Details of FSIS Proposed Rule to Inspect Imported & Domestic Catfish

Comments are due by June 24, 2011.

Catfish Would Move from FDA Regulatory Regime to FSIS Inspection

The catfish industry is currently subject to the Food and Drug Administration's (FDA) seafood Hazard Analysis Critical Control Point (HACCP) regulations (21 CFR 123) and to other FDA regulatory requirements. The proposed rule would move this industry from FDA's regulatory regime to the FSIS inspection system.

(FSIS adds that FDA currently requires importers to either (1) obtain fish or fish products from a country that has an active MOU with FDA that covers the product and documents the equivalence of the foreign inspection system with that of the U.S. or (2) have implemented verification procedures for ensuring compliance with FDA regulations.)

Definition of Catfish Would Determine Scope of Inspection Program

FSIS states that the definition of “catfish” is a threshold issue in this rulemaking as it would determine the scope of its catfish inspection program. The proposed rule provides two options for the definition: (1) one option is the current labeling definition in the 2002 Farm Bill, which includes all species in the family Ictaluridae, and (2) the other option is to define catfish as all species in the order Siluriformes, including the three families typically found in human food channels, including Ictaluridae, Pangasiidae, and Clariidae.

If the term “catfish” is defined as fish of the family Ictaluridae, FSIS would inspect all domestically and foreign produced Ictaluridae, which would account for virtually all of domestically produced Siluriformes and approximately 20-25% of foreign produced Siluriformes. Such a rule would cover approximately 70% of Siluriformes consumed in the U.S. in recent years.

(Note that basa and swai fish are in the order Siluriformes, and that basa and swai frozen fish fillets may be subject to antidumping (AD) duties if from Vietnam (A-552-801).)

Proposed Inspection Requirements for U.S. Processing Establishments

Catfish Processing Establishments Would Need to be Under FSIS Inspection to Sell/Transport Interstate, Etc.

In the proposed rule, U.S. establishments that process catfish for transportation or sale in interstate commerce for use as human food would need to be under FSIS inspection. FSIS would require catfish processing establishments to qualify for a grant of inspection, similar to those that apply to meat processing establishments. These requirements cover sanitation standard operating procedures, HACCP plans and records, records for microbiological testing, and other prerequisite program records.

Establishments would have to apply for inspection. After the application has been filed, FSIS would reserve an official plant number that would identify all inspected and passed products prepared in an establishment. The plant number would have to be printed on the label of any packaged product. All packaged catfish products also would have to bear the U.S. inspection legend and all labeling material would have to be federally approved and on-hand before inspection could be granted.

Official Marks Would Identify Inspected/Passed Catfish, Sealing for Transport

FSIS is proposing to use certain official marks, devices, and certifications to identify catfish/products inspected and passed in establishments and their status. An official inspection legend containing the number of the official establishment would have to be shown on all labels of inspected and passed product. The form of the official legend would be that for meat products or another form that FSIS would prescribe.

The proposed rule would also impose marking requirements for the sealing of transport conveyances (e.g. railroad cars, cargo containers, etc.) by establishments, and separate official inspection marks for catfish imports and exports, which are detailed below.

(See proposed rule for nutrition and safe-handling labeling requirements for catfish and catfish products imposed on establishments.)

Interstate Conveyances Would be Subject to Inspection

FSIS is proposing to require that any catfish product capable of use as human food that is to be transported in interstate commerce be properly handled and maintained to ensure that it is not adulterated and is properly marked and labeled. The proposed rule would also require that a transport conveyance intended to carry catfish products would be subject to FSIS inspection to determine its sanitary condition. Products on an insanitary vehicle would have to be removed and either handled in accordance with the regulations on mandatory dispositions or on the handling of condemned and inedible materials.

(See proposed rule for recordkeeping requirements for persons involved in processing, buying and selling, or rendering catfish/products.)

Proposed Inspection Requirements for Imported Catfish/Products

Foreign Countries Would Need to Obtain FSIS Certification of Equivalence

Under the FMIA, each foreign country from which products of subject species are offered for importation into the U.S. would be required to obtain a certification from FSIS stating that the country maintains a program using reliable analytical methods to ensure compliance with U.S. standards for residues in those products.

FSIS would have to find that a foreign inspection system ensures compliance of processing establishments and catfish products with requirements that are equivalent to the inspection and other requirements of the FMIA that apply to official catfish establishments in the U.S. When the FSIS determines that a foreign country’s inspection system for catfish/products is equivalent to that operated by FSIS, it would give notice of that fact in the Federal Register and would list the name of the country in the regulations.

Only Certified Foreign Establishments Would Be Eligible to Import into U.S.

Under this proposed rule, only certified foreign catfish establishments would be eligible to export their catfish products to the U.S. If a foreign establishment is not in compliance with U.S. requirements for imported products, FSIS would terminate the eligibility of the establishment and would provide notice to the foreign government of the proposed termination of eligibility unless delay in notification could result in the importation of adulterated or misbranded product.

Each Catfish Importer Would Have to Apply for Inspection for U.S. Entry

The proposed rule would require each importer to apply for inspection of any catfish product offered for entry to the U.S. Each application would have to state the approximate date on which the consignment is due to arrive at a U.S. port, the name of the ship or other carrier transporting it, the name of the country from which the product was, or is to be, shipped, the place where inspection is desired, the quantity and kind of product, and whether it is fresh, cured, canned, or otherwise prepared. In case of consignments arriving in the U.S. by water, the application would have to state the port of first arrival in the U.S.

