Brussels, Belgium
February 28, 2012
EFSA Journal 2012;10(2):2558 [38 pp.]. doi:10.2903/j.efsa.2012.2558
Type: Opinion of the Scientific Committee/Scientific Panel
On request from: European Commission
Question number: EFSA-Q-2011-00761
Adopted: 26 January 2012
Published: 23 February 2012
Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Article
Article
Abstract
Abstract Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2010 cultivation season of GM potato EH92-527-1 (variety Amflora) provided by BASF. The EFSA GMO Panel assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology applied by the applicant for the four case-specific studies, the General Surveillance (GS) of potato EH92-527-1 and the field study to monitor potential adverse effects on potato-feeding organisms. From the overall dataset submitted by the applicant in its 2010 Amflora monitoring report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to potato EH92-527-1 cultivation during the 2010 growing season. The outcomes of the 2010 Amflora monitoring report do not invalidate the previous EFSA GMO Panel’s risk assessment conclusions on potato EH92-527-1. Nevertheless, the EFSA GMO Panel notes a number of weaknesses in the methodology for GS and therefore gives specific recommendations for improvement of the strategy, methodology and reporting for GS of potato EH92-527-1. Concerning the field study on potato-feeding organisms as required in the related Commission Decision, the EFSA GMO Panel makes recommendations in order to improve the study. However, the EFSA GMO Panel considers the GS framework as a more proportionate alternative for collecting relevant information on potato-feeding organisms.
© European Food Safety Authority, 2012
Summary
Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2010 cultivation season of GM potato EH92-527-1 (variety Amflora) provided by BASF. The EFSA GMO Panel assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology applied by the applicant for the Case-Specific Monitoring (CSM), the General Surveillance (GS) of potato EH92-527-1 and the study on potato-feeding organisms as requested in the related Commission Decision (EC, 2010).
Firstly, although the EFSA GMO Panel did not recommend CSM (EFSA, 2006a,b), the EFSA GMO Panel assessed the four case-specific studies submitted by the applicant in order to verify a set of assumptions that were made during the Environmental Risk Assessment and their confirmation over a defined monitoring period. The EFSA GMO Panel concludes that these four case-specific studies do not provide scientific evidence that would invalidate the previous safety evaluations of potato EH92- 527-1 (EFSA, 2006a,b).
In response to this mandate from the European Commission, the EFSA GMO Panel assessed the appropriateness of the applicant’s approach for the field study to monitor potential adverse effects on potato-feeding organisms in the potato EH92-527-1 fields and in their vicinity. The EFSA GMO Panel concludes that the hypothesis set by the applicant in response to the request in the related Commission Decision cannot be answered by the study design and method used by the applicant. Hence, to test the hypothesis as set-up by the applicant, the EFSA GMO Panel makes comments and recommendations in order to improve the study. Alternatively, the EFSA GMO Panel considers that the GS framework is a more proportionate way to collect relevant information on potato-feeding organisms and therefore recommends the applicant to further elaborate the farmer questionnaire.
Concerning GS, the EFSA GMO Panel paid particular attention to the design and analysis of the farmer questionnaires and gives recommendations to the applicant in order to improve the design and reporting of the farmers survey. In addition, the EFSA GMO Panel considered the information collected by national surveillance authorities, the literature review as well as the identity preservation system set up by the applicant. The EFSA GMO Panel concludes that the 2010 analysis of the farmer questionnaires on potato EH92-527-1, the observations by national surveillance authorities and the literature review do not indicate any adverse environmental impacts associated with the cultivation of potato EH92-527-1. However, the EFSA GMO Panel notes a number of shortcomings in the methodology for GS. Hence, this Scientific Opinion gives specific recommendations to the applicant for improvement of the strategy, methodology and reporting for GS of potato EH92-527-1. The applicant should also take into consideration the guidance provided by the EFSA GMO Panel in its 2011 Scientific Opinion on Post-Market Environmental Monitoring of Genetically Modified (GM) plants (EFSA, 2011a).
From the overall dataset submitted by the applicant in its 2010 Amflora report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to potato EH92- 527-1 cultivation during the 2010 growing season. The outcomes of the 2010 Amflora report do not invalidate the previous EFSA GMO Panel’s risk assessment conclusions on potato EH92-527-1 (EFSA, 2006a,b).
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