Risk assessment practice in the context of legislation and guidelines Armin Spök

1. Risk assessment practice in the context of legislation and guidelines Armin Spök Inter-University Research Centre for Technology, Work and Culture (IFF/IFZ)Graz Presentation held at the Workshop “Scrutinizing GMO Risk Assessment” Vienna, 10 December 2003

2. Questions that will be dealt with • What was the regulatory context of the investigated dossiers? • What’s about the major changes in the regulatory context? • Is everything settled now? - Putting the project results into a changing context • Overall Conclusions spoek@ifz.tugraz.at

3. What was the regulatory context of the dossiers? spoek@ifz.tugraz.at

4. EU Regulatory Context of Directive 90/220 Dossiers investigated Novel Food Regulation SCP Guidance spoek@ifz.tugraz.at

5. EU Regulatory Context of Novel Food Dossiers investigated Novel Food Regulation SCF Guidance SSC Opinion spoek@ifz.tugraz.at

6. What’s about the major changes in the regulatory context? spoek@ifz.tugraz.at

7. EU Regulatory Context: Summary • For the dossiers investigated • Directive 90/220/ECC (Directives 94/15/EC, 97/35/EC, Decision 92/146/EEC, Guidance Notes), SCP Guidance (1998) • Novel Food Regulation, SCF Guidance (97/618/EC) • Present/upcoming context • Directive 2001/18/EC (Decision 2002/811/EC), SSC Guidance (2003) • Novel Food Regulation (Regulation 1829/2003), SSC Guidance (2003) SSC Guidance was not completed before March 2003 spoek@ifz.tugraz.at

8. Given these changes in legislation and on top of that the new Guidance Document – Is everything settled now ? • Not at all! spoek@ifz.tugraz.at

9. Comparing the Project Proposals to the SSC Guidance • Some suggestions are already included in the SSC Guidance • E.g. stand-alone dossiers • Some are partly considered • E.g. GLP demanded for toxicity testing only • Some points are simply reiterating prior suggestions • E.g. Homology studies are still encouraged – without any qualification or specification • Others are still ambiguous • E.g. toxicity testing requirements • Others are contrasting prior recommendations • E.g. in-vitro digestibility studies spoek@ifz.tugraz.at

10. Comparing the Project Recommendations to those of the SSC Guidance • SSC says... • - 28 d sub-acute, repeated dose • Disregards acute toxicity tests • - still ambiguous if toxicity tests will be required in any case • We say... • - subchronic, repeated dose tests • in any case • Toxicity testing requirements (new proteins) • In-vitro digestibility studies (new proteins) SSC says... - in-vitro studies required We urge for... - further research & clarification spoek@ifz.tugraz.at

11. Toxicity testing requirements: Overview spoek@ifz.tugraz.at

12. In-Vivo vs. In-Vitro Digestibility Studies: Summary • In-vivo digestibility studies required: yes, yes but..., probably, rather not, not at all… • “ The use of in vitro simulation of gastric and intestinal digestion of the gene product should be considered supplementary to in-vivo experiments… “ (SCP 1998) • Disregarded digestibility for toxicity studies in general (SSC 2000) • In-vitro studies criticised (OECD 2000) • In-vitro studies suggested (FAO/WHO 2001, SSC 2003) spoek@ifz.tugraz.at

13. Overall Conclusions spoek@ifz.tugraz.at

14. Overall Conclusion 1 • The study clearly shows differences in risk assessment between dossiers • Particular differences occur because of lack of detailed guidance • They might affect the level of safety provided • Points to a need to • Standardize/harmonize risk assessment requirements where there is a scientific consensus • Clarify or at least pursue research where there is no scientific consensus and agree on interim requirements spoek@ifz.tugraz.at

15. Overall Conclusions 2 • The study also shows possible shortcomings in risk assessment practice • Practice seems to be sometimes not in line • with state of the art knowledge • with standards of risk assessment practice in other regulatory contexts • Points to a need of a debate on possible improvements • The recommendations presented can be seen as an input to both to standardize and to improve risk assessment spoek@ifz.tugraz.at

16. Overall Conclusions 3 • The recommendations point to a level of detail that also applies despite the changed regulatory contexts • Some recommendations are even strengthened by the more explicit precautionary approach laid down in directives and regulations • The recommendations are only partly precluded by the SSC Guidance • Many details and more fundamental questions remain to be dealt with spoek@ifz.tugraz.at

17. Thank you for your attention! spoek@ifz.tugraz.at