NORMATIVE RESOLUTION NO. 06, OF NOVEMBER 06, 2008

Provides on rules for the planned release to the environment of Genetically Modified Organisms (GMO) of plant origin and their derivatives.

The National Technical Biosafety Commission – CTNBio, using the statutory powers vested in it, resolves:

CHAPTER I
GENERAL PROVISIONS
Article 1. Applications for the planned release to the environment of plant Genetically Modified Organisms (GMO) and their derivatives shall comply with the rules of this Ruling Resolution and other legal provisions in effect in Brazil pertaining to the subject of the application, as well as authorizations resulting from technical decisions issued by CTNBio.
Paragraph 1. Provisions of this Ruling Resolution are applicable to the intended release to the environment, within Brazil, of a Genetically Modified Organism of plant origin and its derivatives for the purpose of experimental evaluation.
Paragraph 2. This Ruling Resolution is not applicable to works currently in contention, which shall comply with CTNBio Ruling Resolution no. 02, of November 27, 2006.
Paragraph 3. This Ruling Resolution is not applicable to a plant Genetically Modified Organism that has been authorized for commercial release.
Article 2. For the purpose of this Ruling Resolution the following definitions apply:
I - Risk assessment: a combination of procedures or methods by which the potential effects to the environment and human animal health of a planned release of a GMO and its derivatives are assessed;
II - Genetically Modified Organism of plant origin: plant the genetic material (DNA/RNA) of which has been modified by any technique of genetic engineering;
III - Derivative of GMO of animal origin: product obtained from a plant GMO, which is unable to autonomously replicate or fails to contain any viable form of GMO;
IV - Applicant: a legal entity holder of a Certificate of Quality in Biosafety - CQB that intends to conduct the planned release, under the provisions of this Ruling Resolution;
V - Person legally in charge:  individual in charge of conducting the planned release, under CTNBio rules;
VI - Risk: Likelihood that an adverse effect takes place; and
VII - Planned release:  Release to the environment of a GMO of plant origin or its derivatives, for experimental evaluations under monitoring, according to the provisions of this Ruling Resolution.
Article 3. An authorization for planned release of GMO  of plant origin and its derivatives may be suspended or revoked by CTNBio, at  any time, in case adverse effects to  the environment or to human and animal health are detected  or by verification of fresh scientific  knowledge.
Article 4. The Applicant shall keep a record of individual follow-up of the   planned release to the environment of the plant GMO including, without limitation, information related to safety measures, agronomic practices, data collection, discarding, storage, transfer 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 be charged with securing compliance with the provisions of this Ruling Resolution in what concerns the planned release of a plant GMO and its derivatives to the environment.
Paragraph 1. CTNBio shall be notified of any failure in compliance 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 plant 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, giving 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 affected, with a view to adoption of applicable measures, according to the legislation in effect.
CHAPTER II
DOCUMENTATION OF THE APPLICATION
Article 7. Upon its 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 plant GMO, according to Annex II hereof;
III - Information on the plant GMO Planned Release, according to Annex III hereof;
IV - Maps and sketches for the plant GMO Planned Release, according to Annex IV hereof;
V - Request for importing plant material, as the case may be.
Paragraph 1. The proposal shall be submitted in the Portuguese language, in four copies, accompanied by a copy in electronic medium.
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 do not affect  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 a certain confidential information deemed indispensable to the 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 import of plant material is necessary for conducting the planned release to the environment, the applicant shall forward the relevant 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 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 ninety (90) days from the date of receipt of the relevant notification, under the penalty of 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, 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 plant GMO and its 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 to the environment of Genetically Modified Organisms of plant origin 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 is effective upon publication.
Walter Colli
President of CTNBio
ANNEX I
APPLICATION FOR PLANNED RELEASE OF A PLANT GMO
INFORMATION ON THE APPLYING INSTITUTION
1. Name of Institution in Charge;
2. Address for contact by 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";
