Title 15 — Commerce and Trade
Chapter 53 — Toxic Substances Control
§ 2602. Definitions
Statutory text
As used in this chapter:
the 1 term “Administrator” means the Administrator of the Environmental Protection Agency.
Except as provided in subparagraph (B), the term “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 element or uncombined radical.
Such term does not include—
any mixture,
any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.]) when manufactured, processed, or distributed in commerce for use as a pesticide,
tobacco or any tobacco product,
any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 [42 U.S.C. 2011 et seq.] and regulations issued under such Act),
any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1986 [26 U.S.C. 4181] (determined without regard to any exemptions from such tax provided by section 4182 or 4221 or any other provision of such Code) and any component of such an article (limited to shot shells, cartridges, and components of shot shells and cartridges), and
any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
The term “food” as used in clause (vi) of this subparagraph includes poultry and poultry products (as defined in sections 4(e) and 4(f) of the Poultry Products Inspection Act [21 U.S.C. 453(e) and (f)]), meat and meat food products (as defined in section 1(j) of the Federal Meat Inspection Act [21 U.S.C. 601(j)]), and eggs and egg products (as defined in section 4 of the Egg Products Inspection Act [21 U.S.C. 1033]).
The term “commerce” means trade, traffic, transportation, or other commerce (A) between a place in a State and any place outside of such State, or (B) which affects trade, traffic, transportation, or commerce described in clause (A).
The term “conditions of use” means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.
The terms “distribute in commerce” and “distribution in commerce” when used to describe an action taken with respect to a chemical substance or mixture or article containing a substance or mixture mean to sell, or the sale of, the substance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into commerce.
The term “environment” includes water, air, and land and the interrelationship which exists among and between water, air, and land and all living things.
The term “guidance” means any significant written guidance of general applicability prepared by the Administrator.
The term “health and safety study” 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 chemical substance or mixture, and any test performed pursuant to this chapter.
The term “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), produce, or manufacture.
The term “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 such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and 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.
The term “new chemical substance” means any chemical substance which is not included in the chemical substance list compiled and published under section 2607(b) of this title.
The term “potentially exposed or susceptible subpopulation” means a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.
The term “process” means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce—
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
as part of an article containing the chemical substance or mixture.
The term “processor” means any person who processes a chemical substance or mixture.
The term “protocols and methodologies for the development of information” means a prescription of—
the—
health and environmental effects, and
information relating to toxicity, persistence, and other characteristics which affect health and the environment,
for which information for a chemical substance or mixture are to be developed and any analysis that is to be performed on such information, and
to the extent necessary to assure that information respecting such effects and characteristics are reliable and adequate—
the manner in which such information are 2 to be developed,
the specification of any test protocol or methodology to be employed in the development of such information, and
such other requirements as are necessary to provide such assurance.
The term “State” means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States.
The term “United States”, when used in the geographic sense, means all of the States.
Footnotes
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Toxic Substances Control Act
Pub. L. 94–469 title I § 3 · 90 Stat. 2003
Enacted · 15 U.S.C. § 2602
Pub. L. 94–469, title I, § 3, Oct. 11, 1976, 90 Stat. 2004
Source evidence
Code source credit
Pub. L. 94–469, title I, § 3, Oct. 11, 1976, 90 Stat. 2004Enacted provision · exact public law section
SEC. 3. DEFINITIONS. 15 USC 2602. As used in this Act: (1) the term “Administrator” means the Administrator of the Environmental Protection Agency. (2) (A) Except as provided in subparagraph (B), the term “chemical substance” means 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. (B) Such term does not include— (i) any mixture, (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide, (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act 42 USC 2011 note. 26 USC 4181. of 1954 and regulations issued under such Act), (v) any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954 (determined without regard to any exemptions from such tax provided 26 USC 4182, 4221. by section 4182 or 4221 or any other provision of such Code), and (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and 21 USC 321. Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The term “food” as used in clause (vi) of this subparagraph includes poultry and poultry products (as defined in sections 4(e) and 4(f) 21 USC 453. 