1139.12 Attachment 2

EPA ICR No. 1139.11; OMB Control No. 2070-0033

ATTACHMENT 2
40 CFR 790
Procedures Governing Testing Consent Agreements and Test Rules
(Available on the Internet at http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfr790_main_02.tpl)

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Title 40: Protection of Environment
PART 790—PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND
TEST RULES
Subpart A—General Provisions
§ 790.1 Scope, purpose, and authority.
(a) This part establishes procedures for gathering information, conducting negotiations, and
developing and implementing test rules or consent agreements on chemical substances and
mixtures under section 4 of TSCA.
(b) Section 4 of the Act authorizes EPA to require manufacturers and processors of chemical
substances and mixtures to test these chemicals to determine whether they have adverse health or
environmental effects. Section 4 (a) empowers the Agency to promulgate rules which require
such testing. In addition, EPA has implied authority to enter into enforceable consent agreements
requiring testing where they provide procedural safeguards equivalent to those that apply where
testing is conducted by rule.
(c) EPA intends to use enforceable consent agreements to accomplish testing where a consensus
exists among EPA, affected manufacturers and/or processors, and interested members of the
public concerning the need for and scope of testing. If such a consensus does not exist and the
Agency believes that it can make the findings specified in section 4(a), EPA will initiate
proceedings to promulgate test rules which will be codified in part 799 of this chapter.
(d) Appendix A to this part presents timetables for various steps in the evaluation of chemicals
under consideration for testing, the initiation and completion of negotiations to develop consent
agreements, and the proposal and promulgation of test rules. All deadlines which are imposed by
the Act are binding on EPA and will be observed by the Agency. The remaining deadlines
represent target dates that EPA intends to meet.
[51 FR 23712, June 30, 1986]
§ 790.2 Applicability.
This part is applicable to manufacturers and processors of chemical substances or mixtures who
are subject to the testing requirements of a consent agreement or a rule under section 4(a) of the
Act. The procedures for test rules are applicable to each test rule in part 799 or this chapter
unless otherwise stated in specific test rules in part 799 of this chapter.
[51 FR 23712, June 30, 1986]
§ 790.3 Definitions.
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Terms defined in the Act and not explicitly defined herein are used with the meaning given in the
Act. For the purpose of this part:
Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
Additive means a chemical substance that is intentionally added to another chemical substance to
improve its stability or impart some other desirable quality.
Chemical means a chemical substance or mixture.
Consortium means an association of manufacturers and/or processors who have made an
agreement to jointly sponsor testing.
EPA means the U.S. Environmental Protection Agency.
Equivalence data means chemical data or biological test data intended to show that two
substances or mixtures are equivalent.
Equivalent means that a chemical substance or mixture is able to represent or substitute for
another in a test or series of tests, and that the data from one substance can be used to make
scientific and regulatory decisions concerning the other substance.
Exemption means an exemption from a testing requirement of a test rule promulgated under
section 4 of the Act and part 799 of this chapter.
Impurity means a chemical substance which is uninitentionally present with another chemical
substance.
Joint sponsor means a person who sponsors testing pursuant to section 4(b)(3)(A) of the Act.
Joint sponsorship means the sponsorship of testing by two or more persons in accordance with
section 4(b)(3)(A) of the Act.
Person means an individual, partnership, corporation, association, scientific or academic
establishment, or organizational unit thereof, and any other legal entity.
Principal sponsor means an individual sponsor or the joint sponsor who assumes primary
responsibility for the direction of a study and for oral and written communication with EPA.
Protocol means the plan and procedures which are to be followed in conducting a test.
Reimbursement period refers to a period that begins when the data from the last non-duplicative
test to be completed under a test rule are submitted to EPA and ends after an amount of time
equal to that which had been required to develop data or after five years, whichever is later.
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Sponsor means the person or persons who design, direct and finance the testing of a substance or
mixture.
Test substance means the form of chemical substance or mixture that is specified for use in
testing.
[49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23712, June 30, 1986]
§ 790.5 Submission of information.
(a) All submissions to EPA under this part must bear the Code of Federal Regulations (CFR)
section number of the subject chemical test rule, or indicate the identity of the consent
agreement. For all submissions under this part, six copies must be provided to EPA.
(b) Submissions containing both confidential business information or non-confidential business
information must be addressed to the Document Control Office (7407), Office of Pollution
Prevention and Toxics, U.S. Environmental Protection Agency, Room G–099, 1200
Pennsylvania Ave., NW., Washington, DC 20460, ATTN: TSCA Section 4.
[50 FR 20656, May 17, 1985, as amended at 51 FR 23712, June 30, 1986; 58 FR 34205, June 23,
1993; 60 FR 31922, June 19, 1995; 60 FR 34466, July 3, 1995]
§ 790.7 Confidentiality.
(a) Any person subject to the requirements of a consent agreement or a test rule under section 4
of the Act may assert a claim of confidentiality for certain information submitted to EPA in
response to the consent agreement or the test rule. Any information claimed as confidential will
be treated in accordance with the procedures in part 2 of this title and section 14 of the Act.
Failure to assert a claim of confidentiality at the time the information is submitted will result in
the information being made available to the public without further notice to the submitter.
(b) A claim of confidentiality must be asserted by circling or otherwise marking the specific
information claimed as confidential and designating it with the words “confidential business
information,” “trade secret,” or another appropriate phrase indicating its confidential character.
(c) If a person asserts a claim of confidentiality for study plan information described in
§§790.50(c)(1)(iii)(D), (iv), (v), and (vi) and 790.62(b)(6), (7), (8), (9), and (10), the person must
provide a detailed written substantiation of the claim by answering the questions in this
paragraph. Failure to provide written substantiation at the time the study plan information is
submitted will be considered a waiver of the claim of confidentiality, and the study plan
information will be disclosed to the public without further notice.
(1) Would disclosure of the study plan information disclose processes used in the manufacture or
processing of a chemical substance or mixture? Describe how this would occur.
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(2) Would disclosure of the study plan information disclose the portion of a mixture comprised
by any of the substances in the mixture? Describe how this would occur.
(3) What harmful effects to your competitive position, if any, do you think would result from
disclosure of this information? How would a competitor use such information? How substantial
would the harmful effects be? What is the causal relationship between disclosure and the harmful
effects?
(4) For what period of time should confidential treatment be given? Until a specific date, the
occurrence of a specific event, or permanently? Why?
(5) What measures have you taken to guard against disclosure of this information to others?
(6) To what extent has this information been disclosed to others? What precautions have been
taken in connection with such disclosures?
(7) Has this information been disclosed to the public in any forms? Describe the circumstances.
(8) Has the information been disclosed in a patent?
(9) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality
determination regarding this information? If so, copies of such determinations must be included
in the substantiation.
(d) If the substantiation provided under paragraph (c) of this section contains information which
the submitter considers confidential, the submitter must assert a separate claim of confidentiality
for that information at the time of submission in accordance with paragraph (b) of this section.
[49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23713, June 30, 1986]
Subpart B—Procedures for Developing Consent Agreements and Test Rules
Source: 51 FR 23713, June 30, 1986, unless otherwise noted.
§ 790.20 Recommendation and designation of testing candidates by the ITC.
(a) Recommendations with intent to designate. The ITC has advised EPA that it will discharge its
responsibilities under section 4(e) of the Act in the following manner:
(1) When the ITC identifies a chemical substance or mixture that it believes should receive
expedited consideration by EPA for testing, the ITC may add the substance or mixture to its list
of chemicals recommended for testing and include a statement that the ITC intends to designate
the substance or mixture for action by EPA in accordance with section 4(e)(1)(B) of the Act.
(2) Chemical substances or mixtures selected for expedited review under paragraph (a)(1) of this
section may, at a later time, be designated for EPA action within 12 months of such designation.
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The ITC's subsequent decision would be based on the ITC's review of TSCA sections 8(a) and
8(d) data and other relevant information.
(3) Where the ITC concludes that a substance or mixture warrants testing consideration but that
expedited EPA review of testing needs is not justified, the ITC will add the substance or mixture
to its list of testing recommendations without expressing an intent to designate the substance or
mixture for EPA action in accordance with section 4(e)(1)(B) of the Act.
(4) The ITC reserves its right to designate any chemical that it determines the Agency should,
within 12 months of the date first designated, initiate a proceeding under section 4(a) of the Act.
(b) EPA consideration of ITC recommendations. (1) Where a substance or mixture is designated
for EPA action under section 4(e)(1)(B) of the Act, the Agency will take either one of the
following actions within 12 months after receiving the ITC designation:
(i) Initiate rulemaking proceedings under section 4(a) of the Act.
(ii) Publish a Federal Register notice explaining the Agency's reasons for not initiating such
rulemaking proceedings. EPA may conclude that rulemaking proceedings under section 4(a) of
the Act are unnecessary if it determines that the findings specified in section 4(a) of the Act
cannot be made or if the Agency has entered into a consent agreement requiring testing in
accordance with the provisions of this subpart.
(2) Where a substance or mixture has been recommended for testing by the ITC without an intent
to designate, EPA will use its best efforts to act on the ITC's recommendations as rapidly as
possible consistent with its other priorities and responsiblities. EPA may respond to the ITC's
recommendations either by:
(i) Initiating rulemaking proceedings under section 4(a) of the Act.
(ii) Publishing a Federal Register notice explaining the Agency's reasons for concluding that
testing is unnecessary.
(iii) Entering into a consent agreement in accordance with this subpart.
§ 790.22 Procedures for gathering information and negotiating consent agreements on
chemicals which the ITC has recommended for testing with an intent to designate.
(a) Preliminary EPA evaluation. Following receipt of an ITC report containing a
recommendation with an intent to designate, EPA will use the following procedure for
completing a preliminary evaluation of testing needs. Appendix A 1 to this part presents the
schedule that EPA intends to follow for this purpose.
(1) EPA will publish the ITC report in the Federal Register and announce that interested persons
have 30 days to submit comments on the ITC's testing recommendations.

