March 8, 2011 | Kelley Drye Client AdvisoryLast month, the USDA Food Safety and Inspection Service (FSIS) issued a proposed rule that is intended to ensure that commercial catfish products are properly marked, labeled, and packaged, and are not adulterated.1 The rule implements recently enacted legislation which was advocated by U.S. catfish producers, and singles out domestic and imported catfish for regulation by FSIS under a "continuous inspection" program that is comparable to the FSIS programs governing meat and poultry products.2 Specifically, the proposed rule issued by FSIS would implement provisions of the Food, Conservation, and Energy Act of 2008 (the Farm Bill), which amended the Federal Meat Inspection Act (FMIA) to specify that catfish "is an amenable species," thereby subjecting catfish to FMIA continuous inspection requirements.3
FDA and the Centers for Disease Control (CDC) consider commercially raised catfish to be a "low-risk food" based on the low frequency of adulteration due to chemical or microbiological contaminants. Nevertheless, FSIS has identified examples where catfish shipments have been exposed or contaminated with chemical residues that have been deemed unsafe by the FDA. FSIS proposes to conduct continuous inspection and verification of procedures relating to catfish processing, facility sanitation, hazard mitigation, and product transportation to ensure the safety of catfish and catfish products. In addition to creating new regulations, the proposed rule would apply to catfish and catfish products a substantial number of the FMIA provisions that now apply to meat and meat food products.
Definition of "Catfish"
The FSIS proposal recognizes that a critical threshold issue that the agency ultimately must address, and which ultimately will define the scope and costs associated with the catfish inspection program, is the definition of "catfish." FSIS declines to advocate a particular definition of catfish, and invites public comment concerning the catfish "families" that should appropriately be subjected to continuous inspection under the new FMIA amendments. The FSIS proposal recognizes that options include limiting the catfish definition to fish that belong to the family Ictaluridae, or adopting a more expansive definition that would include all fish belonging to the order Siluriformes. If catfish are confined to the family Ictaluridae, the proposed rule would cover approximately 70 percent of Siluriformes currently consumed in the United States. In contrast, if catfish is defined more broadly to include all fish belonging to the order Siluriformes, FSIS would inspect all domestically produced and imported Siluriformes, including all Ictaluridae, as well as the Pangasiidae fish commonly farmed in Southeast Asian countries.
Current Regulations for Domestic and Imported Catfish
The FSIS proposal recognizes that the FMIA amendments shift primary regulatory oversight for domestic and foreign farm-raised catfish to FSIS and away from FDA, and proposes to implement new food safety requirements under established FMIA standards. Despite the shift in regulatory oversight, the FSIS proposal maintains most of the duties, with respect to facility sanitation and food safety hazard identification, that are currently imposed upon domestic and foreign catfish producers through FDA Seafood Hazard Analysis Critical Control Point (HACCP) regulations4 and FDA current Good Manufacturing Practices (cGMPs).5 The most noteworthy differences between current FDA requirements and the FSIS proposal concern the proposed continuous on-site inspections, enhanced product transportation-related obligations, and more stringent requirements for foreign countries that export catfish to the U.S.
Official Establishments Would Be Subject to Continuous Inspection
The proposed rule would require continuous inspection at every "official establishment," defined as "[a]ny slaughtering, cutting, boning, catfish product canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained."6 All catfish and catfish products prepared in an official establishment would have to be inspected, handled, processed, marked, and labeled as required by the proposed regulations. Retail stores and restaurants would be exempt from the inspection provisions; however, such locations would be subject to periodic inspections or a review of documents relating to their catfish inventory.
Official establishments would be required to make office space and related amenities in the facility available rent free for inspectors who will be located on site at the establishment for eight-hour shifts each day during the standard work week. Official establishments also would have to establish space within the facility to conduct inspections and provide proper instruments, sanitizing agents, and appropriate sanitary means of disposal to facilitate the inspections.
Catfish Establishments Would Be Required to Adopt USDA Sanitation and HACCP System Requirements
Under the proposed rule, official catfish processing establishments generally would be required to meet the same types of food safety requirements that FSIS currently applies to meat processing establishments. For those establishments that currently comply with FDA's Sanitation Standard Operating Procedures (SSOPs) and seafood HACCP requirements, the changes required to comply with the requirements proposed by FSIS are likely to be modest.
FSIS would require official establishments to develop SSOPs based on the model used within meat processing establishments. These SSOPs, which would be designed to achieve the objectives of the sanitation performance standards, would be similar in scope to the SSOPs already mandated by FDA for seafood producers. Thus, catfish processors that currently operate in compliance with FDA's SSOPs requirements, with respect to facilities, equipment, utensils, operations, and personnel, would need to make few, if any, changes to comply with the SSOPs requirements in the FSIS proposal. Under the proposed rule, compliance with FSIS's SSOP requirements would be a condition for a catfish production establishment to receive a grant of inspection, which all affected establishments would have to apply for and obtain before continuous inspection could begin at an establishment. FSIS would then verify the adequacy and effectiveness of the SSOPs as part of its inspection program.
