0A4F4F9BD490A749D5437F821CF06DF1
Biosafety Law 11.105/05 (2005)
http://www.planalto.gov.br/ccivil_03/_ato2004-2006/2005/lei/l11105.htm
http://leaux.net/URLS/ConvertAPI Text Files/C7F6823C14759A3E4A74B111EF550D34.en.txt
Examining the file media/Synopses/C7F6823C14759A3E4A74B111EF550D34.html:
This file was generated: 2020-07-15 04:10:34
| 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): heterologous protein or recombinant DNA.
p.(None): Art. 4 This Law does not apply when genetic modification is obtained through the following techniques, provided that they do not imply the use of GMOs as
p.(None): recipient or donor:
p.(None): I - mutagenesis;
p.(None): II - formation and use of somatic cells from animal hybridoma;
p.(None): III - cell fusion, including that of protoplasm, of plant cells, which can be produced using traditional culture methods;
p.(None): IV - autocloning of non-pathogenic organisms that occurs naturally.
p.(None): Art. 5 It is permitted, 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 - are embryos frozen for 3 (three) years or more, on the date of publication of this Law, or that, already frozen on the date of publication of this Law, after
p.(None): complete 3 (three) years from the date of freezing.
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.
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 February 4
p.(None): 1997.
p.(None): Art. 6 It is prohibited:
p.(None): I - implementation of a project related to GMOs without keeping a record of their individual monitoring;
p.(None): II - genetic engineering in a living organism or the in vitro handling of natural or recombinant DNA / RNA, carried out in disagreement with the rules provided for in this
p.(None): Law;
p.(None): III - genetic engineering in human germ cell, human zygote and human embryo;
p.(None): IV - human cloning;
p.(None): V - destruction or disposal in the environment of GMOs and their derivatives in disagreement with the norms established by CTNBio, by the agencies and entities of
p.(None): registration and inspection, referred to in art. 16 of this Law, and those contained in this Law and its regulations;
p.(None): VI - release into the environment of GMOs or their derivatives, in the scope of research activities, without the favorable technical decision of CTNBio and, in cases of
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
p.(None): activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has
p.(None): been called by him, in the form of this Law and its regulations;
p.(None): VII - the use, commercialization, registration, patenting and licensing of genetic technologies to restrict use.
p.(None): Single paragraph. For the purposes of this Law, genetic technologies for the restriction of use are understood as any human intervention process for the generation or
...
p.(None): to R $ 1,500,000.00 (one million and five hundred thousand reais), in proportion to the seriousness of the violation.
p.(None): § 1 Fines may be applied cumulatively with the other sanctions provided for in this article.
p.(None): § 2 In the event of a repeat offense, the fine will be applied twice.
p.(None): § 3 In the case of a continuous infraction, characterized by the permanence of the action or omission initially punished, the respective penalty will be applied daily
p.(None): until its cause ceases, without prejudice to the immediate interruption of the activity or the interdiction of the laboratory or the institution or company responsible.
p.(None): Art. 23. The fines provided for in this Law will be applied by the registration and inspection bodies and entities of the Ministries of Agriculture, Livestock and Supply,
p.(None): of Health, Environment and the Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic, referred to in art. 16 of this Law, in accordance with its
p.(None): respective competences.
p.(None): § 1 The funds collected with the application of fines will be destined to the registration and inspection bodies and entities, referred to in art. 16 of this Law, which
p.(None): 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): execution of services related to the inspection activity provided for in this Law and may pass on part of the revenue obtained from the application of fines.
p.(None): § 3 The supervisory authority shall forward a copy of the infraction notice to CTNBio.
p.(None): § 4 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): CHAPTER VIII
p.(None): Crimes and Sentences
p.(None): Art. 24. Use human embryo in disagreement with the provisions of art. 5th of this Law:
p.(None): Penalty - imprisonment, from 1 (one) to 3 (three) years, and a fine.
p.(None): Art. 25. Practice genetic engineering in a human germ cell, human zygote or human embryo:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): Art. 26. Perform human cloning:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
p.(None): Art. 27. Releasing or discarding GMOs in the environment, in disagreement with the norms established by CTNBio and by the registration and registration bodies and entities
p.(None): inspection:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): § 1 (VETOED)
p.(None): § 2 The penalty is aggravated:
p.(None): I - from 1/6 (one sixth) to 1/3 (one third), if damage to the property of others results;
p.(None): II - from 1/3 (one third) to half, if damage to the environment results;
p.(None): III - from half to 2/3 (two thirds), if serious bodily injury results in another;
p.(None): IV - from 2/3 (two thirds) to double, if the death of another person results.
p.(None): Art. 28. Use, commercialize, register, patent and license genetic technologies to restrict use:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
...
Health / Drug Usage
Searching for indicator substance:
(return to top)
p.(None): V - genetically modified organism - GMO: organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VI - derived from GMOs: product obtained from GMOs and which does not have an autonomous capacity for replication or which does not contain a viable form of GMOs;
p.(None): VII - 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): VIII - cloning: asexual reproduction process, produced artificially, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): IX - cloning for reproductive purposes: cloning for the purpose of obtaining an individual;
p.(None): X - therapeutic cloning: cloning for the purpose of producing embryonic stem cells for therapeutic use;
p.(None): XI - embryonic stem cells: embryo cells that have the ability to transform into cells in any tissue in an organism.
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): Art. 4 This Law does not apply when genetic modification is obtained through the following techniques, provided that they do not imply the use of GMOs as
p.(None): recipient or donor:
p.(None): I - mutagenesis;
p.(None): II - formation and use of somatic cells from animal hybridoma;
p.(None): III - cell fusion, including that of protoplasm, of plant cells, which can be produced using traditional culture methods;
p.(None): IV - autocloning of non-pathogenic organisms that occurs naturally.
p.(None): Art. 5 It is permitted, 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 - are embryos frozen for 3 (three) years or more, on the date of publication of this Law, or that, already frozen on the date of publication of this Law, after
p.(None): complete 3 (three) years from the date of freezing.
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.
