Dispõe sobre a classificação do nível de risco das atividades econômicas sujeitas a atos públicos de liberação pela Comissão Técnica Nacional de Biossegurança - CTNBio, para os fins da Lei nº 13.874, de 20 de setembro de 2019, regulamentada pelo Decreto nº 10.178, de 18 de dezembro de 2019.

A COMISSÃO TÉCNICA NACIONAL DE BIOSSEGURANÇA – CTNBio, no uso de suas atribuições legais e regulamentares, e tendo em vista o disposto no art. 14, incisos II e XVI, da Lei nº  11.105, de 24 de março de 2005, na Lei nº 13.874, de 20 de setembro de 2019, e no art. 3º do Decreto nº 10.178, de 18 de dezembro de 2019, resolve:

Art. 1º Esta Resolução Normativa estabelece o nível de risco das atividades econômicas sujeitas a atos públicos de liberação pela Comissão Técnica Nacional de Biossegurança - CTNBio.
Parágrafo único. Não se submeterá às disposições desta Resolução Normativa os organismos geneticamente modificados - OGM e seus derivados que tenham obtido autorização destinada à liberação para uso comercial, observado o constante no parecer técnico, emitido pela Comissão Técnica Nacional de Biossegurança - CTNBio.
Art. 2º Para os efeitos desta Resolução Normativa serão consideradas as seguintes definições:
I – atos públicos de liberação: a licença, a autorização, a concessão, a inscrição, a permissão, o alvará, o cadastro, o credenciamento, o estudo, o plano, o registro e os demais atos exigidos, sob qualquer denominação, por órgão ou entidade da administração pública na aplicação de legislação, como condição para o exercício de atividade econômica, inclusive o início, a continuação e o fim para a instalação, a construção, a operação, a produção, o funcionamento, o uso, o exercício ou a realização, no âmbito público ou privado, de atividade, serviço, estabelecimento, profissão, instalação, operação, produto, equipamento, veículo, edificação e outros;
II – nível de risco da atividade econômica: nível de perigo potencial de ocorrência de danos à integridade física e à saúde humana, animal ou ao meio ambiente, em decorrência do exercício de atividade econômica, considerando-se a probabilidade de ocorrência de eventos danosos, bem como a extensão, gravidade ou o grau de irreparabilidade do impacto causado à sociedade na hipótese de ocorrência de evento danoso;
III – organismo geneticamente modificado - OGM: organismo cujo material genético – ADN/ARN tenha sido modificado por qualquer técnica de engenharia genética; e
IV – derivado de OGM: produto obtido de OGM e que não possua capacidade autônoma de replicação ou que não contenha forma viável de OGM.
Art. 3º A classificação de risco de biossegurança dos OGM e seus derivados obedecerá ao disposto na Resolução Normativa nº 18, de 23 de março de 2018, da CTNBio, ou em atos normativos que vierem a substituir.
Art. 4º O nível de risco da atividade econômica submetida a ato público de liberação pela CTNBio será classificado em:
I - nível de risco I - para os casos de risco leve ou irrelevante;
II - nível de risco II - para os casos de risco moderado; ou
III - nível de risco III - para os casos de risco alto.
Parágrafo único. Os níveis de risco das atividades econômicas sujeitas a atos públicos de liberação pela CTNBio estão relacionados no Anexo I desta Resolução Normativa.
Art. 5º Não se aplica a aprovação tácita prevista no inciso IX do caput do art. 3º da Lei 13.874, de 20 de setembro de 2019 às solicitações de atos públicos de liberação pela CTNBio, por se enquadrarem como hipóteses vedadas em lei, com fundamento nos arts. 196 e 225 da Constituição Federal, bem como na Lei nº 11.105, de 24 de março de 2005, no Decreto nº 5.591, de 22 de novembro de 2005 e no Decreto nº 5.705, de 16 de fevereiro de 2006.
Art. 6º Esta Resolução Normativa não altera as normas e procedimentos estabelecidos pela Lei nº 11.105, de 2005, pelo Decreto nº 5.591, de 2005 e pelos atos normativos da CTNBio, bem como não exime as Comissões Internas de Biossegurança- CIBios da concessão de autorizações e do desempenho de outras atribuições delegadas pela CTNBio, nos termos da legislação em vigor.
Art. 7º Esta Resolução Normativa não isenta as requerentes do cumprimento da legislação e das demais normas aplicáveis às atividades realizadas com OGM e seus derivados.
Art. 8º Os casos não previstos nesta Resolução Normativa serão resolvidos pela CTNBio.
Art. 9º Fica revogada a Resolução Normativa Ad Referendum nº 25, de 31 de janeiro de 2020, da CTNBio.
Art. 10. Esta Resolução Normativa entrará em vigor em 1° de setembro de 2020.

