Estabelece as condições de isolamento para a Liberação Planejada no Meio Ambiente (LPMA) de citros e afins geneticamente modificados.

A COMISSÃO TÉCNICA NACIONAL DE BIOSSEGURANÇA - CTNBio, no uso de suas atribuições legais e regulamentares, e tendo em vista o disposto nos incisos II e XVI do art. 14 da Lei nº 11.105, de 24 de março de 2005, resolve:
Art. 1º. Esta Resolução Normativa estabelece as condições de isolamento para a Liberação Planejada no Meio Ambiente (LPMA) de citros e afins geneticamente modificados.
Art. 2º. Para os fins desta Resolução Normativa, considera-se:
I - citros e afins: grupos de espécies do gênero Citrus spp e gêneros próximos, como Poncirus, Microcitrus e Fortunella, Eremocitrus, Oxanthera e Clymenia capazes de produzir híbridos intraespecíficos e intergenéricos férteis, que podem ser utilizados como genótipos copa ou porta-enxertos;
II - citrandarins: híbridos de Poncirus trifoliata com tangerinas ou com microtangerinas;
III - citranges: híbridos de laranja doce (Citrus sinensis) com Poncirus trifoliata;
IV - cultivar, variedade ou genótipo de citros como copa: parte aérea da planta de citros que é utilizada para a produção de frutos, a qual é obtida por enxertia de gemas vegetativas, conhecidas como borbulhas, em um porta-enxerto que normalmente não é da mesma espécie;
V - cultivar, variedade ou genótipo de citros como porta-enxerto: parte da planta de citros representada pelo sistema radicular, obtida de sementes apomíticas e poliembriônicas, com predominância do embrião nucelar (assexual), sendo que dessas plantas serão utilizadas para extração de sementes para produzir plântulas utilizadas como porta-enxertos;
VI - embrião assexual: embrião de origem nucelar que origina clone juvenil da planta que lhe deu origem;
VII - semente apomítica: semente que apresenta um ou vários embriões de origem sexual ou assexual, sendo que, no caso de citros, os embriões assexuais são originados do nucelo, tecido que serve de fonte de nutrientes para os embriões. Nos genótipos poliembriônicos de citros há predominância dos embriões assexuais e menor taxa de embriões sexuais;
VIII - semente poliembriônica: semente que apresenta um ou vários embriões de origem sexual ou assexual, sendo que, no caso de citros, os embriões assexuais são originados do nucelo, tecido que serve de fonte de nutrientes para os embriões, e nos genótipos poliembriônicos de citros há predominância dos embriões assexuais e menor taxa de embriões sexuais;
IX - enxertia: técnica de propagação vegetativa na qual o tecido vegetativo de um genótipo copa é enxertado no caule de outra planta, permitindo a conexão vascular, o desenvolvimento e o crescimento normal e uniforme de ambos os genótipos como uma planta única.
Art. 3º. Na liberação planejada no meio ambiente de citros geneticamente modificado e utilizado como cultivar copa deverá ser observada o uso de bordadura com, no mínimo, três linhas de cultivo (filas de árvores) com genótipo poliembriônico e não geneticamente modificado, ao redor da área que contenha citros geneticamente modificado, observadas as seguintes condições:
I - genótipos poliembriônicos recomendados como bordaduras:
a) citrandarins (preferencial);
b) citranges ou
c) Poncirus trifoliata;
II - realização de monitoramento na área experimental visando a eliminação de plantas espontâneas de citros eventualmente oriundas da germinação de sementes das plantas geneticamente modificadas ou das plantas da bordadura; e
III- realização de monitoramento e eliminação de plantas espontâneas de citros geneticamente modificados remanescentes e de plantas da bordadura dentro da área por um período de 12 (doze) meses após a conclusão da liberação planejada no meio ambiente.
Art. 4º. Na liberação planejada no meio ambiente de citros geneticamente modificado utilizando cultivar porta-enxerto na situação de copa para a produção de sementes, deverá ser observado o uso de bordaduras com, no mínimo, três linhas de cultivo (filas de árvores) com genótipo poliembriônico não geneticamente modificados, ao redor da área que contenha citros geneticamente modificado e as seguintes condições:
I) genótipos poliembriônicos recomendados como bordaduras:
a) citrandarins (preferencial);
