(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.

(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]

(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).

(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]

(a) No later than 30 days after the effective date of a test rule described in § 790.40, each person subject to that test rule and required to comply with the requirements of that test rule as provided in § 790.42(a) must, for each test required, send his or her notice of intent to conduct testing, or submit to EPA an application for exemption from testing by the method specified in § 790.5(b).

(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.

(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.

(7) A payment identity number on the front page of the letter, as required in § 700.45(g)(4) of this chapter.

(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.

(g) Manufacturers and processors subject to a test rule described in § 790.40 and required to comply with the requirements of that test rule as provided in § 790.42(a) must remit the applicable fee specified in § 700.45(c) of this chapter.

[50 FR 20657, May 17, 1985, as amended at 78 FR 72829, Dec. 4, 2013; 83 FR 52723, Oct. 17, 2018]

(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.

(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 (a)(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 of his or her intent to conduct testing, or submit to EPA an application for an exemption from testing requirements for the test. Each such notification to conduct testing or application for exemption from testing must be submitted to EPA by the method specified in § 790.5(b).

(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 EPA through CDX within 30 days after either receipt of the certified letter or publication in the Federal Register notice described in (b)(4) of this section, all manufacturers and processors subject to the test rule will be in violation of the test rule from the 31st day after receipt of the certified letter or publication in the Federal Register.

(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 test rule has notified EPA through CDX 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 to give the processors an opportunity to take corrective action.

(3) If no processor submits a letter of intent through CDX 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 test 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 (c)(2) of this section.

[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986, and amended at 55 FR 18884, May 7, 1990; 78 FR 72829, Dec. 4, 2013]

(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 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 submitted to EPA by the method specified in § 790.5(b). Any 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.

(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 must submit all amendments by the method specified in § 790.5(b).

[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; 78 FR 72829, Dec. 4, 2013]

(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]

(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 by the method specified in § 790.5(b). 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 must submit these requests to EPA by the method format specified 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 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.

(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; 78 FR 72830, Dec. 4, 2013]

(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.

(c) Persons who fail to pay the requisite fee as specified in § 700.45(c) of this chapter will be in violation of the rule.

[50 FR 20657, May 17, 1985, as amended at 83 FR 52723, Oct. 17, 2018]