1139.12 Attachment 1

EPA ICR No. 1139.12; OMB Control No. 2070-0033

ATTACHMENT 1
Toxic Substances Control Act Section 4
15 USC 2603

TITLE 15 - COMMERCE AND TRADE
CHAPTER 53 - TOXIC SUBSTANCES CONTROL
SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES
§2603. Testing of chemical substances and mixtures
(a) Testing requirements
(1) If the Administrator finds that(A)(i)(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 is insufficient information 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
information; or
(ii)(I) a chemical substance or mixture is or will be produced in substantial quantities, and (aa) it
enters or may reasonably be anticipated to enter the environment in substantial quantities or (bb)
there is or may be significant or substantial human exposure to such substance or mixture,
(II) there is insufficient information 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
information; and
(B) 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, or, in the case of a chemical substance or mixture described in
subparagraph (A)(i), by rule, order, or consent agreement, require that testing be conducted on
such substance or mixture to develop information with respect to the health and environmental
effects for which there is an insufficiency of information and experience and which is 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.
(2) Additional testing authority.-In addition to the authority provided under paragraph (1), the
Administrator may, by rule, order, or consent agreement(A) require the development of new information relating to a chemical substance or mixture if the
Administrator determines that the information is necessary-

(i) to review a notice under section 2604 of this title or to perform a risk evaluation under section
2605(b) of this title;
(ii) to implement a requirement imposed in a rule, order, or consent agreement under subsection
(e) or (f) of section 2604 of this title or in a rule promulgated under section 2605(a) of this title;
(iii) at the request of a Federal implementing authority under another Federal law, to meet the
regulatory testing needs of that authority with regard to toxicity and exposure; or
(iv) pursuant to section 2611(a)(2) of this title; and
(B) require the development of new information for the purposes of prioritizing a chemical
substance under section 2605(b) of this title only if the Administrator determines that such
information is necessary to establish the priority of the substance, subject to the limitations that(i) not later than 90 days after the date of receipt of information regarding a chemical substance
complying with a rule, order, or consent agreement under this subparagraph, the Administrator
shall designate the chemical substance as a high-priority substance or a low-priority substance;
and
(ii) information required by the Administrator under this subparagraph shall not be required for
the purposes of establishing or implementing a minimum information requirement of broader
applicability.
(3) Statement of need.-When requiring the development of new information relating to a chemical
substance or mixture under paragraph (2), the Administrator shall identify the need for the new
information, describe how information reasonably available to the Administrator was used to
inform the decision to require new information, explain the basis for any decision that requires the
use of vertebrate animals, and, as applicable, explain why issuance of an order is warranted
instead of promulgating a rule or entering into a consent agreement.
(4) Tiered testing.-When requiring the development of new information under this subsection, the
Administrator shall employ a tiered screening and testing process, under which the results of
screening-level tests or assessments of available information inform the decision as to whether 1
or more additional tests are necessary, unless information available to the Administrator justifies
more advanced testing of potential health or environmental effects or potential exposure without
first conducting screening-level testing.
(b) Testing requirement rule, order, or consent agreement
(1) A rule, order, or consent agreement under subsection (a) shall include(A) identification of the chemical substance or mixture for which testing is required under the
rule, order, or consent agreement,
(B) protocols and methodologies for the development of information 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 information developed in
accordance with the protocols and methodologies referred to in subparagraph (B).

In determining the protocols and methodologies and period to be included, pursuant to
subparagraphs (B) and (C), in a rule, order, or consent agreement under subsection (a), the
Administrator's considerations shall include the relative costs of the various test protocols and
methodologies which may be required under the rule, order, or consent agreement and the
reasonably foreseeable availability of the facilities and personnel needed to perform the testing
required under the rule, order, or consent agreement. Any such rule, order, or consent agreement
may require the submission to the Administrator of preliminary information during the period
prescribed under subparagraph (C).
(2)(A) The health and environmental effects for which protocols and methodologies for the
development of information 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. Protocols and
methodologies for the development of information may also be prescribed for the assessment of
exposure or exposure potential to humans or the environment. The characteristics of chemical
substances and mixtures for which such protocols and methodologies 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 protocols and
methodologies include epidemiologic studies, serial or tiered testing, 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 protocols and methodologies for development of information prescribed in rules,
orders, and consent agreements under subsection (a) and shall, if necessary, institute proceedings
to make appropriate revisions of such protocols and methodologies.
(3)(A) A rule or order under subsection (a) respecting a chemical substance or mixture shall
require the persons described in subparagraph (B) or (C), as applicable, to conduct tests and
submit information 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 information on behalf of the persons making the
designation.
(B) The following persons shall be required to conduct tests and submit information on a chemical
substance or mixture subject to a rule under subsection (a)(1):
(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)(i)(II) or (a)(1)(A)(ii)(II) 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)(i)(II) or (a)(1)(A)(ii)(II) 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)(i)(II)
or (a)(1)(A)(ii)(II) with respect to the distribution in commerce, use, or disposal of such substance
or mixture.

