Transcript Department of Agriculture and Land Affairs Presentation

South African Biosafety Regulatory Framework
Julian Jaftha
Director: Genetic Resources Management
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
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GMO Amendment ACT (Act No. 23 of 2006)
 Alignment with Cartagena Protocol on Biosafety
 Alignment with other legislation such as NEMA
 Amendment of:
the scope
Amend and add definitions
Amend composition of EC (incl. DWAF, DAC)
Facilitate the administrative procedures of the Act
Amplify the duties of the EC, AC & Registrar
Clarify application process
Risk assessment in line with new legislation
Procedures during appeal process
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GMO Amendment ACT (Act No. 23 of 2006)
 Consultation process – Department of Agriculture
Parliamentary Conference – 2003
Publication in Government Gazette
Approved by Cabinet approval in May 2005
 Parliamentary process:
Portfolio committee on Agriculture and Land Affairs
Public hearings (January 2006)
Consultations with NCOP
 Approved by President in April 2007
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GMO ACT
 Act Infrastructure
Registrar
- Administration
Advisory Committee (AC) - National advisory body
Executive Council (EC)
- Decision making body
Inspectors
- Monitoring
Appeal Board
- Review decisions
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REGISTRAR
 Administration of Act
• Secretariat - essential link between other biosafety
structures
 Duties/functions - instructions of Executive Council
• Process applications
• Issue / amend / withdraw permits
• Ensure compliance
• Appoint inspectors
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ADVISORY COMMITTEE
 National advisory body on all GMO matters
 Scientists in applicable fields
 Sub-committee - more expertise & building capacity
 Primary safety assessment of all applications
• Recommendation report based on safety
assessment (advise EC)
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EXECUTIVE COUNCIL
 DoA
DEAT
DoH
thedti
DoL
DST
DWAF
DAC
Chairperson of Advisory Committee
 Decision (consensus) based on • recommendation report
• application & public input & previous trial reports
• sector input (e.g. socio, economic, etc)
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INSPECTORS
 Appointed by Registrar - Department of Agriculture assisted
by other departments
 Routine inspections
 Aim:
• Ensure adherence to permit conditions
– possible contravention - investigation - warrant
• Measure effectiveness of risk management measures
• Detection of adverse impact
 Inspection reports
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Public Participation
 Promotion of Access to Information Act
 Promotion of Administrative Justice Act
 Public understanding of Biotechnology
Programme (DST)
 Newspaper Notifications
 Departmental website
 Agricultural shows, exhibitions
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Public Participation
 Confidential Business information
(gene sequences & construct, methodologies,
processes)
 Non-confidential Business Information:
Name & Address of applicant
A general description of the GMO
The risk assessment
Risk management measures
 Non-CBI copies of applications
 Facilitation by DoA
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APPEAL BOARD
 Any person aggrieved by decision/action by Council,
registrar or inspector - appeal to Minister
 Minister appoint appeal board with required expertise
 Decisions of appeal board • confirm/ set aside/ amend decision or action
• refer back to Council (via registrar)
• any other order
 Decision to Minister - informs appellant
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PERMITS
Different for each activity:
• import, export, contained use, trial release,
general release
Information:
• Contact details
• Identity & trait of GMO
• Quantity & varieties
• Time period
Containment conditions
• prior to planting, how to plant, what to do during
harvest, after harvest, security
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Approved Activities under the GMO ACT
• General release approvals (commercial use)
– Maize (incl. stacked)
– Cotton (incl. stacked)
– Soybean
• Commodity clearance (food and/or feed, not planted)
– Maize, Soybean, Oilseed Rape
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Approved Activities under the GMO ACT
Field trial approvals (not all active)
Crops
– Cotton
– Maize (incl. drought tolerance)
– Soybean
– Sugarcane (antimicrobials, increased CH content)
– Potato (insect resistance)
Vaccines
Tuberculosis
HIV
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Approved Activities under the GMO ACT
• Contained use (facility/structure bound)
– GM bacteria producing amino acids
– Insect resistant sweet potato
– Cassava (improved starch content)
• Registered Facilities across the country
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Non-Approvals under the GMO ACT
 Field trials with improved a/a GM Sorghum
 Field trials with improved starch content GM Cassava
 Contained use with GM flowers
 Trial release of GM mosquitocide
 Trial release of recombinant measles vaccine
 General release of genetically modified yeasts strain
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Supporting elements to the GMO Act
 Guideline documents for applications
 Guidelines for compiling a public notice
 Guideline document for use by the Advisory Committee
 Standard Operating Procedures [Reg 2(2)]
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Supporting elements to the GMO Act
 Policy on GMO consignments in transit
 Policy on extension of permits
 Terms of reference for subcommittees
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Thank you
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APPLICABLE LEGISLATION & POLICIES
AGRICULTURE
Fertilisers, Farm Feeds, Agricultural Remedies and Stock
Remedies Act, 1947
Plant Breeders’ right Act, 1976
Plant Improvement Act, 1976
SPS legislation
ENVIRONMENT
Environmental Conservation Act, 1998
National Environmental Management Act, 1998
National Environmental Management Biodiversity Act, 2004
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APPLICABLE LEGISLATION & POLICIES
 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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