WORLD TRADE
ORGANIZATIONG/SPS/N/USA/353/Add.1
26 July 2001
(01-3712)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 20 July 2001, has been received from the United States.
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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
The Food and Drug Administration (FDA) is announcing the availability of guidance
(previously notified as G/SPS/N/USA/353) for industry entitled "Refusal of Inspection or Access to
HACCP Records Pertaining to the Safe and Sanitary  Processing of Fish and Fishery Products".  This
final 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 andrecords.  The agency is clarifying that a proce ssor'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 duri ng) and some foreign firms cancelled 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.
Interested persons may, at any time, submit written comments on the guidance.  The full text
of this addendum (and the guidance), including instructions for commenting, is available from the
address below.
United States SPS Enquiry Point/Notification Authority:
USDA/FAS/FSTSD
ATTN: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239
Fax: (202) 690-0677
E-mail:  ofsts@fas.usda.gov
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