the impact of two divergent gmo regulation approaches on modern biotechnology innovation and...

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

• is a highly contested and debated technology worldwide

= due to perceived risk on environment and human health

• most rapidly-adopted agricultural technology

= due to its huge demonstrated & potential benefits

Genetic Modification (GM) Technology is a controvercial Technology in agriculture:

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

Hence, GMOs are highly regulated products that are handled, tested, transferred and traded in compliance with certain regulations.

= Biosafety regulations

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

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‖

WTO Agreements:

- Sanitary &Phytosanitary (SPS) measures - Technical Barriers of Trade (TBT)

- Trade Related Aspects of Intellectual Property Rights (TRIPs)

Other International Instruments

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

Two opposing approaches for GMO regulation

• Whether GM technology is inherently safe or unsafe

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

Issues raised European approach USA approachGMO & 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 adequateLabeling Mandatory labeling Not required, voluntaryInternationally endorsed by

Cartagena Protocol, CBD OECD, FAO/WHO, Codex

Main differences in European (Precautionary) & US (Substantial Equivalence) approaches of regulation

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

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)

2) Food and Drug Administration:- regulates GMO for food and feeds use in the market

1) The U.S. Department of Agriculture:- regulates transgenic plants with plant pest components (e.g. Bt)

3) The Environmental Protection Agency: - pesticides in transgenic plants prior to marketing

USA- Coordinated Framework for Regulation of Biotechnology, 1986

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

• 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

Which regulatory approach is better?

• 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

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• Use of improved inputs e.g. seeds, fertilizers, pest control

• GM technology, not well adopted in Africa

GM technology & African Agriculture

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

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

Africa countries divided…

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

• 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

To summarize:

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)

• Independent judgement, urge donors to respect national priorities

• Strengthen Inter-African & South-South Collaboration

• Academia as credible source of information

Ways Forward...