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(2) EPA will publish a Federal Register notice adding all ITC-recommended chemicals to the
automatic reporting provisions of its rules under sections 8(a) and 8(d) of the Act (40 CFR parts
712 and 716).
(3) EPA will hold a public “focus meeting” to discuss the ITC's testing recommendations and
obtain comments and information from interested parties.
(4) EPA will evaluate submissions received under the sections 8(a) and 8(d) reporting
requirements, comments filed on the ITC's recommendations, and other information and data
compiled by the Agency.
(5) EPA will make a preliminary staff determination of the need for testing and, where testing
appears warranted, will tentatively select the studies to be performed.
(6) EPA will hold a public meeting to announce its preliminary testing determinations.
(b) Negotiation procedures for consent agreements. Where EPA believes that testing is
necessary, the Agency will explore whether a consent agreement can be negotiated that satisfies
the testing needs identified by the Agency. EPA will use the following procedures for
negotiating, formulating and accepting consent agreements. Appendix A 1 to this part presents
the schedule that EPA intends to follow for this purpose.
(1) In the Federal Register notice described in paragraph (a)(1) of this section, EPA will explain
its procedures and timetable for negotiating consent agreements and invite persons interested in
participating in or monitoring negotiations to contact the Agency in writing.
(2) Persons who respond to EPA's notice by the announced date of the Agency's course-setting
meeting will be deemed “interested parties” for purposes of any negotiations that EPA conducts.
(3) Following the course-setting meeting announcing EPA's preliminary testing determinations,
the Agency will meet with manufacturers, processors and other interested parties for the purpose
of attempting to negotiate a consent agreement. To facilitate attendance at these meetings, EPA
will contact all interested parties who have expressed a desire to participate in or monitor
negotiations under paragraph (b)(2) of this section and advise them of meeting dates.
(4) All negotiating meetings will be open to members of the public. The minutes of each meeting
will be prepared by EPA. Meeting minutes, testing proposals, background documents and other
materials exchanged at or prepared for negotiating meetings will be included in the public file
established by EPA on each ITC-recommended chemical. Materials in this file will be made
available for inspection in the OPPTS Reading Room during EPA working hours.
(5) While negotiations are underway, EPA will promptly circulate meeting minutes, testing
proposals, correspondence and other relevant materials to interested parties who expressed a
desire to participate in or monitor negotiations pursuant to paragraph (b)(2) of this section.
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(6) As negotiations progress, EPA will make a tentative decision either to proceed with
formulation of a consent agreement or to initiate rulemaking. EPA will terminate negotiations
after 10 weeks and proceed with rulemaking unless negotiations are likely to result in a draft
consent agreement within 4 additional weeks. By the end of this 4-week period, EPA either will
have prepared a draft consent agreement reflecting the apparent consensus of the parties or will
terminate negotiations and proceed with rulemaking. If EPA decides to proceed with rulemaking,
no further opportunity for negotiations will be provided. EPA will promptly send written notice
to all interested parties of the termination of negotiations.
(7) Where EPA prepares a draft consent agreement, it will be circulated for comment to all
interested parties who expressed a desire to participate in or monitor negotiations under
paragraph (b)(2) of this section. A period of 4 weeks will be provided for submitting comments
or written objections under §790.24(a).
(8) If necessary, EPA will hold a public meeting to discuss comments on the draft consent
agreement and to determine whether revisions in the agreement are appropriate.
(9) Where a consensus exists concerning the contents of a draft consent agreement, it will be
circulated to EPA management and interested parties for final approval and signature.
(10) Upon final approval of a consent agreement, EPA will publish a Federal Register notice that
summarizes the agreement, describes the ITC recommendations for the test substance, outlines
the chemical's use and exposure characteristics, and explains the background, objectives and
rationale of the testing to be conducted, and codifies in subpart C of part 799 the name of the
substance(s) to be tested and the citation to the Federal Register notice of the agreement.
§ 790.24 Criteria for determining whether a consensus exists concerning the provisions of a
draft consent agreement.
(a) EPA will enter into consent agreements only where there is a consensus among the Agency,
one or more manufacturers and/or processors who agree to conduct or sponsor the testing, and all
other interested parties who identify themselves in accordance with §790.22(b)(2). EPA will not
enter into a consent agreement in either of the following circumstances:
(1) EPA and affected manufacturers and/or processors cannot reach a consensus on the testing
requirements or other provisions to be included in the consent agreement.
(2) A draft consent agreement is considered inadequate by other interested parties who, pursuant
to §790.22(b)(2), have asked to participate in or monitor negotiations; and these parties have
submitted timely written objections to the draft consent agreement which provide a specific
explanation of the grounds on which the draft agreement is objectionable.
(b) EPA may reject objections described in paragraph (a)(2) of this section only where the
Agency concludes the objections are either:
(1) Not made in good faith.
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(2) Untimely.
(3) Do not involve the adequacy of the proposed testing program or other features of the
agreement that may affect EPA's ability to fulfill the goals and purposes of the Act.
(4) Not accompanied by a specific explanation of the grounds on which the draft agreement is
considered objectionable.
(c) The unwillingness of some manufacturers and/or processors of a prospective test chemical to
sign the draft consent agreement does not, in itself, establish a lack of consensus if EPA
concludes that those manufacturers and/or processors who are prepared to sign the agreement are
capable of accomplishing the testing to be required and that the draft agreement will achieve the
purposes of the Act in all other respects.
§ 790.26 Initiation and completion of rulemaking proceedings on ITC-designated chemicals.
(a) Where EPA concludes that a consensus does not exist concerning the provisions of a draft
consent agreement and that the findings specified by section 4(a) can be made, the Agency will
proceed with rulemaking under section 4(a) of TSCA.
(b) When EPA decides to proceed with rulemaking under paragraph (a) of this section, the
Agency intends to publish a rulemaking proposal and a final rule or a notice terminating the
rulemaking proceeding in accordance with the schedule specified in Appendix A 1 to this part.
1Editorial Note: Appendix A appears at the end of subpart E.
(c) Where the testing recommendations of the ITC raise unusually complex and novel issues that
require additional Agency review and opportunity for public comment, the Agency may publish
an Advance Notice of Proposed Rulemaking (ANPR). The schedule that EPA intends to follow
for rulemaking proceedings initiated by publication of an ANPR is presented in appendix A 1 to
this part.
§ 790.28 Procedures for developing consent agreements and/or test rules for chemicals that
have not been designated or recommended with intent to designate by the ITC.
(a) Where EPA believes that testing is needed, it may also develop consent agreements and/or
test rules on chemical substances or mixtures that either:
(1) Have been recommended but not “recommended with intent to designate” by the ITC.
(2) Have been selected for testing consideration by EPA on its own initiative.
(b) When EPA wishes to initiate negotiations concerning chemicals described in paragraph (a) of
this section, it will publish a Federal Register notice describing its tentative evaluation of testing
needs, announcing a date for a public course-setting meeting, and inviting persons interested in
participating in or monitoring negotiations to contact the Agency in writing. Any negotiations
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that EPA conducts will conform to the procedures specified in §790.22(b) and, to the extent
feasible, will follow the schedules presented in appendix A 1 to this part.
(c) EPA will enter into consent agreements on chemicals described in paragraph (a) of this
section only if there is a consensus among EPA, affected manufacturers and/or processors, and
any other persons who have asked to participate in or monitor negotiations. In determining
whether such a consensus exists, EPA will employ the criteria specified in §790.24. In the
absence of consensus, EPA will initiate rulemaking if it concludes that the findings specified in
section 4(a) of the Act can be made. The schedule for initiating and completing such rulemaking
proceedings will, to the extent feasible, follow the schedule specified in appendix A 1 to this
part.
Subpart C—Implementation, Enforcement, and Modification of Test Rules
Source: 50 FR 20657, May 17, 1985, unless otherwise noted. Redesignated at 51 FR 23713,
June 30, 1986.
§ 790.40 Promulgation of test rules.
(a) If EPA determines that it is necessary to test a chemical substance or mixture by rule under
section 4 of the Act, it will promulgate a test rule in part 799 of this chapter.
(b) EPA will promulgate specific test rules in part 799 of this chapter either by a single-phase
rulemaking procedure or by a two-phase rulemaking procedure.
(1) Under single-phase test rule development, EPA will promulgate a test rule in part 799 of this
chapter through a notice and comment rulemaking which specifies the following:
(i) Identification of the chemical for which testing is required under the rule.
(ii) The health or environmental effect or effects or other characteristics for which testing is
being required.
(iii) Which test substance(s) must be tested.
(iv) Standards for the development of test data.
(v) The EPA Good Laboratory Practice requirements for the required testing.
(vi) Schedule for submission of interim reports and/or final reports to EPA.
(vii) Who must submit either letters of intent to conduct testing or exemption applications.
(viii) What types of data EPA will examine in determining equivalence if more than one test
substance is to be tested.
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(2) Under two-phase test rule development, EPA will promulgate a Phase I test rule in part 799
of this chapter through a notice and comment rulemaking which specifies the following:
(i) Identification of the chemical for which testing is required under the rule.
(ii) The health or environmental effect or effects or other characteristics for which testing is
being required.
(iii) Which test substance(s) must be tested.
(iv) A reference to appropriate guidelines for the development of test data.
(v) The EPA Good Laboratory Practice requirements for the required testing.
(vi) Who must submit either letters of intent to conduct testing and study plans, or exemption
applications.
(vii) What types of data EPA will examine in determining equivalence if more than one test
substance is to be tested.
(3) Under two-phase test rule development, test standards and schedules will be developed in a
second phase of rulemaking as described in §§790.50 and 790.52.
[50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713, June 30, 1986; 54 FR
36313, Sept. 1, 1989]
§ 790.42 Persons subject to a test rule.
(a) Each test rule described in §790.40 will specify whether manufacturers, processors, or both
are subject to the requirement for testing of the subject chemical under section 4(b)(3)(B) of the
Act and will indicate who will be required to submit letters of intent to conduct testing.
(1) If testing is being required to allow evaluation of risks:
(i) Primarily associated with manufacture of the chemical, or
(ii) Associated with both manufacturer and processing of the chemical, or
(iii) Associated with distribution in commerce, use, and/or disposal activities concerning the
chemical, each manufacturer of the chemical will be subject and must comply with the
requirements of the test rule.
(2) While legally subject to the test rule in circumstances described in paragraphs (a)(1) (ii) and
(iii) of this section, processors of the chemical must comply with the requirements of the test rule
only if processors are directed to do so in a subsequent notice as set forth in §790.48(b).
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(3) If testing is being required to allow evaluation of risks associated solely with processing of
the chemical, processors will be subject and must comply with the requirements of the test rule.
(4) While legally subject to the test rule in circumstances described in paragraph (a)(1) of this
section, persons who manufacture less than 500 kg (1,100 lb) of the chemical annually during the
period from the effective date of the test rule to the end of the reimbursement period, must
comply with the requirements of the test rule only if such manufacturers are directed to do so in a
subsequent notice as set forth in §790.48, or if directed to do so in a particular test rule.
(5) While legally subject to the test rule in circumstances described in paragraph (a)(1) of this
section, persons who manufacture small quantities of the chemical solely for research and
development (meaning quantities that are not greater than those necessary for purposes of
scientific experimentation or analysis or chemical research on, or analysis of, such chemical or
another chemical, including such research or analysis for development of a product) from the
effective date of the test rule to the end of the reimbursement period, must comply with the
requirements of the test rule only if such manufacturers are directed to do so in subsequent notice
set forth in §790.48, or if directed to do so in a particular test rule.
(6) If testing is being required to allow evaluation of risks associated primarily with manufacture
of a chemical for research and development (R & D) purposes, manufacturers of the chemical for
R & D will be subject and must comply with the requirements of the test rule.
(b) [Reserved]
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 55
FR 18884, May 7, 1990]
§ 790.45 Submission of letter of intent to conduct testing or exemption application.
(a) No later than 30 days after the effective date of a test rule described in §790.40, each person
subject to that rule and required to comply with the requirements of that rule as provided in
§790.42(a) must, for each test required, either notify EPA by letter of his or her intent to conduct
testing or submit to EPA an application for an exemption from testing requirements for the test.
(b) EPA will consider letters of intent to test as commitments to sponsor the tests for which they
are submitted unless EPA agrees to the substitution of an exemption application in instances
where more than one person indicates an intent to sponsor equivalent tests.
(c) Each letter of intent to conduct testing must include:
(1) Identification of test rule.
(2) Name, address, and telephone number of the firm(s) which will be sponsoring the tests.
(3) Name, address, and telephone number of the appropriate individual to contact for further
information.
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(4) For sponsors participating in a testing consortium—a list of all members of the consortium,
the signature of an authorized representative of each member, and a designation of who is to
serve as principal sponsor.
(5) A list of the testing requirements for which the sponsor(s) intends to conduct tests.
(6) If EPA is requiring testing of more than one representative substance—which test substance
the sponsor(s) intends to use in each of the tests.
(d)(1) Any person not manufacturing or processing the subject chemical as of the effective date
of the test rule describing in §790.40 or by 30 days after the effective date of the rule who, before
the end of the reimbursement period, manufacturers or processes the test chemical and who is
subject to and required to comply with the requirements of the test rule must submit the letter of
intent to test or an exemption application required by paragraph (a) of this section by the date
manufacture or processing begins, or
(2) When both manufacturers and processors are subject to the rule, any person not processing
the subject chemical as of the effective date of the test rule described in §790.40 or by 30 days
after publication of the Federal Register notice described in §790.48(b)(2) who, before the end of
the reimbursement period, processes the test chemical and who is required to comply with the
requirements of the rule must submit the letter of intent to test or an exemption application
required by §790.48(b)(3) of the date processing begins.
(e) Manufacturers subject to a test rule described in §790.40 who do not submit to EPA either a
letter of their intent to conduct tests or a request for an exemption from testing for each test for
which testing is required in the test rule will be considered in violation of that rule beginning on
the 31st day after the effective date of the test rule described in §790.40 or on the date
manufacture begins as described in paragraph (d) of this section.
(f) Processors subject to a test rule described in §790.40 and required to comply with the
requirements of test rule pursuant to §790.42(a)(2) or a Federal Register notice as described in
§790.48(b)(2) who do not submit to EPA either a letter of their intent to conduct tests or a
request for an exemption for each test for which testing is required in the test rule will be
considered in violation of that rule beginning on the 31st day after the effective date of the test
rule described in §790.40 or 31 days after publication of the Federal Register notice described in
§790.48(b)(2) or on the date processing begins as described in paragraph (d) of this section, as
appropriate.
§ 790.48 Procedure if no one submits a letter of intent to conduct testing.
(a) If only manufacturers are subject to the rule. (1) This paragraph applies if testing is being
required solely to allow evaluation of risks associated with manufacturing and the test rule
described in §790.40 states that manufacturers only are responsible for testing.
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(2) If no manufacturer subject to the test rule has notified EPA of its intent to conduct one or
more of the required tests within 30 days after the effective date of the test rule described in
§790.40, EPA will notify all manufacturers, including those described in §790.42(a)(4) and
(a)(5), by certified mail or by publishing a notice of this fact in the Federal Register specifying
the tests for which no letter of intent has been submitted and will give such manufacturers an
opportunity to take corrective action.
(3) If no manufacturer submits a letter of intent to conduct one or more of the required tests
within 30 days after receipt of the certified letter or publication of the Federal Register notice
described in paragraph (a)(2) of this section, all manufacturers subject to the rule will be in
violation of the test rule from the 31st day after receipt of the certified letter or publication of the
Federal Register notice described in this paragraph.
(b) If manufacturers and processors are subject to the rule. (1) This paragraph applies if testing is
being required to allow evaluation of risks associated with manufacturing and processing or with
distribution in commerce, use, or disposal of the chemical and the test rule described in §790.40
states that manufacturers and processors are responsible for testing.
(2) If no manufacturer subject to the rule has notified EPA of its intent to conduct testing for one
or more of the required tests within 30 days after the effective date of the test rule described in
§790.40, EPA will publish a notice in the Federal Register of this fact specifying the tests for
which no letter of intent has been submitted.
(3) No later than 30 days after the date of publication of the Federal Register notice described in
paragraph (b)(2) of this section, each person described in §790.40(a)(4) and (5) and each person
processing the subject chemical as of the effective date of the test rule described in §790.40 or by
30 days after the date of publication of the Federal Register notice described in paragraph (b)(2)
of this section must, for each test specified in the Federal Register notice, either notify EPA by
letter of his or her intent to conduct testing or submit to EPA an application for an exemption
from testing requirements for the test.
(4) If no manufacturer or processor of the test chemical has submitted a letter of intent to conduct
one or more of the required tests within 30 days after the date of publication of the Federal
Register notice described in paragraph (b)(2) of this section, EPA will notify all manufacturers
and processors by certified letter or publish a Federal Register notice of this fact specifying the
tests for which no letter of intent has been submitted. This letter or Federal Register notice will
give the manufacturers and processors an opportunity to take corrective action.
(5) If no manufacturer or processor submits a letter of intent to conduct one or more of the
required tests within 30 days after receipt of the certified letter or publication of the Federal
Register notice described in paragraph (b)(4) of this section, all manufacturers and processors
subject to the rule will be in violation of the test rule from the 31st day after receipt of the
certified letter or publication of the Federal Register notice described in paragraph (b)(4) of this
section.
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(c) Only processors are subject to the rule. (1) This paragraph applies if testing is being required
solely to allow evaluation of risks associated with processing and the test rule described in
§790.40 states that only processors are responsible for testing.
(2) If no processor subject to the rule has notified EPA of its intent to conduct one or more of the
required tests within 30 days after the effective date of the test rule described in §790.40, EPA
will notify all the processors by certified mail or publish a notice in the Federal Register of this
fact, specifying the tests for which no letter of intent has been submitted and give the processors
an opportunity to take corrective action.
(3) If no processor submits a letter of intent to conduct one or more of the required tests within
30 days after receipt of the certified letter or publication of the Federal Register notice described
in paragraph (c)(2) of this section, all processors subject to the rule will be in violation of the test
rule from the 31st day after receipt of the certified letter or publication of the Federal Register
notice described in this paragraph.
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 55
FR 18884, May 7, 1990]
§ 790.50 Submission of study plans.
(a) Who must submit study plans. (1) Persons who notify EPA of their intent to conduct tests in
compliance with the requirements of a single phase test rule as described in §790.40(b)(1) must
submit study plans for those tests prior to the initiation of each of these tests, unless directed by a
particular test rule or consent agreement to submit study plans at a specific time.
(2) Persons who notify EPA of their intent to conduct tests in compliance with the requirements
of a Phase I test rule as described in §790.40(b)(2) must submit the proposed study plans for
those tests on or before 90 days after the effective date of the Phase I rule; or, for processors
complying with the notice described in §790.48(b)(2), 90 days after the publication date of that
notice; or 60 days after the date manufacture or processing begins as described in §790.45(d), as
appropriate, to the address in §790.5(b).
(3) Study plans must be prepared according to the requirements of this subpart B and part 792 of
this chapter. Only one set of study plans should be prepared and submitted by persons who are
jointly sponsoring testing.
(4) Any person subject to a test rule may submit a study plan for any test required by the rule at
any time, regardless of whether the person previously submitted an application for exemption
from testing for that test.
(5) Unless EPA has granted an extension of time for submission of proposed study plans,
manufacturers who notify EPA that they intend to conduct testing in compliance with the
requirements of a Phase I test rule as described in §790.40(b)(2) and who do not submit proposed
study plans for those tests on or before 90 days after the effective date of the Phase I test rule or
15

