ICR Appendix A: Toxic Substances Control Act (TSCA), Section 6(e) (15 USC 2605(e))

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mission 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

§ 2605

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.
(Pub. L. 94–469, title I, § 5, Oct. 11, 1976, 90 Stat.
2012; renumbered title I, Pub. L. 99–519, § 3(c)(1),
Oct. 22, 1986, 100 Stat. 2989.)
§ 2605. Regulation of hazardous chemical substances and mixtures
(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)

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TITLE 15—COMMERCE AND TRADE

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

Page 1452

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

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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 crossexamination 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

§ 2605

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 ag-

§ 2605

TITLE 15—COMMERCE AND TRADE

gregate 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.

Page 1454

(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),
(C), and (D)—
(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 1 year
from the date it is granted, except as provided in
subparagraph (D)) 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.
(D) The Administrator may extend an exemption granted pursuant to subparagraph (B) that

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has not yet expired for a period not to exceed 60
days for the purpose of authorizing the Secretary of Defense and the Secretaries of the
military departments to provide for the transportation into the customs territory of the
United States of polychlorinated biphenyls generated by or under the control of the Department of Defense for purposes of their disposal,
treatment, or storage in the customs territory
of the United States if those polychlorinated
biphenyls are already in transit from their storage locations but the Administrator determines,
in the sole discretion of the Administrator, they
would not otherwise arrive in the customs territory of the United States within the period of
the original exemption. The Administrator shall
promptly publish notice of such extension in the
Federal Register.
(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.
(f) Mercury
(1) Prohibition on sale, distribution, or transfer of elemental mercury by Federal agencies
Except as provided in paragraph (2), effective
beginning on October 14, 2008, no Federal agency shall convey, sell, or distribute to any
other Federal agency, any State or local government agency, or any private individual or
entity any elemental mercury under the control or jurisdiction of the Federal agency.
(2) Exceptions
Paragraph (1) shall not apply to—
(A) a transfer between Federal agencies of
elemental mercury for the sole purpose of facilitating storage of mercury to carry out
this chapter; or
(B) a conveyance, sale, distribution, or
transfer of coal.
(3) Leases of Federal coal
Nothing in this subsection prohibits the
leasing of coal.
(Pub. L. 94–469, title I, § 6, Oct. 11, 1976, 90 Stat.
2020; renumbered title I, Pub. L. 99–519, § 3(c)(1),
Oct. 22, 1986, 100 Stat. 2989; amended Pub. L.
109–364, div. A, title III, § 317(a), Oct. 17, 2006, 120
Stat. 2142; Pub. L. 110–414, § 3, Oct. 14, 2008, 122
Stat. 4342.)
AMENDMENT OF SECTION
For termination of amendment by section
317(b) of Pub. L. 109–364, see Termination Date
of 2006 Amendment note below.
AMENDMENTS
2008—Subsec. (f). Pub. L. 110–414 added subsec. (f).
2006—Subsec. (e)(3)(A). Pub. L. 109–364, § 317(a)(1), (b),
temporarily substituted ‘‘subparagraphs (B), (C), and
(D)’’ for ‘‘subparagraphs (B) and (C)’’ in introductory
provisions. See Termination Date of 2006 Amendment
note below.
Subsec. (e)(3)(B). Pub. L. 109–364, § 317(a)(2), (b), temporarily substituted ‘‘but not more than 1 year from

§ 2606

the date it is granted, except as provided in subparagraph (D)’’ for ‘‘but not more than one year from the
date it is granted’’ in concluding provisions. See Termination Date of 2006 Amendment note below.
Subsec. (e)(3)(D). Pub. L. 109–364, § 317(a)(3), (b), temporarily added subpar. (D). See Termination Date of
2006 Amendment note below.
TERMINATION DATE OF 2006 AMENDMENT
Pub. L. 109–364, div. A, title III, § 317(b), Oct. 17, 2006,
120 Stat. 2142, provided that: ‘‘The amendments made
by subsection (a) [amending this section] shall cease to
have effect on September 30, 2012. The termination of
the authority to grant exemptions pursuant to such
amendments shall not effect the validity of any exemption granted prior to such date.’’

§ 2606. Imminent hazards
(a) Actions authorized and required
(1) The Administrator may commence a civil
action in an appropriate district court of the
United States—
(A) for seizure of an imminently hazardous
chemical substance or mixture or any article
containing such a substance or mixture,
(B) for relief (as authorized by subsection (b)
of this section) against any person who manufactures, processes, distributes in commerce,
or uses, or disposes of, an imminently hazardous chemical substance or mixture or any article containing such a substance or mixture,
or
(C) for both such seizure and relief.
A civil action may be commenced under this
paragraph notwithstanding the existence of a
rule under section 2603 of this title, 2604 of this
title, 2605 of this title, or subchapter IV of this
chapter or an order under section 2604 of this
title or subchapter IV of this chapter, and notwithstanding the pendency of any administrative or judicial proceeding under any provision
of this chapter.
(2) If the Administrator has not made a rule
under section 2605(a) of this title immediately
effective
(as
authorized
by
section
2605(d)(2)(A)(i) of this title) with respect to an
imminently hazardous chemical substance or
mixture, the Administrator shall commence in a
district court of the United States with respect
to such substance or mixture or article containing such substance or mixture a civil action described in subparagraph (A), (B), or (C) of paragraph (1).
(b) Relief authorized
(1) The district court of the United States in
which an action under subsection (a) of this section is brought shall have jurisdiction to grant
such temporary or permanent relief as may be
necessary to protect health or the environment
from the unreasonable risk associated with the
chemical substance, mixture, or article involved
in such action.
(2) In the case of an action under subsection
(a) of this section brought against a person who
manufactures, processes, or distributes in commerce a chemical substance or mixture or an article containing a chemical substance or mixture, the relief authorized by paragraph (1) may
include the issuance of a mandatory order requiring (A) in the case of purchasers of such substance, mixture, or article known to the defend-