['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA']
06/28/2024
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(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.
[78 FR 72830, Dec. 4, 2013]
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['Toxic Substances Control Act - EPA']
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Copyright 2024 J. J. Keller & Associate, Inc. For re-use options please contact copyright@jjkeller.com or call 800-558-5011.