OMB Control Number 2070-0173; EPA ICR Number 2327.02

ICR ATTACHMENT 1

Toxic Substances Control Act Section 5

15 U.S.C. 2604

Sec. 2604. - Manufacturing and processing notices 

 (a) In general 

 (1) Except as provided in subsection (h) of this section, no person may -

 (A) manufacture a new chemical substance on or after the 30th day after the

 date on which the Administrator first publishes the list required by section

 2607(b) of this title, or 

 (B) manufacture or process any chemical substance for a use which the

 Administrator has determined, in accordance with paragraph (2), is a

 significant new use, 

 unless such person submits to the Administrator, at least 90 days before such

 manufacture or processing, a notice, in accordance with subsection (d) of this

 section, of such person's intention to manufacture or process such substance and

 such person complies with any applicable requirement of subsection (b) of this

 section. 

 (2) A determination by the Administrator that a use of a chemical substance is a

 significant new use with respect to which notification is required under paragraph

 (1) shall be made by a rule promulgated after a consideration of all relevant

 factors, including -

 (A) the projected volume of manufacturing and processing of a chemical substance, 

 (B) the extent to which a use changes the type or form of exposure of human

 beings or the environment to a chemical substance, 

 (C) the extent to which a use increases the magnitude and duration of

 exposure of human beings or the environment to a chemical substance, and 

 (D) the reasonably anticipated manner and methods of manufacturing,

 processing, distribution in commerce, and disposal of a chemical substance. 

 (b) Submission of test data 

 (1)(A) If

 (i) a person is required by subsection (a)(1) of this section to submit a notice

 to the Administrator before beginning the manufacture or processing of a

 chemical substance, and

 (ii) such person is required to submit test data for such substance pursuant to

 a rule promulgated under section 2603 of this title before the submission of

 such notice, such person shall submit to the Administrator such data in

 accordance with such rule at the time notice is submitted in accordance

 with subsection (a)(1) of this section. 

 (B)If -
 (i) a person is required by subsection (a)(1) of this section to submit a notice

 to the Administrator, and 

 (ii)such person has been granted an exemption under section 2603(c) of this

 title from the requirements of a rule promulgated under section 2603 of this

 title before the submission of such notice, 

 such person may not, before the expiration of the 90 day period which begins on

 the date of the submission in accordance with such rule of the test data the

 submission or development of which was the basis for the exemption, manufacture

 such substance if such person is subject to subsection (a)(1)(A) of this section or

 manufacture or process such substance for a significant new use if the person is

 subject to subsection (a)(1)(B) of this section. 

 (2)(A) If a person -

 (i) is required by subsection (a)(1) of this section to submit a notice to the

 Administrator before beginning the manufacture or processing of a

 chemical substance listed under paragraph (4), and 

 (ii)is not required by a rule promulgated under section 2603 of this title before

 the submission of such notice to submit test data for such substance, 

 such person shall submit to the Administrator data prescribed by subparagraph

 (B) at the time notice is submitted in accordance with subsection (a)(1) of this section.

 (B) Data submitted pursuant to subparagraph (A) shall be data which the

 person submitting the data believes show that -

 (i) in the case of a substance with respect to which notice is required under

 subsection (a)(1)(A) of this section, the manufacture, processing,

 distribution in commerce, use, and disposal of the chemical substance or

 any combination of such activities will not present an unreasonable risk of

 injury to health or the environment, or 

 (ii) in the case of a chemical substance with respect to which notice is

 required under subsection (a)(1)(B) of this section, the intended

 significant new use of the chemical substance will not present an

 unreasonable risk of injury to health or the environment. 

 (3) Data submitted under paragraph (1) or (2) shall be made available, subject to

 section 2613 of this title, for examination by interested persons. 

 (4)(A) 

 (i) The Administrator may, by rule, compile and keep current a list of chemical

 substances with respect to which the Administrator finds that the

 manufacture, processing, distribution in commerce, use, or disposal, or

 any combination of such activities, presents or may present an

 unreasonable risk of injury to health or the environment. 

 (ii) In making a finding under clause (i) that the manufacture, processing,

 distribution in commerce, use, or disposal of a chemical substance or any

 combination of such activities presents or may present an unreasonable

 risk of injury to health or the environment, the Administrator shall
 consider all relevant factors, including -

 (I) the effects of the chemical substance on health and the magnitude of

 human exposure to such substance; and 

 (II) the effects of the chemical substance on the environment and the

 magnitude of environmental exposure to such substance. 

