Transcript GMOs in South Africa: A Regulatory Perspective

GMOs in South Africa:
A Regulatory Perspective
Chantal Arendse
Director: Biosafety
What is a Genetically Modified
Organism?
Organism whose genetic material has been altered/
modified in a manner that does not occur naturally
through multiplication or natural recombination
How?
Inserting a specific gene
Switching a gene on or off
Removing a specific gene
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What are the potential risks?
Food, animal feed and health safety issues
 Allergenicity
 Toxicity
 Pathogenicity
 Digestibility
Environmental safety issues
 Gene flow and Biodiversity
 Invasiveness/Weediness/Resistance
 Impact on subsoil and other ‘non-targeted’ organisms
 Gene variability / Instability
 New pests and diseases.
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What is Biosafety?
GMOs
Risks
Biosafety:
Provides for risk management
measures to avoid risks to human,
animal health and environment
resulting from GMOs
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GMO Timeline in SA
GM Cotton/
Maize 1997
SAGENE
1990’s
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What does it mean to regulate
GMOs?
Pro-GMO
Stakeholders
Anti-GMO
Stakeholders
Responsibility:
Objectively evaluate the scientific evidence, on a case by case basis and
make decisions relating to GMO activities in the best interest of
the environment, human & animal health.
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SA Legislation
Department of
Science &
Technology
National
Biotechnology
Strategy
Department of
Agriculture
GMO
Act 15, 1997
(Amendment,2007)
Cartagena
Protocol
on
Biosafety
2003
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Department of
Environmental
Affairs and
Tourism
National
Environmental
Management
Act, 1998
National
Environmental
Biodiversity
Act, 2004
Convention
on
Biological
Diversity / Biosafety
Protocol
Department of
Health
Foodstuffs,
Cosmetics, and
Disinfectants
Act, 1972
(Act 54 of 1972)
CODEX
Alimentarius
Genetically Modified Organisms Act
(Act No. 15 of 1997)
Implemented in 1999 - Ensure activities relating to GMOs
are carried out RESPONSIBLY
How is this achieved?
Implement measures:
 Including import, export, production, release &
distribution
 limit adverse impact on environment, human/animal
health
 Lay down criteria for risk assessment
 Measures to evaluate & reduce potential risks
 Ensure effective management of waste
 Prevent accidents
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GMO Amendment Act
(Act 23 of 2006)
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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
Alignment with provisions of Cartagena Protocol on Biosafety
& other legislation such as Biodiversity Act, 2004
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 Amendment process initiated in 2002/3 and included
consultations and public hearings.
 Approved by President in April 2007
 Amendment regulations published for comments – March 2008
GMO Act : Regulatory Instrument
Registrar
• Appointed by Minister
• Administration
• Instructions by EC
(applications & permits)
• Ensure Compliance
• Appoint inspectors
Advisory
Committee (AC)
Executive Council
(EC)
•National Advisory Body
•Primary safety assessment
of applications
•Scientific experts
•Subcommittee –more
expertise & capacity
•GMO Decision Makers
•DoA (Chair), DST, DEAT,
DoH, the dti, DoL,
AC Chair (DAC & DWAF)
•Decisions – consensus
based
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TIMELINE FOR APPLICATIONS: 30-180 DAYS
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What are some of the burning
issues regarding GMO regulation?
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Does GM Food need to be labelled?
