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The Impact of Two Divergent GMO Regulation Approaches on Modern Biotechnology Innovation and Development in Africa

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Title: The Impact of Two Divergent GMO Regulation Approaches on Modern Biotechnology Innovation and Development in Africa


1
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)
2
  • 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

3
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

4
  • 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

5
James, 2012
6
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
    knowlge

7
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
8
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?
9
Other International Instruments
  • WTO Agreements
  • - Sanitary Phytosanitary (SPS) measures
  • - Technical Barriers of Trade (TBT)
  • Trade Related Aspects of Intellectual Property
    Rights (TRIPs)

10
  • Two opposing approaches for GMO regulation
  • Whether GM technology is inherently safe or
    unsafe
  • 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

11
Main differences in European (Precautionary) US
(Substantial Equivalence) approaches of regulation
Issues raised European approach USA approach
GMO risk perception present new risk potentially dangerous No new risks, beneficial once passed safety tests
GMO Safety Unsafe unless proven safe Safe unless proven unsafe
Regulatory focus Risk avoidance, absolute safety Favor safe GM innovation adoption
Basis of regulation Process (technology) Product (trait)
Legisilation New laws regulations Exisitng laws adequate
Labeling Mandatory labeling Not required, voluntary
Internationally endorsed by Cartagena Protocol, CBD OECD, FAO/WHO, Codex
12
The major factors d the driving the difference in
European US approaches of GMO regulations
Factors Europe USA
Public Opinion Anti-GMO, distrust of regulators, natural food, Past food scandals Trust regulators, no past scandals, less aware concerned
Dominant Interest groups Anti-GMO NGOs, farmers, consumers media Pro-GMO businesses, groups, farmers consumers
Economic interest No much gain expected for businesses, farmers or consumers Export trade, use, so Favorable condition for GMO use
Regulatory decisions Consider scientific evidence public opinion Independent, stronger focus on scientific evidence
Political influence Green parties have significant power No such parties minimal influence
13
  • 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)

14
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

15
  • 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

16
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

17
Effect of Regulatory approaches on GMO approval
in three developed economies
18
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

19
GM technology African Agriculture
  • 30-50 GDP, gt60 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

191
20
Challenges for GM technology in Africa
  • Inadequate fund for RD (lt0.5 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

21
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

22
  • 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 RD

23
  • 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

24
  • European donor funds in biotechnology
  • mostly on biosafety risk avoidance, not on GMO
    RD
  • 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

25
  • 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

26
  • US sources promote GM RD 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

27
Africa countries pulled in opposite direction
divided
  • Countries with favorable GMO climate - (GM
    adopters)
  • South Africa, Ghana, Burkina Faso, Kenya,
    Uganda, Egypt Nigeria
  • permissive environment for GMOs RD
  • better capacity for GM RD from local donor
    sources
  • work comfortably with private technology
    providers
  • Commercialized or have active active research

28
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 RD
  • no favorable climate for research adoption or
    PPP

29
Status of GMO research and adoption in Africa
  • 4 countries commercialized
  • 8 countries confined field trials
  • ca 14 countries contained experiments
  • laws

30
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

31
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

32
Way Forward for Africa
  • Invest in Capacity Development of GM RD
  • - develop adopt useful GM technology
  • - assess risk benefits and adopt
  • Harmonization to enable sharing resources
  • regionally, govts 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, envtal
    benefits)

33
Ways Forward...
  • Independent judgement, urge donors to respect
    national priorities
  • Strengthen Inter-African South-South
    Collaboration
  • Academia as credible source of information

34
Thank You!!!
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