Attachment 1 - TSCA Section 5 (15 USC 2604) - Manufacturing and processing notices

§ 2604

TITLE 15—COMMERCE AND TRADE

(g) Petition for standards for the development of
test data
A person intending to manufacture or process
a chemical substance for which notice is required under section 2604(a) of this title and who
is not required under a rule under subsection (a)
of this section to conduct tests and submit data
on such substance may petition the Administrator to prescribe standards for the development of test data for such substance. The Administrator shall by order either grant or deny
any such petition within 60 days of its receipt. If
the petition is granted, the Administrator shall
prescribe such standards for such substance
within 75 days of the date the petition is granted. If the petition is denied, the Administrator
shall publish, subject to section 2613 of this
title, in the Federal Register the reasons for
such denial.
(Pub. L. 94–469, title I, § 4, Oct. 11, 1976, 90 Stat.
2006; renumbered title I, Pub. L. 99–519, § 3(c)(1),
Oct. 22, 1986, 100 Stat. 2989.)
REFERENCES IN TEXT
The Occupational Safety and Health Act of 1970, referred to in text, is Pub. L. 91–596, Dec. 29, 1970, 84 Stat.
1590, as amended, which is classified principally to
chapter 15 (§ 651 et seq.) of Title 29, Labor. For complete
classification of this Act to the Code, see Short Title
note set out under section 651 of Title 29 and Tables.
EFFECTIVE DATE
Section effective Jan. 1, 1977, except as provided in
subsec. (f) of this section, see section 31 of Pub. L.
94–469, set out as a note under section 2601 of this title.

§ 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

Page 1626

(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

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TITLE 15—COMMERCE AND TRADE

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 com-

§ 2604

merce, 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

§ 2604

TITLE 15—COMMERCE AND TRADE

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

Page 1628

(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,

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TITLE 15—COMMERCE AND TRADE

(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

§ 2604

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 per-

§ 2605

TITLE 15—COMMERCE AND TRADE

son 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

Page 1630

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, § 5, Oct. 11, 1976, 90 Stat.
2012; renumbered title I, Pub. L. 99–519, § 3(c)(1),
Oct. 22, 1986, 100 Stat. 2989.)
§ 2605. Regulation of hazardous chemical substances and mixtures
(a) Scope of regulation
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 or mixture, or
that any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment, the Administrator shall by rule apply one or more of the following requirements to such substance or mixture to the extent necessary to protect adequately against such risk using the least burdensome requirements:
(1) A requirement (A) prohibiting the manufacturing, processing, or distribution in commerce of such substance or mixture, or (B)
limiting the amount of such substance or mixture which may be manufactured, processed,
or distributed in commerce.
(2) A requirement—
(A) prohibiting the manufacture, processing, or distribution in commerce of such substance or mixture for (i) a particular use or
(ii) a particular use in a concentration in excess of a level specified by the Administrator
in the rule imposing the requirement, or
(B) limiting the amount of such substance
or mixture which may be manufactured,
processed, or distributed in commerce for (i)
a particular use or (ii) a particular use in a
concentration in excess of a level specified
by the Administrator in the rule imposing
the requirement.