[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: 40CFR160.195]



[Page 153-154]

 

                   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.  160.195  Retention of records.



    (a) Record retention requirements set forth in this section do not 

supersede the record retention requirements of any other regulations in 

this subchapter.

    (b) Except as provided in paragraph (c) of this section, 

documentation records, raw data, and specimens pertaining to a study and 

required to be retained by this part shall be retained in the archive(s) 

for whichever of the following periods is longest:



[[Page 154]]



    (1) In the case of any study used to support an application for a 

research or marketing permit approved by EPA, the period during which 

the sponsor holds any research or marketing permit to which the study is 

pertinent.

    (2) A period of at least 5 years following the date on which the 

results of the study are submitted to the EPA in support of an 

application for a research or marketing permit.

    (3) In other situations (e.g., where the study does not result in 

the submission of the study in support of an application for a research 

or marketing permit), a period of at least 2 years following the date on 

which the study is completed, terminated, or discontinued.

    (c) Wet specimens, samples of test, control, or reference 

substances, and specially prepared material which are relatively fragile 

and differ markedly in stability and quality during storage, shall be 

retained only as long as the quality of the preparation affords 

evaluation. 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. In no case shall retention be required for longer periods 

than those set forth in paragraph (b) of this section.

    (d) The master schedule sheet, copies of protocols, and records of 

quality assurance inspections, as required by Sec.  160.35(c) shall be 

maintained by the quality assurance unit as an easily accessible system 

of records for the period of time specified in paragraph (b) of this 

section.

    (e) Summaries of training and experience and job descriptions 

required to be maintained by Sec.  160.29(b) may be retained along with 

all other testing facility employment records for the length of time 

specified in paragraph (b) of this section.

    (f) Records and reports of the maintenance and calibration and 

inspection of equipment, as required by Sec.  160.63 (b) and (c), shall 

be retained for the length of time specified in paragraph (b) of this 

section.

    (g) If a facility conducting testing or an archive contracting 

facility goes out of business, all raw data, documentation, and other 

material specified in this section shall be transferred to the archives 

of the sponsor of the study. The EPA shall be notified in writing of 

such a transfer.

    (h) Specimens, samples, or other non-documentary materials need not 

be retained after EPA has notified in writing the sponsor or testing 

facility holding the materials that retention is no longer required by 

EPA. Such notification normally will be furnished upon request after EPA 

or FDA has completed an audit of the particular study to which the 

materials relate and EPA has concluded that the study was conducted in 

accordance with this part.

    (i) Records required by this part may be retained either as original 

records or as true copies such as photocopies, microfilm, microfiche, or 

other accurate reproductions of the original records.