[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.9]

[Page 274-275]
 
                        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 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

[[Page 275]]

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.