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Transportability of confined field trial data from cultivation to import countries for environmental risk assessment of genetically modified crops.

ABSTRACT: Requirement of in-country confined field trials for genetically modified (GM) crops prior to unrestricted release is well-established among countries with domestic regulations for the cultivation approval of GM crops. However, the requirement of in-country confined field trials is not common in countries where the scope of the application does not include cultivation. Nonetheless, Japan and China request in-country confined field trials for GM crops which are intended only for use as food, feed and processing. This paper considers the transportability of confined field trial data from cultivation countries (e.g. United States, Canada, and South American countries) to import countries like Japan for the environmental risk assessment of GM crops by reviewing: (1) the purpose of confined field trial assessment, (2) weediness potential, defined as "an ability to establish and persist in an unmanaged area that is frequently disturbed by human activity", of host crops, and (3) reliability of the confined field trial data obtained from cultivation countries. To review the reliability of the confined field data obtained in the US, this paper describes actual examples of three confined field trials of approved GM corn events conducted both in the US and Japan. Based on the above considerations, this paper concludes that confined field data of GM corn and cotton is transportable from cultivation countries to importing countries (e.g. from the US to Japan), regardless of the characteristics of the inserted gene(s). In addition, this paper advocates harmonization of protocols for confined field trials to facilitate more efficient data transportability across different geographies.

SUBMITTER: Nakai S

PROVIDER: S-EPMC4639567 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Transportability of confined field trial data from cultivation to import countries for environmental risk assessment of genetically modified crops.

Nakai Shuichi S Nakai Shuichi S Hoshikawa Kana K Shimono Ayako A Ohsawa Ryo R

Transgenic research 20150703 6

Requirement of in-country confined field trials for genetically modified (GM) crops prior to unrestricted release is well-established among countries with domestic regulations for the cultivation approval of GM crops. However, the requirement of in-country confined field trials is not common in countries where the scope of the application does not include cultivation. Nonetheless, Japan and China request in-country confined field trials for GM crops which are intended only for use as food, feed ...[more]

PMID: 26138875

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Project description:Following a request from the European Commission, EFSA assessed the 2017 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Like previous years, partial compliance with refuge requirements is reported for Spain. European and Mediterranean corn borer populations collected from North-eastern Spain during the 2017 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810. No complaints about unexpected field damage caused by corn borers were received through the farmer complaint system. The assessment of farmer questionnaires and relevant scientific publications does not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. No information about the use of existing networks involved in environmental monitoring is provided. Overall, EFSA concludes that the evidence reported in the 2017 PMEM report does not invalidate previous EFSA and GMO Panel evaluations on the safety of maize MON 810. As in previous years, EFSA identifies methodological and reporting shortcomings pertaining to resistance monitoring that need revision in future PMEM reports. In particular, the monitoring plan, as implemented in 2017, is not sufficiently sensitive to detect the recommended 3% resistance allele frequency. Consequently, EFSA strongly recommends the consent holder to: (1) achieve full compliance with refuge requirements in areas where maize MON 810 adoption is high (i.e. North-eastern Spain); (2) increase the sensitivity of the resistance monitoring plan and address previously mentioned methodological, analytical and/or reporting limitations for resistance monitoring and farmer questionnaires; and (3) perform a F2-screen on European and Mediterranean corn borer populations from North-eastern Spain. Moreover, relevant stakeholders should implement a methodological framework to enable making best use of existing networks involved in environmental monitoring for the general surveillance of genetically modified plants.

Dataset Information

Transportability of confined field trial data from cultivation to import countries for environmental risk assessment of genetically modified crops.

Publications

Transportability of confined field trial data from cultivation to import countries for environmental risk assessment of genetically modified crops.

Similar Datasets

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