(C) A rule or order under paragraph (1) or (2) of subsection (a) may require the development of
information by any person who manufactures or processes, or intends to manufacture or process, a
chemical substance or mixture subject to the rule or order.
(4) Any rule, order, or consent agreement under subsection (a) requiring the testing of and
submission of information for a particular chemical substance or mixture shall expire at the end of
the reimbursement period (as defined in subsection (c)(3)(B)) which is applicable to information
for such substance or mixture unless the Administrator repeals the rule or order or modifies the
consent agreement to terminate the requirement before such date; and a rule, order, or consent
agreement under subsection (a) requiring the testing of and submission of information 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 information for such substance or mixture unless the Administrator before such date
repeals or modifies the application of the rule, order, or consent agreement to such substance or
mixture or repeals the rule or order or modifies the consent agreement to terminate the
requirement.
(c) Exemption
(1) Any person required by a rule or order under subsection (a) to conduct tests and submit
information 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 information has been submitted to the
Administrator in accordance with a rule, order, or consent agreement under subsection (a) or for
which information is being developed pursuant to such a rule, order, or consent agreement, and
(B) submission of information by the applicant on such substance or mixture would be duplicative
of information which has been submitted to the Administrator in accordance with such rule, order,
or consent agreement or which is being developed pursuant to such rule, order, or consent
agreement,
the Administrator shall exempt, in accordance with paragraph (3) or (4), the applicant from
conducting tests and submitting information on such substance or mixture under the rule or order
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 information on a chemical substance or mixture is granted on the basis of the
existence of previously submitted information and if such exemption is granted during the
reimbursement period for such information (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 information, for a portion of the costs incurred by
such person in complying with the requirement to submit such information, 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 information for a
chemical substance or mixture is a period(i) beginning on the date such information is submitted in accordance with a rule, order, or
consent agreement under subsection (a), 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
information,
whichever is later.
(4)(A) If the exemption under paragraph (2) of any person from the requirement to conduct tests
and submit information on a chemical substance or mixture is granted on the basis of the fact that
information is being developed by one or more persons pursuant to a rule, order, or consent
agreement under subsection (a), 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 information, for a portion of the costs incurred by
each such person in complying with such rule, order, or consent agreement, 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, order, or consent agreement, 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 information pursuant to a rule, order, or consent agreement under
subsection (a) and if after such exemption is granted the Administrator determines that no such
person has complied with such rule, order, or consent agreement, 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 or order with respect to which such exemption was granted.
(d) Notice
Upon the receipt of any information pursuant to a rule, order, or consent agreement under
subsection (a), the Administrator shall publish a notice of the receipt of such information 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 information has been
received; (2) list the uses or intended uses of such substance or mixture and the information
required by the applicable protocols and methodologies for the development of information; and
(3) describe the nature of the information developed. Except as otherwise provided in section
2613 of this title, such information 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 development of information under subsection (a). 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 information 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
information 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) 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). 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 revisions 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 issue an order, enter into a consent agreement,
or initiate a rulemaking proceeding under subsection (a), or, if such an order or consent agreement
is not issued or such a proceeding is not initiated within such period, publish in the Federal
Register the Administrator's reason for not issuing such an order, entering into such a consent
agreement, or initiating such a proceeding.
(2)(A) The committee established by paragraph (1)(A) shall consist of ten 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.

