Transcript GMO risk assessment

International Conference
Genetically Modified Crops and Food in Europe –
10. December 2010, Riga
GM Policy in Austria
Aspects of Health and Environmental Risk
Assessment taking into account the Precautionary
Principle
Dr. Michel Haas
Federal Ministry of Health, Dep. II/B/15
Legal Basis
- Directive 2001/18/EC on deliberate release
implemented by Austrian Law on Genetechnology
- Regulation 1829/2003 on GM food and feed
Competent authority: Ministry of Health
(GMO, GM Food)
One Fundamental Principle in the Law on
Gentechnology is the Precautionary Principle
Since 1997 AT very critical in regard of approval of
GMOs, strict policy of precaution
Austrian Bans on GMOs
and main reasons
1997: BT- Maize 176 (Syngenta)
- ARM gene with possible resistance against ampicillin
- Possible unintended effects of BT Toxin on non
target organisms
- Possible resistance development in target pests
1999: Maize MON 810
- No assessment of indirect and long term effects of
the BT – Toxin
- Possible unintended effects on benign non target
organisms
- Possible resistance development in target pests
2000: Maize T 25 (herbicide resistant)
- No integrated assessment of the combined effects of
the GMO and the herbicide under realistic conditions
2004, 2006: EC fails to repeal the Austrian Bans
2006: Ban of oil seed rape GT 73 for import for all
purposes
-Toxicity not adequately assessed
-Outcrossing and contamination of ruderal and
conventional oil seed rape possible
2008: Bans on import of MON 810 and Maize T 25 for
food and feed purposes lifted; Bans for import for
cultivation are maintained
2008: Ban of oil seed rape Ms8xRf3
for similar reasons as for GT 73
Ban of maize MON 863 for import for all purposes
- Tests on subchronic toxicity not state of the art
- ARM Gene npt II problematic, possibility for transfer
of antibiotic resistance against kanamycin, neomycin
an other antibiotics not sufficiently assessed
Scientific dialogue with EFSA
December 2008: Meeting AT Experts with the GMO
Panel of EFSA on Maize MON 810 and T 25
April 2009: Meeting AT Experts with EFSA on MON 863,
oil seed rape Ms8xRf3 and GT 73
No agreement on these Meeting with EFSA on scientific
level
December 2008 (ENVI Council): Council Conclusions
-Environmental risk assessment to be improved
-Scientific expertise must be strengthened
27 April 2010: AT Ban on Amflora Potato
- Potential for transfer of the ARM Gene npt II not
adequately addressed by EFSA GMO Panel
- Environmental effects not sufficiently assessed
- No adequate monitoring plan
- Poor data qualitiy of the dossier
Austrian Agency on Health and Food Security (AGES)
mandated to explore the background resistance levels
in Austria and possible ways of transfer of the ARM
Gene to bacteria in soil and the gut.
Risk Assessment of GMOs in
Austria
- Federal Environmental Agency (UBA Wien)
- Austrian Agency for Health and Food Security (AGES)
Scrutinize GMO Dossiers of applicants within the
harmonized Risk Assessment procedure (EFSA/
Member States)
Issues to be considered
- Molecular characterization (stability and expression
of insert, possible fusion proteins, ARM Genes,
etc.)
- Agricultural parameters (assessment of feld trials)
- Nutritional composition (compared with isogene
varieties), check of antinutrients
- Allergenicity
- Toxicity (tox. tests, feeding studies etc.)
Environmental Risk Assessment
Assessment of possible long term effects on humans,
animals and the environment
-Effects of release on the receiving environment
-Effects of possible gene transfer, outcrossing, spread
of pollen etc.
-Effects of interactions with other organisms
GMO Unit of AGES elaborates combined assessment of
the health and environmental risk aspects of the
dossiers.
Assessment is sent to EFSA by the Ministry of Health.
GMO risk assessment (Molecular
Characterization/Food and Feed):
General Approach (AGES)
Focus of risk assessment concerning GMO dossiers
according to regulation 1829/2003:
1. Data quality
2. Data presentation
3. Adherence to EFSA GMO risk assessment guidelines
4. Comparison of conventionally performed
experiments with experimental design applied
during GMO risk assessment
Major points of criticism raised by Austrian GMO risk
assessors
1. EFSA GMO panel accepts insufficient data (e.g.
inadequate sample number, number of generations etc…
tested)
2. EFSA GMO panel accepts data which cannot be
interpreted (e.g. wrong and/or diffuse banding pattern
on Southern blots, broken gels, over/underexposed blots
etc…)
3. EFSA GMO panel accepts insensitive detection methods
which cannot provide the necessary sensitivity to allow
sound conclusions (e.g. Southern blots with single
restriction enzyme as evidence for genetic stability of the
transgenic insert)
Conclusions of Austrian Food/Feed GMO risk assessors
Data of poor quality (incomplete or otherwise not
interpretable) presented by the notifier do not provide a
sound basis for an adequate risk assessment.
Due to flaws mentioned above the final EFSA opinion on
the respective GMO suffers from a certain degree of
uncertainty, which is proportional to the quality of the
presented GMO dossier. Low quality dossiers result in
EFSA opinions containing a high degree of uncertainty.
AT Position in the Regulatory
Meetings
So far mainly applications for GMOs with agricultural traits
(herbicide resistance or insect resistance) in particular
diverse GMO Maizelines, but also Soja, Cotton and Oil Seed
Rape, have been put to vote in the Regulatory Committee
of Directive 2001/18/EC or in SCFCAH and in the
respective Meetings of the Environment and Agricultural
Councils.
As according to the AT assessment in all these cases data of
risk assement reports provided by the notifyers lacked
completeness and could not resolve questions of scientific
uncertainty AT voted against an approval (due to the
precautionary principle)
Role of the European Commission
- So far no reactions in regard of the Austrian safeguard
measures; bans are still in existence;
- EC now working on Regulation for freedom for
Member State to set up restrictions or bans for
GMO Cultivation
- AT wants reasons of environmental and health
protection to be included
- Socio-economic factors and reasons of public moral
and public policy to be further explored.
Future Aspects
AT experts also involved in the elaboration of Guidelines for
the risk assessment for GMO Food and Feed and for the
assessment of environmental effects of genetically modified
plants.
Contributions for improvement have been put forward
and already been taken into account by the EC in her work to
put these guidelines on a regulatory basis.
AT Ministry of Health will further critically scrutinize relevant
application dossiers.
Work on amending Directive 2001/18/EC will be proactively
tackled further under the Hungarian Presideny.
I thank you for your attention !