21 USC 601. of the Poultry Products Inspection Act), meat and meat food products (as defined in section l(j) of the Federal Meat Inspection Act), and eggs and egg products (as defined in section 4 of the Egg 21 USC 1033. Products Inspection Act). (3) The term “commerce” means trade, traffic, transportation, or other commerce (A) between a place in a State and any place outside of such State, or (11) which affects trade, traffic, transportation, or commerce described in clause (A). (4) The terms “distribute in commerce” and “distribution in commerce” when used to describe an action taken with respect to a chemical substance or mixture or article containing a substance or mixture mean to sell, or the sale of, the substance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance, mixture, or article after its introduction into commerce. (5) The term “environment” includes water, air, and land and the interrelationship which exists among and between water, air, and land and all living things. (6) The term “health and safety 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 studies of a chemical substance or mixture, and any test performed pursuant to this Act. (7) The. term ‘manufacture” means to import into the customs territory of the United States (as defined in general headnote 2 of the Tariff Schedules of the United States), produce, or manufacture. 19 USC 1202. (8) The term “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 such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and 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. (9) The term “new chemical substance” means any chemical substance which is not included in the chemical substance list compiled and published under section 8(b). Post, p. 2027. (10) The term “process” means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce— (A) 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 (B) as part of an article containing the chemical substance or mixture. (11) The term “processor” means any person who processes a chemical substance or mixture. (12) The term “standards for the development of test data” means a prescription of— (A) the— (i) health and environmental effects, and (ii) information relating to toxicity, persistence, and other characteristics which affect health and the environment, for which test data for a chemical substance or mixture are to be developed and any analysis that is to be performed on such data, and (B) to the extent necessary to assure that data respecting such effects and characteristics are reliable and adequate— (i) the manner in which such data are to be developed, (ii) the specification of any test protocol or methodology to be employed in the development of such data, and (iii) such other requirements as are necessary to provide such assurance, (13) The term “State“ means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States. (14) The term “United States”, when used in the geographic sense, means all of the States.Tax Reform Act of 1986
Pub. L. 99–514 § 2 · 100 Stat. 2085
Substituted · 15 U.S.C. § 2602(2)(B)(v)
Pub. L. 99–514 substituted “Internal Revenue Code of 1986” for “Internal Revenue Code of 1954”
Source evidence
Code amendment note
Par. (2)(B)(v). Pub. L. 99–514 substituted “Internal Revenue Code of 1986” for “Internal Revenue Code of 1954”.Enacted provision · exact public law section
SEC. 2. INTERNAL REVENUE CODE OF 1986. (a) Redesignation of 1954 Code.— The Internal Revenue Title enacted August 16, 1954, as heretofore, hereby, or hereafter amended, may be cited as the “Internal Revenue Code of 1986”. (b) References in Laws, Etc.— Except when inappropriate, any reference in any law, Executive order, or other document— (1) to the Internal Revenue Code of 1954 shall include a reference to the Internal Revenue Code of 1986, and (2) to the Internal Revenue Code of 1986 shall include a reference to the provisions of law formerly known as the Internal Revenue Code of 1954.Omnibus Trade and Competitiveness Act of 1988
Pub. L. 100–418 title I § 1214(e)(1) · 102 Stat. 1107
Substituted · 15 U.S.C. § 2602(7)
Pub. L. 100–418 substituted “general note 2 of the Harmonized Tariff Schedule of the United States” for “general headnote 2 of the Tariff Schedules of the United States”
Source evidence
Code amendment note
Par. (7). Pub. L. 100–418 substituted “general note 2 of the Harmonized Tariff Schedule of the United States” for “general headnote 2 of the Tariff Schedules of the United States”.Enacted provision · exact public law section
(1) Section 3(7) of the Toxic Substances Control Act (15 U.S.C. 2602(7)) is amended by striking out “general headnote 2 of the Tariff Schedules of the United States” and inserting “general note 2 of the Harmonized Tariff Schedule of the United States”.Effective date note
Amendment by Pub. L. 100–418 effective Jan. 1, 1989, and applicable with respect to articles entered on or after such date, see section 1217(b)(1) of Pub. L. 100–418, set out as an Effective Date note under section 3001 of Title 19, Customs Duties.National Defense Authorization Act for Fiscal Year 2016
Pub. L. 114–92 div. A title III § 315 · 129 Stat. 726
Substituted · 15 U.S.C. § 2602(2)(B)(v)
Pub. L. 114–92 substituted “and any component of such an article (limited to shot shells, cartridges, and components of shot shells and cartridges), and” for “, and”
Source evidence
Code amendment note
Par. (2)(B)(v). Pub. L. 114–92 substituted “and any component of such an article (limited to shot shells, cartridges, and components of shot shells and cartridges), and” for “, and”.Enacted provision · exact public law section
SEC. 315. EXCLUSIONS FROM DEFINITION OF “CHEMICAL SUBSTANCE” UNDER TOXIC SUBSTANCES CONTROL ACT. Section 3(2)(B)(v) of the Toxic Substances Control Act (15 U.S.C. 2602(2)(B)(v)) is amended by striking “, and” and inserting “and any component of such an article (limited to shot shells, cartridges, and components of shot shells and cartridges), and”.Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 3(1) · 130 Stat. 448
