US (United States) Code. Title 15. Chapter 53: Toxic substances control

Codificación normativa de EEUU (Estados Unidos). Legislación federal estadounidense # Commerce and Trade

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15 USC CHAPTER 53 - TOXIC SUBSTANCES CONTROL 01/06/03

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TITLE 15 - COMMERCE AND TRADE

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

.

-HEAD-

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

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SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

Sec.

2601. Findings, policy, and intent.

(a) Findings.

(b) Policy.

(c) Intent of Congress.

2602. Definitions.

2603. Testing of chemical substances and mixtures.

(a) Testing requirements.

(b) Testing requirement rule.

(c) Exemption.

(d) Notice.

(e) Priority list.

(f) Required actions.

(g) Petition for standards for the development of

test data.

2604. Manufacturing and processing notices.

(a) In general.

(b) Submission of test data.

(c) Extension of notice period.

(d) Content of notice; publications in the Federal

Register.

(e) Regulation pending development of information.

(f) Protection against unreasonable risks.

(g) Statement of reasons for not taking action.

(h) Exemptions.

(i) ''Manufacture'' and ''process'' defined.

2605. Regulation of hazardous chemical substances and mixtures.

(a) Scope of regulation.

(b) Quality control.

(c) Promulgation of subsection (a) rules.

(d) Effective date.

(e) Polychlorinated biphenyls.

2606. Imminent hazards.

(a) Actions authorized and required.

(b) Relief authorized.

(c) Venue and consolidation.

(d) Action under section 2605.

(e) Representation.

(f) ''Imminently hazardous chemical substance or

mixture'' defined.

2607. Reporting and retention of information.

(a) Reports.

(b) Inventory.

(c) Records.

(d) Health and safety studies.

(e) Notice to Administrator of substantial risks.

(f) ''Manufacture'' and ''process'' defined.

2608. Relationship to other Federal laws.

(a) Laws not administered by the Administrator.

(b) Laws administered by the Administrator.

(c) Occupational safety and health.

(d) Coordination.

2609. Research, development, collection, dissemination, and

utilization of data.

(a) Authority.

(b) Data systems.

(c) Screening techniques.

(d) Monitoring.

(e) Basic research.

(f) Training.

(g) Exchange of research and development results.

2610. Inspections and subpoenas.

(a) In general.

(b) Scope.

(c) Subpoenas.

2611. Exports.

(a) In general.

(b) Notice.

2612. Entry into customs territory of the United States.

(a) In general.

(b) Rules.

2613. Disclosure of data.

(a) In general.

(b) Data from health and safety studies.

(c) Designation and release of confidential data.

(d) Criminal penalty for wrongful disclosure.

(e) Access by Congress.

2614. Prohibited acts.

2615. Penalties.

(a) Civil.

(b) Criminal.

2616. Specific enforcement and seizure.

(a) Specific enforcement.

(b) Seizure.

2617. Preemption.

(a) Effect on State law.

(b) Exemption.

2618. Judicial review.

(a) In general.

(b) Additional submissions and presentations;

modifications.

(c) Standard of review.

(d) Fees and costs.

(e) Other remedies.

2619. Citizens' civil actions.

(a) In general.

(b) Limitation.

(c) General.

(d) Consolidation.

2620. Citizens' petitions.

(a) In general.

(b) Procedures.

2621. National defense waiver.

2622. Employee protection.

(a) In general.

(b) Remedy.

(c) Review.

(d) Enforcement.

(e) Exclusion.

2623. Employment effects.

(a) In general.

(b) Investigations.

2624. Studies.

(a) Indemnification study.

(b) Classification, storage, and retrieval study.

2625. Administration.

(a) Cooperation of Federal agencies.

(b) Fees.

(c) Action with respect to categories.

(d) Assistance office.

(e) Financial disclosures.

(f) Statement of basis and purpose.

(g) Assistant Administrator.

2626. Development and evaluation of test methods.

(a) In general.

(b) Approval by Secretary.

2627. State programs.

(a) In general.

(b) Approval by Administrator.

(c) Annual reports.

(d) Authorization.

2628. Authorization of appropriations.

2629. Annual report.

SUBCHAPTER II - ASBESTOS HAZARD EMERGENCY RESPONSE

2641. Congressional findings and purpose.

(a) Findings.

(b) Purpose.

2642. Definitions.

2643. EPA regulations.

(a) In general.

(b) Inspection.

(c) Circumstances requiring response actions.

(d) Response actions.

(e) Implementation.

(f) Operations and maintenance.

(g) Periodic surveillance.

(h) Transportation and disposal.

(i) Management plans.

(j) Changes in regulations.

(k) Changes in guidance document.

(l) Treatment of Department of Defense schools.

(m) Waiver.

2644. Requirements if EPA fails to promulgate regulations.

(a) In general.

(b) Inspection.

(c) Operation and maintenance.

(d) Management plan.

(e) Building occupant protection.

(f) Transportation and disposal.

2645. Submission to State Governor.

(a) Submission.

(b) Governor requirements.

(c) Management plan review.

(d) Deferral of submission.

(e) Status reports.

2646. Contractor and laboratory accreditation.

(a) Contractor accreditation.

(b) Accreditation by State.

(c) Accreditation by Administrator-approved course.

(d) Laboratory accreditation.

(e) Financial assistance contingent on use of

accredited persons.

(f) List of EPA-approved courses.

2647. Enforcement.

(a) Penalties.

(b) Relationship to subchapter I of this chapter.

(c) Enforcement considerations.

(d) Citizen complaints.

(e) Citizen petitions.

(f) Citizen civil actions with respect to EPA

regulations.

(g) Failure to attain accreditation; penalty.

2648. Emergency authority.

(a) Emergency action.

(b) Injunctive relief.

2649. State and Federal law.

(a) No preemption.

(b) Cost and damage awards.

(c) State may establish more requirements.

(d) No Federal cause of action.

(e) Intent of Congress.

2650. Asbestos contractors and local educational agencies.

(a) Study.

(b) State action.

2651. Public protection.

(a) Public protection.

(b) Labor Department review.

2652. Asbestos Ombudsman.

(a) Appointment.

(b) Duties.

2653. EPA Study of asbestos-containing material in public

buildings.

2654. Transitional rules.

2655. Worker protection.

(a) Prohibition on certain activities.

(b) Employee training and equipment.

(c) ''Emergency repair'' defined.

2656. Training grants.

(a) Grants.

(b) Authorization.

SUBCHAPTER III - INDOOR RADON ABATEMENT

2661. National goal.

2662. Definitions.

2663. EPA citizen's guide.

(a) Publication.

(b) Information included.

2664. Model construction standards and techniques.

2665. Technical assistance to States for radon programs.

(a) Required activities.

(b) Discretionary assistance.

(c) Information provided to professional

organizations.

(d) Proficiency rating program and training seminar.

(e) Authorization.

2666. Grant assistance to States for radon programs.

(a) In general.

(b) Application.

(c) Eligible activities.

(d) Preference to certain States.

(e) Priority activities and projects.

(f) Federal share.

(g) Assistance to local governments.

(h) Information.

(i) Limitations.

(j) Authorization.

2667. Radon in schools.

(a) Study of radon in schools.

(b) Authorization.

2668. Regional radon training centers.

(a) Funding program.

(b) Purpose of centers.

(c) Applications.

(d) Selection criteria.

