RULING RESOLUTION Nº 7, of April 27, 2009.

Provides on rules for planned release
into the environment of Risk Class I
Genetically Modified Microorganisms
(GMM) and Genetically Modified
Animals (GMAn) and their derivatives.

THE NATIONAL TECHNICAL BIOSAFETY COMMISSION – CTNBio, using the
powers vested in it and according to applicable regulations, under the provisions
of Article 14(II) of Law nº 11,105, of March 24, 2005, resolves:

CHAPTER 1
GENERAL PROVISIONS
Article 1. The regulations of this Ruling Resolution and other legal
provisions related to the subject of the request, as well as authorizations resulting
from technical decisions issued by CTNBio, apply to the planned release into the
environment of Risk Class I Genetically Modified Microorganisms and Genetically
Modified Animals and their derivatives.
Paragraph 1. The regulations of this Ruling Resolution apply to Risk Class I
Genetically Modified Microorganisms and Genetically Modified Animals and their
derivatives planned to be release into the environment, in Brazil, for the purpose
of experimental assessment.
Paragraph 2. This Ruling Resolution is not applicable to operations under
containment regime, which shall comply with the provisions of CTNBio Ruling
Resolution nº 02, of November 27, 2007.
Paragraph 3. A Genetically Modified Microorganism or a Genetically Modified
Animal 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 a planned release of a Genetically
Modified Microorganism or a Genetically Modified Animal
and their derivatives to the environment and human and
animal health;
II- Genetically Modified Microorganism (GMM) – a
microorganism the genetic material (DNA/RNA) of which
has been modified by any genetic engineering technique;
III- GMM derivative – a product obtained from a GMM that is
unable to autonomously replicate itself or fails to contain
a viable form of Genetically Modified Microorganism;
IV- Genetically Modified Animal (GMAn) – an animal the
genetic material (DNA/RNA) of which has been modified
by any genetic engineering technique;
V- GMAn derivative – a product obtained from a GMAn that
is unable to autonomously replicate itself or fails to
contain a viable form of GMAn;
VI- Applicant: any legal entity, holder of a Quality Certificate
in Biosafety – CQB, intending to conduct a planned
release, according to this Ruling Resolution;
VII- 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 GMM
or a GMAn and their derivatives, for monitored
experimental assessment, under the provisions of this
Ruling Resolution.
Article 3. An authorization for planned release into the environment of a
GMM or GMAn 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
GMM or GMAn planned release into the environment including, without limitation,
details or practices used in the experiment and biosafety measures applied.
Article 5. The Person Legally in Charge of the applying legal entity and the
respective CIBio are in charge of securing compliance with the provisions of this
Ruling Resolution in what concerns the planned release of a GMM or GMAn and
their 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 GMM or GMAn and their 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 - Application for Planned Release: Information on the institution,
dated and executed by the Person Legally in Charge, according
to Annex I hereof;
II - Information on the GMM or GMAn and their derivatives, according
to Annex II hereof;
III - Information on the GMM or GMAn and their derivatives Planned
Release, according to Annex III hereof;
IV - Maps and Sketches for the Planned Release of the GMM or
GMAn and their derivatives, according to Annex IV hereof;
V - CIBIO authorization for importing material, as the case may be.
Paragraph 1. The application shall be submitted in the Portuguese language, in
four conformed counterparts, accompanied by a copy in electronic 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 GMM or GMAn is necessary for conducting
the planned release into the environment, the Applicant shall forward the CIBIO
authorization, 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 have a joint term
of not less than ninety (90) days to examine and prepare their opinions, which in
turn shall be submitted to CTNBio plenary meeting for approval of the planned
release.
Article 12. CTNBio may request additional information and new documents,
which shall be answered by the applicant within sixty (60) days from the date of
receipt of the relevant notification, under the penalty of the application being filed
as cancelled.
Article 13. Within ten (10) days from 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,
the CIBio of the applying institution shall forward to CTNBio a detailed report
according to Annex V hereof.
CHAPTER III
RISK ASSESSMENT AND FINAL PROVISIONS
Article 15. Risk assessment, as defined in Article 3(I) hereof, shall identify
and assess potential adverse effects of a GMM or GMAn and their derivatives,
while maintaining transparency, scientific method and the principle of precaution.
Article 16. Cases not foreseen by this Resolution shall be settled by CTNBio.
Article 17. The provisions hereof apply to applications to planned release
into the environment of Genetically Modified Microorganisms and Genetically
Modified Animals and their derivatives filed with CTNBio after this Resolution
becomes effective.
Article 18. CTNBio Ruling Instruction nº 3, of November 12, 1996, Ruling
Instruction nº 5, of January 08, 1997, Ruling Instruction nº 10, of February 19,
1998 and Ruling Instruction nº 16, of October 30, 1998 are hereby revoked.
Article 19. This Ruling Resolution shall be effective upon publication.

