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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102653
Status
Published
Date of creation
2011-11-01 16:28 UTC (andrew.bowers@cbd.int)
Date of last update
2011-12-01 16:13 UTC (andrew.bowers@cbd.int)
Date of publication
2011-12-01 16:13 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • South Africa
Contact officer for report
Coordinates
Malta Qwathekana
Senior Policy Adviser: International Biodiversity and Heritage
Department of Environmental Affairs
Private Bag X447
Pretoria
South Africa, 0001
Phone:+27123103067
Fax:+27123201714
Email:mqwathekana@environment.gov.za
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Government Agencies consulted were:   Department of Agriculture, Forestry and Fisheries, Department of Trade and Industry, Department of Science and Technology, Department of Environmental Affairs; Industry Stakeholders: South African National Seed Organization, Monsanto, Pioneer, Cargill; Public Entities: South African National Biodiversity Institute, African Centre for Gene Technology, Council for Scientific and Industrial Research; and Civil Society Organisations: African Centre for Biosafety, Africabio -Biotechnology Stakeholders Organization
Submission
10. Date of submission
2011-09-30
11. Time period covered by this report
Start date
2008
Time period covered by this report
End date
2011-08
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
  • One or more sets of biosafety guidelines
  • 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?
  • Less 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:
To fully align the SA legislation to Cartagena Protocol, an Amendment of the principle legislation was approved and implemented in February 2010.

In addition to the GMO Act 15 of 1997, South Africa also has other pieces of legislation that considers biosafety issues. These include:

- National Environmental Management  Act of 1998 (provides for environmental impact assessment of selected categories of LMOs)

- National Environmental Management Biodiversity Act 10 of 2004 (provides for long term monitoring of potential impacts of LMOs)

-Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 (deals with safety standards as well as labeling of certain class of foodstuffs derived from LMOs.
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?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
The transboundary movement of pharmaceuticals which are LMOs is managed like any other activity.  The regulatory framework allows for a cross-sectoral assessment of all activities, as a result, pharmaceuticals for humans would also be assessed by the Department of Health and the Medicines Controls Councils.
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?
  • Partially
28. Here you may provide further details on the implementation of Article 6 in your country:
Decisions regarding contained use or transit has not been communicated to the BCH.  SA's communication has been limited to decisions on the general release or commercialization decisions.

SA's transit policy was communicated to the BCH.  This policy holds that LMOs may only transverse the territory of SA to another country if such country confirms their acceptance of the consignment.
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?
  • Yes
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, to some extent
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?
  • Yes
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?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
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?
  • More than 10
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?
  • None
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?
  • Less than 10
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?
  • Less than 10
43. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes, always
44. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes, always
45. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes, always
46. Has your country informed the notifier(s) and the BCH of its decision(s)?
  • In some cases only
47. Has your country informed the notifier(s) and the BCH of its decision(s) in due time (within 270 days or the period specified in your communication to the notifier)?
  • In some cases only
48. What percentage of your country’s decisions fall into the following categories?
  • Inform the notifier that the period for communicating the decision has been extended
90%
  • Prohibition of the import/use of the LMO(s)
10%
  • Request for additional relevant information
80%
49. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
  • Yes, always
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:
The GMO Act provides for the decision-making for the first and subsequent transboundary movement of LMOs within periods consistent with provisions of the Protocol.

The Scientific capacity is provided for by way of a statutory body, the Advisory Committee.  This Committee undertakes a detailed science-based assessment and provides a recommendation to the decision-making structure
(the Executive Council) where relevant different government departments are represented.

The decision-making process (especially timelines) is impacted by the following:

a.  The involvement of different government departments

b.  The legal prescript of consensus decision-making

c.  Inadequate information provided by the applicants.

d.  The potential impact of new scientific information which needs to be assessed.

e.  New developments or GM events where the regulatory authority may have limited experience.
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?
  • Less than 10
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
60. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • Less than 10
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • In some cases only
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, but with delays (i.e. longer than 15 days)
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:
To ensure alignment of the Act with provisions of the Protocol and related environmental legislation, certain amendments to the Act were approved and implemented  in February 2010
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?
  • Yes
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • Yes, decision reviewed and changed
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • Less than 5
68. Has your country informed the notifier and the BCH of the review and/or changes in the decision?
  • In some cases only the notifier
69. Has your country informed the notifier and the BCH of the review and changes in the decision within thirty days?
  • No
70. Has your country provided reasons to the notifier and the BCH for the review and/or changes in the decision?
  • In some cases only the notifier
71. Here you may provide further details on the implementation of Article 12 in your country:
As part of managing an administratively fair and transparent process, the SA regulatory framework provides for a process of appeal.  Notifiers or applicants have 30 days, after a decision has been communicated, to lodge an appeal to the Executing Authority.

