Thomas E. Nickson Ecological Technology Center Monsanto Company

1. A Proposed Process to Initiate Environmental Risk Assessment of Living Modified Organisms Intended for Direct Use as Food and Feed or for Processing (LMO-FFPs) Thomas E. Nickson Ecological Technology Center Monsanto Company

2. Agenda • Background information • Key Assumptions • Proposed process • Summary T E Nickson

3. 10 Years of Plant Biotechnology • In 2005, farmers around the world will harvest biotech crops for the 10th year • 10 years of commercial experience on over 1 billion acres: • Proven economic and environmental benefits • Solid record of safety • Promising future benefits from new products canola cotton corn soy M. Ac. Source: ISAAA (International Service for the Acquisition of Agri-Biotech Applications) T E Nickson

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5. Need for a Scientifically Proportionate and Thorough Approach to ERA of Plant-based LMO-FFPs • International trade of grain • Corn and soybean, much of which is LMO by definition in the Biosafety Protocol (BSP), is being traded globally • International oversight of LMO-FFPs • Cartagena Protocol for Biosafety (Biosafety Protocol) • Risk assessment according to Annex III • International Plant Protection Convention (IPPC) • Adopted a phytosanitary standard for LMOs (ISPM 11) T E Nickson

6. Biosafety Protocol (BSP) • Article 11 applies to the first transboundary movement of an LMO-FFP • Article 11.4 – allows countries to approve a LMO-FFP using existing regulations that are consistent with the BSP • Article 11.6 – allows parties without regulatory systems to take risk assessment decisions on LMO-FFPs according to Annex III • Article 14.4 applies to Parties determining that their domestic regulations will apply to specific imports • Article 14.4 – requires that Parties are notified through the Biosafety Clearing House of these decisions. T E Nickson

7. International Plant Protection Convention (IPPC) • Established to encourage international co-operation in preventing the introduction and spread of pests of plants and promoting measures of control. • Countries choosing to use phytosanitary measures can use ISPMs or locally developed measures that are consistent with the ISPMs • Elaborated international standards for sanitary and phytosanitary measures (ISPMs) applicable to LMO-FFPs • ISPM 2 – describes a pest risk assessment process for pests of phytosanitary concern • ISPM 11 – describes a pest risk assessment process specifically for LMOs of potential phytosanitary concern T E Nickson

8. ISPM 11 - Pest Risk Analysis for Quarantine Pests, Including Analysis of Environmental Risks and Living Modified Organisms • Broad scope includes direct and indirect effects • 3 step, tiered process • Initiation • Taking a decision concerning the pest potential of a LMO-FFP • Pest risk assessment (PRA) • Pest risk management • “manage risk to achieve the required degree of safety that can be justified and is feasible within the limits of available options and resources” T E Nickson

9. Risk Assessment Principles for LMO-FFPs • Data requirements should be proportionate to the potential risks • Reduced environmental exposure results in lower potential risks for LMO-FFPs (?) • Initial assessment should be based on information from the country(ies) of production • ERA for production must be acceptable under Annex III • ERA principles and methodology are defined in Annex III • Experience with conventional crop/grain is the comparator • Experience with importing grain provides a baseline T E Nickson

10. Proposed Tier I LMO-FFP Decision Tree Is there evidence to show that the trait will not change the ability of the LMO-FFP to establish and spread compared to conventional grain? Do the data in the BCH show the LMO to be familiar compared to the conventional crop? Is there information in the BCH supplied by a party taking a decision according to Article 11.1? Is there local experience with importation for processing a conventional form of the LMO? Yes Yes Yes No No No Yes Refine risk assessment using higher tiered approach described in ISPM 11. Request information Minimal or acceptable risk; no additional information needed If answer is “no” or “uncertain”, proceed to Tier II. T E Nickson

11. Proposed Tier II LMO-FFP Decision Tree Minimal or acceptable risk; no additional information needed Is there evidence to show that the trait will not change the ability of the LMO-FFP to establish and spread compared to conventional grain? Yes Yes Can Risk Management adequately address the risk concerns? Can evidence be collected in a focused experiment demonstrating no change? No No Refine risk assessment using higher tiered approach described in ISPM 11. No A conclusion of minimal or acceptable risk with no additional information needed should enable a decision/approval. T E Nickson

12. LMO-FFP ERA Summary • International trade of commodity LMO-derived grain is currently vulnerable to disruption • LMO-FFPs may require environmental risk assessment based on local interpretation of either the BSP or IPPC • Annex III (BSP) and ISPM 11 could be harmonized based on common principles. • A decision tree consistent with the principles outlined in the BSP and ISPM 11 is proposed • Built upon existing information, experience with the conventional grain, expert opinion, and scientific principles • Provides flexibility to manage to a standard of safety without prescribing potentially excessive requirements T E Nickson