60 days after the date manufacture begins as described in §790.45(d) will be considered in
violation of the test rule as if no letter of intent to test had been submitted.
(6) Unless EPA has granted an extension of time for submission of proposed study plans,
processors who notify EPA that they intend to conduct testing in compliance with the
requirements of a Phase I test rule as described in §790.40(b)(2) and who do not submit proposed
study plans for those tests on or before 90 days after the effective date of the Phase I test rule or
90 days after the publication date of the notice described in §790.48(b)(2), or 60 days after the
date processing begins as described in §790.45(d), as appropriate, will be considered in violation
of the test rule as if no letter of intent to test had been submitted.
(b) Extensions of time for submission of study plans. (1) EPA may grant requests for additional
time for the development of study plans on a case-by-case basis. Requests for additional time for
study plan development must be made in writing to EPA at the address in §790.5(b). Each
extension request must state why EPA should grant the extension.
(2) Under two-phase rulemaking, extension requests must be submitted to EPA within 60 days
after the effective date of the Phase I test rule as described in §790.40(b)(2); or for processors
complying with the notice described in §790.48(b)(2), 60 days after the publication date of that
notice; or 30 days after the date manufacture or processing begins as described in §790.45(d), as
appropriate.
(3) EPA will notify the submitter by certified mail of EPA's decision to grant or deny an
extension request.
(4) Persons who have been granted an extension of time for submission of study plans as
described in paragraph (b)(1) of this section and who do not submit proposed study plans in
compliance with the requirements of a Phase I test rule in accordance with the new deadline
granted by EPA will be considered in violation of the test rule as if no letter of intent to test had
been submitted as described in §790.45(e) and (f).
(c) Content of study plans. (1) All study plans are required to contain the following information:
(i) Identity of the test rule.
(ii) The specific test requirements of that rule to be covered by the study plan.
(iii)(A) The names and addresses of the test sponsors.
(B) The names, addresses, and telephone numbers of the responsible administrative officials and
project manager(s) in the principal sponsor's organization.
(C) The name, address, and telephone number of the appropriate individual to contact for oral
and written communications with EPA.
16