(e) Termination of funding.

(f) Authorization.

2669. Study of radon in Federal buildings.

(a) Study requirement.

(b) High-risk Federal buildings.

(c) Study designs.

(d) Information on risks and testing.

(e) Study deadline.

(f) Report to Congress.

2670. Regulations.

2671. Additional authorizations.

SUBCHAPTER IV - LEAD EXPOSURE REDUCTION

2681. Definitions.

2682. Lead-based paint activities training and certification.

(a) Regulations.

(b) Lead-based paint activities.

(c) Renovation and remodeling.

2683. Identification of dangerous levels of lead.

2684. Authorized State programs.

(a) Approval.

(b) Approval or disapproval.

(c) Withdrawal of authorization.

(d) Model State program.

(e) Other State requirements.

(f) State and local certification.

(g) Grants to States.

(h) Enforcement by Administrator.

2685. Lead abatement and measurement.

(a) Program to promote lead exposure abatement.

(b) Standards for environmental sampling

laboratories.

(c) Exposure studies.

(d) Public education.

(e) Technical assistance.

(f) Products for lead-based paint activities.

2686. Lead hazard information pamphlet.

(a) Lead hazard information pamphlet.

(b) Renovation of target housing.

2687. Regulations.

2688. Control of lead-based paint hazards at Federal facilities.

2689. Prohibited acts.

2690. Relationship to other Federal law.

2691. General provisions relating to administrative proceedings.

(a) Applicability.

(b) Rulemaking docket.

(c) Inspection and copying.

(d) Explanation.

(e) Judicial review.

(f) Effective date.

2692. Authorization of appropriations.

-SECREF-

CHAPTER REFERRED TO IN OTHER SECTIONS

This chapter is referred to in title 10 section 2704; title 16

section 460lll; title 21 section 346a; title 42 sections 4365,

4852d, 6911a, 7412, 9601, 9604, 9621, 9628.

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15 USC SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES 01/06/03

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TITLE 15 - COMMERCE AND TRADE

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

.

-HEAD-

SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

-SECREF-

SUBCHAPTER REFERRED TO IN OTHER SECTIONS

This subchapter is referred to in sections 2647, 2654 of this

title.

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15 USC Sec. 2601 01/06/03

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TITLE 15 - COMMERCE AND TRADE

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

-HEAD-

Sec. 2601. Findings, policy, and intent

-STATUTE-

(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 environment; and

(3) the effective regulation of interstate commerce in such

chemical substances and mixtures also necessitates the regulation

of intrastate 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

substances 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

unnecessary 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

mixtures 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

Administrator shall consider the environmental, economic, and

social impact of any action the Administrator takes or proposes to

take under this chapter.

-SOURCE-

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

renumbered title I, Pub. L. 99-519, Sec. 3(c)(1), Oct. 22, 1986,

100 Stat. 2989.)

-MISC1-

EFFECTIVE DATE

Section 31 of title I of Pub. L. 94-469; renumbered 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

Pub. L. 102-550, title X, Sec. 1021(c), Oct. 28, 1992, 106 Stat.

3924, provided that: ''This subtitle (subtitle B (Sec. 1021) of

title X of Pub. L. 102-550, enacting sections 2681 to 2692 of this

title and amending sections 2606, 2610, 2612, 2615, 2616, 2618, and

2619 of this title) may be cited as the 'Lead-Based Paint Exposure

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 Title 20, and enacting provisions set out

as a note under section 4014 of Title 20) may be cited as the

'Asbestos Hazard Emergency Response Act of 1986'.''

SHORT TITLE

Section 1 of title I of Pub. L. 94-469; renumbered 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 'Toxic Substances 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.

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15 USC Sec. 2602 01/06/03

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TITLE 15 - COMMERCE AND TRADE

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

-HEAD-

Sec. 2602. Definitions

-STATUTE-

As used in this chapter:

(1) the (FOOTNOTE 1) term ''Administrator'' means the

Administrator of the Environmental Protection Agency.

(FOOTNOTE 1) So in original. Probably should be capitalized.

(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, 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.

-SOURCE-

(Pub. L. 94-469, title I, Sec. 3, Oct. 11, 1976, 90 Stat. 2004;

Pub. L. 99-514, Sec. 2, Oct. 22, 1986, 100 Stat. 2095; renumbered

title I, Pub. L. 99-519, Sec. 3(c)(1), Oct. 22, 1986, 100 Stat.

2989; Pub. L. 100-418, title I, Sec. 1214(e)(1), Aug. 23, 1988, 102

Stat. 1156.)

-REFTEXT-

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 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,

Sec. 1, 68 Stat. 921, and amended, which is classified generally to

chapter 23 (Sec. 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.

-MISC2-

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.

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15 USC Sec. 2603 01/06/03

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TITLE 15 - COMMERCE AND TRADE

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

-HEAD-

Sec. 2603. Testing of chemical substances and mixtures

-STATUTE-

(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. The characteristics of chemical substances and

mixtures for which such standards may be prescribed include

persistence, acute toxicity, subacute toxicity, chronic toxicity,

and any other characteristic which may present such a risk. The

methodologies that may be prescribed 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 Administrator 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

Administrator on such substance or mixture, except that the

Administrator may permit two or more of such persons to designate

one such person 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 manufacture 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

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

section 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

Administrator 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

substance or mixture shall expire at the end of the reimbursement

period (as defined in subsection (c)(3)(B) of this section) which

is applicable to test data for such substance or mixture unless the

Administrator repeals the rule before such date; and a rule under

subsection (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 category at the end of the reimbursement

period (as so defined) which is applicable to test data for such

substance or mixture unless the Administrator 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

substantive 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 presentation; and (C) the Administrator shall make

and publish with the rule the findings described in paragraph

(1)(A) or (1)(B) of subsection (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

section 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

Administrator determines that -

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

such application was submitted is equivalent to a chemical

substance or mixture for which data has been submitted to the

Administrator 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 being

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

previously submitted test data and if such exemption is granted

during the reimbursement period for such test data (as prescribed

by subparagraph (B)), then (unless such person and the persons

referred to in clauses (i) and (ii) agree on the amount and method

of reimbursement) the Administrator shall order the person granted

the exemption to provide fair and equitable reimbursement (in an

amount determined 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 equitable

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, consider all relevant factors,

including the effect on the competitive 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 subparagraph shall, for purposes of judicial

review, be considered final 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 accordance

with a rule promulgated under subsection (a) of this section, 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 develop

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 shall

order the person granted the exemption to provide fair and

equitable reimbursement (in an amount determined under rules of the

Administrator) -

(i) to each such person who is developing such test data, for a

portion of the costs incurred by each such person in complying

with such rule, and

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

subparagraph to contribute with respect to the costs of complying

with such rule, for a portion of the amount such person was

required to contribute.

In promulgating rules for the determination of fair and equitable

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, consider the factors described in

the second sentence of paragraph (3)(A). An order under this

subparagraph shall, for purposes of judicial review, be considered

final agency action.

(B) If any exemption is granted under paragraph (2) on the basis

of the fact that one or more persons are developing test data

pursuant to a rule promulgated under subsection (a) of this section

and if after such exemption is granted the Administrator determines

that no such person has complied with such rule, the Administrator

shall (i) after providing written notice to the person who holds

such exemption and an opportunity for a hearing, by order terminate

such exemption, and (ii) notify in writing such person of the

requirements of the rule with respect to which such exemption was

granted.

