[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Draft Guidance for Industry on Refusal of Inspection or Access to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availability of a draft guidance for industry entitled ``Refusal of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 This draft guidance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DATES: Submit written comments on the draft guidance by December 14,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ADDRESSES: Copies of this draft guidance for industry are available on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written requests for single copies of the draft guidance to the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 Submit written comments on the draft guidance to the Dockets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