1. Keller and Heckman LLP Market Access and Trade Barriers and Practices: The Role of the Precautionary Principle and Other Non-Scientific Factors in Regulating Foods Derived from Biotechnology by Mark Mansour

2. Overview l Emergence of the Precautionary Principle l The Misapplication of the Precautionary Principle l The Route to the WTO l Cartagena Protocol on Biosafety l Codex Committee on General Principles l The Sanitary and Phytosanitary Agreement l Costs to the Codex Process and International Trade

3. The Emergence of the Precautionary Principle l 1970s: decision-making tool for environmental risk managers in Europe. l More recent insertion in environmental regulatory schemes, and legislation (e.g., Canada). l Precaution can be appropriate in risk assessment and management if applied so as to not needlessly deprive whole populations of potential improvements in health and environmental quality.

4. The Misapplication of the Precautionary Principle l Use of precaution in risk analysis vs. the precautionary principle. l Article 5.7 of the Sanitary and Phytosanitary (SPS) Agreement provides for the use of precaution, but specifies that where scientific evidence is “insufficient” to establish safety, provisional measures may be adopted. l Principle 15 of the Rio Declaration on Development and the Environment states that “lack of full scientific certainty” shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.

5. The Misapplication of the Precautionary Principle (Cont’d) l EU Communication on Precautionary Principle (Feb. 2000) combined statements from SPS Agreement and Rio declaration on environmental risks and inappropriately applied the concept of “lack of full scientific certainty” to food safety policy. l Food safety risks, unlike environmental concerns, are more minimal in scope and not persistent in duration. Proper scientific evaluation is appropriate and feasible. l Vague definition of the Principle – lends itself to trade disputes over non-scientific criteria.

6. The Route to the World Trade Organization (WTO) The Cartagena Protocol on Biosafety - negotiated in Jan. 2000 - first evidence of precautionary principle’s leap from environmental risk assessment to food safety regulation - establishes the precautionary principle as a component of current international covenant for living modified organisms (LMOs) - sets precedent for application of precautionary principle to international policy on products derived from genetically modified organisms (GMOs) and puts pressure on other organizations to set standards for GMOs

7. The Route to the WTO (Cont’d) The Codex Committee on General Principles - Current debate over inclusion of precautionary principle in its Working Principles for Risk Analysis - application of precaution in risk management - criteria to ensure consistency in decision process

8. The Route to the WTO Codex Committee on GP (Cont’d) Criteria (examples) - Application of precaution where “there is evidence to suggest that a risk exists but the cause or extent of any negative effects are unknown due to gaps or uncertainty in the available scientific data” - Decisions taken under the risk analysis be “the least trade restrictive necessary to achieve protection of the health of consumers” Problems: ambiguous, novel technologies are particularly susceptible, can be used to restrict trade in biotech products when a scientific-based rationale for doing so is not available

9. The SPS Agreement l Inclusion of the precautionary principle in Codex standards and guidelines raises concerns about interpretation of WTO agreements to resolve trade disputes. l 1994 Dispute Settlement Understanding (DSU) relies on international laws, including references to Codex standards and guidelines. l SPS indicates that standards and guidelines of relevant international organizations are to be utilized in the application or risk assessment techniques.

10. Costs to the Codex Process and International Trade l The Codex Alimentarius Commission has determined its standards and guidelines must be based on (1) sound science, and (2) other legitimate factors relevant to the protection of health and fair trade practices, where appropriate. l Precautionary principle does not meet these criteria – distinction between “hazards” and “risks”.

11. Costs to the Codex Process and International Trade (Cont’d) l Mission of the Codex Alimentarius: 1.Consumer health/ food safety 2.Establish a framework by which the WTO can settle disputes over trade in food l Reliance on proper scientific risk assessment, with a recognition that science by its very nature cannot ensure certainty, is paramount. l Countries engaged in international trade should support the use of sound science in developing cost-effective, risk-based precautionary measures that protect human health and the environment and allow for access to technological innovation in food science that can benefit the global community. l Cost-benefit analyses are not only appropriate, but necessary