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CFSAN/Office of Seafood
November 22, 2004
A more recent version of this guidance issued in January 2008. Below is an earlier version.
This guidance document is being distributed for comment purposes only.
Draft released for comment on November 22, 2004.
Comments and suggestions regarding this draft document should be submitted within 30 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood
November 2004
This draft Level One guidance represents FDA's current thinking on Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association. 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 an approach satisfies the requirements of applicable statutes and regulations. The draft guidance is being distributed for comment purposes in accordance with FDA's Good Guidance Practices (21 CFR 10.115; September 19, 2000).
The Food and Drug Administration (FDA or agency) is providing this draft guidance on how it is issuing health certificates that accompany shipments of fish and fishery products from the United States (U.S.) to the European Union (EU), EU Accession Partnership Countries (hereinafter referred to as EU Export Certificates), and members of the European Free Trade Association (EFTA). These certificates are required by the EU and these countries. The purpose of the draft guidance is to clarify the internal processes that FDA uses to issue these EU Export Certificates; the procedures that industry seeking these certificates should follow; the criteria that FDA generally intends to consider in determining whether to issue an EU Export Certificate; and related matters. 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.
Since 1993, the EU has required that an EU Export Certificate accompany all shipments of fish and fishery products that are shipped to the EU. For fish and fishery products generally, the certificates that FDA signs essentially attest that the products have been produced in accordance with a Hazard Analysis Critical Control Point (HACCP)-based safety system that is at least equivalent to the EU system of control. The FDA HACCP regulations have been deemed by the European Commission to be equivalent, in principle, to the EU system of control. In 1996, the EU also began requiring a different certificate specifically for shipments of live molluscan shellfish (e.g., oysters, clams, mussels). These certificates are based partly on equivalence to, and partly on consistency with, EU requirements.
In 1993, to ensure the smooth flow of trade in fish and fishery products to the EU, FDA began signing certificates for shipments of fish and fishery products to the EU. The FDA also signs certificates for shipments of fish and fishery products to EU Accession Partnership Countries and EFTA Members. The certificates certify that the establishment(1) is in regulatory good standing, as defined in section III.B.
The Seafood Inspection Program of the National Oceanic and Atmospheric Administration (NOAA SIP) of the U.S. Department of Commerce also signs EU Export Certificates as one service that it offers U.S. seafood processors and other entities in its voluntary, fee-for-service seafood inspection program. The NOAA SIP typically issues these certificates on the basis of inspections conducted under its voluntary, fee-for-service program.
The roles for the agency generally and for relevant agency components are described below.
As indicated previously, FDA intends to maintain three EU Export Certificate Lists, two for Value-Added Processors (the Value-Added Processors List and the Value-Added Processing Vessels List) and one for exporters that do not engage in value-added processing, as defined below (the Other Than Value-Added Processors List).
EU Export Certificates should be available to U.S. establishments that engage in value-added processing of domestic and/or imported fishery products in the U.S.
For purposes of this document, "value-added processing" is defined as manipulating a product in a way that increases the value or usability of the products. Examples of value-added processing include preparing, heading, eviscerating, shucking, freezing, glazing, changing into different market forms, manufacturing, preserving, packing, repacking, labeling or relabeling of fish and fishery products. "Holding" or "storing," as conducted by a warehouse, should not alone constitute value-added processing. Only products that have been subject to value-added processing that has occurred in the U.S. should be eligible for EU Export Certificates, including such processing that occurs on a processing vessel such as a factory trawler. (For these purposes, when U.S. flag vessels engage in value-added processing on the high seas, this processing is deemed to have occurred in the U.S.) Harvesting vessels that engage in practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board that vessel should not be deemed to be engaged in value-added processing.
EU Export Certificates should be available to certain types of establishments that do not themselves engage in processing so long as they provide appropriate information about the shipment, either to FDA or on the certificate itself.
