[Federal Register: November 26, 2004 (Volume 69, Number 227)]
[Page 68946-68947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004D-0509]

Draft Guidance and Protocol for Industry and Food and Drug 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Guidance and Protocol for 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.'' The draft guidance describes how health 
certificates required for shipments of fish and fishery products from 
the United States to the European Union (EU), EU Accession Partnership 
Countries, and members of the European Free Trade Association (EFTA) 
should be issued. This draft guidance is not final nor is it in effect 
at this time.

DATES: Submit written or electronic comments on this draft guidance by 
December 27, 2004. General comments on agency guidance documents are 
welcome at any time. Submit written or electronic comments on the 
collection of information provisions by January 25, 2005.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Bruce Wilson, Center for Food Safety and Applied Nutrition 
(HFS-417), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 301-436-1425, e-mail: bwilson1@cfsan.fda.gov. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the guidance 
may be sent. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit written comments concerning the draft guidance and the 
proposed information collection provisions to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft 
guidance and the proposed information collection provisions to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments

FOR FURTHER INFORMATION CONTACT: Tim Hansen, Center for Food Safety and 
Applied Nutrition (HFS-415), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-1405, e-mail: 


I. Background

    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. A certificate is issued if it is determined 
that the establishment\1\ is in regulatory good standing with FDA. 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.

    \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.

II. Significance of Guidance

    FDA is providing this draft guidance 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

[[Page 68947]]

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 

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3 and includes agency requests or requirements that members of the 
public submit reports, keep records, or provide information to a third 
party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    FDA invites comments on the following topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
    Title: Health Certificate for Fishery and Aquaculture Products 
Intended for Export to the European Community
    Description: This draft guidance describes the procedures FDA staff 
should use to issue the EU certificates, as well as the procedures 
industry should use for requesting a certificate. As discussed in 
detail in the draft guidance, the EU requires that each shipment have a 
certificate issued by a ``competent authority'' in the exporting 
country. The respondent (shipper) is asked to fill out a certificate-
form (as required by the EU) that provides the following information: 
(1) The identity of the fishery product in terms of its physical state, 
type of packaging, number of packages, net weight, temperature required 
during storage and transport; (2) origin of the product, to include the 
name and registration number of the establishment(s) that processed, 
stored or harvested the product and is registered with FDA for export 
to the EU; (3) destination of the product and place of dispatch from 
the United States, the means of transport, the name and address of the 
dispatcher, the name of the consignee, and address at destination; and 
(4) date of certificate. Certifying agencies will retain this 
information for a reasonable period of time in case it becomes 
necessary to respond to questions about the shipment by officials in 
the importing country.
    The proposed collection of information will take place when an 
establishment fills out a certificate and submits it to FDA for 
signature. Certificates in different languages may be downloaded from 
the Internet at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/eucert.html.

    Description of Respondents: The respondents to this collection of 
information are seafood industry firms that export seafood products to 
one or more of the countries within the EU. FDA estimates the burden of 
this collection of information as follows:

             Table 1.--Estimated Annual Reporting Burden\1\
                               No. of
                No. of       responses       Total     Hours per   Total
   Item      respondents        per         annual     response    hours
                            respondent    responses
Health      928            26            24,500       0.25        6,125
 te for
 Export to
\1\ There are no capital and/or operating and maintenance costs
  associated with this collection of information.

    Estimates of the annual FDA reporting burden were made using the 
number of firms that are currently on the EU Shippers List (928 
respondents after subtracting the number of firms contracting with NOAA 
SIP in 2003), and the approximate total number of EU Health 
Certificates issued in 2003 by FDA (approximately 24,500). The 
estimated annual total hour burden is likely to be more accurate than 
the estimated number of responses per respondent, because the latter 
figure is the average obtained by dividing the recent total annual 
certificates by the current number of potential respondents (928). In 
practice, the frequency of shipments to the EU may vary widely among 
approved firms; some firms may export weekly to the EU, others may 
export only a few times a year or not at all.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    An electronic version of this guidance is available on the Internet 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/guidance.html.

    Dated: November 17, 2004.
Jeffrey Shuren,
Associate Commissioner for Policy.
[FR Doc. 04-26138 Filed 11-22-04; 1:33 pm]