title: The strains recommended for use in the bacterial reverse mutation test (OECD guideline 471) can be certified as non-genetically modified organisms.
abstract: The bacterial reverse mutation test, commonly called Ames test, is used worldwide. In Japan, the genetically modified organisms (GMOs) are regulated under the Cartagena Domestic Law, and organisms obtained by self-cloning and/or natural occurrence would be exempted from the law case by case. The strains of Salmonella typhimurium and Escherichia coli recommended for use in the bacterial reverse mutation test (OECD guideline 471), have been considered as non-GMOs because they can be constructed by self-cloning or naturally occurring bacterial strains, or do not disturb the biological diversity. The present article explains the reasons why these tester strains should be classified as non-GMOs.
authors.affiliation: Division of Genetics and Mutagenesis, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo, 158-8501 Japan.
authors.forename: Kei-Ichi
authors.initials: K
authors.lastname: Sugiyama
authors.affiliation: Division of Genetics and Mutagenesis, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo, 158-8501 Japan.
authors.forename: Masami
authors.initials: M
authors.lastname: Yamada
authors.affiliation: Drug Safety Research Center, Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima, 771-0192 Japan.
authors.forename: Takumi
authors.initials: T
authors.lastname: Awogi
authors.affiliation: Tsukuba Drug Safety, Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki 300-2635 Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hakura
keywords: Bacterial reverse mutation test; Biodiversity; Genetically modified organisms; Natural occurrence; Self-cloning; pAQ1; pKM101