Document ID: EPA-HQ-OPPT-2012-0915-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-08-08T04:00Z

EPA ICR No. 1246.12; OMB Control No. 2070-0072

Attachment A

Toxic Substances Control Act Section 6

15  U.S.C.  2605

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 

        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.