GMO AMENDMENT BILL 2005

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GMO AMENDMENT BILL 2005
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DEPARTMENT OF AGRICULTURE REPRESENTATIVES

• DR. SHADRACK R. MOEPHULIADGAP (EC CHAIR)
• DR. JULIAN B. JAFTHA SMGRM
• MS. MICHELLE VOSGES REGISTRAR
• MS. NDIVHUO RABULI LEGAL SERVICES
• MR. LUFUNO MAKHOSHI LEGAL SERVICES

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STRATEGIES / POLICIES

• African country developmental state
• Convention on Biological Diversity
• Implementation of GMO Act - 1999
• Cartagena Protocol on Biosafety
• (Articles 8 (g) 19.3 of CBD)
• June 2001 - National Biotechnology Strategy
• Agric Biotech Strategy published 26/08/05
• Biosafety policy draft published 26/08/05

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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

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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

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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

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GMO ACT cont

• GMOs
• 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

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GMO ACT cndt

• Act Infrastructure

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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

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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

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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

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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

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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 www.nda.agric.za/geneticreso
  urces/act15.htm

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PUBLIC CONSULTATIONS

• MPs Portfolio Committees of
• Agriculture and Land Affairs, Environmental
  Affairs and Tourism, Science Technology, Health
• Groups / entities concerned about GMOs
• 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 (Catholics Church,
  Anglican)
• Individuals (incl. farmers farmer
  organisations)
• Bodies appointed under the GMO Act (Committee,
  Council, appeal Board)

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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

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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

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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

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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

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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 GMOs
• Sector
• Existing policies legislation
• Any other member ? experts ? motivation

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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

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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

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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

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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

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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

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SECTIONS OF THE BILL, 2005 cntd

• Section 20 Regulations
• Time periods- applications / decisions
• Procedures for drawing up assessments
• Accidents notification / information
• Biosafety Clearing House

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• THANK YOU.
• QUESTIONS?