(d) Notice

Upon the receipt of any test data pursuant to a rule under

subsection (a) of this section, the Administrator shall publish a

notice of the receipt of such data in the Federal Register within

15 days of its receipt. Subject to section 2613 of this title,

each such notice shall (1) identify the chemical substance or

mixture for which data have been received; (2) list the uses or

intended uses of such substance or mixture and the information

required by the applicable standards for the development of test

data; and (3) describe the nature of the test data developed.

Except as otherwise provided in section 2613 of this title, such

data shall be made available by the Administrator for examination

by any person.

(e) Priority list

(1)(A) There is established a committee to make recommendations

to the Administrator respecting the chemical substances and

mixtures to which the Administrator should give priority

consideration for the promulgation of a rule under subsection (a)

of this section. In making such a recommendation with respect to

any chemical substance or mixture, the committee shall consider all

relevant factors, including -

(i) the quantities in which the substance or mixture is or will

be manufactured,

(ii) the quantities in which the substance or mixture enters or

will enter the environment,

(iii) the number of individuals who are or will be exposed to

the substance or mixture in their places of employment and the

duration of such exposure,

(iv) the extent to which human beings are or will be exposed to

the substance or mixture,

(v) the extent to which the substance or mixture is closely

related to a chemical substance or mixture which is known to

present an unreasonable risk of injury to health or the

environment,

(vi) the existence of data concerning the effects of the

substance or mixture on health or the environment,

(vii) the extent to which testing of the substance or mixture

may result in the development of data upon which the effects of

the substance or mixture on health or the environment can

reasonably be determined or predicted, and

(viii) the reasonably foreseeable availability of facilities

and personnel for performing testing on the substance or mixture.

The recommendations of the committee shall be in the form of a list

of chemical substances and mixtures which shall be set forth,

either by individual substance or mixture or by groups of

substances or mixtures, in the order in which the committee

determines the Administrator should take action under subsection

(a) of this section with respect to the substances and mixtures.

In establishing such list, the committee shall give priority

attention to those chemical substances and mixtures which are known

to cause or contribute to or which are suspected of causing or

contributing to cancer, gene mutations, or birth defects. The

committee shall designate chemical substances and mixtures on the

list with respect to which the committee determines the

Administrator should, within 12 months of the date on which such

substances and mixtures are first designated, initiate a proceeding

under subsection (a) of this section. The total number of chemical

substances and mixtures on the list which are designated under the

preceding sentence may not, at any time, exceed 50.

(B) As soon as practicable but not later than nine months after

January 1, 1977, the committee shall publish in the Federal

Register and transmit to the Administrator the list and

designations required by subparagraph (A) together with the reasons

for the committee's inclusion of each chemical substance or mixture

on the list. At least every six months after the date of the

transmission to the Administrator of the list pursuant to the

preceeding (FOOTNOTE 1) sentence, the committee shall make such

previsions in the list as it determines to be necessary and shall

transmit them to the Administrator together with the committee's

reasons for the revisions. Upon receipt of any such revision, the

Administrator shall publish in the Federal Register the list with

such revision, the reasons for such revision, and the designations

made under subparagraph (A). The Administrator shall provide

reasonable opportunity to any interested person to file with the

Administrator written comments on the committee's list, any

revision of such list by the committee, and designations made by

the committee, and shall make such comments available to the

public. Within the 12-month period beginning on the date of the

first inclusion on the list of a chemical substance or mixture

designated by the committee under subparagraph (A) the

Administrator shall with respect to such chemical substance or

mixture either initiate a rulemaking proceeding under subsection

(a) of this section or if such a proceeding is not initiated within

such period, publish in the Federal Register the Administrator's

reason for not initiating such a proceeding.

(FOOTNOTE 1) So in original. Probably should be ''preceding''.

(2)(A) The committee established by paragraph (1)(A) shall

consist of eight members as follows:

(i) One member appointed by the Administrator from the

Environmental Protection Agency.

(ii) One member appointed by the Secretary of Labor from

officers or employees of the Department of Labor engaged in the

Secretary's activities under the Occupational Safety and Health

Act of 1970 (29 U.S.C. 651 et seq.).

(iii) One member appointed by the Chairman of the Council on

Environmental Quality from the Council or its officers or

employees.

(iv) One member appointed by the Director of the National

Institute for Occupational Safety and Health from officers or

employees of the Institute.

(v) One member appointed by the Director of the National

Institute of Environmental Health Sciences from officers or

employees of the Institute.

(vi) One member appointed by the Director of the National

Cancer Institute from officers or employees of the Institute.

(vii) One member appointed by the Director of the National

Science Foundation from officers or employees of the Foundation.

(viii) One member appointed by the Secretary of Commerce from

officers or employees of the Department of Commerce.

(B)(i) An appointed member may designate an individual to serve

on the committee on the member's behalf. Such a designation may be

made only with the approval of the applicable appointing authority

and only if the individual is from the entity from which the member

was appointed.

(ii) No individual may serve as a member of the committee for

more than four years in the aggregate. If any member of the

committee leaves the entity from which the member was appointed,

such member may not continue as a member of the committee, and the

member's position shall be considered to be vacant. A vacancy in

the committee shall be filled in the same manner in which the

original appointment was made.

(iii) Initial appointments to the committee shall be made not

later than the 60th day after January 1, 1977. Not later than the

90th day after such date the members of the committee shall hold a

meeting for the selection of a chairperson from among their number.

(C)(i) No member of the committee, or designee of such member,

shall accept employment or compensation from any person subject to

any requirement of this chapter or of any rule promulgated or order

issued thereunder, for a period of at least 12 months after

termination of service on the committee.

(ii) No person, while serving as a member of the committee, or

designee of such member, may own any stocks or bonds, or have any

pecuniary interest, of substantial value in any person engaged in

the manufacture, processing, or distribution in commerce of any

chemical substance or mixture subject to any requirement of this

chapter or of any rule promulgated or order issued thereunder.

(iii) The Administrator, acting through attorneys of the

Environmental Protection Agency, or the Attorney General may bring

an action in the appropriate district court of the United States to

restrain any violation of this subparagraph.

(D) The Administrator shall provide the committee such

administrative support services as may be necessary to enable the

committee to carry out its function under this subsection.

(f) Required actions

Upon the receipt of -

(1) any test data required to be submitted under this chapter,

or

(2) any other information available to the Administrator,

which indicates to the Administrator that there may be a reasonable

basis to conclude that a chemical substance or mixture presents or

will present a significant risk of serious or widespread harm to

human beings from cancer, gene mutations, or birth defects, the

Administrator shall, within the 180-day period beginning on the

date of the receipt of such data or information, initiate

appropriate action under section 2604, 2605, or 2606 of this title

to prevent or reduce to a sufficient extent such risk or publish in

the Federal Register a finding that such risk is not unreasonable.

For good cause shown the Administrator may extend such period for

an additional period of not more than 90 days. The Administrator

shall publish in the Federal Register notice of any such extension

and the reasons therefor. A finding by the Administrator that a

risk is not unreasonable shall be considered agency action for

purposes of judicial review under chapter 7 of title 5. This

subsection shall not take effect until two years after January 1,

1977.

