OMB Control Number 2070

- 0173 ; EPA ICR Number 2327.0 2

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 sect ion, 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 b y section

2607(b) of this title, or

(B) manufacture or p rocess 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

man ufacture 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

secti on. (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 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 t yp e or form of exposure of human

beings or the environment to a che mical 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 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 sub mission 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 rul e 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 us e if the person is

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

(2)(A) If a person

- (i) is required b y s ubsection (a)(1) of this section to submit a notice to the

Administrator before beginning the manufacture or proc essing 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 b y 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 co mmerce, 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 resp ect 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 chemic al

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

unre asonable 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 an y

combination of su ch activities presents or may present an unreasonable

risk of injury

to health or the environment, the Administrator shallconsider all relevant factors, including

-

(I) the effects of the chemical substance on health a nd 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 sign ificant new use of such substance.

(C) An y 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 opportunit y 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 period

The Administrator may

for good cause extend for addition al periods (not to

exceed in the aggregate 90 day s) the period, prescribed b y 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

reasonabl y 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 ef

fect of any

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 descri ption 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 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 an y 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 fo r 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 su ch 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 a vailable 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 b y subsection (a) of

this section; an d

(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 an y combinatio n 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 e nters 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 i n 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 day s 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 i ssuance 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 s ubstance 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 b y subparagraph (B)(ii)) objections

specify ing 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 b y subsection (a) of this section,

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

and if

- (I) the Administr ator 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 w ere filed under

paragraph (1)(C) with respect 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 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,

distri bution 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 su ch 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 A dministrator 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 b y 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 incommerce, 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 co urt may , upon application of the Administrator made through attorney s of the Environmental

Protection Agency , issue a temporary restraining order or a preliminary

injunction to prohibit the manufacture, processing, distributio n 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 p rocessing 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 subje ct

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 injunction shall, upon petition dissolve the injunction unless t he

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 u ntil 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 agai nst 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 requ ired b y 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 se ction

2605(a) of this title, or(C) an y 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 ti tle 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 attorney s of the Environmental Protection Agency , to the

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

States district court for the jud icial 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 commer ce 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 manufactur e 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, processi ng, 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 h ealth 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 suc h 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

subpar agraph (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 section2605 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 wh ich

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 processing of

such substance, the Administrator shall publish a statemen t 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 no t 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 subsecti on (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 an y 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. I f, 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 w hich data has been

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

section, and

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

duplicative of data which has been su bmitted 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 respec t 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 amo unt determined under rules of the Administrator)

- (i) to the person who previously submitted the data on which the exemptionwas based, for a portion of the costs incurred by such person in

comply ing 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 Adminis trator 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 p ersons 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 t his subparagraph shall be considered final agency action.

(C) For purposes 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 t ermination of the prohibition, imposed under

this section, on the manufacture or processing of 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 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 an y chemical substance which

is manufactured or processed, or proposed to be manufactured or processed, only

in small quantities (as defined b y the Administrator b y rule) solel y for purposes of

- (A) scientific experimentation or anal ys is, or

(B) chemical research on, or anal ys is of such substance or anot her

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

manufacturer or processor are notified (in such form and mann er 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 rul e, exempt the

manufacturer of an y 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 tohealth 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 an y chemical substance(A) which exists temporaril y as a result of a chemical reaction in the

manufacturing or processing of a mixture or another chemical substance, and

(B) to which the re is no, and will not be, human or environmental 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 an y such application and shall, within 45 days of its receipt, either

approve or den y 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