1. GMO AMENDMENT BILL13 March 2006 J.B. Jaftha N. Rabuli C. Booyse

2. 2 Section 1:DEFINITIONS Amend existing definitions contained use general release user Amend existing definitions for alignment with CPB accident: unintentional transboundary movement Provide new definitions activity biosafety BCH commodity clearance conditional general release Convention environmental impact assessment extension permit Protocol release transboundary movement

3. 3 Section 1:DEFINITIONS “activity” “’activity’ means any activity with genetically modified organisms but is not limited to the importation, exportation, transit, development, production, release, distribution, [contained] use, storage and application of genetically modified organisms only”. biosafety “’biosafety’ means the level of safety when risk management measures must be taken to avoid potential risk to human and animal health and safety and to the conservation of the environment, as a result of exposure to activities with genetically modified organisms, and ‘biological safety’ shall have a corresponding meaning”

4. 4 Section 1:DEFINITIONS contained use “’contained use’ means the development, production, cultivation, use, application, storage, movement, destruction or disposal of genetically modified organisms within a facility, installation or other physical structure, including a greenhouse, that are controlled by specific measures, including physical barriers, or a combination of physical barriers together with chemical or biological barriers or both, that effectively limit contact of the GMOs with humans, animals and the external environment and their impact on humans, animals and the external environment.” commodity clearance ‘commodity clearance’ means the authorisation to use [a] genetically modified organisms as a food or feed, or for processing, but excludes the planting of a genetically modified organism as a [direct] release into the environment;

5. 5 Section 1:DEFINITIONS “protocol” ‘Protocol’ means the Cartagena Protocol on Biosafety to the Convention [on Biological Diversity], that has been negotiated and adopted by the Parties to the Convention [on Biological Diversity], acceded to by the Republic on 14 August 2003; a copy of the Protocol is attached for information purposes. transboundary movement’ ‘transboundary movement’ means the movement of a genetically modified organism [across the boundaries of the Republic] from the Republic to another country or from another country into the Republic.”

6. 6 Section 1:DEFINITIONS “user” “user’ means a person who conducts an activity with a genetically modified organism.

7. 7 Section 3: Executive Council  Establishment of the EC as a juristic person Enables EC to institute legal action, e.g. recovery of costs Section 3 (1) There is hereby established a [council] juristic person known as the Executive Council for Genetically Modified Organisms, which shall consist of not more than [eight] 10 members appointed by the Minister  Nominated by their respective departments  Inclusion of DAC & DWAF  Knowledge of policies and legislation in respective sectors

8. 8 Section 3: Objectives of the Executive Council The council shall advise the Minister on all aspects concerning [the development, production, use, application and release of] activities relating to genetically modified organisms, and [to] ensure that [all activities with regard to the development, production, use application and release of] such activities [genetically modified organisms] are performed in accordance with [the provisions of] this Act

9. 9 Section 5 : Powers and duties of the Council Powers & duties: Discretionary & Obligatory  Obligatory “the Council shall…. - determine whether an applicant must submit an EIA in terms of NEMA - an assessment of the socio-economic consideration - approve activities - consider scientifically based risk assessments and proposed risk management measures - determine the conditions for reapplication (change in activities) - Procedures to be followed in case of accidents and contraventions - Advanced informed agreement procedure on user (new) - Advice and information to Minister - Notification procedures to the BCH, affected States in case of accident and unintentional transboundary movements

10. 10 Section 5 : Powers and duties of the Council  Discretionary “ The Council may……” -Consider public input, EIA, socio-economic impact -Authorise the Registrar to issue a permit - consult with the AC on issuance on extension permits - Approve and issue guidelines - Reconsider a decision in light of new and relevant scientific evidence - Co-opt expertise to Council for advice

11. 11 Section7: Meetings of the Council  Quorum: simple majority (50% plus one)  Decision based on consensus  No consensus: application or any matter requiring a decision under this Act is refused or denied  Mechanism for special meetings  Strengthen attendance of meeting: alternate members to be appointed by the Minister

12. 12 Section 9: Functions of the Registrar Subject to instruction by the EC and Independent  Subject to instruction or conditions by the EC - Determine the conformity of an application - Manage permits: Issue a permit or extension permit amend or withdraw - Authorise an inspector to act - Attend to any other matter

13. 13 Section 9: Functions of the Registrar continued  Independent actions - Maintain a register of facilities, trails sites - Arrange for inspections - Require cessation of activities - Submit documents to Council - Communicate with the BCH

14. 14 Section 10: Advisory Committee  Two members from public sector, knowledgeable in: - ecological matters and GMO - impact of GMOs on human and animal health  Other expertise may be co-opted Clause 8(b) of amendment Bill: The committee shall co-opt or invite written comments from knowledgeable persons ……… Section 11(2) of the principle Act The committee may appoint subcommittees to deal with specific matters as required.

15. 15 Section 11: Functions of the Advisory Committee  Providing advise to the Minister, the Council, the Registrar, other Minister and appropriate bodies.  Co-opt or invite written comments from knowledgeable persons in the specific fields of science on any aspect of genetically modified organisms which lies within the Committee’s brief, to assist the Committee in performing its functions.

16. 16 Section 12: Funding  Remuneration of: - Any other person who may be included on the Council [section 3(2)(c)] - Invited knowledgeable persons co opted to serve on the Council [section 5 (2)(h)] - Members of the Advisory Committee - Members co-opted or invited to provide comments to AC

17. 17 Section 15: Inspectors  Inspector under authority of a warrant to: To seize any appliance, book, statement, document or GMO To give notice to owner before any seizure To dispose of or repatriate any GMO used or any material or substance used, affected or potentially affected if such activity has an adverse impact on the environment or human or animal health

18. 18 Section 17: Determination of risks and liability  Users shall ensure that appropriate measures are taken to avoid damage  In case of damage, the user shall: - inform the Registrar immediately - consult with Registrar to cease, minimise and contain movement of GMO, eliminate source of damage and remedy effect of the damage  EC is empowered to take measures when user fails to take adequate measures to remedy the situation  User is liable  New clause on the Recovery of Cost: Arising from damage Arising from actions taken by EC

19. 19 Section 18: Confidentiality  The section aims to protect the confidential business information of the applicant  Places an obligation on those involved in the administration of the Act to protect the CBI  The following is not regarded as confidential: -The general description of the GMO -The name and address of the applicant - The purpose of use - Summary of the risk assessments on environment, human and animal health

20. 20 Section 19: Appeals  Allows for 60 days for appointment of an Appeal Board  Minister may extend for another 30 days  Type of decisions an appeal board may take: confirm, set aside, substitute or amend make an order as it deems fit to minimize a significant negative impact on the environment or human or animal health  In making a decision consider new scientific or technical evidence or any other information.  Decision to be communicated within 30 days after final decision has been taken

21. 21 Section 20: Regulations  Period within which a decision on an application must be taken  Prescribing the procedure to be followed for drawing up a scientifically based risk assessment, environmental impact assessmet, socio-economic conideration and risk management measuresMinister should not have sole discretion in determining when and what information would constitute a risk assessment, EIA and socio-economic impact assessment.  Content of information be supplied by the user in case of an accident to the Registrar, to the BCH  Information in terms of the Advanced Informed agreement

22. 22 Section 21: Offences and Penalties

23. 23 Long title of Act 15 of 1997  [International agreement] = Protocol