DECREE NO. 5,591, OF NOVEMBER 22, 2005

Regulates provisions of Law no. 11,105, of March 24, 2005, which regulates Article 225 Paragraph 1(II), (IV) and (V) of the Federal Constitutions and makes other provisions

THE PRESIDENT OF THE REPUBLIC, using the powers vested in him by Article 84(IV) and (VI)(a) of the Federal Constitution, and in view of the provisions of Law no. 11,105, of March 24, 2005,

, using the powers vested in him by Article 84(IV) and (VI)(a) of the Federal Constitution, and in view of the provisions of Law no. 11,105, of March 24, 2005,
DECREES:

CHAPTER 1

PRELIMINARY AND GENERAL PROVISIONS

Article 1. This Decree regulates provisions of Law no. 11,105, of March 24, 2005, which sets up safety rules and monitoring arrangements for 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 health under the principle of precaution to secure environment protection, as well as rules for the authorized use of embryo stem cells obtained from human embryos produced by in vitro fertilization and not used in the related procedure, for therapeutic and research purposes.

Article 2. Activities and projects involving GMO and GMO derivatives related to education with manipulation of living organisms, scientific research, technology development and industrial production are restricted to public and private law entities that shall remain responsible for compliance with the provisions of Law no. 11,105, of 2005, this Decree and supplementary related rules as well as for any consequence or result from default hereof and thereof.

Paragraph 1. For the purposes of this Decree, public and private law entity projects and activities are those conducted in such entities own facilities or under the administrative, technical or scientific responsibility of such entity.

Paragraph 2. Activities and projects mentioned by this Article 2 may not be autonomously and independently conducted by natural persons, despite employment or any other bonds with a juristic person.

Paragraph 3. Those interested in conducting activity mentioned by this Decree shall apply for authorization to the National Biosafety Technical Commission – CTNBio, which shall respond within the term set up in the appropriate regulation.

Article 3. For the purposes of this Decree:

I- research activity means any activity conducted in a laboratory, under field containment, as part of the process of obtaining a GMO and its derivatives, or assessment of the GMO and its derivatives biosafety involving, in the experimental context, construction, cultivation, manipulation, transport, transfer, import, export, storage, disposal to the environment and discarding of GMO and its derivatives;

II- GMO and GMO derivatives commercial use activity means any activity not included as research, and involving cultivation, production, manipulation, transport, transfer, marketing, import, export, storage, consumption, disposal and discarding of GMO and its derivatives for commercial purposes;

III- organism means any biological entity able to reproduce or transfer genetic material, including viruses and other classes that may become known in the future;

IV- deoxyribonucleic acid – DNA, ribonucleic acid – RNA mean genetic material containing information determining hereditary characters transmissible to descendants;

V- 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 considered equivalent to natural DNA/RNA segments;

VI- genetic engineering means production and manipulation of recombinant DNA/RNA molecules;

VII- genetically modified organism – GMO means an organism the genetic material of which – DNA/RNA has been modified by any genetic engineering technique;

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

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

X- in vitro fertilization means the fusion of gametes conducted by any technique of extracorporeal fertilization;

XI- cloning means an asexual reproduction process, artificially produced, based in one single genetic asset, with the use of genetic engineering techniques or otherwise;

XII- embryo stem cells mean embryo cells able to change into cells of any tissue of an organism;

XIII- non-viable embryo means an embryo with genetic alterations evidenced by preimplant diagnosis, according to the Ministry of Health specific rules, whose development has been interrupted by spontaneous absence of cleavage for a period exceeding twenty-four hours from the in vitro fertilization, or an embryo with morphologic alteration that adversely affects its full development;

XIV- available frozen embryo means an embryo frozen on or before March 28, 2005, after three years from the date of its freezing have elapsed;

XV- genitors mean the final users of in vitro fertilization;

XVI- registration and monitoring bodies and entities mean the bodies and entities mentioned in Article 53 hereof;

XVII- limited use genetic technologies mean any process of human intervention to generate or multiply plants genetically modified to produce sterile reproductive structures, as well as any form of genetic manipulation with the purpose of activating or deactivating genes related to plant fertility by external chemical inductors.

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 that does not contain GMO, heterolog protein or recombinant DNA.

CHAPTER II

NATIONAL BIOSAFETY TECHNICAL COMMISSION

Article 4. 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.

Section I

Article 5. 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, under applicable regulations, 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;

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 this Decree;

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

XV- monitor the 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 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;

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

XXIII- submit a draft of CTNBio internal regulation to the Ministry of Science and Technology.

Paragraph 1. Reexamination mentioned by Article 5(XXI) above shall be requested to the CTNBio Chairperson in a petition containing the applicant name and personal data, the grounds for reexamination duly documented describing facts or reporting fresh scientific knowledge that warrant such reexamination and the request for a new decision related the relevant GMO and GMO derivatives biosafety.

Section II

Composition

Article 6. 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 and 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) Ministry of Foreign Relations;

(i) Office of the Special Secretary for Aquiculture and Fisheries, The Presidency of the Republic;

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 Ministry 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. Each regular member shall have a deputy, who shall be in charge of relevant duties in the regular member's absence.