As part of the decision-making process, reasons for decisions are provided to notifiers or applicants
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?
  • Yes
73. Has your country ever applied the simplified procedure?
  • Yes
74. If you answered Yes to question 73, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?
  • In some cases only
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • More than 5
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?
  • In some cases only
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)?
  • Yes, always
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • No
93. Here you may provide further details on the implementation of Article 15 in your country:
In order for applications to be considered compliant under the GMO Act, one of the requirements is the completion of a risk assessment.Two risk assessment documents are submitted for the purposes of evaluation by the regulatory authorities. One being a comprehensive environemntal risk assessment document that covers all the requirements for South Africa, and the other ebing a risk assessment as outline in Annex 3 of the Cartagena Protocol on Biosafety.          
                                                                                             
National Treasury annually approves a tariff for services rendered by government.  All applications under the GMO Act are subjected to such tariffs, however, most of the costs assocaited with processing of applications are covered by the government.
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?
  • Yes
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?
  • Yes
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:
As part of a broader cooperation with Argentina within the context of strengthening South-South Cooperation, biosafety has been identified as a key area of cooperation.  The two countries regularly exchange information on new developments in the area of risk assessment and management.

This is further supported through the long term monitoring requirements manadated through the National Environmental Management: Biodiversity Act.
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:
The current legislation provides for the Executive Council, consisting of various government department to serve as the mechanism to implement emergency measures in case of unintentional transboundary movement.
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
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
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
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
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, to some extent
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
115. Here you may provide further details on the implementation of Article 18 in your country:
South Africa is required to take measures ensuring that LMOs subject to intentional transboundary movement (exports) are accompanied by documentation identifying the LMOs and providing contact details of persons responsible for such movement. The details of these requirements vary according to the intended use of the LMOs but require that certain basic requirements be fulfilled. These are:

• A letter indicating the intent of the potential exporter

• Completed application forms

• Payment of appropriate fees in terms of the GMO Act

• Notification of the country of import into whose environment the LMO will be introduced intentionally

• Affidavit from applicant on the accuracy of the information submitted

• Acknowledgement and confirmation by the Party of Import to the intended introduction of the LMO to its environment. However failure by the Party of Import to acknowledge receipt of a notification shall not imply its consent to the proposed import.

• A permit for exportation is only issued if the Registrar of the GMO Act has received written consent (original) from the Party of Import or via the potential exporter. The export permit will contain at least the following information:

 Identification of the LMO (relevant traits/characteristics of the LMO)

 Requirements for the safe handling, storage, transport and use

 Contact details for further information on the exporter, the importer and

 A declaration that the transboundary movement is in accordance with the Protocol's requirements

 Additional information may be requested by the Competent National Authorities, i.e. the Party of Import or Export.

SA only allows importation from countries which have similar GMO events approved or commercialised.
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, one
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
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
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 but only partially available 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 but only partially available in the BCH
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 and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
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 but only partially available 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 not available
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 available but only partially available in the BCH
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 but only partially available 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?
  • Yes, always
128. Has your country experienced difficulties accessing or using the BCH?
  • No
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Not applicable
130. Is the information submitted by your country to the BCH complete and up-to date?
  • No
131. Here you may provide further details on the implementation of Article 20 in your country:
Currently, SA has no bilateral, multilateral and regional agreements within the context of Article 14

SA has no specific domestic regulation which applies to specific imports as envisioned in Article 14(4).
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:
Applications are submitted in two formats: with confidential business information and without confidential business information.  The non-CBI is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA).  Non-Confidential Business Information copy (NON-CBI copy) - is a copy where any information that is regarded as confidential business information is deleted.
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?
  • Regional 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?
  • Regional channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
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
  • 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
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • 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
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.
  • 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
  • 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
  • Taking into account risks to human health
148. Has your country developed a capacity-building strategy or action plan?
  • Yes
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
South Africa has recently completed a biosafety project in collaboration with the government of Norway. This project also included a regional workshop that was important for sharing experiences in risk assessment and risk management. As part of a binational commisson with Argentina, another workshop was held in collaboration with ICGEB.        
                                          
In addition, South Africa has continuosly particiapted in a number of regional capacity buidling initiaves that include:

ABNE meeting on 'Emerging Biosafety Legislation in Africa" - held in Nairobi, Kenya during April 2011

ASSAf lead workshop on "GMOs for African Agriculture: Opportunities and Challenges" - held on 07 June 2011 in Reduit, Mauritius.

ICGEB workshop focusing on Biosafety Risk Communication in Sub-Saharan countries.

SADC High LEvel Dialogue on Biotechnology and Biosafety, in November 2010
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:
The non-CBI copy of an application is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA).

The public is also notified of all intentional environmental releases through a public notification placed in newspapers (or other means) circulating in the area where the intended release is due to take place.

