EPA ICR No. 1188.12; OMB Control No. 2070-0038

ATTACHMENT 1

Toxic Substances Control Act Section 5

15 U.S.C. 2604
TITLE 15--COMMERCE AND TRADE

CHAPTER 53--TOXIC SUBSTANCES CONTROL

SUBCHAPTER I--CONTROL OF TOXIC SUBSTANCES

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 therefore 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 therefore, 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 he 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.

(Pub. L. 94-469, title I, Sec. 5, Oct. 11, 1976, 90 Stat. 2012; renumbered title I, Pub. L. 

99-519, Sec. 3(c)(1), Oct. 22, 1986, 100 Stat. 2989.)