Risk assessment practice in the context of

legislation and guidelines

Armin SpökInter-University Research Centre

for Technology, Work and Culture (IFF/IFZ)Graz

Presentation held at the Workshop “Scrutinizing GMO Risk Assessment”

Vienna, 10 December 2003

spoek@ifz.tugraz.at

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

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What was the regulatory context of the dossiers?

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EU Regulatory Context of Directive 90/220 Dossiers investigated

1995 1996 1997 1998 Status Intended useRape Topas 19/2 approved Cultivation, food, feed

(cultivation not appr.)

Potato EH92-527-1 pending Cultivation, feed, fertilizer, technical application

Bt-cotton 531 pending Cultivation, feed

Maize Bt11 approved Import, food, feed

Maize Bt11 pending Cultivation

RR-maize GA21 withdrawn Import, feed

RR-fodder beet A5/15

pending Cultivation, feed, seed production

RR-cotton 1445 pending Cultivation, feed

Carnation 66 approved Cultivation, cut flowers

Carnation 959A etc

approved Cultivation, cut flowers

RR-maize GA21 pending Cultivation, feed

SCP Guidance

Novel FoodRegulation

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EU Regulatory Context of Novel Food Dossiers investigated

1995 and before

1996 1997 1998 1999 2001 Status

Maize GA21 pendingSoybean 260-05 pending

Sweet maize Bt11 pendingMaize NK603 pendingMaize 1507 pending

(to ACNFP) Rape MS1xRF1, MS1xRF2 approved(to ACNFP) Rape Topas 19/2 approved(to ACNFP) Rape GT73 approved

(to ACNFP) Maize T25 approved(to ACNFP) Maize MON810 approved(to ACNFP) Maize Bt11 approved(to ACNFP) Maize MON809 approved

Novel FoodRegulation

SCF Guidance

SSC Opinion

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What’s about the major changes in the regulatory context?

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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

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Given these changes in legislation and on top of that the new Guidance Document – Is everything settled now ?

Not at all!

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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

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Comparing the Project Recommendations to those of the SSC Guidance Toxicity testing requirements (new proteins)

In-vitro digestibility studies (new proteins)

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

SSC says...

- in-vitro studies required

We urge for...

- further research & clarification

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Toxicity testing requirements: OverviewSource Requirements (new proteins)

SCF (1997) Not specified

SCP (1998) Not specified

In practice (90/220/EEC) 14 day acute toxicity, single dose

In practice (Novel Food) 14 day acute toxicity, single dose

SSC (2003) 28 day repeated dose (not standard)

EuropaBio (2003) Acute toxicity

NL Biosafety Council (2003) 28 day acute toxicity, repeated dose

Royal Society (Canada) 90 day, sub-chronic, repeated dose

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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)

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Overall Conclusions

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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

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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

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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

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Thank you for your attention!