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U.S. Code as of:
01/19/04
Section 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.
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