(g) Petition for standards for the development of test data

A person intending to manufacture or process a chemical substance

for which notice is required under section 2604(a) of this title

and who is not required under a rule under subsection (a) of this

section to conduct tests and submit data on such substance may

petition the Administrator to prescribe standards for the

development of test data for such substance. The Administrator

shall by order either grant or deny any such petition within 60

days of its receipt. If the petition is granted, the Administrator

shall prescribe such standards for such substance within 75 days of

the date the petition is granted. If the petition is denied, the

Administrator shall publish, subject to section 2613 of this title,

in the Federal Register the reasons for such denial.

-SOURCE-

(Pub. L. 94-469, title I, Sec. 4, Oct. 11, 1976, 90 Stat. 2006;

renumbered title I, Pub. L. 99-519, Sec. 3(c)(1), Oct. 22, 1986,

100 Stat. 2989.)

-REFTEXT-

REFERENCES IN TEXT

The Occupational Safety and Health Act of 1970, referred to in

text, is Pub. L. 91-596, Dec. 29, 1970, 84 Stat. 1590, as amended,

which is classified principally to chapter 15 (Sec. 651 et seq.) of

Title 29, Labor. For complete classification of this Act to the

Code, see Short Title note set out under section 651 of Title 29

and Tables.

-MISC2-

EFFECTIVE DATE

Section effective Jan. 1, 1977, except as provided in subsec. (f)

of this section, see section 31 of Pub. L. 94-469, set out as a

note under section 2601 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 2604, 2606, 2607, 2611,

2613, 2614, 2617 to 2620, 2623, 2625, 2626, 2630 of this title;

title 21 section 346a; title 42 section 9604.

-CITE-

15 USC Sec. 2604 01/06/03

-EXPCITE-

TITLE 15 - COMMERCE AND TRADE

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

-HEAD-

Sec. 2604. Manufacturing and processing notices

-STATUTE-

(a) In general

(1) Except as provided in subsection (h) of this section, no

person may -

(A) manufacture a new chemical substance on or after the 30th

day after the date on which the Administrator first publishes the

list required by section 2607(b) of this title, or

(B) manufacture or process any chemical substance for a use

which the Administrator has determined, in accordance with

paragraph (2), is a significant new use,

unless such person submits to the Administrator, at least 90 days

before such manufacture or processing, a notice, in accordance with

subsection (d) of this section, of such person's intention to

manufacture or process such substance and such person complies with

any applicable requirement of subsection (b) of this section.

(2) A determination by the Administrator that a use of a chemical

substance is a significant new use with respect to which

notification is required under paragraph (1) shall be made by a

rule promulgated after a consideration of all relevant factors,

including -

(A) the projected volume of manufacturing and processing of a

chemical substance,

(B) the extent to which a use changes the type or form of

exposure of human beings or the environment to a chemical

substance,

(C) the extent to which a use increases the magnitude and

duration of exposure of human beings or the environment to a

chemical substance, and

(D) the reasonably anticipated manner and methods of

manufacturing, processing, distribution in commerce, and disposal

of a chemical substance.

(b) Submission of test data

(1)(A) If (i) a person is required by subsection (a)(1) of this

section to submit a notice to the Administrator before beginning

the manufacture or processing of a chemical substance, and (ii)

such person is required to submit test data for such substance

pursuant to a rule promulgated under section 2603 of this title

before the submission of such notice, such person shall submit to

the Administrator such data in accordance with such rule at the

time notice is submitted in accordance with subsection (a)(1) of

this section.

(B) If -

(i) a person is required by subsection (a)(1) of this section

to submit a notice to the Administrator, and

(ii) such person has been granted an exemption under section

2603(c) of this title from the requirements of a rule promulgated

under section 2603 of this title before the submission of such

notice,

such person may not, before the expiration of the 90 day period

which begins on the date of the submission in accordance with such

rule of the test data the submission or development of which was

the basis for the exemption, manufacture such substance if such

person is subject to subsection (a)(1)(A) of this section or

manufacture or process such substance for a significant new use if

the person is subject to subsection (a)(1)(B) of this section.

(2)(A) If a person -

(i) is required by subsection (a)(1) of this section to submit

a notice to the Administrator before beginning the manufacture or

processing of a chemical substance listed under paragraph (4),

and

(ii) is not required by a rule promulgated under section 2603

of this title before the submission of such notice to submit test

data for such substance,

such person shall submit to the Administrator data prescribed by

subparagraph (B) at the time notice is submitted in accordance with

subsection (a)(1) of this section.

(B) Data submitted pursuant to subparagraph (A) shall be data

which the person submitting the data believes show that -

(i) in the case of a substance with respect to which notice is

required under subsection (a)(1)(A) of this section, the

manufacture, processing, distribution in commerce, use, and

disposal of the chemical substance or any combination of such

activities will not present an unreasonable risk of injury to

health or the environment, or

(ii) in the case of a chemical substance with respect to which

notice is required under subsection (a)(1)(B) of this section,

the intended significant new use of the chemical substance will

not present an unreasonable risk of injury to health or the

environment.

(3) Data submitted under paragraph (1) or (2) shall be made

available, subject to section 2613 of this title, for examination

by interested persons.

(4)(A)(i) The Administrator may, by rule, compile and keep

current a list of chemical substances with respect to which the

Administrator finds that the manufacture, processing, distribution

in commerce, use, or disposal, or any combination of such

activities, presents or may present an unreasonable risk of injury

to health or the environment.

(ii) In making a finding under clause (i) that the manufacture,

processing, distribution in commerce, use, or disposal of a

chemical substance or any combination of such activities presents

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

environment, the Administrator shall consider all relevant factors,

including -

(I) the effects of the chemical substance on health and the

magnitude of human exposure to such substance; and

(II) the effects of the chemical substance on the environment

and the magnitude of environmental exposure to such substance.

(B) The Administrator shall, in prescribing a rule under

subparagraph (A) which lists any chemical substance, identify those

uses, if any, which the Administrator determines, by rule under

subsection (a)(2) of this section, would constitute a significant

new use of such substance.

(C) Any rule under subparagraph (A), and any substantive

amendment or repeal of such a rule, shall be promulgated pursuant

to the procedures specified in section 553 of title 5, except that

(i) 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, (ii) a transcript

shall be kept of any oral presentation, and (iii) the Administrator

shall make and publish with the rule the finding described in

subparagraph (A).

(c) Extension of notice period

The Administrator may for good cause extend for additional

periods (not to exceed in the aggregate 90 days) the period,

prescribed by subsection (a) or (b) of this section before which

the manufacturing or processing of a chemical substance subject to

such subsection may begin. Subject to section 2613 of this title,

such an extension and the reasons therefor shall be published in

the Federal Register and shall constitute a final agency action

subject to judicial review.

(d) Content of notice; publications in the Federal Register

(1) The notice required by subsection (a) of this section shall

include -

(A) insofar as known to the person submitting the notice or

insofar as reasonably ascertainable, the information described in

subparagraphs (A), (B), (C), (D), (F), and (G) of section

2607(a)(2) of this title, and

(B) in such form and manner as the Administrator may prescribe,

any test data in the possession or control of the person giving

such notice which are related to the effect of any manufacture,

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

substance or any article containing such substance, or of any

combination of such activities, on health or the environment, and

(C) a description of any other data concerning the

environmental and health effects of such substance, insofar as

known to the person making the notice or insofar as reasonably

ascertainable.

Such a notice shall be made available, subject to section 2613 of

this title, for examination by interested persons.

