2. Regulatory Procedure for the Assessment of GM Foods

3. Traditional Views of Food Safety Õ Historically, our beliefs about the safety of foods have been based almost entirely on tradition and cultural experience Õ In practice, very few of the foods we eat today have been subject to any toxicological studies and yet they are genetically accepted as safe ÕEven foods that contain toxins or anti-nutrients have been considered safe through a long history of use

4. What’s Changed? ä Genetically modified (GM) foods Õ Scrutinized by scientists, regulators and the public Õ Subject to unprecedented regulatory oversight Õ Have caused us to rethink our traditional views of food safety Õ Definition of “safe”  Approaches to systematically evaluating safety

5. FOOD SAFETY FOOD SAFETY, involves all those hazards, whether chronic or acute, that may make the food injurious to the health of consumers. IT IS NOT NEGOTIABLE (FAO 2003)

6. Can Safety be Proven? ÕIt is impossible to prove that something is safe Õ “Zero” risk and “Absolute” safety are impossible to achieve in the food system

7. GM Foods- Safety Review  Takes around 10-14 years: Laboratory research Contained greenhouse evaluation Contained small scale field trials Pre-commercial testing Commercial release

8. Key Initiatives Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology  General Principles for the Risk Analysis of Foods Derived from Recombinant DNA Plants  Guidelines for the Conduct of Safety Assessment of Foods Derived from Recombinant DNA plants and Microorganisms

9. The Comparative Approach Õ Based on the principle that you can compare a GM food with a counterpart having a history of safe use  Comparison can include an evaluation of the same risk factors established for the counterpart  This approach is commonly referred to as the “Substantial Equivalence” approach

10. Goals of Substantial Equivalence Õ To structure the safety assessment relative to the counterpart food Õ To identify intended or unintended differences on which further safety assessment should focus Õ To determine “…as safe as…”

11. Substantial Equivalence is not... Õ A safety assessment in itself Õ A characterization of the hazard Õ An endpoint in the risk assessment process

12. Limitations of Substantial Equivalence Õ Availability of a counterpart ÕAvailability of data on agronomic / compositional properties ÕAvailability of data on natural variations ÕAvailability of analytical methods

13. Codex Guidelines for Foods Derived from Recombinant DNA Microorganisms The Safety assessment of a food produced using a recombinant DNA microorganism follows a stepwise process of addressing relevant factors, including: Õ Description of the rDNA microorganism ÕDescription of recipient microorganism and its use in food production ÕDescription of donor organism ÕDescription of the genetic modification(s) including vector and construct ÕCharacterisation of the genetic modification(s)

14. Codex Guidelines for Foods Derived from Recombinant DNA Microorganisms Õ Safety assessment: -Expressed substances: assessment of potential toxicity and other traits related to pathogenicity; -Compositional analyses of key components; -Evaluation of metabolites; -Effects of food processing; -Assessment of immunological effects; allergenicity -Assessment of viability and residence of microorganisms in the human GI tract -Anitibiotic resistance and gene transfer -Nutritional modification

15. International Consensus Õ Even considering its limitations, the concept of substantial equivalence as a tool to help regulators structure the safety assessment process has been reaffirmed on numerous occasions internationally Õ There are no alternative strategies that provide a better assurance of safety (WHO/FAO Joint Expert Consultation, 2000) Õ ‘some form of substantial equivalence, starting with a direct comparison of the novel foodstuffs with their unmodified counterparts, appears to be the only practical solution’

16. The goal of each safety assessment is to provide assurance, in the light of the best available scientific knowledge that the food does not cause harm when prepares, used and/or eaten according to its intended use.

17. Questions that need to be answered ÕIs the transferred DNA safe to consume? ÕIf an antibiotic resistance marker is used, is it safe? ÕAre the newly produced proteins safe to consume? ÕHave potential allergens been introduced into the food? ÕAre the composition and nutritional value changed?

18. Questions that need to be answered ÕAre there changes in the content of important substances? ÕIn what forms will the food or food products isolated from it be consumed? ÕDo the newly introduced substances survive processing, shipment, storage and preparation? ÕWhat is the expected human dietary exposure?

19. BAFPS Framework on Food Safety Assessment of GM Foods  Sound scientific evidence  Pursued in accordance with recognized risk assessment guidelines and appropriate sampling techniques  Carried out in a transparent manner  Evaluation shall consider the safety of its conventional counterparts  Shall take into account the history of safe use as food source from the importing country

20. BAFPS Assessment of GM Foods  Focused on Horizontal Gene transfer Safe use of Antibiotic Resistance Marker Gene Nutritional Composition Possible allergenicity Unintended effects

21. General Approach to Biosafety AgricultureHealth Environment Guidelines

22. Summary Õ Important components of GM regulation Õ Guidelines – risk assessment, management Õ Legislation – GM process, GM products

23.  Periodic re-evaluation of Guidelines and implementation procedures give the applicants, reviewers, administrators, regulators and the public an opportunity to assess how well the system is working

24. THANK YOU!