Paulo Augusto Vianna Barroso
PRESIDENTE DA CTNBio

ANEXO I
Atividade: Desenvolvimento de atividades de detecção, quantificação e identificação de OGM.
Nível de risco econômico: Nível de risco I

Atividade: Obtenção de credenciamento Certificado de Qualidade em Biossegurança – CQB para desenvolver quaisquer atividades com OGM.
Nível de risco econômico: Nível de risco III

Atividade: Desenvolvimento de atividades com OGM e seus derivados que não tenham sido liberados comercialmente, englobando a construção, o cultivo, a manipulação, o transporte, a transferência, a importação, a exportação, o armazenamento e o descarte.
Nível de risco econômico: Nível de risco III

Atividade: Realização de liberação planejada no meio ambiente com OGM e seus derivados da classe de risco de biossegurança 1 e 2.
Nível de risco econômico: Nível de risco III

Atividade: Realização de liberação planejada no meio ambiente com OGM e seus derivados da classe de risco de biossegurança 1, em conformidade com a Resolução Normativa n° 23, de 2019 da CTNBio, ou ato que vier a substituí-la.
Nível de risco econômico: Nível de risco III

Atividade: Uso comercial de Microrganismos Geneticamente Modificados -MGM e seus derivados mantidos exclusivamente em regime de contenção, em conformidade com os arts. 5º, 6º e com o Anexo VI da Resolução Normativa n° 21, de 2018 da CTNBio, ou ato que vier a substituí-los.
Nível de risco econômico: Nível de risco III

Atividade: Liberação comercial de OGM e derivados de todas as classes de risco.
Nível de risco econômico: Nível de risco III

Approves the Internal Regulation of the National Biosafety
Council – CNBS.

THE PRESIDENT OF THE NATIONAL BIOSAFETY COUNCIL – CNBS, in
the use of her attributions and due to Plenary decision, at
meeting on January 29th, 2008, decides:

Art.1. The Internal Regulations of the National Biosafety
Council – CNBS are approved, according to this Resolution
Attachment.
Art. 2. This Resolution is in force from its date of
publication.

DILMA ROUSSEFF

INTERNAL REGULATION OF THE NATIONAL BIOSAFETY COUNCIL- CNBS

CHAPTER I
THE OBJECTIVE AND THE COMPOSITION OF CNBS
Art. 1. The National Biosafety Council – CNBS, a collegiate
organ that takes part of the structure of the Presidency of
the Republic, created by article 8 of Law No. 11.105, of
March 24th, 2005, and regulated by Decree No. 5.591, of
November 22nd, 2005, aims at, among other things, the
higher assistance to the President of the Republic for the
formulation and implementation of the National Policy of
Biosafety.
Art. 2. CNBS is composed by the following members:
I – State Ministry Head of the Civil Cabinet of the
Presidency of the Republic, who will preside it;
II – State Ministry of Science and Technology;
III – State Ministry of Agrarian Development;
IV – State Ministry of Agriculture, Cattle Breading and
Supply;
V – State Ministry of Justice;
VI – State Ministry of Health;
VII – State Ministry of the Environment;
VIII – State Ministry of Development, Industry and Foreign
Trade;
IX – State Ministry of Foreign Affairs;
X - State Ministry of Defense; and
XI – Special Secretary of Aquiculture and Fishing of the
Presidency of the Republic.
Paragraph 1. The members of CNBS will be substituted, in
their absences or hindrances, by the Executive-Secretaries
of the respective Ministries, or, if there is no such an
office, by the substitutes of the State Ministry of the
Special Secretary.
Paragraph 2. In the President's absence, he will appoint
the State Ministry to preside the works.

CHAPTER II
CNBS' COMPETENCE
Art. 3. It is CMBS's responsibility:
I – to assist the President of the Republic on the
formulation and implementation of the National Policy of
Biosafety;
II – stipulate principles and policies for the
administrative action of federal organs and entities with
competences on the matter;
III – at request from the National Technical Biosafety
Commission – CTNBio, regarding the aspects of living and
socio-economical opportunity, and of the national interest,
analyze the requests of release for the commercial use of
genetically modified organisms – GMO, and its derivatives;
and
IV – based on CTNBio's manifestation and when it deems
necessary, out of the organs and entities referred to on
art. 16 of Law No. 11.105, of 2005, in the ambit of ther
competences, claim and decide, in last and definite
jurisdiction, about the process regarding the activities
that involve the commercial use of GMO and its derivatives.

