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Domestic Import Regulations for GMOs and their Compatibility with

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									  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
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
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
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    –   draft Guidance for voluntary labelling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
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
A labelling example
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)
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)
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
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)
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
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
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)
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?
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?
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?
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?
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?

								
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