The Impact of Two Divergent GMO Regulation
Approaches on Modern Biotechnology
Innovation and Development in Africa
Adane Abraham (PhD)
Ethopian Institute of Agricultural Research
National Agricultural Biotechnology Laboratory (Holetta)
Outline
• GMOs – benefits, concerns & the need to regulate
• Main International instruments for GMO regulation
•Two opposing regulatory approaches:
- European (Precautionary Principle)
- US (Substantial Equivalence Principle)
• GMOs and their regulation in Africa
• Influence of the two approaches in Africa
• Way Forward for Africa
Genetic Modification (GM) Technology is a
controvercial Technology in agriculture:
• most rapidly-adopted agricultural technology
= due to its huge demonstrated & potential benefits
• is a highly contested and debated technology worldwide
= due to perceived risk on environment and human health
The Benefits
• Increased agricultural productivity
• Reduced production cost
• Nutrient-enhancement in crops
• Tolerance to harsh environmental stresses – drought,
salinity, etc.
• Environmental- reduced pesticides, usage no /zero tillage
James, 2012
Potential Risks & Concerns
• Environment:
- impact on biodiversity (gene flow)
- effect on non-target species
- superweed emergence
• Health:
- safety of food for humans and livestock
- new allergens, toxins
- increased resistance to antibiotics
• Socio-economic: - loss of export market
- lack of access to patented technologies
- corporate dominance of seed sector
- loss of land races & traditional knowl’ge
The consensus by international community:
GMOs have a huge potential for economic development but
have to be used after a regulatory approval that minimizes
the perceived risks to environment and human health
Hence, GMOs are highly regulated products that are
handled, tested, transferred and traded in compliance with
certain regulations.
= Biosafety regulations
International Instruments for GMO Regulation
• Cartagena Protocol on Biosafety (CBD):
- to lay down a common and coordinated approach
among countries to address potential risks of LMOs
(GMOs) on biological diversity and human health
- Key driving force in establishment of National Biosafety
Frameworks
- National Biosafety Frameworks: includes the necessary
policy, legislation, administrative systems, for compliance
& public engagement to ensure adequate level of safety‖
Other International Instruments
WTO Agreements:
- Sanitary &Phytosanitary (SPS) measures
- Technical Barriers of Trade (TBT)
- Trade Related Aspects of Intellectual Property Rights (TRIPs)
Two opposing approaches for GMO regulation
• Whether GM technology is inherently safe or unsafe
1. Precautionary Principle (Europeans)
GM crops are potentially dangerous and pose new risks and
thus their use should be avoided until they are proven safe
2. Substantial Equivalence Principle (USA)
GMOs are no different from conventional crops, if the
products so derived are “substantially equivalent” in
composition, nutritive value or safety after thorough
comparative testing
Main differences in European (Precautionary) & US
(Substantial Equivalence) approaches of regulation
Issues raised
GMO & risk
perception
GMO Safety
European approach
present new risk
potentially dangerous
Unsafe unless proven
safe
Regulatory focus Risk avoidance, absolute
safety
Basis of regulation Process (technology)
New laws & regulations
Legisilation
Labeling
Mandatory labeling
Internationally
Cartagena Protocol, CBD
endorsed by
USA approach
No new risks, beneficial
once passed safety tests
Safe unless proven
unsafe
Favor safe GM
innovation & adoption
Product (trait)
Exisitng laws adequate
Not required, voluntary
OECD, FAO/WHO,
Codex
The major factors d the driving the difference in
European & US approaches of GMO regulations
Factors
Public Opinion
Europe
Anti-GMO, distrust of
regulators, natural food,
Past food scandals
Dominant Interest Anti-GMO NGOs,
groups
farmers, consumers
media
Economic interest No much gain expected
for businesses, farmers
or consumers
Regulatory
Consider scientific
decisions
evidence & public
opinion
Political influence Green parties have
significant power
USA
Trust regulators, no
past scandals, less
aware & concerned
Pro-GMO businesses,
groups, farmers &
consumers
Export trade, use, so
Favorable condition
for GMO use
Independent, stronger
focus on scientific
evidence
No such parties &
minimal influence
The EU legislative framework:
• Directive 2001/18/EC: procedures for the environmental release of
GMOs for both experimental and commercial purposes.
• Directive (98/81/CE) to regulate the confined use of GM microorgsms,
• Directive 90/219 for regulating contained use (lab. experiment)
• Directives 1830/2003 on labeling and traceability
• Directive 1829/2003 on GM food and feed have been prepared
• Regulation 1946/2003 regarding transboundary movement of GMOs
is harmonized with the Cartagena Protocol.
• Indepedent body for risk assessment (European Food Safety Agency)
USA- Coordinated Framework for Regulation of
Biotechnology, 1986
1) The U.S. Department of Agriculture:
- regulates transgenic plants with plant pest components (e.g. Bt)
2) Food and Drug Administration:
- regulates GMO for food and feeds use in the market
3) The Environmental Protection Agency:
- pesticides in transgenic plants prior to marketing
Criticisms on Precautionary Principle
• Focuses exclusively on risks disregarding benefits
• Difficult to prove absence of risk
• Too many interepretations, ambiguous, not good
decision tool
• Discourages innovation & adoption of useful
technologies by minimizing potential risks
Criticisms on Substantial Equivalence Principle:
• Similarity in composition is not a guarantee that GM food and its
conventional counterpart has the same nutritional value as
unexpected substances may appear.
