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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109498
Status
Published
Date of creation
2015-12-08 19:55 UTC (andrew.bowers@cbd.int)
Date of publication
2015-12-08 19:55 UTC (andrew.bowers@cbd.int)

Origin of report
1. Country
  • South Africa
Contact officer for report
Coordinates
Malta Qwathekana
Senior Policy Advisor
Department of Environmental Affairs
Private Bag X447
Pretoria
South Africa, 0001
Phone:+2712 399 9624
Fax:+2712 359 3636
Email:mqwathekana@environment.gov.za
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Government departments consulted were: Department of Agriculture, Forestry and Fisheries, Department of Trade and Industry, Department of Science and Technology, Department of International Relations and Cooperation; Department of Environmental Affairs; Industry Stakeholders: Monsanto, Du Pont Pioneer, South African Cereals and Oilseeds Trade Association, Forestry SA, Cargill; Public Entities: South African National Biodiversity Institute, African Centre for Gene Technology, Biosafety SA, Public Understanding of Biotechnology; Civil Society Organisations: African Centre for Biodiversity, Africabio -Biotechnology Stakeholders Association; Others: NEPAD-Biosafety
Submission
10. Date of submission
2015-12-08
11. Time period covered by this report
Start date
2011
11. Time period covered by this report
End date
2015
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2001 or earlier
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
South Africa regulates all activities relating to genetically modified organisms (GMOs) in terms of the Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997) which is administered by the Department of Agriculture, Forestry and Fisheries (DAFF). Section 3 of the GMO Act makes provision for the establishment of an Executive Council, an intergovernmental body which includes representation from the departments of Agriculture, Forestry and Fisheries, Arts and Culture (DAC), Science and Technology (DST), Environmental Affairs (DEA), Trade and Industry (the dti), Labour (DoL) and Health (DoH). The Executive council is the decision making body. In addition to the GMO Act, South Africa also has the following pieces of legislation that considers biosafety issues:
1) National Enviromental Management Act 107 of 1998 (provides for environmental impact assessment of selected categories of LMOs)
2) National Environmental Management Biodiversity Act 10 of 2004 (provides for long term monitoring of potential impacts of LMOs)
3) Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 (deals with safety standards as well as labelling 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 Control Council.
In addition, South Africa is in a process of developing a guidance document for the Environmental Risk Assessment (ERA) Framework for Pharmaceutical crops (Pharma Crops).
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • 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 have not been communicated to the BCH. South Africa's communication has been limited to decisions on the general/commercial release and commodity clearance.
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 OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. 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
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • Yes
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • Yes
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • More than 10
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • None
38. 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
39. 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
40. 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
41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes
42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes
43. Has your country informed the notifier(s) and the BCH of its decision(s)?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
44. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) with conditions
100%
  • 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%
45. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
46. 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 decision making for the first and subsequent transboundary movement of the LMOs within periods consistent with provisions of the Protocol.
Furthermore, the GMO Act in South Africa provides for the establishment of regulatory bodies namely: the Advisory Committee (AC) and the Executive Council (EC). The AC is composed of independent scientists with various scientific backgrounds and is responsible for the review of applications and advising the EC as to the level of risk associated with proposed activities and whether a permit for that particular activity can be issued. This may include risk management strategies that may need to be implemented should the permit application be approved.

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)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. 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
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
57. 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)
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • Yes
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • Yes, decision reviewed and changed
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • Yes
68. Has your country ever applied the simplified procedure?
  • Yes
69. If you answered Yes to question 68, has your country informed the Parties through the BCH of the cases where the simplified procedure applies?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
70. 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
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • 100 or more
b) Management / Control:
  • 100 or more
c) Monitoring:
  • 100 or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • Yes
84. Does your country have the capacity to detect, 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?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • Yes
88. 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?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • Yes
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Commercial production
  • Field trial
  • LMOs for Contained use
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
94. 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
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
Applications considered under the GMO Act are required to be accompanied by a risk assessment which is considered by the Advisory Committee (AC) and the Executive Council (EC). The AC evaluates the applicant's risk assessment and management measures, and advises the EC on the adequacy of the recommended risk management measures. The EC takes the recommendations of the AC into consideration during decision making. Permits issued include risk management measures that the permit holders must comply with.

Monitoring of GMOs in South Africa is two fold: 1) The Department of Agriculture, Forestry and Fisheries monitors contained use and field trial activities. Monitoring of GMOs commerically released into the environment is conducted by the South African National Biodiversity Institute as provided for in Chapter 2 of the National Environmental Management Biodiversity Act.

In order for applications to be considered compliant under the GMO Act, one of the requirements is the completion of the risk assessement. Two risk assessment documents are submitted for the purpose of evaluation by the regulatory authorities, one being a comprehensive environmental risk assessment document that covers all the requirements for South Africa, and the other being a risk assessment as outlined in Annex 3 of the Cartagena Protocol on Biosafety.

