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U.S. Code as of:
01/19/04
Section 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
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(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.
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