E9-2802. 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 ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled “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.” The revised guidance only changes the date on which FDA intends to stop issuing export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). The date FDA now intends to stop issuing EU Export Certificates is June 17, 2009.

DATES:

Submit written or electronic comments on the guidance at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Office of Food Safety (HFS-300), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835. Send one self-addressed adhesive label to assist that office in processing your request. Submit written comments concerning the 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 guidance to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

William Jones, Center for Food Safety and Applied Nutrition (HFS-325), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2300.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 15, 2009 (74 FR 2600) (the January 15 notice), FDA announced the availability of a guidance entitled “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.” In the January 15 notice, FDA announced that it: (1) Intends to proceed with a Certification Referral Program to the National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP), without a 24-month test period, (2) intends to expand the program to include all fish and fishery products for export to the EU and EFTA, and (3) intends to stop issuing EU Export Certificates effective February 17, 2009. The agency stated that it intends to adopt this approach because the industry's demand for EU Export Certificates continues to rise dramatically, and FDA can no longer justify the use of our limited food safety resources for issuance of EU Export Certificates. The implementation of this guidance should free up resources that the agency can allocate for higher priority public health activities that are intended to protect the U.S. consuming public, while still providing a mechanism for the industry to continue obtaining EU certification. Seafood processors and other entities involved in the exporting of seafood to the EU may obtain EU Export Certificates from the NOAA SIP.

After publication of the January 15 notice, FDA received comments and has determined it would be beneficial to have more time to deliberate further on the policy issues presented by this action. Consequently, FDA is revising the guidance to announce that it intends to stop issuing EU Export Certificates on June 17, 2009.

FDA is issuing this guidance document as a level 2 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). The guidance represents 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, NOAA SIP, or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. 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. The guidance and received comments maybe seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the guidance document at http://www.cfsan.fda.gov/​guidance.html.

Dated: February 5, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.