[Code of Federal Regulations]
[Title 40, Volume 31]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR792.195]

[Page 45]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 792_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents
 
                      Subpart J_Records and Reports
 
Sec.  792.195  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)(1) 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 a period of at least ten years following the effective date of the 
applicable final test rule.
    (2) In the case of negotiated testing agreements, each agreement 
will contain a provision that, 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 a period of at least ten years following the 
publication date of the acceptance of a negotiated test agreement.
    (3) In the case of testing submitted under section 5, except for 
those items listed 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 a 
period of at least five years following the date on which the results of 
the study are submitted to the agency.
    (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, 
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.  792.35(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.  792.29(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.  792.63 (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.

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