1. Codex Science-based Approach to the Safety of Foods Derived from Modern Biotechnology James H. Maryanski, Ph.D. Food and Drug Administration Center for Food Safety and Applied Nutrition Department of Health & Human Services

2. Codex Alimentarius Commission Established in 1962 by the United Nations’ World Health Organization and the Food and Agriculture Organization Codex is a collection of internationally adopted food standards that protect consumers’ health and ensure fair practices in the food trade

3. Ad Hoc Intergovernmental Task Force: Foods Derived from Modern Biotechnology Established by CAC 4 years – 1999-2003 Host - Japan, MHLW Meetings March 2000, 2001, 2002, & 2003

4. Task Force Terms of Reference “ Consideration of the Elaboration of Standards, Guidelines, or Other Principles for Foods Derived from Biotechnology”

5. New Codex Guidelines Principles for Risk Analysis Guideline for Safety Assessment of Foods Derived from rDNA Plants Guideline for Safety Assessment of Foods Produced Using rDNA Microorganisms Source: www.codexalimentarius.net

6. Codex Principles for Risk Analysis Risk Assessment –Safety Assessment (Hazard identification) Risk Management Risk Communication

7. Safety Assessment Within the Risk Assessment Framework Substantial Equivalence: –Comparison: New Food v. Counterpart –Identify Differences –Evaluate safety –Intended & Unintended Effects Considered If Hazard Identified, Risk to Health Assessed

8. Definitions Modern Biotechnology (Cartegena Biosafety Protocol) – in vitro nucleic acid techniques, including rDNA… Recombinant-DNA Plant - changed through in vitro nucleic acid techniques (rDNA) & direct injection of cells Conventional Counterpart – related organism/component…safety based on common use as food.

9. Food Safety Assessment Description of rDNA plant Description of the host plant & use as food Description of the donor organism(s) Description of the genetic modification Characterization of the genetic modification Safety assessment……

10. Safety Assessment, cont’d Expressed substances (non-nucleic acid) Annex- Possible allergenicity Compositional analyses (key components) Evaluation of metabolites Food processing Nutritional modification Other considerations (e.g. marker genes)

11. Description of the Genetic Modification The transformation process/host plant –Specific method (Agrobacterium-mediated) –Source, identity, function of DNA –Intermediate hosts The DNA to be introduced All genetic components (genes, markers, regulatory sequences, etc.) Size, identity; location/orientation; function

12. Characterization of the Genetic Modification/DNA Insertion Number of sites & organization; copy number & sequence data of insert & surrounding region, sufficient to identify expressed substances, or analysis of transcripts or expression products that may be present in food. Open reading frames & insertions with contiguous plant DNA (fusion proteins)

13. Characterization of the Genetic Modification/ Expressed Substances Gene products, including un-translated RNA Function & phenotype Level & site of expression; level of metabolites in food Amount of target gene product, if function is to alter endogenous mRNA or protein

14. Genetic Modification Additional Information Arrangement of genetic material Whether modifications to protein sequence affect post-translation/function Intended effect & heritable stability Expression in appropriate tissues & any evidence that host plant is affected Identity & expression of any fusion protein

15. Goals of Safety Assessment Food will not cause harm based on its intended use New food is as safe as its conventional counterpart Account for dietary impact of any nutritional changes Risk managers can determine if any special measures are needed