Added · 15 U.S.C. § 2602(4)(7)
Pub. L. 114–182, § 3(1)–(3), added pars. (4) and (7)
Redesignated · 15 U.S.C. § 2602(4)(7)
Pub. L. 114–182, § 3(1)–(3), redesignated former pars. (4) and (5) as (5) and (6), respectively. Former pars. (6) and (7) redesignated (8) and (9), respectively
Source evidence
Code amendment note
Pars. (4) to (7). Pub. L. 114–182, § 3(1)–(3), added pars. (4) and (7) and redesignated former pars. (4) and (5) as (5) and (6), respectively. Former pars. (6) and (7) redesignated (8) and (9), respectively.Enacted provision · exact public law section
(1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively;Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 19(c)(1) · 130 Stat. 448
Substituted · 15 U.S.C. § 2602(8)
Pub. L. 114–182, § 19(c)(1), substituted “information” for “data”
Source evidence
Code amendment note
Par. (8). Pub. L. 114–182, § 19(c)(1), substituted “information” for “data”.Enacted provision · exact public law section
(1) in paragraph (8) (as redesignated by section 3 of this Act), by striking “data” and inserting “information”; andFrank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 3(1) · 130 Stat. 448
Redesignated · 15 U.S.C. § 2602(8)
Pub. L. 114–182, § 3(1), redesignated par. (6) as (8). Former par. (8) redesignated (10)
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 114–182, § 3(1), redesignated par. (6) as (8). Former par. (8) redesignated (10).Enacted provision · exact public law section
(1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively;Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 3(1) · 130 Stat. 448
Added · 15 U.S.C. § 2602(9)(14)
Pub. L. 114–182, § 3(1), (4), added par. (12)
Redesignated · 15 U.S.C. § 2602(9)(14)
Pub. L. 114–182, § 3(1), (4), redesignated former pars. (7) to (11) as (9), (10), (11), (13), and (14), respectively. Former pars. (12) to (14) redesignated (15) to (17), respectively
Source evidence
Code amendment note
Pars. (9) to (14). Pub. L. 114–182, § 3(1), (4), added par. (12) and redesignated former pars. (7) to (11) as (9), (10), (11), (13), and (14), respectively. Former pars. (12) to (14) redesignated (15) to (17), respectively.Enacted provision · exact public law section
(1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively;Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 19(c)(2)(A) · 130 Stat. 448
Substituted · 15 U.S.C. § 2602(15)
Pub. L. 114–182, § 19(c)(2)(A), (B), in introductory provisions, substituted “protocols and methodologies for the development of information” for “standards for the development of test data”
Source evidence
Code amendment note
Par. (15). Pub. L. 114–182, § 19(c)(2)(A), (B), in introductory provisions, substituted “protocols and methodologies for the development of information” for “standards for the development of test data”.Enacted provision · exact public law section
(A) by striking “standards” and inserting “protocols and methodologies”;Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 3(1) · 130 Stat. 448
Redesignated · 15 U.S.C. § 2602(15)
Pub. L. 114–182, § 3(1), redesignated par. (12) as (15)
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 114–182, § 3(1), redesignated par. (12) as (15).Enacted provision · exact public law section
(1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively;Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 19(c)(2)(C) · 130 Stat. 448
Substituted · 15 U.S.C. § 2602(15)(A)
Pub. L. 114–182, § 19(c)(2)(C), substituted “on such information” for “on such data” in concluding provisions
Source evidence
Code amendment note
Par. (15)(A). Pub. L. 114–182, § 19(c)(2)(C), substituted “on such information” for “on such data” in concluding provisions.Enacted provision · exact public law section
(C) by striking “data” each place it appears and inserting “information”.Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 19(c)(2)(B) · 130 Stat. 448
Substituted · 15 U.S.C. § 2602(15)(A)
Pub. L. 114–182, § 19(c)(2)(B), substituted “for which information” for “for which test data” in concluding provisions
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 114–182, § 19(c)(2)(B), substituted “for which information” for “for which test data” in concluding provisions.Enacted provision · exact public law section
(B) by striking “test data” both places it appears and inserting “information”; andFrank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 19(c)(2)(C) · 130 Stat. 448
Substituted · 15 U.S.C. § 2602(15)(B)
Pub. L. 114–182, § 19(c)(2)(C), substituted “information” for “data” wherever appearing
Source evidence
Code amendment note
Par. (15)(B). Pub. L. 114–182, § 19(c)(2)(C), substituted “information” for “data” wherever appearing.Enacted provision · exact public law section
(C) by striking “data” each place it appears and inserting “information”.Frank R. Lautenberg Chemical Safety for the 21st Century Act
Pub. L. 114–182 § 3(1) · 130 Stat. 448
Redesignated · 15 U.S.C. § 2602(16); 15 U.S.C. § 2602(17)
Pub. L. 114–182, § 3(1), redesignated pars. (13) and (14) as (16) and (17), respectively
Source evidence
Code amendment note
Pars. (16), (17). Pub. L. 114–182, § 3(1), redesignated pars. (13) and (14) as (16) and (17), respectively.Enacted provision · exact public law section
(1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively;
16 of 16 references resolved to an enrolled provision
Editorial Notes
References in Text
The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (2)(B)(ii), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, , 86 Stat. 973, which is classified generally to subchapter II (§ 136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.