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): Art. 11. CTNBio, composed of full and alternate members, designated by the Minister of State for Science and Technology, will consist of 27 (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 - 12 (twelve) specialists of notorious scientific and technical knowledge, in effective professional practice, being:
p.(None): a) 3 (three) from the human health area;
p.(None): b) 3 (three) of the animal area;
p.(None): c) 3 (three) of the plant area;
p.(None): d) 3 (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) Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic;
p.(None): i) Ministry of Foreign Affairs;
p.(None): III - a consumer protection specialist, appointed by the Minister of Justice;
p.(None): IV - a health specialist, appointed by the Minister of Health;
p.(None): V - an expert on the environment, appointed by the Minister of the Environment;
p.(None): VI - a specialist in biotechnology, appointed by the Minister of Agriculture, Livestock and Supply;
p.(None): VII - a specialist in family farming, appointed by the Minister of Agrarian Development;
p.(None): VIII - a specialist in occupational health, appointed by the Minister of Labor and Employment.
p.(None): § 1 The specialists referred to in item I of the caput of this article will be chosen from a triple list, prepared with the participation of scientific societies,
p.(None): as provided by regulation.
p.(None): § 2 The specialists dealt with in items III to VIII of the caput of this article will be chosen from a triple list, prepared by society organizations
p.(None): civil, as provided by regulation.
p.(None): § 3 Each effective member will have an alternate, who will participate in the work in the absence of the holder.
p.(None): § 4º CTNBio members will have a term of 2 (two) years, renewable for up to 2 more (2) consecutive periods.
p.(None): Paragraph 5. The president of CTNBio will be appointed, among its members, by the Minister of Science and Technology for a term of 2 (two) years, renewable equally.
p.(None): period.
p.(None): § 6 The members of CTNBio must guide their performance by strictly observing the 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, in the form of the regulation.
p.(None): § 7 The CTNBio meeting may be installed with the presence of 14 (fourteen) of its members, including at least one representative from each of the areas
p.(None): referred to in item I of the caput of this article.
p.(None): § 8 (VETOED)
p.(None): § 8-A CTNBio's decisions will be taken with votes in favor of the absolute majority of its members. (Included by Law No. 11,460, of 2007)
p.(None): § 9th Organs 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.
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.(None): II - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): III - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying segments of natural DNA / RNA or
p.(None): synthetic and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; segments are also considered
p.(None): synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): IV - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): V - genetically modified organism - GMO: organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VI - derived from GMOs: product obtained from GMOs and which does not have an autonomous capacity for replication or which does not contain a viable form of GMOs;
p.(None): VII - 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): VIII - cloning: asexual reproduction process, produced artificially, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): IX - cloning for reproductive purposes: cloning for the purpose of obtaining an individual;
p.(None): X - therapeutic cloning: cloning for the purpose of producing embryonic stem cells for therapeutic use;
p.(None): XI - embryonic stem cells: embryo cells that have the ability to transform into cells in any tissue in an organism.
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): Art. 4 This Law does not apply when genetic modification is obtained through the following techniques, provided that they do not imply the use of GMOs as
p.(None): recipient or donor:
p.(None): I - mutagenesis;
p.(None): II - formation and use of somatic cells from animal hybridoma;
p.(None): III - cell fusion, including that of protoplasm, of plant cells, which can be produced using traditional culture methods;
p.(None): IV - autocloning of non-pathogenic organisms that occurs naturally.
p.(None): Art. 5 It is permitted, 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 - are embryos frozen for 3 (three) years or more, on the date of publication of this Law, or that, already frozen on the date of publication of this Law, after
p.(None): complete 3 (three) years from the date of freezing.
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.
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 February 4
p.(None): 1997.
p.(None): Art. 6 It is prohibited:
p.(None): I - implementation of a project related to GMOs without keeping a record of their individual monitoring;
p.(None): II - genetic engineering in a living organism or the in vitro handling of natural or recombinant DNA / RNA, carried out in disagreement with the rules provided for in this
p.(None): Law;
p.(None): III - genetic engineering in human germ cell, human zygote and human embryo;
p.(None): IV - human cloning;
p.(None): V - destruction or disposal in the environment of GMOs and their derivatives in disagreement with the norms established by CTNBio, by the agencies and entities of
p.(None): registration and inspection, referred to in art. 16 of this Law, and those contained in this Law and its regulations;
p.(None): VI - release into the environment of GMOs or their derivatives, in the scope of research activities, without the favorable technical decision of CTNBio and, in cases of
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
p.(None): activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has
p.(None): been called by him, in the form of this Law and its regulations;
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.(None): CHAPTER I
p.(None): PRELIMINARY AND GENERAL PROVISIONS
p.(None): Art. 1 This Law establishes safety rules and inspection mechanisms on construction, cultivation, production, handling, transportation,
p.(None): transfer, import, export, storage, research, marketing, consumption, release into the environment and disposal of organisms
p.(None): genetically modified - GMOs and their derivatives, having as guidelines the stimulation of scientific advancement in the area of biosafety and biotechnology, the protection of life
p.(None): and human, animal and plant health, and observance of the precautionary principle for the protection of the environment.
p.(None): § 1 For the purposes of this Law, research activity is considered to be carried out in the laboratory, containment regime or field, as part of the process of obtaining
p.(None): GMOs and their derivatives or for assessing the biosafety of GMOs and their derivatives, which includes, in the experimental scope, the construction, cultivation, manipulation,
p.(None): transport, transfer, import, export, storage, release into the environment and disposal of GMOs and their derivatives.
p.(None): § 2 For the purposes of this Law, commercial use of GMOs and their by-products is considered to be a research activity, which deals with the
p.(None): cultivation, production, handling, transport, transfer, marketing, import, export, storage, consumption, release
p.(None): and the disposal of GMOs and their derivatives for commercial 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 this Law and its regulation, as well as for any consequences or effects arising from its non-compliance.
p.(None): § 1 For the purposes of this Law, 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 Law must request authorization from the National Technical Commission on Biosafety - CTNBio, which
p.(None): manifest within the period set in the regulation.
p.(None): § 4 - Public and private organizations, national, foreign or international, financing or sponsoring activities or projects referred to in the
p.(None): caput of this article must require the presentation of a Biosafety Quality Certificate, issued by CTNBio, under penalty of becoming co-responsible for the
p.(None): any effects arising from the non-compliance with this Law or its regulations.
p.(None): Art. 3 For the purposes of this Law, it is considered:
p.(None): I - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): II - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): III - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying segments of natural DNA / RNA or
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): caput of this article must require the presentation of a Biosafety Quality Certificate, issued by CTNBio, under penalty of becoming co-responsible for the
p.(None): any effects arising from the non-compliance with this Law or its regulations.
p.(None): Art. 3 For the purposes of this Law, it is considered:
p.(None): I - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): II - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): III - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying segments of natural DNA / RNA or
p.(None): synthetic and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; segments are also considered
p.(None): synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): IV - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): V - genetically modified organism - GMO: organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VI - derived from GMOs: product obtained from GMOs and which does not have an autonomous capacity for replication or which does not contain a viable form of GMOs;
p.(None): VII - 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): VIII - cloning: asexual reproduction process, produced artificially, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): IX - cloning for reproductive purposes: cloning for the purpose of obtaining an individual;
p.(None): X - therapeutic cloning: cloning for the purpose of producing embryonic stem cells for therapeutic use;
p.(None): XI - embryonic stem cells: embryo cells that have the ability to transform into cells in any tissue in an organism.
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): Art. 4 This Law does not apply when genetic modification is obtained through the following techniques, provided that they do not imply the use of GMOs as
p.(None): recipient or donor:
p.(None): I - mutagenesis;
p.(None): II - formation and use of somatic cells from animal hybridoma;
p.(None): III - cell fusion, including that of protoplasm, of plant cells, which can be produced using traditional culture methods;
p.(None): IV - autocloning of non-pathogenic organisms that occurs naturally.
...
