E9-14475. 2009 European Union Export Certification for Fishery Products

AGENCY:

Seafood Inspection Program (SIP), National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice of procedural change.

SUMMARY:

The National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP) will become the sole certifying agency for all fish and fishery products for export to European Union (EU) or European Free Trade Association (EFTA) member countries. Due to the large volume of demand for these certificates and the need for expedient service, SIP, through this notice, is announcing a change from current practices, including fee structure, for providing Health Certificates for the EU and EFTA.

DATES:

Effective June 16, 2009.

FOR FURTHER INFORMATION CONTACT:

Timothy Hansen, [e-mail], Program Director SIP NMFS/NOAA [phone] EXT. 214

SUPPLEMENTARY INFORMATION:

Background

On January 15, 2009 (74 FR 2600), the U.S. Food and Drug Administration (FDA) published a Federal Register Notice announcing that after February 17, 2009, FDA will no longer issue health certificates required by the EU for export of fish or fishery products to the EU or the EFTA. By subsequent notice in the Federal Register on February 11, 2009 (74 FR 6902), FDA announced a 120-day delay in the effective date of the January 15, 2009 notice. FDA now intends to cease issuing EU Health Certificates on June 17, 2009. The U. S. Department of Commerce Seafood Inspection Program will continue to issue these certificates upon request on a fee-for-service basis.

The Seafood Inspection Program of the National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce, operating under authority of the Agricultural Marketing Act (7 U.S.C. 1621 et seq.) and the Fish and Wildlife Act (16 U.S.C. 742a et seq.), is responsible for the development and advancement of commercial grade standards for fishery products and better health and sanitation standards in the industry and for furnishing inspection, evaluation, analytical, grading, and certification services to interested parties. Its major purpose is to encourage and assist the industry in improving the quality, wholesomeness, safety, proper labeling, and marketability of its products.

In 1993, the EU began requiring health certificates for fish and fishery products that entered the EU. Both the FDA and SIP were recognized by the EU as competent U.S. Government authorities and acceptable sources for EU health certificates. The EU also required that shippers to the EU be on a list of firms that demonstrated compliance with the U.S. food safety laws and regulations. Since 1993, FDA has issued health certificates for seafood processing firms appearing on the EU Export Certificate List free of charge. By contrast, SIP examined the product and labeling, confirmed all the shipping information and issued health certificates on a fee for service basis. FDA initially issued approximately 3000 certificates per year, but as European demand for U.S. fishery products increased over the years, the number of certificates issued annually by FDA has grown ten-fold to over 30,000. FDA currently issues about 80 percent of all EU health certificates. The increased volume of certificates issued and concomitant decrease in agency resources has made FDA reassess its involvement in the issuance of EU health certificates.

New Procedures for Receiving EU Certificates From SIP

Effective immediately, SIP policy is as follows: SIP, upon request, will issue EU Health Certificates to SIP program participants and rely on inspection results or an approved control system, e.g. the Hazard Analysis and Critical Control Points Quality Management Program (HACCP QMP) or the Integrated Quality Assurance (IQA) Program, to issue the certificate. Seafood processors and other entities that are not SIP program participants may receive EU Health Certificates from SIP based on a periodic verification of the information provided, compliance of the product labeling to EU requirements and the condition of the product. Instructions for requesting an EU Health Certificate can be found on the SIP Web site at: http://www.seafood.nmfs.noaa.gov.

All applicants for EU Health Certificates must be in regulatory good standing with the FDA and must be on the FDA's EU Export Certificate List. In addition, prior to the issuance of EU Health Certificates, all applicants will be required to sign an agreement including, but not limited to, the following provisions:

• The applicant agrees to allow SIP auditors or EC Food and Veterinary auditors entrance to the processing facility at reasonable times when periodic audits occur.
• The applicant agrees to keep information about the origin of foreign raw material to ensure that it was produced in a firm and country that are approved by the EC, make this information available to SIP auditors upon request and provide this information for each certificate request when foreign product is to be certified by SIP.
• The applicant acknowledges that s/he has read the terms and conditions of the agreement and understands that making false statements in connection with issuance of an EU Health Certificate would be a violation of 7 U.S.C.1622(h), punishable by a fine of not more than $1,000 or imprisonment for not more than one year, or both.

Fee Structure

Program Participants

For participants in SIP's continuous on-site inspection service program, certificates will be provided at no extra cost assuming that the work demands can be adequately addressed in the agreed upon contract hours. If additional time is needed for EU Health Certificate completion, it will be charged at the appropriate hourly rate, published on the SIP Web site. EU Health Certificates for facilities operating under the HACCP QMP or the IQA Program will be charged $50 for each EU Health Certificate request. Participants may choose to contract specifically for EU Health Certificate services if there is a significant volume.

Non-Program Participants

Seafood processors and other entities that are not SIP program participants will be charged $69 for each EU Health Certificate request. Fees and charges may be adjusted as necessary to recover costs. Changes in this fee structure will be announced via notice in the Federal Register.

Dated: June 16, 2009.

Samuel D. Rauch III,

Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.