An establishment should be considered in regulatory good standing and eligible to receive EU Export Certificates for its products when it is in adequate compliance with all applicable FDA laws and regulations. Regulatory good standing should be based primarily on the results of the most recent inspection of the establishment by either FDA or by another governmental entity in the U.S., such as a State regulatory authority, with which FDA has a contract, partnership arrangement, or other Memorandum of Understanding (MOU), for the purpose of conducting inspections that count against the establishment's compliance status with FDA.
An applicant should apply for inclusion on the Value-Added Processors List, the Value-Added Processing Vessels List, or the Other Than Value-Added Processors List by sending a request to the EU coordinator in the FDA Office covering the geographical location of the establishment seeking the certificate (see www.cfsan.fda.gov/~dms/eucert.html for a list of EU coordinators and the area they cover) that includes the following:
An establishment that has been placed on an EU Export Certificate List, or one that is acting solely as a dispatcher of product (as defined in II.A.2.b.) from establishments on any of the lists, and is now seeking EU Export Certificates should complete the appropriate EU Export Certificate(s) and submit it/them to the EU coordinator in the FDA Office covering the geographical location of the person issuing the certificate in accordance with this guidance. A list of EU coordinators and the area they cover is available at www.cfsan.fda.gov/~dms/eucert.html. If the establishment meets all the provisions in this guidance, the EU Export Certificate(s) should be signed and returned to the establishment.
A completed EU Certificate should accompany each shipment of product to the EU and, in some cases, to non-EU countries. It is the establishment's responsibility to make additional (legible) copies of EU Certificates required to meet their exporting needs, and to submit any additional information requested by the country.
If an imported fishery product should not be eligible for EU certification because it was not subjected to value-added processing in the United States, as described in Section III of this document, the establishment may request a health certificate from the foreign source of the product. If an imported product has been warehoused in the U.S. for an extended period of time, there is a possibility that the EU will reject the entry in the absence of an EU certificate from the U.S. To preclude this from occurring, the shipper can ask for a specific lot certification from NOAA SIP.
The establishment shipping the product (i.e., the establishment listed as the dispatcher on the non-molluscan certificate or the consignor listed on the molluscan certificate), or its representative, should deliver the EU Certificate to the EU Monitor at the FDA office covering their geographical location for review and signature. The establishment, or its representative, should also arrange the return of the signed EU Certificate and prepay all postage, express package service, or courier fees. If the EU Certificate is to be returned by the U.S. Postal Service, the establishment should provide a self-addressed, stamped envelope. If the establishment wants the EU Certificate returned by express package service, it should provide a completed return air bill form under its account number.
The completed form (not including the sections to be completed by FDA, i.e., the reference number, the "official signature," and the official seal) should be delivered to the EU coordinator in the FDA Office covering the geographical location of the establishment seeking the certificate. The following provides guidance for completing various sections of the EU Certificate:
Reference Number - FDA will assign and enter a certificate number.
Country of Dispatch - Enter "United States of America."
Competent Authority - Enter "United States Food and Drug Administration," and the district name and address.
Description of fishery/aquaculture product - Enter an appropriate description of the product(s) being shipped, i.e., "Frozen, Dressed Head-off Coho Salmon." Cross out either "fishery" or "aquaculture," whichever does not apply.
Species (scientific name) - Enter the scientific name of the species being shipped, e.g., "Oncorhynchus kisutch" for Coho salmon. The FDA Seafood List is a listing of common and species fish names. It can be viewed on the FDA website at www.cfsan.fda.gov/~frf/seaintro.html.
Presentation of Product and Type of Treatment - Enter "frozen," "canned," "dried," "smoked," "preserved," or other description as appropriate.
Code Number (where available) - Enter lot number if available. If none, leave blank.
Type of Packaging - Enter a description of the packaging, e.g., "Fiberboard Master Cartons with Plastic Liners."
Number of Packages - Enter the exact number of packages in the shipment.
Net Weight - Enter the total net weight of the shipment.
Requisite Storage and Transport Temperature - Enter the manufacturer's recommendation for shipping temperature, e.g., "45° F or 6° C." General storage terms, such as "ambient," "refrigerated" "iced," or "frozen" are acceptable.
