[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR160.15]

[Page 154]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 160.15  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 should not apply to quality 
assurance unit records of findings and problems, or to actions 
recommended and taken, except that EPA may seek production of these 
records in litigation or formal adjudicatory hearings.
    (b) EPA will not consider reliable for purposes of supporting an 
application for a research or marketing permit 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 in support of an application for a research or marketing 
permit does not, however, relieve the applicant for such a permit of any 
obligation under any applicable statute or regulation to submit the 
results of the study to EPA.