Contains Nonbinding Recommendations
November 22, 2004; Revised January 2008
This guidance document is being distributed for comment purposes only.
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be submitted within 30 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Center for Food Safety and Applied Nutrition (CFSAN), (Tel) ; . (Updated phone: 240-402-2300).
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Food Safety
Contains Nonbinding Recommendations
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
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 The draft guidance is being distributed for comment purposes in accordance with FDA's Good Guidance Practices (21 CFR 10.115; September 19, 2000).
The Food and Drug Administration (FDA or agency) is providing this draft guidance on health certificates that accompany shipments of fish and fishery products from the United States (U.S.) to the European Union (EU), EU Accession Partnership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 The purpose of the draft guidance is to clarify the procedures that industry seeking these certificates should follow . This guidance, when finalized, is intended to supersede all previous protocols that were written by the various District 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. 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.
The Seafood Inspection Program of the National Oceanic and Atmospheric Administration (NOAA SIP) of the U.S. Department of Commerce 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.
II. Agency Roles
The roles for the agency generally and for relevant agency components are described below.
- FDA intends to:
- Continue to serve as the lead competent authority in the U.S. for fish and fishery products.
- Determine whether an establishment is eligible for EU Export Certificates based on whether the establishment is in regulatory good standing, as defined in section III.B.
- Consider the results of inspections conducted by other governmental entities within the U.S. with which FDA has a contract, partnership arrangement, or MOU for a regulatory inspection when making the final determination as to whether or not an establishment is in regulatory good standing and, therefore eligible for an EU Export Certificate. Provide guidance and oversight to these governmental entities with regard to EU-related certificates.
- Provide information regarding the regulatory standing of an establishment to facilitate the issuance of certificates by NOAA SIP under their authorities.
- Maintain an updated database on the current regulatory status of U.S. entities that have applied to receive EU Export Certificates based upon the information provided by the District Offices pursuant to II.C. 2.
- FDA Office of Seafood intends to:
- Serve as liaison with EU officials regarding fish and fishery products. Information will be provided to the District Offices, other agencies of government, and the industry as appropriate.
- Issue guidance to industry, NOAA SIP, and FDA District Offices on the EU Export Certificate List program.
- Maintain and provide to the EU on a quarterly basis the EU Export Certificate List . Make the updated EU Export List available on the web.
- FDA District Offices intend to:
- Process requests submitted by establishments for inclusion on the EU Export Certificate List , including deciding whether an applicant should be listed after considering the information described in section III of this document and providing written notification to applicants. FDA intends that the FDA District Offices will process all such requests for all establishments, even when the regulatory inspection is performed by another governmental entity in the U.S. with which FDA has a contract, partnership arrangement, or MOU for such an inspection .
- Notify the Office of Seafood as soon as possible with changes to the EU Export Certificate List , including the addition of new establishments and changes in eligibility status of establishments already on the list. In addition, the District Offices may remove establishments from the list if they have not applied for an EU Export Certificate from NOAA SIP within two years or if FDA has reliable information indicating that the establishment is no longer exporting fish and fishery products.
- Provide written notification to the establishment of any change in its status on the list that means it should no longer be considered in good standing. This notification may be included as part of a regulatory notice (e.g., warning letter) and need not be issued as a separate notification.
III. Eligibility for inclusion on the EU Export Certificate Lists
- Classification as a Value-Added Processor, a Value-Added Processing Vessel, an Other Than Value-Added Processor, or a Dispatcher
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).
- Whether the establishment is a Value-Added Processor or a Value-Added Processing Vessel
- Definition of Value-Added Processing:
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.
- Frozen tuna loins that were processed in Indonesia are shipped to the U.S. where an establishment saws them into steaks, places them in vacuum packages and sells them to a customer in the United Kingdom. The U.S. establishment is a Value-Added Processor under this guidance.
- Farm raised Atlantic salmon is skinned and filleted in Chile and shipped to the U.S. chilled on gel ice via air freight. An establishment in the U.S. brines, dries, and smokes the fillets and packages them into reduced oxygen packages. The product is then shipped via air freight to a super market chain in The Netherlands. The U.S. establishment is a Value-Added Processor under this guidance.
- An imported product that enters the U.S. and proceeds directly to a warehouse for storage before it is shipped "as is" to the EU, should not be eligible for an EU Export Certificate under this guidance because no "value-added" processing occurred in the U.S. In such instances the establishment should request an EU Export Certificate from the country of origin. If an imported product has been warehoused in the U.S. for an extended period of time, however, 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.
- Live lobsters from Canada that are held in pounds, repacked in the U.S. and shipped to the EU may be eligible for EU Export Certificates. However, if the lobsters are just shipped as received from Canada, without repacking, they should not be eligible for EU Export Certificates under this guidance.
