[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.9]
[Page 279-280]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 123 FISH AND FISHERY PRODUCTS--Table of Contents
Subpart A General Provisions
Sec. 123.9 Records.
(a) General requirements. All records required by this part shall
include:
(1) The name and location of the processor or importer;
(2) The date and time of the activity that the record reflects;
(3) The signature or initials of the person performing the
operation; and
(4) Where appropriate, the identity of the product and the
production code, if any. Processing and other information shall be
entered on records at the time that it is observed.
(b) Record retention. (1) All records required by this part shall be
retained at the processing facility or importer's place of business in
the United States for at least 1 year after the date they were prepared
in the case of refrigerated products and for at least 2 years after the
date they were prepared in the case of frozen, preserved, or shelf-
stable products.
(2) Records that relate to the general adequacy of equipment or
processes being used by a processor, including the results of scientific
studies and evaluations, shall be retained at the processing facility or
the importer's place of business in the United States
[[Page 280]]
for at least 2 years after their applicability to the product being
produced at the facility.
(3) If the processing facility is closed for a prolonged period
between seasonal packs, or if record storage capacity is limited on a
processing vessel or at a remote processing site, the records may be
transferred to some other reasonably accessible location at the end of
the seasonal pack but shall be immediately returned for official review
upon demand.
(c) Official review. All records required by this part and all plans
and procedures required by this part shall be available for official
review and copying at reasonable times.
(d) Public disclosure. (1) Subject to the limitations in paragraph
(d)(2) of this section, all plans and records required by this part are
not available for public disclosure unless they have been previously
disclosed to the public as defined in Sec. 20.81 of this chapter or
they relate to a product or ingredient that has been abandoned and they
no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61 of this chapter.
(2) However, these records and plans may be subject to disclosure to
the extent that they are otherwise publicly available, or that
disclosure could not reasonably be expected to cause a competitive
hardship, such as generic-type HACCP plans that reflect standard
industry practices.
(e) Tags. Tags as defined in Sec. 123.3(t) are not subject to the
requirements of this section unless they are used to fulfill the
requirements of Sec. 123.28(c).
(f) Records maintained on computers. The maintenance of records on
computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
signatures.
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