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Law nº 11.105, of 24 march 2005


This is to certify that I, Marco Antonio Rochadel, Official Public Translator, designated and installed in Office according to The Official Gazette of June 23, 1982, page 5428, have received and translated, to the best of my knowledge and belief, a document with the following contents:

LAW Nº 11.105, OF 24 MARCH 2005.


Regulates the Federal Constitution Article 225 Paragraph 10(II), (IV) and (V) and establishes safety rules and monitoring arrangements for activities that involve genetically modified organisms ? GMO and GMO derivatives, establishes Conselho Nacional de Biosegurança ? CNBS, the National Biosafety Council, restructures Comissão Técnica Nacional de Biossegurança - CTNBio, the National Biosafety Technical Commission, makes provisions on Política Nacional de Biosegurança ? PNB, the National Biosafety Policy, revokes Law no. 8,974, of January 05, 1995 and Provisional Measure no. 2,191-9, of August 23, 2001, and Articles 5, 6, 7, 8, 9, 10 and 16 of Law no. 10,814, of December 15, 2003 and makes other provisions.

THE PRESIDENT OF THE REPUBLIC I make it known that the National Congress decrees and I sanction the following Law:

CHAPTER I

GENERAL AND PRELIMINARY PROVISIONS



Article 1. This Law establishes security rules and monitoring arrangements on construction, cultivation, production, manipulation, transport, transfer, import, export, storage, research, marketing, consumption, disposal to the environment and discarding of genetically modified organisms ? GMO and GMO derivatives, following the guidelines of promoting scientific advancements in biosafety and biotechnology, protecting human, animal and plant life and health, under the principle of precaution to secure environment protection.

Paragraph 1. For the purpose of this Law, research is a laboratory activity, under field containment, part of the process of obtaining a GMO and GMO derivatives, or assessment of the GMO and GMO derivatives biosafety involving, in the experimental context, construction, cultivation, manipulation, transport, transfer, import, export, storage, disposal to the environment and discarding of GMO and GMO derivatives.

Paragraph 2. . For the purpose of this Law, commercial use GMO and GMO derivatives activity are activities not included as research, involving cultivation, production, manipulation, transport, transfer, marketing, import, export, storage, consumption, disposal and discarding of GMO and its derivatives for commercial purposes.

Article 2. . Activities and projects involving GMO and GMO derivatives related to education with manipulation of living organisms, scientific research, technological development and industrial production shall be restricted to public and private bodies liable for abiding with the provisions of this Law and related regulation, as well as for any consequence or event resulting from any default hereof or thereof.

Paragraph 1. For the purposes of this Law, activities and projects under responsibility of an entity are those conducted in such entities? facilities or under administrative, technical or scientific responsibility of such entity.

Paragraph 2. Activities and projects mentioned by this Article 2 are barred to natural persons acting autonomously and independently, even under employment or any other link with juristic persons.

Paragraph 3. Those interested in conducting activity mentioned by this Law shall apply for authorization to the National Biosafety Technical Commission ? CTNBio, which shall respond within the term established by applicable regulation.

Paragraph 4. Public and private, domestic, foreign and international organizations, financing or sponsoring activities or projects mentioned by this Article 2 shall require a Biosafety Quality Certificate, issued by the National Biosafety Technical Commission ? CTNBio, under the penalty of becoming co-responsible for any effect resulting from lack of compliance with this Law and related regulation.

Article 3. For purposes of this Law:

I ? organism means any biological form able to reproduce itself or transfer genetic material, including viruses and other classes that may become known;

II ? deoxyribonucleic acid - deoxyribonucleic acid ? DNA, ribonucleic acid ? RNA, mean genetic material containing important information on hereditary characters transmissible to descendants;

III- Recombinant DNA/RNA molecules mean molecules manipulated outside living cells by modifying segments of natural or synthetic DNA/RNA and that may multiply within a living cell, or DNA/RNA molecules resulting from such multiplication; synthetic DNA/RNA segments are deemed equivalent to natural DNA/RNA segments; IV- Genetic engineering means production and manipulation of recombinant DNA/RNA molecules;

