[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: 40CFR790.62]



[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]