The Atomic Energy Act of 1954, referred to in par. (2)(B)(iv), is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch. 1073, § 1, 68 Stat. 919, and amended, which is classified principally to chapter 23 (§ 2011 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 2011 of Title 42 and Tables.
The Harmonized Tariff Schedule of the United States, referred to in par. (9), is not set out in the Code. See Publication of Harmonized Tariff Schedule note set out under section 1202 of Title 19, Customs Duties.
For definition of Canal Zone, Governor of the Canal Zone, and Panama Canal Company, referred to in par. (16), see section 3602(b) of Title 22, Foreign Relations and Intercourse.
Amendments1986–2016 · 4 rounds
2016
Pars. (4) to (7). Pub. L. 114–182, § 3(1)–(3), added pars. (4) and (7) and redesignated former pars. (4) and (5) as (5) and (6), respectively. Former pars. (6) and (7) redesignated (8) and (9), respectively.
Par. (8). Pub. L. 114–182, § 19(c)(1), substituted “information” for “data”.
Pub. L. 114–182, § 3(1), redesignated par. (6) as (8). Former par. (8) redesignated (10).
Pars. (9) to (14). Pub. L. 114–182, § 3(1), (4), added par. (12) and redesignated former pars. (7) to (11) as (9), (10), (11), (13), and (14), respectively. Former pars. (12) to (14) redesignated (15) to (17), respectively.
Par. (15). Pub. L. 114–182, § 19(c)(2)(A), (B), in introductory provisions, substituted “protocols and methodologies for the development of information” for “standards for the development of test data”.
Pub. L. 114–182, § 3(1), redesignated par. (12) as (15).
Par. (15)(A). Pub. L. 114–182, § 19(c)(2)(C), substituted “on such information” for “on such data” in concluding provisions.
Pub. L. 114–182, § 19(c)(2)(B), substituted “for which information” for “for which test data” in concluding provisions.
Par. (15)(B). Pub. L. 114–182, § 19(c)(2)(C), substituted “information” for “data” wherever appearing.
Pars. (16), (17). Pub. L. 114–182, § 3(1), redesignated pars. (13) and (14) as (16) and (17), respectively.
2015
Par. (2)(B)(v). Pub. L. 114–92 substituted “and any component of such an article (limited to shot shells, cartridges, and components of shot shells and cartridges), and” for “, and”.
1988
Par. (7). Pub. L. 100–418 substituted “general note 2 of the Harmonized Tariff Schedule of the United States” for “general headnote 2 of the Tariff Schedules of the United States”.
1986
Par. (2)(B)(v). Pub. L. 99–514 substituted “Internal Revenue Code of 1986” for “Internal Revenue Code of 1954”.
Statutory Notes and Related Subsidiaries
Effective Date of 1988 Amendment
Amendment by Pub. L. 100–418 effective , and applicable with respect to articles entered on or after such date, see section 1217(b)(1) of Pub. L. 100–418, set out as an Effective Date note under section 3001 of Title 19, Customs Duties.
Effective Date
Section effective , see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title.
Credits
1976–2016 · 6 acts
- 1976Pub. L. 94–469, title I, § 3, , 90 Stat. 2004
- 1986Pub. L. 99–514, § 2, , 100 Stat. 2095
- 1986renumbered title I, Pub. L. 99–519, § 3(c)(1), , 100 Stat. 2989
- 1988Pub. L. 100–418, title I, § 1214(e)(1), , 102 Stat. 1156
- 2015Pub. L. 114–92, div. A, title III, § 315, , 129 Stat. 791
- 2016Pub. L. 114–182, title I, §§ 3, 19(c), , 130 Stat. 448, 505.
Show as published
(Pub. L. 94–469, title I, § 3, , 90 Stat. 2004; Pub. L. 99–514, § 2, , 100 Stat. 2095; renumbered title I, Pub. L. 99–519, § 3(c)(1), , 100 Stat. 2989; Pub. L. 100–418, title I, § 1214(e)(1), , 102 Stat. 1156; Pub. L. 114–92, div. A, title III, § 315, , 129 Stat. 791; Pub. L. 114–182, title I, §§ 3, 19(c), , 130 Stat. 448, 505.)