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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102351
Status
Published
Date of creation
2011-09-27 21:11 UTC (larissa.costa@itamaraty.gov.br)
Date of last update
2011-09-27 22:29 UTC (larissa.costa@itamaraty.gov.br)
Date of publication
2011-09-27 22:30 UTC (larissa.costa@itamaraty.gov.br)

Origin of report
Country
  • Brazil
Contact officer for report
Coordinates
Mr. Paulino Franco de Carvalho Neto
Minister - Head of the Environment Division of Itamaraty
Ministry of External Relations of Brazil - Itamaraty (MRE)
Esplanada dos Ministérios, Palácio do Itamaraty, Anexo I, sala 439, Brasília, Brazil
Brasília, Distrito Federal
Brazil, 70170-900
Phone:+ 55 61 3450 - 8450
Fax:+ 55 613411 8446
Email:dema@itamaraty.gov.br
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
National Biosafety Commitee (CTNBio)
Ministry of Science, Technology and Inovation (MCT)
Ministry of Health (MS)
National Agency of Sanitary Surveillance (ANVISA)
Ministry of Agriculture, Livestock and Supply (MAPA)
Ministry of Environment (MMA)
Brazilian Institute of Environment and Renewable Natural Resources (IBAMA)
Ministry of Fishery and Aquaculture (MPA)    
Submission
10. Date of submission
2011-09-27
11. Time period covered by this report
Start date
2008-09-01
Time period covered by this report
End date
2011-08-31
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
Legal regulations concerning LMOs related to the environment, health and agriculture are in force in Brazil. The most relevant regulations are:
i) Federal Constitution of 1988 - Articles 196 and 225;
ii) Law No 6,938 (08/31/1981), which establishes the National Environment Policy;
iii) Resolutions of the National Environment Council (CONAMA) No 001/86 (01/23/1986), 237/97 (12/19/1997), and 305/02 (07/04/2002);
iv) Law No 7,802/89 regulates research, experiments, production, packaging, labeling, transport, storage, commercialization, marketing, use, import and export, registration, final destination of waste packaging of pesticides and their components, in the cases where LMOs are used as raw material for a pesticide;
v) Decree No 4,074/02 implements Law No 7,802/89;
vi) Law No 11,105/05 implements Article 225 of the Federal Constitution and defines safety rules and oversight mechanisms for the construction, cultivation, manipulation, transport, transfer, import and export, storage, research, release into the environment of GMOs and their derivatives. These rules must take into account scientific advances, protection of life, of human, animal and plant health, and also observe the precautionary principle for the protection of the environment. This legislation is included in the BCH;
vii) Decree No 5.591/05: implements Law Nr 11.105/05 (above). The activities referred to by the decree must be authorized by the National Technical Commission on Biosafety (CTNBio). The Commission, among other responsibilities, will carry out the risk analysis with respect to activities and projects that involve GMOs. It will issue a technical decision on the biosafety of the GMO and its derivatives, within the scope of research activities and commercial use, including the classification as to the biosafety level required and degree of risk, as well as required safety measures and use restrictions. The decree also defines the competency of the National Biosafety Council, associated to the Presidency of the Republic, which will analyze the requests for commercial use of GMOs and their derivatives with respect to socioeconomic opportunity and convenience and to national interest, and it may take the final decision with respect to the processes related to activities that involve the commercial use of GMOs and their derivatives. This legislation is included in the BCH;
viii) Decree No 5.705 (02/16/2006): promulgates the Cartagena Protocol on Biosafety.
ix) Decree No 6.925 (08-06/2009) regulates de implementation of art. 19 of the Cartagena Protocol and establishes other provisions.
x) Portaria No 2.355 (17/08/2010) establishes the Commitee for the articulation of the action of the Ministry of Health as one of the National Authority for the Cartagena Protocol.
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Yes
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
Brazil already has specific legislation (CTNBio Normative Instruction n. 4 for movement inside the country and Normative Resolution n. 2 for contention research).
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • No
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • No
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Not applicable
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Not applicable
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • Not applicable
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
Brazil, through CTNBio, authorizes several intentional introductions of LMOs for field studies in the research stage. LMOs, after receiving commercial approval, are controlled by the Ministry of Agriculture or Ministry of Health.
According to art. 3, "i", of the Presidential Decree No. 6.925/09, the import of LMO must occur in accordance with the domestic law. This provision is in line with the objectives of the Protocol and is based on the second paragraph "c". 7 of that treaty.
With regard to item 35, in 2010, the Ministry of Agriculture, Livestock and Food Supply of Brazil has initiated a public hearing with a view to proposing a standard regulation to operationalize the notification procedure established in art. 8 of the Cartagena Protocol on agricultural products. At the moment, that Ministry is finalizing the analysis of the contributions sent by all stakeholders.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • More than 10
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • None
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • Yes, always
62. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, always
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
Commercial approvals in Brazil include the production of food, feed and commercial plantations. Brasil have a variety of corn, soybeans, cotton and microrganisms approved. Thus, many questions in this section do not follow the Brazilian regulatory system, which is more especific than the mechanisms proposed in the Protocol.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
71. Here you may provide further details on the implementation of Article 12 in your country:
Even though Brazilian law allows the review of any decision based on new scientific facts, no review was requested based on these arguments so far.
