[Federal Register: November 26, 2004 (Volume 69, Number 227)]
[Notices]               
[Page 68948-68949]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no04-85]                         


[[Page 68948]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0510]

 
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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or agency) is announcing 
the availability of the draft guidance entitled ``Proposed Referral 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.'' 
The draft guidance proposes a 24-month Referral Program in which 
European Union (EU) Export Certificates for all shipments of live and 
perishable fish and fishery products destined for the EU, EU Accession 
Partnership Countries, and members of the European Free Trade 
Association (EFTA) would be issued by the National Oceanic and 
Atmospheric Administration Seafood Inspection Program (NOAA SIP) under 
the Agricultural Marketing Act (AMA). This draft guidance is not final 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DATES: Submit written or electronic comments on this draft guidance by 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.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to Bruce Wilson, Center for Food Safety and Applied Nutrition 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access to the draft guidance.
    Submit written comments concerning the draft guidance to the 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 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: 
thansen@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

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. FDA also signs certificates for 
shipments of fish and fishery products to EU Accession Countries and 
EFTA Members. A certificate is issued if it is determined that the 
establishment\1\ is in regulatory good standing with FDA. The 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.
---------------------------------------------------------------------------

    The demand for EU Export Certificates by industry has risen 
dramatically in recent years and has caused significant resource 
allocation problems for FDA. The diversion of resources to lower 
priority, discretionary activities diminishes the agency's ability to 
carry out public health activities and regulatory oversight that are 
intended to protect the U.S. consuming public.

II. Significance of Guidance

    In order to expedite the exportation of live and perishable fish 
and fishery products, FDA is considering what parts of its current EU 
certification activities related to fish and fishery products could be 
conducted by NOAA SIP. FDA is, therefore, proposing to operate a 
Referral Program for a 24-month period to test the viability and 
effectiveness of such an arrangement. 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 AMA. The basis 
for issuing EU Export Certificates under the Referral Program would be, 
as it is now, whether the establishment or establishments in question 
are in regulatory good standing with FDA. FDA intends to cease to issue 
EU Export Certificates for live and perishable fish and fishery 
products during this period. FDA seeks comment on this referral 
program, including whether it should be expanded beyond live and 
perishable to all shipments of fish and fishery products destined for 
the EU, EU Accession Partnership Countries, and other countries with 
certificate requirements. During this 24-month period, however, both 
agencies intend to continue to issue EU Export Certificates for 
shipments of canned, frozen, dried, vacuum packed, etc., products, as 
requested by appropriate parties.

III. 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.


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.


[[Page 68949]]


    Dated: November 17, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26139 Filed 11-22-04; 1:33 pm]

BILLING CODE 4160-01-S