§ 2603. — Testing of chemical substances and mixtures.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 15USC2603]
TITLE 15--COMMERCE AND TRADE
CHAPTER 53--TOXIC SUBSTANCES CONTROL
SUBCHAPTER I--CONTROL OF TOXIC SUBSTANCES
Sec. 2603. Testing of chemical substances and mixtures
(a) Testing requirements
If the Administrator finds that--
(1)(A)(i) the manufacture, distribution in commerce, processing,
use, or disposal of a chemical substance or mixture, or that any
combination of such activities, may present an unreasonable risk of
injury to health or the environment,
(ii) there are insufficient data and experience upon which the
effects of such manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data; or
(B)(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or
(II) there is or may be significant or substantial human exposure to
such substance or mixture,
(ii) there are insufficient data and experience upon which the
effects of the manufacture, distribution in commerce, processing,
use, or disposal of such substance or mixture or of any combination
of such activities on health or the environment can reasonably be
determined or predicted, and
(iii) testing of such substance or mixture with respect to such
effects is necessary to develop such data; and
(2) in the case of a mixture, the effects which the mixture's
manufacture, distribution in commerce, processing, use, or disposal
or any combination of such activities may have on health or the
environment may not be reasonably and more efficiently determined or
predicted by testing the chemical substances which comprise the
mixture;
the Administrator shall by rule require that testing be conducted on
such substance or mixture to develop data with respect to the health and
environmental effects for which there is an insufficiency of data and
experience and which are relevant to a determination that the
manufacture, distribution in commerce, processing, use, or disposal of
such substance or mixture, or that any combination of such activities,
does or does not present an unreasonable risk of injury to health or the
environment.
(b) Testing requirement rule
(1) A rule under subsection (a) of this section shall include--
(A) identification of the chemical substance or mixture for
which testing is required under the rule,
(B) standards for the development of test data for such
substance or mixture, and
(C) with respect to chemical substances which are not new
chemical substances and to mixtures, a specification of the period
(which period may not be of unreasonable duration) within which the
persons required to conduct the testing shall submit to the
Administrator data developed in accordance with the standards
referred to in subparagraph (B).
In determining the standards and period to be included, pursuant to
subparagraphs (B) and (C), in a rule under subsection (a) of this
section, the Administrator's considerations shall include the relative
costs of the various test protocols and methodologies which may be
required under the rule and the reasonably foreseeable availability of
the facilities and personnel needed to perform the testing required
under the rule. Any such rule may require the submission to the
Administrator of preliminary data during the period prescribed under
subparagraph (C).
(2)(A) The health and environmental effects for which standards for
the development of test data may be prescribed include carcinogenesis,
mutagenesis, teratogenesis, behavioral disorders, cumulative or
synergistic effects, and any other effect which may present an
unreasonable risk of injury to health or the environment. The
characteristics of chemical substances and mixtures for which such
standards may be prescribed include persistence, acute toxicity,
subacute toxicity, chronic toxicity, and any other characteristic which
may present such a risk. The methodologies that may be prescribed in
such standards include epidemiologic studies, serial or hierarchical
tests, in vitro tests, and whole animal tests, except that before
prescribing epidemiologic studies of employees, the Administrator shall
consult with the Director of the National Institute for Occupational
Safety and Health.
(B) From time to time, but not less than once each 12 months, the
Administrator shall review the adequacy of the standards for development
of data prescribed in rules under subsection (a) of this section and
shall, if necessary, institute proceedings to make appropriate revisions
of such standards.
(3)(A) A rule under subsection (a) of this section respecting a
chemical substance or mixture shall require the persons described in
subparagraph (B) to conduct tests and submit data to the Administrator
on such substance or mixture, except that the Administrator may permit
two or more of such persons to designate one such person or a qualified
third party to conduct such tests and submit such data on behalf of the
persons making the designation.
(B) The following persons shall be required to conduct tests and
submit data on a chemical substance or mixture subject to a rule under
subsection (a) of this section:
(i) Each person who manufactures or intends to manufacture such
substance or mixture if the Administrator makes a finding described
in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) of this section with
respect to the manufacture of such substance or mixture.
