Loading (50 kb)...'

National
United States
15 USC CHAPTER 53 - TOXIC SUBSTANCES CONTROL ACT

-CITE-
15 USC CHAPTER 53 - TOXIC SUBSTANCES CONTROL 01/19/04

-EXPCITE-
TITLE 15 - COMMERCE AND TRADE
CHAPTER 53 - TOXIC SUBSTANCES CONTROL

-HEAD-
CHAPTER 53 - TOXIC SUBSTANCES CONTROL


-MISC1-
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.

-End-


-CITE-
15 USC SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES 01/19/04

-EXPCITE-
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.

-End-



-CITE-
15 USC Sec. 2601 01/19/04

-EXPCITE-
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.

-End-



-CITE-
15 USC Sec. 2602 01/19/04

-EXPCITE-
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 (!1) term "Administrator" means the Administrator of the
Environmental Protection Agency.

(2)(A) Except as provided in subparagraph (B), the term "chemical
substance" means any organic or inorganic substance of a particular
molecular identity, including -
(i) any combination of such substances occurring in whole or in
part as a result of a chemical reaction or occurring in nature
and
(ii) any element or uncombined radical.

(B) Such term does not include -
(i) any mixture,
(ii) any pesticide (as defined in the Federal Insecticide,
Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.]) when
manufactured, processed, or distributed in commerce for use as a
pesticide,
(iii) tobacco or any tobacco product,
(iv) any source material, special nuclear material, or
byproduct material (as such terms are defined in the Atomic
Energy Act of 1954 [42 U.S.C. 2011 et seq.] and regulations
issued under such Act),
(v) any article the sale of which is subject to the tax imposed
by section 4181 of the Internal Revenue Code of 1986 [26 U.S.C.
4181] (determined without regard to any exemptions from such tax
provided by section 4182 or 4221 or any other provision of such
Code), and
(vi) any food, food additive, drug, cosmetic, or device (as
such terms are defined in section 201 of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 321]) when manufactured, processed,
or distributed in commerce for use as a food, food additive,
drug, cosmetic, or device.

The term "food" as used in clause (vi) of this subparagraph
includes poultry and poultry products (as defined in sections 4(e)
and 4(f) of the Poultry Products Inspection Act [21 U.S.C. 453(e)
and (f)]), meat and meat food products (as defined in section 1(j)
of the Federal Meat Inspection Act [21 U.S.C. 601(j)]), and eggs
and egg products (as defined in section 4 of the Egg Products
Inspection Act [21 U.S.C. 1033]).
(3) The term "commerce" means trade, traffic, transportation, or
other commerce (A) between a place in a State and any place outside
of such State, or (B) which affects trade, traffic, transportation,
or commerce described in clause (A).
(4) The terms "distribute in commerce" and "distribution in
commerce" when used to describe an action taken with respect to a
chemical substance or mixture or article containing a substance or
mixture mean to sell, or the sale of, the substance, mixture, or
article in commerce; to introduce or deliver for introduction into
commerce, or the introduction or delivery for introduction into
commerce of, the substance, mixture, or article; or to hold, or the
holding of, the substance, mixture, or article after its
introduction into commerce.
(5) The term "environment" includes water, air, and land and the
interrelationship which exists among and between water, air, and
land and all living things.
(6) The term "health and safety study" means any study of any
effect of a chemical substance or mixture on health or the
environment or on both, including underlying data and
epidemiological studies, studies of occupational exposure to a
chemical substance or mixture, toxicological, clinical, and
ecological studies of a chemical substance or mixture, and any test
performed pursuant to this chapter.
(7) The term "manufacture" means to import into the customs
territory of the United States (as defined in general note 2 of the
Harmonized Tariff Schedule of the United States), produce, or
manufacture.
(8) The term "mixture" means any combination of two or more
chemical substances if the combination does not occur in nature and
is not, in whole or in part, the result of a chemical reaction;
except that such term does include any combination which occurs, in
whole or in part, as a result of a chemical reaction if none of the
chemical substances comprising the combination is a new chemical
substance and if the combination could have been manufactured for
commercial purposes without a chemical reaction at the time the
chemical substances comprising the combination were combined.
(9) The term "new chemical substance" means any chemical
substance which is not included in the chemical substance list
compiled and published under section 2607(b) of this title.
(10) The term "process" means the preparation of a chemical
substance or mixture, after its manufacture, for distribution in
commerce -
(A) in the same form or physical state as, or in a different
form or physical state from, that in which it was received by the
person so preparing such substance or mixture, or
(B) as part of an article containing the chemical substance or
mixture.

(11) The term "processor" means any person who processes a
chemical substance or mixture.
(12) The term "standards for the development of test data" means
a prescription of -
(A) the -
(i) health and environmental effects, and
(ii) information relating to toxicity, persistence, and other
characteristics which affect health and the environment,

for which test data for a chemical substance or mixture are to be
developed and any analysis that is to be performed on such data,
and
(B) to the extent necessary to assure that data respecting such
effects and characteristics are reliable and adequate -
(i) the manner in which such data are to be developed,
(ii) the specification of any test protocol or methodology to
be employed in the development of such data, and
(iii) such other requirements as are necessary to provide
such assurance.

(13) The term "State" means any State of the United States, the
District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands, Guam, the Canal Zone, American Samoa, 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.


-MISC1-
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.

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


-End-



-CITE-
15 USC Sec. 2603 01/19/04

-EXPCITE-
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 (continued)