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.
ANNEX II
INFORMATION ON THE PLANT GMO
1. Species of the plant to be released (include, as appropriate, scientific name, subspecies, cultivar, etc.);
2. Genetic modifications introduced and their consequences;
3. Vector used and methodology of transformation;
4. Exogenous DNA/RNA sequence, indicating the regulating elements that are present;
5. Indication of one or more markers (phenotypic, cytogenetic or molecular) that enable identification of the plant GMO;
6. Number of proceedings approved by CTNBio of which the current proposal is a sequel;
7. Genetic characteristics of the plant GMO that may affect its survival in the environment;
8. Existence of species sexually compatible at the location of release and measures used to contain the genic flux;
9. Description on how survival of the plant GMO will be monitored at the location of the planned release.
ANNEX III
INFORMATION ON THE PLANT GMO PLANNED RELEASE
1. Title of proposal;
2. Objective of the proposal;
3. Address of the proposed location where the planned release is to be conducted;
4. Procedures for transportation of the plant GMO to the location of the planned release, indicating its origin;
5. Experimental protocol for the planned release and monitoring during the experiment – include biosafety procedures, isolation conditions, agronomic practices and procedures for discarding and storage;
6. Total size of the planned release area and area occupied by the GMO;
7. Quantity of plant GMO to be released;
8. Date foreseen for starting the planned release;
8. Date foreseen for conclusion of the planned release;
10. Supervision procedures for the  area of planned release and safety procedures that shall be conducted by the persons  in charge – CIBio shall list  the individuals in charge for developing  the experiment and describe the training given to staff members, together  with the letter informing the planting of  the experiment;
11. Whether there will be or not a transfer or sending of material for analysis or storage by another unit and what will be the destination;
12. Whether the planned release is likely to affect the characteristics or abundance of other species, and how this will be monitored;
13. In case the GMO remains in the environment after the planned release experiment, inform: length in time and possible consequences, as well as measures used to reduce populations or remains of plant GMO and the monitoring to be conducted;
11. Measures to be taken to remove the plant GMO in case of any evident threat occurs during the planned release experiment.
ANNEX IV
MAPS AND SKETCHES FOR THE PLANNED RELEASE TO THE ENVIRONMENT OF A PLANT GMO
1. Name of Municipality and State;
2. Name of the property and property's owner;
3. Street 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, which shall be in line with the GMO  considering the isolation communiqués published by CTNBio;
?{ Cartographic (nominal and graphic)  scale, orientation by compass cards and geographic coordinates of the  experimental area;
?{ Existing improvements;
?{ Identification of boundaries of CQB accredited  area;
?{ Identification of permanent protection areas and legal reserve;
?{ Contour lines each 2 meters of altitude in terrains with slopes from 2% to 5% or, according to technical criteria, in cases of slopes higher than 5%, indicating the points of watershed irruptions.
?{ Water bodies (rivers, rivulets, natural and artificial lakes, dams);
?{ Maximum and minimum depth of ground waters.
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;
7. Description of the area surrounding the property:
?{ Description of neighboring cultures and, whenever possible, include a sketch of their location;
?{ Indication of access roads in the  area;
?{ Type of biome, according to IBGE  official map;
?{ Type of vegetation,  according to IBGE  official map;
8. Map of introduction or, if not possible, the distance to Conservation Units located within a radius of 5 km around the experimental station;
9. Maps of introduction shall include a text describing in further detail the assessment zone, containing the following information:
?{ Climatologic data (frequency of abnormally strong winds and storms, average rain by month, average temperatures by month);
?{ Edaphology data (type of soil, with emphasis on "A" horizon).
ANNEX V
FINAL REPORT ON PLANT GMO PLANNED RELEASE TO 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. Main Technician;
7. Person Legally in Charge;
8. Plant GMO released;
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 employed and whether such measures were in line with the CTNBio Technical Opinion:
?{ Information on survival of the plant GMO at  the location of  the release after completion of  the experiment;
18. Summary of results achieved and whether the objectives of the planned release were attained;
19. Unexpected effects recorded during the planned release;
20. Amount of plant GMO originated from the release and its destination. Inform the procedure for discarding;
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.