(ii) Each person who processes or intends to process such
substance or mixture if the Administrator makes a finding described
in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) of this section with
respect to the processing of such substance or mixture.
(iii) Each person who manufactures or processes or intends to
manufacture or process such substance or mixture if the
Administrator makes a finding described in subsection (a)(1)(A)(ii)
or (a)(1)(B)(ii) of this section with respect to the distribution in
commerce, use, or disposal of such substance or mixture.
(4) Any rule under subsection (a) of this section requiring the
testing of and submission of data for a particular chemical substance or
mixture shall expire at the end of the reimbursement period (as defined
in subsection (c)(3)(B) of this section) which is applicable to test
data for such substance or mixture unless the Administrator repeals the
rule before such date; and a rule under subsection (a) of this section
requiring the testing of and submission of data for a category of
chemical substances or mixtures shall expire with respect to a chemical
substance or mixture included in the category at the end of the
reimbursement period (as so defined) which is applicable to test data
for such substance or mixture unless the Administrator before such date
repeals the application of the rule to such substance or mixture or
repeals the rule.
(5) Rules issued under subsection (a) of this section (and any
substantive amendment thereto or repeal thereof) shall be promulgated
pursuant to section 553 of title 5 except that (A) 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; (B) a transcript shall be made of any oral
presentation; and (C) the Administrator shall make and publish with the
rule the findings described in paragraph (1)(A) or (1)(B) of subsection
(a) of this section and, in the case of a rule respecting a mixture, the
finding described in paragraph (2) of such subsection.
(c) Exemption
(1) Any person required by a rule under subsection (a) of this
section to conduct tests and submit data on a chemical substance or
mixture may apply to the Administrator (in such form and manner as the
Administrator shall prescribe) for an exemption from such requirement.
(2) If, upon receipt of an application under paragraph (1), the
Administrator determines that--
(A) the chemical substance or mixture with respect to which such
application was submitted is equivalent to a chemical substance or
mixture for which data has been submitted to the Administrator in
accordance with a rule under subsection (a) of this section or for
which data is being developed pursuant to such a rule, and
(B) submission of data by the applicant on such substance or
mixture would be duplicative of data which has been submitted to the
Administrator in accordance with such rule or which is being
developed pursuant to such rule,
the Administrator shall exempt, in accordance with paragraph (3) or (4),
the applicant from conducting tests and submitting data on such
substance or mixture under the rule with respect to which such
application was submitted.
(3)(A) If the exemption under paragraph (2) of any person from the
requirement to conduct tests and submit test data on a chemical
substance or mixture is granted on the basis of the existence of
previously submitted test data and if such exemption is granted during
the reimbursement period for such test data (as prescribed by
subparagraph (B)), 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 such test data, for a
portion of the costs incurred by such person in complying with the
requirement 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 or mixture, 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 person to be reimbursed and the share
of the market for such substance or mixture of the person required to
provide reimbursement in relation to the share of such market of the
persons to be reimbursed. An order under this subparagraph shall, for
purposes of judicial review, be considered final agency action.
(B) For purposes of subparagraph (A), the reimbursement period for
any test data for a chemical substance or mixture is a period--
(i) beginning on the date such data is submitted in accordance
with a rule promulgated under subsection (a) of this section, 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 which is equal to the period which
the Administrator determines was necessary to develop such data,
whichever is later.
(4)(A) If the exemption under paragraph (2) of any person from the
requirement to conduct tests and submit test data on a chemical
substance or mixture is granted on the basis of the fact that test data
is being developed by one or more persons pursuant to a rule promulgated
under subsection (a) of this section, 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 each such person who is developing such test data, for a
portion of the costs incurred by each such person in complying with
such rule, and
(ii) to any other person who has been required under this
subparagraph to contribute with respect to the costs of complying
with such rule, 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 or mixture, the
Administrator shall, after consultation with the Attorney General and
the Federal Trade Commission, consider the factors described in the
second sentence of paragraph (3)(A). An order under this subparagraph
shall, for purposes of judicial review, be considered final agency
action.