Article 7. Specialists mentioned in Article 6(I) above shall be selected from a triple list of regular and deputy members.

Paragraph 1. The Minister of State of Science and Technology shall appoint an ad hoc commission, comprised by members external to CTNBio, representing scientific societies, Sociedade Brasileira para o Progresso da Ciência – SBPC, the Brazilian Society for the Progress of Science and Academia Brasileira de Ciências – ABC, the Brazilian Academy of Science, which shall be in charge of preparing the triple list mentioned by this Article 6 above within thirty days of the commission's inauguration.

Article 8. The representatives and respective deputies mentioned by Article 6(II) above shall be appointed by the related incumbent authorities within thirty (30) days from the notification by the Minister of State of Science and Technology.

Article 9. The appointment of specialists mentioned by this Article 6(III) to (VIII) hereof shall be made by the respective Ministers of State from a triple list prepared by civil society organizations holders of juristic personality, whose corporate goals are in line with the expertise envisaged in such sections, under procedures to be defined by the respective Ministries.

Article 10. Consultation with civil society organizations, for the purposes of Article 9 hereof shall be held sixty (60) days after the end of the term of office of the member to be replaced.

Article 11. Appointment of any CTNBio replacement member shall comply with the same provisions applicable to appointment of a regular member.

Article 12. CTNBio members shall be appointed for a term of two (2) years, renewable for two consecutive terms.

Paragraph 1. Time, for the purpose of a term of office of a deputy member shall be counted on a continuous basis, even though the deputy takes office as a regular member.

Article 13. Expenses with transportation, meals and accommodation of CTNBio members shall be defrayed by the Ministry of Science and Technology.

Paragraph 1. Actions and activities performed by CTNBio members shall be deemed highly relevant and honorable.

Article 14. CTNBio members shall guide their actions in strict compliance with ethical and professional standards, and may not participate in judging of issues involving their professional or personal interest under the penalty of loss of office.

Paragraph 1. Upon his or her inauguration, a CTNBio member shall execute a statement of conduct disclosing any conflict of interest, under CTNBio Internal Regulation.

Paragraph 2. A CTNBio member shall state his or her conflict of interest in cases delivered to him or her for analysis upon receipt, or, when the member is not the one in charge of the case, upon deliberation in meetings of sub-commissions or plenary sittings.

Paragraph 3. A CTNBio member or any interested person under Article 9 of Law no. 9,784, of January 29, 1999, may argue conflict of interest of any member.

Paragraph 4. The argument of conflict of interest shall be formalized in a duly documented petition stating the grounds of the conflict, to be decided over by the CTNBio plenary sitting.

Paragraph 5. Any technical decision in which the vote of a disabled member has been decisive to its judgment shall be null and void.

Paragraph 6. The CTNBio plenary sitting, upon deliberating on a member's conflict of interest shall issue a fresh technical decision in which it expressly regulates the subject of the impaired decision and the ensuing effects thereof since its publication.

Article 15. CTNBio Chairperson and his or her substitute shall be appointed, among its members, by the Minister of State of Science and Technology from a triple list voted in a plenary sitting.

Paragraph 1. The CTNBio Chairperson shall hold office for two years, renewable for even period.

Paragraph 2. The CTNBio Chairperson may, among other duties to be defined by internal regulation:

I- represent CTNBio;

II- preside over CTNBio plenary meetings;

III- assign his or her duties to a third party;

IV- cause information to be given and enable access to documents as requested by registration and monitoring bodies.

Section III

Administrative Structure

Article 16. CTNBio shall have an Office of the Executive Secretary, provided with technical and administrative support by the Ministry of Science and Technology.

Paragraph 1. CTNBio Office of the Executive Secretary shall, among other duties to be defined by internal regulation:

I- provide technical and administrative support to CTNBio members;

II- receive, document and cause to be processed the demands submitted to CTNBio deliberation;

III- forward CTNBio deliberations to government bodies in charge of their implementation and provide them the due disclosure;

IV- update the Biosafety Information System – SIB.

Article 17. CTNBio shall establish permanent sectoral sub-commissions in human health, animal, plant and environment issues, and may establish special sub-commissions for previous examination of issues to be submitted to plenary sitting.

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 in CTNBio internal regulation.

Section IV

Meetings and Deliberations

Article 18. A deputy member shall have a right to speak and, in the absence of the respective regular member, to vote in deliberations.

Article 19. 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 by Article 6(I) above.

Paragraph 1. CTNBio decisions shall be taken by favorable vote of the absolute majority of its members, except for deliberations on commercial licensing of GMO and GMO derivatives, when the decision shall be taken by favorable vote of at least two thirds of the members.

Article 20. A member shall loose his or her office in case of

I- violation of the provisions of Article 14 hereof;

II- absence to three consecutive CTNBio regular plenary sittings with no excuse.

Article 21. CTNBio shall gather in regular meeting once a month and in special meeting at any time, convened by its Chairperson or by well-founded request executed by the absolute majority of its members.

