. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/353
17 November 2000
(00-4892)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:  UNITED STATES
If applicable, name of local government involved:           
2. Agency responsible:  US Food and Drug Administration
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, whereapplicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Fish and fishery products
4. Title and number of pages of the notified document:  Draft Guidance for Industry on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/comments accepted (2 pages plus
guidance document)
5. Description of content:  The Food and Drug Administra tion (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availability of a draft guidance for industry entitled "Refusal of Inspection or Access to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 FisheryProducts".  This draft guidance sets forth the agency's interpretation of its Hazard Analysis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 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.
6. Objective and rationale: [  X ] food safety,  [    ] animal health,  [    ] plant protection,
[    ] protect humans from animal/plant pest or disease, [    ] protect territory from
other damage from pests           
7. An international standard, guideline or recommendation does not exist [    ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:  The HACCP Annex to the Recommended
International Code of Practice General Principles for Food Hygiene [CAC/RCP1-1969,
REV3(1997)] has been adopted by the Codex Alimentarius Commission.
8. Relevant documents and language(s) in which these are available: 65 FR 68150,
14 November 2000 (Available in English)G/SPS/N/USA/353
Page 2
9. Proposed date of adoption:  Will be published as future guidance.
10. Proposed date of entry into force:  Same as paragraph 9
11. Final date for comments:  14 December 2000
Agency or authority designated to handle comments:  Food and Drug Administration
[    ] National notification authority, [     ] National enquiry point, or address, fax
number and E-mail address (if available) of other body:  Detailed instruction on where
and how to send comments is in the body of the full text - which will be sent upon request
to the address in paragraph 12.
12. Texts available from: [  X ] National notification authority, [  X ] National enquiry point
or address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
USDA/FAS/FSTSD
ATTN: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov