GMOs and their derivatives to which they refer.
p.(None): Section II
p.(None): Composition
p.(None): Art. 6 CTNBio, composed of full and alternate members, designated by the Minister of State for Science and Technology, will consist of twenty-seven
p.(None): Brazilian citizens of recognized technical competence, notorious performance and scientific knowledge, with an academic degree as a doctor and with outstanding professional activity
p.(None): in the areas of biosafety, biotechnology, biology, human and animal health or the environment, being:
p.(None): I - twelve specialists of notorious scientific and technical knowledge, in effective professional practice, being:
p.(None): a) three in the area of human health;
p.(None): b) three from the animal area;
p.(None): c) three from the plant area;
p.(None): d) three from the environmental area;
p.(None): II - one representative from each of the following bodies, appointed by the respective holders:
p.(None): a) Ministry of Science and Technology;
p.(None): b) Ministry of Agriculture, Livestock and Supply;
p.(None): c) Ministry of Health;
p.(None): d) Ministry of the Environment;
p.(None): e) Ministry of Agrarian Development;
p.(None): f) Ministry of Development, Industry and Foreign Trade;
p.(None): g) Ministry of Defense;
p.(None): h) Ministry of Foreign Affairs;
p.(None): i) Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic;
p.(None): III - a consumer protection specialist, appointed by the Minister of State for Justice;
p.(None): IV - a specialist in the health field, appointed by the Minister of State for Health;
p.(None): V - an expert on the environment, appointed by the Minister of State for the Environment;
p.(None): VI - a biotechnology specialist, appointed by the Minister of State for Agriculture, Livestock and Supply;
p.(None): VII - a specialist in family farming, appointed by the Minister of State for Agrarian Development;
p.(None): VIII - a specialist in occupational health, appointed by the Minister of State for Labor and Employment.
p.(None): Single paragraph. Each effective member will have an alternate, who will participate in the work in the absence of the holder.
p.(None): Art. 7 The specialists referred to in item I of art. 6th will be chosen from a triple list of members and alternates.
p.(None): Single paragraph. The Minister of State for Science and Technology will set up an ad hoc commission, made up of members external to CTNBio, representatives of
p.(None): scientific societies, the Brazilian Society for the Progress of Science - SBPC and the Brazilian Academy of Sciences - ABC, in charge of preparing the list
p.(None): the triple of which the caput of this article deals, within up to thirty days of its constitution.
p.(None): Art. 8 The representatives referred to in item II of art. 6, and their alternates, shall be appointed by the members of the respective bodies within thirty days from the date
p.(None): notice of the Minister of State for Science and Technology.
p.(None): Art. 9 The indication of the specialists dealt with in items III to VIII of art. 6th will be made by the respective Ministers of State, based on a triple list prepared
p.(None): civil society organizations with legal personality, whose social objective is compatible with the specialization provided for in those items, in
p.(None): procedure to be defined by the respective Ministries.
p.(None): Art. 10. Consultations with civil society organizations, for the purposes referred to in art. 9, must be held sixty days before the end of the mandate of the
p.(None): member to be replaced.
p.(None): Art. 11. The appointment of any CTNBio member due to vacancy will obey the same procedures to which the ordinary appointment is
p.(None): submitted.
p.(None): Art. 12. CTNBio members will have a two-year term, renewable for up to two more consecutive periods.
p.(None): Single paragraph. The period of the alternate member term of office is continuous, even if he assumes the term of office.
p.(None): Art. 13. The expenses with transportation, meals and accommodation for CTNBio members will be the responsibility of the Ministry of Science and Technology.
p.(None): Single paragraph. The functions and activities developed by CTNBio members will be considered highly relevant and honorable.
p.(None): Art. 14. CTNBio members must guide their performance by strict observance of ethical-professional concepts, being forbidden to participate in the judgment of
p.(None): issues with which they have some professional or personal involvement, under penalty of loss of mandate.
p.(None): § 1 The CTNBio member, upon taking office, will sign a declaration of conduct, explaining any conflict of interest, in the form of the internal regulations.
p.(None): Paragraph 2. The CTNBio member must manifest his eventual impediment in the processes distributed to him for analysis, upon receipt, or, when
p.(None): is not the rapporteur, at the time of deliberations at subcommittee or plenary meetings.
p.(None): § 3º The CTNBio member or the one legitimized as interested may argue the impediment, under the terms of art. 9 of Law No. 9,784, of January 29, 1999.
p.(None): § 4 The impediment argument will be formalized in a reasoned and duly instructed petition, and will be decided by the CTNBio plenary.
p.(None): § 5 The technical decision in which the vote of a member declared impeded has been decisive for the outcome of the judgment is null.
p.(None): § 6 The CTNBio plenary, when deciding on the impediment, will issue a new technical decision, in which it will expressly regulate the object of the defective decision and the effects
p.(None): arising from it, since its publication.
p.(None): Art. 15. The President of CTNBio and his replacement will be appointed, among its members, by the Minister of State for Science and Technology, from a list
p.(None): triple voted by the plenary.
p.(None): Paragraph 1. The mandate of the President of CTNBio will be for two years, renewable for the same period.
p.(None): § 2 The CTNBio President is responsible for, among other duties to be defined in the internal regulations:
p.(None): I - represent CTNBio;
p.(None): II - preside over the CTNBio plenary meeting;
p.(None): III - delegate their duties;
p.(None): IV - determine the provision of information and grant access to documents, requested by the registration and inspection bodies.
p.(None): Section III
p.(None): Administrative Structure
p.(None): Art. 16. CTNBio will have an Executive Secretariat, with the Ministry of Science and Technology providing technical and administrative support.
p.(None): Single paragraph. It is incumbent upon the CTNBio Executive Secretariat, among other duties to be defined in the bylaws:
p.(None): I - provide technical and administrative support to CTNBio members;
p.(None): II - receive, instruct and process the requests submitted to CTNBio's decision;
p.(None): III - forward CTNBio's deliberations to the government agencies responsible for their implementation and provide the necessary publicity;
p.(None): IV - update the SIB.
p.(None): Art. 17. CTNBio will set up permanent sectoral subcommittees in the area of human health, animal, plant and environmental areas, and may
p.(None): set up extraordinary subcommittees, for prior analysis of the topics to be submitted to the plenary.
p.(None): § 1 Full and alternate members will participate in the sectoral subcommittees, and the distribution of the processes for analysis may be made to any of them.
p.(None): § 2 The operation and coordination of work in the sectoral and extraordinary subcommittees will be defined in the CTNBio internal regulations.
p.(None): Section IV
p.(None): Meetings and Resolutions
p.(None): Art. 18. The alternate member will have the right to speak and, in the absence of the respective holder, to vote in the deliberations.
p.(None): Art. 19. The CTNBio meeting may be installed with the presence of fourteen of its members, including at least one representative from each of the areas
p.(None): referred to in item I of art. 6th.
p.(None): Single paragraph. CTNBio's decisions will be taken with votes in favor of the absolute majority of its members, except in the commercial release processes
p.(None): GMOs and derivatives, for which the decision will be required to be taken with favorable votes from at least two thirds of the members.
p.(None): Art. 20. A member who:
p.(None): I - violate the provisions of art. 14;
p.(None): II - not attending three consecutive ordinary meetings of the CTNBio plenary, without justification.
p.(None): Art. 21. CTNBio will meet, on an ordinary basis, once a month and, extraordinarily, at any time, when convened by its President or by
p.(None): reasoned request signed by an absolute majority of its members.
p.(None): Single paragraph. The periodicity of ordinary meetings may, exceptionally, be changed by resolution of CTNBio.
p.(None): Art. 22. CTNBio meetings will be recorded, and the respective minutes, when deciding on requests, must contain a menu indicating the process number,
p.(None): interested party, object, motivation of the decision, possible divergence and result.
p.(None): Art. 23. The extracts of the claim must be published in the Official Gazette of the Union and in the SIB, at least thirty days in advance of being placed on the agenda, Art.
p.(None): except for urgent cases, which will be defined by the CTNBio President.
p.(None): Art. 24. Extracts of opinion and technical decisions must be published in the Federal Official Gazette.
p.(None): Single paragraph. The reasoned votes of each member must be included in the SIB.
p.(None): Art. 25. The bodies and entities that are part of the federal public administration may request participation in CTNBio meetings to deal with matters of their
p.(None): special interest, without voting rights.
p.(None): Single paragraph. The request to the CTNBio Executive Secretariat must be accompanied by justification that demonstrates the motivation and demonstrates the interest of the
p.(None): applicant in the biosafety of GMOs and their derivatives submitted to the decision of CTNBio.
p.(None): Art. 26. Representatives of the scientific community, the public sector and entities of the
p.(None): civil society without voting rights.
p.(None): Section V
p.(None): Proceedings of Processes
p.(None): Art. 27. The processes pertinent to the competences of CTNBio, dealt with in items IV, VIII, IX, XII, and XXI of art. 5, will obey the procedure defined in this
p.(None): Section.
p.(None): Art. 28. The application filed with the Executive Secretariat of CTNBio, after being assessed and duly instructed, will have its previous extract published in the Diário
p.(None): Union Official and published in the SIB.
p.(None): Art. 29. The process will be distributed to one of the members, incumbent or alternate, for reporting and preparing an opinion.
p.(None): Art. 30. The opinion will be submitted to one or more permanent or extraordinary sector subcommittees for the formation and approval of the final opinion.
p.(None): Art. 31. The final opinion, after its approval in the sectoral or extraordinary subcommittees to which the process was distributed, will be forwarded to the plenary
p.(None): CTNBio for deliberation.
p.(None): Art. 32. The unsuccessful vote of a member of a permanent or extraordinary sectoral subcommittee must be presented in an express and reasoned manner and shall be
...
p.(None): CHAPTER V
p.(None): OF THE BIOSAFETY INFORMATION SYSTEM
p.(None): Art. 58. The SIB, linked to the Executive Secretariat of CTNBio, is intended for the management of information resulting from analysis, authorization, registration,
p.(None): monitoring and follow-up of activities involving GMOs and their derivatives.
p.(None): § 1 The provisions of legal, regulatory and administrative acts that alter, complement or produce effects on the biosafety legislation of
p.(None): GMOs and their derivatives must be disclosed in the SIB concurrently with the entry into force of these acts.
p.(None): § 2 The registration and inspection bodies and entities shall supply the SIB with information related to the activities covered by this Decree, processed in the
p.(None): within its competence.
p.(None): Art. 59. CTNBio will give wide publicity to its activities through the SIB, among which, its work agenda, calendar of meetings, processes in
p.(None): proceedings and their respective rapporteurs, annual reports, minutes of meetings and other information about their activities, excluding only confidential information,
p.(None): commercial interest, so considered by it.
p.(None): Art. 60. The SIB will allow electronic interaction between CNBS, CTNBio and the federal agencies and entities responsible for the registration and inspection of GMOs.
p.(None): CHAPTER VI
p.(None): OF INTERNAL BIOSAFETY COMMITTEES - CIBio
p.(None): Art. 61. The institution that dedicates itself to teaching, scientific research, technological development and industrial production, using techniques and methods of
p.(None): genetic engineering or carry out research with GMOs and their derivatives, should create an Internal Biosafety Commission - CIBio, whose
p.(None): functioning will be established by CTNBio.
p.(None): Single paragraph. The institution referred to in the caput of this article will appoint a principal technician responsible for each specific project.
p.(None): Art. 62. CIBio is responsible, within the scope of each institution:
p.(None): I - keep workers and other members of the community informed, when they are likely to be affected by the activity, on issues related to
p.(None): health and safety, as well as on accident procedures;
p.(None): II - establish preventive and inspection programs to guarantee the functioning of the facilities under its responsibility, within the standards and norms of
p.(None): biosafety, defined by CTNBio;
p.(None): III - forward to CTNBio the documents whose relationship will be established by it, for the purposes of analysis, registration or authorization by the competent body, when
p.(None): fit;
p.(None): IV - keep a record of the individual monitoring of each activity or project under development involving GMOs and their derivatives;
p.(None): V - notify CTNBio, the registration and inspection bodies and entities and workers' entities the result of risk assessments to which they are subjected
p.(None): exposed persons, as well as any accident or incident that may cause the spread of biological agents;
p.(None): VI - investigate the occurrence of accidents and illnesses possibly related to GMOs and their derivatives and notify their conclusions and measures to the
p.(None): CTNBio.
p.(None): CHAPTER VII
p.(None): STEM CELL RESEARCH AND THERAPY
p.(None): HUMAN EMBIONARIES OBTAINED BY FERTILIZATION
p.(None): IN VITRO
p.(None): Art. 63. For research and therapy purposes, the use of embryonic stem cells obtained from human embryos produced by in vitro fertilization and
p.(None): not used in the respective procedure, provided the following conditions are met:
...
p.(None): conclusions and actions to CTNBio;
p.(None): XXVII - producing, storing, transporting, trading, importing or exporting GMOs and their derivatives, without authorization or in breach of regulations
p.(None): established by CTNBio and by the registration and inspection bodies and entities.
p.(None): Section II
p.(None): Administrative Sanctions
p.(None): Art. 70. Administrative infractions, regardless of precautionary measures to seize products, suspend product sales and
p.(None): activities, will be punished with the following sanctions:
p.(None): I - warning;
p.(None): II - fine;
p.(None): III - seizure of GMOs and their derivatives;
p.(None): IV - suspension of the sale of GMOs and their derivatives;
p.(None): V - embargo of the activity;
p.(None): VI - partial or total interdiction of the establishment, activity or enterprise;
p.(None): VII - suspension of registration, license or authorization;
p.(None): VIII - cancellation of registration, license or authorization;
p.(None): IX - loss or restriction of tax incentive and benefit granted by the government;
p.(None): X - loss or suspension of participation in a financing line at an official credit institution;
p.(None): XI - intervention in the establishment;
p.(None): XII - prohibition to contract with the public administration, for a period of up to five years.
p.(None): Article 71. For the imposition of the penalty and its gradation, the registration and inspection bodies and entities shall take into account:
p.(None): I - the seriousness of the infraction;
p.(None): II - the offender's record of compliance with agricultural, health, environmental and biosafety rules;
p.(None): III - the economic advantage obtained by the infringer;
p.(None): IV - the economic situation of the offender.
p.(None): Single paragraph. For the purpose of item I, the infractions provided for in this Decree will be classified as light, serious and very serious, according to the following criteria:
p.(None): I - the risk classification of the GMO;
p.(None): II - the means used to achieve the infraction;
p.(None): III - the consequences, actual or potential, for human dignity, human, animal and plant health and for the environment;
p.(None): IV - the offender's guilt.
p.(None): Art. 72. The warning will only be applied to infractions of a light nature.
p.(None): Art. 73. The fine will be applied according to the following gradation:
p.(None): I - from R $ 2,000.00 (two thousand reais) to R $ 60,000.00 (sixty thousand reais) in light infractions;
p.(None): II - from R $ 60,001.00 (sixty thousand and one reais) to R $ 500,000.00 (five hundred thousand reais) in serious infractions;
p.(None): III - from R $ 500,001.00 (five hundred thousand and one reais) to R $ 1,500,000.00 (one million and five hundred thousand reais) in very serious violations.
p.(None): § 1 The fine will be applied twice in cases of recurrence.
p.(None): § 2 The fines may be applied cumulatively with the other sanctions provided for in this Decree.
p.(None): Article 74. The fines provided for in Law No. 11,105, 2005, and in this Decree will be applied by the registration and inspection bodies and entities, in accordance with their
p.(None): respective competences.
p.(None): § 1 The funds collected through the application of fines will be allocated to the registration and inspection bodies and entities that apply the fine.
p.(None): § 2 The inspection bodies and entities of the federal public administration may enter into agreements with States, the Federal District and Municipalities, for the
...
p.(None): Section III
p.(None): Administrative Process
p.(None): Art. 80. Any person, noting the occurrence of administrative infraction, may direct representation to the competent inspection body or entity, for
p.(None): effect of the exercise of police power.
p.(None): Art. 81. Administrative infractions are investigated in a specific administrative process, ensuring the right to ample defense and the adversary.
p.(None): Art. 82. The competent authorities are competent to draw up an infraction notice, institute administrative proceedings and indicate the applicable penalties.
p.(None): of inspection provided for in art. 53.
p.(None): Art. 83. The supervisory authority will forward a copy of the infraction notice to CTNBio.
p.(None): Art. 84. When the infraction constitutes a crime or misdemeanor, or injury to the Public Treasury or the consumer, the supervisory authority will represent with the agency
p.(None): competent to determine administrative and penal responsibilities.
p.(None): Art. 85. The provisions of Law No. 9,784 of 1999 apply to this Decree, as appropriate.
p.(None): CHAPTER IX
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 86. CTNBio, in ninety days after its installation, will define:
p.(None): I - proposal for its internal regulations, to be submitted to the approval of the Minister of State for Science and Technology;
p.(None): II - the risk classes of GMOs;
p.(None): III - the levels of biosafety to be applied to GMOs and their derivatives, observing the GMO risk class.
p.(None): Single paragraph. Until the definition of the GMO risk classes by CTNBio, the table in the Annex to this Decree will be observed for classification purposes.
p.(None): Art. 87. The CNBS Executive Secretariat will submit, within ninety days, a proposal for internal regulations to the collegiate body.
p.(None): Art. 88. GMOs that have obtained a technical decision from CTNBio favorable to their commercial release until March 28, 2005 may be registered and
p.(None): commercialized, in compliance with CNBS Resolution No. 1, of May 27, 2005.
p.(None): Art. 89. The institutions that carry out activities regulated by this Decree must adapt to its provisions within one hundred and twenty days, counted from the
p.(None): publication.
p.(None): Art. 90. The provisions of Law No. 7,802, of July 11, 1989, do not apply to GMOs and their derivatives, except for cases in which they are developed for
p.(None): serve as raw material for the production of pesticides.
p.(None): Art. 91. Foods and food ingredients intended for human or animal consumption that contain or are produced from GMOs and their derivatives
p.(None): should contain information in this sense on their labels, in the form of a specific decree.
p.(None): Art. 92. CTNBio will promote the review and, if necessary, the adequacy of the CQB, of the communications, technical decisions and normative acts, issued under the aegis of the
p.(None): Law No. 8,974, of January 5, 1995, which are not in compliance with Law No. 11,105, of 2005, and this Decree.
p.(None): Article 93. CTNBio and the registration and inspection bodies and entities shall review their deliberations of a normative nature within one hundred and twenty days, counted
p.(None): publication of this Decree, in order to promote its adaptation to the provisions contained therein.
p.(None): Art. 94. This Decree comes into force on the date of its publication.
...
p.(None): Sergio Machado Rezende
p.(None): Marina Silva
p.(None): This text does not replace the one published in the DOU of 11.23.2005
p.(None): ATTACHMENT
p.(None): Risk Classification of Genetically Modified Organisms
p.(None): Risk Class I: comprises the organisms that fulfill the following criteria:
p.(None): A. Receiving or parental organism:
p.(None): - non-pathogenic;
p.(None): - free of adventitious agents;
p.(None): - with a broad documented history of safe use, or the incorporation of biological barriers that, without interfering in the optimal growth in reactor or
p.(None): fermenter, allows limited survival and multiplication, without negative effects on the environment;
p.(None): B. Vector / insert:
p.(None): - it must be adequately characterized and without known harmful sequences;
p.(None): - it should be limited in size, as far as possible, to the genetic sequences necessary to perform the projected function;
p.(None): - it must not increase the stability of the modified organism in the environment;
p.(None): - must be sparsely mobilized;
p.(None): - should not transmit any resistance marker to organisms that, according to available knowledge, do not acquire it naturally;
p.(None): C. Genetically modified organisms:
p.(None): - non-pathogenic;
p.(None): - that offer the same security as the recipient or parental organism in the reactor or fermenter, but with limited survival or multiplication, with no effects
p.(None): negative for the environment;
p.(None): D. Other genetically modified organisms that could be included in Risk Class I, provided they meet the conditions stipulated in item C above:
p.(None): - microorganisms constructed entirely from a single prokaryotic receptor (including plasmids and endogenous viruses) or a single eukaryotic receptor
p.(None): (including their chloroplasts, mitochondria and plasmids, but excluding viruses) and organisms composed entirely of genetic sequences from different
p.(None): species that exchange such sequences through known physiological processes;
p.(None): Risk Class II: all those not included in Risk Class I.
...
Social / Police Officer
Searching for indicator police:
(return to top)
p.(None): § 2 The inspection bodies and entities of the federal public administration may enter into agreements with States, the Federal District and Municipalities, for the
p.(None): execution of services related to the inspection activity provided for in this Decree, allowing the transfer of part of the revenue obtained with the application of fines.
p.(None): Art. 75. The sanctions provided for in items III, IV, V, VI, VII, IX and X of art. 70 will only be applied to infractions of a serious or very serious nature.
p.(None): Art. 76. The sanctions provided for in items VIII, XI and XII of art. 70 will be applied only in very serious violations.
p.(None): Art. 77. If the infringer commits two or more infractions simultaneously, the sanctions imposed on each one will be applied cumulatively.
p.(None): Art. 78. In the case of a continuous infraction, characterized by the permanence of the action or omission initially punished, the respective penalty will be applied
p.(None): daily until its cause ceases, without prejudice to the immediate stoppage of the activity or the interdiction of the laboratory or the institution or company responsible.
p.(None): Art. 79. The registration and inspection bodies and entities may, regardless of the application of administrative sanctions, impose precautionary measures of
p.(None): seizure of products, suspension of product sales and embargoes of activities whenever there is an imminent risk of damage to human dignity, health
p.(None): human, animal and plant life and the environment.
p.(None): Section III
p.(None): Administrative Process
p.(None): Art. 80. Any person, noting the occurrence of administrative infraction, may direct representation to the competent inspection body or entity, for
p.(None): effect of the exercise of police power.
p.(None): Art. 81. Administrative infractions are investigated in a specific administrative process, ensuring the right to ample defense and the adversary.
p.(None): Art. 82. The competent authorities are competent to draw up an infraction notice, institute administrative proceedings and indicate the applicable penalties.
p.(None): of inspection provided for in art. 53.
p.(None): Art. 83. The supervisory authority will forward a copy of the infraction notice to CTNBio.
p.(None): Art. 84. When the infraction constitutes a crime or misdemeanor, or injury to the Public Treasury or the consumer, the supervisory authority will represent with the agency
p.(None): competent to determine administrative and penal responsibilities.
p.(None): Art. 85. The provisions of Law No. 9,784 of 1999 apply to this Decree, as appropriate.
p.(None): CHAPTER IX
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 86. CTNBio, in ninety days after its installation, will define:
p.(None): I - proposal for its internal regulations, to be submitted to the approval of the Minister of State for Science and Technology;
p.(None): II - the risk classes of GMOs;
p.(None): III - the levels of biosafety to be applied to GMOs and their derivatives, observing the GMO risk class.
p.(None): Single paragraph. Until the definition of the GMO risk classes by CTNBio, the table in the Annex to this Decree will be observed for classification purposes.
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.(None): GMOs and their derivatives;
p.(None): XI - issue Biosafety Quality Certificates - CQB for the development of activities with GMOs and their derivatives in a laboratory, institution or
p.(None): company and send a copy of the process to the registration and inspection bodies;
p.(None): XII - issue a technical decision, on a case-by-case basis, on the biosafety of GMOs and their derivatives, within the scope of research activities and commercial use of GMOs and
p.(None): its derivatives, including classification as to the degree of risk and level of biosafety required, as well as required safety measures and restrictions on use;
p.(None): XIII - to define the level of biosafety to be applied to the GMO and its uses, and the respective procedures and safety measures regarding its use, as
p.(None): the rules established in this Decree, as well as regarding its derivatives;
p.(None): XIV - classify GMOs according to the risk class, observing the criteria established in this Decree;
p.(None): XV - to monitor the development and technical-scientific progress in the biosafety of GMOs and their derivatives;
p.(None): XVI - issue resolutions, of a normative nature, on matters within its competence;
p.(None): XVII - provide technical support to the competent bodies in the process of prevention and investigation of accidents and illnesses, verified in the course of projects and
p.(None): activities with recombinant DNA / RNA techniques;
p.(None): XVIII - provide technical support to registration and inspection bodies and entities, in the exercise of their activities related to GMOs and their derivatives;
p.(None): XIX - disseminate in the Official Gazette of the Union, prior to the analysis, extracts of the claims and, subsequently, of the opinions of the processes submitted to it,
p.(None): as well as giving wide publicity in the Biosafety Information System - SIB to its agenda, processes in process, annual reports, minutes of meetings and
p.(None): other information about its activities, excluding confidential information, of commercial interest, pointed out by the applicant and so considered by him;
p.(None): XX - identify activities and products resulting from the use of GMOs and their derivatives that potentially cause degradation of the environment or that may
p.(None): cause risks to human health;
p.(None): XXI - reassess its technical decisions at the request of its members or by appeal by the registration and inspection bodies and entities, based on facts or
p.(None): new scientific knowledge, relevant to the biosafety of GMOs and their derivatives;
p.(None): XXII - to propose the carrying out of research and scientific studies in the field of biosafety of GMOs and their derivatives;
p.(None): XXIII - present a proposal for its internal regulations to the Minister of State for Science and Technology.
p.(None): Single paragraph. The reassessment referred to in item XXI of this article will be requested to the President of CTNBio in a petition that will contain the name and qualification of the
p.(None): requesting party, the reasoned statement with a description of the facts or a report of the new scientific knowledge that provided it and the request for a new decision regarding the
p.(None): biosafety of GMOs and their derivatives to which they refer.
p.(None): Section II
p.(None): Composition
p.(None): Art. 6 CTNBio, composed of full and alternate members, designated by the Minister of State for Science and Technology, will consist of twenty-seven
...
p.(None): Section IV
p.(None): Meetings and Resolutions
p.(None): Art. 18. The alternate member will have the right to speak and, in the absence of the respective holder, to vote in the deliberations.
p.(None): Art. 19. The CTNBio meeting may be installed with the presence of fourteen of its members, including at least one representative from each of the areas
p.(None): referred to in item I of art. 6th.
p.(None): Single paragraph. CTNBio's decisions will be taken with votes in favor of the absolute majority of its members, except in the commercial release processes
p.(None): GMOs and derivatives, for which the decision will be required to be taken with favorable votes from at least two thirds of the members.
p.(None): Art. 20. A member who:
p.(None): I - violate the provisions of art. 14;
p.(None): II - not attending three consecutive ordinary meetings of the CTNBio plenary, without justification.
p.(None): Art. 21. CTNBio will meet, on an ordinary basis, once a month and, extraordinarily, at any time, when convened by its President or by
p.(None): reasoned request signed by an absolute majority of its members.
p.(None): Single paragraph. The periodicity of ordinary meetings may, exceptionally, be changed by resolution of CTNBio.
p.(None): Art. 22. CTNBio meetings will be recorded, and the respective minutes, when deciding on requests, must contain a menu indicating the process number,
p.(None): interested party, object, motivation of the decision, possible divergence and result.
p.(None): Art. 23. The extracts of the claim must be published in the Official Gazette of the Union and in the SIB, at least thirty days in advance of being placed on the agenda, Art.
p.(None): except for urgent cases, which will be defined by the CTNBio President.
p.(None): Art. 24. Extracts of opinion and technical decisions must be published in the Federal Official Gazette.
p.(None): Single paragraph. The reasoned votes of each member must be included in the SIB.
p.(None): Art. 25. The bodies and entities that are part of the federal public administration may request participation in CTNBio meetings to deal with matters of their
p.(None): special interest, without voting rights.
p.(None): Single paragraph. The request to the CTNBio Executive Secretariat must be accompanied by justification that demonstrates the motivation and demonstrates the interest of the
p.(None): applicant in the biosafety of GMOs and their derivatives submitted to the decision of CTNBio.
p.(None): Art. 26. Representatives of the scientific community, the public sector and entities of the
p.(None): civil society without voting rights.
p.(None): Section V
p.(None): Proceedings of Processes
p.(None): Art. 27. The processes pertinent to the competences of CTNBio, dealt with in items IV, VIII, IX, XII, and XXI of art. 5, will obey the procedure defined in this
p.(None): Section.
p.(None): Art. 28. The application filed with the Executive Secretariat of CTNBio, after being assessed and duly instructed, will have its previous extract published in the Diário
p.(None): Union Official and published in the SIB.
p.(None): Art. 29. The process will be distributed to one of the members, incumbent or alternate, for reporting and preparing an opinion.
p.(None): Art. 30. The opinion will be submitted to one or more permanent or extraordinary sector subcommittees for the formation and approval of the final opinion.
p.(None): Art. 31. The final opinion, after its approval in the sectoral or extraordinary subcommittees to which the process was distributed, will be forwarded to the plenary
p.(None): CTNBio for deliberation.
p.(None): Art. 32. The unsuccessful vote of a member of a permanent or extraordinary sectoral subcommittee must be presented in an express and reasoned manner and shall be
p.(None): assigned as a divergent vote in the final opinion for consideration and resolution by the plenary.
p.(None): Art. 33. The processes of commercial release of GMOs and their derivatives will be submitted to all permanent subcommittees.
p.(None): Art. 34. The draftsman of the opinion of subcommittees and the plenary shall consider, in addition to the proposers' reports, the existing scientific literature, as well as
p.(None): studies and other documents filed at public hearings or at CTNBio.
p.(None): Art. 35. CTNBio will adopt the necessary measures to protect confidential information, of commercial interest, indicated by the proponent and so on.
p.(None): considered, provided that no constitutionally guaranteed private or collective interests fall on that information.
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): IV - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): V - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying natural or synthetic DNA / RNA segments
p.(None): and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; the segments of
p.(None): Synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): VI - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): VII - genetically modified organism - GMO: an organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VIII - derived from GMOs: product obtained from GMOs and that does not have autonomous capacity for replication or that does not contain a viable form of GMOs;
p.(None): IX - human germ cell: mother cell responsible for the formation of gametes present in the female and male sex glands and their descendants
p.(None): direct in any degree of ploidy;
p.(None): X - in vitro fertilization: the fusion of gametes performed by any extracorporeal fertilization technique;
p.(None): XI - cloning: asexual reproduction process, artificially produced, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): XII - embryonic stem cells: embryo cells that have the ability to transform into cells of any tissue in an organism;
p.(None): XIII - non-viable embryos: those with genetic alterations confirmed by preimplantation diagnosis, according to specific norms established by the
p.(None): Ministry of Health, which had its development interrupted due to spontaneous absence of cleavage after a period longer than twenty-four hours from the
p.(None): in vitro fertilization, or with morphological changes that compromise the full development of the embryo;
p.(None): XIV - frozen embryos available: those frozen until March 28, 2005, after three years from the date of their
p.(None): freezing;
p.(None): XV - parents: end users of in vitro fertilization;
p.(None): XVI - registration and inspection bodies and entities: those referred to in the caput of art. 53;
p.(None): XVII - genetic technologies for use restriction: any human intervention process for the generation or multiplication of genetically modified plants
p.(None): to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at activating or deactivating genes related to
p.(None): plant fertility by external chemical inducers.
p.(None): § 1 The GMO category does not include the result of techniques that involve the direct introduction of hereditary material into an organism, provided that
p.(None): involve the use of recombinant DNA / RNA or GMO molecules, including in vitro fertilization, conjugation, transduction, transformation, polyploid induction and
p.(None): any other natural process.
p.(None): § 2 The category of GMO derivative does not include the pure, chemically defined substance obtained through biological processes and which does not contain GMOs,
p.(None): heterologous protein or recombinant DNA.
p.(None): CHAPTER II
p.(None): OF THE NATIONAL TECHNICAL COMMISSION ON BIOSAFETY
p.(None): Art. 4 CTNBio, member of the Ministry of Science and Technology, is a multidisciplinary collegiate body of an advisory and deliberative nature, to provide support
p.(None): technical and advisory services to the Federal Government in the formulation, updating and implementation of the National Biosafety Policy - GMO GNP and its
...
p.(None): III - fail to require the presentation of the CQB issued by CTNBio to legal entities that finance or sponsor activities and projects involving GMOs and their
p.(None): derivatives;
p.(None): IV - use, for research and therapy purposes, embryonic stem cells obtained from human embryos produced by in vitro fertilization without the consent of the
p.(None): parents;
p.(None): V - carry out research or therapy activities with human embryonic stem cells without approval from the respective research ethics committee, as
p.(None): norm of the National Health Council;
p.(None): VI - commercialize embryonic stem cells obtained from human embryos produced by in vitro fertilization;
p.(None): VII - use, for research and therapy purposes, embryonic stem cells obtained from human embryos produced by in vitro fertilization without meeting the
p.(None): provisions of Chapter VII;
p.(None): VIII - fail to keep a record of the individual monitoring of each activity or project under development involving GMOs and their derivatives;
p.(None): IX - perform genetic engineering on a living organism in disagreement with the rules of this Decree;
p.(None): X - carry out the in vitro handling of natural or recombinant DNA / RNA in disagreement with the rules provided for in this Decree;
p.(None): XI - carry out genetic engineering in human germ cell, human zygote and human embryo;
p.(None): XII - perform human cloning;
p.(None): XIII - destroy or dispose of GMOs and their by-products in the environment in disagreement with the rules established by CTNBio, by the agencies and entities of
p.(None): registration and inspection and in this Decree;
p.(None): XIV - release GMOs and their derivatives into the environment, within the scope of research activities, without the favorable technical decision of CTNBio, or in disagreement with the
p.(None): norms of this;
p.(None): XV - release GMOs and their derivatives into the environment, within the scope of commercial activity, without the licensing of the responsible environmental agency or entity, when
p.(None): CTNBio considers the activity as potentially causing environmental degradation;
p.(None): XVI - release GMOs and their derivatives into the environment, within the scope of commercial activity, without the approval of CNBS, when the process has been carried out by it
p.(None): avocado;
p.(None): XVII - use, commercialize, register, patent or license genetic technologies to restrict use;
p.(None): XVIII - leave the institution to send an investigation report of an accident occurred in the course of research and projects in the field of genetic engineering within the deadline
p.(None): maximum of five days from the date of the event;
p.(None): XIX - leave the institution to immediately notify CTNBio and the authorities of public health, agricultural defense and the environment about accidents that
p.(None): may cause the spread of GMOs and their derivatives;
p.(None): XX - let the institution adopt the necessary means to fully inform CTNBio, the authorities of public health, the environment, defense
p.(None): agriculture, the community and other employees of the institution or company on the risks to which they may be subject, as well as the procedures to be
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): XII - perform human cloning;
p.(None): XIII - destroy or dispose of GMOs and their by-products in the environment in disagreement with the rules established by CTNBio, by the agencies and entities of
p.(None): registration and inspection and in this Decree;
p.(None): XIV - release GMOs and their derivatives into the environment, within the scope of research activities, without the favorable technical decision of CTNBio, or in disagreement with the
p.(None): norms of this;
p.(None): XV - release GMOs and their derivatives into the environment, within the scope of commercial activity, without the licensing of the responsible environmental agency or entity, when
p.(None): CTNBio considers the activity as potentially causing environmental degradation;
p.(None): XVI - release GMOs and their derivatives into the environment, within the scope of commercial activity, without the approval of CNBS, when the process has been carried out by it
p.(None): avocado;
p.(None): XVII - use, commercialize, register, patent or license genetic technologies to restrict use;
p.(None): XVIII - leave the institution to send an investigation report of an accident occurred in the course of research and projects in the field of genetic engineering within the deadline
p.(None): maximum of five days from the date of the event;
p.(None): XIX - leave the institution to immediately notify CTNBio and the authorities of public health, agricultural defense and the environment about accidents that
p.(None): may cause the spread of GMOs and their derivatives;
p.(None): XX - let the institution adopt the necessary means to fully inform CTNBio, the authorities of public health, the environment, defense
p.(None): agriculture, the community and other employees of the institution or company on the risks to which they may be subject, as well as the procedures to be
p.(None): be taken in the case of accidents with GMOs and their derivatives;
p.(None): XXI - stop creating CIBio, according to CTNBio rules, the institution that uses genetic engineering techniques and methods or conducts research with GMOs and
p.(None): its derivatives;
p.(None): XXII - keep CIBio in operation in disagreement with CTNBio rules;
p.(None): XXIII - let the institution keep workers and other members of the community informed, through CIBio, when they are likely to be affected
p.(None): by activity, on issues related to health and safety, as well as on procedures in case of accidents;
p.(None): XXIV - leave the institution to establish preventive and inspection programs, through CIBio, to guarantee the functioning of the facilities under its
p.(None): responsibility, within the standards and norms of biosafety, defined by CTNBio;
p.(None): XXV - let the institution notify CTNBio, the registration and inspection bodies and entities, and the workers' entities, through CIBio, of the result
p.(None): risk assessments to which exposed persons are subjected, as well as any accident or incident that may cause the dissemination of agents
p.(None): biological;
p.(None): XXVI - leave the institution to investigate the occurrence of accidents and diseases possibly related to GMOs and their derivatives and notify their
p.(None): conclusions and actions to CTNBio;
p.(None): XXVII - producing, storing, transporting, trading, importing or exporting GMOs and their derivatives, without authorization or in breach of regulations
p.(None): established by CTNBio and by the registration and inspection bodies and entities.
p.(None): Section II
p.(None): Administrative Sanctions
...
Social / genetic heritage
Searching for indicator genetic heritage:
(return to top)
p.(None): transport, transfer, commercialization, import, export, storage, consumption, release and disposal of GMOs and their
p.(None): derivatives for commercial purposes;
p.(None): III - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): IV - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): V - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying natural or synthetic DNA / RNA segments
p.(None): and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; the segments of
p.(None): Synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): VI - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): VII - genetically modified organism - GMO: an organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VIII - derived from GMOs: product obtained from GMOs and that does not have autonomous capacity for replication or that does not contain a viable form of GMOs;
p.(None): IX - human germ cell: mother cell responsible for the formation of gametes present in the female and male sex glands and their descendants
p.(None): direct in any degree of ploidy;
p.(None): X - in vitro fertilization: the fusion of gametes performed by any extracorporeal fertilization technique;
p.(None): XI - cloning: asexual reproduction process, artificially produced, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): XII - embryonic stem cells: embryo cells that have the ability to transform into cells of any tissue in an organism;
p.(None): XIII - non-viable embryos: those with genetic alterations confirmed by preimplantation diagnosis, according to specific norms established by the
p.(None): Ministry of Health, which had its development interrupted due to spontaneous absence of cleavage after a period longer than twenty-four hours from the
p.(None): in vitro fertilization, or with morphological changes that compromise the full development of the embryo;
p.(None): XIV - frozen embryos available: those frozen until March 28, 2005, after three years from the date of their
p.(None): freezing;
p.(None): XV - parents: end users of in vitro fertilization;
p.(None): XVI - registration and inspection bodies and entities: those referred to in the caput of art. 53;
p.(None): XVII - genetic technologies for use restriction: any human intervention process for the generation or multiplication of genetically modified plants
p.(None): to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at activating or deactivating genes related to
p.(None): plant fertility by external chemical inducers.
p.(None): § 1 The GMO category does not include the result of techniques that involve the direct introduction of hereditary material into an organism, provided that
p.(None): involve the use of recombinant DNA / RNA or GMO molecules, including in vitro fertilization, conjugation, transduction, transformation, polyploid induction and
p.(None): any other natural process.
...
Social / parents
Searching for indicator parents:
(return to top)
p.(None): VII - genetically modified organism - GMO: an organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VIII - derived from GMOs: product obtained from GMOs and that does not have autonomous capacity for replication or that does not contain a viable form of GMOs;
p.(None): IX - human germ cell: mother cell responsible for the formation of gametes present in the female and male sex glands and their descendants
p.(None): direct in any degree of ploidy;
p.(None): X - in vitro fertilization: the fusion of gametes performed by any extracorporeal fertilization technique;
p.(None): XI - cloning: asexual reproduction process, artificially produced, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): XII - embryonic stem cells: embryo cells that have the ability to transform into cells of any tissue in an organism;
p.(None): XIII - non-viable embryos: those with genetic alterations confirmed by preimplantation diagnosis, according to specific norms established by the
p.(None): Ministry of Health, which had its development interrupted due to spontaneous absence of cleavage after a period longer than twenty-four hours from the
p.(None): in vitro fertilization, or with morphological changes that compromise the full development of the embryo;
p.(None): XIV - frozen embryos available: those frozen until March 28, 2005, after three years from the date of their
p.(None): freezing;
p.(None): XV - parents: end users of in vitro fertilization;
p.(None): XVI - registration and inspection bodies and entities: those referred to in the caput of art. 53;
p.(None): XVII - genetic technologies for use restriction: any human intervention process for the generation or multiplication of genetically modified plants
p.(None): to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at activating or deactivating genes related to
p.(None): plant fertility by external chemical inducers.
p.(None): § 1 The GMO category does not include the result of techniques that involve the direct introduction of hereditary material into an organism, provided that
p.(None): involve the use of recombinant DNA / RNA or GMO molecules, including in vitro fertilization, conjugation, transduction, transformation, polyploid induction and
p.(None): any other natural process.
