40 CFR § 716.3 - Definitions.
The definitions in section 3 of TSCA apply to this subpart. In addition, the following definitions are provided for the purposes of this subpart:
Chemical Information Submission System or CISS means EPA's electronic, web-based tool for the completion and submission of data, reports, and other information, or its successors.
Copy of study means the written presentation of the purpose and methodology of a study and its results.
EPA means the United States Environmental Protection Agency.
Health and safety study or study means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological or other studies of a chemical substance or mixture, and any test performed under TSCA.
(1) It is intended that the term health and safety study be interpreted broadly. Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or the environment would be included. Chemical identity is part of, or underlying data to, a health and safety study.
(2) Examples are:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; and acute, subchronic, and chronic effects.
(ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life-stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; structure/activity relationships; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility.
(iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.
Import means to import for commercial purposes.
Import for commercial purposes means to import with the purpose of obtaining an immediate or eventual commercial advantage for the importer, and includes the importation of any amount of a chemical substance or mixture. If a chemical substance or mixture containing impurities is imported for commercial purposes, then those impurities are also imported for commercial purposes.
Importer means any person who imports a chemical substance, including a chemical substance as a part of a mixture or article, into the customs territory of the United States and includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his behalf (as defined in 19 CFR 1.11). Importer also includes, as appropriate:
The importer of record.
(4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. For the purpose of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia.
Listed mixture means any mixture listed in § 716.120.
Manufacture means to manufacture for commercial purposes.
Manufacture for commercial purposes means: (1) To produce, with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, and includes among other things such “manufacture” of any amount of a chemical substance or mixture:
(i) For commercial distribution, including for test marketing.
Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including by products and impurities. Such by products and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.
Manufacturer means a person who produces or manufactures a chemical substance. A person who extracts a component chemical substance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance.
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 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. If a chemical substance or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes.
Propose to manufacture, import, or process means that a person has made a management decision to commit financial resources toward the manufacture, importation, or processing of a substance or mixture.