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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