[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: 40CFR160.190]



[Page 153]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                      Subpart J_Records and Reports

 

Sec.  160.190  Storage and retrieval of records and data.



    (a) All raw data, documentation, records, protocols, specimens, and 

final reports generated as a result of a study shall be retained. 

Specimens obtained from mutagenicity tests, specimens of soil, water, 

and plants, and wet specimens of blood, urine, feces, and biological 

fluids, do not need to be retained after quality assurance verification. 

Correspondence and other documents relating to interpretation and 

evaluation of data, other than those documents contained in the final 

report, also shall be retained.

    (b) There shall be archives for orderly storage and expedient 

retrieval of all raw data, documentation, protocols, specimens, and 

interim and final reports. Conditions of storage shall minimize 

deterioration of the documents or specimens in accordance with the 

requirements for the time period of their retention and the nature of 

the documents of specimens. A testing facility may contract with 

commercial archives to provide a repository for all material to be 

retained. Raw data and specimens may be retained elsewhere provided that 

the archives have specific reference to those other locations.

    (c) An individual shall be identified as responsible for the 

archives.

    (d) Only authorized personnel shall enter the archives.

    (e) Material retained or referred to in the archives shall be 

indexed to permit expedient retrieval.