Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM) report from BASF Plant Science Company GmbH on the cultivation of genetically modified potato EH92-527-1 in 2011

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Article
EFSA Journal 2012;10(12):3015 [35 pp.].
doi
10.2903/j.efsa.2012.3015
EFSA Panel on Genetically Modified Organisms (GMO)
Panel Members
Salvatore Arpaia, Nicholas Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare M. Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks, Christoph Tebbe.
Acknowledgement

The Panel wishes to thank the members of the Standing Working Group on annual PMEM reports: Salvatore Arpaia, Jozsef Kiss, Antoine Messéan, Joe Perry, Jeremy Sweet for the preparation of this scientific opinion, and Lieve Hermann, Hans Christer Andersson and EFSA staff: Saghir Bashir, Jose Cortinas Abrahantes, Andrea Gennaro, Sylvie Mestdagh and Jane Richardson, for the support provided to this scientific opinion.

Possible conflict of interest
Two members of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2012-00643
Adopted
6 Dezember 2012
Published
17 Dezember 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (213.73 KB)213.73 KB
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 2011 growing season, provided by BASF, on the genetically modified (GM) potato EH92-527-1 (variety Amflora). On 26 January 2012, the EFSA GMO Panel had adopted a scientific opinion on the 2010 monitoring report on potato EH92-527-1. The EFSA GMO Panel followed the same approach as for the assessment of the 2010 monitoring report and assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology used by the applicant in 2011 for the case-specific studies, the general surveillance of potato EH92-527-1 and the field study to monitor potential adverse effects on potato-feeding organisms as required in the related Commission Decision. The EFSA GMO Panel notes similar shortcomings in the methodology for general surveillance and for the specific field study on potato-feeding organisms as were found in the 2010 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology for the post-market environmental monitoring of potato EH92-527-1 as it did in its scientific opinion on the 2010 monitoring report. The EFSA GMO Panel also assessed the methodology of a new study monitoring GM volunteers within and around fields cropped with potato EH92-527-1 in 2010. The EFSA GMO Panel identified flaws in that study and therefore makes recommendations to the applicant to improve the study design. However, from the overall dataset submitted by the applicant, the EFSA GMO Panel did not identify adverse effects on the environment or human and animal health due to potato EH92-527-1 cultivation. The outcomes of the 2011 monitoring report do not invalidate the conclusions of the EFSA GMO Panel’s previous opinions on potato EH92-527-1.

Summary

On 26 January 2012, in response to a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority(EFSA GMO Panel) adopted a scientific opinion on the monitoring report for the 2010 growing season, provided by BASF, on genetically modified (GM) potato EH92-527-1 (variety Amflora). During its assessment of the 2010 monitoring report, the EFSA GMO Panel had identified shortcomings in the methodology for both general surveillance and the specific field study on potato-feeding organisms as required in the related Commission Decision, and hence provided recommendations for the improvement of the Post-Market Environmental Monitoring (PMEM) of potato EH92-527-1.

Following a similar request from the European Commission to assess the monitoring report of the same potato EH92-527-1 for the 2011 growing season, the EFSA GMO Panel assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology used by the applicant in the case-specific studies, the general surveillance of potato EH92-527-1 and the specific field study to monitor potential adverse effects on potato-feeding organisms as required in the related Commission Decision. The methodology used for the monitoring of potato EH92-527-1 in 2011 is similar to that used in 2010. Therefore, the EFSA GMO Panel mostly focused on the new 2011 datasets, i.e., data from farmer questionnaires, monitoring of potato-feeding organisms and monitoring of volunteers in fields in which potato EH92-527-1 was grown for starch production in 2010.

The EFSA GMO Panel notes similar shortcomings in the methodology for general surveillance and the specific field study to monitor potential adverse effects on potato-feeding organisms as were found in the 2010 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology used in the PMEM of potato EH92-527-1 as it did in its scientific opinion on the 2010 monitoring report.

The EFSA GMO Panel also assessed the methodology of a new study monitoring GM volunteers within and around fields cropped with potato EH92-527-1 in 2010. The EFSA GMO Panel identified flaws in the study and therefore makes recommendations to the applicant to improve the study design.

However, from the overall dataset submitted by the applicant in its 2011 monitoring report, the EFSA GMO Panel did not identify any adverse effects on the environment or human and animal health due to potato EH92-527-1 cultivation. The outcomes of this 2011 monitoring report do not invalidate the conclusions of the EFSA GMO Panel’s previous opinions on potato EH92-527-1.

Keywords
GMO, potato, PMEM, annual report, cultivation, case-specific monitoring, general surveillance
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Number of Pages
35