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Funding institutions:
Inter-University Research Centre for Technology, Work and Culture (IFZ), Austria
Environment Agency Austria
Project manager:
Dr. Susanne Stirn
Funding period:
01.03.2001 - 31.05.2001
This project was part of a larger Austrian project looking into the safety assessment of genetically modified plants for food use. The aim of this project was to compare the documents presented by the applicants to substantiate food safety for 12 genetically modified plants approved for food use in Europe (maize, oilseed rape, soybeans). Gaps in the safety assessment were identified and recommendations for standardization were formulated.
In our project, we concentrated on the comparison of the regulation of genetically modified (gm) plants for food use in Europe and the USA. The question was whether the kind of regulation favours applicants on either side of the Atlantic.
The most obvious difference between the US and the European regulation of foods derived from gm foods is the overall regulatory approach taken. The basic assumption behind the regulation of gm foods in the USA is that they are not inherently more risky than traditional foods. Therefore, foods derived from genetically modified plants are regulated according to the same regulations as traditional foods (product-orientated approach). From the European perspective, foods derived from gm plants might bear new risks that have to be assessed and regulated specifically. Particular directives for the contained use and the deliberate releases of genetically modified organisms have been implemented (process-orientated approach).
A further difference between the USA and the EU regulation is the party responsible for food safety (USA: consultations; responsibility rests with the producer; EU: approval; responsibility is mainly on the side of the agency) and the extent of liability (USA: no maximum limit; EU: in accordance with national laws (Germany: about 80 Million Euro)).
Despite all the differences mentioned above in regulative approaches, the tests performed to assess the safety of genetically modified foods are principally the same. The safety assessments are built on the principle of "substantial equivalence" (GM foods are best to be compared with traditional counterparts) and the risk assessment focuses on the potential negative health effects of the differences identified.
Therefore, at first glance it might seem as if getting an approval for gm crop plants is easier in the USA with no specific regulation for genetically modified organisms in place. Taking a closer look, we found that the tests required to establish food safety are more or less the same and in practice, the same documentation is presented by the applicants, since most of the gm plants were first approved in the USA and afterwards in Europe.
Reference:
Spök, Armin, Hofer, Heinz, Lehner, Petra, Valenta, Rudolf, Stirn, Susanne & Gaugitsch, Helmut(2005): Risk Assessment of GMO Products in the European Union. Toxicity assessment, allergenicity assessment and substantial equivalence in practice and proposals for improvement and standardisation. Berichte, Bd. BE-0253. Umweltbundesamt, Wien. PDF