 (B) The Administrator shall, in prescribing a rule under subparagraph (A)

 which lists any chemical substance, identify those uses, if any, which the

 Administrator determines, by rule under subsection (a)(2) of this section,

 would constitute a significant new use of such substance. 

 (C) Any rule under subparagraph (A), and any substantive amendment or

 repeal of such a rule, shall be promulgated pursuant to the procedures

 specified in section 553 of title 5, except that 

 (i) the Administrator shall give interested persons an opportunity for the oral

 presentation of data, views, or arguments, in addition to an opportunity to

 make written submissions,

 (ii) a transcript shall be kept of any oral presentation, and

 (iii) the Administrator shall make and publish with the rule the finding

 described in subparagraph (A). 

 (c) Extension of notice period 

 The Administrator may for good cause extend for additional periods (not to

 exceed in the aggregate 90 days) the period, prescribed by subsection (a) or (b) of this

 section before which the manufacturing or processing of a chemical substance

 subject to such subsection may begin. Subject to section 2613 of this title, such an

 extension and the reasons therefor shall be published in the Federal Register and shall

 constitute a final agency action subject to judicial review. 

 (d) Content of notice; publications in the Federal Register 

 (1) The notice required by subsection (a) of this section shall include -

 (A) insofar as known to the person submitting the notice or insofar as

 reasonably ascertainable, the information described in subparagraphs (A), (B),

 (C), (D), (F), and (G) of section 2607(a)(2) of this title, and 

 (B) in such form and manner as the Administrator may prescribe, any test

 data in the possession or control of the person giving such notice which are

 related to the effect of any manufacture, processing, distribution in commerce,

 use, or disposal of such substance or any article containing such substance,

 or of any combination of such activities, on health or the environment, and 

 (C) a description of any other data concerning the environmental and health

 effects of such substance, insofar as known to the person making the notice

 or insofar as reasonably ascertainable. 

 Such a notice shall be made available, subject to section 2613 of this title, for

 examination by interested persons. 

 (2) Subject to section 2613 of this title, not later than five days (excluding

 Saturdays, Sundays and legal holidays) after the date of the receipt of a notice

 under subsection (a) of this section or of data under subsection (b) of this

 section, the Administrator shall publish in the Federal Register a notice which -
 (A) identifies the chemical substance for which notice or data has been

 received; 

 (B) lists the uses or intended uses of such substance; and 

 (C) in the case of the receipt of data under subsection (b) of this section,

 describes the nature of the tests performed on such substance and any data

 which was developed pursuant to subsection (b) of this section or a rule

 under section 2603 of this title. 

 A notice under this paragraph respecting a chemical substance shall identify the

 chemical substance by generic class unless the Administrator determines that more

 specific identification is required in the public interest. 

 (3) At the beginning of each month the Administrator shall publish a list in the

 Federal Register of

 (A) each chemical substance for which notice has been received under

 subsection (a) of this section and for which the notification period prescribed

 by subsection (a), (b), or (c) of this section has not expired, and 

 (B) each chemical substance for which such notification period has expired

 since the last publication in the Federal Register of such list. 

 (e) Regulation pending development of information 

 (1) 

 (A) If the Administrator determines that -

 (i) the information available to the Administrator is insufficient to permit a

 reasoned evaluation of the health and environmental effects of a chemical

 substance with respect to which notice is required by subsection (a) of

 this section; and 

 (ii)(I) in the absence of sufficient information to permit the Administrator to

 make such an evaluation, the manufacture, processing, distribution in

 commerce, use, or disposal of such substance, or any combination of

 such activities, may present an unreasonable risk of injury to health or

 the environment, or 

 (II) such substance is or will be produced in substantial quantities, and

 such substance either enters or may reasonably be anticipated to enter

 the environment in substantial quantities or there is or may be

 significant or substantial human exposure to the substance, 

 the Administrator may issue a proposed order, to take effect on the expiration of

 the notification period applicable to the manufacturing or processing of such

 substance under subsection (a), (b), or (c) of this section, to prohibit or limit the

 manufacture, processing, distribution in commerce, use, or disposal of such

 substance or to prohibit or limit any combination of such activities. 

