Ruling Resolution nº 9, of December 2, 2011

Makes provisions on rules for genetically modified organisms postcommercial
release monitoring.

The Biosafety National Technical Commission – CTNBio, using the legal and regulatory powers
vested in it, complying with provisions of Article 14(III) of Law nº 11105, of March 24, 2005,
resolves:
Article 1. Post-commercial release monitoring of Genetically Modified Organisms –
GMO or exemption thereof are regulated by the provisions of this Ruling Resolution.
§1. Post-commercial release monitoring intends to gather information that may
suggest adverse effects from commercial release of the GMO to the environment and
human and animal health, according to the GMO application used.
§2. Monitoring mentioned in this Article 1 includes general monitoring and casespecific
monitoring pursuant to the definitions on Article 2(IV) and (V) hereof and
according to the flowchart of post-commercial release monitoring appearing on
CTNBio Internet site at the address http://www.ctnbio.gov.br.
§3. Preparation, submission and later implementation of a post-commercial
release monitoring plan is a responsibility of the applicant, who may conduct such
plan through the hiring of services from capable institutions, under the provisions of
Article 11 of this Ruling Resolution.
Article 2. For the purposes of this Ruling Resolution, the definitions appearing on
CTNBio Ruling Resolution nº 5 of March 12, 2008, providing on rules for commercial release of
GMO and its derivatives, in addition to the following definitions, shall be complied with:
I - damage: adverse effects to the environment or to human and animal health;
II - negligible risk: risk associated to any reduced damage with negligible
likelihood to take place over the probable term of the GMO commercial use;
III - significant risk: risk associated to any damage with actual likelihood to take
place over the probable term of the GMO commercial use;
IV - general monitoring: set of procedures aimed at detecting and identifying
unanticipated adverse effects in assessment of risk resulting from commercial release
of the GMO to the environment or to human and animal health; and
V - Case-specific monitoring: set of procedures aimed at assessing adverse
effects evidenced during general monitoring or foreseen by CTNBio risk assessment,
resulting from commercial release of the GMO into the environment or to human and
animal health.
Article 3. The applicant shall submit the post-commercial release monitoring plan or
request exemption thereof within thirty (30) days from the date the approval of the request
for commercial release of the GMO, according to CTNBio risk assessment as well as to the
opinion contained in CTNBio technical decision.
§1. In case CTNBio identifies just negligible risks, related to the GMO biosafety,
the applicant shall submit the general monitoring plan as foreseen by Article 11
hereof, which shall be analyzed on a case-by-case basis, or may submit a well
grounded request for exemption of the monitoring plan.
§ 2. In case the CTNBio risk assessment identifies substantial risks related to the
GMO biosafety, indicating mitigating measures in case of commercial release, the
applicant shall submit a general monitoring plan as foreseen by Article 11 hereof and a
case-specific monitoring plan, as foreseen by Article 16 hereof.
§3. The thirty (30) days term mentioned in the head of this Article may be
extended only once, for an equal thirty (30) days term, by decision of CTNBio plenary
meeting.
Article 4. The application filed with CTNBio Office of the Executive-Secretary, after
registered and duly documented, shall have its summary published in the Federal Official
Gazette.
§1. In case an information confidentiality request is presented by the applicant,
the rite established by the Ministry of Science, Technology and Innovation Directive nº
373, of June 1, 2011 shall be applied.
Article 5. A proposed post-commercial release monitoring plan or exemption thereof
shall be forwarded to all Permanent Sectoral Subcommissions for preparation and approval of
a final opinion in the first sectoral meeting subsequent to the receipt of the proposed plan or
exemption thereof.
§1. The Permanent Sectoral Subcommissions shall analyze and prepare their
opinions not later than the next sectoral meeting, except in case an extension is
granted to the subsequent meeting by CTNBio plenary decision.
Article 6. CTNBio may request supplementary information and, in case new documents
are demanded, the applicant shall answer within thirty (30) days from the date of the receipt
of CTNBio notification, which may be extended by an equal period at the discretion of CTNBio
plenary decision, under penalty of discontinuing the procedure.
§1. The term foreseen in Article 5 hereof shall be suspended during the time
required for compliance with CTNBio requirements.
Article 7. The final opinion, after approval by the Permanent Sectoral Subcommissions,
shall be submitted to approval by the CTNBio plenary meeting.
Article 8. In case CTNBio denies the request for exemption, the applicant shall submit
the general monitoring plan within thirty (30) days from the date such decision is published, to
analyzed and receive opinions, and such 30 days period may be extended once, for an equal
term, by decision of the CTNBio plenary meeting.
Article 9. CTNBio shall be in charge of forwarding the post-commercial release
monitoring plan to registration and supervising bodies for their knowledge and adoption of
measures under their responsibility.
Article 10. Implementation of the post-commercial monitoring plan shall begin upon
commercial use of the product.
Article 11. The post-commercial monitoring plan shall basically contain a general
monitoring and may include:
I - reports on specific technical meetings held to assess the technology
employed by users;
II - use of accessible and appropriate communication media or Consumer Service
made available by the applicant;
III - questionnaires to the technology users and other actors involved in the
process, prepared by the applicant;
IV - report containing summary and references to scientific literature published