(D)(1) The names and addresses of the testing facilities and the names, addresses, and telephone
numbers of the testing facilities’ administrative officials and project manager(s) responsible for
the testing.
(2) Brief summaries of the training and experience of each professional involved in the study,
including study director, veterinarian(s), toxicologist(s), pathologist(s), chemist(s),
microbiologist(s), and laboratory assistants.
(iv) Identity and data on the chemical substance(s) being tested, including physical constants,
spectral data, chemical analysis, and stability under test and storage conditions, as appropriate.
(v) Study protocol, including the rationale for any combination of test protocols; the rationale for
species/strain selection; dose selection (and supporting data); route(s) or method(s) of exposure;
description of diet to be used and its source; including nutrients and contaminants and their
concentrations; for in vitro test systems, a description of culture medium and its source; and a
summary of expected spontaneous chronic diseases (including tumors), genealogy, and life span.
(vi) Schedule for initiation and completion of each short-term test and of each major phase of
long-term tests; dates for submission of interim progress and final reports to EPA that are within
the reporting deadlines specified by EPA In the final test rule.
(2) Information required in paragraph (c)(1)(iii)(D) of this section is not required in proposed
study plans submitted in compliance with the requirements of a Phase I test rule if the
information is not available at the time of study plan submission; however, the information must
be submitted before the initiation of testing.
(d) Incomplete study plans. (1) Upon receipt of a study plan, EPA will review the study plan to
determine whether it complies with paragraph (c) of this section. If EPA determines that the
study plan does not comply with paragraph (c) of this section, EPA will notify the submitter that
the submission is incomplete and will identify the deficiencies and the steps necessary to
complete the submission.
(2) The submitter will have 15 days after the day it receives this notice to submit appropriate
information to make the study plan complete.
(3) If the submitter fails to provide appropriate information to complete a proposed study plan
submitted in compliance with the requirements of a Phase I test rule on or before 15 days after
receipt of the notice, the submitter will be considered in violation of the test rule as if no letter of
intent to conduct the test had been submitted as described in §790.45(e) and (f).
(e) Amendments to study plans. Test sponsors shall submit all amendments to study plans to the
Director, Office of Compliance Monitoring at the address in §790.5(d).
[50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713, June 30, 1986; 52 FR
36569, Sept. 30, 1987; 54 FR 36313, Sept. 1, 1989; 55 FR 18884, May 7, 1990; 58 FR 34205,
June 23, 1993; 60 FR 34466, July 3, 1995]
17