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 February 4
p.(None): 1997.
p.(None): Art. 6 It is prohibited:
p.(None): I - implementation of a project related to GMOs without keeping a record of their individual monitoring;
p.(None): II - genetic engineering in a living organism or the in vitro handling of natural or recombinant DNA / RNA, carried out in disagreement with the rules provided for in this
p.(None): Law;
p.(None): III - genetic engineering in human germ cell, human zygote and human embryo;
p.(None): IV - human cloning;
p.(None): V - destruction or disposal in the environment of GMOs and their derivatives in disagreement with the norms established by CTNBio, by the agencies and entities of
p.(None): registration and inspection, referred to in art. 16 of this Law, and those contained in this Law and its regulations;
p.(None): VI - release into the environment of GMOs or their derivatives, in the scope of research activities, without the favorable technical decision of CTNBio and, in cases of
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
p.(None): activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has
p.(None): been called by him, in the form of this Law and its regulations;
p.(None): VII - the use, commercialization, registration, patenting and licensing of genetic technologies to restrict use.
p.(None): Single paragraph. For the purposes of this Law, genetic technologies for the restriction of use are understood as any human intervention process for the generation or
p.(None): multiplication of genetically modified plants to produce sterile reproductive structures, as well as any form of genetic manipulation
p.(None): activation or deactivation of genes related to plant fertility by external chemical inducers.
p.(None): Art. 7 The following are mandatory:
p.(None): I - the investigation of accidents occurring in the course of research and projects in the field of genetic engineering and the sending of a report to the authority
p.(None): competent within a maximum period of 5 (five) days from the date of the event;
p.(None): II - immediate notification to CTNBio and to the authorities of public health, agricultural defense and the environment about accidents that may cause
p.(None): dissemination of GMOs and their derivatives;
p.(None): III - the adoption of the necessary means to fully inform CTNBio, the authorities of public health, the environment, agricultural and livestock defense,
p.(None): collectivity and the other employees of the institution or company on the risks to which they may be submitted, as well as the procedures to be taken in the
p.(None): case of accidents with GMOs.
p.(None): CHAPTER II
p.(None): National Biosafety Council - CNBS
p.(None): Art. 8 The National Biosafety Council - CNBS is created, linked to the Presidency of the Republic, the highest advisory body of the President of the
p.(None): Republic for the formulation and implementation of the National Biosafety Policy - PNB.
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): 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 convened by the Minister of State Chief of Staff of the Presidency of the Republic, or upon provocation by the majority of
p.(None): its members.
p.(None): § 2 (VETOED)
p.(None): Paragraph 3. Representatives of the public sector and civil society entities may be invited to participate in the meetings on an exceptional basis.
p.(None): § 4 CNBS will have an Executive Secretariat, linked to the Civil Office of the Presidency of the Republic.
p.(None): § 5 The CNBS meeting may be installed with the presence of 6 (six) of its members and decisions will be taken with votes in favor of an absolute majority.
p.(None): CHAPTER III
p.(None): From the National Technical Commission on Biosafety - CTNBio
p.(None): Art. 10. 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, update and implementation of the GMO GNP and its derivatives, as well as in the establishment of
p.(None): technical safety standards and technical opinions regarding authorization for activities involving research and commercial use of GMOs and their derivatives,
p.(None): based on the assessment of its zoofytosanitary risk, human health and 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): Art. 11. CTNBio, composed of full and alternate members, designated by the Minister of State for Science and Technology, will consist of 27 (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 - 12 (twelve) specialists of notorious scientific and technical knowledge, in effective professional practice, being:
p.(None): a) 3 (three) from the human health area;
p.(None): b) 3 (three) of the animal area;
p.(None): c) 3 (three) of the plant area;
p.(None): d) 3 (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) Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic;
p.(None): i) Ministry of Foreign Affairs;
...
p.(None): § 2 In the case of commercial use, among other technical aspects of its analysis, the registration and inspection bodies, in the exercise of their duties in the event of
p.(None): As requested by CTNBio, they will observe, regarding the biosafety aspects of the GMO and its derivatives, CTNBio's technical decision.
p.(None): § 3 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): entities referred to in art. 16 of this Law, for the exercise of its duties.
p.(None): § 4 The CTNBio 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,
p.(None): referred to in art. 16 of this Law, in the exercise of its powers.
p.(None): § 5º 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): § 6 The natural or legal persons involved in any of the stages of the process of agricultural production, commercialization or transportation of genetically modified products
p.(None): modified that have obtained the release for commercial use are exempted from the presentation of the CQB and constitution of CIBio, unless otherwise decided by
p.(None): CTNBio.
p.(None): Art. 15. CTNBio may hold public hearings, guaranteed participation of civil society, in accordance with the regulation.
p.(None): Single paragraph. In cases of commercial release, a public hearing may be requested by interested parties, including among these organizations of the
p.(None): civil society that prove interest related to the matter, in the form of the regulation.
p.(None): CHAPTER IV
p.(None): Registration and inspection bodies and entities
p.(None): Art. 16. The registration and inspection bodies and entities of the Ministry of Health, the Ministry of Agriculture, Livestock and Supply and the Ministry of
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 Law and in its regulation:
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 - keep the register of institutions and technical responsible persons that carry out activities and projects related to GMOs and their derivatives updated in the SIB;
p.(None): V - make public, including in the SIB, the registrations and authorizations granted;
p.(None): VI - apply the penalties referred to in this Law;
p.(None): VII - subsidize CTNBio in the definition of biosafety assessment items for GMOs and their derivatives.
p.(None): § 1 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): the risk to which exposed persons are subjected, as well as any accident or incident that may cause the spread of biological agents;
p.(None): VI - investigate the occurrence of accidents and diseases possibly related to GMOs and their derivatives and notify their conclusions and measures to the
p.(None): CTNBio.
p.(None): CHAPTER VI
p.(None): Information System in Biosafety - SIB
p.(None): Article 19. The Biosafety Information System - SIB, created for the management of information, is created within the scope of the Ministry of Science and Technology.
p.(None): arising from the activities of analysis, authorization, registration, monitoring and monitoring 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, referred to in art. 16 of this Law, must supply the SIB with information related to the activities it deals with
p.(None): this Law, processed within the scope of its competence.
p.(None): CHAPTER VII
p.(None): Civil and Administrative Liability
p.(None): Art. 20. Without prejudice to the application of the penalties provided for in this Law, those responsible for damage to the environment and third parties will be jointly and severally liable for
p.(None): their indemnity or full reparation, regardless of fault.
p.(None): Art. 21. Any action or omission that violates the rules provided for in this Law and other relevant legal provisions is considered an administrative infraction.
p.(None): Single paragraph. Administrative infractions will be punished in the manner established in the regulation of this Law, regardless of the precautionary measures of
p.(None): seizure of products, suspension of product sales and activity embargoes, 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 5 (five) years.
p.(None): Art. 22. The registration and inspection bodies and entities, referred to in art. 16 of this Law, to define criteria, values and apply fines of R $ 2,000.00 (two thousand
p.(None): to R $ 1,500,000.00 (one million and five hundred thousand reais), in proportion to the seriousness of the violation.
p.(None): § 1 Fines may be applied cumulatively with the other sanctions provided for in this article.
p.(None): § 2 In the event of a repeat offense, the fine will be applied twice.
p.(None): § 3 In the case of a continuous infraction, characterized by the permanence of the action or omission initially punished, the respective penalty will be applied daily
p.(None): until its cause ceases, without prejudice to the immediate interruption of the activity or the interdiction of the laboratory or the institution or company responsible.