CHAPTER III
CNBS' MEMBERS' ATTRIBUTIONS
Art. 4. CNBS' Members' attributions are:
I – to zeal for the full and total development of CNBS
attributions;
II – to analyze and report, within pre-established terms,
subjects distributed to it;
III – to appreciate, and whenever it is the case,
deliberate about subjects presented to CNBS;
IV – to request from CNBS President, the voting of subject
in urgency character, and the request should be submitted
to Plenary Approval; and
V – perform other activities that are necessary to the
fulfillment of its attributions and to the functioning of
CNBS.

CHAPTER IV
THE ORGANIZATION AND THE FUNCTIONING OF CNBS
Section I
The General Dispositions
Art. 5. CNBS has the following internal organization:
I – Plenary;
II – Presidency; and
III – Executive-Secretariat.
Subsection I
The Plenary
Art. 6. The Plenary is the decisive instance of CNBS,
composed by members appointed on art. 2, and it will meet
through calling or provocation, in accordance with the
requisites of functioning established on this Internal
Regulation.
Subsection II
The Plenary Functioning
Art. 7. CNBS will meet through calling from its President
or through provocation of most of its members.
Paragraph 1. CNBS calling provocation referred to on the
caput should be founded, explicating the motives and the
meeting agenda.
Paragraph 2. On the document calling the meeting, the
President will record the agenda, the date, the time and
the place the session will take place.
Art. 8. CNBS sessions will only take place with the
presence of at least six members, and the decisions will be
taken with favorable votes from the absolute majority.
Art.9. On CNBS sessions, the following procedures will be
adopted:
I – works installations by the President;
II – checking of the presence and existence of quorum for
the collegiate installation;
III – reading and approval of the previous meeting minutes;
IV – reading of general information, when it is the case;
V – presentation, discussion and deliberation of subjects
on the agenda; and
VI – closing of the works.
Art.10. Alteration of subjects on record will take place
through CNBS' President's decision or by proposition of any
of the members, as long as it is approved by the Plenary.
Subsection III
The Processes
Art. 11. The processes will be processed at the Executive-
Secretariat of CNBS, and the term for the respective
judgment will start from this date.
Sole Paragraph. The process receipt registration will
indicate the date and sole number of protocol.
Art.12. CNBS' competence processes distribution shall be
made by the President.
Art.13. After distributing the process, the reporter member
will write the report, and submit it to CNBS' judgment.
Art. 14. After the reporter's vote, CNBS' President should
open a discussion period for the subject, for its members'
judgment.
Sole Paragraph. After consulting the Plenary, the President
will determine the closing of oral debate, and open for
voting.
Art.15. The President will proclaim the result, whose final
decision will be written by the Executive-Secretariat.
Sole Paragraph. CNBS' deliberations will be constituted of:
I – propositions: when there is higher assistance to the
President of the Republic on the formulation and
implementation of the National Policy of Biosafety;
II – guidance: when there is stipulation of principles and
policies for the administrative action of federal organs
and entities; and
III – resolutions: when there is final decision about the
analysis, at CTNBio's request, regarding the aspects of
convenience and socio-economical opportunity, and of
national interest, of release requests for commercial use
of GMO and its derivatives, appeal and decision, in last
and definite jurisdiction, of the processes regarding
activities that involve the commercial use of GMO and its
derivatives, and judgment of resources interposed by
registration and inspection organs and entities.
Art.16. At every CNBS' meeting minutes will drawn up,
which, after being approved and signed by he present
members, will be filed at the Executive-Secretariat.
Art.17. The final decision will only be effective from its
publication date, by the Executive-Secretariat, at the
Official Gazette.
Art. 18. The President or CNBS may requested urgency on the
appreciation of a subject on the agenda.
Art.19. The President or the Executive–Secretariat will be
able to request manifestation from the Sub-office for
Juridical Subjects, and from the Sub-office of Analysis and
Follow-up of Governmental Policies at the Civil Cabinet of
the Presidency of the Republic, in the ambit of its
competences, to subsidize CNBS' decisions.
Art.20. The requests, requirements or resources that do not
fit on the legal hypotheses of CNBS' competence, are, at
preliminary order, not granted by the President ad
referendum of CNBS.
Sub-section IV
The Executive-Secretariat
Art.21. It is the Executive-Secretariat's responsibility,
together with the Civil Cabinet of the Presidency of the
Republic:
I – to zeal for the full development of CNBS' attributions;
II – to plan, organize, and coordinate CNBS' technical and
administrative activities;
III – to provide the necessary means for CNBS' works
execution;
IV – to promote the handling of processes subject to CNBS'
