1. GMO AMENDMENT BILL 2005

2. DEPARTMENT OF AGRICULTURE REPRESENTATIVES
DR. SHADRACK R. MOEPHULI:ADGAP (EC: CHAIR)
DR. JULIAN B. JAFTHA: SMGRM
MS. MICHELLE VOSGES: REGISTRAR
MS. NDIVHUO RABULI: LEGAL SERVICES
MR. LUFUNO MAKHOSHI: LEGAL SERVICES

3. STRATEGIES / POLICIES African country – developmental state
Convention on Biological Diversity
Implementation of GMO Act
Cartagena Protocol on Biosafety
(Articles 8 (g) & 19.3 of CBD)
June National Biotechnology Strategy
Agric – Biotech Strategy published 26/08/05
Biosafety policy – draft published 26/08/05

4. APPLICABLE LEGISLATION & POLICIES
ENVIRONMENT
Environmental Conservation Act, 1998
National Environmental Management Act, 1998
National Environmental Management Biodiversity Act, 2004
FOOD SAFETY
Foodstuffs, Cosmetics and Disinfectants Act, 1972
ADMINISTRATIVE JUSTICE
Promotion of Administrative Justice Act, 2000
Promotion of Access to Information Act, 2000

5. What have we done to date?
Parliamentary Conference – 2003 (DoA, DEAT, DoH etc)
Publication in Government Gazette - 8/10/04
Responses from 89 interested & affected parties.
Cabinet approval on 11 May 2005
Publication of Explanatory Summary - 26/08/05
Certification by State Law Advisors – 07/10/05

6. INTRODUCTION TO GMO ACT (Act No. 15 of 1997)
Promulgated 1997 and implemented 1999
Objective - Implement measures to
ensure RESPONSIBLE activities
Including import, production, release & distribution
limit adverse impact on environment, human/animal health
ensure effective management of waste
prevent accidents
Measures to evaluate & reduce potential risks
Lay down criteria for risk assessment
Establishment of Council
LMO: Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology

7. GMO ACT cont
GMO’s
organism/gene/genetic material – modified - not naturally through mating or natural recombination or both…
LMO: any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology --- CPB
RSA – GMO = LMO

8. GMO ACT cndt
Act Infrastructure

9. GMO ACT cntd GMO activities approved to date:
General release approvals (commercial use)
Maize, Cotton, Soybean
Commodity clearance (food and/or feed, not planted)
Maize, Soybean, Oilseed Rape
Field trial approvals (not all active)
Cotton, Maize, Soybean, Sugarcane, Vaccines (HIV), Potatoes, Wheat
Contained use (facility/structure bound)
Maize, Sweet potato, Potato

10. Changes required from Protocol
Article 17 – Unintentional transboundary movement and emergency measures
Notification to BCH, affected & potentially affected parties
Measures to minimize significant adverse effects
Prescribed information
Article 20 – Information sharing & BCH
Submission of the following information to BCH:
Relevant existing domestic laws, regulations and guidelines
Bilateral, regional and multilateral agreements
Summaries of risk assessments/environmental reviews
Decisions taken on importation or release
Monitoring reports on implementation of the protocol
etc

11. Changes required from Protocol
Article 27 Liability and Redress
Section 17 of principal Act – technical changes
Under negotiation – must be in accordance with international rules and procedures in the field of liability and redress for damage resulting from transboundary movement of LMO

12. Changes required from Protocol
Culture & Socio – economic issues (article 26)
May consider the following:
Impact on biodiversity in areas inhabited or used by indigenous or local communities;
Loss of access to genetic resources previously available to indigenous or local communities;
Loss of cultural traditions, knowledge, and practices resulting from loss of biodiversity
RSA – included in duties & powers of council

13. PUBLIC AWARENESS & PARTICIPATION
Article 23 of Protocol
Promote & facilitate awareness, education & participation
Provide for access to information
Consult with public in decision-making process
Public access to BCH
RSA approach
Public Understanding of Biotechnology – DST
PAIA, PAJA, public notifications in newspapers, radio & TV
Newspaper adverts
Departmental Website:

14. PUBLIC CONSULTATIONS MP’s – Portfolio Committees of
Agriculture and Land Affairs, Environmental Affairs and Tourism, Science & Technology, Health
Groups / entities concerned about GMO’s
Biowatch, SAFeAge, African Centre for Biosafety, Earthlife Africa, AfricaBio, etc.
Seed, grain and animal feed industry
Research institutes and scientists
Medicines Control Council
Processing companies (Tiger Food Brands)
Organic Industry
Government departments
Legal institutes (Legal Resources Centre)
Church organizations (Catholic’s Church, Anglican)
Individuals (incl. farmers & farmer organisations)
Bodies appointed under the GMO Act (Committee, Council, appeal Board)
Indicate the extent of participants

15. SUMMARY OF PUBLIC COMMENTS
Need for national policy and redrafting of GMO Act
No precautionary approach adopted
Publication of proposed amendments to regulations
Direction required on different assessments
Constitution and related legislation
Decision of the Council - majority decision
Department of Arts and Culture - be removed as member of the Council
Extension permit applications - public consultations & socio-economic considerations in all cases.
Extension permits granted for trial release permits without further Council approval
Civil representation on Advisory Committee
End-user and consumer not “user”
Lack of post commercialisation monitoring
Not all, only a summary
Long term monitoring: a function of South African Biodiversity Institute

16. GMO AMENDMENT BILL, 2005
Give effect to international agreements - CPB;
Amend certain definitions and add new definitions;
Amend the composition and remuneration of members of the Committee and Council;
Amplify the powers and duties of the Council, the Committee and the functions of registrar
Clarify the procedure relating to the application and issuing of permits;

17. GMO AMENDMENT BILL 2005 Amplify the provisions on risks assessments
Amend the liability determinations;
Amend the information requirements contemplated in the confidentiality clause;
Lay down criteria with regard to offences;
Provide for certain procedures during an appeal process

18. SECTIONS OF THE BILL, 2005 Section 1 – Definitions Amendments to
Accident , contained use, general release,
New definitions
Activity , biosafety, biosafety clearing house, commodity clearance, conditional general release, Convention, environmental impact assessment, extension permit, protocol, release, transboundary movement

19. SECTIONS OF THE BILL, 2005 cntd
Section 3 - Composition of Council
10 members - additions
Department of Arts & Culture
Department of Water Affairs & Forestry
Nominated by departments
Knowledge of implications of GMO’s
Sector
Existing policies & legislation
Any other member – ? experts ? motivation

20. SECTIONS OF THE BILL, 2005 cntd
Section 5 - Duties of Council (must..)
Type of assessments required
Science-based risk assessment
Risk management measures
Decisions (consensus) – facilities & activities
Accidents – notification; emergency measures
Section 5 - Powers of Council (may..)
Public input
Environmental impact assessment
Socio-economic considerations
Authorise issuance of permit / extension permit
Reconsider decisions
EIA: elements of the EIA in all risk assessments
economic implications of conducting a full EIA.

21. SECTIONS OF THE BILL, 2005 cntd
Section 7 – Functions of the Registrar
Subject to instructions from Council
Not subject to instruction from Council
Register – facilities / trial sites & contact details
Interact with Biosafety clearing house
Issue extension permits
Section 10 – composition of Advisory Committee
Public sector representative: expert on human & animal health
Public sector representative previously only with expertise in ecological matters, now it also includes human and animal health

22. SECTIONS OF THE BILL, 2005 cntd
Section 17- liability and redress
Article 27 of the Protocol
Users – appropriate measures to avoid adverse impact on environment, human and animal health
Liability – user concerned

23. SECTIONS OF THE BILL, 2005 cntd
Section 18 – Disclosure of information
(Protocol – Article 21)
General description of GMO
Summary of Science-based risk assessment
Mechanisms
Promotion of Access to Information Act, 2000 – notification
Promotion of Administrative Justice Act, 2000 – decisions & reasons for decisions
National Biosafety Clearing-House – increase transparency

24. SECTIONS OF THE BILL, 2005 cntd
Section 19 – appeal
Time periods
Appeal board appointment
Decision
Type of decisions
Confirm, set aside, substitute, amend
Other order – minimize significant negative impact on environment or human / animal health
New scientific / technical evidence / information – directly applicable

25. SECTIONS OF THE BILL, 2005 cntd
Section 20 – Regulations
Time periods- applications / decisions
Procedures for drawing up assessments
Accidents –notification / information
Biosafety Clearing House
As prescribed in the amendment

26. THANK YOU….
QUESTIONS?