p.(None): § 2 The category of GMO derivative does not include the pure, chemically defined substance obtained through biological processes and which does not contain GMOs,
p.(None): heterologous protein or recombinant DNA.
p.(None): CHAPTER II
p.(None): OF THE NATIONAL TECHNICAL COMMISSION ON BIOSAFETY
p.(None): Art. 4 CTNBio, member of the Ministry of Science and Technology, is a multidisciplinary collegiate body of an advisory and deliberative nature, to provide support
p.(None): technical and advisory services to the Federal Government in the formulation, updating and implementation of the National Biosafety Policy - GMO GNP and its
p.(None): derivatives, as well as in the establishment of technical safety standards and technical opinions regarding authorization for activities involving research and
...
p.(None): health and safety, as well as on accident procedures;
p.(None): II - establish preventive and inspection programs to guarantee the functioning of the facilities under its responsibility, within the standards and norms of
p.(None): biosafety, defined by CTNBio;
p.(None): III - forward to CTNBio the documents whose relationship will be established by it, for the purposes of analysis, registration or authorization by the competent body, when
p.(None): fit;
p.(None): IV - keep a record of the individual monitoring of each activity or project under development involving GMOs and their derivatives;
p.(None): V - notify CTNBio, the registration and inspection bodies and entities and workers' entities the result of risk assessments to which they are subjected
p.(None): exposed persons, as well as any accident or incident that may cause the spread of biological agents;
p.(None): VI - investigate the occurrence of accidents and illnesses possibly related to GMOs and their derivatives and notify their conclusions and measures to the
p.(None): CTNBio.
p.(None): CHAPTER VII
p.(None): STEM CELL RESEARCH AND THERAPY
p.(None): HUMAN EMBIONARIES OBTAINED BY FERTILIZATION
p.(None): IN VITRO
p.(None): Art. 63. For research and therapy purposes, the use of embryonic stem cells obtained from human embryos produced by in vitro fertilization and
p.(None): not used in the respective procedure, provided the following conditions are met:
p.(None): I - are non-viable embryos; or
p.(None): II - frozen embryos are available.
p.(None): § 1 In any case, the consent of the parents is required.
p.(None): § 2 Research institutions and health services that carry out research or therapy with human embryonic stem cells must submit their projects to
p.(None): appreciation and approval of the respective research ethics committees, in the form of a resolution by the National Health Council.
p.(None): § 3 The sale of biological material referred to in this article is prohibited, and its practice implies the crime typi fi ed in art. 15 of Law No. 9,434, of 4
p.(None): February 1997.
p.(None): Article 64. It is the responsibility of the Ministry of Health to promote the survey and maintain an updated record of human embryos obtained by in vitro fertilization and not used in
p.(None): respective procedure.
p.(None): § 1 The institutions that carry out activities that involve freezing and storage of human embryos must inform, according to the specific norm
p.(None): which will establish deadlines, the necessary data for the identification of non-viable embryos produced in their establishments and of the available frozen embryos.
p.(None): § 2 The Ministry of Health will issue the rule referred to in § 1 within thirty days of the publication of this Decree.
p.(None): Article 65. The National Health Surveillance Agency - ANVISA will establish rules for procedures for the collection, processing, testing, storage,
p.(None): transport, quality control and use of human embryonic stem cells for the purposes of this Chapter.
p.(None): Art. 66. Parents who donate, for research or therapy purposes, human embryonic stem cells obtained in accordance with the provisions of this Chapter,
p.(None): must sign a Free and Informed Consent Form, according to a specific rule of the Ministry of Health.
p.(None): Art. 67. The use, in therapy, of human embryonic stem cells, observing art. 63, will be carried out in accordance with the guidelines of the Ministry of
p.(None): Health for the evaluation of new technologies.
p.(None): CHAPTER VIII
p.(None): CIVIL AND ADMINISTRATIVE RESPONSIBILITY
p.(None): Art. 68. Without prejudice to the application of the penalties provided for in Law No. 11,105, 2005, and in this Decree, those responsible for damage to the environment and third parties
p.(None): will be jointly and severally liable for their indemnity or full reparation, regardless of fault.
p.(None): Section I
p.(None): Administrative Offenses
p.(None): Article 69. An administrative infraction is considered to be any action or omission that violates the rules provided for in Law No. 11,105, 2005, and in this Decree and other provisions
p.(None): relevant legal provisions, in particular:
p.(None): I - carry out an activity or project involving GMOs and their derivatives, related to teaching with manipulation of living organisms, scientific research,
p.(None): technological development and industrial production as an individual working independently;
p.(None): II - carry out research and commercial use of GMOs and their derivatives without authorization from CTNBio or in disagreement with the rules issued by it;
p.(None): III - fail to require the presentation of the CQB issued by CTNBio to legal entities that finance or sponsor activities and projects involving GMOs and their
p.(None): derivatives;
p.(None): IV - use, for research and therapy purposes, embryonic stem cells obtained from human embryos produced by in vitro fertilization without the consent of the
p.(None): parents;
p.(None): V - carry out research or therapy activities with human embryonic stem cells without approval from the respective research ethics committee, as
p.(None): norm of the National Health Council;
p.(None): VI - commercialize embryonic stem cells obtained from human embryos produced by in vitro fertilization;
p.(None): VII - use, for research and therapy purposes, embryonic stem cells obtained from human embryos produced by in vitro fertilization without meeting the
p.(None): provisions of Chapter VII;
p.(None): VIII - fail to keep a record of the individual monitoring of each activity or project under development involving GMOs and their derivatives;
p.(None): IX - perform genetic engineering on a living organism in disagreement with the rules of this Decree;
p.(None): X - carry out the in vitro handling of natural or recombinant DNA / RNA in disagreement with the rules provided for in this Decree;
p.(None): XI - carry out genetic engineering in human germ cell, human zygote and human embryo;
p.(None): XII - perform human cloning;
p.(None): XIII - destroy or dispose of GMOs and their by-products in the environment in disagreement with the rules established by CTNBio, by the agencies and entities of
p.(None): registration and inspection and in this Decree;
p.(None): XIV - release GMOs and their derivatives into the environment, within the scope of research activities, without the favorable technical decision of CTNBio, or in disagreement with the
p.(None): norms of this;
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): Art. 19. The CTNBio meeting may be installed with the presence of fourteen of its members, including at least one representative from each of the areas
p.(None): referred to in item I of art. 6th.
p.(None): Single paragraph. CTNBio's decisions will be taken with votes in favor of the absolute majority of its members, except in the commercial release processes
p.(None): GMOs and derivatives, for which the decision will be required to be taken with favorable votes from at least two thirds of the members.
p.(None): Art. 20. A member who:
p.(None): I - violate the provisions of art. 14;
p.(None): II - not attending three consecutive ordinary meetings of the CTNBio plenary, without justification.
p.(None): Art. 21. CTNBio will meet, on an ordinary basis, once a month and, extraordinarily, at any time, when convened by its President or by
p.(None): reasoned request signed by an absolute majority of its members.
p.(None): Single paragraph. The periodicity of ordinary meetings may, exceptionally, be changed by resolution of CTNBio.
p.(None): Art. 22. CTNBio meetings will be recorded, and the respective minutes, when deciding on requests, must contain a menu indicating the process number,
p.(None): interested party, object, motivation of the decision, possible divergence and result.
p.(None): Art. 23. The extracts of the claim must be published in the Official Gazette of the Union and in the SIB, at least thirty days in advance of being placed on the agenda, Art.
p.(None): except for urgent cases, which will be defined by the CTNBio President.
p.(None): Art. 24. Extracts of opinion and technical decisions must be published in the Federal Official Gazette.
p.(None): Single paragraph. The reasoned votes of each member must be included in the SIB.
p.(None): Art. 25. The bodies and entities that are part of the federal public administration may request participation in CTNBio meetings to deal with matters of their
p.(None): special interest, without voting rights.
p.(None): Single paragraph. The request to the CTNBio Executive Secretariat must be accompanied by justification that demonstrates the motivation and demonstrates the interest of the
p.(None): applicant in the biosafety of GMOs and their derivatives submitted to the decision of CTNBio.
p.(None): Art. 26. Representatives of the scientific community, the public sector and entities of the
p.(None): civil society without voting rights.
p.(None): Section V
p.(None): Proceedings of Processes
p.(None): Art. 27. The processes pertinent to the competences of CTNBio, dealt with in items IV, VIII, IX, XII, and XXI of art. 5, will obey the procedure defined in this
p.(None): Section.
