title: 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.
authors.affiliation: Monsanto Japan Limited, Kyobashi Soseikan Building 6F, 2-5-18, Kyobashi, Chuo-ku, Tokyo, 104-0031, Japan. shuichi.nakai@monsanto.com.
authors.forename: Shuichi
authors.identifier: http://orcid.org/0000-0001-9314-2291
authors.initials: S
authors.lastname: Nakai
authors.affiliation: Monsanto Japan Limited, Kyobashi Soseikan Building 6F, 2-5-18, Kyobashi, Chuo-ku, Tokyo, 104-0031, Japan.
authors.forename: Kana
authors.initials: K
authors.lastname: Hoshikawa
authors.affiliation: Faculty of Science, Toho University, 2-2-1 Miyata, Funabashi, Chiba, 274-8510, Japan.
authors.forename: Ayako
authors.initials: A
authors.lastname: Shimono
authors.affiliation: Faculty of Life and Environmental Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8572, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Ohsawa
mesh_terms: D003257:Consumer Product Safety; D018556:Crops, Agricultural / Q000235:genetics*; D004781:Environmental Exposure / Q000517:prevention & control*; D006801:Humans; D030821:Plants, Genetically Modified / Q000009:adverse effects*; D018570:Risk Assessment; D013223:Statistics as Topic
keywords: Confined field trial; Data transportability; Environmental risk assessment; Genetically modified crops; Weediness potential