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