What is a chemical substance for purposes of regulation under TSCA?

TSCA規(guī)定的化學(xué)物質(zhì)是什么？

The Toxic Substances Control Act (TSCA) defines the term "chemical substance" as "any organic or inorganic substance of a particular molecular identity, including -- (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical." The Environmental Protection Agency (EPA) states: "TSCA defines ‘chemical substance’ broadly and in terms which cover microorganisms as well as traditional chemicals."

“有毒物質(zhì)控制法”（TSCA）將術(shù)語“化學(xué)物質(zhì)”定義為“具有特定分子特性的任何有機或無機物質(zhì)，包括 - （i）由于以下原因而全部或部分出現(xiàn)的此類物質(zhì)的任何組合化學(xué)反應(yīng)或在自然界中發(fā)生的和（ii）任何元素或未結(jié)合的自由基。“美國環(huán)境保護署（EPA）表示：“TSCA廣義地定義了'化學(xué)物質(zhì)'，涵蓋了微生物和傳統(tǒng)化學(xué)品。”

Are there any exemptions from the definition of a "chemical substance"?

“化學(xué)物質(zhì)”的定義是否有任何豁免？

TSCA specifically exempts from the definition of "chemical substance" (1) mixtures; (2) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticides; (3) tobacco and tobacco products; (4) certain materials regulated under the Atomic Energy Act; (5) firearms and ammunition; and (6) foods, food additives, drugs, cosmetics, and devices regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition to those substances specifically excluded from TSCA, EPA has exempted other categories of substances from certain TSCA requirements. For example, certain chemical substances -- including impurities and byproducts -- are excluded from TSCA Section 5 requirements because "[a]lthough they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part." EPA also exempts "articles" from various TSCA requirements.

TSCA特別豁免“化學(xué)物質(zhì)”的定義（1）混合物;（2）聯(lián)邦殺蟲劑，殺真菌劑和滅鼠劑法（FIFRA）殺蟲劑; （3）煙草和煙草制品;（4）根據(jù)“原子能法”規(guī)定的某些材料;（五）槍支彈藥;（6）根據(jù)聯(lián)邦食品，藥品和化妝品法案（FFDCA）管制的食品，食品添加劑，藥品，化妝品和設(shè)備。 除了特別排除在TSCA之外的那些物質(zhì)，EPA還豁免了其他類別的物質(zhì)來滿足TSCA的某些要求。例如，某些化學(xué)物質(zhì) - 包括雜質(zhì)和副產(chǎn)品 - 被排除在TSCA第5節(jié)的要求之外，因為“雖然它們是根據(jù)該法案為商業(yè)目的而制造的，但它們不是作為化學(xué)物質(zhì)本身在商業(yè)上制造的。與他們所屬的物質(zhì)，混合物或物品沒有任何商業(yè)目的?！?EPA還免除了“物品”的各種TSCA要求。

What are "articles" under TSCA?

TSCA下的“物質(zhì)”是什么？

TSCA defines "article" as "a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) depending in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition that have no commercial purpose separate from that of an article, and that results from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles." Fluids and particles are not considered articles, however, regardless of shape or design. Articles that contain chemical substances which are not intended to be removed and have no separate commercial purpose are generally exempt from TSCA. Articles that contain chemical substances designed to be used or released (i.e., ink in pens) are subject to TSCA requirements.