Toxic Substances Control Act

• Author: Environmental Law Reporter
• Pages: 1031-1074

Toxic Substances Control Act

15 U.S.C. §§2601-2692

Subchapter I—Control of Toxic Substances

§2601.[TSCA §2]

Findings, policy, and intent

(a) Findings

The Congress finds that—

(1) human beings and the environment are being exposed each

year to a large number of chemical substances and mixtures;

(2) among the many chemical substances and mixtures which are

constantly being developed and produced, there are some whose

manufacture, processing, distribution in commerce, use, or disposal

may present an unreasonable risk of injury to health or the environ-

ment; and

(3) the effective regulation of interstate commerce in such chemi-

cal substances and mixtures also necessitates the regulation of intra-

state commerce in such chemical substances and mixtures.

(b) Policy

It is the policy of the United States that—

(1) adequate data should be developed with respect to the effect

of chemical substances and mixtures on health and the environment

and that the development of such data should be the responsibility

of those who manufacture and those who process such chemical

substances and mixtures;

(2) adequate authority should exist to regulate chemical sub-

stances and mixtures which present an unreasonable risk of injury

to health or the environment, and to take action with respect to

chemical substances and mixtures which are imminent hazards; and

(3) authority over chemical substances and mixtures should be

exercised in such a manner as not to impede unduly or create un-

necessary economic barriers to technological innovation while

fulfilling the primary purpose of this chapter to assure that such

innovation and commerce in such chemical substances and mix-

tures do not present an unreasonable risk of injury to health or the

environment.

(c) Intent of Congress

It is the intent of Congress that the Administrator shall carry out

this chapter in a reasonable and prudent manner,and that the Admin-

istrator shall consider the environmental, economic, and social im-

pact of any action the Administrator takes or proposes to take under

this chapter.

(Pub. L. 94-469, title I, §2, Oct. 11, 1976, 90 Stat. 2003; redesignated title I,

Pub. L. 99-519, §3(c)(1), Oct. 22, 1986, 100 Stat. 2989.)

Effective Date

Section 31 of title I of Pub. L. 94-469; redesignated title I, Pub. L. 99-519, Sec.

3(c),Oct. 22, 1986, 100 Stat. 2989, provided that: “Except as provided in section 4(f)

[section 2603(f) of this title], this Act [enacting this chapter] shall take effect on

January 1, 1977.”

Short Title of 1992 Amendment

Section 1021(c) of Pub. L. 102-550, Oct. 28, 1992, 106 Stat. 3924, provided that:

“Thissubtitle [enacting subchapter IV] may be cited as the ‘Lead-Based Paint Expo-

sure Reduction Act’.”

Short Title Of 1986 Amendment

Section 1 of Pub. L. 99-519 provided that: “This Act [enacting sections 2641 to

2654 of this title and section 4022 of Title 20, Education, amending sections 2614,

2618, and 2619 of this title and sections 4014 and 4021 of Title20, and enacting pro-

visions set out as a note under section 4014 of Title20] may be cited as the ‘Asbestos

Hazard Emergency Response Act of 1986’.”

Short Title

Section1 of title I of Pub. L. 94-469; redesignated title I, Pub. L. 99-519, Sec. 3(c),

Oct. 22, 1986, 100 Stat. 2989, provided that: “This Act [enacting this chapter and

provisions set out as notes under this section] may be cited as the ‘ToxicSubstances

Control Act’.”

Federal Compliance With Pollution Control Standards

For provisions relating to the responsibility of the head of each Executive agency

for compliance with applicable 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.[TSCA §3]

Definitions

As used in this chapter:

(1) the1term “Administrator” means the Administrator of the En-

vironmental Protection Agency.

(2)(A) Except as provided in subparagraph (B), the term “chemi-

cal substance” means any organic or inorganic substance of a par-

ticular 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 na-

ture 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, Fun-

gicide, 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 by-

product material (as such terms are defined in the Atomic En-

ergy 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 in-

cludes 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 In-

spection 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 out-

side 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 com-

merce” 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 com-

merce, or the introduction or delivery for introduction into com-

merce of, the substance, mixture, or article; or to hold, or the hold-

ing of, the substance, mixture, or article after its introduction into

commerce.