deliberation;
V – to forward CNBS' manifestation to the registration and
inspection organs and entities referred to on art. 16 of
Law No. 11.105, of 2005, whenever there is final decision
in favor of the execution of the analyzed activity;
VI – to forward CNBS' manifestation to CTNBio for the
petitioner's awareness, whenever there is final decision
against the analyzed activity;
VII – to assist CNBS' members in issues of the Council's
competence;
VIII- to request manifestation from the Sub-office of
Juridical Subjects and from the Sub-office of Analysis and
Follow-up of Governmental Policies of the Civil Cabinet of
the Presidency of the Republic, in the ambit of its
competences, to subsidize CNBS' decisions; and
IX – to execute other attributions determined by CNBS'
President.
Section II
The Specific Dispositions of Process of CNBS' Competence
Sub-Section I
The Analysis of Convenience and Opportunity
Art.22. CNBS will decide, at CTNBio's request, about
convenience and socio-economical opportunity aspects, and
of national interest on the release for commercial use of
GMO and its derivatives.
Paragraph 1. CTNBio should enter in a protocol, with CNBS'
Executive-Secretariat, the process regarding the activity
to be analyzed, or its integral copy, indicating motives
for such forwarding.
Paragraph 2. After the processing of CTNBio's request, CNBS
Executive-Secretariat shall send to the members of the
Council, within five days, a copy of the request, of the
motivation, and of CTNBio's technical decision, and it will
make the process available for eventual consultation or
copy requests.
Sub-section II
The Processes Appeal
Art.23. CNBS shall appeal to a higher court the processes
regarding the activities that involve the commercial use of
GMO and its derivatives for analysis and decision, in last
and definite jurisdiction, within thirty days from the date
of publication of CTNBio's technical decision on the
Official Gazette.
Paragraph 1. In case of appeal, the Executive-Secretariat
will notify CTNBio so that it remits to CNBS the process
that was appealed to higher court, or its full copy, within
five days.
Paragraph 2. Within five days, the Executive-Secretariat
will send to CNBS' members, contacts of the registration of
the copy of the process, a copy of CTNBIo's technical
decision, and it will make the process available for
eventual consultations or copy requests.
Subsection III
Registration and Inspection Organs and Entities Resources
Art.24. CNBS will decide about the registration and
inspection organs and entities resources regarding the
commercial liberation of GMO and its derivatives, which
have entered in a protocol in its Executive-Secretariat,
within thirty days counting from the date of publication of
CTNBio's technical decision on the Official Gazette.
Paragraph 1. The resource dealt with in this article shall
be instructed with technically founded justification that
demonstrates the divergences of the registration and
inspection organ or entity, in the ambit of their
competences regarding CTNBio's decision in relation to
biosafety aspects of GMO and its derivatives.
Paragraph 2. After the resource has entered in the protocol
referred to on the caput, CNBS Executive-Secretariat will
request from CTNBio the process, or its full copy, within
five days.
Paragraph 3. Within five days, CTNBio shall send to CNBS
the process, or its full copy.
Paragraph 4. After having received the process, or its full
copy, within five days, CNBS Executive-Secretariat shall
send to the Council's members a copy of the resource, and
of the appealed technical opinion, and it will make the
process available for consultations and requests of copies
by CNBS' members.
Paragraph 5. Within the period foreseen on paragraph 4,
CNBS Executive-Secretariat will send to CTNBio a copy of
the interposed resource.
Paragraph 6. The untimely resources will not be granted by
the President at preliminary order.

CHAPTER V
THE FINAL DISPOSITIONS
Art. 25. CNBS will publicize its activities and decisions,
except for secret information, of public, commercial or
business interest.
Sole Paragraph. Requests for certificates and copies of
processes pieces shall be directed by the interested party
to CTNBio, who will make the process available for
consultation or copy, observing the secrecy of the
documents and information in accordance with Decree No.
5.591, of 2005.
Art.26. The participation on CNBS' activities will be
considered relevant function, not remunerated.
Art.27. The proposal for this Internal Regulation
alteration shall be presented by any member at a CNBS
session.
Sole Paragraph. This Internal Regulation alteration will
only be approved by favorable vote of the majority of CNBS'
members.
Art.28. The missing cases and the doubts arising on the
application of this Internal Regulation will be solved by
CNBS' President, ad referendum of the Council.
Sole Paragraph. The President or CNBS may request
manifestation of the Sub-office for Juridical Issues and
the Sub-office of Analysis and Follow-up of Governmental
Policies of the Civil Cabinet of the Presidency of the
Republic, in the ambit of their competences, to subsidize
the resolution of missing cases, and of doubts arising from
the application of this Internal Regulation.