[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
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

[[Page 154]]

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:
    (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.