§5.2 - TSCA Requirements Applicable to Manufacturers

• Jurisdiction: Washington

§5.2 TSCA Requirements Applicable to Manufacturers

TSCA generally requires manufacturers of chemical substances or mixtures to do three things: (1) notify the Environmental Protection Agency (EPA) of the manufacturers intent to manufacture a chemical substance or mixture or to use an existing chemical substance for a new purpose; (2) conduct testing on new or existing chemical substances and mixtures; and (3) keep records and submit reports to the EPA. The Lautenberg Act retains these three basic requirements. Before discussing these obligations, however, it will be useful to outline TSCAs scope.

(1) Statutory scope

The most stringent requirements of TSCA apply to those who manufacture chemical substances or mixtures. The term manufacture means to produce, or manufacture. 15 U.S.C. § 2602(9). It also includes the import into the customs territory of the United States. Thus, if one imports a chemical substance, all of the manufacturing requirements of TSCA, such as premanufacture notice, testing, and recordkeeping, apply to an importer as if the importer actually produced the chemical in the United States.

TSCA applies to all chemical substances and mixtures. 15 U.S.C. §2601. These definitions are extremely broad. Any organic or inorganic substance of a particular molecular identity is a chemical substance. 15 U.S.C. §2602(2)(A). Mixtures are unreacted combinations of chemical substances. 15 U.S.C. § 2602(10). The distinction between chemical substances and mixtures is important. TSCA regulates chemical substances differently, and more stringently, than mixtures.

The term process under TSCA means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce. 15 U.S.C. § 2602(13). The EPA explains that the following are processing activities under TSCA when associated with the distribution of a chemical substance into commerce: use of a substance as part of a chemical reaction to produce another substance; addition of additives or stabilizers to a substance; formulation of a mixture containing a substance; repackaging a substance; or using a substance to produce an article that contains either the substance itself or another substance derived from it during production of the article. U.S. Envtl. Prot. Agency, Question and Answer Document: Comprehensive Assessment Information Rule q. 8 (Dec. 1988) (ELR No. AD00485).

The definition of process is extraordinarily broad and has created great uncertainty within the regulated community and within the EPA. It applies without regard to the quantity or volume of the substance used. Arguably, one who paints or coats a nonchemical item (such as a car or furniture) for subsequent sale is a processor because a substance has been added to an article and then distributed in commerce. The principal limit on the scope of TSCAs processor definition is the reference to distribution in commerce. The end user of a substance is not a processor. End use is defined by the EPA as completely consuming a substance on site. U.S. Envtl. Prot. Agency, Question and Answer Document: Comprehensive Assessment Information Rule qq. 26-27 (Mar. 1989) (ELR No. AD00486). Thus, even if a chemical substance is being repackaged, stabilized, mixed with other substances, or used to produce an article that is then distributed in commerce, if the substance is completely consumed on site, there is no processing activity under TSCA.

TSCA includes some important exclusions from the definition of chemical substances. Mixtures are not chemical substances. 15 U.S.C. §2602(2)(B)(i). Also, pesticides, as defined in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. §§136-136y, are not chemical substances when manufactured, processed, or distributed for use as a pesticide. TSCA also excludes the following from the definition of chemical substance: tobacco and tobacco products; nuclear material and byproducts regulated under the Atomic Energy Act, 42 U.S.C §§2011-2296b-7; firearms or ammunition; and food, food additives, drugs and cosmetics regulated under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§301-395. 15 U.S.C. §2602(2)(iii)-(vi).

These exclusions generally remove a chemical entirely from TSCAs jurisdiction. However, an excluded chemical can...