 (B) A proposed order may not be issued under subparagraph (A) respecting

 a chemical substance

 (i) later than 45 days before the expiration of the notification period

 applicable to the manufacture or processing of such substance under

 subsection (a), (b), or (c) of this section, and
 (ii) unless the Administrator has, on or before the issuance of the proposed

 order, notified, in writing, each manufacturer or processor, as the case may

 be, of such substance of the determination which underlies such order. 

 (C) If a manufacturer or processor of a chemical substance to be subject to a

 proposed order issued under subparagraph (A) files with the Administrator

 (within the 30-day period beginning on the date such manufacturer or

 processor received the notice required by subparagraph (B)(ii)) objections

 specifying with particularity the provisions of the order deemed objectionable

 and stating the grounds therefor, the proposed order shall not take effect. 

 (2)(A)

(i) Except as provided in clause (ii), if with respect to a chemical substance

 with respect to which notice is required by subsection (a) of this section,

 the Administrator makes the determination described in paragraph (1)(A)

 and if -

 (I) the Administrator does not issue a proposed order under paragraph (1)

 respecting such substance, or 

 (II) the Administrator issues such an order respecting such substance but

 such order does not take effect because objections were filed under

 paragraph (1)(C) with respect to it, 

 the Administrator, through attorneys of the Environmental Protection Agency,

 shall apply to the United States District Court for the District of Columbia or the

 United States district court for the judicial district in which the manufacturer or

 processor, as the case may be, of such substance is found, resides, or transacts

 business for an injunction to prohibit or limit the manufacture, processing,

 distribution in commerce, use, or disposal of such substance (or to prohibit or limit

 any combination of such activities). 

 (ii) If the Administrator issues a proposed order under paragraph (1)(A)

 respecting a chemical substance but such order does not take effect

 because objections have been filed under paragraph (1)(C) with respect to

 it, the Administrator is not required to apply for an injunction under clause

 (i) respecting such substance if the Administrator determines, on the basis

 of such objections, that the determinations under paragraph (1)(A) may

 not be made. 

 (B) A district court of the United States which receives an application under

 subparagraph (A)(i) for an injunction respecting a chemical substance shall

 issue such injunction if the court finds that -

 (i) the information available to the Administrator is insufficient to permit a

 reasoned evaluation of the health and environmental effects of a chemical

 substance with respect to which notice is required by subsection (a) of

 this section; and 

 (ii)(I) in the absence of sufficient information to permit the Administrator to

 make such an evaluation, the manufacture, processing, distribution in
 commerce, use, or disposal of such substance, or any combination of

 such activities, may present an unreasonable risk of injury to health or

 the environment, or 

 (II) such substance is or will be produced in substantial quantities, and

 such substance either enters or may reasonably be anticipated to enter

 the environment in substantial quantities or there is or may be

 significant or substantial human exposure to the substance. 

 (C) Pending the completion of a proceeding for the issuance of an injunction

 under subparagraph (B) respecting a chemical substance, the court may, upon

 application of the Administrator made through attorneys of the Environmental

 Protection Agency, issue a temporary restraining order or a preliminary

 injunction to prohibit the manufacture, processing, distribution in commerce,

 use, or disposal of such a substance (or any combination of such activities) if

 the court finds that the notification period applicable under subsection (a), (b),

 or (c) of this section to the manufacturing or processing of such substance

 may expire before such proceeding can be completed. 

 (D) After the submission to the Administrator of test data sufficient to

 evaluate the health and environmental effects of a chemical substance subject

 to an injunction issued under subparagraph (B) and the evaluation of such

 data by the Administrator, the district court of the United States which issued

 such injunction shall, upon petition dissolve the injunction unless the

 Administrator has initiated a proceeding for the issuance of a rule under

 section 2605(a) of this title respecting the substance. If such a proceeding has

 been initiated, such court shall continue the injunction in effect until the

 effective date of the rule promulgated in such proceeding or, if such

 proceeding is terminated without the promulgation of a rule, upon the

 termination of the proceeding, whichever occurs first. 

 (f) Protection against unreasonable risks 

 (1) 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 with respect to which notice is required by subsection (a) of

 this section, or that any combination of such activities, presents or will present an

 unreasonable risk of injury to health or environment before a rule promulgated

 under section 2605 of this title can protect against such risk, the Administrator

 shall, before the expiration of the notification period applicable under subsection

 (a), (b), or (c) of this section to the manufacturing or processing of such

 substance, take the action authorized by paragraph (2) or (3) to the extent

 necessary to protect against such risk. 