Under the proposed rule, official establishments also would have to comply with HACCP program requirements for meat processing establishments, which closely resemble FDA's Seafood HACCP program requirements. The principle HACCP elements under both FDA rules and the FSIS proposal include an analysis to determine food safety hazards reasonably likely to occur in the production process, and preventive measures to control the identified hazards. The analysis must account for hazards that can occur before, during, and after a catfish harvest, and the analysis must be incorporated into a written HACCP plan that identifies critical control points that are designed to mitigate food safety hazards. Further, both FDA HACCP and the proposed FSIS HACCP programs require ongoing verification activities to ensure effective implementation of the written HACCP plan, as well as recordkeeping relating to documents associated with the critical control points, and documents supporting the monitoring and verification procedures. All documents would have to be made available for review by FSIS. Under the FSIS proposal, catfish products produced at an establishment that has failed to develop and implement a HACCP plan would be rendered adulterated.
FSIS Would Have Authority to Condemn Catfish and Catfish Products that Meet Specified Criteria
The proposed rule describes conditions that will result in condemnation of catfish or catfish product. Catfish affected by various parasites or diseases, in a state of spoilage or decomposition, or containing unacceptable concentrations of drugs, pesticides, or other chemicals would be subject to condemnation. The condemned or inedible catfish, if not disposed of at the establishment, would have to be enclosed in containers that are "conspicuously marked" to indicate that the contents are condemned or inedible and then shipped under official seal to a rendering plant or another establishment for non-food use.
Upon determination by an inspector that catfish arriving at an official establishment died by means other than slaughter, the catfish would not be permitted on the premises without advance permission from a FSIS frontline supervisor. Once the catfish is allowed onto the premises, the official establishment would have to maintain physical separation between slaughtered catfish and catfish that died by other means.
Catfish Transported in Commerce Would Be Accompanied By Official Marks
The proposed rule incorporates by reference current meat product regulations that relate to the use of official marks. The marks would be adopted to more easily identify catfish that has passed inspection, and to minimize the risk that such product will become misbranded while in commerce. Under the proposed rule, labels of inspected and passed product would have to include an official inspection legend containing the number of the official processing establishment. Further, equipment used to transport catfish, such as cargo containers and railroad cars, would be required to display a seal approved by FSIS. Lastly, catfish that is intended for export outside of the U.S., or is detained by U.S. inspectors, would be required to display official inspection marks similar to those currently used for meat products.
Catfish Would Have to Be Properly Labeled to Avoid Misbranding
Basic labeling requirements under the proposed rule are similar to current FDA labeling requirements; however, unlike FDA provisions, the proposed rule would require that the label bear the official inspection legend and that safe-handling instructions appear on the label of every not-ready-to-eat catfish product that is destined for homes, hotels, or restaurants. Under the proposed rule, FSIS also would have to pre-approve all final labeling before it can be placed on the catfish product.
The proposed rule also prohibits any wrapper, packaging, or container that is used in a misleading manner. To prevent mislabeling with respect to the net weight of catfish, for example, packages of fresh or fresh-frozen catfish would be labeled to reflect 100-percent net weight (gross weight less the weight of ice glaze placed on the fish by processors) after thawing. The de-glazed net weight would have to average 100 percent of the stated net weight of the frozen product when sampled and weighed.
Inspectors Would Also Monitor the Ingredients Used to Prepare the Catfish
Under the proposed rule, inspectors would continually monitor all processes used to prepare catfish and catfish products. Inspectors would monitor and sample the ingredients used by official establishments to prepare the catfish product, including chemicals, spices, and water. Inspectors would then condemn any catfish or ingredients that are rendered adulterated by polluted water that enters an establishment. Once the polluted water is removed, the establishment would be required to clean and sanitize the affected facility and equipment before resuming operations.
Recordkeeping Provisions Would Mirror Those Used For Meat Products
The proposed recordkeeping requirements, which would apply to entities that process, package, transport, store, or import catfish products, are generally consistent with current recordkeeping requirements for meat products, and are more extensive than those currently required under FDA's seafood HACCP regulations.7 For example, the FSIS proposal would require that official establishments maintain invoices and shipping information for each transaction involving the sale or receipt of catfish, including the net weight of the shipment, the number of containers, the contact information of parties to the transaction, the transaction date, and the seal numbers for shipments of any inedible product.
The records, which would have to be made available to inspectors upon request, could be kept at either the place where business is conducted or the establishment's headquarters. Further, establishments would be required to maintain the records "for a period of two years after December 31 of the year in which the transaction to which the record relates has occurred," or longer if required by FSIS.
Lastly, the operator of an official establishment would be required to provide on-site inspectors with information that will allow the inspectors to conduct proper reporting. The operator would also submit to the inspector a quarterly report on the volume of catfish produced at the establishment.
