§ 705.3 - Definitions.

§ 705.3 Definitions.

The definitions in this section and the definitions in TSCA section 3 apply to this part. In addition, the definitions in 40 CFR 704.3 also apply to this part, except the definition for small quantities solely for research and development.

Article means a manufactured item which:

(1) Is formed to a specific shape or design during manufacture;

(2) Has end use function(s) depending in whole or in part upon its shape or design during end use; and

(3) 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 result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.

Central Data Exchange or CDX means EPA's centralized electronic submission receiving system.

Chemical Information Submission System or CISS means EPA's electronic, web-based reporting tool for the completion and submission of data, reports, and other information, or its successors.

Commercial use means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services.

Consumer use means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) when sold to or made available to consumers for their use.

Environmental or health effects information means any information of any effect of a chemical substance or mixture containing a chemical substance on health or the environment or on both. This includes all health and safety studies.

(1) Not only is information that arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture containing a chemical substance on health or the environment is also included. Any information that bears on the effects of a chemical substance on health or the environment would be included.

(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 containing a chemical substance 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, including but not limited to when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture containing a chemical substance.

Health and safety studies means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemicals substance or mixture containing a chemical substance, and any test performed under TSCA. The following information is not part of a health and safety study:

(1) The name, address, or other identifying information for the submitting company, including identification of the laboratory that conducted the study in cases where the laboratory is part of or closely affiliated with the submitting company;

(2) Internal product codes (i.e., code names for the test substance used internally by the submitting company or to identify the test substance to the test laboratory);

(3) Names and contact details for testing laboratory personnel and names and other private information for health and safety study participants or persons involved in chemical incidents such as would typically be withheld under 5 U.S.C. 552(b)(6) or under other privacy laws; and

(4) Information pertaining to test substance product development, advertising, or marketing plans, or to cost and other financial data.

Highest-level U.S. parent company means the highest-level company of the site's ownership hierarchy as of the start of the submission period during which data are being reported according to the following instructions. The highest-level U.S. parent company is located within the United States. The following rules govern how to identify the highest-level U.S. parent company:

(1) If the site is entirely owned by a single U.S. company that is not owned by another company, that single company is the U.S. parent company.

(2) If the site is entirely owned by a single U.S. company that is, itself, owned by another U.S.-based company (e.g., it is a division or subsidiary of a higher-level company), the highest-level domestic company in the ownership hierarchy is the U.S. parent company.

(3) If the site is owned by more than one company (e.g., company A owns 40 percent, company B owns 35 percent, and company C owns 25 percent), the company with the largest ownership interest in the site is the U.S. parent company. If a higher-level company in the ownership hierarchy owns more than one ownership company, then determine the entity with the largest ownership by considering the lower-level ownerships in combination (e.g., corporation X owns companies B and C, for a total ownership of 60 percent for the site).

(4) If the site is owned by a 50:50 joint venture or a cooperative, the joint venture or cooperative is its own parent company. If the site is owned by a U.S. joint venture or cooperative, the highest level of the joint venture or cooperative is the U.S. parent company.

(5) If the site is federally owned, the highest-level Federal agency or department is the U.S. parent company.

(6) If the site is owned by a non-Federal public entity, that entity (such as a municipality, State, or tribe) is the U.S. parent company.

Industrial function means the intended physical or chemical characteristic for which a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product or article; repackaged; or used.

Industrial use means use at a site at which one or more chemical substances or mixtures are manufactured (including imported) or processed.

Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children aged 14 or younger. A chemical substance or mixture containing a chemical substance is intended for use by children when the submitter answers “yes” to at least one of the following questions for the product into which the submitter's chemical substance or mixture containing a chemical substance is incorporated:

(1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children aged 14 or younger?

(2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children aged 14 or younger?

(3) Is the advertising, promotion, or marketing of the product aimed at children aged 14 or younger?

Known to or reasonably ascertainable by means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.

Manufacture means to import into the customs territory of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States (19 U.S.C. 1202)), produce, or manufacture for commercial purposes.

Manufacture for commercial purposes means:

(1) To import, produce, or manufacture 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 containing a chemical substance:

(i) For commercial distribution, including for test marketing; and/or

(ii) For use by the manufacturer, including use for product research and development, or as an intermediate.

(2) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture containing a chemical substance, including both byproducts that are separated from that other substance or mixture containing a chemical substance and impurities that remain in that substance or mixture containing a chemical substance. Such byproducts 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.

Per- and polyfluoroalkyl substances or PFAS means, for the purpose of this part, any chemical substance or mixture containing a chemical substance that structurally contains at least one of the following three sub-structures:

(1) R-(CF₂)-CF(R′)R″, where both the CF₂ and CF moieties are saturated carbons.

(2) R-CF₂OCF₂-R′, where R and R′ can either be F, O, or saturated carbons.

(3) CF₃C(CF₃)R′R″, where R′ and R″ can either be F or saturated carbons.

Possession or control means in possession or control of the submitter, or of any subsidiary, partnership in which the submitter is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the submitter in the research, development, test marketing, or commercial marketing of the chemical substance in question. (A parent company owns or controls another company if the parent owns or controls 50 percent or more of the other company's voting stock. A parent company owns or controls any partnership in which it is a general partner.) Information is included within this definition if it is:

(1) In files maintained by submitter's employees who are:

(i) Associated with research, development, test marketing, or commercial marketing of the chemical substance in question; and/or

(ii) Reasonably likely to have such data.

(2) Maintained in the files of other agents of the submitter who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question in the course of their employment as such agents.

Research and development (R&D) means activities intended solely as scientific experimentation, research, or analysis. R&D focuses on the analysis of the chemical or physical characteristics, the performance, or the production characteristics of a chemical substance, a mixture containing the substance, or an article. R&D encompasses a wide range of activities which may occur in a laboratory, pilot plant, commercial plant outside the research facility, or at other sites appropriate for R&D. General distribution of chemical substances to consumers does not constitute R&D.

Site-limited means a chemical substance is manufactured and processed only within a site and is not distributed as a chemical substance or as part of a mixture or article containing a chemical substance outside the site. Imported chemical substances are never site-limited.

Worker means someone at a site of manufacture, import, or processing who performs work activities near sources of a chemical substance or mixture or directly handles the chemical substance or mixture during the performance of work activities.