(2) Subject to section 2613 of this title, not later than five

days (excluding Saturdays, Sundays and legal holidays) after the

date of the receipt of a notice under subsection (a) of this

section or of data under subsection (b) of this section, the

Administrator shall publish in the Federal Register a notice which

-

(A) identifies the chemical substance for which notice or data

has been received;

(B) lists the uses or intended uses of such substance; and

(C) in the case of the receipt of data under subsection (b) of

this section, describes the nature of the tests performed on such

substance and any data which was developed pursuant to subsection

(b) of this section or a rule under section 2603 of this title.

A notice under this paragraph respecting a chemical substance shall

identify the chemical substance by generic class unless the

Administrator determines that more specific identification is

required in the public interest.

(3) At the beginning of each month the Administrator shall

publish a list in the Federal Register of (A) each chemical

substance for which notice has been received under subsection (a)

of this section and for which the notification period prescribed by

subsection (a), (b), or (c) of this section has not expired, and

(B) each chemical substance for which such notification period has

expired since the last publication in the Federal Register of such

list.

(e) Regulation pending development of information

(1)(A) If the Administrator determines that -

(i) the information available to the Administrator is

insufficient to permit a reasoned evaluation of the health and

environmental effects of a chemical substance with respect to

which notice is required by subsection (a) of this section; and

(ii)(I) in the absence of sufficient information to permit the

Administrator to make such an evaluation, the manufacture,

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

substance, or any combination of such activities, may present an

unreasonable risk of injury to health or the environment, or

(II) such substance is or will be produced in substantial

quantities, and such substance either enters or may reasonably be

anticipated to enter the environment in substantial quantities or

there is or may be significant or substantial human exposure to

the substance,

the Administrator may issue a proposed order, to take effect on the

expiration of the notification period applicable to the

manufacturing or processing of such substance under subsection (a),

(b), or (c) of this section, to prohibit or limit the manufacture,

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

substance or to prohibit or limit any combination of such

activities.

(B) A proposed order may not be issued under subparagraph (A)

respecting a chemical substance (i) later than 45 days before the

expiration of the notification period applicable to the manufacture

or processing of such substance under subsection (a), (b), or (c)

of this section, and (ii) unless the Administrator has, on or

before the issuance of the proposed order, notified, in writing,

each manufacturer or processor, as the case may be, of such

substance of the determination which underlies such order.

(C) If a manufacturer or processor of a chemical substance to be

subject to a proposed order issued under subparagraph (A) files

with the Administrator (within the 30-day period beginning on the

date such manufacturer or processor received the notice required by

subparagraph (B)(ii)) objections specifying with particularity the

provisions of the order deemed objectionable and stating the

grounds therefor, the proposed order shall not take effect.

(2)(A)(i) Except as provided in clause (ii), if with respect to a

chemical substance with respect to which notice is required by

subsection (a) of this section, the Administrator makes the

determination described in paragraph (1)(A) and if -

(I) the Administrator does not issue a proposed order under

paragraph (1) respecting such substance, or

(II) the Administrator issues such an order respecting such

substance but such order does not take effect because objections

were filed under paragraph (1)(C) with respect to it,

the Administrator, through attorneys of the Environmental

Protection Agency, shall apply to the United States District Court

for the District of Columbia or the United States district court

for the judicial district in which the manufacturer or processor,

as the case may be, of such substance is found, resides, or

transacts business for an injunction to prohibit or limit the

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

of such substance (or to prohibit or limit any combination of such

activities).

(ii) If the Administrator issues a proposed order under paragraph

(1)(A) respecting a chemical substance but such order does not take

effect because objections have been filed under paragraph (1)(C)

with respect to it, the Administrator is not required to apply for

an injunction under clause (i) respecting such substance if the

Administrator determines, on the basis of such objections, that the

determinations under paragraph (1)(A) may not be made.

(B) A district court of the United States which receives an

application under subparagraph (A)(i) for an injunction respecting

a chemical substance shall issue such injunction if the court finds

that -

(i) the information available to the Administrator is

insufficient to permit a reasoned evaluation of the health and

environmental effects of a chemical substance with respect to

which notice is required by subsection (a) of this section; and

(ii)(I) in the absence of sufficient information to permit the

Administrator to make such an evaluation, the manufacture,

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

substance, or any combination of such activities, may present an

unreasonable risk of injury to health or the environment, or

(II) such substance is or will be produced in substantial

quantities, and such substance either enters or may reasonably be

anticipated to enter the environment in substantial quantities or

there is or may be significant or substantial human exposure to

the substance.

(C) Pending the completion of a proceeding for the issuance of an

injunction under subparagraph (B) respecting a chemical substance,

the court may, upon application of the Administrator made through

attorneys of the Environmental Protection Agency, issue a temporary

restraining order or a preliminary injunction to prohibit the

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

of such a substance (or any combination of such activities) if the

court finds that the notification period applicable under

subsection (a), (b), or (c) of this section to the manufacturing or

processing of such substance may expire before such proceeding can

be completed.

(D) After the submission to the Administrator of test data

sufficient to evaluate the health and environmental effects of a

chemical substance subject to an injunction issued under

subparagraph (B) and the evaluation of such data by the

Administrator, the district court of the United States which issued

such injunction shall, upon petition dissolve the injunction unless

the Administrator has initiated a proceeding for the issuance of a

rule under section 2605(a) of this title respecting the substance.

If such a proceeding has been initiated, such court shall continue

the injunction in effect until the effective date of the rule

promulgated in such proceeding or, if such proceeding is terminated

without the promulgation of a rule, upon the termination of the

proceeding, whichever occurs first.

(f) Protection against unreasonable risks

(1) If the Administrator finds that there is a reasonable basis

to conclude that the manufacture, processing, distribution in

commerce, use, or disposal of a chemical substance with respect to

which notice is required by subsection (a) of this section, or that

any combination of such activities, presents or will present an

unreasonable risk of injury to health or environment before a rule

promulgated under section 2605 of this title can protect against

such risk, the Administrator shall, before the expiration of the

notification period applicable under subsection (a), (b), or (c) of

this section to the manufacturing or processing of such substance,

take the action authorized by paragraph (2) or (3) to the extent

necessary to protect against such risk.

(2) The Administrator may issue a proposed rule under section

2605(a) of this title to apply to a chemical substance with respect

to which a finding was made under paragraph (1) -

(A) a requirement limiting the amount of such substance which

may be manufactured, processed, or distributed in commerce,

(B) a requirement described in paragraph (2), (3), (4), (5),

(6), or (7) of section 2605(a) of this title, or

(C) any combination of the requirements referred to in

subparagraph (B).

Such a proposed rule shall be effective upon its publication in the

Federal Register. Section 2605(d)(2)(B) of this title shall apply

with respect to such rule.

(3)(A) The Administrator may -

(i) issue a proposed order to prohibit the manufacture,

processing, or distribution in commerce of a substance with

respect to which a finding was made under paragraph (1), or

(ii) apply, through attorneys of the Environmental Protection

Agency, to the United States District Court for the District of

Columbia or the United States district court for the judicial

district in which the manufacturer, or processor, as the case may

be, of such substance, is found, resides, or transacts business

for an injunction to prohibit the manufacture, processing, or

distribution in commerce of such substance.

A proposed order issued under clause (i) respecting a chemical

substance shall take effect on the expiration of the notification

period applicable under subsection (a), (b), or (c) of this section

to the manufacture or processing of such substance.