National Treasury annualy approves tariffs for services rendered by government. All applications under the GMO Act are subjected to such tariffs; however, most of the costs associated with processing of applications are covered by the government.
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
99. 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
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. 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
105. Here you may provide further details on the implementation of Article 17 in your country
The current legislation provides for the Executive Council, a decision-making body consisting of various government departments which serves as a mechanism to implement emergency measures in case of unintentional transboundary movement.
Article 18 – Handling, transport, packaging and identification
106. 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
107. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
108. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. 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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • Yes
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes, to some extent
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 50 or more
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • 10 or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • One or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • One or more
122. 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 fulfiled. These are:
1. A letter indicating the intent of the potential exporter
2. Completed application forms
3. Payment of appropriate fees in terms of the GMO Act
4. Notification of the country of import into whose environment the LMO will be introduced
5. Affidavit from the applicant on the accuracy of the information submitted 
6. Acknowledgment and cofirmation by the Party of Import to the intended introduction of the LMO to its environment.
A permit of exportation is only issued if the Registrar of the GMO Act has received written consent from the Party of import or via the potential exporter. The export permit will contain at least the following information:
1. Identification of the LMO (relevant traits/characteristics of the LMO)
2. Requirements for the safe handling, storage, transport and use
3. Contact details for further information on the exporter and the importer
South Africa only allows importation from countries which have same or less number of GMO events approved or commercialised
Article 19 – Competent National Authorities and National Focal Points
123. 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?
  • No
124. 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
125. Here you may provide further details on the implementation of Article 19 in your country
The Department of Agriculture, Forestry and Fisheries is the Competent National Authority responsible for the administration of the Cartagena Protocol on Biosafety whereas the Department of Environmental Affairs is the National Focal Point of the Protocol.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126. Please provide an overview of the status of the mandatory 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.
This question is relevant to indicator 3.1.5 of the Strategic Plan
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
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
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
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
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
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
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
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
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
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
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information available but only partially available in the BCH
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
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
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
128. 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
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • No
132. 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:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 10 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • 10 or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
  • National Libraries
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. Here you may provide further details on the implementation of Article 21 in your country
Applications are submitted in two formats: 1) confidential business information which is limited to regulators only and 2) the non-Confidential Business Information (NON-CBI) which is made available  for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA).
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • Yes
140. 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, to some extent
141. If you answered Yes to question 140, how were these resources made available?
  • Bilateral channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes, to some extent
143. If you answered Yes to question 142, how were these resources made available?
  • Bilateral channels
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • No
147. 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, to some extent
148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Socio-economic considerations
  • Scientific biosafety research relating to LMOs
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes, a few
152. If you answered Yes to question 151, indicate which of the following areas still need capacity-building.
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • No
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • Yes
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 1 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
157. 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
1. AfricaBio hosts delegations from various African countries including Kenyan farmers, regulators, journalists, cereal milling associations, and seed traders.
2. Support has been provided by a number of training workshops in which instruments of government and other players were involved such as:
- Biosafety South Africa & Regional Agricultural and Environment Initiatives Network-Africa (RAEIN Africa): Malawi-20 trained; Zimbabwe- 25 trained and Zambia-25 trained
- Biosafety South Africa & GMASSURE: Pretoria- 41 trained, Namibia- 37 trained and Zimbabwe- 40 trained
- Biosafety South Africa and African Biosafety Network of Expertise (ABNE):  Kenyan regulators - 25 trained
- Biosafety South Africa and the Department of Science and Technology:  Zimbabwean regulators -50 trained
- Uganda Bilateral meeting 29 July 2013
- Namibia bilateral meeting held 27 October 2014
- African Biosafety Network of Expertise (ABNE) Study Tour Program for African Regulators, June 4 - 11, 2014, Pretoria, South Africa (Uganda, Ethiopia, Malawi, Mozambique, Zimbabwe, Kenya, Ghana and Togo)
- Agric-Biotech & Biosafety Conference 2014 Southern African 4-5 March 2014 Sheraton hotel, Pretoria
Article 23 – Public awareness and participation
158. 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, to some extent
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • No
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • Yes
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
The Public Understanding of Biotechnology (PUB) programme and Biosafety South Africa which are entities of the Department of Science and Technology (DST). The PUB aims to ensure a clear, balanced understanding of the scientific principles, related issues and potential of biotechnology and to stimulate public debate around its applications in society. Biosafety South Africa supports innovation in biotechnology by ensuring the development of safe, sustainable biotechnological products
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. 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?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • None
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Newspaper
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Newspaper
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • One or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • One or more
173. 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
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • Yes
175. 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
176. Here you may provide further details on the implementation of Article 23 in your country
The public is 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. Applicants are required in terms of the GMO Act to submit two sets of Risk Assessments: the Confidential Business Information (CBI) and Non-CBI copy of an application which is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA). It is worth noting that public inputs are taken into consideration in the decision-making process.
In South Africa there are a number of public awareness initiatives that are conducted by various institutions including the Biotechnology Industry Association. Such initiatives include:  Agri-youth Indaba, Farmers Agric Expo; Exhibition at the Rand Easter Shows; Journalists Business breakfast, national newspaper, national radios and TV adverts. Such platforms provide opportunities for the public and participants to network, share information and to improve knowledge concerning the safe transfer, handling and use of living modified organisms in relation to the conservation and sustainable use of biological diversity, also taking into account risks to human health.
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • Yes
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • In some cases only
Article 25 – Illegal transboundary movements
184. 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
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes, to some extent
186. 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?
If you replied Never to question 186 please go to question 191
  • Never
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • Yes
193. 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
194. 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?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 5 or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
South Africa took a decision to reject an application for general (commercial) release of genetically modified potato into the South African market. The decision to reject the application was not necessarily taking into account the impact of living modified organisms on the conservation and sustainable use of biodiversity. The reason for rejection was based on risk assessment and economic considerations
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to some extent
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
199. If you answered No to question 198, is there any national process in place towards becoming a Party?
  • Yes
200. 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?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • No
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • Yes
202. 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
In order to adequately prepare for the signing and ratification process, a specialist study was commissioned in 2012 to assess the impact of the Nagoya-Kuala Lumpur Supplementary Protocol on South Africa. This was informed by the fact that the regulation of GMOs in South Africa is overseen by a number of state entities. As a result, the implications required extensive input from a number of core sector departments.
Article 28 – Financial Mechanism and Resources
203. 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?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • Not applicable
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due National Reports?
  • Yes