[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR790.62]

[Page 19-20]
 
                   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 D--Implementation, Enforcement and Modification of Consent 
                               Agreements
 
Sec. 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.
    (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.

[[Page 20]]

    (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 Sec. 790.65 (c) and (d).
    (4) The test sponsor shall submit any amendments to study plans to 
EPA at the address specified in Sec. 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]