V- Genetically modified organism ? GMO means organism the genetic material of which ? DNA/RNA has been modified by any genetic engineering technique;

VI- GMO derivative means product obtained from GMO with no autonomous ability to multiply, or not containing a viable form of GMO;

VII- Human germinal cell means mother cell responsible for the formation of gametes present in male and female sexual cells and their direct descendents in any degree of ploidy;

VIII- Cloning means asexual reproduction process, artificially conducted, based in one single genetic asset, with the use of genetic engineering techniques or otherwise; IX- Cloning for reproductive purposes means cloning targeted to obtaining one individual;

X- Therapeutic cloning means cloning with the purpose of producing embryo stem cells for therapeutic use;

XI- embryo stem cells mean embryo cells able to differentiate into cells of any tissue of an organism.

Paragraph 1. GMO, as a category, does not include the product of techniques implying direct introduction of hereditary material in an organism, provided the use of recombinant DNA/RNA or GMO molecules is not involved, including in vitro fertilization, conjugation, transduction, transformation, polyploid induction or any other natural process.

Paragraph 2. GMO derivative, as a category, does not include a pure substance, chemically defined, obtained by biological processes and not containing GMO, heterolog protein or recombinant DNA.

Article 4. This Law is not applicable for genetic modification obtained by any of the following techniques, provided it does not use GMO as receptor or donor;

I- mutagenesis;
II- formation and use of somatic cells from animal hybridoma;
III- cell fusion, including protoplasm, of plant cells, which may be conducted through traditional cultivation methods;
IV- self-cloning of non-pathogen organisms processed in a natural manner.

Article 5. Embryo stem cells obtained from human embryos produced by in vitro fertilization and not used in the respective procedure may be used for research and therapy provided that:
I- the embryos are unviable; or
II- the embryos have been frozen for three (3) or more years on the date this Law is published or the embryos are already frozen on the date this Law is published and three (3) years have elapsed from the date of their freezing.
Paragraph 1. In any case, parental consent is required.
Paragraph 2. Research and health service institutions conducting research or therapy involving embryo stem cells shall submit their projects to their respective research ethics committees for review and approval.

Paragraph 3. Marketing biologic material mentioned in this Article 5 is forbidden, and its practice implies crime typified in Article 15 of Law no. 9,434, of February 04, 1997.

Article 6. The following is prohibited:

I- implementing a GMO project without maintaining a record of the project?s individual monitoring;
II- genetic engineering a living organism or performing in vitro manipulation of natural or recombinant DNA/RNA in disagreement with the provisions of this Law;

III- genetic engineering a human germinal cell, human zygote and human embryo;
IV- human cloning;

V- destructing or discarding to the environment of GMO and GMO derivatives in disagreement with the rules established by the National Biosafety Technical Commission ? CTNBio and the registration and monitoring bodies mentioned in Article 16 hereof, the provisions of this Law and the regulation hereto;

VI- disposal to the environment of GMO and GMO derivatives in the context of research activities, without favorable technical decision by National Biosafety Technical Commission ? CTNBio and, in cases of commercial disposal, without a favorable CTNBio technical opinion or without licensing from the environmental body or entity in charge, whenever CTNBio considers the activity as a potentially capable of causing environmental degradation, or without approval by the National Biosafety Council ? CNBS, whenever the matter has been avocated to that Council according to this Law and relevant regulation;

VII- utilization, marketing, registration, patenting and licensing of use restricted genetic technologies.

Paragraph 1. For the purposes of this Law, use restriction genetic technology is any process of human intervention for generating or multiplying genetically modified plants to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at deactivating genes related to plant fertility by means of external chemical inductors.

Article 7. The following is mandatory:

I- investigating accidents occurred in the course of genetic engineering research and projects and reporting them to the competent authority within five (5) days from the event;

II- immediately notifying CTNBio and public health, agricultural and environment defense authorities of any accident that may cause dissemination of GMO and GMO derivatives;

III- using the necessary means to fully inform CTNBio, public health, environment and agricultural defense authorities, population, institution or corporation employees on the risks to which they may be subject and measures to be taken in case of accidents with GMO.