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • Yes
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • Yes, always
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • More than 10
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Not applicable
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Not applicable
93. Here you may provide further details on the implementation of Article 15 in your country:
Brazilian biosafety law is one of the most modern in the world and has made possible the risk analysis and introduction into commerce of more than 28 products from modern biotechnology. All petitions relating to LMOs (research, trade, etc.) are subject to public consultation. When necessary, public hearings are held for the manifestation of all stakeholders. According Brazilian legislation, the risk assessment of LMOS is made in a case by case analysis and is based on the precautionary principle. All products are rigorously analyzed by scientific principles in line with those internationally recognized. All reports for risk assessments (Technical Reports) are available on CTNBio website, in Portuguese and English.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
In Brazil, no LMOs is released into the market if there is a risk which is not negligible. Even in the commercial phase, a monitoring pos-market surveillance is based on the risk analysis carried out during the commercial studies.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • Yes
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
Brazilian biosafety law provides mechanisms of protection and penalties for unauthorized introduction of LMOs.
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes, to some extent
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes, to some extent
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes, to some extent
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes, to some extent
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, more than one
119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?
  • Yes
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
121. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes, to some extent
123. Here you may provide further details on the implementation of Article 19 in your country:
Decree 6.925/09 appointed as National Competent Authority under the Cartagena Protocol: the National Biosafety Commitie (CTNBio); The Ministry of Health (MS);The National Agency of Sanitary Surveillance (ANVISA); The Ministry of Agriculture, Livestock and Supply (MAPA); The Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) and The Ministry of Fishery and Aquaculture (MPA). According to this Decree, CTNBio is responsible for the advance informed agreement (AIA), which refers to the share of import and export of genetically modified living (LMOs ), as established in article 7 of the Protocol. All National Authorities are obliged to inform the Focal Point of all information and measures taken to the implementation of the Protocol.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available but not in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information available but not in the BCH
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available and in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information available and in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available and in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • No
128. Has your country experienced difficulties accessing or using the BCH?
  • Yes
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Yes
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
All information related to the LMOs, such as legislation, rules for the field trials, risk assessments and national decisions and authorizations are available at the CTNBio website. Whenever the BCH Focal Point is informed by the National Authorities of the release of a new information, legislation, rik assessment or national decision related to the Cartagena Protocol requirements, the BCH is updated to include the new data.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
Brazilian law has a specific chapter for confidential information.                                                     
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Bilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Bilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Average
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Building Capacity for Effective Participation in the BCH (Phase I)
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • Yes
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • More than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
Any application that involves genetically modified organisms is subject to public consultation for 30 days. If necessary, CTNBio may hold public hearings to hear the concerned sectors of society.
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • No
163. Has your country ever exported LMOs to a non-Party?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
Brazilian law provides penalties for illegal transboundary movements. In this respect, the penalties are competence of the national authorities.
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Yes
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • No
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
From our point of view, some questions related to item 124 are not well addressed. Instead of "information not available", "not aplicable" should have been given as an option.
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2001 or earlier
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 10 per year or more
Here you may provide further details
There are courses offered by the Brazilian Government and independent courses offered by the Academy
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • Yes
Here you may provide further details
National Technical Biosafety Commission - CTNBio
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • No funds mobilized
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • Yes
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • None
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
CTNBio set their own standards for risk assessment and risk management, based on other national and international standards, such as standards of the Food and Agriculture Organization of the United Nations - FAO
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • Yes
Here you may provide further details
Documents of OECD and USDA were used as guidances for risk assessment reports
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • No
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
CTNBio conducts monthly meetings which evaluate the risks of research and applications for marketing of LMOs
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Here you may provide further details
Brazil has the capacity to identify and assess living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health. There is a need to improve monitoring capacity.
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • Yes
Here you may provide further details
Brazil developed guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms.
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
At the request of CTNBio, the National Biosafety Council as the competence to examine the socio-economic aspects of applications for commercial release of GMOs and their derivatives.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • None
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
At the request of CTNBio, the National Biosafety Council as the competence to examine the socio-economic aspects of applications for commercial release of GMOs and their derivatives.
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Here you may provide further details
Actions in the event of accidental releases are provided in Brazilian legislation. Nonetheless, there is a need for further guidance.
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • 100 or more
Survey 19.b) Monitoring
  • 50 or more
Survey 19.c) Management / Control
  • 100 or more
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
Methodology for Assessing Ecological Risks of the Environmental Risk Assessment of Genetically Modified Organisms Project
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • Yes
Survey 22.b) Effective
  • Yes
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • 50 or more
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 50 or more
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Here you may provide further details
all processes analyzed in CTNBio undergo public consultation
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • National website
  • Public newspaper
Survey 32. If you indicated multiple modalities for public participation in the question above, which one was most used?
indicator 2.5.2
  • National website
Here you may provide further details
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • 10 or more
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • None
Here you may provide further details
No information could be found
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • 25 or more
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • 10 or more
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • National Libraries
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • None
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • No
Here you may provide further details
No information could be found
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • Yes
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • One or more