[Code of Federal Regulations]
[Title 40, Volume 30]
[Revised as of July 1, 2004]
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]