CHAPTER II
National Biosafety Council ? CNBS



Article 8. The National Biosafety Council ? CNBS is hereby established under the Presidency of the Republic, as a higher advisory body to the President of the Republic on formulation and implementation of the National Biosafety Policy ? PNB.

Paragraph 1. The National Biosafety Council ? CNBS shall:

I- set up the principles and guidelines for administrative actions of federal bodies and authorities with jurisdiction over the matter;

II- analyze, upon request by CTNBio, in the context of convenience, socioeconomic opportunity and national interest, requests to grant license on the commercial use of GMO and GMO derivatives;

III- avocate to itself and decide, in last and definite resort, based on consultation with CTNBio and, as deemed necessary, with bodies and entities mentioned in Article 16 hereof, within their respective jurisdictions, on proceedings related to activities involving commercial use of GMO and GMO derivatives;

IV- (VETOED)

Paragraph 2. (VETOED)

Paragraph 3. Whenever CNBS decides favorably to the development of an activity under examination, it shall forward its opinion to registration and monitoring bodies and entities mentioned in Article 16 hereof.

Paragraph 4. Whenever CNBS decides against the development of an activity, it shall forward its opinion to CTNBio for notification to the applicant.

Article 9. CNBS members are:

I- The Minister of State Chief of the Civil House, The Presidency of the Republic, who is CNBS chairperson;

II- The Minister of State of Science and Technology;

III- The Minister of State of Agrarian Development;

IV- Minister of State of Agriculture and Supply;

V- Ministry of State of Justice;

VI- Ministry of State of Health;

VII- Ministry of State of Environment;

VIII- Ministry of State of Development, Industry and Foreign Trade;

IX- Ministry of State of Foreign Relations;

X- Ministry of State of Defense;

XI- Special Secretary for Aquaculture and Fisheries, The Presidency of the Republic.

Paragraph 1. CNBS shall meet whenever convened by the Minister of State Chief of the Civil House, The Presidency of the Republic, or by a majority of its members.

Paragraph 2. (VETOED)

Paragraph 3. Exceptionally, public sector and civil society entity representatives may be invited to CNBS meetings.

Paragraph 4. CNBS shall have an Executive Secretary Office, under the Civil House of the Presidency of the Republic.

Paragraph 5. CNBS meetings may be validly held with the presence of six (6) members and decisions shall be taken by absolute majority vote.



CHAPTER III
National Biosafety Technical Commission ? CTNBio


Article 10. CTNBio, under the Ministry of Science and Technology, is a consulting and deliberative multidisciplinary collegiate body providing technical and advisory support to the Federal Government in formulating, updating and implementing the PNB of GMO and GMO derivatives and establishing safety technical rules, issuing technical opinions on matters of authorization sought for activities involving research and commercial use of GMO and GMO derivatives, based on assessment of zoophytosanitary, human health and environmental risk.

Paragraph 1. CTNBio shall monitor the development and technical and scientific progress on biosafety, biotechnology, bioethics and related areas, with the purpose of enhancing its ability to protect human, animal, plant and environmental health.

Article 11. CTNBio, comprising regular members and deputies appointed by the Minister of State of Science and Technology, shall have twenty-seven (27) members, Brazilian citizens of renowned technical capacity, recognized scientific contribution and knowledge, holders of doctor degrees, who develop prominent professional activities in biosafety, biotechnology, biology, human and animal health and environment, of which:

I- twelve (12) members are specialists of recognized technical and scientific knowledge, who are currently active professionals, of which:

(a) three (3) human health specialists; (b) three (3) animal specialists; (c) three (3) plant specialists; (d) three (3) environment specialists;

II- one (1) member representing one of the following bodies, appointed by their respective incumbents:

(a) Ministry of Science and Technology; (b) Ministry of Agriculture and Supply; (c) Ministry of Health; (d) Ministry of Environment; (e) Ministry of Agrarian Development; (f) Ministry of Development, Industry and Foreign Trade; (g) Ministry of Defense; (h) Office of the Special Secretary for Aquaculture and Fisheries, The Presidency of the Republic; (i) Ministry of Foreign Relations;

III- one (1) consumer rights specialist, appointed by the Minister of State of Justice;

IV- one (1) health specialist, appointed by the Minister of State of Health;

V- one (1) environment specialist, appointed by the Minister of State of Environment;

VI- one biotechnology specialist, appointed by the Minister of State of Agriculture and Supply;

VII- one (1) family agriculture specialist, appointed by the Minister of State of Agrarian Development;

VIII- one (1) specialist in occupational health, appointed by the Minister of State of Labor and Employment.

