RULING RESOLUTION Nº 8, of July 03, 2009.

Provides on simplified rules for
Planned Release into the environment
of Risk Class I Genetically Modified
Organisms (GMO) and their
derivatives.

THE NATIONAL TECHNICAL BIOSAFETY COMMISSION – CTNBio, using the
powers vested in it, resolves:

CHAPTER 1
GENERAL PROVISIONS
Article 1. The simplified rules of Planned Release into the environment
mentioned in this Ruling Resolution are applicable to the Risk Class I Genetically
Modified Organisms and their derivatives that have previously being passed by
CTNBio for the purpose of experimental assessment.
Paragraph 1. This Ruling Resolution is not applicable to cases under
containment regime, which shall comply with the provisions of CTNBio Ruling
Resolution nº 02, of November 27, 2007.
Paragraph 2. A GMO that has been granted authorization to be Released into
the environment for Commercial Use shall not be submitted to the provisions of
this Ruling Resolution.
Article 2. For the purpose of this Ruling Resolution the following meanings
apply:
I- Risk Assessment: a combination of procedures or
methods used to assess, on a case by case basis, the
potential effects of planned release of a GMO and its
derivatives to the environment and to human and animal
health;
II- Genetically Modified Organism: an organism the genetic
material (DNA/RNA) of which has been modified by any
genetic engineering technique;
III- GMO derivative: a product obtained from a GMO that is
unable to autonomously replicate itself or fails to contain
a viable form of GMO;
IV- Applicant: any legal entity, holder of a Quality Certificate
in Biosafety – CQB, intending to conduct a planned
release, according to this Ruling Resolution;
V- Person Legally in Charge: individual responsible for
conducting the planned release under CTNBio rules;
VIII- Risk: probability of an adverse event;
IX- Planned release: release into the environment of a GMO
or its derivatives, for monitored experimental assessment,
under the provisions of this Ruling Resolution.
Article 3. An authorization for planned release into the environment of a
GMO may be suspended or revoked by CTNBio at any time in case adverse
effects on the environment or human and animal health are detected or otherwise
in the light of fresh scientific knowledge.
Article 4. The Applicant shall keep an individual follow-up record of the
GMO Planned Release into the environment including, without limitation, details
on safety measures, agronomic practices, data collection, discarding procedures,
storage procedures, transference of material and any destination of the GMO and
its derivatives.
Article 5. The person legally in charge of the applying legal entity and the
respective CIBio shall secure compliance with the provisions of this Ruling
Resolution in what concerns the planned release of a GMO and its derivatives
into the environment.
Paragraph 1. CTNBio shall be notified of any failure in complying with the rules
of this Resolution and with the biosafety procedures and measures established by
CTNBio in the technical opinion related to the Planned Release.
Article 6. Any accidental release of a GMO and its derivatives shall be
promptly notified to CIBio and CTNBio. CIBio shall forward to CTNBIO, within five
(5) days, a report on corrective actions taken, including the names of the
individuals and authorities who have been notified.
Paragraph 1. The notification mentioned in this Article 6 does not exempt the
Applicant to inform the competent authorities and individuals who may be
exposed, with a view to adoption of applicable measures, according to the
legislation in effect.
CHAPTER II
DOCUMENTATION OF THE APPLICATION
Article 7. Following approval by CIBio, the applicant shall submit the
proposal to CTNBio accompanied by:
I - Simplified Application for Planned Release into the Environment
according to Annex I hereof;
II - Maps for the Planned Release of the GMO according to Annex II
hereof;
III - Request for importing materials, as the case may be.
Paragraph 1. The application shall be submitted in the Portuguese language, in
four conformed counterparts, accompanied by a file in digital support.
Article 8. CTNBio shall take the necessary measures to safeguard the
confidential information of commercial interest identified by the applicant and
considered as such by CTNBio, provided such information does not attract
private or collective interests protected by the Brazilian Constitution.
Paragraph 1. In order to maintain the confidentiality mentioned in this Article 8,
the applicant shall forward to the President of CTNBio an express and well
grounded request containing specifications on the information to be kept
confidential.
Paragraph 2. The request may be dismissed through a well grounded order,
which may be subject to appeal to CTNBio plenary meeting, and confidentiality
shall be maintained until a final decision is reached to the contrary.
Paragraph 3. The appeal shall be filed within fifteen (15) days from the date the
decision is published in the Federal Official Gazette and shall be examined by a
CTNBio plenary meeting within sixty (60) days.
Paragraph 4. The applicant may select to withdraw its proposal in case the
request for confidentiality is definitely dismissed and, in this case, CTNBio may
not disclose the information for which confidentiality has been sought.
Article 9. Registration and monitoring bodies and entities may request
access to certain confidential information deemed to be indispensable to such
body or entity in a petition explaining the request and indicating the agent that
may have access to the confidential information.
Paragraph 1. Registration bodies and entities may not disclose any confidential
information.
Article 10. The proposal for Planned Release filed with CTNBio Executive
Secretariat, after being processed and duly documented, shall have a Previous
Summary published in the Federal Official Gazette, within thirty (30) days.
Paragraph 1. In case importing a GMO is necessary for conducting the Planned
Release into the environment, the applicant shall forward the importing request,
together with the proposal of the planned release, for joint examination by
CTNBio.
Article 11. Each proposal shall be examined by not less than two CTNBio
Permanent Sector Sub-commissions.
Paragraph 1. The Permanent Sector Sub-commissions shall give preferential
treatment to analysis and preparation of opinions, which in turn shall be submitted
to the CTNBio plenary meeting for approval of the Planned Release.
Article 12. CTNBio may request additional information and new documents,
which shall be answered by applicant within thirty (30) days from the date of
receipt of the relevant notification, under the penalty of CTNBio filing the
application as cancelled.
Article 13. Within ten (10) days from the approval by CTNBio, a summary of
the technical decision shall be published in the Federal Official Gazette.
Article 14. Within six (6) months from the completion of a Planned Release,
of the applying institution's CIBio shall forward to CTNBio a detailed report
according to Annex III hereof.
Article 15. Cases not foreseen by this Ruling Resolution shall be settled by
CTNBio.
Article 16. The provisions of this Ruling Resolution apply to applications to
Planned Release into the environment of Risk Class I Genetically Modified
Organisms and its derivatives previously passed by CTNBio, filed with CTNBio
Executive Secretariat after this Resolution becomes effective.
Article 17. This Ruling Resolution shall be effective upon publication.