p.(None): Art. 28. The application filed with the Executive Secretariat of CTNBio, after being assessed and duly instructed, will have its previous extract published in the Diário
p.(None): Union Official and published in the SIB.
p.(None): Art. 29. The process will be distributed to one of the members, incumbent or alternate, for reporting and preparing an opinion.
p.(None): Art. 30. The opinion will be submitted to one or more permanent or extraordinary sector subcommittees for the formation and approval of the final opinion.
p.(None): Art. 31. The final opinion, after its approval in the sectoral or extraordinary subcommittees to which the process was distributed, will be forwarded to the plenary
p.(None): CTNBio for deliberation.
p.(None): Art. 32. The unsuccessful vote of a member of a permanent or extraordinary sectoral subcommittee must be presented in an express and reasoned manner and shall be
p.(None): assigned as a divergent vote in the final opinion for consideration and resolution by the plenary.
p.(None): Art. 33. The processes of commercial release of GMOs and their derivatives will be submitted to all permanent subcommittees.
p.(None): Art. 34. The draftsman of the opinion of subcommittees and the plenary shall consider, in addition to the proposers' reports, the existing scientific literature, as well as
p.(None): studies and other documents filed at public hearings or at CTNBio.
p.(None): Art. 35. CTNBio will adopt the necessary measures to protect confidential information, of commercial interest, indicated by the proponent and so on.
p.(None): considered, provided that no constitutionally guaranteed private or collective interests fall on that information.
p.(None): § 1 In order to safeguard the confidentiality referred to in the caput of this article, the applicant must address to the President of CTNBio an express request and
p.(None): reasoned, containing the specification of the information whose confidentiality it intends to protect.
p.(None): § 2 The request will be rejected by reasoned order, against which the plenary may appeal, in a procedure to be established in the bylaws
p.(None): CTNBio's internal system, guaranteeing the required confidentiality until the final decision to the contrary.
p.(None): § 3 The applicant may choose to withdraw from the case, if his request for secrecy has been definitively denied, in which case CTNBio will be prohibited from giving
p.(None): advertising the information subject to the intended confidentiality.
p.(None): Article 36. The registration and inspection bodies and entities will request access to certain confidential information, as long as it is indispensable for the exercise of their duties.
p.(None): functions, in a petition that will substantiate the request and indicate the agent who will have access to it.
p.(None): Section VI
p.(None): Technical Decision
p.(None): Art. 37. As for the biosafety aspects of GMOs and their derivatives, CTNBio's technical decision is binding on the other management bodies and entities.
p.(None): Art. 38. In cases of commercial use, among other technical aspects of its analysis, the registration and inspection bodies, in the exercise of their duties in
p.(None): upon request by CTNBio, they will observe, regarding the biosafety aspects of GMOs and their derivatives, the technical decision of CTNBio.
p.(None): Art. 39. In the event of a favorable technical decision on biosafety within the scope of the research activity, CTNBio will send the respective process to the agencies and
p.(None): registration and inspection entities, for the exercise of their duties.
p.(None): Art. 40. CTNBio's technical decision must contain a summary of its technical basis, explain the security measures and restrictions on the use of GMOs and their
p.(None): derivatives and consider the particularities of the different regions of the country, with the objective of guiding and subsidizing registration and inspection bodies and entities, in the
p.(None): exercise of its duties.
p.(None): Art. 41. The derivative whose GMO has already been approved by CTNBio will not be submitted to analysis and issue of technical opinion by CTNBio.
p.(None): Art. 42. Individuals or legal entities involved in any of the phases of the agricultural production, commercialization or product transportation process
p.(None): genetically modified products that have been released for commercial use are exempted from presenting the CQB and constituting CIBio, unless
p.(None): contrary to CTNBio.
p.(None): Section VII
p.(None): Public Hearings
p.(None): Art. 43. CTNBio may hold public hearings, ensuring the participation of civil society, which will be required:
p.(None): I - by one of its members and approved by an absolute majority, in any event;
p.(None): II - by a party evidently interested in the subject matter of resolution and approved by an absolute majority, in the case of commercial release.
p.(None): Paragraph 1 CTNBio shall publish in the SIB and in the Federal Official Gazette, at least thirty days in advance, the summons for a public hearing, including the
p.(None): subject, date, time and place of work.
p.(None): § 2 The public hearing will be coordinated by the President of CTNBio who, after the objective presentation of the subject matter of the hearing, will open discussions with
p.(None): interested parties present.
p.(None): § 3 After the conclusion of the work of the public hearing, the manifestations, opinions, suggestions and documents will be available to those interested in the Secretariat-
p.(None): CTNBio Executive Board.
p.(None): Paragraph 4. For the purposes of item II of the caput of this article, the interested party is considered the applicant for the process or legal entity whose social objective is related
p.(None): to the areas provided for in the caput and in items III, VII and VIII of article 6.
p.(None): Section VIII
...
p.(None): Environment, and the Presidency of the Republic's Special Secretariat for Aquaculture and Fisheries, among other
p.(None): technical decision of CTNBio, the deliberations of CNBS and the mechanisms established in this Decree:
p.(None): I - supervise the research activities of GMOs and their derivatives;
p.(None): II - register and supervise the commercial release of GMOs and their derivatives;
p.(None): III - issue authorization for the import of GMOs and their derivatives for commercial use;
p.(None): IV - establish rules for registration, authorization, inspection and environmental licensing of GMOs and their derivatives;
p.(None): V - inspect the compliance with the biosafety rules and measures established by CTNBio;
p.(None): VI - promote the training of inspectors and technicians responsible for the registration, authorization, inspection and environmental licensing of GMOs and their derivatives;
p.(None): VII - institute an internal committee specialized in the biosafety of GMOs and their derivatives;
p.(None): VIII - keep the register of institutions and technicians responsible for carrying out activities and projects related to GMOs and their derivatives updated in the SIB;
p.(None): IX - make public, including in the SIB, the environmental registrations, authorizations and licenses granted;
p.(None): X - apply the penalties referred to in this Decree;
p.(None): XI - subsidize CTNBio in the definition of biosafety assessment items for GMOs and their derivatives.
p.(None): § 1 The rules referred to in item IV shall consist, when applicable, of the adaptation to CTNBio's decisions of the procedures, means and actions in force
p.(None): applicable to conventional products.
p.(None): § 2 After a favorable opinion by CTNBio, or CNBS, in case of appeal or appeal, it will be due, due to specific analysis and pertinent decision:
p.(None): I - to the Ministry of Agriculture, Livestock and Supply to issue authorizations and records and to monitor products and activities that use GMOs and their derivatives
p.(None): intended for animal use, in agriculture, livestock, agribusiness and related areas, in accordance with the legislation in force and according to the rules that may be established;
p.(None): II - the competent agency of the Ministry of Health to issue authorizations and registrations and to monitor products and activities with GMOs and their derivatives intended for use
p.(None): human, pharmacological, household cleaning and related areas, in accordance with the legislation in force and the rules that may be established;
p.(None): III - to the competent body of the Ministry of the Environment to issue authorizations and registrations and to inspect products and activities involving GMOs and their derivatives to
p.(None): be released into natural ecosystems, in accordance with the legislation in force and according to the rules that may be established, as well as licensing, in the cases
p.(None): in which CTNBio decides, pursuant to this Decree, that the GMO is a potential cause of significant degradation of the environment;
p.(None): IV - to the Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic to issue authorizations and registrations of products and activities with GMOs and their
p.(None): derivatives intended for use in fishing and aquaculture, in accordance with the legislation in force and according to this Decree and the rules that may be established.
p.(None): Art. 54. CTNBio deliberates, in the last and definitive instance, on the cases in which the activity is potentially or effectively causing environmental degradation,
p.(None): as well as on the need for environmental licensing.
...