§ 790.52 Phase II test rule.
(a) If EPA determines that the proposed study plan described in §790.50(a)(2) complies with
§790.50(c), EPA will publish a proposed Phase II test rule in the Federal Register requesting
comments on the ability of the proposed study plan to ensure that data from the test will be
reliable and adequate.
(b) EPA will provide a 45-day comment period and will provide an opportunity for an oral
presentation upon the request of any person. EPA may extend the comment period if it appears
from the nature of the issues raised by EPA's review or from public comments that further
comment is warranted.
(c) After receiving and considering public comments on the study plan, EPA will adopt, as
proposed or as modified in response to EPA review and public comments, the study protocol
section of the study plan, as defined by §790.50(c)(1)(v) of this chapter, as the test standard for
the required testing, and the schedule section of the study plan, as defined by §790.50(c)(1)(vi)
of this chapter, as the schedule for the required testing in a final Phase II test rule.
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 52
FR 36569, Sept. 30, 1987]
§ 790.55 Modification of test standards or schedules during conduct of test.
(a) Application. Any test sponsor who wishes to modify the test schedule for the mandatory
testing conditions or requirements (i.e., “shall statements”) in the test standard for any test
required by a test rule must submit an application in accordance with this paragraph. Application
for modification must be made in writing to EPA at the address in §790.5(b), or by phone with
written confirmation to follow within 10 working days. Applications must include an appropriate
explanation and rationale for the modification. Where a test sponsor requests EPA to provide
guidance or to clarify a non-mandatory testing requirement (i.e., “should statements”) in a test
standard, the test sponsor should submit these requests to EPA at the address in §790.5(b).
(b) Adoption. (1) Where EPA concludes that the requested modification of a test standard or
schedule for a test required under a test rule is appropriate, EPA will proceed in accordance with
this paragraph (b).
(2) Where, in EPA's judgment, the requested modification of the test standard or schedule would
not alter the scope of the test or significantly change the schedule for completing the test, EPA
will not ask for public comment before approving the modification. EPA will notify the test
sponsor by letter of EPA's approval. EPA will place copies of each application and EPA
approval letter in the rulemaking record for the test rule in question. EPA will publish a notice
annually in the Federal Register indicating the test standards or schedules for tests required in
test rules which have been modified under this paragraph (b)(2) and describing the nature of the
modifications. Until the Federal Register notice is published, any modification approved by EPA
18

under this paragraph (b)(2) shall apply only to the test sponsor who applied for the modification
under this paragraph (a) of this section.
(3) Where, in EPA's judgment, the requested modification of a test standard or schedule would
significantly alter the scope of the test or significantly change the schedule for completing the
test, EPA will publish a notice in the Federal Register requesting comment on the proposed
modification. However, EPA will approve a requested modification of a test standard under
paragraph (b)(3) of this section without first seeking public comment if EPA believes that an
immediate modification to the test standard is necessary to preserve the accuracy or validity of
an ongoing test. EPA may also modify a testing requirement or test condition in a test standard if
EPA determines that the completion or achievement of this requirement or condition is not
technically feasible. EPA may approve a test schedule extension under paragraph (b)(3) of this
section without first seeking public comment if EPA determines, on a case-by-case basis, that a
delay of over 12 months is not the fault of the test sponsor and is the result of unforeseen
circumstances such as a lack of laboratory availability, lack of availability of suitable test
substance (e.g., 14–C labelled test substance), lack of availability of healthy test organisms, or
the unexpected failure of a long-term test. EPA will publish an annual notice in the Federal
Register announcing the approval of any test standard modifications and test schedule extensions
under paragraph (b)(3) of this section and provide a brief rationale of why the modification was
granted.
(4) For purposes of this paragraph (b), a requested modification of a test standard or schedule for
a test required under a test rule would alter the scope of the test or significantly change the
schedule for completing the test if the modification would:
(i) Change the test species.
(ii) Change the route of administration of the test chemical.
(iii) Change the period of time during which the test species is exposed to the test chemical.
(iv) Except as provided in paragraph (b)(3) of this section, extend the final reporting deadline
more than 12 months from the date specified in the final rule.
(c) Disapproval. Where EPA concludes that the requested modification of a test standard or
schedule for a test required under a test rule is not appropriate, EPA will so notify the test
sponsor in writing.
(d) Timing. (1) Test sponsors should submit all applications for test schedule modifications at
least 60 days before the reporting deadline for the test in question.
(2) EPA will not normally approve any test schedule extensions submitted less than 30 days
before the reporting deadline for the test in question.

19

(3) Except as provided in paragraph (b)(3) of this section, EPA may grant extensions for up to 1
year but will normally limit extensions to a period of time equal to the in-life portion of the test
plus 60 days.
(4) EPA will normally approve only one deadline extension for each test.
(5) Test sponsors should submit requests for test standard modifications as soon as they
determine that the test cannot be successfully completed according to the test standard specified
in the rule.
[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 52
FR 36571, Sept. 30, 1987; 54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3, 1995]
§ 790.59 Failure to comply with a test rule.
(a) Persons who notified EPA of their intent to conduct a test required in a test rule in part 799 of
this chapter and who fail to conduct the test in accordance with the test standards and schedules
adopted in the test rule, or as modified in accordance with §790.55, will be in violation of the
rule.
(b) Any person who fails or refuses to comply with any aspect of this part or a test rule under
part 799 of this chapter is in violation of section 15 of the Act. EPA will treat violations of the
Good Laboratory Practice standards as indicated in §792.17 of this chapter.
Subpart D—Implementation, Enforcement and Modification of Consent Agreements
Source: 51 FR 23715, June 30, 1986, unless otherwise noted.
§ 790.60 Contents of consent agreements.
(a) Standard provisions. All consent agreements will contain the following provisions:
(1) Identification of the chemical(s) to be tested.
(2) The health effects, environmental effects and/or other characteristics for which testing will be
required.
(3) The names and addresses of each manufacturer and/or processor who will sign the
agreement.
(4) The name and address of the manufacturer, processor or other entity who has agreed to act as
the principal test sponsor.
(5) The technical or commercial grade, level of purity or other characteristics of the test
substances(s) or mixture(s).
20

