[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR160.15]



[Page 145]

 

                   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.