RE: GMO Assessment – Sustainable Development and Societal Utility
This is a report by the Directorate for Nature Management of Norway, which regulates GMOs and conduct assessment of notification of GMOs in the country. The report assesses how applications for marketing of GMOs fulfil the criteria of sustainable development and benefit to society as required in the country’s law.
Norway is unique in that it is the only country which requires assessment of the impact of GMOs on sustainable development and societal utility which the EU process does not require though both Norway and EU regulations are fairly similar with regards to the required health and environmental risk assessments.
Using two GM plants as case studies - Pioneer Hi-Bred’s 1507xNK603 maize and Monsanto’s soy 40-3-2 (or Roundup Ready soy) – both which are approved for import into the EU, the report tests if they meet the two criteria. However, in examining the documentation that accompanied the GMO application for these two plants, the report found that information about sustainable development and benefit to society is lacking.
The report discusses how the two assessment criteria could be operationalised, their implications and the challenges they face.
The summary of the report “GMO Assessment in Norway as Compared to EU Procedures: Societal Utility and Sustainable Development” is reproduced below. The full document is available at: www.dirnat.no/attachment.ap?id=10784.
With best wishes,
The report assesses how applications for marketing of GMOs fulfil the criteria of sustainable development and societal utility in the Norwegian Gene Technology Act. GMO legislation in Norway is closely linked to that of the EU through the Agreement on the European Economic Area (EEA). There are many similarities both regulatory and in practice between Norway and the EU in GMO assessments. Norway and the EU put more or less equal regulatory weight on the criteria of ethics, health and environment. An overall finding in this report is the wide range of practices and advice that characterises GMO policy at the regional and member-state level within the EU.
Norway is the only country to formally ask about sustainable development and societal utility. As a result, industry cannot be expected to, and does not, provide information about such matters. This puts Norway in a difficult position. It would seem inappropriate for Norwegian authorities to accept a reversal of the burden of proof; failure by industry to provide information on sustainable development and public benefits cannot be the responsibility of Norwegian authorities. One way of dealing with the situation according to the legal requirements is to invest in more research on these issues, as a large amount of documentation would be required to substantiate the practical consequences of the criteria.
In examining the decision-making and assessment procedures, the report addresses one of the major differences between Norwegian and EU assessments of GMOs: the cases of antibiotic resistance. It also discusses the basis for the assessments, i.e. the documentation following the GMO applications. We find that the documentation accompanying GMO applications may be problematic for several reasons: It is lacking in transparency as large parts of it is confidential, violating the Århus Convention; there are many different interpretations of the scientific findings; it is huge – making thorough assessment very difficult; it is lacking in sound science as it largely stems from research departments of the applicant itself. Finally, information is lacking about sustainable development and societal utility.
Part of our analysis was to evaluate the adequacy of the supplemented information and follow this up with a discussion of how these concepts can be applied in a broader sense, by testing on two GM plants. With regard to sustainability, we found that information provided by the applicants was of high relevance for questions with regard to global impacts and ecological limits required by the impact assessment. However, these questions entail also much wider concerns as for instance effects on socio-ecological relationships by introduction of GMOs, of which the applications we investigated did not give any relevant information. Further we found no information that can be used to answer questions about impacts on basic human needs, distribution between generations, distribution between rich and poor countries, and economic growth.
We also assessed how the two applications fulfilled the criteria of societal utility. The information was very scarce and not substantiated and we found that the assessment warrants broader analysis. Important aspects would include the consideration of factors such as whether the technology is suited to small or large farming enterprises, effects on employment, food security, landscape aesthetics, human and animal health and welfare and a consideration of who would benefit from the technology.
There is significant international interest tied to the developing practice in Norway with regard to these issues. If Norwegian politicians and bureaucrats are to demonstrate genuine interest and concern for sustainable development and societal utility with the use and release of GM-crops, it will be necessary to apply a more constructive use of the legal instrument. Hence, at the end of the report we present our recommendations concerning assessments of sustainable development and societal utility. We also suggest research needs linked to identify how GM crops in practice affect sustainability and societal utility around in the world.