TSCA certification是什么，TSCA statement代办机构

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

TSCA规定的化学物质是什么？

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."

“有毒物质控制法”（TSCA）将术语“化学物质”定义为“具有特定分子特性的任何有机或无机物质，包括 - （i）由于以下原因而全部或部分出现的此类物质的任何组合化学反应或在自然界中发生的和（ii）任何元素或未结合的自由基。“美国环境保护署（EPA）表示：“TSCA广义地定义了'化学物质'，涵盖了微生物和传统化学品。”

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

“化学物质”的定义是否有任何豁免？

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特别豁免“化学物质”的定义（1）混合物;（2）联邦杀虫剂，杀真菌剂和灭鼠剂法（FIFRA）杀虫剂; （3）烟草和烟草制品;（4）根据“原子能法”规定的某些材料;（五）枪支弹药;（6）根据联邦食品，药品和化妆品法案（FFDCA）管制的食品，食品添加剂，药品，化妆品和设备。 除了特别排除在TSCA之外的那些物质，EPA还豁免了其他类别的物质来满足TSCA的某些要求。例如，某些化学物质 - 包括杂质和副产品 - 被排除在TSCA第5节的要求之外，因为“虽然它们是根据该法案为商业目的而制造的，但它们不是作为化学物质本身在商业上制造的。与他们所属的物质，混合物或物品没有任何商业目的。“ EPA还免除了“物品”的各种TSCA要求。

What are "articles" under TSCA?

TSCA下的“物质”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.