[Federal Register Volume 65, Number 220 (Tuesday, November 14, 2000)]
[Notices]
[Pages 68150-68151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1555]


Draft Guidance for Industry on Refusal of Inspection or Access to 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availability of a draft guidance for industry entitled ``Refusal of 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 This draft guidance 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

[[Page 68151]]

thus may trigger a regulatory response by the agency. FDA is issuing 
this clarification because some domestic firms have questioned whether 
records can be made available after an inspection (rather than during) 
and some foreign firms have canceled scheduled inspections by FDA, but 
offered to make records available for review. This guidance applies to 
foreign processors that export fish and fishery products to the United 
States as well as to domestic processors.

DATES: Submit written comments on the draft guidance by December 14, 
2000. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://vm.cfsan.fda.gov/dms/guidance.html. Submit 
written requests for single copies of the draft guidance to the 
Industry Activities Staff, Office of Constituent Operations (HFS-565), 
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 
reuqests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary I. Snyder, Center for Food Safety 
and Applied Nutrition (HFS-415), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3133.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft 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 is intended to clarify that on-
site 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 (21 CFR part 123). These regulations require 
processors of fish and fishery products to operate preventive control 
systems for human food safety that incorporate the principles of HACCP. 
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)). The agency expects 
that it will regard the failure to provide records and plans by a 
domestic or foreign processor as a significant program violation, even 
if a firm volunteers the documents after the inspection.
    FDA believes that the best way for a regulatory authority to 
determine whether a processor is effectively operating a HACCP system 
is by inspecting the processor to assess whether the system is 
operating properly and is appropriate for the circumstances. Review of 
monitoring and other records generated by the HACCP system is a 
critical component of an inspection because it allows the inspector to 
match records against practices and conditions being observed in the 
plant and it discourages fraud. Thus, FDA always has intended that its 
review of processors' HACCP plans and records would occur as part of an 
inspection of a processor's entire HACCP system.
    For domestic processors, failure to allow an inspection would not 
only violate the HACCP regulations; it is also a prohibited act under 
section 301(f) of the act (21 U.S.C. 331(f)). Moreover, if a domestic 
processor refuses an FDA inspection, FDA can obtain an inspectional 
warrant from the U.S. district court in which the processor is located.
    Failure to allow an FDA inspection by a foreign processor can also 
result in a regulatory response. The definition of ``processor'' at 
Sec. 123.3(l) specifically includes persons in foreign countries. Thus, 
like domestic processors, foreign processors who ship to the United 
States must operate under conditions that satisfy FDA's HACCP 
regulations, including the requirement that records be made available 
during the course of an FDA inspection.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (65 FR 56468, September 19, 2000). The draft 
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 statutes and regulations.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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 draft 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.

    Dated: October 30, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-29011 Filed 11-13-00; 8:45 am]
BILLING CODE 4160-01-F