Document ID: EPA-HQ-OPPT-2010-1011-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-08-03T04:00Z

Attachment A

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