To: Seafood HACCP Community
Fr: Pamela Tom, University of California - Sea Grant Extension Program
FDA has issued two DRAFT guidance documents relating to certification of
seafood for export to the EU.
The first draft guidance, Guidance and Protocol for Industry and Food and
Drug Administration Staff - Certification of Fish and Fishery Products for
Export to the European Union and the European Free Trade Association, is a
draft protocol for industry and FDA for purposes of overall clarification
and to ensure uniformity in the procedures used to issue these
certificates. The draft guidance provides considerable detail on the
circumstances under which a firm is eligible to receive a certificate,
e.g., when products are produced in the U.S. or value is somehow added in
the U.S., and when a firm is not eligible, e.g., when a product is
transshipped through the U.S. with no value added. This guidance, when
finalized, is intended to supersede all previous protocols that were
written by the various Districts Offices that provide EU certification for
seafood products. Source: http://www.cfsan.fda.gov/~comm/seaguid4.html
The second draft guidance, Guidance for Industry - Proposed Referral
Program from the Food and Drug Administration to the National Oceanic and
Atmospheric Administration Seafood Inspection Program for the
Certification of Live and Perishable Fish and Fishery Products for Export
to the European Union and the European Free Trade Association, proposes a
Referral Program for a 24-month period to test the viability and
effectiveness of referring requests for EU certification for live and
fresh products to NOAA SIP. During this period, EU Export Certificates for
all shipments of live and perishable fish and fishery products destined
for the EU, EU Accession Partnership Countries, and EFTA Members would be
issued by the NOAA SIP under the authority of the Agricultural Marketing
Act. Source: http://www.cfsan.fda.gov/~comm/seaguid5.html
Live and fresh fish and fishery products e.g. live lobster and crab, fresh
salmon, fresh monkfish fillets are included in the referral program.
Products that are preserved, such as frozen, canned, dried, vacuum packed,
etc. are not affected by the referral program.
Source: http://www.cfsan.fda.gov/~dms/eucertqa.html
These draft guidances are not final nor are they in effect at this time.
Comments and suggestions regarding these draft documents should be
submitted within 30 days of publication (due December 27, 2004) in the
Federal Register of the notice announcing the availability of the draft
guidance. Submit comments to Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with the Docket Number 2004D-0509. For
questions regarding this draft document contact Tim Hansen, Center for
Food Safety and Applied Nutrition (CFSAN), (301) 436-1405.
Questions and answers addressing the FDA Guidance on EU Export
Certificates for Seafood are posted at:
http://www.cfsan.fda.gov/~dms/eucertqa.html
If you have questions on live and fresh fish and fishery product
shipments, these web sites offer information:
http://seafood.nmfs.noaa.gov/ (US Dept. of Commerce Seafood Inspection
Program)
http://www.cfsan.fda.gov/~lrd/certifi3.html (FDA-Issued/Supported Export
Certificates for Foods)
# # # # # # # #
This archive was generated by hypermail 2b29 : Mon Nov 29 2004 - 20:00:01 PST