Paragraph 1. Periodicity of regular meetings may exceptionally be changed by deliberation by CTNBio.

Article 22. A recording shall be made of CTNBio meetings and the respective minutes, when related to demands, shall contain a note indicating the number of the proceeding, interested person, subject matter, reason for the decision, any divergence and result.

Article 23. A summary of demands submitted shall be published in the Federal Official Gazette and SIB at least thirty days before the inclusion in the order of the day, except for urgent matters that shall be defined by CTNBio Chairperson.

Article 24. A summary of opinions and technical decisions shall be published in the Federal Official Gazette.

Paragraph 1. Each member vote and the grounds for such vote shall be recorded in SIB.

Article 25. Federal public administration bodies and entities may apply for participation in CTNBio meetings dealing with matters of their respective special interest, with no right to vote.

Paragraph 1. The appropriate application to CTNBio Office of the Executive Secretary shall be accompanied by justification giving the reasons and interest of the applicant in the GMO and GMO derivatives biosafety submitted to CTNBio deliberation.

Article 26. Representatives of the scientific community, public sector and civil society entities may be exceptionally invited to participate in CTNBio meetings, with no right to vote.

Section V

Procedural Steps

Article 27. Proceedings related to CTNBio duties, mentioned in Article 5(IV), (VIII), (IX), (XII) and (XXI) hereof, shall follow the steps defined by this Section V.

Article 28. A request filed with the Office of CTNBio Executive Secretary, after accepted and documented, shall have a previous summary published in the Federal Official Gazette and disseminated in SIB.

Article 29. The proceeding shall be assigned to one of the members, either a regular or a deputy member, for examination and preparation of such member's opinion.

Article 30. The member's opinion shall be submitted to one or more permanent or special sectoral sub-commissions for preparation and approval of the final opinion.

Article 31. The final opinion, after approved by the permanent or special sectoral sub-commissions to which the proceedings were distributed, shall be forwarded to CTNBio plenary sitting for deliberation.

Article 32. A defeated vote by a member of a permanent or special sectoral sub-commission shall be submitted in an express and well-founded form and recorded as a diverging vote in the final opinion for review and deliberation by the plenary sitting.

Article 33. Proceedings related to commercial licensing of GMO and GMO derivatives shall be submitted to all permanent sub-commissions.

Article 34. The members in charge of preparing the Sub-commission and plenary sitting opinions shall take into consideration, in addition to the reports of the applicants, existing scientific literature as well as studies and other documents recorded in public hearings or CTNBio.

Article 35. CTNBio shall take the necessary steps to protect confidential information, of commercial interest, mentioned and considered as such by the applicant, provided that the information is not the subject of private or collective interests protected by the Brazilian Federal Constitution.

Paragraph 1. In order to keep the confidentiality provided by this Article 37 above, the applicant shall deliver to the CTNBio Chairperson a well-founded and express request mentioning the specific confidential information he or she intends to protect.

Paragraph 2. The request shall be denied by well-founded argument, of which an appeal may be submitted to the plenary sitting under procedure to be set up by CTNBio internal regulation, remaining the confidentiality sought warranted until final decision to the contrary.

Paragraph 3. The applicant may select to abandon his or her demand, in case the request for confidentiality is not granted in definite, and CTNBio may not disseminate the information subject of the confidentiality sought.

Article 36. The registration and monitoring bodies and entities may request access to certain confidential information, in case it proves indispensable for the performance of their duties, in a petition including the reasons for the request and indicating the agent to whom access shall be granted.

Section VI

Technical Decision

Article 37. A CTNBio technical decision on GMO and GMO derivatives biosafety is binding upon the remaining government bodies and entities.

Article 38. In case of commercial use, among other technical aspects of their analysis, registration and monitoring bodies, in performing their respective duties in case requested by CTNBio to do so, shall comply with any CTNBio technical decision regarding matters of GMO and GMO derivatives biosafety.

Article 39. In case of favorable biosafety technical decision related to a research activity, CTNBio shall forward the related proceedings to the bodies and entities for performance of their respective duties.

Article 40. 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 in the performance of their duties.

Article 41. Any derivative whose GMO had been already approved by CTNBio shall not be required to submit to CTNBio analysis and technical opinion.

Article 42. Natural and juristic persons 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 in case of CTNBio decision to the contrary.

Section VII

Public Hearings

Article 44. CTNBio may hold public hearings, with warranted participation of the civil society, as requested by:

I- one of CTNBio members and approved by absolute majority, in any case;

II- by a party proven interested in the matter under deliberation and approved by absolute majority, in case of granting of commercial license.

Paragraph 1. CTNBio shall publish in the SIB and the Federal Official Gazette, not later than thirty (30) days from the relevant date, a call for the hearing, including the agenda, date, time and place of the meeting.

Paragraph 2. The public hearing shall be coordinated by CTNBio Chairperson who, after objectively outlining the matter under deliberation, shall open the hearing for discussion with the interested parties.

Paragraph 3. After the public hearing is closed, statements, opinions, suggestions and documents shall remain available for examination by the interested parties at the Office of CTNBio Executive Secretary.

