EPA ICR No. 1139.09; OMB Control No. 2070-0033

ATTACHMENT 1

Toxic Substances Control Act Section 4

15 USC 2603

  SEQ CHAPTER \h \r 1 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
provisions 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

[1] So in original. Probably should be ''preceding''.