...
p.(None): CHAPTER IX
p.(None): Final and Transitional Provisions
p.(None): Art. 30. GMOs that have obtained a technical decision from CTNBio favorable to their commercial release until the entry into force of this Law may be registered and
p.(None): unless otherwise stated by CNBS, within 60 (sixty) days from the date of publication of this Law.
p.(None): Art. 31. CTNBio and the registration and inspection bodies and entities, referred to in art. 16 of this Law, shall review their deliberations of a normative nature, within the
p.(None): 120 (one hundred and twenty) days, in order to promote its adaptation to the provisions of this Law.
p.(None): Art. 32. Biosafety Quality Certificates remain in effect, communications and technical decisions already issued by CTNBio, as well as, in what does not
p.(None): contrary to the provisions of this Law, normative acts issued under the terms of Law No. 8,974, of January 5, 1995.
p.(None): Art. 33. Institutions that develop activities regulated by this Law on the date of its publication must adapt its provisions within 120
p.(None): (one hundred and twenty) days, counted from the publication of the decree that regulates it.
p.(None): Art. 34. Provisional registrations granted under Law No. 10,814, of December 15, 2003, are valid and permanent.
p.(None): Art. 35. The production and commercialization of genetically modified soybean cultivars tolerant to glyphosate registered in the
p.(None): National Cultivar Registry - RNC of the Ministry of Agriculture, Livestock and Supply.
p.(None): Art. 36. The planting of genetically modified soybeans tolerant to glyphosate is authorized, reserved by rural producers for their own use, in the harvest
p.(None): 2004/2005, and the commercialization of production as seed is prohibited. (See Decree No. 5,534, of 2005)
p.(None): Single paragraph. The Executive Branch may extend the authorization referred to in the caput of this article.
p.(None): Art. 37. The description of Code 20 of Annex VIII of Law No. 6,938, of August 31, 1981, added by Law No. 10,165, of December 27, 2000, becomes
p.(None): take effect with the following wording:
p.(None): "ANNEX VIII
p.(None): Code Category Description Pp / gu
p.(None): ........... ................ ....................... .................................................. ..................................... .............
p.(None): 20 Use of Silviculture; economic exploitation of wood or firewood and Middle
p.(None): Forest by-product resources; import or export of fauna and flora
p.(None): Native Brazilian naturals; activity of creation and economic exploitation of
p.(None): exotic and wild fauna; use of genetic heritage
p.(None): Natural; exploitation of living aquatic resources; introduction of
p.(None): exotic species, except for plant breeding and use
p.(None): in the farming; introduction of genetically modified species
p.(None): previously identified by CTNBio as potentially
p.(None): causing significant degradation of the environment; use of
p.(None): biological diversity by biotechnology in activities previously
p.(None): identified by CTNBio as potentially causing
p.(None): significant degradation of the environment.
p.(None): ........... ................ ....................... .................................................. ...................................... ............ .
p.(None): Art. 38. (VETOED)
p.(None): Art. 39. The provisions of Law No. 7,802, of July 11, 1989, and its amendments do not apply to GMOs and their derivatives, except for cases in which they are
p.(None): developed to serve as raw material for the production of pesticides.
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.(None): execution of services related to the inspection activity provided for in this Law and may pass on part of the revenue obtained from the application of fines.
p.(None): § 3 The supervisory authority shall forward a copy of the infraction notice to CTNBio.
p.(None): § 4 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): CHAPTER VIII
p.(None): Crimes and Sentences
p.(None): Art. 24. Use human embryo in disagreement with the provisions of art. 5th of this Law:
p.(None): Penalty - imprisonment, from 1 (one) to 3 (three) years, and a fine.
p.(None): Art. 25. Practice genetic engineering in a human germ cell, human zygote or human embryo:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): Art. 26. Perform human cloning:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
p.(None): Art. 27. Releasing or discarding GMOs in the environment, in disagreement with the norms established by CTNBio and by the registration and registration bodies and entities
p.(None): inspection:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): § 1 (VETOED)
p.(None): § 2 The penalty is aggravated:
p.(None): I - from 1/6 (one sixth) to 1/3 (one third), if damage to the property of others results;
p.(None): II - from 1/3 (one third) to half, if damage to the environment results;
p.(None): III - from half to 2/3 (two thirds), if serious bodily injury results in another;
p.(None): IV - from 2/3 (two thirds) to double, if the death of another person results.
p.(None): Art. 28. Use, commercialize, register, patent and license genetic technologies to restrict use:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
p.(None): Art. 29. Produce, store, transport, commercialize, import or export GMOs or their derivatives, without authorization or in violation of the rules
p.(None): established by CTNBio and by the registration and inspection bodies and entities:
p.(None): Penalty - imprisonment, from 1 (one) to 2 (two) years, and a fine.
p.(None): CHAPTER IX
p.(None): Final and Transitional Provisions
p.(None): Art. 30. GMOs that have obtained a technical decision from CTNBio favorable to their commercial release until the entry into force of this Law may be registered and
p.(None): unless otherwise stated by CNBS, within 60 (sixty) days from the date of publication of this Law.
p.(None): Art. 31. CTNBio and the registration and inspection bodies and entities, referred to in art. 16 of this Law, shall review their deliberations of a normative nature, within the
p.(None): 120 (one hundred and twenty) days, in order to promote its adaptation to the provisions of this Law.
p.(None): Art. 32. Biosafety Quality Certificates remain in effect, communications and technical decisions already issued by CTNBio, as well as, in what does not
p.(None): contrary to the provisions of this Law, normative acts issued under the terms of Law No. 8,974, of January 5, 1995.
p.(None): Art. 33. Institutions that develop activities regulated by this Law on the date of its publication must adapt its provisions within 120
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
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 referred to in art. 16 of this Law;
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 the regulation of this Law, as well as regarding its derivatives;
p.(None): XIV - classify GMOs according to the risk class, observing the criteria established in the regulation of this Law;
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 - to provide technical support to registration and inspection bodies and entities, referred to in art. 16 of this Law, in the exercise of its activities related to GMOs and
p.(None): its 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 thus considered by CTNBio;
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 registration and inspection bodies and entities, based on facts
p.(None): or new scientific knowledge, relevant to the biosafety of the GMO or derivative, in the form of this Law and its regulation;
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 internal regulations to the Minister of Science and Technology.
p.(None): § 1 As for the biosafety aspects of the GMO and its derivatives, CTNBio's technical decision is binding on the other management bodies and entities.
p.(None): § 2 In the case of commercial use, among other technical aspects of its analysis, the registration and inspection bodies, in the exercise of their duties in the event of
p.(None): As requested by CTNBio, they will observe, regarding the biosafety aspects of the GMO and its derivatives, CTNBio's technical decision.
p.(None): § 3 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): entities referred to in art. 16 of this Law, for the exercise of its duties.