Name(s) and Official Approval/Registration number(s) of establishment(s), factory vessel(s), or Cold Store(s) Approved or Freezer Vessel(s) Registered by the Competent Authority to the EC - For Value-Added Processors: Enter the name of the last Value-Added Processor, city, state, and CFN or FEI number. If the processor is a vessel, enter the vessel name. If the shipment includes product from more than one establishment, the names and CFN or FEI numbers of all the establishments should be entered.
Example:
Basalt Cove Seafood, Somewhere City, AK
CFN: 12645667
Fresh Fish Express, Inc., Astoria, OR
FEI: 9999999999
If the product has been value added by several different establishments, the EU Certificate should identify the last establishment that processed the product. For example, if salmon were eviscerated and frozen at establishment "A," portioned at establishment "B," and breaded and placed in the final package at establishment "C," then the EU Certificate should identify establishment "C" as the processor.
For establishments acting solely as dispatchers: Enter the names, city, state, and CFN or FEI numbers of the last value added processor of the product being shipped.
For Other Than Value-Added Processors: Enter the name, city, state, and CFN or FEI numbers of the Other Than Value-Added Processor shipping the product. You should supply FDA with the names, cities, states, and CFN or FEI numbers of the Value-Added Processors of the product being shipped.
The Products are Dispatched: From - Enter the place the product left the country, e.g., Los Angeles, CA , USA.
The Products are Dispatched: To - Enter the port of debarkation, e.g., "Le Havre, France," or if it is an air shipment, "Charles De Gaulle International Airport, Paris, France."
By the Following Means of Transport - Enter the means of transport, e.g., "Air freight Northwest Airlines Flight 666." (Note: Flight information is optional but advisable, as there many need to be additional confirmation of this by some EU countries.)
Name and Address of Dispatcher - Enter the establishment name and address of the company or person that is making the shipment, e.g., "East West Seafood, P.O. Box 123 Nahcotta, WA, USA"
Name and Address of Consignee at Place of Destination - Enter the name and address of the final destination, e.g., "Pierre's Seafood, 508 Rue Lafayette, Paris, France."
Done at - Enter the place the certificate will be signed (not prepared), e.g., "Boston, MA, USA."
On - Enter the actual date of the voyage or flight.
Signature of Official Inspector - FDA official signs here in non-black ink.
Name in capitals, capacity and qualifications - FDA should enter in non-black ink the signatory's name, capacity, and qualifications, as appropriate in capitals.
Official Seal - FDA will apply the official seal (or stamp) to the circle as indicated.
The completed form (not including the (reference) No. and the Signature of the Official Inspector, which are completed by FDA) should be delivered to the EU coordinator in the FDA Office covering the geographical location of the establishment seeking the certificate. The following provides guidance for completing various sections of the EU Certificate:
No. - FDA will assign and enter a certificate number.
Dispatching country - Enter "United States of America."
Competent authority - Enter "United States Food and Drug Administration," and the district name and address.
Inspection service - Enter "United States Food and Drug Administration," and the district name, and address.
Product wild/farmed - Check between the appropriate parentheses whether the product is wild or farmed.
Species - Enter the scientific name of the species being shipped, e.g., Crassostrea gigas for Pacific Oysters. The FDA Seafood List is a listing of common and species fish names. It can be viewed on the FDA website at www.cfsan.fda.gov/~frf/seaintro.html.
Nature of packaging - Describe the packaging material, e.g., "burlap bags with wire closures" or "wetlock boxes with individual molluscs in trays."
Number of packages - Enter the exact number of packages in the shipment.
Net weight - Enter the total net weight for the shipment.
Necessary Storage and transport temperature - Enter the manufacturer's recommendation for shipping temperature that is needed to keep the product alive or in the case of processed products, safe for the consumer, e.g., "45° Fahrenheit or 6° Centigrade".
Reference number of analysis report - Enter the reference number of analytical reports required by the consignee, if known and available.
Approved production area - Enter the designation of the growing area provided by the shipper, e.g., "Willapa Bay, Washington, area 2A north." (Note: This applies to molluscan shellfish only. If the product is an echinoderm, tunicate, or marine gastropod, enter "not applicable.")
