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. NicksonEcological Technology CenterMonsanto Company

October 26, 2005 T E Nickson 2

Agenda

Background information Key Assumptions Proposed process Summary

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10 Years of Plant Biotechnology

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canolacottoncornsoy

M. A

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Source: ISAAA (International Service for the Acquisition of Agri-Biotech Applications)

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

October 26, 2005 T E Nickson 4

October 26, 2005 T E Nickson 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)

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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.

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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

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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”

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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

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Proposed Tier I LMO-FFP Decision TreeIs there

information in the BCH

supplied by a party taking a

decision according to Article 11.1?

Do the data in the BCH show the LMO to be

familiar compared to

the conventional

crop?

Is there local experience with importation for processing a conventional form of the

LMO?

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?

Minimal or acceptable risk;

no additional information needed

Refine risk assessment using higher

tiered approach described in

ISPM 11.

No

YesYes Yes

Yes

No No

If answer is “no” or “uncertain”,

proceed to Tier II.

Request information

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Proposed Tier II 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?

Can evidence be collected in a

focused experiment

demonstrating no change?

Can Risk Management adequately

address the risk concerns?

Minimal or acceptable risk;

no additional information needed

Refine risk assessment using

higher tiered approach described

in ISPM 11.

No No

Yes

No

Yes

A conclusion of minimal or acceptable risk with no additional information needed should enable a

decision/approval.

October 26, 2005 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