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): offspring;
p.(None): III - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying segments of natural DNA / RNA or
p.(None): synthetic and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; segments are also considered
p.(None): synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): IV - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): V - genetically modified organism - GMO: organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VI - derived from GMOs: product obtained from GMOs and which does not have an autonomous capacity for replication or which does not contain a viable form of GMOs;
p.(None): VII - 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): VIII - cloning: asexual reproduction process, produced artificially, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): IX - cloning for reproductive purposes: cloning for the purpose of obtaining an individual;
p.(None): X - therapeutic cloning: cloning for the purpose of producing embryonic stem cells for therapeutic use;
p.(None): XI - embryonic stem cells: embryo cells that have the ability to transform into cells in any tissue in an organism.
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): Art. 4 This Law does not apply when genetic modification is obtained through the following techniques, provided that they do not imply the use of GMOs as
p.(None): recipient or donor:
p.(None): I - mutagenesis;
p.(None): II - formation and use of somatic cells from animal hybridoma;
p.(None): III - cell fusion, including that of protoplasm, of plant cells, which can be produced using traditional culture methods;
p.(None): IV - autocloning of non-pathogenic organisms that occurs naturally.
p.(None): Art. 5 It is permitted, 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 - are embryos frozen for 3 (three) years or more, on the date of publication of this Law, or that, already frozen on the date of publication of this Law, after
p.(None): complete 3 (three) years from the date of freezing.
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.
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 February 4
p.(None): 1997.
p.(None): Art. 6 It is prohibited:
p.(None): I - implementation of a project related to GMOs without keeping a record of their individual monitoring;
p.(None): II - genetic engineering in a living organism or the in vitro handling of natural or recombinant DNA / RNA, carried out in disagreement with the rules provided for in this
p.(None): Law;
p.(None): III - genetic engineering in human germ cell, human zygote and human embryo;
p.(None): IV - human cloning;
p.(None): V - destruction or disposal in the environment of GMOs and their derivatives in disagreement with the norms established by CTNBio, by the agencies and entities of
p.(None): registration and inspection, referred to in art. 16 of this Law, and those contained in this Law and its regulations;
p.(None): VI - release into the environment of GMOs or their derivatives, in the scope of research activities, without the favorable technical decision of CTNBio and, in cases of
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
p.(None): activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has
p.(None): been called by him, in the form of this Law and its regulations;
p.(None): VII - the use, commercialization, registration, patenting and licensing of genetic technologies to restrict use.
p.(None): Single paragraph. For the purposes of this Law, genetic technologies for the restriction of use are understood as any human intervention process for the generation or
p.(None): multiplication of genetically modified plants to produce sterile reproductive structures, as well as any form of genetic manipulation
p.(None): activation or deactivation of genes related to plant fertility by external chemical inducers.
p.(None): Art. 7 The following are mandatory:
p.(None): I - the investigation of accidents occurring in the course of research and projects in the field of genetic engineering and the sending of a report to the authority
p.(None): competent within a maximum period of 5 (five) days from the date of the event;
...
p.(None): until its cause ceases, without prejudice to the immediate interruption of the activity or the interdiction of the laboratory or the institution or company responsible.
p.(None): Art. 23. The fines provided for in this Law will be applied by the registration and inspection bodies and entities of the Ministries of Agriculture, Livestock and Supply,
p.(None): of Health, Environment and the Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic, referred to in art. 16 of this Law, in accordance with its
p.(None): respective competences.
p.(None): § 1 The funds collected with the application of fines will be destined to the registration and inspection bodies and entities, referred to in art. 16 of this Law, which
p.(None): 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): execution of services related to the inspection activity provided for in this Law and may pass on part of the revenue obtained from the application of fines.
p.(None): § 3 The supervisory authority shall forward a copy of the infraction notice to CTNBio.
p.(None): § 4 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): CHAPTER VIII
p.(None): Crimes and Sentences
p.(None): Art. 24. Use human embryo in disagreement with the provisions of art. 5th of this Law:
p.(None): Penalty - imprisonment, from 1 (one) to 3 (three) years, and a fine.
p.(None): Art. 25. Practice genetic engineering in a human germ cell, human zygote or human embryo:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): Art. 26. Perform human cloning:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
p.(None): Art. 27. Releasing or discarding GMOs in the environment, in disagreement with the norms established by CTNBio and by the registration and registration bodies and entities
p.(None): inspection:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): § 1 (VETOED)
p.(None): § 2 The penalty is aggravated:
p.(None): I - from 1/6 (one sixth) to 1/3 (one third), if damage to the property of others results;
p.(None): II - from 1/3 (one third) to half, if damage to the environment results;
p.(None): III - from half to 2/3 (two thirds), if serious bodily injury results in another;
p.(None): IV - from 2/3 (two thirds) to double, if the death of another person results.
p.(None): Art. 28. Use, commercialize, register, patent and license genetic technologies to restrict use:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
p.(None): Art. 29. Produce, store, transport, commercialize, import or export GMOs or their derivatives, without authorization or in violation of the rules
p.(None): established by CTNBio and by the registration and inspection bodies and entities:
p.(None): Penalty - imprisonment, from 1 (one) to 2 (two) years, and a fine.
p.(None): CHAPTER IX
p.(None): Final and Transitional Provisions
p.(None): Art. 30. GMOs that have obtained a technical decision from CTNBio favorable to their commercial release until the entry into force of this Law may be registered and
p.(None): unless otherwise stated by CNBS, within 60 (sixty) days from the date of publication of this Law.
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
p.(None): activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has
p.(None): been called by him, in the form of this Law and its regulations;
p.(None): VII - the use, commercialization, registration, patenting and licensing of genetic technologies to restrict use.
p.(None): Single paragraph. For the purposes of this Law, genetic technologies for the restriction of use are understood as any human intervention process for the generation or
p.(None): multiplication of genetically modified plants to produce sterile reproductive structures, as well as any form of genetic manipulation
p.(None): activation or deactivation of genes related to plant fertility by external chemical inducers.
p.(None): Art. 7 The following are mandatory:
p.(None): I - the investigation of accidents occurring in the course of research and projects in the field of genetic engineering and the sending of a report to the authority
p.(None): competent within a maximum period of 5 (five) days from the date of the event;
p.(None): II - immediate notification to CTNBio and to the authorities of public health, agricultural defense and the environment about accidents that may cause
p.(None): dissemination of GMOs and their derivatives;
p.(None): III - the adoption of the necessary means to fully inform CTNBio, the authorities of public health, the environment, agricultural and livestock defense,
p.(None): collectivity and the other employees of the institution or company on the risks to which they may be submitted, as well as the procedures to be taken in the
p.(None): case of accidents with GMOs.
p.(None): CHAPTER II
p.(None): National Biosafety Council - CNBS
p.(None): Art. 8 The National Biosafety Council - CNBS is created, linked to the Presidency of the Republic, the highest advisory body of the President of the
p.(None): Republic for the formulation and implementation of the National Biosafety Policy - PNB.