Paragraph 1. Specialists mentioned in this Article 11(I) above shall be selected from a triple list prepared with the participation of scientific societies as provided by applicable regulation.

Paragraph 2. Specialists mentioned in this Article 11(III) to (VIII) above shall be selected from a triple list prepared by civil society organizations as provided by applicable regulation.

Paragraph 3. Each regular member shall have a deputy, who shall be in charge of relevant duties in the regular member?s absence.

Paragraph 4. CTNBio members shall be appointed for a term of two (2) years, renewable for two consecutive terms.

Paragraph 5. CTNBio chairperson shall be appointed among CTNBio members by the Minister of State of Science and Technology for a term of office of two (2) years, renewable for one (1) even term.

Paragraph 6. CTNBio members shall act in strict compliance with ethical and professional paradigms and may not participate in discussions related to matters in which they may hold professional or personal interest, under the penalty of loss of office according to applicable regulations.

Paragraph 7. CTNBio meetings may be validly held with a quorum of fourteen (14) members, provided there is at least one member from each of the areas mentioned in this Article 11(I) above.

Paragraph 8. (VETOED)

Paragraph 9. Federal public administration bodies and entities may apply for attending CTNBio meetings dealing with matters of their special interest, without voting rights;

Paragraph 10. Representatives of the scientific community, public sector and civil society entities may be invited to participate in CTNBio meetings, without voting rights.

Article 12. CTNBio operation shall be defined by the regulation to this Law. Paragraph 1. CTNBio shall have an Office of the Executive Secretary supported, regarding technical and administrative matters, by the Ministry of Science and Technology.
Paragraph 2. (VETOED)

Article 13. CTNBio shall set up permanent sectoral sub-commissions for human health and animal, plant and environment issues, and may set up special sub-commissions for prior analysis of matters to be submitted to the Commission?s meetings. Paragraph 1. Regular and deputy members shall take part in sectoral sub-commissions and any of them may be assigned matters to be analyzed.

Paragraph 2. Operation and coordination of works in sectoral and special sub-commissions shall be defined by CTNBio internal regulations.

Article 14. CTNBio shall:

I- set up rules for GMO and GMO derivatives research;

II- set up rules for GMO and GMO derivatives activities and projects;

III- set up, within its jurisdiction, GMO and GMO derivatives risk assessment and monitoring criteria;

IV- perform case-by-case risk assessment analysis in GMO and GMO derivatives activities and projects;

V- set up the operating arrangements of Comissões Internas de Biosegurança ? CIBio, the Biosafety Internal Commissions, in the context of each institution dedicated to education, scientific research, technological development and industrial production related to GMO and GMO derivatives;

VI- set up the biosafety requirements related to the operation of laboratories, institutions and corporations intending to carry out GMO and GMO derivatives activities;
VII- establish relationships with domestic and international institutions dedicated to GMO and GMO derivatives biosafety;

VIII- authorize, file and monitor GMO and GMO derivative research activities, under applicable legislation in effect;

IX- authorize the import of GMO and GMO derivatives for research activities;

X- provide consulting and advisory technical support to CNBS in the establishment of the PNB for GMO and GMO derivatives;

XI- issue Certificado de Qualidade em Biosegurança - CQB, the Biosafety Quality Certificate, for the development of activities involving GMO and GMO derivatives in laboratories, institutions and corporations and forward a copy of the proceedings to the registration and monitoring bodies mentioned by Article 16 hereof;

XII- issue technical decision, on a case-by-case basis, on GMO and GMO derivatives biosafety in the context of research activities and commercial use of GMO and GMO derivatives, including classification of degree of risk and biosafety level requirements, as well as security measures required and use restrictions;

