Transcript Aktuelle Entwicklungen auf EU Ebene

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
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
Rape Topas 19/2
Status
approved
Intended use
Potato EH92-527-1
pending
Bt-cotton 531
pending
Cultivation, food, feed
(cultivation not appr.)
Cultivation, feed,
fertilizer, technical
application
Cultivation, feed
approved
Import, food, feed
pending
Cultivation
withdrawn
Import, feed
RR-fodder beet
A5/15
RR-cotton 1445
pending
Cultivation, feed, seed
production
Cultivation, feed
Carnation 66
approved
Carnation 959A
etc
approved
Maize Bt11
Novel Food
Regulation
Maize Bt11
RR-maize GA21
SCP
Guidance
pending
RR-maize GA21 pending
Cultivation, cut
flowers
Cultivation, cut
flowers
Cultivation, feed
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EU Regulatory Context of Novel Food Dossiers
investigated
1995 and
before
1996
1997
Novel Food
Regulation
(to ACNFP)
(to ACNFP)
(to ACNFP)
(to ACNFP)
(to ACNFP)
(to ACNFP)
(to ACNFP)
1998
2001
Maize GA21
Soybean 260-05
Rape MS1xRF1, MS1xRF2
Rape Topas 19/2
Rape GT73
Maize T25
Maize MON810
Maize Bt11
Maize MON809
SCF
Guidance
1999
Sweet maize Bt11
Maize NK603
Maize 1507
SSC
Opinion
Status
pending
pending
pending
pending
pending
approved
approved
approved
approved
approved
approved
approved
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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)
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
 In-vitro digestibility studies (new proteins)
SSC says...
We urge for...
- in-vitro studies required
- further research & clarification
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Toxicity testing requirements: Overview
Source
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!
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