For purposes of this part:
(a) The following terms will have the meaning contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations issued under such Act: Cosmetic, device, drug, food, and food additive. In addition, the term food includes poultry and poultry products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 453 et seq.; meats and meat food products, as defined in the Federal Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
(b) The term pesticide will have the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq., and the regulations issued thereunder.
(c) The following terms will have the meaning contained in the Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq., and the regulations issued thereunder: Byproduct material, source material, and special nuclear material.
(d) The following definitions also apply to this part:
Act means the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq.
Administrator means the Administrator of the U.S. Environmental Protection Agency, any employee or authorized representative of the Agency to whom the Administrator may either herein or by order delegate his/her authority to carry out his/her functions, or any other person who will by operation of law be authorized to carry out such functions.
Article means a manufactured item:
(1) Which is formed to a specific shape or design during manufacture,
(2) Which has end use function(s) dependent 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 which have no commercial purpose separate from that of the article and that may occur as described in § 710.4(d)(5); except that fluids and particles are not considered articles regardless of shape or design.
Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s).
CASRN means Chemical Abstracts Service Registry Number.
Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical; except that “chemical substance” does not include:
(1) Any mixture;
(2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide;
(3) Tobacco or any tobacco product, but not including any derivative products;
(4) Any source material, special nuclear material, or byproduct material;
(5) Any pistol, firearm, revolver, shells, and cartridges; and
(6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
Commerce means trade, traffic, transportation, or other commerce:
(1) Between a place in a State and any place outside of such State or
(2) Which affects trade, traffic, transportation, or commerce between a place in a State and any place outside of such State.
Customs territory of the United States means the 50 States, Puerto Rico, and the District of Columbia.
Distribute in commerce and distribution in commerce means to sell in commerce, to introduce or deliver for introduction into commerce, or to hold after its introduction into commerce.
Domestic means within the geographical boundaries of the 50 United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States.
EPA means the U.S. Environmental Protection Agency.
Importer means any person who imports any chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the United States. “Importer” includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his or her behalf. The term also includes, as appropriate,
(1) The consignee,
(2) The importer of record,
(3) the actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20, or
(4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR 144.
Impurity means a chemical substance which is unintentionally present with another chemical substance.
Intermediate means any chemical substance that is consumed, in whole or in part, in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or that is intentionally present for the purpose of altering the rate(s) of such chemical reaction(s).
Inventory means the TSCA Chemical Substance Inventory, which is EPA's comprehensive list of confidential and non-confidential chemical substances manufactured or processed in the United States for nonexempt commercial purpose that EPA compiled and keeps current under section 8(b) of the Act.
Manufacture means to manufacture, produce, or import, for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or complex combination of chemical substances. When a chemical substance, manufactured other than by import, is:
(1) Produced exclusively for another person who contracts for such production, and
(2) that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technology for the plant process, then that chemical substance is co-manufactured by the producing manufacturer and the person contracting for such production.
Manufacture for commercial purposes means:
(1) To manufacture, produce, or import with the purpose of obtaining an immediate or eventual commercial advantage, and includes, among other things, the “manufacture” of any amount of a chemical substance or mixture
(i) for commercial distribution, including for test marketing, or
(ii) for use by the manufacturer, including use for product research and development or as an intermediate.
(2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture of a chemical substance for commercial purposes.
Manufacturer means a person who manufactures a chemical substance.
Mixture means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that “mixture” does include
(1) any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined, and if all of the chemical substances comprising the combination are not new chemical substances, and
(2) hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water, so long as the nonhydrated form is itself not a new chemical substance.
New chemical substance means any chemical substance which is not included on the Inventory.
Person includes any individual, firm, company, corporation, joint-venture, partnership, sole proprietorship, association, or any other business entity; any State or political subdivision thereof; any municipality; any interstate body; and any department, agency, or instrumentality of the Federal Government.
Process means to process for commercial purposes. Process includes the preparation of a chemical substance or mixture, after its manufacture,
(1) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or
(2) as part of a mixture or article containing the chemical substance or mixture.
Process for commercial purposes means the preparation of a chemical substance or mixture after its manufacture for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes.
Processor means any person who processes a chemical substance or mixture.
Site means a contiguous property unit. Property divided only by a public right-of-way will be considered one site. More than one manufacturing plant may be located on a single site.
(1) For chemical substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured.
(2) The site for an importer who imports a chemical substance described in § 710.25 is the U.S. site of the operating unit within the person's organization that is directly responsible for importing the chemical substance. The import site, in some cases, may be the organization's headquarters in the United States. If there is no such operating unit or headquarters in the United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of process for the importer.
Small quantities solely for research and development (or “small quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product”) means quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes.
State means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States.
Technically qualified individual means a person:
(1) Who because of his/her education, training, or experience, or a combination of these factors, is capable of appreciating the health and environmental risks associated with the chemical substance which is used under his/her supervision,
(2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research in order to minimize such risks, and
(3) Who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting the research and development activity. The responsibilities in this paragraph may be delegated to another individual, or other individuals, as long as each meets the criteria in paragraph (1) of this definition.
Test marketing means the distribution in commerce of no more than a predetermined amount of a chemical substance, mixture, or article containing that chemical substance or mixture, by a manufacturer or processor to no more than a defined number of potential customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution of that chemical substance, mixture, or article in commerce.
United States, when used in the geographic sense, means all of the States, territories, and possessions of the United States.
[68 FR 888, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004; 76 FR 50859, Aug. 16, 2011; 76 FR 54933, Sept. 6, 2011; 82 FR 37539, Aug. 11, 2017]