(B) If the district court of the United States to which an

application has been made under subparagraph (A)(ii) finds that

there is a reasonable basis to conclude that the manufacture,

processing, distribution in commerce, use, or disposal of the

chemical substance with respect to which such application was made,

or that any combination of such activities, presents or will

present an unreasonable risk of injury to health or the environment

before a rule promulgated under section 2605 of this title can

protect against such risk, the court shall issue an injunction to

prohibit the manufacture, processing, or distribution in commerce

of such substance or to prohibit any combination of such

activities.

(C) The provisions of subparagraphs (B) and (C) of subsection

(e)(1) of this section shall apply with respect to an order issued

under clause (i) of subparagraph (A); and the provisions of

subparagraph (C) of subsection (e)(2) of this section shall apply

with respect to an injunction issued under subparagraph (B).

(D) If the Administrator issues an order pursuant to subparagraph

(A)(i) respecting a chemical substance and objections are filed in

accordance with subsection (e)(1)(C) of this section, the

Administrator shall seek an injunction under subparagraph (A)(ii)

respecting such substance unless the Administrator determines, on

the basis of such objections, that such substance does not or will

not present an unreasonable risk of injury to health or the

environment.

(g) Statement of reasons for not taking action

If the Administrator has not initiated any action under this

section or section 2605 or 2606 of this title to prohibit or limit

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

disposal of a chemical substance, with respect to which

notification or data is required by subsection (a)(1)(B) or (b) of

this section, before the expiration of the notification period

applicable to the manufacturing or processing of such substance,

the Administrator shall publish a statement of the Administrator's

reasons for not initiating such action. Such a statement shall be

published in the Federal Register before the expiration of such

period. Publication of such statement in accordance with the

preceding sentence is not a prerequisite to the manufacturing or

processing of the substance with respect to which the statement is

to be published.

(h) Exemptions

(1) The Administrator may, upon application, exempt any person

from any requirement of subsection (a) or (b) of this section to

permit such person to manufacture or process a chemical substance

for test marketing purposes -

(A) upon a showing by such person satisfactory to the

Administrator that the manufacture, processing, distribution in

commerce, use, and disposal of such substance, and that any

combination of such activities, for such purposes will not

present any unreasonable risk of injury to health or the

environment, and

(B) under such restrictions as the Administrator considers

appropriate.

(2)(A) The Administrator may, upon application, exempt any person

from the requirement of subsection (b)(2) of this section to submit

data for a chemical substance. If, upon receipt of an application

under the preceding sentence, the Administrator determines that -

(i) the chemical substance with respect to which such

application was submitted is equivalent to a chemical substance

for which data has been submitted to the Administrator as

required by subsection (b)(2) of this section, and

(ii) submission of data by the applicant on such substance

would be duplicative of data which has been submitted to the

Administrator in accordance with such subsection,

the Administrator shall exempt the applicant from the requirement

to submit such data on such substance. No exemption which is

granted under this subparagraph with respect to the submission of

data for a chemical substance may take effect before the beginning

of the reimbursement period applicable to such data.

(B) If the Administrator exempts any person, under subparagraph

(A), from submitting data required under subsection (b)(2) of this

section for a chemical substance because of the existence of

previously submitted data and if such exemption is granted during

the reimbursement period for such data, then (unless such person

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

amount and method of reimbursement) the Administrator shall order

the person granted the exemption to provide fair and equitable

reimbursement (in an amount determined under rules of the

Administrator) -

(i) to the person who previously submitted the data on which

the exemption was based, for a portion of the costs incurred by

such person in complying with the requirement under subsection

(b)(2) of this section 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 equitable

reimbursement to the persons described in clauses (i) and (ii) for

costs incurred with respect to a chemical substance, the

Administrator shall, after consultation with the Attorney General

and the Federal Trade Commission, consider all relevant factors,

including the effect on the competitive position of the person

required to provide reimbursement in relation to the persons to be

reimbursed and the share of the market for such substance of the

person required to provide reimbursement in relation to the share

of such market of the persons to be reimbursed. For purposes of

judicial review, an order under this subparagraph shall be

considered final agency action.

(C) For purposes of this paragraph, the reimbursement period for

any previously submitted data for a chemical substance is a period

-

(i) beginning on the date of the termination of the

prohibition, imposed under this section, on the manufacture or

processing of such substance by the person who submitted such

data to the Administrator, 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 is equal to the period which the

Administrator determines was necessary to develop such data,

whichever is later.

(3) The requirements of subsections (a) and (b) of this section

do not apply with respect to the manufacturing or processing of any

chemical substance which is manufactured or processed, or proposed

to be manufactured or processed, only in small quantities (as

defined by the Administrator by rule) solely for purposes of -

(A) scientific experimentation or analysis, or

(B) chemical research on, or analysis of such substance or

another substance, including such research or analysis for the

development of a product,

if all persons engaged in such experimentation, research, or

analysis for a manufacturer or processor are notified (in such form

and manner as the Administrator may prescribe) of any risk to

health which the manufacturer, processor, or the Administrator has

reason to believe may be associated with such chemical substance.

(4) The Administrator may, upon application and by rule, exempt

the manufacturer of any new chemical substance from all or part of

the requirements of this section if the Administrator determines

that the manufacture, processing, distribution in commerce, use, or

disposal of such chemical substance, or that any combination of

such activities, will not present an unreasonable risk of injury to

health or the environment. A rule promulgated under this paragraph

(and any substantive amendment to, or repeal of, such a rule) shall

be promulgated in accordance with paragraphs (2) and (3) of section

2605(c) of this title.

(5) The Administrator may, upon application, make the

requirements of subsections (a) and (b) of this section

inapplicable with respect to the manufacturing or processing of any

chemical substance (A) which exists temporarily as a result of a

chemical reaction in the manufacturing or processing of a mixture

or another chemical substance, and (B) to which there is no, and

will not be, human or environmental exposure.

(6) Immediately upon receipt of an application under paragraph

(1) or (5) the Administrator shall publish in the Federal Register

notice of the receipt of such application. The Administrator shall

give interested persons an opportunity to comment upon any such

application and shall, within 45 days of its receipt, either

approve or deny the application. The Administrator shall publish

in the Federal Register notice of the approval or denial of such an

application.

(i) ''Manufacture'' and ''process'' defined

For purposes of this section, the terms ''manufacture'' and

''process'' mean manufacturing or processing for commercial

purposes.

-SOURCE-

(Pub. L. 94-469, title I, Sec. 5, Oct. 11, 1976, 90 Stat. 2012;

renumbered title I, Pub. L. 99-519, Sec. 3(c)(1), Oct. 22, 1986,

100 Stat. 2989.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 2603, 2606, 2607, 2611 to

2613, 2614, 2616 to 2620, 2623, 2625, 2630 of this title; title 42

section 7412.

