§ 2604. — Manufacturing and processing notices.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 15USC2604]
TITLE 15--COMMERCE AND TRADE
CHAPTER 53--TOXIC SUBSTANCES CONTROL
SUBCHAPTER I--CONTROL OF TOXIC SUBSTANCES
Sec. 2604. Manufacturing and processing notices
(a) In general
(1) Except as provided in subsection (h) of this section, no person
may--
(A) manufacture a new chemical substance on or after the 30th
day after the date on which the Administrator 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.
(Pub. L. 94-469, title I, Sec. 5, Oct. 11, 1976, 90 Stat. 2012;
renumbered title I, Pub. L. 99-519, Sec. 3(c)(1), Oct. 22, 1986, 100
Stat. 2989.)
Section Referred to in Other Sections
This section is referred to in sections 2603, 2606, 2607, 2611 to
2613, 2614, 2616 to 2620, 2623, 2625, 2630 of this title; title 42
section 7412.
