§ 2602 TITLE 15—COMMERCE AND TRADE Page 1442 

1So in original. Probably should be capitalized. 

plicable pollution control standards, see Ex. Ord. No. 

12088, Oct. 13, 1978, 43 F.R. 47707, set out as a note under 

section 4321 of Title 42, The Public Health and Welfare. 

§ 2602. Definitions 

As used in this chapter: 

(1) the 1 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 [7 

U.S.C. 136 et seq.]) 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 of 1954 

[42 U.S.C. 2011 et seq.] 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 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 

(vi) 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]). 

(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 (B) 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 chapter. 

(7) 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. 

(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 2607(b) of this title. 

(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, 
Page 1443 TITLE 15—COMMERCE AND TRADE § 2603 

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. 

(Pub. L. 94–469, title I, §3, Oct. 11, 1976, 90 Stat. 

2004; Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 

2095; renumbered title I, Pub. L. 99–519, §3(c)(1), 

Oct. 22, 1986, 100 Stat. 2989; Pub. L. 100–418, title 

I, §1214(e)(1), Aug. 23, 1988, 102 Stat. 1156.) 

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, Oct. 21, 

1972, 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. 921, and amended, 

which is classified generally 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. (7), 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. 

(13), see section 3602(b) of Title 22, Foreign Relations 

and Intercourse. 

AMENDMENTS

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’’. 

EFFECTIVE DATE OF 1988 AMENDMENT

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. 

§ 2603. Testing of chemical substances and mixtures 

(a) Testing requirements 

If the Administrator finds that— 

(1)(A)(i) the manufacture, distribution in 

commerce, processing, use, or disposal of a 

chemical substance or mixture, or that any 

combination of such activities, may present 

an unreasonable risk of injury to health or the 

environment, 

(ii) there are insufficient data and experience upon which the effects of such manufacture, distribution in commerce, processing, 

use, or disposal of such substance or mixture 

or of any combination of such activities on 

health or the environment can reasonably be 

determined or predicted, and 

(iii) testing of such substance or mixture 

with respect to such effects is necessary to develop such data; or 

(B)(i) a chemical substance or mixture is or 

will be produced in substantial quantities, and 

(I) it enters or may reasonably be anticipated 

to enter the environment in substantial quantities or (II) there is or may be significant or 

substantial human exposure to such substance 

or mixture, 

(ii) there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, 

use, or disposal of such substance or mixture 

or of any combination of such activities on 

health or the environment can reasonably be 

determined or predicted, and 

(iii) testing of such substance or mixture 

with respect to such effects is necessary to develop such data; and 

(2) in the case of a mixture, the effects which 

the mixture’s manufacture, distribution in 

commerce, processing, use, or disposal or any 

combination of such activities may have on 

health or the environment may not be reasonably and more efficiently determined or predicted by testing the chemical substances 

which comprise the mixture; 

the Administrator shall by rule require that 

testing be conducted on such substance or mixture to develop data with respect to the health 

and environmental effects for which there is an 

insufficiency of data and experience and which 

are relevant to a determination that the manufacture, distribution in commerce, processing, 

use, or disposal of such substance or mixture, or 

that any combination of such activities, does or 

does not present an unreasonable risk of injury 

to health or the environment. 

(b) Testing requirement rule 

(1) A rule under subsection (a) of this section 

shall include— 

(A) identification of the chemical substance 

or mixture for which testing is required under 

the rule, 

(B) standards for the development of test 

data for such substance or mixture, and 

(C) with respect to chemical substances 

which are not new chemical substances and to 

mixtures, a specification of the period (which 

period may not be of unreasonable duration) 

within which the persons required to conduct 

the testing shall submit to the Administrator 

data developed in accordance with the standards referred to in subparagraph (B). 

In determining the standards and period to be 

included, pursuant to subparagraphs (B) and (C), 

in a rule under subsection (a) of this section, the 

Administrator’s considerations shall include the 

relative costs of the various test protocols and 

methodologies which may be required under the 

rule and the reasonably foreseeable availability 

of the facilities and personnel needed to perform 

the testing required under the rule. Any such 

rule may require the submission to the Administrator of preliminary data during the period prescribed under subparagraph (C). 

(2)(A) The health and environmental effects 

for which standards for the development of test 

data may be prescribed include carcinogenesis, 

mutagenesis, teratogenesis, behavioral disorders, cumulative or synergistic effects, and 

any other effect which may present an unreasonable risk of injury to health or the environment.