[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: 40CFR792.15]



[Page 36]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 792_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  792.15  Inspection of a testing facility.



    (a) A testing facility shall permit an authorized employee or duly 

designated representative of EPA or FDA, at reasonable times and in a 

reasonable manner, to inspect the facility and to inspect (and in the 

case of records also to copy) all records and specimens required to be 

maintained regarding studies to which this part applies. The records 

inspection and copying requirements shall not apply to quality assurance 

unit records of findings and problems, or to actions recommended and 

taken, except the EPA may seek production of these records in litigation 

or formal adjudicatory hearings.

    (b) EPA will not consider reliable for purposes of showing that a 

chemical substance or mixture does not present a risk of injury to 

health or the environment any data developed by a testing facility or 

sponsor that refuses to permit inspection in accordance with this part. 

The determination that a study will not be considered reliable does not, 

however, relieve the sponsor of a required test of any obligation under 

any applicable statute or regulation to submit the results of the study 

to EPA.

    (c) Since a testing facility is a place where chemicals are stored 

or held, it is subject to inspection under section 11 of TSCA.