b) citranges;
c) ou Poncirus trifoliata;
II) realização de monitoramento na área experimental visando a eliminação de plantas espontâneas de citros eventualmente oriundas da germinação de sementes das plantas geneticamente modificadas ou das plantas da bordadura; e
III) realização de monitoramento e eliminação de plantas espontâneas de citros geneticamente modificados remanescentes e de plantas da bordadura dentro da área por um período de 12 meses após a conclusão da liberação planejada no meio ambiente.
Art. 5º. Na liberação planejada no meio ambiente de citros geneticamente modificado e utilizados como porta-enxertos deverão ser observadas as seguintes condições:
I - ao término das avaliações, a copa deverá ser decepada e o porta-enxerto tratado, de modo a impedir brotações, mediante a aplicação de herbicida ou arranquio da planta com o sistema radicular; e
II - as brotações de raízes de plantas de citros geneticamente modificados remanescentes deverão ser monitoradas e eliminadas dentro da área por um período de 12 (doze) meses após a conclusão da liberação planejada no meio ambiente.
Art. 6º. Em relação às colmeias destinadas à apicultura comercial pré-existentes à época da instalação da liberação planejada no meio ambiente de citros como copa geneticamente modificados, deverá ser garantida a distância mínima de:
I - 1 (um) quilômetro em relação a estabelecimentos apícolas com Apis mellifera, cadastrados no Ministério da Agricultura, Pecuária e Abastecimento, Departamento de Inspeção de Produtos de Origem Animal ou equivalente, nos termos do Decreto nº 9.013, de 29 de março de 2017; e
II - 3 (três) quilômetros em relação a estabelecimentos apícolas com abelhas da Tribo Meliponini.
Art. 7º. As áreas com citros geneticamente modificados utilizados como variedade copa devem estar a pelo menos 1 (um) quilômetro de áreas de produção de sementes de porta-enxertos de citros.
Art. 8º. Na instalação do experimento de que trata esta Resolução Normativa deverá ser respeitada a distância de, pelo menos, 100 (cem) metros de áreas de preservação natural.
Art. 9º. Para o descarte de frutas, sementes, ramos e troncos de plantas geneticamente modificadas e demais plantas da bordadura deverá ser observada uma das seguintes alternativas:
I - enterrio, incorporação, deposição ou manutenção na área com Certificado de Qualidade em Biossegurança – CQB até a completa perda da capacidade vegetativa;
II - trituração do material com triturador mecânico, com posterior manutenção dos restos vegetais na área com CQB para decomposição natural e completa perda da capacidade vegetativa;
III - queima, incineração em fornos, caldeiras ou outros meios que permitam a decomposição térmica do material por meio de combustão controlada, não havendo necessidade de ser o estabelecimento portador de CQB, quando da queima da madeira após secagem ao ar por cerca de 60(sessenta) dias.
IV -tratamento químico com herbicidas; ou
V - outras, caso a caso, a critério da CTNBio.
§1º A completa utilização da biomassa deverá ser assegurada pelas Comissões Internas de Biossegurança – CIBio da requerente.
§2º A inativação da capacidade de propagação da biomassa, assim como da rebrota de citros quando porta-enxerto geneticamente modificado, poderá ser realizada por método mecânico, químico ou secagem natural, a critério da Comissão Interna de Biossegurança – CIBio da requerente.
§3º O transporte da biomassa (ramos e troncos) derivada de OGM e a sua utilização é de inteira responsabilidade da CIBio da requerente e deverá ser feito de acordo com a classificação de risco estabelecida em normativa vigente.
Art. 10º. Mais de um ensaio com citros geneticamente modificado, tanto como copa quanto porta-enxerto, poderá estar contido dentro de uma única bordadura, desde que a bordadura seja pré-existente ou plantada juntamente com as parcelas dos ensaios.
Art. 11º. Os casos não previstos nesta Resolução Normativa serão resolvidos pela CTNBio.
Art. 12º. Fica revogada a Resolução Normativa no 10, de 2 de outubro de 2013, da CTNBio.
Art. 13º. Esta Resolução Normativa entra em vigor em 1° de outubro de 2020.

Paulo Augusto Vianna Barroso
PRESIDENTE DA CTNBio
 

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.