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.