(ix) One member appointed by the Chairman of the Consumer Product Safety Commission from
Commissioners or employees of the Commission.
(x) One member appointed by the Commissioner of Food and Drugs from employees of the Food
and Drug Administration.
(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 information 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 a significant risk of serious or widespread harm to human
beings, the Administrator shall, within the 180-day period beginning on the date of the receipt of
such information, initiate applicable 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, made

without consideration of costs or other nonrisk factors, 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 protocols and methodologies for the development of information
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, order, or consent
agreement under subsection (a) to conduct tests and submit information on such substance may
petition the Administrator to prescribe protocols and methodologies for the development of
information 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 protocols and methodologies 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.
(h) Reduction of testing on vertebrates
(1) In general
The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and
consistent with the policies of this subchapter, the use of vertebrate animals in the testing of
chemical substances or mixtures under this subchapter by(A) prior to making a request or adopting a requirement for testing using vertebrate animals, and
in accordance with subsection (a)(3), taking into consideration, as appropriate and to the extent
practicable and scientifically justified, reasonably available existing information, including(i) toxicity information;
(ii) computational toxicology and bioinformatics; and
(iii) high-throughput screening methods and the prediction models of those methods; and
(B) encouraging and facilitating(i) the use of scientifically valid test methods and strategies that reduce or replace the use of
vertebrate animals while providing information of equivalent or better scientific quality and
relevance that will support regulatory decisions under this subchapter;
(ii) the grouping of 2 or more chemical substances into scientifically appropriate categories in
cases in which testing of a chemical substance would provide scientifically valid and useful
information on other chemical substances in the category; and
(iii) the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication
of tests, provided that such consortia make all information from such testing available to the
Administrator.
(2) Implementation of alternative testing methods
To promote the development and timely incorporation of new scientifically valid test methods and
strategies that are not based on vertebrate animals, the Administrator shall-

(A) not later than 2 years after June 22, 2016, develop a strategic plan to promote the development
and implementation of alternative test methods and strategies to reduce, refine, or replace
vertebrate animal testing and provide information of equivalent or better scientific quality and
relevance for assessing risks of injury to health or the environment of chemical substances or
mixtures through, for example(i) computational toxicology and bioinformatics;
(ii) high-throughput screening methods;
(iii) testing of categories of chemical substances;
(iv) tiered testing methods;
(v) in vitro studies;
(vi) systems biology;
(vii) new or revised methods identified by validation bodies such as the Interagency Coordinating
Committee on the Validation of Alternative Methods or the Organization for Economic Cooperation and Development; or
(viii) industry consortia that develop information submitted under this subchapter;

(B) as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in
the development of requirements for testing under this section;
(C) include in the strategic plan developed under subparagraph (A) a list, which the Administrator
shall update on a regular basis, of particular alternative test methods or strategies the
Administrator has identified that do not require new vertebrate animal testing and are
scientifically reliable, relevant, and capable of providing information of equivalent or better
scientific reliability and quality to that which would be obtained from vertebrate animal testing;
(D) provide an opportunity for public notice and comment on the contents of the plan developed
under subparagraph (A), including the criteria for considering scientific reliability and relevance
of the test methods and strategies that may be identified pursuant to subparagraph (C);
(E) beginning on the date that is 5 years after June 22, 2016, and every 5 years thereafter, submit
to Congress a report that describes the progress made in implementing the plan developed under
subparagraph (A) and goals for future alternative test methods and strategies implementation; and
(F) prioritize and, to the extent consistent with available resources and the Administrator's other
responsibilities under this subchapter, carry out performance assessment, validation, and
translational studies to accelerate the development of scientifically valid test methods and
strategies that reduce, refine, or replace the use of vertebrate animals, including minimizing
duplication, in any testing under this subchapter.
(3) Voluntary testing

(A) In general
Any person developing information for submission under this subchapter on a voluntary basis and
not pursuant to any request or requirement by the Administrator shall first attempt to develop the
information by means of an alternative test method or strategy identified by the Administrator
pursuant to paragraph (2)(C), if the Administrator has identified such a test method or strategy for
the development of such information, before conducting new vertebrate animal testing.
(B) Effect of paragraph
Nothing in this paragraph shall, under any circumstance, limit or restrict the submission of any
existing information to the Administrator.
(C) Relationship to other law
A violation of this paragraph shall not be a prohibited act under section 2614 of this title.
(D) Review of means
This paragraph authorizes, but does not require, the Administrator to review the means by which a
person conducted testing described in subparagraph (A).
(Pub. L. 94–469, title I, §4, Oct. 11, 1976, 90 Stat. 2006 ; renumbered title I, Pub. L. 99–519,
§3(c)(1), Oct. 22, 1986, 100 Stat. 2989 ; amended Pub. L. 114–182, title I, §§4, 19(d), June 22,
2016, 130 Stat. 449 , 505.)

1 So in original. Probably should be "preceding".