**EPA ICR No. 1188**  **.1 2**  **; OMB Control No. 2070**

**- 0038** 

**ATTACHMENT 1**

**Toxic Substances Control Act Section 5**

**15 U.S.C. 2604**TI TL E 15

-- COMMERCE AND TRADE

CHAPTER 53

-- TOXIC SUBSTANCES CONTROL

SUBCHAPTER I

-- CONTROL OF TOXI C 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 firs t publishes the list required by section 2607(b) of this title, or (B) manufacture or process an y 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 day s 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 applic able 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 b y a rule promulga ted 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 t yp e 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 reasonabl y anticipated manner and methods of manu facturing, processing, distribution in commerce, and disposal of a chemical substance. (b) Submission of test data (1)(A) If (i) a person is required b y subsection (a)(1) of this section to submit a notice to the Administrator before beginning the m anufacture 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

Admi nistrator, 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 b y subsection (a)(1) of this section to submit a notice to the Administrator

before beginning the manufacture or processing of a chemical substance list ed 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 o f 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 an y combination of such activities will not pre sent 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 chemic al 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 an y combination of such activities, p resents or may present an unreasonable risk of injury to health or the environment. (ii) I n making a finding under clause (i) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or an y combination of su ch 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 expo sure 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, b y rule under subsection (a)(2) of this section, would constitute a significant new use of such substance. (C) An y rule under subparagraph (A), and an y substantiv e 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 an y oral presentation, and (iii) the Administrator shall make and publish with the rule the finding described in subparagraph (A). (c) Extension of notice perio d The Administrator may

for good cause extend for additional periods (not to exceed in the aggregate 90 day s) the period, prescribed by subsection (a) or (b) of this section before which the manufacturing or processing of a chemical substance subject t o 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; public ations 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 reasonabl y ascertainable, the information described in subparagra phs (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 an y manufacture, processing, distribution in commerce, use, or disposal of such substance or an y article containing such substance, or of an y 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 day s (excluding Saturday s, Sunday s and legal holiday s) 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 substanc e; 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 t he 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 b y 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

substan ce, or an y 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, ordisposal of such substance or to prohibit or limit any co mbination of such activities. (B) A proposed order may not be issued under subparagraph (A) respecting a chemical substance (i) later than 45 day s before the expiration of the notification period applicable to the manufacture or processing of such subs tance 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

determinatio n 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 p rocessor received the notice required by subparagraph (B)(ii)) objections specify ing with particularit y the provisions of the order deemed objectionable and stating the grounds therefore, the proposed order shall not take effect. (2)(A)(i) Except as pr ovided 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 n ot 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 re spect to it, the Administrator, through attorney s 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 manufacture r 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 com bination 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 appl y 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 Adm inistrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or an y 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 attorney s of the Environme ntal Protection Agency , issue atemporary restraining order or a preliminary injunction to prohibit the manufacture, processing, distribution in commerce, use, or disposal of such a substance (or an y 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 suf ficient 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 b y the Administrator, the district court of the United States which issued such injunct ion 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 continu e 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 u nreasonable 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 shal l, 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 aga inst 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 su bstance 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) an y combination of the requirements referred t o 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 t o 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 attorney s of the Environmental Protection Agency , to the United States

Dis trict 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 proh ibit 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 man ufacture, processing, distribution in commerce, use, or disposal of the chemical substance with respect towhich such application was made, or that an y 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, distrib ution in commerce, use, or disposal of a chemical substance, with respect to which notification or data is required b y subsection (a)(1)(B) or (b) of this section, before the expiration of the notification period applicable to the manufacturing or processi ng 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

stateme nt 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 perso n 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 manufact ure, processing, distribution in commerce, use, and disposal of such substance, and that any combination of such activities, for such purposes will not present an y unreasonable risk of injury to health or the environment, and (B) under su ch 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

app lication 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 b y subsection (b)(2) o f this section, and (ii) submission of data b y 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 requ irement 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 datarequired under subsection (b)(2) of this section for a chemical substance because of the existence

of previousl y submitted data and if such exemption is granted d uring 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 e quitable 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 b y such person in comply ing with the re quirement 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 t o 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 Att orney 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 purp oses of this paragraph, the reimbursement period for an y 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 o f such substance b y the person who submitted such data to the Administrator, and (ii) ending

-- (I) five ye ars after the date referred to in clause (i), or (II) at the expiration of a period which begins on the date refe rred 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

manufactu ring or processing of an y chemical substance which is manufactured or processed, or proposed to be manufactured or processed, onl y i n small quantities (as defined by the Administrator by

rule) solely

for purposes of

-- (A) scientific experimentation or anal ys is, or (B) chemical research on, or anal ys is of such substance or another substance, including such

research or anal ys is for the development of a product, if all persons engaged in such experimentation, research, or anal ys is for a manu facturer 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 an y 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 withparagraphs (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 manufa cturing or processing of an y 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 environme ntal exposure. (6) Immediatel y 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 day s 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.)