• Does not allow rigorous tests & hence unintended changes in
may go undetected and still cause harm
•
Stimulates GM innovation & adoption & to favor businesses
• Can be used as risk assessment tool but not decision tool
Effect of Regulatory approaches on GMO approval in three
developed economies
Number of GM events approved over time for
consumption
100
80
60
40
20
0
JPN
EU
US
Which regulatory approach is better?
• The best regulatory approach
- allows new technologies to be used
- preventing new risks to human health or the
environment.
• Using this standard, US approach has done a better job
than the EU
• Countries adopt a “mixed approach” to suit their
situations
191
GM technology & African Agriculture
• 30-50% GDP, >60% employment from agriculture
• Characterized by low yield
• Estimates of maize yields around the world
- SS Africa
1.2 MT/Ha
- Indonesia
3.8 MT/ha
- USA & Europe
8 MT/ha - 15MT/Ha
• Use of improved inputs e.g. seeds, fertilizers, pest control
• GM technology, not well adopted in Africa
Challenges for GM technology in Africa
• Inadequate fund for R&D (<0.5% GDP, 75% from donors)
• Insufficient scientific & technical expertise
– research & development
– regulatory (Biosafety) capacity
• Higher risk perception, misinformation & confusion
• Low Public awareness
• Foreign interests interfering in regulatory system
• Weak regulatory policy – rate limiting factor in access for
resource poor farmers and consumers
GMOs & Biosafety Regulation Policies in Africa
• Generally follows European model
• Influenced Cartagena Protocol
– Special or new laws
– Precautionary principle
– strict labeling requirement
– More stringent regulations than CPB
e.g. African Model Law
Consequently, Regulations in Africa typically are:
• Too much focused on risks; not reflect global experience
• broad socioeconomic considerations
• Strict liability/insurance clauses
• Regulations are costly, unaffordable & unenforceable
• Disincentive to private technology investors
• Not favoring R&D
European Influence has been through (Paarlbeg,
2006):
• Bilateral assistance
• Multilateral assistance (UNEP-GEF Biosafety framework)
• NGO advocacy campaigns
• Refusing Imports of African farm commodities
• Cultural influence over African elites
European donor funds in biotechnology:
• mostly on biosafety risk avoidance, not on GMO R&D
• bilateral assistance
- GTZ/GIZ – African model law on biosafety
- precationary principle – extreme interpretation
- strict liability, GMO-free areas
- broad socioeconomic consideration
- Norway – Zambia, South Africa & Ethiopia
- Sweden (Bioinnovate – non-GM biotechnology)
• Multilateral - UNEP-GEF – mostly European funded
- Promotes precautinary approach
USA funding – encourages GMO research & Use:
• Positive experience with use of GMOs
• Trade interest as GMO developers & exporters
• Actively involved in shaping biosafety policies in some
countries
• Promote public private partnership
US sources promote GM R&D funds through:
- USAID
- Pro-GMO NGOs like AATF, PBS, ABSP, ISAAA, ABNE, etc.
- Multinational Private technology owners
- Pro-GMO NGOs & CGIAR centers
- Philanthrophic Foundations: BMGF, Rockefeller
- Food aid
Africa countries pulled in opposite direction
& divided:
1. Countries with favorable GMO climate - (GM adopters)
• South Africa, Ghana, Burkina Faso, Kenya, Uganda, Egypt
& Nigeria
- permissive environment for GMOs R&D
- better capacity for GM R&D from local & donor sources
- work comfortably with private technology providers
- Commercialized or have active active research
Africa countries divided…
2. Countries with stringent regulations: European model
e.g. Ethiopia, Zambia, Tanzania & Malawi
- stringent interpretation of Precautionary Principle
- strict liablity and/or insurance clauses
- broad socioeconomic issues in the agenda
- focus GM monitoring & risk assessment capacity, not R&D
- no favorable climate for research adoption or PPP
Status of GMO research and adoption in Africa
• 4 countries commercialized
• 8 countries confined field trials
• ca 14 countries contained experiments
• laws
Initiatives at African/Regional level:
- AU Initiatives
– High level Panel on Biotechnology
– NEPAD – e.g. Regional Hubs, ABNE, etc.
– African strategy on Biosafety
e.g. African Model Law on safety in Biotechnology
- REC Initiatives for biosafety harmonization
SADC
COMESA
ECOWAS
• Polarization still evident
To summarize:
• Africa “main beneficiaries” or the “main losers”.
• Deficiency of scientific, technical, regulatory resources
• Deep divergence in regulatory approaches
• External influences shape its GMO policies
• Africa divided, confused in what policy to adopt
• Failed to meet the unique needs & interests regarding
GMOs
Way Forward for Africa
• Invest in Capacity Development of GM R&D:
- develop & adopt useful GM technology
- assess risk & benefits and adopt
• Harmonization to enable sharing resources
regionally, gov’ts depts, regionally & African level
• Adopt policies balancing risk minimisation, cost and need
to promote useful GM technologies
• Weigh risks of not adopting the technology
(competitiveness, illegal import, env’tal benefits)
Ways Forward...
• Independent judgement, urge donors to respect
national priorities
• Strengthen Inter-African & South-South Collaboration
• Academia as credible source of information