Domestic Import Regulations for GMOs and their Compatibility with WTO Rules: Some Key Issues

1. Domestic Import Regulations for GMOs and their Compatibility with WTO Rules:Some Key Issues Heike Baumüller ICTSD Trade and Development Symposium 11-12 September 2003, Cancun, Mexico

2. Overview • Outline of various import regulations for GMOs • EU, US, Australia • regional trends in Latin America, Asia and Africa • Relevant WTO agreements and how they apply • The role of precaution • Cartagena Protocol on Biosafety

3. European Union • Approval for environmental release:revised Council Directive 2001/18/EC– entered into force on 17 October 2002 • GM foods: Regulation (EC) 258/97 on novel foods and novel food ingredients • Labelling and traceability: new rules for GM food/feed adopted in July 2002 • “One door, one key” procedure • Labelling of GM feed • No exceptions for substantially equivalent GM food or feed • Threshold for accidental presence of unapproved GMOs

4. United States • Regulated under existing legislation and implemented by USDA, FDA and EPA • No mandatory risk assessment • In 2001 FDA proposed • rules on pre-market notice for bioengineered foods • draft Guidance for voluntary labelling • Labelling initiatives in the US Congress and at State level

5. Australia / New Zealand • Approval for environmental release:Gene Technology Regulator under the Gene Technology Act (2000) • Labelling of GM foods: Standard A18 Foods Produced using Gene Technology (1999) – entered into force in December 2001 • Amended in 2000 to include mandatory labelling for GM foods (entered into force in December 2001) • Exemption: highly refined foods • New Zealand: Hazardous Substances and New Organisms Act 1996, moratorium on approvals until 31 October 2003

6. A labelling example

7. Latin America • Significant difference in status of regulations and use of GMOs, e.g. • Argentina: well-developed legislation, widespread use of GMOs • Brazil: regulatory framework (labelling), but no (approved) commercial release of GMOs • Mexico: labelling pending, concerns over GM maize • Bolivia: temporary ban (revoked in October 2001)

8. Asia • Growing use of import regulations, highly controversial in some countries, e.g. • China: complex rules for imports, safety assessment and labelling, entry into force postponed three times • India: recently approved Bt cotton, strong consumer resistance • Japan, Korea: labelling requirements • Philippines: permits required for certain GM foods after 1 July 2003, strong consumer resistance • Thailand, Sri Lanka: import restrictions for certain GM foods (later revoked in Sri Lanka)

9. Africa • Very limited import regulations and approval of GMOs, concerns over GM food aid, e.g. • South Africa: permits required for imports, labelling pending, only country to approve commercial release of GMOs • Zimbabwe: rules for research and field testing, no labelling • Regional initiatives: OAU Model Law, SADC, COMESA, NEPAD

10. Relevant WTO Agreements • Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) • Agreement on Technical Barriers to Trade (TBT) • General Agreement on Tariffs and Trade (GATT)

11. SPS Agreement • Ensure that SPS measures do not represent unnecessary, arbitrary, scientifically unjustifiable or disguised restrictions on international trade • Measures must be based on international standards or risk assessment • Article 5.7: precaution • GMOs: measures aimed at protecting against foods safety risks or damage by pest, e.g. • Regulation concerning toxic substances • Environment-related measures aimed at pest risks

12. TBT Agreement • Applies to technical regulations and standards • Measures should not be more trade-restrictive than required to achieve a “legitimate objective” • Does not allow discrimination between “like” products • SPS measures explicitly excluded • GMOs: labelling and other import regulations, e.g. • Measures related to nutritional value of food • Non-pest related environmental concerns

13. GATT • Deals with trade in goods • Article XX exceptions: • protect public morals(a) • protect human, animal or plant life or health (b) • conserve exhaustible natural resources (g)

14. Some questions… • Are mandatory labelling and traceability requirements unnecessarily trade-restrictive? • Are import regulations covering substantially equivalent GM products trade-discriminatory? • Could a ban on imports of GMOs be justified as a precautionary measure? • How might the Cartagena Protocol on Biosafety impact on possible WTO disputes related to GMO import regulations?

15. Some questions… • Are mandatory labelling and traceability requirements unnecessarily trade-restrictive? • Are import regulations covering substantially equivalent GM products trade-discriminatory? • Could a ban on imports of GMOs be justified as a precautionary measure? • How might the Cartagena Protocol on Biosafety impact on possible WTO disputes related to GMO import regulations?

16. Some questions… • Are mandatory labelling and traceability requirements unnecessarily trade-restrictive? • Are import regulations covering substantially equivalent GM products trade-discriminatory? • Could a ban on imports of GMOs be justified as a precautionary measure? • How might the Cartagena Protocol on Biosafety impact on possible WTO disputes related to GMO import regulations?

17. Some questions… • Are mandatory labelling and traceability requirements unnecessarily trade-restrictive? • Are import regulations covering substantially equivalent GM products trade-discriminatory? • Could a ban on imports of GMOs be justified as a precautionary measure? • How might the Cartagena Protocol on Biosafety impact on possible WTO disputes related to GMO import regulations?

18. Some questions… • Are mandatory labelling and traceability requirements unnecessarily trade-restrictive? • Are import regulations covering substantially equivalent GM products trade-discriminatory? • Could a ban on imports of GMOs be justified as a precautionary measure? • How might the Cartagena Protocol on Biosafety impact on possible WTO disputes related to GMO import regulations?