Name and Official Number of Approved Establishment - For Value-Added Processors covered under the National Shellfish Sanitation Program (live or shucked molluscan shellfish): Enter the name, city and state of the establishment that processed or handled the molluscan shellfish and the Interstate Shellfish Shippers List number. If the shipment includes product from more than one establishment the names, cities and the Interstate Shellfish Shippers List numbers of all the establishments should be entered.
Examples:
Scrimshaw Oyster Co.
South Bend, WA
WA 999
John's Mussel Farm Inc.
Bath, ME
ME 0000
Note: Shellfish that are further processed (e.g., cooked, breaded, or canned) are considered processed fishery products and should be certified using the Non-molluscan Shellfish certificate. For processed shellfish, whether your are shipping as a value added processor, dispatcher or Other than Value-Added Processor, follow instructions for the non-molluscan certificate under V. C. above.
For establishments acting solely as dispatchers: If the molluscan shellfish is live or shucked, enter the name, city and state, and Interstate Shellfish Shippers List number of the last value added processor under the National Shellfish Sanitation Program.
For Other Than Value-Added Processors: Enter the name city, state and CFN or FEI number of the Other Than Value Added Processor shipping the product. You should supply FDA with the names, cities, states, and Interstate Shellfish Shipper list number of the value added processors of the product being shipped.
The products are to be sent from - Enter the place the product left the country, e.g., "Seattle, WA USA."
The products are to be sent to -Enter the port of debarkation, e.g., "Le Havre, France," or if it is an air shipment, "Charles De Gaulle International Airport, Paris, France."
By the following means of transport - Enter the means of transport, e.g., "Air freight Northwest Airlines Flight 666." (Note: Flight or voyage information is optional but advisable as there may need to be additional confirmation of this by some EU countries.)
Name and Address of Consignors - Enter the name and address of the company or person that is making the shipment, e.g., East-West Shellfish, P.O. Box 123 Nahcotta, WA U.S.A"
Name of Consignee and address of the place of destination - Enter the name and address of the consignee, e.g., "Pierre's Seafood, 508 Rue Lafayette, Paris France".
Done at - Enter the place the certificate will be signed (not prepared), i.e., "Boston, MA USA"
On - Enter the actual date of the voyage or flight.
Signature of official inspector - FDA official signs here in non-black ink.
Name, title and designation of the signatory in capitals - FDA should enter in non-black ink the signatory's name, capacity, and qualifications, as appropriate, in capitals.
Official Seal - FDA should apply the official seal (or stamp) to the circle as indicated.
The following websites may be useful to firms that ship fish and fishery products to the EU, EU Accession Partnership Countries, and EFTA Members.
The following list of EU references can be found at http://www.europa.eu.int/eur-lex/en/search/search_lif.html:
A list of EU coordinators can be found at: http://www.cfsan.fda.gov/~dms/eucert.html.
Interested persons may submit written comments on the draft guidance to the Dockets Management Branch (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 106, Rockville, MD 20852. Two copies of any comments are to be submitted, except that individuals may submit one copy. All comments are to be identified with the Docket Number 2004D-0509. Submit electronic comments on the draft guidance to www.fda.gov/dockets/ecomments. The draft guidance and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: November 22, 2004
(1) "Establishment" refers to any structure, or structures under one ownership at one general physical location, or, in the case of a mobile establishment, traveling to multiple locations, that manufactures/processes, packs, or holds food. Transport vehicles are not establishments if they hold food only in the usual course of business as carriers. An establishment may consist of one or more contiguous structures, and a single building may house more than one distinct establishment if the establishments are under separate ownership.
(2) The terms "Value-Added Processor," "Value-Added Processing Vessel," and "Other Than Value-Added Processor are defined in III.A.
FDA Guidance on EU Export Certificates for Seafood: Questions and Answers November 22, 2004
Federal Register Notice of Availability November 26, 2004
A more recent version of this guidance issued in January 2008. Above is an earlier version.