40 CFR § 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:
(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 § 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 § 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 § 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.
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