The government has also put in place structures established through the implementation of the National Biotechnology Strategy (Public Understanding of Biotechnology (PUB) and Biosafety SA that provide an ongoing platform for broad public engagement on biosafety issues.
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?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • Yes
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • In some cases only
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?
  • No
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
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:
The current regulatory framework provides for the institution of penalties in the form of fines or imprisonment for any contravention of the prescripts of the Act.
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?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
South Africa is currently undertaking a national consultative process towards understanding the impact of the Supplemetary Protocol.  This outcome of this impact study will inform a decision towards ratification, acceptance or approval of the Supplementary Protocol.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
Re: Q. 14 - South Africa is also party to the Convention on Biological Diversity

Re: Q. 46 - In some cases only the notifier & In some cases only the BCH as well

Re: Q. 64 - In some cases only the notifier & In some cases only the BCH as well

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
Here you may provide further details
The cooperation with the Norwegian government also included a capacity building component and a workshop of regional training that had 60 participants was also convened. Other capacity building initiatives have been convened in partnership the government of Argentina and ICGEB. Biosafety SA platform, contributing to support certain aspects of the Cartagena Protocol, has spent approximately over R6 million per year over the last 4 years as well as North West University securing money from donors to conduct biosafety research
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
The National Biotechnology Strategy recognised the importance of developing capacity for biosafety in South Africa. To this end, there are a number of government led interventions that are held annually with the specific intention of developing biosafety capacity. In addition, universities also conduct specific short term courses on biosafety during the course of any reporting year.
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
One of the key initiatives of the government of South Africa has been the established of a state owned organization under the auspices of the epartment of Science and Technology, named Biosafety South Africa. Coordination of capacity building in biosafety is an integral part of the mandate of Biosafety South Africa. In addition, the National decision making mechanism for GMOs, the Executive Council, also coordinates and provides advice on biosafety capacity development needs and interventions.
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
  • 100,000 USD or more
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
Here you may provide further details
South Africa has standard competitive grant opportunities for academic capacity building (Through National research Foundation). Further, the Biosafety SA Platform, funded by government, supports certain "strategic" research opprojects that have some element of capacity building.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • One or more
Here you may provide further details
Argentina  There was also a partnership with Norway from 2008 to 2011 that considered biosafety objectives.
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
SA developed its own guidance documents, namely Environmnetal Risk assessment Framework for GMOs: a guidance document; Risk analysis of contained use research and development activities with GM aquatic organisms in South Africa.
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
The application process used in South Africa requires the notifiers to complete the risk assessment report in accordance with annex III of the Cartagena Protocol on Biosafety
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
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
The National Environmental Management Biodiversity Act makes provision for monitoring of LMOs released into the environment for commercial production. South Africa has developed a framework for the monitoring of MON810 maize.
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
There are provisions for the the safe handling, transport, and packaging of living modified organisms in the GMO Act and its Amendment Act. The GMO Act regulations (Gazetted on 26 February 2010) set out the guidance.
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
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
  • One or more
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
N/A
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
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
  • One 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
Here you may provide further details
There are two independent laboratory facilities that are used testing for LMOs. GMO testing lab at Free State University and Incotec SA (Pty) Ltd.
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
A number of training materials have been developed for training by the various stakeholders, although there is no formal national training material that has been developed.
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
  • No
Here you may provide further details
Training materials on risk assessment and risk management can only be used to provide a basis for decision making. However, it is not possible to guage the effectiveness of the material as risk assessment needs to be conducted on a case by case basis taking into account local conditions and imperatives. Onerous requirements may not be effective for decision making in situations of limited technical capacity.
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • None
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 100 or more
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Here you may provide further details
Yes, particularly through specialised academic and research institution laboratories
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
The GMO testing lab at the Free State University is accredited for the detection LMOs.
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
Here you may provide further details
1. GMO Act, and its Amendment Act ; Consumer Protection Act (68 of 2008) and NEMA.
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
This is a standard requirement for all field trials and general releases
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • Newspaper
  • Forums
Survey 32. If you indicated multiple modalities for public participation in the question above, which one was most used?
indicator 2.5.2
  • Newspaper
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • One or more
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • One or more
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
Here you may provide further details
Monitoring-South Africa National Biodiversity Institute (SANBI), enforcement- Inspection services in terms of GMO Act
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
  • 10 or more
Here you may provide further details
AfricaBio events: Media conference, Stewardship workshop;Farmer's day events;Symposium on GM crops and food safety;Preparatory meeting for COP-MOP6; Biotech Indaba; Insect Resistance Management Training Programme and Business Brunch -GM labelling  RAEIN-Africa events: Negotiation training workshop and SADC biotech and biosafety workshop.
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
  • One or more
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • International Publications that can be sourced from the internet
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
  • One or more
Here you may provide further details
South Africa- Argentina bilateral on biosafety issues.
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Here you may provide further details
State-funded : Public Awareness on Biotechnology (PUB) programme and awareness and outreach programmes are conducted by AfricaBio: NGO.
Survey 41. If you answered yes to the question above, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place.
indicator 5.3.1
E.g. local, national, etc.,
PUB, a programme of the SA Association for Science and Technology Advancement (which is part of the National Research Foundation) - national level.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • No
Here you may provide further details
Yes, this includes Media engagement, theatre, journalist training on biosafety, scientist training on communication, critical thinker sessions which the media are invited to, and curriculum development.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 25 or more
Here you may provide further details
PUB programme publications