Walter Colli
President of CTNBio

ANNEX I
SIMPLIFIED APPLICATION FOR PLANNED RELEASE OF A GENETICALLY
MODIFIED ORGANISM
1. Name of Institution in Charge;
2. Address for contact with CIBio;
3. Name, title and address of the Person Legally in Charge and the Chief
Technician;
4. CIBio opinion, including comments on the ability of the Chief Technician
to manage the works, adequacy of experimental plan contained in the
proposal, selection of location and emergency security plan;
5. Statement for the purpose that "The information contained in this
document is, to the best of my knowledge, complete, accurate and true".
(name and signature of the Person Legally in Charge and date);
6. CIBio endorsing statement: "CIBio has assessed and endorses this
proposal" (name, date and signature of the President of CIBio);
7. Name and signature of the Person Legally in Charge and date;
8. Title of the Planned Release;
9. Objective and description of the experiment;
10. GMO to be released;
11. Information on the number of previous proceedings passed by CTNBio, of
which the current proposal is a sequel;
12. Information on the location of the experiment and geographic coordinates
within the area accredited in CQB. In case changing the location is
necessary, provided the new location keeps within the same area
accredited in CQB and following CTNBio rules, the applicant shall inform
the exact location within fifteen (15) days from the date the experiment
started.
13. Information on the total Planned Release area;
14. Information on the area containing the GMO;
15. Start and completion dates foreseen for the Planned Release;
16. Monitoring period after the Planned Release is completed;
17. List of biosafety measures;
18. Additional information.

ANNEX II
MAPS FOR THE PLANNED RELEASE INTO THE ENVIRONMENT OF A GMO
1. Name of the Municipality and State;
2. Name of the property and property's owner;
3. Full address of the property, including telephone, facsimile numbers and
electronic mail address.
4. Location of the experiment, including geographic coordinates within the
area accredited in CQB. In case changing the location is necessary,
provided the new location keeps within the same area accredited in CQB
and following CTNBio rules, the applicant shall inform the exact location
within fifteen (15) days from the date the experiment started;
5. Experimental design.

ANNEX III
FINAL REPORT ON GMO PLANNED RELEASE INTO THE ENVIRONMENT
1. Institution;
2. Number of CQB;
3. Number of Release Proceedings;
4. Name of CIBio President and CIBio address;
5. Title of Proposal;
6. Chief Technician;
7. Person Legally in Charge;
8. Released GMO;
9. Risk classification;
10. Genetic modifications introduced and consequences;
11. Releases foreseen;
12. Released conducted;
13. Place of release;
14. Date of beginning;
15. Date of completion;
16. Biosafety measures adopted;
17. Monitoring procedures employed. Information on whether there is any
surviving GMO at the place of the release after the experiment has been
completed.
18. Submission of a summary of results achieved and whether the objectives
of the Planned Release were attained;
19. Report on any unexpected effects recorded during the Planned Release;
20. Information on the amount of GMO resulting from this Release and
destination of such GMO. Information on GMO disposal procedures;
21. Information on whether the competent body supervised the experiment,
including a copy of the Supervision Report and the Infraction Record, as
the case may be.
Date:
Signature of CIBio President
Signature of the Chief Technician