• The DoH, Directorate: Food Control is the sole regulatory authority on
labelling of genetically modified food;
• Regulations Relating to the Labelling of Foodstuffs Obtained Through
Certain Techniques of Genetic Modification No. R25 of 2004 [Foodstuffs,
Cosmetics, and Disinfectants Act, 1972 (Act 54 of 1972)]
• Labelling regulations consider nutritional and safety aspects;
 Must Label foodstuff significantly different in respect of the composition,
nutritional value, mode of storage, preparation or cooking, allergenicity or
human or animal origin
 May label for enhanced Characteristic Claim must be validated by certified
body
• CODEX – International committee on food labelling - awaiting outcome of
decision regarding labeling of GM foods
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• Use of terminology: “GM Free” vs “Non GM” under consideration
SOCIO ECONOMIC CONCERNS
• GM Technology raises concerns relating to the impact on the livelihoods
of emerging farmers and rural communities in the developing world
• The specific concerns of GM crop adoption in developing countries
relates to:
 Monopoly on the price of the GM seeds
 dependency on new generation of GM seeds
 GM Crops are not suitable and do not address the needs of developing
countries
 possible loss of existing traditional varieties and indigenous
technologies, thereby reducing the diversity, flexibility and resilience of
indigenous farming systems
• Most of these concerns are not unique to GM crops.
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• Cartagena Protocol on Biosafety – Article 26: Focuses on the impact in
terms of the value of conservation and biological diversity to indigenous
and rural communities
PRECAUTIONARY PRINCIPLE
Cartagena Protocol on Biosafety: Article 10
What does it mean?
Lack of scientific certainty regarding the extent of potential harm
to the environment is not a valid ground for refraining from taking a
decision, which could include preventative measures.
Provisions of the precautionary principle have been adopted in the
decision making procedures contained in the GMO Act (&
Amendment).
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ACCESS TO INFORMATION
• Biowatch Court Case (2004):
Court ruling in February 2005 that information relating to the
administration of the Act should be provided but confirmed that DoA still
has a responsibility to protect confidential business information.
• In terms of Promotion of Access to Information Act (PAIA): access to
non confidential business information.
•
• Departmental website: www.nda.agric.za
• BIOSAFETY CLEARING HOUSE – a provision of the Biosafety Protocol
-Represents a web based information portal to facilitate exchange of
information.
-The national BCH web portal is in the final stages of development.
• Interaction with media: All media requests be directed via the office of
the Chief of Communications
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PUBLIC NOTIFICATION
Intention to introduce GMOs into the environment.
Notification includes: Information of applicant, objective of activity,
description of the GMO and description of the intended release site.
Facilitates access to the non-confidential copy of the application for
interested parties to submit comments to the Registrar.
Comments and the responses from applicants are considered by the EC
during the decision making process.
Improvements to public notification is being considered in terms of the
amendment regulations.
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GMOs in South Africa…..the last 10
years?
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GMOs Approved for Commercial use
Type of approval:
General release – conditional
Use of the event: Importation/exportation; commercial planting; food
and/or feed
Company
Crop
Trait
Year approved
InsectR HerbT
2005, 2007
HerbT
2000, 2007
Cotton
InsectR
1997, 2003
InsectR HerbT
2007
Monsanto
Herbicide
2002
tolerant
Maize
Insect resistant 1997
Herbicide
Soybean
2001
tolerant
Syngenta
Maize
Insect resistant 2003
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SA Area planted with GM crops
2007
White maize: 1, 040 million hectares, 62% crop
Yellow maize: 567 000 hectares, 52% crop
Soybean: 144 000 hectares, 80% crop
Cotton: 10 000 hectares, 90% crop (90% small scale farmers)
Total Area : 1,8 million hectares
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(Source: Clive James, ISAAA 2007)
GMO Activities approved?
Trial Approvals
Crops
Vaccines
Maize (DroughtT)
Tuberculosis & HIV
Sugarcane (antimicrobials)
Potato (InsectR)
Contained Use (linked to facility)
– GM bacteria producing amino acids
– Sweet potato (InsectR)
– Cassava (improved starch content)
Registered Facilities across the country
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GMOs & the Wine Industry
GM Vine field Trials – Institute for Wine Biotechnology, US
• Objective: Long term stability and expression of transgenes
• Application still pending
GM Malolactic Wine Yeast
• Application not approved
• Guidelines and standards for the use of GMOs in wine production
still under consideration by the International Organisation of Wine
and Vine (OIV)
• Impact on export markets
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GMOs: Looking towards the future?
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Global Area (Million Hectares) of Biotech Crops, 2007:
by Country
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Thank You
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