Title: The Impact of Two Divergent GMO Regulation Approaches on Modern Biotechnology Innovation and Development in Africa
1The 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
3Genetic 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
5James, 2012
6Potential 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
7The 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
8International 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?
9Other 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
11Main 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
12The 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)
14USA- 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
16Criticisms 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
17Effect of Regulatory approaches on GMO approval
in three developed economies
18Which 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
19GM 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
20Challenges 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
21GMOs 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
27Africa 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
28Africa 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
29Status of GMO research and adoption in Africa
- 4 countries commercialized
- 8 countries confined field trials
- ca 14 countries contained experiments
- laws
30Initiatives 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
31To 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
32Way 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) -
33Ways Forward...
- Independent judgement, urge donors to respect
national priorities - Strengthen Inter-African South-South
Collaboration - Academia as credible source of information
34Thank You!!!