
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 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''.
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    (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.
