[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR790.55]



[Page 16-18]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 790_PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES

--Table of Contents

 

  Subpart C_Implementation, Enforcement, and Modification of Test Rules

 

Sec.  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 Sec.  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 Sec.  

790.5(b).



[[Page 17]]



    (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



[[Page 18]]



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]