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 !