To fully align the SA legislation to Cartagena Protocol, an Amendment of the principle legislation was approved and implemented in February 2010.<br /><br />In addition to the GMO Act 15 of 1997, South Africa also has other pieces of legislation that considers biosafety issues. These include:<br /><br />- National Environmental Management&nbsp; Act of 1998 (provides for environmental impact assessment of selected categories of LMOs)<br /><br />- National Environmental Management Biodiversity Act 10 of 2004 (provides for long term monitoring of potential impacts of LMOs)<br /><br />-Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 (deals with safety standards as well as labeling of certain class of foodstuffs derived from LMOs.<br />

The transboundary movement of pharmaceuticals which are LMOs is managed like any other activity.&nbsp; 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.

Decisions regarding contained use or transit has not been communicated to the BCH.&nbsp; SA's communication has been limited to decisions on the general release or commercialization decisions.<br /><br />SA's transit policy was communicated to the BCH.&nbsp; This policy holds that LMOs may only transverse the territory of SA to another country if such country confirms their acceptance of the consignment.

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. <br /><br />The Scientific capacity is provided for by way of a statutory body, the Advisory Committee.&nbsp; This Committee undertakes a detailed science-based assessment and provides a recommendation to the decision-making structure <br />(the Executive Council) where relevant different government departments are represented.<br /><br />The decision-making process (especially timelines) is impacted by the following:<br /><br />a.&nbsp; The involvement of different government departments<br /><br />b.&nbsp; The legal prescript of consensus decision-making<br /><br />c.&nbsp; Inadequate information provided by the applicants.<br /><br />d.&nbsp; The potential impact of new scientific information which needs to be assessed.<br /><br />e.&nbsp; New developments or GM events where the regulatory authority may have limited experience.

To ensure alignment of the Act with provisions of the Protocol and related environmental legislation, certain amendments to the Act were approved and implemented&nbsp; in February 2010

As part of managing an administratively fair and transparent process, the SA regulatory framework provides for a process of appeal.&nbsp; Notifiers or applicants have 30 days, after a decision has been communicated, to lodge an appeal to the Executing Authority.<br /><br />As part of the decision-making process, reasons for decisions are provided to notifiers or applicants<br />

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.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; <br />&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; <br />National Treasury annually approves a tariff for services rendered by government.&nbsp; 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.

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.&nbsp; The two countries regularly exchange information on new developments in the area of risk assessment and management.<br /><br />This is further supported through the long term monitoring requirements manadated through the National Environmental Management: Biodiversity Act.

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.

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:<br /><br />• A letter indicating the intent of the potential exporter<br /><br />• Completed application forms<br /><br />• Payment of appropriate fees in terms of the GMO Act<br /><br />• Notification of the country of import into whose environment the LMO will be introduced intentionally<br /><br />• Affidavit from applicant on the accuracy of the information submitted<br /><br />• 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. <br /><br />• 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:<br /><br /> Identification of the LMO (relevant traits/characteristics of the LMO)<br /><br /> Requirements for the safe handling, storage, transport and use<br /><br /> Contact details for further information on the exporter, the importer and<br /> <br /> A declaration that the transboundary movement is in accordance with the Protocol’s requirements<br /><br /> Additional information may be requested by the Competent National Authorities, i.e. the Party of Import or Export.<br /><br />SA only allows importation from countries which have similar GMO events approved or commercialised.

Currently, SA has no bilateral, multilateral and regional agreements within the context of Article 14<br /><br />SA has no specific domestic regulation which applies to specific imports as envisioned in Article 14(4).

Applications are submitted in two formats: with confidential business information and without confidential business information.&nbsp; The non-CBI is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA).&nbsp; Non-Confidential Business Information copy (NON-CBI copy) - is a copy where any information that is regarded as confidential business information is deleted.

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.&nbsp; &nbsp; &nbsp; &nbsp;&nbsp; <br />&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; <br />In addition, South Africa has continuosly particiapted in a number of regional capacity buidling initiaves that include:<br /><br />ABNE meeting on 'Emerging Biosafety Legislation in Africa" - held in Nairobi, Kenya during April 2011 <br /><br />ASSAf lead workshop on "GMOs for African Agriculture: Opportunities and Challenges" - held on 07 June 2011 in Reduit, Mauritius. <br /><br />ICGEB workshop focusing on Biosafety Risk Communication in Sub-Saharan countries. <br /><br />SADC High LEvel Dialogue on Biotechnology and Biosafety, in November 2010

The non-CBI copy of an application is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA).<br /> <br />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.<br /><br />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.

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.

South Africa is currently undertaking a national consultative process towards understanding the impact of the Supplemetary Protocol.&nbsp; This outcome of this impact study will inform a decision towards ratification, acceptance or approval of the Supplementary Protocol.

Re: Q. 14 - South Africa is also party to the Convention on Biological Diversity<br /><br />Re: Q. 46 - In some cases only the notifier &amp; In some cases only the BCH as well<br /><br />Re: Q. 64 - In some cases only the notifier &amp; In some cases only the BCH as well<br /><br />

N/A

PUB, a programme of the SA Association for Science and Technology Advancement (which is part of the National Research Foundation) - national level.