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