アメリカ:化学物質に関する法律に動物実験削減の条文が
日本の化審法にあたるアメリカの法律は、有害物質管理法(略称TSCA:トスカ)ですが、この4月15日にすでに改正法案が提出されています。
その法案の第31条というのが、動物実験の削減に関するものなんですが、けっこう長いので、思わず下記にコピペしてしまいました。
審議状況がわかるサイトで全文が読めます。
http://www.opencongress.org/bill/111-s3209/show
http://www.govtrack.us/congress/bill.xpd?bill=s111-3209
(面白いですね、アメリカはこういうサイトがあるんですね。わかりやすい・・・)
改正が成立すれば、いずれ和訳が出されると思うので訳しませんが^^;、ポイントは、
・新しい動物実験をする代わりに、既存のデータを使うこと。
・使われる動物の数をなくすか、減らすような試験方法を使用すること。
・特定の化学製品に関するデータを集めるために、産業コンソーシアムを編成すること。
・動物に基づく研究と動物を使わない新規の方法によるものとを平行して使うこと。また、動物実験の削減、代替、苦痛の軽減に関するバリデーション研究に資金を提供すること。
・法律制定から90日以内に、動物実験の代替に関する科学勧告委員会を立ち上げること。
(以下、その詳細という感じです)
日本にいるせいか華々しく感じられますが、でもこの法改正自体は、REACHと同じで「動物実験をもっとせよ」という改正だと思います(特に既存物質について)。アメリカの団体が署名など呼びかけていますが、住所がアメリカでないと送信できないようなので割愛します。
以下、第31条の全文です。
SEC. 31. REDUCTION OF ANIMAL-BASED TESTING.
(a) Administration- The Administrator shall take action to minimize the use of animals in testing of chemical substances or mixtures, including–
(1) encouraging and facilitating, where practicable–
(A) use of existing data of sufficient scientific quality;
(B) use of test methods that eliminate or reduce the use of animals but provide data of high scientific quality;
(C) grouping of 2 or more chemical substances into scientifically appropriate categories where testing of one chemical substance will provide reliable and useful data on others in the category;
(D) formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; and
(E) parallel submission of data from animal-based studies and from emerging methods and models; and
(2) funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with this subsection.
(b) Interagency Science Advisory Board on Alternative Testing Methods-
(1) ESTABLISHMENT- Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2010, the Administrator shall establish an advisory board to be known as the Interagency Science Advisory Board on Alternative Testing Methods’. The Board shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.).
(2) COMPOSITION- The Administrator shall–
(A) appoint the members of the Interagency Science Advisory Board on Alternative Testing Methods, including, at a minimum, representatives of–
(i) the National Institute of Environmental Health Sciences;
(ii) the Centers for Disease Control and Prevention;
(iii) the National Toxicology Program;
(iv) the National Cancer Institute; and
(v) the National Tribal Science Council; and
(B) ensure that no individual appointed to serve on the Interagency Science Advisory Board on Alternative Testing Methods has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Administrator determines that the conflict is unavoidable.
(3) PURPOSE- The purpose of the Interagency Science Advisory Board on Alternative Testing Methods shall be to provide independent advice and peer review to the Administrator and Congress on the scientific and technical aspects of issues relating to the implementation of this subchapter with respect to minimizing the use of animals in testing of chemical substances or mixtures.
(4) REPORT- Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, and triennially thereafter, the Administrator, in consultation with the Interagency Science Advisory Board on Alternative Testing Methods established under paragraph (1), shall publish a list of testing methods that reduce the use of animals in testing under section 4.
(c) Implementation of Alternative Testing Methods- To promote the development and timely incorporation of new testing methods that are not animal-based, the Administrator shall–
(1) in consultation with the Interagency Science Advisory Board on Alternative Testing Methods established under subsection (b)(1), and after providing an opportunity for public comment, develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information used for safety standard determinations under section 6(b) that do not use animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening;
(2) biennially report to Congress on progress made in implementing this section; and
(3) fund and carry out research, development, performance assessment, and translational studies to accelerate the development of test methods and testing strategies that are not animal-based for use in safety standard determinations under section 6(b).
(d) Criteria for Adapting or Waiving Animal Testing Requirements- Upon request from a manufacturer or processor that is required to conduct animal-based testing of a chemical substance or mixture under this subchapter, the Administrator may adapt or waive such requirement if the Administrator determines that–
(1) there is sufficient weight-of-evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has, or does not have, a particular property, in any case in which the information from each individual source alone is regarded as insufficient to support the conclusion;
(2) testing for a specific endpoint is technically not practicable to conduct as a consequence of 1 or more physical or chemical properties of the chemical substance or mixture; or
(3) a chemical substance or mixture cannot be tested in animals at concentrations that do not result in significant pain or distress, due to physical or chemical properties of the chemical substance or mixture, such as potential to cause severe corrosion or severe irritation to tissues.