 (2) The Administrator may issue a proposed rule under section 2605(a) of this

 title to apply to a chemical substance with respect to which a finding was made

 under paragraph (1) -

 (A) a requirement limiting the amount of such substance which may be

 manufactured, processed, or distributed in commerce, 

 (B) a requirement described in paragraph (2), (3), (4), (5), (6), or (7) of section

 2605(a) of this title, or 
 (C) any combination of the requirements referred to in subparagraph (B). 

 Such a proposed rule shall be effective upon its publication in the Federal

 Register. Section 2605(d)(2)(B) of this title shall apply with respect to such rule. 

 (3)(A) The Administrator may -

 (i) issue a proposed order to prohibit the manufacture, processing, or

 distribution in commerce of a substance with respect to which a finding

 was made under paragraph (1), or 

 (ii) apply, through attorneys of the Environmental Protection Agency, to the

 United States District Court for the District of Columbia or the United

 States district court for the judicial district in which the manufacturer, or

 processor, as the case may be, of such substance, is found, resides, or

 transacts business for an injunction to prohibit the manufacture,

 processing, or distribution in commerce of such substance. 

 A proposed order issued under clause (i) respecting a chemical substance shall

 take effect on the expiration of the notification period applicable under subsection (a),

 (b), or (c) of this section to the manufacture or processing of such substance. 

 (B) If the district court of the United States to which an application has been

 made under subparagraph (A)(ii) finds that there is a reasonable basis to

 conclude that the manufacture, processing, distribution in commerce, use, or

 disposal of the chemical substance with respect to which such application

 was made, or that any combination of such activities, presents or will present

 an unreasonable risk of injury to health or the environment before a rule

 promulgated under section 2605 of this title can protect against such risk, the

 court shall issue an injunction to prohibit the manufacture, processing, or

 distribution in commerce of such substance or to prohibit any combination of

 such activities. 

 (C) The provisions of subparagraphs (B) and (C) of subsection (e)(1) of this

 section shall apply with respect to an order issued under clause (i) of

 subparagraph (A); and the provisions of subparagraph (C) of subsection

 (e)(2) of this section shall apply with respect to an injunction issued under

 subparagraph (B). 

 (D) If the Administrator issues an order pursuant to subparagraph (A)(i)

 respecting a chemical substance and objections are filed in accordance with

 subsection (e)(1)(C) of this section, the Administrator shall seek an injunction

 under subparagraph (A)(ii) respecting such substance unless the

 Administrator determines, on the basis of such objections, that such

 substance does not or will not present an unreasonable risk of injury to health

 or the environment. 

 (g) Statement of reasons for not taking action 

 If the Administrator has not initiated any action under this section or section
 2605 or 2606 of this title to prohibit or limit the manufacture, processing, distribution

 in commerce, use, or disposal of a chemical substance, with respect to which

 notification or data is required by subsection (a)(1)(B) or (b) of this section, before the

 expiration of the notification period applicable to the manufacturing or processing of

 such substance, the Administrator shall publish a statement of the Administrator's

 reasons for not initiating such action. Such a statement shall be published in the

 Federal Register before the expiration of such period. Publication of such statement in

 accordance with the preceding sentence is not a prerequisite to the manufacturing or

 processing of the substance with respect to which the statement is to be published. 

 (h) Exemptions 

 (1) The Administrator may, upon application, exempt any person from any

 requirement of subsection (a) or (b) of this section to permit such person to

 manufacture or process a chemical substance for test marketing purposes -

 (A) upon a showing by such person satisfactory to the Administrator that

 the manufacture, processing, distribution in commerce, use, and disposal of

 such substance, and that any combination of such activities, for such

 purposes will not present any unreasonable risk of injury to health or the

 environment, and 

 (B) under such restrictions as the Administrator considers appropriate. 

 (2)(A) The Administrator may, upon application, exempt any person from the

 requirement of subsection (b)(2) of this section to submit data for a chemical

 substance. If, upon receipt of an application under the preceding sentence,

 the Administrator determines that -

 (i) the chemical substance with respect to which such application was

 submitted is equivalent to a chemical substance for which data has been

 submitted to the Administrator as required by subsection (b)(2) of this

 section, and 

 (ii) submission of data by the applicant on such substance would be

 duplicative of data which has been submitted to the Administrator 

in accordance with such subsection, 

 the Administrator shall exempt the applicant from the requirement to submit

 such data on such substance. No exemption which is granted under this

 subparagraph with respect to the submission 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 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