XIII- define the biosafety level to be applied to the use of GMO and GMO derivatives, and related security procedures and measures, according to rules set up in the regulation to this Law;

XIV- classify GMO according to risk classes, under the criteria set up in the regulation to this Law;

XV- monitor technical and scientific development and progress in GMO and GMO derivatives biosafety;

XVI- issue resolutions, of regulatory nature, on matters within CTNBio jurisdiction;

XVII- provide technical support to relevant bodies in the process of prevention and investigation of accidents and diseases reported in the course of projects and activities using recombinant DNA/RNA techniques;
XVIII- provide technical support to registration and monitoring bodies and entities mentioned in Article 16 hereof in the performance of their activities related to GMO and GMO derivatives;

XIX- publish in the Federal Official Gazette, prior to analysis, a summary of applications and, later, of opinions in proceedings submitted, as well as provide full disclosure on Sistema de Informações de Biosegurança ? SIB, the Biosafety Information System, of its agenda, proceedings in progress, yearly reports, meeting minutes and other information on CTNBio activities, except confidential information of commercial interest, as notified by the applicant and agreed by CTNBio;

XX- identify activities and products resulting from the use of GMO and GMO derivatives that may potentially degrade the environment or cause risks to human health;

XXI- reexamine its technical decisions as requested by CTNBio members or on appeal by registration and monitoring bodies and entities, based on new scientific fact or knowledge, which are relevant for the GMO or GMO derivative biosafety, according to this Law and related regulation;

XXII- suggest the carrying out of research and scientific studies regarding GMO and GMO derivatives biosafety;

XXIII- submit a draft of CTNBio internal regulations to the Minister of State of Science and Technology.

Paragraph 1. A technical CTNBio decision on GMO and GMO derivatives biosafety is binding upon the remaining public administration bodies and entities.

Paragraph 2. In case of commercial use, among other technical aspects of their analysis, registration and monitoring bodies, in performing their respective duties, shall comply with any CTNBio technical decision regarding matters of GMO and GMO derivatives biosafety.

Paragraph 3. In case of favorable biosafety technical decision related to a research activity, CTNBio shall forward the related proceedings to the bodies and entities mentioned in Article 16 hereof, for performance of their respective duties.

Paragraph 4. In any technical decision CTNBio shall summarize the technical foundations, detailing security measures and restrictions to the use of GMO and GMO derivatives, taking into account the particulars of different regions of the country, with the purpose of providing guidance and support to registration and monitoring bodies and entities mentioned in Article 16 hereof in the performance of their duties.

Paragraph 5. Any derivative whose GMO had been already approved by CTNBio shall not be required to submit to CTNBio analysis and technical opinion.

Paragraph 6. Natural persons and corporations involved in any phase of the agricultural production process, marketing or transport of a genetically modified product that has been granted commercial use license are released from producing a Biosafety Quality Certificate ? CQB and setting up a Biosafety Internal Commission ? CIBio, except CTNBio decision to the contrary.

Article 15. CTNBio may hold public hearings to which attendance by the civil society is secured, under applicable regulations.

Paragraph 1. In cases of commercial clearance, interested parties, including civil society organizations, may request a public hearing, provided their interest in the matter is evidenced under applicable regulation.



CHAPTER IV

Registration and Monitoring Bodies and Entities


Article 16. Registration and monitoring bodies and entities of the Ministry of Health; Ministry of Agriculture and Supply; Ministry of the Environment; and Office of the Special Secretary for Aquaculture and Fisheries of The Presidency of the Republic, in their respective jurisdictions, under CTNBio technical decisions, CNBS decisions and in compliance with the arrangements provided by this Law and respective regulation shall:

I- inspect and monitor GMO and GMO derivatives research activities;

II- register and monitor the commercial clearance of GMO and GMO derivatives;

III- authorize the import of GMO and GMO derivatives;

IV- maintain the Biosafety Information Systems (SIB) updated with files of institutions and related technicians in charge of GMO and GMO derivatives activities and projects;