General/Other / Manipulable
Searching for indicator manipulated:
(return to top)
p.(None): administrative, technical or scientific entity.
p.(None): § 2 The activities and projects referred to in this article are prohibited to individuals in autonomous and independent activities, even if they maintain a bond
p.(None): employment or any other with legal entities.
p.(None): Paragraph 3. Those interested in carrying out the activity provided for in this Decree must request authorization from the National Technical Commission on Biosafety - CTNBio, which
p.(None): will manifest within the period established in a specific rule.
p.(None): Art. 3 For the purposes of this Decree, it is considered:
p.(None): I - research activity: that carried out in the laboratory, containment regime or field, as part of the process of obtaining GMOs and their derivatives or of
p.(None): evaluation of the biosafety of GMOs and their derivatives, which includes, in the experimental scope, the construction, cultivation, handling, transport, transfer,
p.(None): import, export, storage, release into the environment and disposal of GMOs and their derivatives;
p.(None): II - activity for commercial use of GMOs and their derivatives: that which does not fit as a research activity, and which deals with cultivation, production, handling,
p.(None): transport, transfer, commercialization, import, export, storage, consumption, release and disposal of GMOs and their
p.(None): derivatives for commercial purposes;
p.(None): III - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): IV - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): V - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying natural or synthetic DNA / RNA segments
p.(None): and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; the segments of
p.(None): Synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): VI - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): VII - genetically modified organism - GMO: an organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VIII - derived from GMOs: product obtained from GMOs and that does not have autonomous capacity for replication or that does not contain a viable form of GMOs;
p.(None): IX - human germ cell: mother cell responsible for the formation of gametes present in the female and male sex glands and their descendants
p.(None): direct in any degree of ploidy;
p.(None): X - in vitro fertilization: the fusion of gametes performed by any extracorporeal fertilization technique;
p.(None): XI - cloning: asexual reproduction process, artificially produced, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): XII - embryonic stem cells: embryo cells that have the ability to transform into cells of any tissue in an organism;
p.(None): XIII - non-viable embryos: those with genetic alterations confirmed by preimplantation diagnosis, according to specific norms established by the
p.(None): Ministry of Health, which had its development interrupted due to spontaneous absence of cleavage after a period longer than twenty-four hours from the
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): Art. 76. The sanctions provided for in items VIII, XI and XII of art. 70 will be applied only in very serious violations.
p.(None): Art. 77. If the infringer commits two or more infractions simultaneously, the sanctions imposed on each one will be applied cumulatively.
p.(None): Art. 78. In the case of a continuous infraction, characterized by the permanence of the action or omission initially punished, the respective penalty will be applied
p.(None): daily until its cause ceases, without prejudice to the immediate stoppage of the activity or the interdiction of the laboratory or the institution or company responsible.
p.(None): Art. 79. The registration and inspection bodies and entities may, regardless of the application of administrative sanctions, impose precautionary measures of
p.(None): seizure of products, suspension of product sales and embargoes of activities whenever there is an imminent risk of damage to human dignity, health
p.(None): human, animal and plant life and the environment.
p.(None): Section III
p.(None): Administrative Process
p.(None): Art. 80. Any person, noting the occurrence of administrative infraction, may direct representation to the competent inspection body or entity, for
p.(None): effect of the exercise of police power.
p.(None): Art. 81. Administrative infractions are investigated in a specific administrative process, ensuring the right to ample defense and the adversary.
p.(None): Art. 82. The competent authorities are competent to draw up an infraction notice, institute administrative proceedings and indicate the applicable penalties.
p.(None): of inspection provided for in art. 53.
p.(None): Art. 83. The supervisory authority will forward a copy of the infraction notice to CTNBio.
p.(None): Art. 84. When the infraction constitutes a crime or misdemeanor, or injury to the Public Treasury or the consumer, the supervisory authority will represent with the agency
p.(None): competent to determine administrative and penal responsibilities.
p.(None): Art. 85. The provisions of Law No. 9,784 of 1999 apply to this Decree, as appropriate.
p.(None): CHAPTER IX
p.(None): OF THE FINAL AND TRANSITIONAL PROVISIONS
p.(None): Art. 86. CTNBio, in ninety days after its installation, will define:
p.(None): I - proposal for its internal regulations, to be submitted to the approval of the Minister of State for Science and Technology;
p.(None): II - the risk classes of GMOs;
p.(None): III - the levels of biosafety to be applied to GMOs and their derivatives, observing the GMO risk class.
p.(None): Single paragraph. Until the definition of the GMO risk classes by CTNBio, the table in the Annex to this Decree will be observed for classification purposes.
p.(None): Art. 87. The CNBS Executive Secretariat will submit, within ninety days, a proposal for internal regulations to the collegiate body.
p.(None): Art. 88. GMOs that have obtained a technical decision from CTNBio favorable to their commercial release until March 28, 2005 may be registered and
p.(None): commercialized, in compliance with CNBS Resolution No. 1, of May 27, 2005.
p.(None): Art. 89. The institutions that carry out activities regulated by this Decree must adapt to its provisions within one hundred and twenty days, counted from the
p.(None): publication.
p.(None): Art. 90. The provisions of Law No. 7,802, of July 11, 1989, do not apply to GMOs and their derivatives, except for cases in which they are developed for
p.(None): serve as raw material for the production of pesticides.
...
Orphaned Trigger Words
p.(None): Art. 47. Cases not provided for in this Chapter will be defined by CTNBio's internal regulations.
p.(None): CHAPTER III
p.(None): OF THE NATIONAL BIOSAFETY COUNCIL
p.(None): Art. 48. The CNBS, linked to the Presidency of the Republic, is a superior advisory body to the President of the Republic for the formulation and implementation of the
p.(None): GNP.
p.(None): § 1 CNBS is responsible for:
p.(None): I - establish principles and guidelines for the administrative action of federal bodies and entities with competences on the matter;
p.(None): II - analyze, at the request of CTNBio, as regards the aspects of socioeconomic convenience and opportunity and national interest, requests for release for use
p.(None): commercialization of GMOs and their derivatives;
p.(None): III - summon and decide, in the last and final instance, based on a manifestation by CTNBio and, when deemed necessary, by the registration bodies and entities and
p.(None): inspection, within the scope of its competences, on processes related to activities involving the commercial use of GMOs and their derivatives.
p.(None): Paragraph 2. Whenever CNBS decides in favor of carrying out the activity analyzed, it will forward its manifestation to the registration bodies and entities and
p.(None): inspection.
p.(None): § 3 Whenever CNBS decides contrary to the activity analyzed, it will forward its statement to CTNBio for information to the applicant.
p.(None): Art. 49. The CNBS is composed of the following members:
p.(None): I - Minister of State Chief of Staff of the Presidency of the Republic, who will preside over it;
p.(None): II - Minister of State for Science and Technology;
p.(None): III - Minister of State for Agrarian Development;
p.(None): IV - Minister of State for Agriculture, Livestock and Supply;
p.(None): V - Minister of State for Justice;
p.(None): VI - Minister of State for Health;
p.(None): VII - Minister of State for the Environment;
p.(None): VIII - Minister of State for Development, Industry and Foreign Trade;
p.(None): IX - Minister of State for Foreign Affairs;
p.(None): X - Minister of State for Defense;
p.(None): XI - Special Secretary for Aquaculture and Fisheries of the Presidency of the Republic.
p.(None): § 1 CNBS will meet whenever called by its President or at the provocation of the majority of its members.
p.(None): § 2 CNBS members will be replaced, in their absences or impediments, by the respective Executive Secretaries or, in the absence of the position, by
p.(None): their legal substitutes.
p.(None): § 3 In the absence of the President, he shall appoint a Minister of State to preside over the work.
p.(None): § 4 The CNBS meeting will be installed with the presence of at least six of its members and decisions will be taken by an absolute majority of its members.
p.(None): members.
p.(None): § 5 CNBS 'internal regulations will define the procedures for calling and holding meetings and deliberations.
p.(None): Art. 50. CNBS will decide, at the request of CTNBio, on the aspects of socioeconomic convenience and opportunity and of national interest in the release for use
p.(None): commercialization of GMOs and their derivatives.
p.(None): § 1 CTNBio shall file with the CNBS Executive Secretariat a full copy of the process related to the activity to be analyzed, with an indication of the reasons
p.(None): this referral.
p.(None): § 2 The effectiveness of CTNBio's technical decision, if it was rendered in the specific case, will remain suspended until the final decision of CNBS.
p.(None): § 3 CNBS will decide the request for analysis referred to in the caput within sixty days, counted from the filing date of the request at its Executive Secretariat.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| crime | Illegal Activity |
| embryo | embryo |
| employees | employees |
| family | Motherhood/Family |
| genetic heritage | genetic heritage |
| manipulated | Manipulable |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| party | political affiliation |
| police | Police Officer |
| restricted | Incarcerated |
| single | Marital Status |
| stem cells | stem cells |
| substance | Drug Usage |
| union | Trade Union Membership |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
justice
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input