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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 
16

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.
17

(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]
18

§ 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 
19

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.
20

(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).
21

(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.
22

(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.
23

(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.
24

(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 
25

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.
26

(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.
27

(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.
28

(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;
29

(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
30

(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
31

(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 
32

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
33

 rule or no-test

decision, agency

 review and sign-

 off.\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]