V- disclose to the public in general, records and authorizations granted, including through SIB;

VI- apply the penalties provided by this Law;

VII- assist CTNBio in defining biosafety assessment standards for GMO and GMO derivatives;

Paragraph 1. Upon favorable opinion by CTNBio or by CNBS, in case of avocation to it or appeal, the following bodies shall perform the actions described after specific review and decision:

I- the Ministry of Agriculture and Supply shall grant appropriate authorizations and registrations and monitor products and activities related to GMO and GMO derivatives targeted to animal use and use farming, agribusiness and related areas, under the legislation in effect and the provisions hereof;

II- the competent body of the Ministry of Health shall grant appropriate authorizations and registrations and monitor products and activities related to GMO and GMO derivatives targeted for human use, and use in pharmacology, home cleansing and related areas, under the legislation in effect and the provisions hereof;

III- the competent body of the Ministry of Environment shall grant appropriate authorizations and registrations and monitor products and activities related to GMO and GMO derivatives to be discharged to natural ecosystems, under the legislation in effect and the provisions hereof, as well as the licensing, whenever determined by CTNBio, under this Law, that the GMO is a potential environment degrading agent;

IV- the office of the Special Secretary of Aquaculture and Fisheries of The Presidency of the Republic shall grant the authorizations and registrations related to GMO and GMO derivatives products and activities targeted to use in fishery and Aquaculture, under the legislation in effect and the provisions of this Law and related regulation.

Paragraph 2. Provisions of Article 8(I) and (II) hereof and Article 10 of Law no. 6,398, of August 31, 1981, are not applicable, except in cases when CTNBio has determined that the relevant GMO is a potential source of significant environment degradation.

Paragraph 3. CTNBio shall deliberate, in last and definite resort, on cases in which the activity is a potential or effective cause of environment degradation, as well as on whether an environmental licensing is required.

Paragraph 4. The granting of registration, authorization and environmental licensing mentioned hereof shall take place within one hundred and twenty (120) days.

Paragraph 5. The deadline mentioned in Paragraph 4 above shall be suspended for up to one hundred and eighty (180) days pending preparation, by the applicant, of the studies or required clarifications.

Paragraph 6. Authorizations and registrations mentioned by this Article 16 shall be bound by the related CTNBio technical decision, remaining forbidden, in biosafety matters, any technical requirement additional to the conditions treated in such decision.

Paragraph 7. In case of disagreement with the CTNBio technical decision on commercial clearance of GMO and GMO derivatives, registration and monitoring bodies and entities, within their respective jurisdictions, may submit appeals to CNBS within thirty (30) days from the publication of such CTNBio technical decision.



CHAPTER V

Biosafety Internal Commission ? CIBio



Article 17. An institution using techniques and methods of genetic engineering or conducting research with GMO and GMO derivatives must establish a Comissão Interna de Biosegurança - CIBio, an Internal Biosafety Commission and appoint one technician as the principal responsible for each specific project.

Article 18. A CIBio shall, within the institution where it is established:

I- keep workers and other members of the community who may be potentially affected by the activity informed on issues related to health and safety and on measures to be taken in case of accident;
II- set up preventive and inspection programs to secure the operation of facilities under its responsibility, under the biosafety standards and rules defined by CTNBio in the regulation to this Law;
III- forward to CTNBio the documents to be mentioned in the regulation to this Law for the purpose of analysis, registration or authorization by the appropriate body, as the case may be;
IV- keep tracking records for each activity and project in progress involving GMO and GMO derivatives;
V- notify CTNBio, bodies and entities of registration and monitoring mentioned by Article 16 hereof and labor unions on the results of risk assessment for individuals exposed, and any accident or incident that may cause dissemination of biological agent.

VI- investigate on accidents and diseases that may be related to GMO and GMO derivatives and notify CTNBio of conclusions and measures taken.



CHAPTER VI

Biosafety Information System ? SIB



Article 19. Sistema de Informações em Biosegurança ? SIB, the Biosafety Information System is hereby established under the Ministry of Science and Technology, in charge of managing information resulting from analysis, registration, monitoring and follow-up of activities involving GMO and GMO derivatives.