(5) The term “environment” includes water, air, and land and the

TSCA §3 TOXIC SUBSTANCES CONTROL ACT 15 U.S.C. §2602

1031

1. So in original. Probably should be “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 ef-

fect of a chemical substance or mixture on health or the environ-

ment 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 chemi-

cal 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 sub-

stance 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 Vir-

gin 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.

(Pub. L. 94-469, title I, §3, Oct. 11, 1976, 90 Stat. 2004; Pub. L. 99-514, §2,

Oct. 22, 1986, 100 Stat. 2095; redesignated 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 (Sec. 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 EnergyAct 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, Sec. 1, 68 Stat. 921, and amended,

which is classified generally to chapter 23 (Sec. 2011et seq.) of Title 42, The Public

Healthand Welfare. For complete classification of this Act to the Code, see Short Ti-

tle note set out under section 2011 of Title 42 and Tables.

The Harmonized TariffSchedule of the United States, referred to in par. (7), is not

set out in the Code. See Publication of Harmonized TariffSchedule note set out un-

der section 1202 of Title 19, Customs Duties.

For definition of Canal Zone, Governor of the Canal Zone, and Paname Canal

Company,referred to in par. (13), see section 3602(b) of Title 22, Foreign Relations

and Intercourse.

Effective Date Of 1988 Amendment

Amendment by Pub. L. 100-418 effective Jan. 1, 1989, and applicable with re-

spect to articles entered on or after such date, see section 1217(b)(1) of Pub. L.

100-418, set out as an Effective Date noteunder section 3001 of Title 19, Customs

Duties.

§2603.[TSCA §4]

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 com-

bination of such activities, may present an unreasonable risk of in-

jury 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 environ-

ment 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 an-

ticipated 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, proc-

essing, 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 manu-

facture, 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 requirementrule

(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 sub-

stance or mixture, and

(C) with respect to chemical substances which are not new

chemical substances and to mixtures, a specification of the pe-

riod (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 stan-

dards 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 sec-

tion, 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 re-

quired under the rule. Any such rule may require the submission to

15 U.S.C. §2603 ENVIRONMENTALLAW DESKBOOK TSCA §4

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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 carcino-

genesis, mutagenesis, teratogenesis, behavioral disorders, cumula-

tive or synergistic effects, and any other effect which may present

an unreasonable risk of injury to health or the environment. The

characteristics of chemical substances and mixtures for which such

standards may be prescribed include persistence, acute toxicity,

subacute toxicity, chornic toxicity, and any other characteristic

which may present such a risk. The methodologies that may be pre-

scribed in such standards include epidemiologic studies, serial or

hierarchical tests, in vitro tests, and whole animal tests, except that

before prescribing epidemiologic studies of employees, the Admin-

istrator shall consult with the Director of the National Institute for

Occupational Safety and Health.

(B) From time to time, but not less than once each 12 months,

the Administrator shall review the adequacy of the standards for

development of data prescribed in rules under subsection (a) of

this section and shall, if necessary, institute proceedings to make

appropriate revisions of such standards.

(3)(A) A rule under subsection (a) of this section respecting a

chemical substance or mixture shall require the persons described

in subparagraph (B) to conduct tests and submit data to the Admin-

istrator on such substance or mixture, except that the Administrator

may permit two or more of such persons to designate one such per-

son or a qualified third party to conduct such tests and submit such

data on behalf of the persons making the designation.

(B) The following persons shall be required to conduct tests

and submit data on a chemical substance or mixture subject to a

rule under subsection (a) of this section:

(i) Each person who manufactures or intends to manufac-

ture such substance or mixture if the Administrator makes a

finding described in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) of

this section with respect to the manufacture of such substance

or mixture.

(ii) Each person who processes or intends to process such

substance or mixture if the Administrator makes a finding de-

scribed in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) of this sec-

tion with respect to the processing of such substance or

mixture.

(iii) Each person who manufactures or processes or intends

to manufacture or process such substance or mixture if the Ad-

ministrator makes a finding described in subsection

(a)(1)(A)(ii) or (a)(1)(B)(ii) of this section with respect to the

distribution in commerce, use, or disposal of such substance or

mixture.