Paragraph 4. An interested party, for the purposes of this Article 43, is the applicant of the proceeding or juristic person whose corporate goal is related to the areas envisaged in Article 6 and Article 6(III), (VII), and (VIII) hereof.

Section VIII

General GMO Risk Classification Rules

Article 44. In order to rank GMO according to risk classes, CTNBio shall take into account, among other criteria:

I- general characteristics of the GMO;

II- characteristics of the vector;

III- characteristics of the insert;

IV- characteristics of donor and recipient organisms;

V- product of inserted sequences genic expression;

VI- proposed activity and GMO recipient medium;

VII- proposed GMO use;

VIII- GMO adverse effects to human health and environment.

Section IX

Biosafety Quality Certificate – CQB

Article 45. A public or private law institution intending to conduct research in laboratory, under field containment, as part of the process of obtaining a GMO and its derivatives, or assessment of the GMO and its derivatives biosafety involving, in the experimental context, construction, cultivation, manipulation, transport, transfer, import, export, storage, disposal to the environment and discarding of GMO and its derivatives, shall apply to CTNBio for a Biosafety Quality Certificate – CQB.

Paragraph 1. CTNBio shall establish the criteria and procedures for the application, issuance, revision, scope, suspension and cancellation of a CQB.

Paragraph 2. CTNBio shall forward copy of the CQB issuance proceedings and related updates to the registration and monitoring bodies.

Article 46. Public and private organizations, domestic and foreign, financing or sponsoring activities and projects mentioned in Article 2 above shall require production of the appropriate CQB under the penalty of joint liability for any effect caused by lack of compliance with this Decree.

Article 47. Cases omitted in this Chapter shall be defined by CTNBio internal regulation.

CHAPTER III

NATIONAL BIOSAFETY COUNCIL – CNBS

Article 48. CNBS, reporting to the Presidency of the Republic, is a higher advisory body to the President of the Republic for PNB formulation and implementation.

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 registration and monitoring bodies and entities, within their respective jurisdictions, on proceedings related to activities involving commercial use of GMO and GMO derivatives;

Paragraph 2. Whenever CNBS decides favorably to the development of an activity under examination, it shall forward its opinion to registration and monitoring bodies and entities.

Paragraph 3. Whenever CNBS decides against the development of an activity under examination, 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 shall be the 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 its Chairperson or a majority of its members.

Paragraph 2. CNBS members shall be replaced, in their absences or impediments, by the respective Executive Secretaries or, in the absence of such authority, by his of her legal deputies.

Paragraph 3. In the absence of the Chairperson, he or she shall appoint a Minister of State to preside over CNBS meetings.

Paragraph 4. CNBS meetings may be validly held with a quorum of at least six (6) members and decisions shall be taken by absolute majority voting.

Paragraph 5. CNBS internal regulation shall define the procedures for the convening and conduction of meetings and deliberations.

Article 50. CNBS shall decide, upon request by CTNBio, on matters of socioeconomic convenience and opportunity and national interest on the granting of a license for GMO and GMO derivatives commercial license.

Paragraph 1. CTNBio shall cause to be filed, with the Office of the Executive CNBS Secretary, a full copy of the proceedings related to the activity to be examined, indicating the reasons for such forwarding.

Paragraph 2. The efficacy of a CTNBio technical decision, in case it had been given in the specific case, shall remain suspended pending CNBS final decision.

Paragraph 3. CNBS shall decide on the request for analysis mentioned by this Article 50 above within sixty days from the date the request is filed with the Office of the CNBS Executive Secretary.

Paragraph 4. The term envisaged in Paragraph 3 above may be suspended pending investigation or preparation of opinions by ad hoc consultants, as decided by CNBS.

Article 51. CNBS may avocate to itself proceedings related to activities involving analysis and decision on commercial use of GMO and GMO derivatives, in last and definite resort, within thirty days from the date the CTNBio technical decision is published in the Federal Official Gazette.

Paragraph 1. CNBS may request, at its discretion, opinions of registration and monitoring bodies and entities.

Paragraph 2. A CTNBio technical decision shall remain suspended up to expiry of the term envisaged in this Article 51 above or final decision by CNBS, in case the proceedings are avocated by it.

Paragraph 3. CNBS shall reach a decision within sixty (60) days from the date in which the full copy of the proceedings so avocated is received by the Office of CNBS Executive Secretary.

Paragraph 4. The term envisaged in Paragraph 3 above may be suspended pending investigation or preparation of opinions by ad hoc consultants, as decided by CNBS.

Article 52. CNBS shall reach a decision on appeals by registration and monitoring bodies and entities related to license for commercial use of GMO and GMO derivatives filed with the Office of the Executive Secretary within thirty (30) days from the date the CTNBio technical decision is published in the Federal Official Gazette.

Paragraph 1. The appeal mentioned by this Article 52 shall be accompanied by a well-founded technical justification showing any disagreement of the registration and monitoring body or entity, within its respective jurisdiction, with the CTNBio decision on matters of GMO and GMO derivatives biosafety.