-CITE-

15 USC Sec. 2605 01/06/03

-EXPCITE-

TITLE 15 - COMMERCE AND TRADE

CHAPTER 53 - TOXIC SUBSTANCES CONTROL

SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES

-HEAD-

Sec. 2605. Regulation of hazardous chemical substances and mixtures

-STATUTE-

(a) Scope of regulation

If the Administrator finds that there is a reasonable basis to

conclude that the manufacture, processing, distribution in

commerce, use, or disposal of a chemical substance or mixture, or

that any combination of such activities, presents or will present

an unreasonable risk of injury to health or the environment, the

Administrator shall by rule apply one or more of the following

requirements to such substance or mixture to the extent necessary

to protect adequately against such risk using the least burdensome

requirements:

(1) A requirement (A) prohibiting the manufacturing,

processing, or distribution in commerce of such substance or

mixture, or (B) limiting the amount of such substance or mixture

which may be manufactured, processed, or distributed in commerce.

(2) A requirement -

(A) prohibiting the manufacture, processing, or distribution

in commerce of such substance or mixture for (i) a particular

use or (ii) a particular use in a concentration in excess of a

level specified by the Administrator in the rule imposing the

requirement, or

(B) limiting the amount of such substance or mixture which

may be manufactured, processed, or distributed in commerce for

(i) a particular use or (ii) a particular use in a

concentration in excess of a level specified by the

Administrator in the rule imposing the requirement.

(3) A requirement that such substance or mixture or any article

containing such substance or mixture be marked with or

accompanied by clear and adequate warnings and instructions with

respect to its use, distribution in commerce, or disposal or with

respect to any combination of such activities. The form and

content of such warnings and instructions shall be prescribed by

the Administrator.

(4) A requirement that manufacturers and processors of such

substance or mixture make and retain records of the processes

used to manufacture or process such substance or mixture and

monitor or conduct tests which are reasonable and necessary to

assure compliance with the requirements of any rule applicable

under this subsection.

(5) A requirement prohibiting or otherwise regulating any

manner or method of commercial use of such substance or mixture.

(6)(A) A requirement prohibiting or otherwise regulating any

manner or method of disposal of such substance or mixture, or of

any article containing such substance or mixture, by its

manufacturer or processor or by any other person who uses, or

disposes of, it for commercial purposes.

(B) A requirement under subparagraph (A) may not require any

person to take any action which would be in violation of any law

or requirement of, or in effect for, a State or political

subdivision, and shall require each person subject to it to

notify each State and political subdivision in which a required

disposal may occur of such disposal.

(7) A requirement directing manufacturers or processors of such

substance or mixture (A) to give notice of such unreasonable risk

of injury to distributors in commerce of such substance or

mixture and, to the extent reasonably ascertainable, to other

persons in possession of such substance or mixture or exposed to

such substance or mixture, (B) to give public notice of such risk

of injury, and (C) to replace or repurchase such substance or

mixture as elected by the person to which the requirement is

directed.

Any requirement (or combination of requirements) imposed under this

subsection may be limited in application to specified geographic

areas.

(b) Quality control

If the Administrator has a reasonable basis to conclude that a

particular manufacturer or processor is manufacturing or processing

a chemical substance or mixture in a manner which unintentionally

causes the chemical substance or mixture to present or which will

cause it to present an unreasonable risk of injury to health or the

environment -

(1) the Administrator may by order require such manufacturer or

processor to submit a description of the relevant quality control

procedures followed in the manufacturing or processing of such

chemical substance or mixture; and

(2) if the Administrator determines -

(A) that such quality control procedures are inadequate to

prevent the chemical substance or mixture from presenting such

risk of injury, the Administrator may order the manufacturer or

processor to revise such quality control procedures to the

extent necessary to remedy such inadequacy; or

(B) that the use of such quality control procedures has

resulted in the distribution in commerce of chemical substances

or mixtures which present an unreasonable risk of injury to

health or the environment, the Administrator may order the

manufacturer or processor to (i) give notice of such risk to

processors or distributors in commerce of any such substance or

mixture, or to both, and, to the extent reasonably

ascertainable, to any other person in possession of or exposed

to any such substance, (ii) to give public notice of such risk,

and (iii) to provide such replacement or repurchase of any such

substance or mixture as is necessary to adequately protect

health or the environment.

A determination under subparagraph (A) or (B) of paragraph (2)

shall be made on the record after opportunity for hearing in

accordance with section 554 of title 5. Any manufacturer or

processor subject to a requirement to replace or repurchase a

chemical substance or mixture may elect either to replace or

repurchase the substance or mixture and shall take either such

action in the manner prescribed by the Administrator.

(c) Promulgation of subsection (a) rules

(1) In promulgating any rule under subsection (a) of this section

with respect to a chemical substance or mixture, the Administrator

shall consider and publish a statement with respect to -

(A) the effects of such substance or mixture on health and the

magnitude of the exposure of human beings to such substance or

mixture,

(B) the effects of such substance or mixture on the environment

and the magnitude of the exposure of the environment to such

substance or mixture,

(C) the benefits of such substance or mixture for various uses

and the availability of substitutes for such uses, and

(D) the reasonably ascertainable economic consequences of the

rule, after consideration of the effect on the national economy,

small business, technological innovation, the environment, and

public health.

If the Administrator determines that a risk of injury to health or

the environment could be eliminated or reduced to a sufficient

extent by actions taken under another Federal law (or laws)

administered in whole or in part by the Administrator, the

Administrator may not promulgate a rule under subsection (a) of

this section to protect against such risk of injury unless the

Administrator finds, in the Administrator's discretion, that it is

in the public interest to protect against such risk under this

chapter. In making such a finding the Administrator shall consider

(i) all relevant aspects of the risk, as determined by the

Administrator in the Administrator's discretion, (ii) a comparison

of the estimated costs of complying with actions taken under this

chapter and under such law (or laws), and (iii) the relative

efficiency of actions under this chapter and under such law (or

laws) to protect against such risk of injury.

(2) When prescribing a rule under subsection (a) the

Administrator shall proceed in accordance with section 553 of title

5 (without regard to any reference in such section to sections 556

and 557 of such title), and shall also (A) publish a notice of

proposed rulemaking stating with particularity the reason for the

proposed rule; (B) allow interested persons to submit written data,

views, and arguments, and make all such submissions publicly

available; (C) provide an opportunity for an informal hearing in

accordance with paragraph (3); (D) promulgate, if appropriate, a

final rule based on the matter in the rulemaking record (as defined

in section 2618(a) of this title), and (E) make and publish with

the rule the finding described in subsection (a) of this section.

(3) Informal hearings required by paragraph (2)(C) shall be

conducted by the Administrator in accordance with the following

requirements:

(A) Subject to subparagraph (B), an interested person is

entitled -

(i) to present such person's position orally or by

documentary submissions (or both), and

(ii) if the Administrator determines that there are disputed

issues of material fact it is necessary to resolve, to present

such rebuttal submissions and to conduct (or have conducted

under subparagraph (B)(ii)) such cross-examination of persons

as the Administrator determines (I) to be appropriate, and (II)

to be required for a full and true disclosure with respect to

such issues.

(B) The Administrator may prescribe such rules and make such

rulings concerning procedures in such hearings to avoid

unnecessary costs or delay. Such rules or rulings may include

(i) the imposition of reasonable time limits on each interested

person's oral presentations, and (ii) requirements that any

cross-examination to which a person may be entitled under

subparagraph (A) be conducted by the Administrator on behalf of

that person in such manner as the Administrator determines (I) to

be appropriate, and (II) to be required for a full and true

disclosure with respect to disputed issues of material fact.