(6) Standards for the development of test data.
(7) A requirement that testing will be conducted in accordance with the EPA Good Laboratory
Practice (GLP) regulations (40 CFR part 792).
(8) Schedules with reasonable deadlines for submitting interim progress and/or final reports to
EPA.
(9) A requirement that the principal sponsor will submit a study plan to EPA in accordance with
§790.62.
(10) A statement that the results of testing conducted pursuant to the consent agreement will be
announced to the public in accordance with the procedures specified in section 4(d) of the Act
and that the disclosure of data generated by such testing will be governed by section 14(b) of the
Act.
(11) A requirement that the manufacturers and/or processors signing the consent agreement will
comply with the notification requirements of section 12(b)(1) of the Act and part 707 of this
chapter if they export or intend to export the substance or mixture for which the submission of
data is required under the agreement and a statement that any other person who exports or
intends to export such substance or mixture is subject to the above cited export notification
requirements.
(12) A requirement that, in the event EPA promulgates a significant new use rule applicable to
the test chemical under section 5(a)(2), the consent agreement will have the status of a test rule
for purposes of section 5(b)(1)(A) and manufacturers and/or processors signing the agreement
will comply with the data submission requirements imposed by that provision.
(13) A statement that each manufacturer and/or processor signing the agreement agrees that
violation of its requirements will constitute a “prohibited act” under section 15(1) of the Act and
will trigger all provisions of TSCA applicable to a violation of section 15.
(14) A statement that, in the event one or more provisions of the agreement are determined to be
unenforceable by a court, the remainder of the agreement would not be presumed to be valid and
EPA will then either initiate a rulemaking proceeding or publish in the Federal Register the
Administrator's reason for not initiating such a proceeding.
(15) A statement that the Agency may conduct laboratory inspections and/or study audits of the
testing being conducted pursuant to the consent agreement in accordance with the authority and
procedures contained in section 11 of the Act.
(16) A statement that EPA acceptance of a consent agreement constitutes “final agency action”
for purposes of 5 U.S.C. 704.
(17) Any other requirements that the parties agree are necessary to achieve the purposes of the
Act.
21

(b) Contents of standards for the development of data. The standards for the development of the
data included in consent agreements will be based on the TSCA test guidelines in 40 CFR parts
796, 797, and 798, the Organization for Economic Cooperation and Development (OECD) test
guidelines, the EPA pesticide assessment guidelines published by The National Technical
Information Service (NTIS), or other suitable test methodologies. During the negotiation of
consent agreements, EPA will initially propose suitable test guidelines as the required test
standards; manufacturers and processors or other interested parties may then suggest alternative
methodologies or modifications to the Agency's proposed guidelines. These alternative
methodologies or modifications will be adopted only where, in the judgment of EPA, they will
develop at least equally reliable and adequate data on the chemical substance or mixture subject
to the agreement.
(c) Statement of rationale for consent agreement. EPA will prepare a written explanation of the
basis for each consent agreement. This document will summarize the agreement, describe any
ITC testing recommendations for the chemical involved, outline the chemical's use and exposure
characteristics, and explain the objectives of the testing to be conducted and the rationale for the
specific studies selected. This document will be published in the Federal Register and, for ITCdesignated chemicals, will constitute the statement of EPA's reasons for not initiating rulemaking
required by section 4(e)(1)(B) of the Act.
[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989]
§ 790.62 Submission of study plans and conduct of testing.
(a) Timing of submission. The principal sponsor of testing conducted pursuant to a consent
agreement shall submit a study plan no later than 45 days prior to the initiation of testing.
(b) Content of study plans. All study plans are required to contain the following information:
(1) Identity of the consent agreement under which testing will be performed.
(2) The specific test requirements to be covered by the study plan.
(3) The name and address of the principal test sponsor.
(4) The names, addresses, and telephone numbers of the responsible administrative official[s]
and project manager[s] in the principal sponsor's organization.
(5) The names, addresses, and telephone numbers of the technical contacts at each manufacturer
and/or processor subject to the agreement.
(6) The names and addresses of the testing facilities responsible for the testing and the names,
addresses, and telephone numbers of the administrative officials[s] and project manager[s]
assigned to oversee the testing program at these facilities.
22

(7) Brief summaries of the training and experience of each professional involved in the study,
including study director, veterinarian[s], toxicologist[s], pathologist[s], chemist[s],
microbiologist[s], and laboratory assistants.
(8) Identity and supporting data on the chemical substance[s] being tested, including physical
constants, spectral data, chemical analysis, and stability under test and storage conditions, as
appropriate.
(9) Study protocol, including the rationale for any combination of test protocols; the rationale for
species/strain selection; dose selection (and supporting data); route(s) or method(s) of exposure;
description of diet to be used and its source, including nutrients and contaminants and their
concentrations; for in vitro test systems, a description of culture medium and its source; and a
summary of expected spontaneous chronic diseases (including tumors), genealogy, and life span.
(10) A schedule, with reasonable timeables and deadlines, for initiation and completion of each
short-term test and of each major phases of long-term tests, and submission of interim progress
and/or final reports to EPA.
(c) Review and modification. (1) Upon receipt of a study plan, EPA will review it to determine
whether it complies with paragraph (b) of this section. If EPA determines that the study plan
does not comply with paragraph (b) of this section, EPA will notify the submitter that the plan is
incomplete and will identify the deficiencies and the steps necessary to complete the plan. It is
the responsibility of the test sponsor to review the study protocols to determine if they comply
with all the mandatory testing conditions and requirements in the test standards (i.e., “shall
statements”).
(2) The submitter will have 15 days after the day it receives a notice under paragraph (c)(1) of
this section to submit appropriate information to make the study plan complete.
(3) If the submitter fails to provide appropriate information to complete a study plan within 15
days after having received a notice under paragraph (c)(1) of this section, the submitter will be
considered to be in violation of the consent agreement and subject to enforcement proceedings
pursuant to §790.65 (c) and (d).
(4) The test sponsor shall submit any amendments to study plans to EPA at the address specified
in §790.5(b).
(d) Functions of the principal test sponsor. When testing is being conducted pursuant to a consent
agreement, the principal test sponsor will be responsible for submitting interim progress and final
reports to EPA, informing the Agency of any proposed changes in standards for the development
of data, study plans or testing schedules, and communicating with the Agency about laboratory
inspections and other matters affecting the progress of testing.
[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3,
1995]
§ 790.65 Failure to comply with a consent agreement.
23

(a) Manufacturers and/or processors who have signed a consent agreement and who fail to
comply with the test requirements, test standards, GLP regulations, schedules, or other
provisions contained in the consent agreement, or in modifications to the agreement adopted
pursuant to §790.68, will be in violation of the consent agreement.
(b) The Agency considers failure to comply with any aspect of a consent agreement to be a
“prohibited act” under section 15 of TSCA, subject to all of the provisions of the Act applicable
to violations of section 15. Section 15(1) of TSCA makes it unlawful for any person to fail or
refuse to comply with any rule or order issued under section 4. Consent agreements adopted
pursuant to this part are “orders issued under section 4” for purposes of section 15(1) of TSCA.
(c) Manufacturers and/or processors who violate consent agreements are subject to criminal
and/or civil liability. Under the penalty provisions of section 16 of TSCA, such firms could be
subject to a civil penalty of up to $25,000 per violation with each day in violation constituting a
separate violation of section 15. Intentional violations could lead to the imposition of criminal
penalties of up to $25,000 for each day of violation and imprisonment for up to one year. In
addition, EPA could invoke the remedies available under section 17 of TSCA, including seeking
an injunction to compel adherence to the requirements of the consent agreement.
(d) Noncompliance with a consent agreement will constitute conduct “in violation of this Act”
under section 20(a)(1) of TSCA. Thus, failure to comply with the requirements of a consent
agreement could result in a citizens’ civil action under section 20(a)(1) of TSCA.
§ 790.68 Modification of consent agreements.
(a) Changes in the scope of testing. (1) Manufacturers or processors subject to a consent
agreement, other persons or EPA may seek modifications in the scope of testing performed under
the consent agreement. If, upon receiving a request for modification, EPA determines that new
issues have been raised that warrant reconsideration of the scope of testing, or if EPA determines
on its own that such reconsideration is appropriate, EPA will publish a Federal Register notice
describing the proposed modification and soliciting public comment. If, based on the comments
received, EPA concludes that differences of opinion may exist about the proposed modification,
EPA will establish a schedule for conducting negotiations and invite parties who wish to
participate in or monitor these negotiations to contact the Agency in writing. Any negotiations
that EPA conducts will conform to the procedures specified in §790.22(b).
(2) The scope of testing required by a consent agreement will be modified only where there is a
consensus concerning the modified testing requirements among EPA, affected manufacturers
and/or processors, and other persons who have asked to participate in or monitor negotiations
under paragraph (a)(1) of this section. In determining whether a consensus exists, EPA will
employ the criteria specified in §790.24. In the absence of consensus, EPA may initiate
rulemaking under section 4(a) of the Act if it concludes that any testing beyond that required by
the consent agreement is necessary and that the other statutory findings required by section 4(a)
can be made. While such rulemaking proceedings are underway, the consent agreement will
24