Paragraph 2. The efficacy of a CTNBio technical decision shall remain suspended up to expiry of the term mentioned by this Article 52 above in the absence of appeal by the monitoring and registration bodies or, in case the appeal has been received and accepted, up to CNBS final decision.

Paragraph 3. CNBS shall reach a decision on the appeal within sixty (60) days from the date of filing of such appeal with the Office of CNBS Executive Secretary.

Paragraph 4. The term envisaged in Paragraph 3 above may be suspended pending investigation or preparation of opinions by ad hoc consultants, as decided by CNBS.

CHAPTER IV

REGISTRATION AND MONITORING BODIES AND ENTITIES

Article 53. Registration and monitoring bodies of the Ministry of Health; Ministry of Agriculture and Supply; Ministry of Environment; and Office of the Special Secretary of Aquiculture and Fisheries, the Presidency of the Republic shall, in addition to other duties, within their respective jurisdictions, under CTNBio technical decisions, CNBS deliberations and the arrangements set up by this Decree:

I- monitor research activities of GMO and GMO derivatives;

II- register and monitor licenses for commercial use of GMO and GMO derivatives;

III- issue authorization to import GMO and GMO derivatives for commercial use;

IV- set up registration, authorization, monitoring and environment licensing rules for GMO and GMO derivatives;

V- monitor compliance with biosafety rules and measures established by CTNBio;

VI- promote training of officials and technicians in charge of registration, authorization, monitoring and environmental licensing of GMO and GMO derivatives;

VII- set up internal commission specialized in GMO and GMO derivatives biosafety;

VIII- maintain the file of institutions and technicians in charge of activities and projects related to GMO and GMO derivatives updated;

IX- publicize, in SIB and other media, the records, authorizations and environmental licensing granted;

X- apply the penalties envisaged by this Decree;

XI- assist CTNBio in defining issues of GMO and GMO derivatives biosafety assessment.

Paragraph 1. The rules mentioned by this Article 53(IV) shall include, as the case may be, compliance with CTNBio decision of procedures, means and actions in effect applicable to conventional products.

Paragraph 2. Following a favorable opinion by CTNBio or CNBS, in case of avocation or appeal, the following shall take place as a result of specific analysis and relevant decision, as the case may be:

I- the Ministry of Agriculture and Supply shall issue the authorizations and registrations and monitor products and activities using GMO and GMO derivatives targeted to animal use in agriculture, farming, agribusiness and related areas, according to the legislation in effect and the rules that it may establish; or

II- the body of the Ministry of Heath of appropriate jurisdiction shall issue the authorizations and registrations and monitor products and activities using GMO and GMO derivatives targeted to human, pharmacological, house cleansing and related areas, according to the legislation in effect and the rules that it may establish; or

III- the body of the Ministry of Environment of appropriate jurisdiction shall issue the authorizations and registrations and monitor products and activities using GMO and GMO derivatives targeted to disposal in natural ecosystems, according to the legislation in effect and the rules that it may establish, as well as the licensing, as determined by CTNBio, under this Decree, that the GMO is may potentially degrade the environment; or

IV- the Office of the Special Secretary of Aquiculture and Fisheries, the Presidency of the Republic, shall issue the authorizations and registrations of products and activities using GMO and GMO derivatives targeted to use in fisheries and aquiculture, according to the legislation in effect and the rules that it may establish.

Article 54. CTNBio shall determine, in last and definite resort, on cases in which the activity potentially or effectively degrades the environment, as well as on the need to environmental licensing.

Article 55. The registrations, authorizations and environmental licensing mentioned by this Decree shall be issued within twenty (20) days.

Paragraph 1. The term mentioned in this Article 55 above shall be suspended for not longer than one hundred and eighty (180) days pending preparation, by the applicant, of necessary studies or clarification.

Article 56. Authorizations and registrations mentioned in this Chapter shall be granted under CTNBio technical decision, and further technical requirements in addition to the conditions established by such decision in aspects related to biosafety may not be imposed.

Article 57. Registration and monitoring bodies and entities may establish joint actions with a view to the performance of their duties.

CHAPTER V

BIOSAFETY INFORMATION SYSTEM – SIB

Article 58. SIB, under the Office of the CTNBio Executive Secretary, has the purpose of managing the information resulting from analysis, authorization, registration, monitoring and follow-up of activities involving GMO and GMO derivatives.

Paragraph 1. Provisions of legal, regulatory and administrative acts changing, complementing or producing effect on the biosafety legislation of GMO and GMO derivatives shall be disseminated in SIB simultaneously with the entry into effect thereof.

Paragraph 2. Registration and monitoring bodies and entities shall feed SIB with the information related to the activities mentioned by this Decree conducted in their respective jurisdiction.

Article 59. CTNBio shall give full publicity to its activities through SIB, including its agenda, calendar of meetings, pending procedures and respective members in charge, minutes of meetings and other information on its activities, except for confidential information, of commercial interest, at CTNBio discretion.

Article 60. SIB shall enable electronic interaction among CNBS, CTNBio and federal bodies and entities in charge of GMO registration and monitoring.