on the object of the monitoring in peer reviews or government agencies reports;
V - official notification systems; and
VI - other monitoring tools in line with the GMO use application.
§1 The term of the general monitoring, as well as the frequency of the reports to
be forwarded to CTNBio shall be set in the general monitoring plan and approved by
CTNBio on a case-by-case basis.
Article 12. In case any adverse effect related to the environment or human and animal
health is reported during the general monitoring, the applicant must notify the fact to the
CTNBio Executive Secretary not later that fifteen (15) days from the fact, including a well
ground technical report on the adverse effects found.
§1. The report mentioned in this Article 12 shall be forwarded to the competent
Permanent Subcommission, which shall examine the report in the next meeting
subsequent to the receipt thereof.
§2. In case CTNBio understands that the adverse effect is unrelated to the GMO,
the applicant shall proceed with just the general monitoring.
§3. In case CTNBio understands that the adverse effect found is related to the
GMO, the applicant shall submit a proposal of scientific experiment within thirty (30)
days from the date of the receipt acknowledgment of CTNBio notification, a term that
may be extended not more than once, for an even period.
Article 13. The scientific experiment proposed under §3 of Article 12 hereof shall be
examined, under appropriate urgency, by the same Permanent Subcommission and its
approval shall be deliberated in a plenary meeting.
Article 14. The scientific experiment proposed must be specific to the adverse effect
recorded in the general monitoring, observed the following aspects:
I - In case the scientific experiment fails to confirm causality between the
adverse effect and the commercially released GMO, the applicant shall proceed just
with the general monitoring;
II - In case the scientific experiment does confirm the causality between the
adverse effect and the commercially release GMO, the applicant must submit to
CTNBio a case-specific monitoring plan the target, term of submission and form of
which as foreseen by Articles 15 and 16 hereof;
§1. The applicant shall submit proposal for a term to present its conclusive
technical report of the scientific experiment.
§2. The conclusive technical report related to the scientific experiment
mentioned by this Article 14 shall be submitted by applicant within the term agreed
with CTNBio and shall be assessed by the competent Permanent Subcommission
within thirty (30) days from the receipt thereof, and its approval submitted to a
plenary meeting.
Article 15. The applicant shall have thirty (30) days from the date of the CTNBio
technical decision notification, mentioned in Article 14(II) hereof, to submit the case-specific
monitoring plan with a view to assess efficiency of mitigating measures on the adverse effects
recorded.
Article 16. The case-specific monitoring shall be an supervisory activity designed to a
specific risk hypothesis, taking into consideration the following aspects:
I - In case the case-specific monitoring indicates that the related adverse effect
was reduced or eliminated, at the end of its term, the applicant shall notify CTNBio, by
means of a conclusive report, on the biosafety of the event.
II - In case the case-specific monitoring indicates that the adverse effect was not
reduced or eliminated, CTNBio shall make an assessment and decide on suspension or
revocation of the commercial release technical decision.
§1. The term of the case-specific monitoring as well as the frequency of reports
to be forwarded to CTNBio shall be established at the case-specific monitoring plan
and approved by CTNBio on a case-by-case basis.
§2. The general monitoring shall not be interrupted during the conduction of the
case-specific monitoring.
Article 17. The applicant shall forward to CTNBio partial reports on post-commercial
release during its conduction, at periods to be set at the appropriate monitoring plan and
submit a final report after completion of such monitoring.
§1. The information gathered at the general monitoring and, as the case may be,
at the case-specific monitoring shall be included in partial and final reports.
Article 18. In case of commercial release of product containing two or more transgenes,
homologues thereof or artificial constructs of equal function, implementation of postcommercial
release monitoring of the product shall enable interruption, through substitution,
of monitoring of events containing a lower level of such transgenes, at the discretion of
CTNBio.
§1. Alternatively, post-commercial release monitoring of a stacked product
containing two or more transgenes may be complied with, in the whole or in part, by
the results obtained in post-commercial release monitoring of the partial events,
either in progress or already completed, at the discretion of CTNBio.
Article 19. In case there are technical and scientific grounds, CTNBio may at any time
review the criteria of post-commercial monitoring.
Article 20. An applicant that has its post-commercial release monitoring plan approved
prior to entrance into effect of this Ruling Resolution must, within sixty (60) days from the
date of publication hereof, request either accommodation of the post-commercial monitoring
plan to the provisions of this Ruling Resolution or maintenance of the previously approved
plan.
Article 21. CTNBio Ruling Resolution nº 3, of August 16, 2007; Article 10(VIII) and Annex I
of CTNBio Ruling Resolution nº 5, of March 12, 2008; are hereby revoked.
Article 22. The head of Article 10 of CTNBio Ruling Resolution nº 5, of March 12, 2008,
comes into effect with the following wording:
"Article 20. The information requested in Annexes II, III and IV hereof shall be
included in the respective applications for commercial release, duly supported by
scientific reports on the results obtained during the planned commercial releases into
the environment or other studies, without prejudice of other information held as
relevant by CTNBio."
Article 23. This Ruling Resolution shall be effective upon publication.

Edison Paiva
CTNBio President

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.