directorate: genetic resources department of … · application for commodity clearance of gm maize...
TRANSCRIPT
DIRECTORATE: GENETIC RESOURCES
DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES
13 September 2013
GENETICALLY MODIFIED ORGANISMS
SA REGULATORY FRAMEWORK
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Department of Agriculture, Forestry & Fisheries
Department of Environmental
Affairs
Department of Health
Department of Science &
Technology
Department of Trade and
Industry
National
Environmental
Management
Act, 1998
GMO Act, 1997 (Amendment in
2006)
National
Environmental
Biodiversity
Act, 2004
Convention on
Biological Diversity/
Cartagena Protocol
*Focal Point
Foodstuffs,
Cosmetics, and
Disinfectants
Act, 1972
CODEX
Alimentarius
Contact Point
Cartagena
Protocol for
Biosafety-2003
*Competent
Authority
National
Biotechnology
Strategy
2001
Consumer
Protection
Act, 2008
Promulgated 1997 and implemented 1999
Objective –
ensure activities relating to GMO’s are carried out RESPONSIBLY
import, export, production, use, release & distribution
limit adverse impact on environment, human/animal health
effective management of waste
measures to evaluate & reduce potential risks
criteria for risk assessment
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GENETICALLY MODIFIED ORGANISMS ACT (Act No. 15 of 1997)
Act makes provision for the Minister to appoint members to
regulatory bodies which exercise oversight over the safety
assessment and approval of GMO applications.
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REGULATORY PROCESS
•Environmental Safety
•Food & feed safety
•Non safety issues e.g.
trade &
socio-economics
Registrar (Administration)
Executive Council (EC) Decision makers represented
Advisory Committee Technical experts responsible for safety
assessment
ASSESSMENT PROCESS
Application
Advisory
Committee
Advisory sub-
Committee
Review Committee
Chair: AC member
Sub-committee members Executive
Council
TIMELINE FOR APPLICATIONS: 30-270 DAYS
THE ADVISORY COMMITTEE SCIENTIFIC EXPERTISE • Agricultural biotechnology
• Allergenecity
• Bacteriology
• Biotechnology
(medical/plant/veterinary/wine)
• Botany
• Ecology
• Entomology
• Food toxicology
• Genetics
• Microbiology
• Molecular biology
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• Nutrition
• Pharmacology
• Plant biochemistry
• Plant breeding
• Plant physiology
• Poultry science
• Proteomics
• Vaccine development
• Virology
AC (10 members, Ministerial Appointments)
Sub-committee
(54 members, appointed by Registrar)
DUTIES:
National Advisory Body
Scientific experts
Primary safety assessment of applications
Subcommittee –more expertise
Recommendation report to the EC
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THE ADVISORY COMMITTEE
Sub-Comm.
Member
Sub-comm.
Member
Sub-Comm
Member
Review Chairperson
(AC member)
EXECUTIVE COUNCIL
Appointed by DAFF Minister
Composition: DAFF, DEA, DST, the dti, DoH, DoL, DAC & AC Chair
Duties:
• Advise the Minister on all matters
• Considering recommendation of AC decide on an application
• Compliance to their respective mandates
• Approve relevant guidance documents
• Recommendations on appointment of members of AC
Consensus decision-making
Engagement with interest groups/ applicants: At EC’s request
Non-CBI minutes available to public
GMO EVENTS APPROVED FOR CONDITIONAL COMMERCIAL RELEASE
Use of event: importation/exportation, commercial planting and food and/or feed
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Company
Crop Trait Year approved
Monsanto,
Syngenta and
Pioneer
Maize
Insect resistance
Herbicide tolerant (4) 2007, 2010, 2012
Herbicide tolerant(2) 2002, 2010
Insect resistance (3) 1997,2003, 2010
Monsanto Cotton
Insect resistant
Herbicide tolerant (2) 2005, 2007
Insect resistant (2) 1997, 2003
Herbicide tolerant (2) 2000
Monsanto Soybean Herbicide tolerant (1) 2001
GMO EVENTS APPROVED FOR COMMODITY CLEARANCE
Use of event: importation for food and/or feed
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Company
Crop Trait Year approved
Monsanto,
Syngenta
Dow
AgroScience
and
Pioneer
Maize
Insect resistance
Herbicide tolerant
(19)
2002, 2003, 2004, 2011,
2012
Herbicide tolerant (4) 2011,2012
Insect resistance (8) 2011
Bayer Cotton Herbicide tolerant (1) 2011
AgrEvo, Dow
AgroScience,
BASF and
Pioneer
Soybean Herbicide tolerant (6) 2013, 2012, 2001
Bayer Rice Herbicide tolerant (1)
2011
GMO EVENTS APPROVED FOR FIELD TRIAL (2012/2013)
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Company
Oganism Trait
Triclinium
Wits
Vaccines
TB
HIV
Syngenta, Pioneer and
Monsanto Maize
Insect resistance
Herbicide tolerant (9)
Male fertility
Female infertility (1)
Bayer Cotton Insect resistance
Herbicide tolerant (1)
ACTIVITIES REGULATED UNDER THE GMO ACT
Import & Export
Contained use
(Activities in laboratories, greenhouse, glasshouse depending on
containment levels)
Trial release (Limited environmental release to provide for generation of SA data in
different agro-ecological zones)
General release (conditional)
(Preceded by field trials, feeding studies, monitoring plan and annual reports)
Commodity Clearance (conditional)
COMMODITY CLEARANCES
Use in food, feed and processing
Only food/ feed safety data considered
Special conditions for import: SABS standard
• Limit environmental contact
Asynchrony limits commodity imports: lack of segregation
Imports usually for coastal regions
COMMODITY CLEARANCE APPLICATION-DOW AGRO
Application for commodity clearance of GM maize event DAS-
40278-9, reference number Dow Agro Sciences -12/002
Short description of the genetic modification
GM maize has been modified to be resistant to the herbicide 2, 4-
dichlorophenoxyacetic acid (commonly referred to as 2,4-D).
This trait is achieved through the expression of a protein (enzyme)
in the maize which degrades 2.4D into herbicidally-inactive 2, 4-
dichlorophenol (DCP).
This means that in the production of the GM maize, a herbicide
spraying regime may be applied which will not affect the GM
maize.
Public Notification
Sunday Times, City Press &
Rapport newspapers of 04 March
2012.
Notices include: Applicant
Type of Application
Origin of the inserted gene
Call for comments
Deadline for comments
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CONTD...
Public notifications of the intended activity were placed in the Sunday Times,
City Press and Rapport newspapers of 04 March 2012.
Received by the Office of the Registrar 05 March 2012
No comments were submitted by the public
ACB PAIA request -EC Decision document July 2012
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Thank you
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