CHAPTER VI

INTERNAL BIOSAFETY COMMISSIONS – CIBio

Article 61. An institution committed to education, scientific research, technological development and industrial production, using genetic engineering techniques and methods or conducting research with GMO and GMO derivatives shall set up an Internal Biosafety Commission – CIBio, with operating mechanisms defined by CTNBio.

Paragraph 1. The institution mentioned in this Article 61 above shall appoint one principal technician in charge of each specific project.

Article 62. A CIBio shall, in the context of each institution:

I- keep workers and remaining members of the community susceptible of being affected by the activity informed on issues related to health and safety, as well as on procedures in case of accidents;

II- set up preventive and inspection programs to secure the operation of facilities under its responsibility, within the biosafety standards and regulations defined by CTNBio;

III- forward to CTNBio the documents it may request for the purpose of analysis, registration or authorization by the competent body, as the case may be;

IV- keep individual monitoring records of each activity or project conducted involving GMO and GMO derivatives;

V- notify CTNBio, registration and monitoring bodies and entities and workers entities on the assessment of risks involving the individuals exposed, as well on any accident or event that may promote dissemination of biological agent;

VI- investigate accidents and diseases likely to be related to GMO and GMO derivatives and notify CTNBio of conclusions and actions taken.

CHAPTER VII

RESEARCH AND THERAPY USING HUMAN EMBRYO STEM CELLS OBTAINED BY IN VITRO FERTILIZATION

Article 63. The use of embryo stem cells obtained from human embryos produced by in vitro fertilization and not used in the respective procedure is permitted provided the following conditions are met:

I- the embryos are unviable; or

II- the embryos are available frozen embryos.

Paragraph 1. In any case, the genitors' consent is required.

Paragraph 2. Research and health service institutions conducting research or therapy using human embryo stem cells shall submit their projects to review and approval by their respective ethic and research committees, according to the National Health Council resolution.

Paragraph 3. Marketing of biological material mentioned in this Article 63 is forbidden and its practice implies crime under Article 15 of Law no. 9,434, of February 04, 1997.

Article 64. The Ministry of Health shall conduct a survey and maintain updated a file of human embryos obtained by in vitro fertilization and not used in their respective procedure.

Paragraph 1. Institutions conducting activities involving freezing and storage of human embryos shall inform, within the terms set by in specific regulation, the data needed for identification of unviable embryos produced in their facilities and available frozen embryos.

Paragraph 2. The Ministry of Health shall issue the regulation mentioned by Paragraph 1 above within thirty (30) days from publication of this Decree.

Article 65. Agência Nacional de Vigilância Sanitária – ANVISA, the National Sanitary Surveillance Agency, shall establish the rules guiding the procedures of collection, processing, testing, and storage, transportation, quality control and use of human embryo stem cells for the purposes of this Chapter VII.

Article 66. Genitors who donate, for the purpose of research or therapy, human embryo stem cells obtained according to the provisions of this Chapter shall execute a Certificate of Free and Knowledgeable Consent under specific regulation of the Ministry of Health.

Article 67. The use of human embryo stem cells in therapy, under Article 63 hereof, shall be conducted under the guidelines set by the Ministry of Health for the assessment of new technologies.

CHAPTER VIII

CIVIL AND ADMINISTRATIVE LIABILITY

Article 68. Without prejudice of the penalties envisaged by Law no. 11,105, of 2005, and this Decree, those liable for damages to the environment and third parties shall respond, jointly, for indemnification or full redress, independently of guilt.

Section I

Administrative Infringements

Article 69. An administrative infringement is any action or omission violating the rules set by Law no. 11,105, of 2005, this Decree and other applicable legal provisions, especially:

I- conducting activity or project involving GMO and GMO derivatives, related to education with manipulation of living organisms, scientific research, technological development and industrial production as a natural person performing independent actions;

II- performing activities of research and commercial use of GMO and GMO derivatives without CTNBio authorization or in disagreement with the rules issued by it;

III- failing to require a CQB issued by CTNBio to the juristic person funding or sponsoring activities and projects involving GMO and GMO derivatives;

IV- using, for the purpose of research and therapy, embryo stem cells obtained from human embryos produced by in vitro fertilization without the genitors' consent;

V- performing research or therapy with human embryo stem cells without approval by the ethic in research committee, as regulated by the National Health Council;

VI- marketing embryo stem cells obtained from human embryos produced by in vitro fertilization;

VII- using, for research and therapy, embryo stem cells obtained from human embryos produced by in vitro fertilization without compliance with the provisions of Chapter VII hereof;

VIII- failing to maintain record of individual follow-up for each activity or project in progress involving GMO and GMO derivatives;

IX- performing genetic engineering in living organism without complying with the provisions of this Decree;

X- performing in vitro manipulation of natural or recombinant DNA/RNA without complying with the provisions of this Decree;

XI- performing genetic engineering in human germinal cell, zygote and embryo;

XII- performing human cloning;

XIII- destroying or disposing to the environment GMO and GMO derivatives in disagreement with the rules set by CTNBio, registration and monitoring bodies and entities and this Decree;