remain in effect unless EPA finds that the testing required by the agreement is or may be
unnecessary in view of the testing requirements included in EPA's proposed rule.
(b) Changes in test standards or schedules. (1) Any test sponsor who wishes to modify the test
schedule for any test required under a consent order must submit an application in accordance
with this paragraph. Application for modification must be made in writing to EPA at the address
in §790.5(b), or by phone with written confirmation to follow within 10 working days.
Applications must include an appropriate explanation and rationale for the modification. EPA
will consider only those applications that request modifications to mandatory testing conditions
or requirements (“shall statements” in the consent order). Where a test sponsor requests EPA to
provide guidance or to clarify a non-mandatory testing requirement (i.e., “should statements”),
the test sponsor should submit these requests to EPA at the address in section 790.5(b).
(2)(i) Where EPA concludes that the requested modification of a test standard or schedule for a
test required under a consent agreement is appropriate, EPA will proceed in accordance with this
paragraph (b)(2).
(ii) Where, in EPA's judgment, the requested modification of a test standard or schedule would
not alter the scope of the test or significantly change the schedule for completing the test, EPA
will not ask for public comment before approving the modification. EPA will notify the test
sponsor, and any other persons who have signed the consent agreement, by letter of EPA's
approval. EPA will place copies of each application and EPA approval letter in the
administrative record maintained for the consent agreement in question. EPA will publish a
notice annually in the Federal Register indicating the test standards or schedules for test required
in consent agreements which have been modified under this paragraph (b)(2)(ii) and describing
the nature of the modifications.
(iii) Where, in EPA's judgment, the requested modification of a test standard or schedule would
significantly alter the scope of the test or significantly change the schedule for completing the
test, EPA will publish a notice in the Federal Register requesting comment on the proposed
modification. However, EPA will approve a requested modification of a test standard under
paragraph (b)(2)(iii) of this section without first seeking public comment if EPA believes that an
immediate modification to the test standard is necessary to preserve the accuracy or validity of
an ongoing test. EPA also may modify a testing requirement or test condition in a test standard if
EPA determines that the completion or achievement of this requirement or condition is not
technically feasible. EPA may approve a requested modification of a test schedule under
paragraph (b)(2)(iii) of this section without first seeking public comment if EPA determines, on a
case-by-case basis, that a delay of over 12 months is not the fault of the test sponsor and is due to
unforeseen circumstances such as a lack of laboratory availability, lack of availability of suitable
test substance (e.g., 14–C labelled test substance), lack of availability of healthy test organisms,
or the unexpected failure of a long-term test. EPA will publish an annual notice in the Federal
Register announcing the approval of any test standard modifications and test scheduled
extensions under paragraph (b)(2)(iii) of this section, and provide a brief rationale of why the
modification was granted.
25

(iv) For purposes of this paragraph (b)(2), a requested modification of a test standard of schedule
for a test required under a consent agreement would alter the scope of the test or significantly
change the schedule for completing the test if the modification would:
(A) Change the test species.
(B) Change the route of administration of the test chemical.
(C) Change the period of time during which the test species is exposed to the test chemical.
(D) Except as provided in paragraph (b)(2)(iii) of this section, extend the final reporting deadline
more than 12 months from the date specified in the consent order.
(3) Where EPA concludes that the requested modification of a test standard or schedule for a test
requirement under a consent agreement is not appropriate, EPA will so notify the test sponsor in
writing.
(c) Timing. (1) Test sponsors should submit all applications for test schedule modifications at
least 60 days before the reporting deadline for the test in question.
(2) EPA will not normally approve any test schedule extensions submitted less than 30 days
before the reporting deadline for the test in question.
(3) Except as provided in paragraph (b)(2)(iii) of this section, EPA may grant extensions as
shown necessary for up to 1 year but will normally limit extensions to a period of time equal to
the in-life portion of the test plus 60 days.
(4) EPA will normally approve only one deadline extension for each test.
(5) Test sponsors should submit requests for test standard modifications as soon as they
determine that the test cannot be successfully completed according to the test standard specified
in the consent order.
[51 FR 23715, June 30, 1986, as amended at 52 FR 36571, Sept. 30, 1987; 54 FR 36314, Sept. 1,
1989; 60 FR 34466, July 3, 1995]
Subpart E—Exemptions From Test Rules
Source: 50 FR 20660, May 17, 1985, unless otherwise noted.
§ 790.80 Submission of exemption applications.
(a) Who should file applications. (1) Any manufacturer or processor subject to a test rule in part
799 of this chapter may submit an application to EPA for an exemption from performing any or
all of the tests required under the test rule.
26

(2) Processors will not be required to apply for an exemption or conduct testing unless EPA so
specifies in a test rule or in a special Federal Register notice as described in §790.48(b)(2) under
the following circumstances:
(i) If testing is being required to allow evaluation of risks associated with manufacturing and
processing or with distribution in commerce, use, or disposal of the chemical and manufacturers
do not submit notice(s) of intent to conduct the required testing; or
(ii) If testing is being required solely to allow evaluation of risks associated with processing of
the chemical.
(b) When applications must be filed. (1) Exemption applications must be filed within 30 days
after the effective date of the test rule described in §790.40 or, if being submitted in compliance
with the Federal Register notice described in §790.48(b)(2), within 30 days after the publication
of that notice.
(2) Exemption applications must be filed by the date manufacture or processing begins by any
person not manufacturing or processing the subject chemical as of the effective date of the test
rule described in §790.40 or by 30 days after the effective date of the test rule described in
§790.40, who, before the end of the reimbursement period, manufactures or processes the test
substance and who is subject to the requirement to submit either a letter of intent to test or an
exemption application.
(3) When both manufacturers and processors are subject to the rule, exemption applications must
be filed by the date processing begins by any person not processing as of the effective date of the
test rule described in §790.40 or by 30 days after publication of the Federal Register notice
described in §790.48(b)(2) who, before the end of the reimbursement period, processes the test
substance and who is subject to the requirement to submit either a letter of intent to test or an
exemption application.
(c) Scope of application. A person may apply for an exemption from all, or one or more, specific
testing requirements in a test rule in part 799 of this chapter.
[50 FR 20660, May 17, 1985, as amended at 58 FR 34205, June 23, 1993]
§ 790.82 Content of exemption application.
The exemption application must contain:
(a) The identity of the test rule, the chemical identity, and the CAS No. of the test substance on
which the application is based.
(b) The specific testing requirement(s) from which an exemption is sought and the basis for the
exemption request.
(c) Name, address, and telephone number of applicant.
27

(d) Name, address, and telephone number of appropriate individual to contact for further
information.
(e)(1) If required in the test rule to establish equivalence:
(i) The chemical identity of the test substance on which the application is based.
(ii) Equivalence data specified in §790.85.
(2) If a test rule requires testing of a single representative substance, EPA will consider all forms
of the chemical subject to that rule to be equivalent and will not require the submission of
equivalence data as described in §790.85.
[50 FR 20660, May 17, 1985, as amended at 54 FR 36315, Sept. 1, 1989]
§ 790.85 Submission of equivalence data.
If EPA requires in a test rule promulgated under section 4 of the Act the testing of two or more
test substances which are forms of the same chemical, each exemption applicant must submit the
following data:
(a) The chemical identity of each technical-grade chemical substance or mixture manufactured
and/or processed by the applicant for which the exemption is sought. The exact type of
identifying data required will be specified in the test rule, but may include all characteristics and
properties of the applicant's substance or mixture, such as boiling point, melting point, chemical
analysis (including identification and amount of impurities), additives, spectral data, and other
physical or chemical information that may be relevant in determining whether the applicant's
substance or mixture is equivalent to the specific test substance.
(b) The basis for the applicant's belief that the substance or mixture is equivalent to the test
substance or mixture.
(c) Any other data which exemption applicants are directed to submit in the test rule which may
bear on a determination of equivalence. This may include a description of the process by which
each technical-grade chemical substance or mixture for which an exemption is sought is
manufactured or processed prior to use or distribution in commerce by the applicant.
§ 790.87 Approval of exemption applications.
(a) EPA will conditionally approve exemption applications if:
(1)(i) For single-phase test rules, EPA has received a letter of intent to conduct the testing from
which exemption is sought;