(B) If any exemption is granted under paragraph (2) on the basis of
the fact that one or more persons are developing test data pursuant to a
rule promulgated under subsection (a) of this section and if after such
exemption is granted the Administrator determines that no such person
has complied with such rule, the Administrator shall (i) after providing
written notice to the person who holds such exemption and an opportunity
for a hearing, by order terminate such exemption, and (ii) notify in
writing such person of the requirements of the rule with respect to
which such exemption was granted.
(d) Notice
Upon the receipt of any test data pursuant to a rule under
subsection (a) of this section, the Administrator shall publish a notice
of the receipt of such data in the Federal Register within 15 days of
its receipt. Subject to section 2613 of this title, each such notice
shall (1) identify the chemical substance or mixture for which data have
been received; (2) list the uses or intended uses of such substance or
mixture and the information required by the applicable standards for the
development of test data; and (3) describe the nature of the test data
developed. Except as otherwise provided in section 2613 of this title,
such data shall be made available by the Administrator for examination
by any person.
(e) Priority list
(1)(A) There is established a committee to make recommendations to
the Administrator respecting the chemical substances and mixtures to
which the Administrator should give priority consideration for the
promulgation of a rule under subsection (a) of this section. In making
such a recommendation with respect to any chemical substance or mixture,
the committee shall consider all relevant factors, including--
(i) the quantities in which the substance or mixture is or will
be manufactured,
(ii) the quantities in which the substance or mixture enters or
will enter the environment,
(iii) the number of individuals who are or will be exposed to
the substance or mixture in their places of employment and the
duration of such exposure,
(iv) the extent to which human beings are or will be exposed to
the substance or mixture,
(v) the extent to which the substance or mixture is closely
related to a chemical substance or mixture which is known to present
an unreasonable risk of injury to health or the environment,
(vi) the existence of data concerning the effects of the
substance or mixture on health or the environment,
(vii) the extent to which testing of the substance or mixture
may result in the development of data upon which the effects of the
substance or mixture on health or the environment can reasonably be
determined or predicted, and
(viii) the reasonably foreseeable availability of facilities and
personnel for performing testing on the substance or mixture.
The recommendations of the committee shall be in the form of a list of
chemical substances and mixtures which shall be set forth, either by
individual substance or mixture or by groups of substances or mixtures,
in the order in which the committee determines the Administrator should
take action under subsection (a) of this section with respect to the
substances and mixtures. In establishing such list, the committee shall
give priority attention to those chemical substances and mixtures which
are known to cause or contribute to or which are suspected of causing or
contributing to cancer, gene mutations, or birth defects. The committee
shall designate chemical substances and mixtures on the list with
respect to which the committee determines the Administrator should,
within 12 months of the date on which such substances and mixtures are
first designated, initiate a proceeding under subsection (a) of this
section. The total number of chemical substances and mixtures on the
list which are designated under the preceding sentence may not, at any
time, exceed 50.
(B) As soon as practicable but not later than nine months after
January 1, 1977, the committee shall publish in the Federal Register and
transmit to the Administrator the list and designations required by
subparagraph (A) together with the reasons for the committee's inclusion
of each chemical substance or mixture on the list. At least every six
months after the date of the transmission to the Administrator of the
list pursuant to the preceeding \1\ sentence, the committee shall make
such previsions in the list as it determines to be necessary and shall
transmit them to the Administrator together with the committee's reasons
for the revisions. Upon receipt of any such revision, the Administrator
shall publish in the Federal Register the list with such revision, the
reasons for such revision, and the designations made under subparagraph
(A). The Administrator shall provide reasonable opportunity to any
interested person to file with the Administrator written comments on the
committee's list, any revision of such list by the committee, and
designations made by the committee, and shall make such comments
available to the public. Within the 12-month period beginning on the
date of the first inclusion on the list of a chemical substance or
mixture designated by the committee under subparagraph (A) the
Administrator shall with respect to such chemical substance or mixture
either initiate a rulemaking proceeding under subsection (a) of this
section or if such a proceeding is not initiated within such period,
publish in the Federal Register the Administrator's reason for not
initiating such a proceeding.