- Tuna that was canned in Thailand is shipped to the U.S. in "bright stacks," which are plastic wrapped pallets of product with no label on the individual cans. In the U.S., a packing company labels and cases the product and stores it in a warehouse. The packer should be eligible for an EU Export Certificate as a Value-Added Processor because the addition of a label constitutes value-added processing in the U.S.
- Definition of Value-Added Processing:
- Whether an establishment is an Other Than a Value-Added Processor or a Dispatcher
- Other Than Value-Added Processors: Establishments such as brokers that only ship products that have been processed by others in the U.S. may become eligible for inclusion on the List. Such establishments would obtain their own Central File Number (CFN) or FDA Establishment Identifier (FEI) number from FDA . Other Than Value-Added Processors ship at their own risk in that respect.
- Dispatchers: EU Export Certificates provide for shipments by "dispatchers," which are also establishments such as brokers that ship products that have been processed by others in the U.S. Unlike Other Than Value-Added Processors, dispatchers list on the EU Export Certificate the names and CFN or FEI numbers of their U.S. processors. Dispatchers do not need to be listed on the EU Export Certificate List .
- A warehouse in the U.S. stores frozen cod fish from Alaska. A broker sells the product to a French company. At the time of sale, the product is still owned by the Alaska fishing company. The broker is a Dispatcher if it identifies the names and CFN or FEI numbers of the Alaska fishing company. If it does not identify the Alaska fishing company the broker would be an Other Than Value-Added Processor.
- Frozen shrimp from the Gulf of Mexico is shipped to Los Angeles where it is breaded and re-packaged. The value-added product is stored in a warehouse which finds a buyer in Ireland. The warehouse is an Other Than Value-Added Processor.
- White shrimp from an aquaculture farm in Ecuador are transported on ice to a local Ecuadorian processor who washes, shells and cooks the products, individually quick freezes the shrimp, packages the lot into 2 kilo poly bags, and then has them cased. These cases are shipped to the U.S. and held in a cold storage freezer. The owner of the product eventually ships the product to France. Because no value-added processing occurred in the U.S., the owner of the cold storage freezer should not be eligible for an EU Export Certificate as an Other Than Value-Added Processor. The owner should request a certificate from Ecuador.
- Whether the establishment is a Value-Added Processor or a Value-Added Processing Vessel
- Determination of whether an establishment should be considered in regulatory good standing
An establishment should be considered in regulatory good standing 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 establishment should not be considered in regulatory good standing after a Warning Letter has been issued or an FDA legal action has been filed in court, such as an injunction, seizure, or prosecution, under any of the laws or regulations administered by FDA. Nor shall an establishment be considered in good standing if it is being prosecuted for false statements to FDA. The establishment should be returned to regulatory good standing when the FDA District Office has concluded that the conditions that resulted in the Warning Letter or legal action have been resolved.
- In addition to item 1, a Value-Added Processor of molluscan shellfish should be listed on the Interstate Certified Shellfish Shippers List (ICSSL) in order to be in regulatory good standing for shipments of molluscan shellfish.
IV. Guidance to Industry for inclusion on the EU Export Certificate List
An applicant should apply for inclusion on the List by sending a request to the EU coordinator in the FDA Office covering the geographical location of the establishment seeking the certificate (see FDA Coordinators for European Union (EU) Export Health Certificates for a list of EU coordinators and the area they cover) that includes the following:
- list of the product(s) and packing types intended for export to the EU.
- The name, address and telephone number of the person(s) designated as the contact(s) for each applicant.
- For molluscan shellfish, assurance that the tag or other labeling includes the species name of the shellfish, the country of origin of the shellfish and, when in-shell oysters are being shipped, assurance that the oysters are being packaged with the concave side down, in accordance with EU non-safety requirements.
- A statement that the establishment and individual submitters of information are aware of, and know that, their EU Certificate submissions are subject to the provisions of Title 18, Chapter 47, Section 1001, United States Code (U.S.C.). Under 18 U.S.C. 1001, anyone who, among other things, makes a materially false, fictitious, or fraudulent statement to the U.S. government is subject to criminal penalties.
- For Other Than Value-Added Processors, in addition to items A-D, the name and address of each supplier that engages in value-added processing of the fish and fishery product, as well as the name, address and telephone number of the person(s) designated as the contact(s) for each or these value-added suppliers.
- Submissions should be updated by the applicant whenever any information covered by item 1-5 changes, including notification to FDA if the applicant ceases shipment to the EU.
Additional Background Information
The following websites may be useful to firms that ship fish and fishery products to the EU, EU Accession Partnership Countries, and EFTA Members.
List of EU References
The following list of EU references can be found at http://eur-lex.europa.eu/RECH_menu.do?ihmlang=en:
- Council Directive 91/493/EEC
- Council Directive 1/492/EEC
- Commission Decision 93/185/EEC
- Commission Decision 94/356/EC
- Council Decision 95/408/EC
- FDA EU Coordinators
A list of EU coordinators can be found at: http://eur-lex.europa.eu/homepage.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.
(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.
This document supercedes the previous version issued November 22, 2004.