Origin Marking and Other Labeling Proposed for Imported Catfish and Products

The proposed rule would apply to catfish and catfish products the requirements in 9 CFR 327.14 and 327.15 for the marking and labeling of immediate and outside containers of catfish products that are imported. An imported catfish product would have to be marked with the country of origin and should bear a label with the name of the product, a list of ingredients, name and place of business of the manufacturer, packer, or distributor, net quantity of contents, official inspection legend, and the establishment number assigned by the foreign inspection system and certified to the program.

Imports Would be Re-Inspected for Condition, Certification and Label Compliance

In the proposed rule, all catfish products offered for entry from any foreign country would be re-inspected by a program inspector before they would be allowed entry into the U.S. Program inspectors or U.S. Customs and Border Protection (CBP) officers at border or seaboard ports would report the sealing of cars, trucks, or other means of conveyance, and the sealing or identification of containers of foreign product to program personnel at points where such product is to be inspected.

Proposed Authorization of Catfish/Products Export Certificates

FSIS Inspector for the Catfish Establishment Would Issue Export Certificates

FSIS proposes to adopt requirements for exported catfish and catfish products that are similar to those that apply to meat articles under the FMIA. Under the proposed rule, the FSIS inspector in charge of an official catfish establishment would be authorized to issue official export certificates for shipments of inspected and passed catfish product to any foreign country. FSIS states that it expects that the certificates would be issued at the time the products leave the official establishment but could be issued at a later time only after identification and re-inspection of the catfish products. The certification would have to show the names of the exporter and consignee, the destination, the number and types of packages, the shipping marks, the kinds of products, and the weight of the products.

Outside Containers of Catfish for Export Would Need Official Export Stamp

The proposed rule would require that the outside container of any inspected and passed catfish product for export (with certain exceptions) bear an official export stamp including the export certificate number.

Proposed Phase-In Schedule for Catfish/Products Inspections

FSIS is proposing a four-phase approach to implement the new catfish inspection program. The proposed phasing would begin 90 days after the final rule is published in the Federal Register. FSIS is requesting suggestions for the duration of each phase.

The following is FSIS' proposed timeline for requiring continuous inspection of catfish and catfish products (note that phase one applies differently to imported and domestic catfish/products but phases 2-4 apply equally to both):

Phase One (imports)

• Foreign countries exporting catfish to the U.S. at the time the final rule is published, and that intend to continue to do so, would need to submit documentation to demonstrate that they have a law or other appropriate legal measure in place that would provide authority to regulate the growing and processing of catfish for human food.
• FSIS would then post a list on its Web site of countries that have met this initial, minimum requirement and would recognize current arrangements under the FDA's seafood HACCP regulations, including certification of foreign facilities by competent third parties, until complete implementation of the final rule or until FSIS determines whether foreign inspection systems are equivalent to that of the U.S.
• FSIS would then begin a series of on-site audits of foreign countries that export catfish products to the U.S. to verify that establishments that produce catfish products for export to the U.S. are complying with the required transitional measures.
• Labels of catfish products produced in foreign establishments would be required, at a minimum, to bear the basic labeling features proposed in this rule. These features would include the product name, handling statement, net weight statement, ingredients statement, address line, and nutrition facts panel. The labels would also need to include safe handling instructions as well as the inspection legend and establishment number by the final implementation date.

Phase One (domestic establishments)

• FSIS would deploy inspection personnel to domestic catfish processing establishments.
• Domestic establishments would be required to continue to comply with the requirements of the HACCP, which require processors to monitor conditions and practices to ensure conformity with FDA’s current Good Manufacturing Practices (21 CFR 110) until FSIS sanitation procedures are in place.
• Domestic producers would be required to begin to submit the labels of catfish products to FSIS for prior approval. Labels would have to meet the requirements proposed in this rule.

Phase Two

• Persons and firms covered by the recordkeeping requirements of this proposed rule would have to register with FSIS.

Phase Three

• Domestic and foreign establishments would be required to comply with proposed sanitation requirements.

Phase Four

• The transitional measures would expire and FSIS would then require that all establishments that produce catfish and catfish products comply with all provisions of the final catfish inspection regulations.
• Foreign countries that export catfish products to the U.S. would be required to have implemented a catfish inspection program equivalent to that of the U.S. To be eligible for the importation of their products into the U.S., the countries would have to be listed in this rule.

¹The Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) amended the FMIA, to require all catfish undergo inspection by FSIS. FSIS is therefore adapting the FMIA meat inspection regulations (21 USC 601)² for use in the regulation and inspection of catfish/products. In addition, the Secretary must take into account the conditions under which catfish are raised and transported to processing establishments as part of the new inspection program.

FSIS would inspect food products derived from catfish, verify that the products are prepared for commerce under sanitary conditions, and inspect products that are exported from or imported into the U.S. The inspection could include testing for pathogens or for drug or other chemical residues.

(See ITT's Online Archives or 02/10/11 news, 11021055, for BP summary of OMB approving FSIS proposed rule on catfish and products.

See ITT's Online Archives or 06/10/10 news, 10060953, for BP announcing hearing on FSIS nominee to focus on inspection of imported catfish.

See ITT's Online Archives or 05/19/08 news, 08051905, for BP summary of 2008 Farm Bill.

See ITT's Online Archives or 07/02/07 news, 07070210, for BP summary of FDA detaining Chinese farm-raised catfish, etc. contaminated with antimicrobial agents unapproved in the U.S.

See ITT's Online Archives or 12/21/09 news, 09122125, for BP summary of importer mislabeling Vietnamese catfish to avoid AD duties.

See ITT's Online Archives or 03/20/09 news, 09032040, for BP summary of the International Trade Administration's AD duty administrative review of certain frozen fish fillets from Vietnam.)