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 bodies and entities referred to in art.
p.(None): 16 of this Law, within the scope of its powers, on the processes related to activities involving the commercial use of GMOs and their derivatives;
p.(None): IV - (VETOED)
p.(None): § 2 (VETOED)
p.(None): § 3 Whenever CNBS decides in favor of carrying out the activity analyzed, it will forward its statement to the registration bodies and entities and
p.(None): inspection referred to in art. 16 of this Law.
p.(None): § 4 Whenever the CNBS decides contrary to the activity analyzed, it will forward its statement to CTNBio for information to the applicant.
p.(None): Art. 9 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;
...
Social / genetic heritage
Searching for indicator genetic heritage:
(return to top)
p.(None): any effects arising from the non-compliance with this Law or its regulations.
p.(None): Art. 3 For the purposes of this Law, it is considered:
p.(None): I - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): II - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): III - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying segments of natural DNA / RNA or
p.(None): synthetic and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; segments are also considered
p.(None): synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): IV - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): V - genetically modified organism - GMO: organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VI - derived from GMOs: product obtained from GMOs and which does not have an autonomous capacity for replication or which does not contain a viable form of GMOs;
p.(None): VII - 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): VIII - cloning: asexual reproduction process, produced artificially, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): IX - cloning for reproductive purposes: cloning for the purpose of obtaining an individual;
p.(None): X - therapeutic cloning: cloning for the purpose of producing embryonic stem cells for therapeutic use;
p.(None): XI - embryonic stem cells: embryo cells that have the ability to transform into cells in any tissue in an organism.
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): Art. 4 This Law does not apply when genetic modification is obtained through the following techniques, provided that they do not imply the use of GMOs as
p.(None): recipient or donor:
p.(None): I - mutagenesis;
p.(None): II - formation and use of somatic cells from animal hybridoma;
p.(None): III - cell fusion, including that of protoplasm, of plant cells, which can be produced using traditional culture methods;
p.(None): IV - autocloning of non-pathogenic organisms that occurs naturally.
...
p.(None): Art. 33. Institutions that develop activities regulated by this Law on the date of its publication must adapt its provisions within 120
p.(None): (one hundred and twenty) days, counted from the publication of the decree that regulates it.
p.(None): Art. 34. Provisional registrations granted under Law No. 10,814, of December 15, 2003, are valid and permanent.
p.(None): Art. 35. The production and commercialization of genetically modified soybean cultivars tolerant to glyphosate registered in the
p.(None): National Cultivar Registry - RNC of the Ministry of Agriculture, Livestock and Supply.
p.(None): Art. 36. The planting of genetically modified soybeans tolerant to glyphosate is authorized, reserved by rural producers for their own use, in the harvest
p.(None): 2004/2005, and the commercialization of production as seed is prohibited. (See Decree No. 5,534, of 2005)
p.(None): Single paragraph. The Executive Branch may extend the authorization referred to in the caput of this article.
p.(None): Art. 37. The description of Code 20 of Annex VIII of Law No. 6,938, of August 31, 1981, added by Law No. 10,165, of December 27, 2000, becomes
p.(None): take effect with the following wording:
p.(None): "ANNEX VIII
p.(None): Code Category Description Pp / gu
p.(None): ........... ................ ....................... .................................................. ..................................... .............
p.(None): 20 Use of Silviculture; economic exploitation of wood or firewood and Middle
p.(None): Forest by-product resources; import or export of fauna and flora
p.(None): Native Brazilian naturals; activity of creation and economic exploitation of
p.(None): exotic and wild fauna; use of genetic heritage
p.(None): Natural; exploitation of living aquatic resources; introduction of
p.(None): exotic species, except for plant breeding and use
p.(None): in the farming; introduction of genetically modified species
p.(None): previously identified by CTNBio as potentially
p.(None): causing significant degradation of the environment; use of
p.(None): biological diversity by biotechnology in activities previously
p.(None): identified by CTNBio as potentially causing
p.(None): significant degradation of the environment.
p.(None): ........... ................ ....................... .................................................. ...................................... ............ .
p.(None): Art. 38. (VETOED)
p.(None): Art. 39. The provisions of Law No. 7,802, of July 11, 1989, and its amendments do not apply to GMOs and their derivatives, except for cases in which they are
p.(None): developed to serve as raw material for the production of pesticides.
p.(None): Art. 40. Foods and food ingredients intended for human or animal consumption that contain or are produced from GMOs or derived
p.(None): should contain information to that effect on their labels, as per regulation.
p.(None): Art. 41. This Law enters into force on the date of its publication.
p.(None): Art. 42. Law No. 8,974, of January 5, 1995, Provisional Measure No. 2,191-9, of August 23, 2001, and arts. 5th, 6th, 7th, 8th, 9th, 10th and 16th of the Law
p.(None): 10,814, of December 15, 2003.
p.(None): Brasília, March 24, 2005; 184th of Independence and 117th of the Republic.
p.(None): LUIZ INÁCIO LULA DA SILVA
p.(None): Márcio Thomaz Bastos
p.(None): Celso Luiz Nunes Amorim
p.(None): Roberto Rodrigues
p.(None): Humberto Sérgio Costa Lima
p.(None): Luiz Fernando Furlan
p.(None): Patrus Ananias
p.(None): Eduardo Campos
p.(None): Marina Silva
p.(None): Miguel Soldatelli Rossetto
p.(None): José Dirceu de Oliveira e Silva
...
Social / parents
Searching for indicator parents:
(return to top)
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): Art. 4 This Law does not apply when genetic modification is obtained through the following techniques, provided that they do not imply the use of GMOs as
p.(None): recipient or donor:
p.(None): I - mutagenesis;
p.(None): II - formation and use of somatic cells from animal hybridoma;
p.(None): III - cell fusion, including that of protoplasm, of plant cells, which can be produced using traditional culture methods;
p.(None): IV - autocloning of non-pathogenic organisms that occurs naturally.
p.(None): Art. 5 It is permitted, 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 - are embryos frozen for 3 (three) years or more, on the date of publication of this Law, or that, already frozen on the date of publication of this Law, after
p.(None): complete 3 (three) years from the date of freezing.
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.
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 February 4
p.(None): 1997.
p.(None): Art. 6 It is prohibited:
p.(None): I - implementation of a project related to GMOs without keeping a record of their individual monitoring;
p.(None): II - genetic engineering in a living organism or the in vitro handling of natural or recombinant DNA / RNA, carried out in disagreement with the rules provided for in this
p.(None): Law;
p.(None): III - genetic engineering in human germ cell, human zygote and human embryo;
p.(None): IV - human cloning;
p.(None): V - destruction or disposal in the environment of GMOs and their derivatives in disagreement with the norms established by CTNBio, by the agencies and entities of
p.(None): registration and inspection, referred to in art. 16 of this Law, and those contained in this Law and its regulations;
p.(None): VI - release into the environment of GMOs or their derivatives, in the scope of research activities, without the favorable technical decision of CTNBio and, in cases of
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
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.