XIV- discarding to the environment GMO and GMO derivatives, in the context of research activity, without a favorable technical decision by CTNBio or in disagreement with the rules thereof;

XV- discarding to the environment GMO and GMO derivatives, in the context of commercial activity, without the licensing from the environmental body or entity in charge, whenever CTNBio deems such activity as a potential cause of environment degradation;

XVI- discarding to the environment GMO and GMO derivatives, in the context of commercial activity, without CNBS approval, whenever the proceedings have been avocated by it;

XVII- using, marketing, registering, patenting or licensing genetic restricted use technologies;

XVIII- failing to forward investigation report on accident occurred in the course of research and activity in the area of genetic engineering within five days from the date of the event;

XIX- failing to promptly notify CTNBio and agricultural defense and environment public health authorities on accident that may cause dissemination of GMO and GMO derivatives;

XX- failing to use the necessary means to fully inform CTNBio and public health, environment, agricultural and defense authorities, community and remaining employees of the institution or corporation on the risk to which they may be subject, as well as the actions to be taken in case of accident with GMO and GMO derivatives;

XXI- failing to establish a CIBio, under CTNBio rules, in case the institution uses genetic engineering techniques and methods or conducts research with GMO and GMO derivatives;

XXII- maintaining in operation CIBio in disagreement with CTNBio rules;

XXIII- failing to keep employees and other members of the community informed, through CIBio, whenever they are likely to be affected by the activity, on issues related to health and security, as well as procedures in case of accidents;

XXIV- failing to set up preventive and inspection programs, through CIBio, to secure the operation of facilities under the institution's responsibility, within biosafety standards and rules defined by CTNBio;

XXV- failing to notify CTNBio and other registration and monitoring bodies and entities, and employees entities, through CIBio, of the results of risk assessment to which those exposed are subject, as well as of any accident or incident that may cause dissemination of biological agent;

XXVI- failing to investigate the occurrence of accidents and diseases possibly related to GMO and GMO derivatives and notify its conclusions and remedial actions to CTNBio;

XXVII- producing, storing, transporting, marketing, importing or exporting GMO and GMO derivatives without authorization or in disagreement with rules established by CTNBio and registration and monitoring bodies and authorities.

Section II
Administrative Sanctions

Article 70. Administrative infringements, in addition provisional remedies such as product seizure, sale suspension and restraint of activities, shall be subject the following sanctions:

I- admonishment;

II- fine;

III- apprehension of GMO and GMO derivatives;

IV- suspension of GMO and GMO derivatives sale;

V- restraint of activities;

VI- full or partial interdiction of the facility, activity or establishment;

VII- suspension of registration, license or authorization;

VIII- cancellation of registration, license or authorization;

IX- loss or restriction to fiscal incentive and benefit granted by the government;

X- loss or suspension of participation in credit lines in official credit establishment;

XI- intervention in the establishment;

XII- impediment to enter into agreements and contracts with the public administration for a period of up to five years;

Article 71. In order to apply and grade a penalty, registration and monitoring bodies and entities shall take into account:

I- severity of the infringement;

II- background of the defaulting party regarding compliance with agricultural, sanitary, environmental and biosafety rules;

III- economic advantage held by the defaulting party;

IV- economic situation of the defaulting party;

Paragraph 1. For the purposes of this Article 71(I) above, infringements mentioned in this Decree shall be classified as light, severe an extremely severe, according to the following criteria:

I- risk classification of GMO;

II- means used to materialize the infringement;

III- effective or potential consequences for human dignity, human, animal and plant health and the environment;

IV- culpability of the defaulting party;

Article 72. An admonishment shall be applied only to light infringements.

Article 73. A fine shall be applied according to the following grades:

I- from R$2,000 (two thousand Brazilian Reals) to R$60,000 (sixty thousand Brazilian Reals), for light infringements;

II- from R$60,001 (sixty thousand and one Brazilian Reals) to R$500,000 (five hundred thousand Brazilian Reals) for severe infringements;

III- from R$500,001 (five hundred thousand and one Brazilian Reals) to R$1,500,000 (one million five hundred thousand Brazilian Reals) for extremely severe infringements.

Paragraph 1. A fine shall be doubled in case of relapse.

Paragraph 2. Fines may be applied concurrently with other sanctions envisaged by this Decree.

Article 74. Fines mentioned in Law no. 11,105 and in this Decree shall be applied by registration and monitoring bodies and entities within their respective jurisdictions.

Paragraph 1. Funds collected through application of fines shall be applied to registration and monitoring bodies and entities applying the fine.

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

Article 75. Sanctions mentioned in Article 70(III), (IV), (V), (VI), (VII), (IX) and (X) shall be applied only to severe or extremely severe infringements.

Article 76. Sanctions mentioned in Article 70(VIII), (IX) and (XII) shall be applied only to extremely severe infringements.

Article 77. In case a defaulting party commits two or more infringements, sanctions attached to each infringement shall be applied jointly.

