Page 1442 TITLE 15—COMMERCE AND TRADE § 2602

1 So 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 [7U.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 InternalRevenue 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 CosmeticAct [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 thissubparagraph 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 suchState, 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 saleof, the substance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or deliveryfor 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 onboth, including underlying data and epidemiological studies, studies of occupational exposureto 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 thechemical 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 inthe 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, thatin 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 substanceor mixture are to be developed and any analysis that is to be performed on such data, and

(B) to the extent necessary to assure thatdata 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 protocolor 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, theCommonwealth 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.)

R EFERENCES IN T EXT

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.

A MENDMENTS

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’’.

E FFECTIVE D ATE OF 1988 A MENDMENT

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 mixturewith 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 anticipatedto 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 mixturewith 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 onhealth 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 thattesting 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 Administratordata 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 suchrule 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, andany other effect which may present an unreasonable risk of injury to health or the environment.