28

(ii) For two-phase test rules, EPA has received a complete proposed study plan for the testing
from which exemption is sought and has adopted the study plan, as proposed or modified, as test
standards and schedules in a final Phase II test rule; and
(2) The chemical substance or mixture with respect to which the application was submitted is
equivalent to a test substance or mixture for which the required data have been or are being
submitted in accordance with a test rule; and
(3) Submission of the required test data concerning that chemical substance or mixture would be
duplicative of data which have been or are being submitted to EPA in accordance with a test rule.
(b)(1) If a single representative substance is to be tested under a test rule, EPA will consider all
forms of the chemical subject to that rule to be equivalent and will contact the exemption
applicant only if information is missing or unclear.
(2) If two or more representative substances are to be tested under a test rule, EPA will evaluate
equivalence claims made in each exemption application according to the criteria discussed in the
test rule.
(i) If EPA finds an equivalence claim to be in error or inadequately supported, the applicant will
be notified by certified mail. The applicant will be given 15 days to provide clarifying
information.
(ii) Exemption applicants will be notified that equivalence has been accepted or rejected.
(c) The final Phase II test rule which adopts the study plans in two-phase rulemaking, a separate
Federal Register notice in single-phase rulemaking, or a letter by certified mail will give
exemption applicants final notice that they have received a conditional exemption. All
conditional exemptions thus granted are contingent upon the test sponsors’ successful
completion of testing according to the specifications in the test rule.
§ 790.88 Denial of exemption application.
(a) EPA may deny any exemption application if:
(1) EPA determines that the applicant has failed to demonstrate that the applicant's chemical is
equivalent to the test substance; or
(2) The exemption applicant fails to submit any of the information specified in §790.82; or
(3) The exemption applicant fails to submit any of the information specified in §790.85 if
required in the test rule; or
(4)(i) For single-phase test rules, EPA has not received a letter of intent to conduct the test for
which exemption is sought; or
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(ii) For two-phase test rules, EPA has not received an adequate study plan for the test for which
exemption is sought; or
(5) The study sponsor(s) fails to initiate the required testing by the deadlines adopted in the test
rule; or
(6) The study sponsor(s) fails to submit data as required in the test standard and deadlines for
submission of test data as adopted in the test rule or as modified in accordance with §790.55.
(b) EPA will notify the exemption applicant by certified mail or Federal Register notice of EPA's
determination that the exemption application is denied.
§ 790.90 Appeal of denial of exemption application.
(a) Within 30 days after receipt of notification that EPA has denied an application for exemption,
the applicant may file an appeal with EPA.
(b) The appeal shall indicate the basis for the applicant's request for reconsideration.
(c)(1) The applicant may also include a request for a hearing. Hearings will be held according to
the procedures described in §790.97.
(2) Hearing requests must be in writing and must be received by EPA within 30 days of receipt
of the letter or publication of the Federal Register notice described in §790.88(b). Hearing
requests must provide reasons why a hearing is necessary.
(d) If EPA determines that there are material issues of fact, then the request for a hearing will be
granted. If EPA denies a hearing request, EPA will base its decision on the written submission.
(e) EPA will notify the applicant of its decision within 60 days after EPA receives the appeal
described in paragraph (a) of this section or within 60 days after completion of a hearing
described in paragraph (c) of this section.
(f) The filing of an appeal from the denial of an exemption shall not act to stay the applicant's
legal obligations under a test rule promulgated under section 4 of the Act.
§ 790.93 Termination of conditional exemption.
(a) EPA shall terminate a conditional exemption if it determines that:
(1) The test which provided the basis for approval of the exemption application has not been
started by the deadlines for initiation of testing adopted in the test rule or modified in accordance
with §790.55; or

30

(2) Data required by the test rule have not been generated in accordance with the test standards
or submitted in accordance with the deadlines for submission of test data that were adopted in the
test rule or modified in accordance with §790.55; or
(3) The testing has not been conducted or the data have not been generated in accordance with
the Good Laboratory Practice requirements in part 792 of this chapter.
(b) If EPA determines that one or more of the criteria listed in paragraph (a) of this section has
been met, EPA will notify each holder of an affected conditional exemption by certified mail or
Federal Register notice of EPA's intent to terminate that conditional exemption.
(c) Within 30 days after receipt of a letter of notification or publication of a notice in the Federal
Register that EPA intends to terminate a conditional exemption, the exemption holder may
submit information to rebut EPA's preliminary decision or notify EPA by letter of its intent to
conduct the required test pursuant to the test standard established in the final test rule. Such a
letter of intent shall contain all of the information required by §790.45(c).
(d)(1) The exemption holder may also include a request for a hearing. Hearings will be held in
accordance with the procedures set forth in §790.97.
(2) Hearing requests must be in writing and must be received by EPA within 30 days after
receipt of the letter or publication in the Federal Register notice described in paragraph (b) of this
section.
(e) EPA will notify the exemption holder by certified letter or by Federal Register notice of
EPA's final decision concerning termination of conditional exemptions and will give instructions
as to what actions the former exemption holder must take to avoid being found in violation of the
test rule.
§ 790.97 Hearing procedures.
(a) Hearing requests must be in writing to EPA and must include the applicant's basis for
appealing EPA's decision.
(b) If more than one applicant has requested a hearing on similar grounds, all of those appeals
will be considered at the same hearing unless confidentiality claims preclude a joint hearing.
(c) EPA will notify each applicant of EPA's decision within 60 days after the hearing.
§ 790.99 Statement of financial responsibility.
Each applicant for an exemption shall submit the following sworn statement with his or her
application:
I understand that if this application is granted before the reimbursement period described in
section 4(c)(3)(B) of TSCA expires, I must pay fair and equitable reimbursement to the person or
31

persons who incurred or shared in the costs of complying with the requirement to submit data
and upon whose data the granting of my application was based.
Appendix A to Subpart E of Part 790—Schedule for Developing Consent Agreements and Test
Rules
EPA intends to follow the schedule set forth in this Appendix to evaluate testing candidates,
conduct negotiations, develop consent agreements where appropriate, and propose and promulate
test rules in those instances where testing can be required under section 4(a) of TSCA but
agreement cannot be reached in timely manner on a consent agreement. Where deadlines are
imposed by the statute, they are binding on EPA and will be observed by the Agency. The
remaining dates represent targets that EPA intends to meet.
This schedule is based on what EPA currently believes are reasonable target dates. As EPA gains
experience with the process and determines the feasibility of these schedules, it may adjust the
schedule accordingly. EPA will solicit public comment before implementing any changes in the
schedule.
-----------------------------------------------------------------------Week \1\
Event
-----------------------------------------------------------------------0............................. Receive ITC report, recommendation.
2............................. Publish ITC report, 8(a) and 8(d) notices, and invitation for public
participation in negotiations.
3-6........................... Comment period on ITC report.
6............................. Public focus meeting.
7-14..........................8(a) and 8(d) reporting period.
22............................ Public meeting on course-setting decision and deadline for requests to
participate in negotiations.
22-30........................Negotiations.
32............................ EPA decision point: consent agreement or test rule.
-----------------------------------------------------------------------\1\ The dates contained in the left-hand column are calculated from the date EPA receives the
ITC report recommending a chemical for testing.
-----------------------------------------------------------------------Week
Consent Agreement
Week
Test Rule
-----------------------------------------------------------------------36-40.......... Comment period on
32-60 Rule preparation,
consent agreement.
agency review and
sign-off.
42............. Comment resolution
62
Publish proposed rule
meeting if necessary.
in Federal Register.\1\
48............. Sign-off consent
70-106 Agency reviews
agreement and Federal
comments;
Register notice.
preparation of final
32

rule or no-test
decision, agency
review and signoff.\1\
50............. Publish Federal
108
Publish final rule or
Register notice.
no-test decision in
Federal Register.\1\
-----------------------------------------------------------------------\1\ As stated in § 790.26, EPA may publish an Advance Notice of Proposed Rulemaking
(ANPR) where the testing recommendations of the ITC raise unusually novel and complex issues
that require additional Agency review and opportunity for public comment. EPA intends to
publish such ANPRs by Week 62 following receipt of the initial ITC report; to publish a
proposed rule or decision-not-to-test by Week 108; and to publish a final rule or notice
terminating the rulemaking process by Week 154.
[51 FR 23717, June 30, 1986]

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