Paragraph 1. Any provision of law, regulation and administrative act that change, complement or affect the GMO and GMO derivatives biosafety legislation shall be disclosed in SIB concurrently to their respective entry into effect.

Paragraph 2. Registration and monitoring bodies and entities mentioned by Article 16 hereof shall feed SIB with the information on activities hereby regulated, conducted within their respective jurisdiction.

CHAPTER VII

Civil and Administrative Liability



Article 20. Without prejudice of the penalties envisaged by this Law, those liable for damages to the environment and third parties are jointly accountable for indemnification or full redress, regardless of guilt.

Article 21. An administrative fault is any action or lack of action that may infringe this Law and other related legal provisions.

Paragraph 1. An administrative fault shall be punished as established in the regulation to this Law, regardless of provisional remedies such as seizure and sales suspension of a product and activity arrests, with the following penalties:

I- admonishment; II- fine; III- seizure of GMO and GMO derivatives; IV- suspension of GMO and GMO derivatives sales; V- ban of the activity; VI- partial or full interdiction of the facility, activity or corporation; VII- suspension of registration, license or authorization; VIII- cancellation of registration, license or authorization; IX- loss or restriction of government fiscal incentive or benefit previously granted; X- loss or suspension of credit line granted by government credit establishment; XI- intervention in the facility; XII- prohibition of entering into agreements with the government for a period up to five (5) years.

Article 22. Bodies and entities in charge of registration and monitoring, mentioned in Article 16 hereof may set up criteria, values and apply penalties ranging from R$2,000 (two thousand Brazilian Reals) to R$1,500,000 (one million and five hundred thousand Brazilian Reals) according to fault severity.

Paragraph 1. The fines may be applied in addition to other penalties envisaged by this Article 22.

Paragraph 2. The applicable fine shall be doubled in case of relapse.

Paragraph 3. In case of contumacy, in which the action or lack of action initially punished continues, the penalty shall be applied on a daily basis until cessation of the cause, without prejudice of immediate arrest of the activity or interdiction of the laboratory, facility or corporation charged.

Article 23. The penalties envisaged by this Law shall be applied by registration and monitoring bodies and entities belonging to the Ministry of Agriculture and Supply; Ministry of Health; Ministry of the Environment; and the Office of the Special Secretary for Aquaculture and Fisheries of The Presidency of the Republic, as mentioned in Article 16 of this Law, according to their respective jurisdictions.

Paragraph 1. Revenues gathered with the above fines shall be channeled to the same registration and monitoring bodies and entities mentioned in Article 16 hereof applying such fines.

Paragraph 2. Federal public administration bodies and entities in charge of monitoring may enter into agreements with States, the Federal District and Municipalities for the carrying out of services related to the monitoring activities mentioned hereby and may transfer to such States, Federal District and Municipalities part of the revenue resulting from application of fines.

Paragraph 3. The monitoring authority shall forward a copy of the fine notice to CTNBio.

Paragraph 4. Whenever the fault is deemed to constitute crime or misdemeanor, or damage to the Treasury or the consumer, the monitoring authority shall notify the appropriate law enforcement body regarding potential administrative and penal liabilities.




CHAPTER VIII

Crimes and penalties



Article 24. Using an human embryo against the provisions of Article 5 hereof: Penalty: Confinement from one (1) to three (3) years and fine.

Article 25. Performing genetic engineering in human germinal cell, human zygote or human embryo: Penalty: imprisonment from one (1) to four (4) years and fine.

Article 26. Performing human cloning: Penalty: imprisonment from two (2) to five (5) years and fine.

Article 27. Discarding or disposing of GMO to the environment against the rules established by CTNBio and registration and monitoring bodies and entities: Penalty: imprisonment from one (1) to four (4) years and fine.

Paragraph 1. (VETOED).

Paragraph 2. The penalty shall be aggravated:

I- from one sixth (1/6) to one third (1/3) in case of damage to third party assets; II- from one third (1/3) to one half (1/2), in case of damage to the environment; III- from one half (1/2) to two thirds (2/3) in case of severe bodily injury to third parties; IV- from two thirds (2/3) to twice in case of death to a third party.