(C)(i) Except as provided in clause (ii), if a group of persons

each of whom under subparagraphs (A) and (B) would be entitled to

conduct (or have conducted) cross-examination and who are

determined by the Administrator to have the same or similar

interests in the proceeding cannot agree upon a single

representative of such interests for purposes of

cross-examination, the Administrator may make rules and rulings

(I) limiting the representation of such interest for such

purposes, and (II) governing the manner in which such

cross-examination shall be limited.

(ii) When any person who is a member of a group with respect to

which the Administrator has made a determination under clause (i)

is unable to agree upon group representation with the other

members of the group, then such person shall not be denied under

the authority of clause (i) the opportunity to conduct (or have

conducted) cross-examination as to issues affecting the person's

particular interests if (I) the person satisfies the

Administrator that the person has made a reasonable and good

faith effort to reach agreement upon group representation with

the other members of the group and (II) the Administrator

determines that there are substantial and relevant issues which

are not adequately presented by the group representative.

(D) A verbatim transcript shall be taken of any oral

presentation made, and cross-examination conducted in any

informal hearing under this subsection. Such transcript shall be

available to the public.

(4)(A) The Administrator may, pursuant to rules prescribed by the

Administrator, provide compensation for reasonable attorneys' fees,

expert witness fees, and other costs of participating in a

rulemaking proceeding for the promulgation of a rule under

subsection (a) of this section to any person -

(i) who represents an interest which would substantially

contribute to a fair determination of the issues to be resolved

in the proceeding, and

(ii) if -

(I) the economic interest of such person is small in

comparison to the costs of effective participation in the

proceeding by such person, or

(II) such person demonstrates to the satisfaction of the

Administrator that such person does not have sufficient

resources adequately to participate in the proceeding without

compensation under this subparagraph.

In determining for purposes of clause (i) if an interest will

substantially contribute to a fair determination of the issues to

be resolved in a proceeding, the Administrator shall take into

account the number and complexity of such issues and the extent to

which representation of such interest will contribute to widespread

public participation in the proceeding and representation of a fair

balance of interests for the resolution of such issues.

(B) In determining whether compensation should be provided to a

person under subparagraph (A) and the amount of such compensation,

the Administrator shall take into account the financial burden

which will be incurred by such person in participating in the

rulemaking proceeding. The Administrator shall take such action as

may be necessary to ensure that the aggregate amount of

compensation paid under this paragraph in any fiscal year to all

persons who, in rulemaking proceedings in which they receive

compensation, are persons who either -

(i) would be regulated by the proposed rule, or

(ii) represent persons who would be so regulated,

may not exceed 25 per centum of the aggregate amount paid as

compensation under this paragraph to all persons in such fiscal

year.

(5) Paragraph (1), (2), (3), and (4) of this subsection apply to

the promulgation of a rule repealing, or making a substantive

amendment to, a rule promulgated under subsection (a) of this

section.

(d) Effective date

(1) The Administrator shall specify in any rule under subsection

(a) of this section the date on which it shall take effect, which

date shall be as soon as feasible.

(2)(A) The Administrator may declare a proposed rule under

subsection (a) of this section to be effective upon its publication

in the Federal Register and until the effective date of final

action taken, in accordance with subparagraph (B), respecting such

rule if -

(i) the Administrator determines that -

(I) the manufacture, processing, distribution in commerce,

use, or disposal of the chemical substance or mixture subject

to such proposed rule or any combination of such activities is

likely to result in an unreasonable risk of serious or

widespread injury to health or the environment before such

effective date; and

(II) making such proposed rule so effective is necessary to

protect the public interest; and

(ii) in the case of a proposed rule to prohibit the

manufacture, processing, or distribution of a chemical substance

or mixture because of the risk determined under clause (i)(I), a

court has in an action under section 2606 of this title granted

relief with respect to such risk associated with such substance

or mixture.

Such a proposed rule which is made so effective shall not, for

purposes of judicial review, be considered final agency action.

(B) If the Administrator makes a proposed rule effective upon its

publication in the Federal Register, the Administrator shall, as

expeditiously as possible, give interested persons prompt notice of

such action, provide reasonable opportunity, in accordance with

paragraphs (2) and (3) of subsection (c) of this section, for a

hearing on such rule, and either promulgate such rule (as proposed

or with modifications) or revoke it; and if such a hearing is

requested, the Administrator shall commence the hearing within five

days from the date such request is made unless the Administrator

and the person making the request agree upon a later date for the

hearing to begin, and after the hearing is concluded the

Administrator shall, within ten days of the conclusion of the

hearing, either promulgate such rule (as proposed or with

modifications) or revoke it.

(e) Polychlorinated biphenyls

(1) Within six months after January 1, 1977, the Administrator

shall promulgate rules to -

(A) prescribe methods for the disposal of polychlorinated

biphenyls, and

(B) require polychlorinated biphenyls to be marked with clear

and adequate warnings, and instructions with respect to their

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

respect to any combination of such activities.

Requirements prescribed by rules under this paragraph shall be

consistent with the requirements of paragraphs (2) and (3).

(2)(A) Except as provided under subparagraph (B), effective one

year after January 1, 1977, no person may manufacture, process, or

distribute in commerce or use any polychlorinated biphenyl in any

manner other than in a totally enclosed manner.

(B) The Administrator may by rule authorize the manufacture,

processing, distribution in commerce or use (or any combination of

such activities) of any polychlorinated biphenyl in a manner other

than in a totally enclosed manner if the Administrator finds that

such manufacture, processing, distribution in commerce, or use (or

combination of such activities) will not present an unreasonable

risk of injury to health or the environment.

(C) For the purposes of this paragraph, the term ''totally

enclosed manner'' means any manner which will ensure that any

exposure of human beings or the environment to a polychlorinated

biphenyl will be insignificant as determined by the Administrator

by rule.

(3)(A) Except as provided in subparagraphs (B) and (C) -

(i) no person may manufacture any polychlorinated biphenyl

after two years after January 1, 1977, and

(ii) no person may process or distribute in commerce any

polychlorinated biphenyl after two and one-half years after such

date.

(B) Any person may petition the Administrator for an exemption

from the requirements of subparagraph (A), and the Administrator

may grant by rule such an exemption if the Administrator finds that

-

(i) an unreasonable risk of injury to health or environment

would not result, and

(ii) good faith efforts have been made to develop a chemical

substance which does not present an unreasonable risk of injury

to health or the environment and which may be substituted for

such polychlorinated biphenyl.

An exemption granted under this subparagraph shall be subject to

such terms and conditions as the Administrator may prescribe and

shall be in effect for such period (but not more than one year from

the date it is granted) as the Administrator may prescribe.

(C) Subparagraph (A) shall not apply to the distribution in

commerce of any polychlorinated biphenyl if such polychlorinated

biphenyl was sold for purposes other than resale before two and one

half years after October 11, 1976.

(4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be

promulgated in accordance with paragraphs (2), (3), and (4) of

subsection (c) of this section.

(5) This subsection does not limit the authority of the

Administrator, under any other provision of this chapter or any

other Federal law, to take action respecting any polychlorinated

biphenyl.

-SOURCE-

(Pub. L. 94-469, title I, Sec. 6, Oct. 11, 1976, 90 Stat. 2020;

renumbered title I, Pub. L. 99-519, Sec. 3(c)(1), Oct. 22, 1986,

100 Stat. 2989.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 2603, 2604, 2606 to 2608,

2611, 2612, 2614, 2616 to 2620, 2623, 2630 of this title; title 10

section 2708; title 42 sec