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 February 4
p.(None): 1997.
p.(None): Art. 6 It is prohibited:
p.(None): I - implementation of a project related to GMOs without keeping a record of their individual monitoring;
p.(None): II - genetic engineering in a living organism or the in vitro handling of natural or recombinant DNA / RNA, carried out in disagreement with the rules provided for in this
p.(None): Law;
p.(None): III - genetic engineering in human germ cell, human zygote and human embryo;
p.(None): IV - human cloning;
p.(None): V - destruction or disposal in the environment of GMOs and their derivatives in disagreement with the norms established by CTNBio, by the agencies and entities of
p.(None): registration and inspection, referred to in art. 16 of this Law, and those contained in this Law and its regulations;
p.(None): VI - release into the environment of GMOs or their derivatives, in the scope of research activities, without the favorable technical decision of CTNBio and, in cases of
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
p.(None): activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has
p.(None): been called by him, in the form of this Law and its regulations;
p.(None): VII - the use, commercialization, registration, patenting and licensing of genetic technologies to restrict use.
p.(None): Single paragraph. For the purposes of this Law, genetic technologies for the restriction of use are understood as any human intervention process for the generation or
p.(None): multiplication of genetically modified plants to produce sterile reproductive structures, as well as any form of genetic manipulation
p.(None): activation or deactivation of genes related to plant fertility by external chemical inducers.
p.(None): Art. 7 The following are mandatory:
p.(None): I - the investigation of accidents occurring in the course of research and projects in the field of genetic engineering and the sending of a report to the authority
p.(None): competent within a maximum period of 5 (five) days from the date of the event;
p.(None): II - immediate notification to CTNBio and to the authorities of public health, agricultural defense and the environment about accidents that may cause
p.(None): dissemination of GMOs and their derivatives;
p.(None): III - the adoption of the necessary means to fully inform CTNBio, the authorities of public health, the environment, agricultural and livestock defense,
p.(None): collectivity and the other employees of the institution or company on the risks to which they may be submitted, as well as the procedures to be taken in the
...
p.(None): cause risks to human health;
p.(None): XXI - reassess its technical decisions at the request of its members or by appeal by registration and inspection bodies and entities, based on facts
p.(None): or new scientific knowledge, relevant to the biosafety of the GMO or derivative, in the form of this Law and its regulation;
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 internal regulations to the Minister of Science and Technology.
p.(None): § 1 As for the biosafety aspects of the GMO and its derivatives, CTNBio's technical decision is binding on the other management bodies and entities.
p.(None): § 2 In the case of commercial use, among other technical aspects of its analysis, the registration and inspection bodies, in the exercise of their duties in the event of
p.(None): As requested by CTNBio, they will observe, regarding the biosafety aspects of the GMO and its derivatives, CTNBio's technical decision.
p.(None): § 3 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): entities referred to in art. 16 of this Law, for the exercise of its duties.
p.(None): § 4 The CTNBio 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,
p.(None): referred to in art. 16 of this Law, in the exercise of its powers.
p.(None): § 5º 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): § 6 The natural or legal persons involved in any of the stages of the process of agricultural production, commercialization or transportation of genetically modified products
p.(None): modified that have obtained the release for commercial use are exempted from the presentation of the CQB and constitution of CIBio, unless otherwise decided by
p.(None): CTNBio.
p.(None): Art. 15. CTNBio may hold public hearings, guaranteed participation of civil society, in accordance with the regulation.
p.(None): Single paragraph. In cases of commercial release, a public hearing may be requested by interested parties, including among these organizations of the
p.(None): civil society that prove interest related to the matter, in the form of the regulation.
p.(None): CHAPTER IV
p.(None): Registration and inspection bodies and entities
p.(None): Art. 16. The registration and inspection bodies and entities of the Ministry of Health, the Ministry of Agriculture, Livestock and Supply and the Ministry of
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 Law and in its regulation:
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 - keep the register of institutions and technical responsible persons that carry out activities and projects related to GMOs and their derivatives updated in the SIB;
p.(None): V - make public, including in the SIB, the registrations and authorizations granted;
p.(None): VI - apply the penalties referred to in this Law;
p.(None): VII - subsidize CTNBio in the definition of biosafety assessment items for GMOs and their derivatives.
p.(None): § 1 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 regulation of this Law;
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, according to the legislation in force and according to the regulation of this Law;
p.(None): III - to the competent agency of the Ministry of the Environment to issue authorizations and records and to monitor products and activities involving GMOs and their derivatives
p.(None): to be released into natural ecosystems, according to the legislation in force and according to the regulation of this Law, as well as the licensing, in the cases where
p.(None): CTNBio resolves, pursuant to this Law, that the GMO is potentially a 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 in accordance with this Law and its regulations.
p.(None): § 2 Only the provisions of items I and II of art. 8 and the caput of art. 10 of Law No. 6,938, of August 31, 1981, in cases where CTNBio
p.(None): decide that the GMO is a potential cause of significant degradation of the environment.
...
General/Other / Manipulable
Searching for indicator manipulated:
(return to top)
p.(None): precepts of this Law and its regulation, as well as for any consequences or effects arising from its non-compliance.
p.(None): § 1 For the purposes of this Law, 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 Law must request authorization from the National Technical Commission on Biosafety - CTNBio, which
p.(None): manifest within the period set in the regulation.
p.(None): § 4 - Public and private organizations, national, foreign or international, financing or sponsoring activities or projects referred to in the
p.(None): caput of this article must require the presentation of a Biosafety Quality Certificate, issued by CTNBio, under penalty of becoming co-responsible for the
p.(None): any effects arising from the non-compliance with this Law or its regulations.
p.(None): Art. 3 For the purposes of this Law, it is considered:
p.(None): I - organism: any biological entity capable of reproducing or transferring genetic material, including viruses and other classes that may become known;
p.(None): II - deoxyribonucleic acid - DNA, ribonucleic acid - RNA: genetic material that contains information that determines hereditary transmissible traits
p.(None): offspring;
p.(None): III - recombinant DNA / RNA molecules: molecules manipulated outside living cells by modifying segments of natural DNA / RNA or
p.(None): synthetic and that can multiply in a living cell, or the DNA / RNA molecules resulting from that multiplication; segments are also considered
p.(None): synthetic DNA / RNA equivalent to natural DNA / RNA;
p.(None): IV - genetic engineering: activity of production and manipulation of recombinant DNA / RNA molecules;
p.(None): V - genetically modified organism - GMO: organism whose genetic material - DNA / RNA has been modified by any genetic engineering technique;
p.(None): VI - derived from GMOs: product obtained from GMOs and which does not have an autonomous capacity for replication or which does not contain a viable form of GMOs;
p.(None): VII - 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): VIII - cloning: asexual reproduction process, produced artificially, based on a single genetic heritage, with or without the use of
p.(None): genetic engineering;
p.(None): IX - cloning for reproductive purposes: cloning for the purpose of obtaining an individual;
p.(None): X - therapeutic cloning: cloning for the purpose of producing embryonic stem cells for therapeutic use;
p.(None): XI - embryonic stem cells: embryo cells that have the ability to transform into cells in any tissue in an organism.