Article 28. Using, marketing, registering, patenting and licensing restricted use genetic technologies: Penalty: imprisonment from two (2) to five (5) years and fine.

Article 29. Producing, storing, transporting, marketing, importing or exporting GMO and GMO derivatives without authorization or in disagreement with the rules established by CTNBio and registration and monitoring bodies and entities: Penalty: imprisonment from one (1) to two (2) years and fine.



CHAPTER IX

Final and Temporary Provisions



Article 30. Any GMO that has been granted commercial clearance by CTNBio prior to the entry into effect of this Law may be registered and marketed, except in case of decision by CNBS to the contrary taken not later than sixty (60) days from the date of publication hereof.

Article 31. CTNBio and registration and monitoring bodies and entities mentioned by Article 16 hereof shall revise their regulatory decisions within one hundred and twenty (120) days in order to secure compliance with the provisions of this Law.

Article 32. Biosafety Quality Certificates, communiqués and technical decisions already issued by CTNBio remain in effect, as well as regulatory acts issued under Law no. 8,974, of January 05, 1955, provided there is no conflict with the provisions of this Law.

Article 33. Any institution developing activities regulated by this Law on the date of its publication shall comply with the provisions hereof within one hundred and twenty (120) days from the publication of the decree regulating this Law.

Article 34. Provisional registrations granted under Law no. 10,814, of December 15, 2003, are hereby ratified and made permanent.

Article 35. Production and marketing of farmed genetically modified glyphosphate-tolerant soybean seeds registered with Registro National de Cultivares ? RNC, the National Crop File, of the Ministry of Agriculture and Supply, is hereby authorized.

Article 36. Sowing of genetically modified glyphosphate-tolerant soybean seeds, saved by farmers for their own use, in the 2004/2005 crop year, is hereby authorized, provided, however, that the crops are not marketed as seed.

Paragraph 1. The government administration may extend the authorization mentioned in this Article 36.

Article 37. The description under Code 20, Schedule VIII, of Law no. 6,938, of August 31, 1981, as amended by Law no. 10,165, of December 27, 2000, is hereby changed to read as follows:



"?SCHEDULE VIII

Code

Category

Description

PP/UD*

....

.........

........................................................................

.....

20

Use of Natural Resources

Silviculture; economic exploitation of timber or firewood and forestry by-products, Brazilian native fauna and flora imports or exports; breeding and economic exploitation of exotic fauna and wild fauna; use of natural genetic heritage; exploitation of living water resources; introduction of exotic species, except for plant genetics improvement and agricultural use; introduction of genetically modified species previously identified by CTNBio as a potential and significant environmental degradation agent; use of biological diversity by biotechnology in activities previously identified by CTNBio as potential and significant environment degradation agent.

Medium

......

........

.........

.......

*

PP = Pollutant Potential; UD = Environmental Resources Utilization Degree.?

Article 38. (VETOED)


Article 39. Provisions of Law no. 7,802, of July 11, 1989, and amendments thereto are not applicable to GMO and GMO derivatives, except when used as a raw material for pesticide production.

Article 40. Foods and food ingredients for human or animal consumption containing, or produced from, GMO or GMO derivatives shall be accordingly labeled under appropriate regulation.

Article 41. This Law shall be effective upon publication.

Article 42. Law no. 8,794, of January 05, 1995, Provisional Measure no. 2,191-29, of August 23, 2001 and Articles 5, 6, 7, 8, 9, 10 and 16 of Law no. 10,814, of December 15, 2003 are hereby revoked.


Brasília, 24 March 2005; 184th Year of the Independence and 117th Year of the Republic

LUIZ INÁCIO LULA DA SILVA
Márcio Thomaz Bastos
Celso Luiz Nunes Amorim
Humberto Sérgio Costa Lima
Luiz Fernando Furlan
Patrus Ananias
Eduardo Campos
Marina Silva
Miguel Soldatelli Rossetto
José Dirceu de Oliveira e Silva

This text does not replace that which was published in the Federal Gazette of 28.3.2005.


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