[Federal Register Volume 66, Number 138 (Wednesday, July 18, 2001)]
[Notices]
[Page 37482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17920]



[[Page 37482]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1555]


Guidance for Industry on Refusal of Inspection or Access to HACCP 
Records Pertaining to the Safe and Sanitary Processing of Fish and 
Fishery Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of guidance for industry entitled ``Refusal of Inspection 
or Access to HACCP Records Pertaining to the Safe and Sanitary 
Processing of Fish and Fishery Products.'' This guidance sets forth the 
agency's interpretation of its Hazard Analysis Critical Control Point 
(HACCP) regulations for fish and fishery products as they pertain to 
the inspection of facilities and records. The agency is clarifying that 
a processor's refusal to allow FDA to inspect its processing 
facilities, or to provide HACCP records or plans to an inspector during 
an inspection, violates the regulations and thus may trigger a 
regulatory response by the agency. FDA determined that there was a need 
for clarification because some domestic firms questioned whether 
records can be made available after an inspection (rather than during) 
and some foreign firms canceled scheduled inspections by FDA, but 
offered to make records available for review. This guidance is for 
domestic processors and for foreign processors that export fish and 
fishery products to the United States.

DATES: Submit written comments on agency guidance documents at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Industry Activities Staff, Office of Constituent Operations, Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
200 C St. SW., Washington DC 20204. Send one self-addressed adhesive 
label to assist that office in processing your requests. Submit written 
comments on the guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Anthony P. Brunetti, Center for Food 
Safety and Applied Nutrition, (HFS-415) Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3150.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Refusal of Inspection or Access to HACCP Records Pertaining 
to the Safe and Sanitary Processing of Fish and Fishery Products.'' FDA 
seafood safety regulations require processors of fish and fishery 
products to operate preventive control systems for human food safety 
that incorporate the principles of HACCP (part 123 (21 CFR part 123)). 
The regulations further provide that fish and fishery products are 
adulterated under section 402(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 342(a)(4)) if their processor fails 
to have and implement a HACCP plan when one is necessary, or otherwise 
fails to meet any of the requirements of the regulations, including 
allowing the official review of records (Sec.  123.6(g)). Processors 
must make their HACCP records and plans available ``for official review 
and copying at reasonable times'' (Sec. 123.9 (c)). This guidance, 
previously made available in draft for public comment, is intended to 
clarify that onsite inspection of a processing facility and concurrent 
review of HACCP records are essential elements of FDA's Seafood HACCP 
program as set forth at part 123. Thus, the failure to provide records 
and plans by a domestic or foreign processor during an inspection 
violates the regulation, even if a firm volunteers the documents after 
the inspection. FDA believes that violations of these provisions are 
significant.
    In the Federal Register of November 14, 2000 (65 FR 68150) FDA 
published a notice announcing the availability of the draft version of 
this guidance and requested the submission of written comments by 
December 14, 2000. One comment was received in response to the draft 
guidance. That comment expressed concern that FDA is modifying the 
regulation so that offsite storage of HACCP records will no longer be 
permitted. FDA disagrees. This guidance does not change any provision 
of the regulation, but seeks to clarify those provisions dealing with 
inspections and records availability. The provision in question, 
Sec. 123.9(b)(3), allows a processor to store records offsite under two 
circumstances: (1) The facility is closed for prolonged periods between 
seasonal packs, or (2) the facility is a processing vessel or remote 
site with limited storage capacity. However, 123.9(b)(3) requires that 
records be returned to the processing site immediately for official 
review upon demand (e.g., within 24 hours). As made clear by this 
requirement for immediate return, this provision does not contemplate 
that records would be made available for review offsite or after the 
inspection is completed. Thus, the guidance does not affect offsite 
storage of records under Sec. 123.9(b)(3). The guidance addresses the 
circumstances in which processors want to submit HACCP records to FDA 
for review only after an onsite inspection has been conducted without 
access to records.
    This guidance is being issued consistent with FDA's good guidance 
practices (21 CFR 10.115; 65 FR 56468, September 19, 2000). The 
guidance represents the agency's current thinking on refusal of 
inspection or access to HACCP records that pertain to the safe and 
sanitary processing of fish and fishery products. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute, regulations, or 
both.

II. Comments

    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://vm.cfsan.fda.gov/dms/guidance.html.

    Dated: July 11, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17920 Filed 7-17-01; 8:45 am]
BILLING CODE 4160-01-S