Article 78. In case of continued infringement, characterized by permanence of the action or omission initially punished, the respective penalty shall be applied on a daily basis until cessation the cause, regardless of immediate restraint of activity or interdiction of the laboratory, institution, or corporation in charge.

Article 79. Registration and monitoring bodies and entities may, notwithstanding the application of administrative sanctions, apply provisional remedies of product seizure, sale suspension and restraint of activities whenever there is impending risk to human dignity, human, animal and plant health and the environment.

Section III

Administrative Proceedings

Article 80. Any person, verified occurrence of administrative infringement, may apply to the monitoring body or entity of competent jurisdiction, for the purpose of exercising police power.

Article 81. Administrative infringements shall be investigated in separate administrative proceedings, securing the right of legal defense and contradiction.

Article 82. Officials of monitoring bodies mentioned in Article 53 hereof are competent authorities to draw up infringement notices, file administrative proceedings and indicate applicable penalties.

Article 83. The monitoring authority shall forward a copy of the infringement notice to CTNBio.

Article 84. Whenever the infringement constitutes crime or misdemeanor, or imply damage to public finances or to the consumer, the monitoring authority shall notify the competent body for investigation of penal and administrative liabilities.

Article 85. Provisions of Law no, 9,784, of 1999, are applicable to this Decree, as the case may be.

CHAPTER IX

FINAL AND TEMPORARY PROVISIONS

Article 86. CTNBio, within ninety days of its establishment shall define:

I- the draft of its internal regulation, to be submitted to approval by the Minister of State of Science and Technology;

II- GMO risk classes;

III- biosafety levels to be applied to GMO and GMO derivatives, according to the GMO risk class;

Paragraph 1. Pending the GMO risk class definition by CTNBio, the classification table of the Schedule to this Decree applies.

Article 87. The Office of the CTNBio Executive Secretary shall submit, within ninety days, a draft of CTNBio internal regulation to the collegiate body.

Article 88. GMO that have been granted, on or before March 25, 2005, favorable technical decision by CTNBio regarding their commercial use may be registered and marketed under CNBS Resolution no. 1, of May 27, 2005.

Article 89. Institutions conducting activities regulated by this Decree shall conform to its provisions within one hundred and twenty (120) days from the publication hereof.

Article 90. Provisions of Law no, 7,802, of July 11, 1989 are not applicable to GMO and GMO derivatives, except in case such GMO and GMO derivatives are developed to be used as raw material for pesticide production.

Article 91. Food and food ingredients for human or animal consumption containing, or produced from, GMO and GMO derivatives shall contain such information in their label, as provided by specific Decree.

Article 92. CTNBio shall cause to be revised and, if required, adapted, CQBs, communiqués, technical decisions and regulatory acts issued under Law no. 8,974, of January 05, 1995, which are not in conformity with Law no. 11,105, of 2005, and this Decree.

Article 93. CTNBio and registration and monitoring bodies shall revise their regulatory deliberations within one hundred and twenty (120) days from the publication of this Decree in order to adapt such deliberations to the provisions hereof.

Article 94. This Decree shall be effective upon publication.

Article 95. Decree no. 4,602, of February 21, 2003 is hereby revoked.

Brasília, November 22, 2005, 184th of the Independence and 117th of the Republic.

Luiz Inácio Lula da Silva

Roberto Rodrigues

Saraiva Felipe

Sérgio Machado Rezende

Marina Silva

This text does not replace the one published in the Federal Official Gazette of 11.23.2005.

 

SCHEDULE

Risk Classification of Genetically Modified Organisms

Risk Class 1	Comprises the organisms falling under the following criteria:
	A	Recipient or parental organism:
		- nonpathogenic;
		- exempt from adventitious agents
		- with fully documented background of safe use, or incorporating biologic barriers that, without interfering in optimal growth in reactor or fermentator, enables limited survival and multiplication, with no harmful effects to the environment;
	B	Vector/insert
		- adequately characterized and devoid of known noxious sequences;
		- whenever possible, limited in size to genetic sequences required to realize the projected function;
		- shall not improve stability of a modified organism in the environment;
		- shall be scarcely mobilizable;
		- shall not transmit any marker of resistance to organisms that, according to available knowledge, does not acquires it naturally;
	C	Genetically modified organisms:
		- nonpathogenic;
		- offering the same safety as the receiving or parental organism in a reactor or fermentator, yet with limited survival or multiplication, without harmful effects to the environment;
	D	Other genetically modified organisms that might be included in Risk Class I, provided they meet the conditions of subparagraph C above:
		- microorganisms constructed entirely from one single prokaryotic receiver (including plasmids and endogenous viruses) or one single eukaryotic receiver (including cytoplasts, mithochondrias and plasmids, excluding viruses) and organisms entirely made from genetic sequences of different species that interchange such sequences through known physiological processes;
Risk Class II	Comprises all organisms not included in Risk Class I

[Reverse of the twenty-one pages of the original document blank].

In Witness Whereof, I have hereunto set my hand and seal in this City of Brasília, Federal District, Brazil, this Monday, April 17, 2006. Fees according to Official Gazette of 11/10/2003 Marco Antônio Rochadel Page 098 Public Translator