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
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): IV - human cloning;
p.(None): V - destruction or disposal in the environment of GMOs and their derivatives in disagreement with the norms established by CTNBio, by the agencies and entities of
p.(None): registration and inspection, referred to in art. 16 of this Law, and those contained in this Law and its regulations;
p.(None): VI - release into the environment of GMOs or their derivatives, in the scope of research activities, without the favorable technical decision of CTNBio and, in cases of
p.(None): commercial release, without the favorable technical opinion of CTNBio, or without the licensing of the responsible environmental agency or entity, when CTNBio considers the
p.(None): activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has
p.(None): been called by him, in the form of this Law and its regulations;
p.(None): VII - the use, commercialization, registration, patenting and licensing of genetic technologies to restrict use.
p.(None): Single paragraph. For the purposes of this Law, genetic technologies for the restriction of use are understood as any human intervention process for the generation or
p.(None): multiplication of genetically modified plants to produce sterile reproductive structures, as well as any form of genetic manipulation
p.(None): activation or deactivation of genes related to plant fertility by external chemical inducers.
p.(None): Art. 7 The following are mandatory:
p.(None): I - the investigation of accidents occurring in the course of research and projects in the field of genetic engineering and the sending of a report to the authority
p.(None): competent within a maximum period of 5 (five) days from the date of the event;
p.(None): II - immediate notification to CTNBio and to the authorities of public health, agricultural defense and the environment about accidents that may cause
p.(None): dissemination of GMOs and their derivatives;
p.(None): III - the adoption of the necessary means to fully inform CTNBio, the authorities of public health, the environment, agricultural and livestock defense,
p.(None): collectivity and the other employees of the institution or company on the risks to which they may be submitted, as well as the procedures to be taken in the
p.(None): case of accidents with GMOs.
p.(None): CHAPTER II
p.(None): National Biosafety Council - CNBS
p.(None): Art. 8 The National Biosafety Council - CNBS is created, linked to the Presidency of the Republic, the highest advisory body of the President of the
p.(None): Republic for the formulation and implementation of the National Biosafety Policy - PNB.
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 bodies and entities referred to in art.
p.(None): 16 of this Law, within the scope of its powers, on the processes related to activities involving the commercial use of GMOs and their derivatives;
p.(None): IV - (VETOED)
p.(None): § 2 (VETOED)
...
p.(None): Art. 22. The registration and inspection bodies and entities, referred to in art. 16 of this Law, to define criteria, values and apply fines of R $ 2,000.00 (two thousand
p.(None): to R $ 1,500,000.00 (one million and five hundred thousand reais), in proportion to the seriousness of the violation.
p.(None): § 1 Fines may be applied cumulatively with the other sanctions provided for in this article.
p.(None): § 2 In the event of a repeat offense, the fine will be applied twice.
p.(None): § 3 In the case of a continuous infraction, characterized by the permanence of the action or omission initially punished, the respective penalty will be applied daily
p.(None): until its cause ceases, without prejudice to the immediate interruption of the activity or the interdiction of the laboratory or the institution or company responsible.
p.(None): Art. 23. The fines provided for in this Law will be applied by the registration and inspection bodies and entities of the Ministries of Agriculture, Livestock and Supply,
p.(None): of Health, Environment and the Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic, referred to in art. 16 of this Law, in accordance with its
p.(None): respective competences.
p.(None): § 1 The funds collected with the application of fines will be destined to the registration and inspection bodies and entities, referred to in art. 16 of this Law, which
p.(None): 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): execution of services related to the inspection activity provided for in this Law and may pass on part of the revenue obtained from the application of fines.
p.(None): § 3 The supervisory authority shall forward a copy of the infraction notice to CTNBio.
p.(None): § 4 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): CHAPTER VIII
p.(None): Crimes and Sentences
p.(None): Art. 24. Use human embryo in disagreement with the provisions of art. 5th of this Law:
p.(None): Penalty - imprisonment, from 1 (one) to 3 (three) years, and a fine.
p.(None): Art. 25. Practice genetic engineering in a human germ cell, human zygote or human embryo:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): Art. 26. Perform human cloning:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
p.(None): Art. 27. Releasing or discarding GMOs in the environment, in disagreement with the norms established by CTNBio and by the registration and registration bodies and entities
p.(None): inspection:
p.(None): Penalty - imprisonment, from 1 (one) to 4 (four) years, and a fine.
p.(None): § 1 (VETOED)
p.(None): § 2 The penalty is aggravated:
p.(None): I - from 1/6 (one sixth) to 1/3 (one third), if damage to the property of others results;
p.(None): II - from 1/3 (one third) to half, if damage to the environment results;
p.(None): III - from half to 2/3 (two thirds), if serious bodily injury results in another;
p.(None): IV - from 2/3 (two thirds) to double, if the death of another person results.
p.(None): Art. 28. Use, commercialize, register, patent and license genetic technologies to restrict use:
p.(None): Penalty - imprisonment, from 2 (two) to 5 (five) years, and a fine.
p.(None): Art. 29. Produce, store, transport, commercialize, import or export GMOs or their derivatives, without authorization or in violation of the rules
...
Orphaned Trigger Words
p.(None): referred to in item I of the caput of this article.
p.(None): § 8 (VETOED)
p.(None): § 8-A CTNBio's decisions will be taken with votes in favor of the absolute majority of its members. (Included by Law No. 11,460, of 2007)
p.(None): § 9th Organs 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): § 10. Representatives of the scientific community and the public sector and entities of the
p.(None): civil society without voting rights.
p.(None): Art. 12. The functioning of CTNBio will be defined by the regulation of this Law.
p.(None): § 1 CTNBio will have an Executive Secretariat and the Ministry of Science and Technology is responsible for providing technical and administrative support.
p.(None): § 2 (VETOED)
p.(None): Art. 13. CTNBio will establish permanent sectoral subcommittees in the area of human health, in the animal area, in the plant area and in the environmental area, and may
p.(None): set up extraordinary subcommittees, for prior analysis of the topics to be submitted to the plenary of the Commission.
p.(None): § 1 Both the full members and the alternates will participate in the sectoral subcommittees and it will be up to everyone to distribute the processes for analysis.
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): Art. 14. It is incumbent upon CTNBio:
p.(None): I - establish rules for research with GMOs and derivatives of GMOs;
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 or 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 or derived from GMOs, under the terms of the legislation in force;
p.(None): IX - authorize the importation of GMOs and their derivatives for research activities;
p.(None): X - provide technical advisory and advisory support to CNBS in the formulation of the GNP of 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 referred to in art. 16 of this Law;
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;
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| 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 |
| property | Property Ownership |
| 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