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FDA and EPA No mandatory risk assessment In 2001 FDA proposed – rules on pre-market notice for bioengineered foods – draft Guidance for voluntary labelling Labelling initiatives in the US Congress and at State level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?