(4) Any rule under subsection (a) of this section requiring the

testing of and submission of data for a particular chemical sub-

stance or mixture shall expire at the end of the reimbursement pe-

riod (as defined in subsection (c)(3)(B) of this section) which is ap-

plicable to test data for such substance or mixture unless the Admin-

istrator repeals the rule before such date; and a rule under subsec-

tion (a) of this section requiring the testing of and submission of

data for a category of chemical substances or mixtures shall expire

with respect to a chemical substance or mixture included in the cate-

gory at the end of the reimbursement period (as so defined) which is

applicable to test data for such substance or mixture unless the Ad-

ministrator before such date repeals the application of the rule to

such substance or mixture or repeals the rule.

(5) Rules issued under subsection (a) of this section (and any sub-

stantive amendment thereto or repeal thereof) shall be promulgated

pursuant to section 553 of title 5 except that (A) the Administrator

shall give interested persons an opportunity for the oral presentation

of data, views, or arguments, in addition to an opportunity to make

written submissions; (B) a transcript shall be made of any oral pres-

entation; and (C) the Administrator shall make and publish with the

rule the findings described in paragraph (1)(A) or (1)(B) of subsec-

tion (a) of this section and, in the case of a rule respecting a mixture,

the finding described in paragraph (2) of such subsection.

(c) Exemption

(1) Any person required by a rule under subsection (a) of this sec-

tion to conduct tests and submit data on a chemical substance or

mixture may apply to the Administrator (in such form and manner

as the Administrator shall prescribe) for an exemption from such

requirement.

(2) If, upon receipt of an application under paragraph (1), the Ad-

ministrator determines that—

(A) the chemical substance or mixture with respect to which

such application was submitted is equivalent to a chemical sub-

stance or mixture for which data has been submitted to the Ad-

ministrator in accordance with a rule under subsection (a) of this

section or for which data is being developed pursuant to such a

rule, and

(B) submission of data by the applicant on such substance or

mixture would be duplicative of data which has been submitted

to the Administrator in accordance with such rule or which is be-

ing developed pursuant to such rule,

the Administrator shall exempt, in accordance with paragraph (3)

or (4), the applicant from conducting tests and submitting data on

such substance or mixture under the rule with respect to which such

application was submitted.

(3)(A) If the exemption under paragraph (2) of any person from

the requirement to conduct tests and submit test data on a chemical

substance or mixture is granted on the basis of the existence of pre-

viously submitted test data and if such exemption is granted during

the reimbursement period for such test data (as prescribed by sub-

paragraph (B)), then (unless such person and the persons referred to

in clauses (i) and (ii) agree on the amount and method of reimburse-

ment) the Administrator shall order the person granted the exemp-

tion to provide fair and equitable reimbursement (in an amount de-

termined under rules of the Administrator)—

(i) to the person who previously submitted such test data, for

a portion of the costs incurred by such person in complying

with the requirement to submit such data, and

(ii) to any other person who has been required under this

subparagraph to contribute with respect to such costs, for a

portion of the amount such person was required to contribute.

In promulgating rules for the determination of fair and equita-

ble reimbursement to the persons described in clauses (i) and

(ii) for costs incurred with respect to a chemical substance or

mixture, the Administrator shall, after consultation with the

Attorney General and the Federal Trade Commission, con-

sider all relevant factors, including the effect on the competi-

tive position of the person required to provide reimbursement

in relation to the person to be reimbursed and the share of the

market for such substance or mixture of the person required to

provide reimbursement in relation to the share of such market

of the persons to be reimbursed. An order under this subpara-

graph shall, for purposes of judicial review, be considered fi-

nal agency action.

(B) For purposes of subparagraph (A), the reimbursement

period for any test data for a chemical substance or mixture is a

period—

(i) beginning on the date such data is submitted in accor-

dance with a rule promulgated under subsection (a) of this sec-

tion, and

(ii) ending—

(I) five years after the date referred to in clause (i), or

(II) at the expiration of a period which begins on the date

referred to in clause (i) and which is equal to the period

which the Administrator determines was necessary to de-

velop such data,

whichever is later.

(4)(A) If the exemption under paragraph (2) of any person from

the requirement to conduct tests and submit test data on a chemical

substance or mixture is granted on the basis of the fact that test

data is being developed by one or more persons pursuant to a rule

promulgated under subsection (a) of this section, then (unless

such person and the persons referred to in clauses (i) and (ii) agree

on the amount and method of reimbursement) the Administrator

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