§ 2605. — Regulation of hazardous chemical substances and mixtures.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 15USC2605]
TITLE 15--COMMERCE AND TRADE
CHAPTER 53--TOXIC SUBSTANCES CONTROL
SUBCHAPTER I--CONTROL OF TOXIC SUBSTANCES
Sec. 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)
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.
(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.)
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 section 6925.
