Guidance and Protocol for Industry and Food and Drug Administration Staff
Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association
Draft Guidance
This guidance document is being distributed for comment purposes only.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availability of the draft guidance.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 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 Food Safety
January 2008
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
Draft Guidance
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 The draft guidance is being distributed for comment
purposes in accordance with FDA's Good Guidance Practices (21 CFR 10.115;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).
I. Purpose
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agency) is providing this draft guidance on how it is issuing health certificates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 The purpose of the draft guidance is to clarify the internal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.
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 intends to maintain three
EU Export Certificate Lists:
- The EU Export Certificate List of Value-Added
Processors (hereafter called the "Value-Added Processors List");
- The EU Export Certificate List - Value-Added
Processing Vessels (hereafter called the "Value-Added Processing Vessels
List"); and
- The EU Export Certificate List - Other
Than Value-Added Processors (hereafter called the "Other Than Value-Added
Processors List").(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 three current EU Export Certificate Lists. Make
the updated EU Export Lists available on the web.
- FDA District Offices intend to:
- Process requests submitted by establishments for inclusion on any of the three EU
Export Certificate Lists, 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, or
when the EU Export Certificates for that establishment are issued by
a certifying body authorized by FDA to issue those certificates.
- Notify
the Office of Seafood as soon as possible with changes to the EU Export
Certificate Lists, 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 FDA or NOAA
SIP within two years or if FDA has reliable information indicating
that the establishment is no longer exporting fish and fishery products.
- Review
each EU Export Certificate submitted by an establishment for FDA certification
to determine whether all appropriate information has been included and
entered in accordance with EU requirements, as noted in Section V.
- Determine eligibility when the establishment
requests the issuance of an EU Export Certificate. If the establishment
is a Value-Added Processor or Value-Added Processing Vessel, eligibility
should be based upon whether that establishment is in regulatory good standing
as defined in section III.B. If the Value-Added Processor or Value-Added
Processing Vessel has no inspectional history, a regulatory inspection
should be performed as soon as work plan priorities permit. If the establishment is an Other Than Value-Added
Processor or a Dispatcher as described in section III.A., eligibility should
be based upon the regulatory good standing of the establishment's supplier(s). For
the purposes of the EU Certificate Lists, regulatory inspections may be
performed by FDA or by another governmental entity in the U.S. with which
FDA has a contract, partnership arrangement, or MOU for such a regulatory
inspection.
- Respond to an establishment's request for
certificates by signing the certificates, if appropriate, and providing
them back to the establishment.
- Provide
written notification to the establishment of any change in its status on
any of the lists 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.
- As
necessary, where an establishment becomes eligible and requests certification
before the Office of Seafood submits its quarterly listing of eligible
establishments to the EU, provide to the establishment a letter to
accompany the EU Export
Certificates explaining that the establishment has become eligible
and should appear on the web, as described in section II.B.3, at: www.cfsan.fda.gov/~frf/sfeuexp.html. It
should be understood, however, that such a letter may not be acceptable
to some EU countries that may require that the firm appear on the official
list.
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
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.
- 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.
- Examples:
- 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.
- Whether an establishment is an Other Than a Value-Added Processor or a Dispatcher
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.
- 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 Other Than Value-Added Processors List. Such establishments would
obtain their own Central File Number (CFN) or FDA Establishment Identifier
(FEI) number from FDA and include it on the certificate in lieu of the
names and CFN or FEI numbers of their suppliers. It should be understood,
however, that the absence of such identifying information about suppliers
might cause the certificate to be rejected by some EU countries. Other
Than Value-Added Processors ship at their own risk in that respect. In
any event, the CFN or FEI numbers of all U.S. processors relevant to the
shipment for which a certificate is being sought should be provided to
FDA along with the request for certification. All such processors
should be in regulatory good standing.
- 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 any of the three
EU Export Certificate Lists. Certificates should be issued when
the listed processors are in current regulatory good standing.
- Examples
- 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.
- Determination of whether an establishment should be considered
in regulatory good standing
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 establishment should not be considered in regulatory good
standing and should not be issued an EU Export Certificate for any of its
products 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 any of the three EU Export Certificate Lists
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
FDA Coordinators for European Union (EU) Export Health
Certificates for a list of EU coordinators and the area they cover) that includes the
following:
- Identity of the list on which it is applying for inclusion and a 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.
V. Guidance to Industry for Obtaining Completed EU Export Certificates
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
FDA Coordinators for European Union (EU) Export Health
Certificates. If
the establishment meets all the provisions in this guidance, the EU Export
Certificate(s) should be signed and returned to the establishment.
- General Guidance:
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.
- The establishment should use the EU Health Certificate in the official language (or one
of the official languages) of the country in which the product lands
and clears customs, even if it is not the final destination EU country. Copies of
the EU Certificate in each of the official languages are available on FDA's
Center for Food Safety and Applied Nutrition web site at:
European Union (EU) and European Free Trade Association (EFTA)
Export Certificates for Fishery/Aquaculture Products and Live/Raw Molluscan Shellfish.
The website also provides additional information on how to handle certificate
issues related to EU Accession Partnership Countries and EFTA Members.
- In cases where a shipment is being trans-shipped to a non-EU country after
landing in an EU country, two certificates may be required, the EU
Certificate and a "Certificate of Export" for the non-EU country. See
Compliance Policy
Guide 110.100-Certification of Exports
for other types of export certificates available from FDA headquarters
for shipments made to non-EU member countries. Further, information
on these certificates can be obtained by calling FDA's Office of Seafood
at 301-436-1416.
- The establishment should complete all entries on the EU Certificate in English. FDA will insert the reference number, sign as the "official signature," and
apply the official seal.
- Guidance for completing various sections of the EU Certificate is contained in section V.C.3 and 4.
- Guidance on Whether a Single or Multiple Certificates Are Appropriate for a Shipment
- A single EU Certificate is appropriate for a shipment of fishery products that underwent the same type of processing (e.g., all smoked, all canned, all fresh, etc.), is presented at the border in the same means of transportation as one shipment, and is being shipped to the same destination. As the following illustrates, variations on this scenario may exist:
- A single EU Certificate is appropriate when the only difference is
that the fishery products are shipped in several units, but by one
means of transportation (for example, several container vans on a cargo vessel), provided
the units are shipped together.
- A single EU Certificate is appropriate when the only difference is that the fishery
products come from more than one value-added processing establishment,
provided the EU Certificate identifies the different value-added
establishments.
- A single EU Certificate is appropriate if a combination of a and/or b apply to a shipment.
- A single EU certificate is generally not appropriate if:
- The shipment is shipped to different destinations;
- The shipment is conveyed in different means of transportation; or
- The shipment is in multiple shipping containers that are entered at different
times.
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.
- Guidance to Industry for Completing the EU Non-Molluscan Health Certificate
This information can be found in the Instructions for completing EU Health Certificates for Fish and Fishery Products January 2008.
- Guidance to Industry for Completing EU Molluscan Shellfish Health Certificate
This information can be found in the Instructions for completing EU Health Certificates for Fish and Fishery Products January 2008.
- 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.
- Sample EU Health Certificates
- For non-molluscan fishery and aquaculture products, and
- For molluscan fishery and aquaculture products
- 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: FDA Coordinators
for European Union (EU) Export Health Certificates
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.