---------------------------------------------------------------------------
\1\ So in original. Probably should be ``preceding''.
---------------------------------------------------------------------------
(2)(A) The committee established by paragraph (1)(A) shall consist
of eight members as follows:
(i) One member appointed by the Administrator from the
Environmental Protection Agency.
(ii) One member appointed by the Secretary of Labor from
officers or employees of the Department of Labor engaged in the
Secretary's activities under the Occupational Safety and Health Act
of 1970 [29 U.S.C. 651 et seq.].
(iii) One member appointed by the Chairman of the Council on
Environmental Quality from the Council or its officers or employees.
(iv) One member appointed by the Director of the National
Institute for Occupational Safety and Health from officers or
employees of the Institute.
(v) One member appointed by the Director of the National
Institute of Environmental Health Sciences from officers or
employees of the Institute.
(vi) One member appointed by the Director of the National Cancer
Institute from officers or employees of the Institute.
(vii) One member appointed by the Director of the National
Science Foundation from officers or employees of the Foundation.
(viii) One member appointed by the Secretary of Commerce from
officers or employees of the Department of Commerce.
(B)(i) An appointed member may designate an individual to serve on
the committee on the member's behalf. Such a designation may be made
only with the approval of the applicable appointing authority and only
if the individual is from the entity from which the member was
appointed.
(ii) No individual may serve as a member of the committee for more
than four years in the aggregate. If any member of the committee leaves
the entity from which the member was appointed, such member may not
continue as a member of the committee, and the member's position shall
be considered to be vacant. A vacancy in the committee shall be filled
in the same manner in which the original appointment was made.
(iii) Initial appointments to the committee shall be made not later
than the 60th day after January 1, 1977. Not later than the 90th day
after such date the members of the committee shall hold a meeting for
the selection of a chairperson from among their number.
(C)(i) No member of the committee, or designee of such member, shall
accept employment or compensation from any person subject to any
requirement of this chapter or of any rule promulgated or order issued
thereunder, for a period of at least 12 months after termination of
service on the committee.
(ii) No person, while serving as a member of the committee, or
designee of such member, may own any stocks or bonds, or have any
pecuniary interest, of substantial value in any person engaged in the
manufacture, processing, or distribution in commerce of any chemical
substance or mixture subject to any requirement of this chapter or of
any rule promulgated or order issued thereunder.
(iii) The Administrator, acting through attorneys of the
Environmental Protection Agency, or the Attorney General may bring an
action in the appropriate district court of the United States to
restrain any violation of this subparagraph.
(D) The Administrator shall provide the committee such
administrative support services as may be necessary to enable the
committee to carry out its function under this subsection.
(f) Required actions
Upon the receipt of--
(1) any test data required to be submitted under this chapter,
or
(2) any other information available to the Administrator,
which indicates to the Administrator that there may be a reasonable
basis to conclude that a chemical substance or mixture presents or will
present a significant risk of serious or widespread harm to human beings
from cancer, gene mutations, or birth defects, the Administrator shall,
within the 180-day period beginning on the date of the receipt of such
data or information, initiate appropriate action under section 2604,
2605, or 2606 of this title to prevent or reduce to a sufficient extent
such risk or publish in the Federal Register a finding that such risk is
not unreasonable. For good cause shown the Administrator may extend such
period for an additional period of not more than 90 days. The
Administrator shall publish in the Federal Register notice of any such
extension and the reasons therefor. A finding by the Administrator that
a risk is not unreasonable shall be considered agency action for
purposes of judicial review under chapter 7 of title 5. This subsection
shall not take effect until two years after January 1, 1977.
(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, Sec. 4, Oct. 11, 1976, 90 Stat. 2006;
renumbered title I, Pub. L. 99-519, Sec. 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 (Sec. 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.
Section Referred to in Other Sections
This section is referred to in sections 2604, 2606, 2607, 2611,
2613, 2614, 2617 to 2620, 2623, 2625, 2626, 2630 of this title; title 21
section 346a; title 42 section 9604.