Walter Colli
President of CTNBio

ANNEX I
APPLICATION FOR PLANNED RELEASE OF GENETICALLY MODIFIED
MICROORGANISMS OR GENETICALLY MODIFIED ANIMALS AND THEIR
DERIVATIVES
INFORMATION ON THE APPLYING INSTITUTION
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); and
7. Name and signature of the Person Legally in Charge, and date.

ANNEX II
INFORMATION ON THE GMM or GMAn
1. Information on the species of Genetically Modified Microorganism or
Genetically Modified Animal to be released (include, as appropriate,
scientific name, subspecies, lineage, etc.);
2. Information on genetic modifications introduced and their consequences;
3. Information on vector used and methodology of transformation;
4. Description of exogenous DNA/RNA sequence, indicating the regulating
elements that may be present;
5. Indication of one or more markers (phenotypic, cytogenetic or molecular)
that enable identification of the GMM or GMAn;
6. Information on number of proceedings approved by CTNBio of which the
current proposal is a sequel;
7. Description of genetic characteristics of the GMM or GMAn that may
affect their survival in the environment;
8. Information on measures taken to contain gene flow;
9. Description on how survival of the GMM or GMAn will be monitored at the
location of the planned release;
10. Information on whether the release relates to GMM or GMAn, as well as
type of derivative, its composition, degradability, possible toxic or
allergenic effect.

ANNEX III
INFORMATION ON THE PLANNED RELEASE OF THE GMM OR GMAn AND
THEIR DERIVATIVES
1. Title of proposal;
2. Purpose of the proposal;
3. Address of the proposed location where the planned release is to be
conducted;
4. Procedures for transporting the GMM or GMAn and their derivatives to
the location of the planned release, indicating their origin;
5. Experimental protocol for the planned release and monitoring during the
experiment – include biosafety and discarding procedures, information on
the size of the total area of GMM or GMAn and their derivatives planned
release;
6. Information on the date foreseen for starting the planned release;
7. Information on the date foreseen for the completion of the planned
release;
8. Description of supervision procedures for the area of planned release and
safety procedures to be conducted by the persons in charge;
9. CIBio shall make a list of individuals in charge for developing the
experiment and describe the training given to staff members, together
with a letter informing the installation of the experiment;
10. Information on whether there will be or not a transfer or sending of
material for analysis or storage by another unit and what will the
destination be;
11. Information on whether the planned release is likely to affect the
characteristics or abundance of other species, and how this will be
monitored;
12. In case the GMM or GMAn and their derivatives remain in the
environment after the planned release experiment, inform: length in time
and possible consequences, and the monitoring to be conducted; and
13. Measures to be taken to remove the GMM or GMAn and their derivatives
in case of any evident threat occurs during the planned release
experiment.

ANNEX IV
MAPS AND SKETCHES FOR THE PLANNED RELEASE INTO THE
ENVIRONMENT OF A GMM OR GMAn AND THEIR DERIVATIVES
1. Name of Municipality and State;
2. Name of property and property's owner;
3. Full address of the property, telephone, fax and electronic address;
4. Sketch, indicating the name of the main highway of access to the
property, reference to the nearest city identifying the entrance to the
property, kilometer of reference for entering the property and
secondary/feeder road;
5. Map of the area accredited by CQB, including:
- Map size and scale used. Inform cartographic (nominal and
graphic) scale, orientation by compass card and by geographic
and topographic coordinates, as the case may be, of the
experimental area.
- Indication of any existing improvements;
- Identification of boundaries of CQB accredited area;
- Identification of permanent protection areas and legal reserve;
- Indication of water bodies (rivers, rivulets, natural and artificial
lakes, dams);
6. Location of the experiment, including geographic coordinates, within the
area accredited by CQB. In case it proves necessary to change the
location, within the same area accredited by CQB and under CTNBio
rules, the applicant shall inform the exact location within fifteen (15) days
from the establishment of the experiment.

ANNEX V
FINAL REPORT ON GMM OR GMAn 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 GMM or GMAn and their derivatives;
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 and whether such measures were in line
with the CTNBio Technical Opinion;
17. Monitoring procedures used and whether such measures were in line with
the CTNBio Technical Opinion;
18. Information on survival of the GMM or GMAn and their derivatives at the
location of the release after completion of the experiment;
19. Submission of a summary of results achieved and whether the objectives
of the planned release were attained;
20. Report on any unexpected effects recorded during the planned release; and
21. Information on whether the competent body supervised the experiment,
including a copy of the Supervision Report and the Violation Record, as
the case may be.
Date:
Signature of CIBio President.
Signature of the Chief Technician.