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GUIDANCE DOCUMENT

Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association February 2009

Read the Federal Register Notice
Final
Docket Number:
FDA-2004-D-0043
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Table of Contents

  1. Introduction
  2. Discussion
  3. How to Obtain EU Export Certificates
  4. Appendix

I. Introduction

The Food and Drug Administration (FDA) is providing this guidance for seafood processors and other entities that are interested in obtaining "export certificates" for fish or fishery products that are required by countries in the European Union (EU) or the European Free Trade Association if certain U.S. products are to be shipped to the EU or the European Free Trade Association (EFTA).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Discussion

The EU has required that "Health Certificates" (hereinafter referred to as EU Export Certificates) accompany all shipments of fish and fishery products that are shipped to the EU or EFTA since 1993. At that time, FDA voluntarily began issuing such EU Export Certificates free of charge. When FDA agreed to begin issuing EU Export Certificates, FDA anticipated that this would be an interim program and issued approximately 3,000 certificates annually. FDA now issues over 30,000 certificates each year for shipments of fish and fishery products to the EU and EFTA member countries.

Since 2003, FDA has experienced significant increases in food safety responsibilities and concomitant declines in resources available for food safety. In order to carry out public health activities and regulatory oversight that are intended to protect the U.S. consuming public, FDA has found it necessary to focus these resources to higher priority programs (based on public health significance) and has determined that it can no longer justify the use of its limited food safety resources for issuance of EU Export Certificates, especially when another agency has resources available to issue these certificates and has as part of their mission the issuance of such certificates. Therefore, FDA intends to proceed with a Certification Referral Program to the National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP) to include all fish and fishery products for export to EU or EFTA member countries. Thus, on June 17, 2009, FDA intends to discontinue its issuance of EU Export Certificates and intends to refer to NOAA SIP any requests for such certificates that are sent to FDA.

FDA also intends, however, to continue producing its EU Export Certificate List, which identifies all fish and fishery product establishments in the U.S. that are in regulatory good standing with FDA and that seek to export fish and fishery products to the EU and EFTA that NOAA SIP could consult to determine whether particular fish and fishery product establishments are in regulatory good standing with FDA when issuing EU Export Certificates.

III. How to Obtain EU Export Certificates

Establishments seeking EU Export Certificates should contact NOAA SIP. See the appendix to this document for a list of NOAA SIP offices and contacts.

IV. Appendix

NOAA SIP Office and Contacts for EU Export Certificates

NOAA Seafood Inspection Program - Headquarters
NOAA Seafood Inspection Program
1315 East-West Highway
Silver Spring, MD 20910
Telephone: 301-427-8300
Fax: 301-713-1081

Northeast Inspection Branch
NOAA Seafood Inspection Program
55 Great Republic Drive, Suite 01-500
Gloucester, MA 10930
Telephone: 978-281-9228
Fax: 978-281-9134

Southeast Inspection Branch
NOAA Seafood Inspection Program
263 13th Avenue South, 3rd Floor
St. Petersburg, FL 33701
Telephone: 727-570-5383
Fax: 727-570-5387

Northwest Inspection Branch
NOAA Seafood Inspection Program
7600 Sand Point Way, N.E.
Building 1
Seattle, WA 98115
Telephone: 206-526-4259
Fax: 206-526-4265

Southwest Inspection Branch
NOAA Seafood Inspection Program
501 West Ocean Boulevard, Suite 1200
Long Beach, CA 90802
Telephone: 562-388-7346
Fax: 562-388-7353

More information about NOAA Seafood Inspection Program may be found at http://www.seafood.nmfs.noaa.gov/.

Related Information

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2004-D-0043.

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