The Proposed Rule Would Expand The Scope of Existing Transportation Provisions
The proposed rule includes transportation-related provisions that provide greater detail and expand the scope of obligations facing transportation providers, in comparison to related transportation provisions within current FDA and USDA policies and guidance. In addition to new requirements, the proposed rule also adopts several existing regulations concerning the transportation of animal products.8 An overview of the new transportation provisions is set forth below.
Transport Provisions. Catfish product that it "is not wrapped, packaged, or otherwise enclosed" to prevent adulteration by airborne contaminants could not be transported, unless the transport vehicle "is completely enclosed with tight fitting doors or other covers for all openings."9 The proposed rule also would require transport vehicles to be reasonably free of dust, dirt, rust, or chemical residues. Further, catfish that are dead, dying, or diseased, or parts of catfish that died by means other than slaughter, could not be transported in commerce unless such catfish are delivered to official entities that are subject to federal inspection or FSIS-approved state inspection systems, or entities that include registered animal food manufacturers, renderers, or collection stations.
Cleaning Provisions. Under the proposed rule, cleaning chemicals or compounds would have to be thoroughly removed from any transport vehicle that would be used shortly thereafter to transport catfish, and the transport vehicles would be subject to inspection. Vehicles that transport dead, dying or diseased catfish would have to be leak proof and equipped to permit thorough sanitizing. Further, the proposed rule would require that vehicles are cleaned and disinfected before being used to transport human food.
Inspection Provisions. Under the proposed rule, FSIS could inspect a transport vehicle at its discretion to determine if the catfish product in the vehicle is subject to adulteration. The inspector would consider weather conditions, trip duration and distance, and the nature of the product covering to determine whether the catfish are susceptible to adulteration. If such a determination is made, the condition would have to be corrected before the transport vehicle could be used. Lastly, if an inspector were to determine that conditions within a transport vehicle may have resulted in adulteration of the catfish product, the catfish would have to be removed and handled according to proposed provisions that address contaminated or condemned animal product.
Importers of Foreign Catfish Would Face New Requirements
Current FDA regulations require an importer of catfish to either (1) obtain fish or fish products from a country that has a memorandum of understanding with FDA that documents the equivalence or compliance of the foreign inspection system with that of the United States, or (2) provide written verification that the fish and fish products offered for import into the United States were processed in accordance with FDA regulations. The proposed rule would increase the regulatory burden on foreign countries that export catfish products to the United States by requiring these countries to implement a catfish inspection program that is equivalent to the U.S. inspection program. A country seeking eligibility to import its catfish product into the United States would have to be recognized by FSIS, deemed equivalent and then listed as a foreign exporter of catfish in the adopted regulations. Key proposed provisions affecting the importation of catfish include the following:
Adulterated and misbranded catfish are prohibited. The proposed rule would prohibit the importation of catfish and catfish products that are adulterated or misbranded. FSIS would enforce this provision through random inspection, sampling, and testing of the product offered for export by the foreign country.
Importers must apply for catfish product inspection. Each catfish importer would be required to apply for inspection of any catfish product offered for entry. The application would have to be made in advance of the product's anticipated arrival into the United States, and each application would have to include information regarding the country of origin, the shipment contents, and the preferred inspection location. All catfish products offered for entry from any foreign country would have to receive a visual inspection by an import inspector, and then checked for certification and label compliance.
Transport vehicles must be clean and sanitized. Compartments of equipment, including ocean vessels and railroad cars, used to transport imported catfish to the United States, as well as "all trucks, chutes, platforms, racks, tables, tools, utensils, and all other devices" used to move or handle the catfish product offered for entry into the United States, would have to be maintained in sanitary condition.
Foreign countries must enact catfish processing standards. Foreign countries that wish to import catfish into the U.S. would be required to establish quality standards for the preparation and processing of catfish and would have to conduct continuous monitoring to ensure that adulterated or misbranded product is not prepared for export into the United States.
FSIS will evaluate applicable laws and regulations. Under the proposed rule, foreign countries would be required to provide FSIS with copies of "laws, regulations, and other information pertaining to their systems of catfish products inspection." FSIS's decision on whether a foreign country is eligible to export catfish to the United States would be based on these documents as well as on-site visits to the country by FSIS inspectors.
Implementation of the Proposed Rule
FSIS is proposing a four-phase approach to implementation of the final rule that is intended to provide an orderly transition from FDA's regulatory program to FSIS's continuous inspection program. The phased implementation is expected to provide a reasonable timeframe for countries to develop and implement equivalent catfish inspection programs. The proposed implementation approach, which would begin on the effective date of the final rule, is described below:
Phase One: Domestic establishments would continue to comply with FDA requirements with respect to sanitation and processing practices; however, FSIS would begin to deploy inspection personnel to domestic catfish processing establishments. Further, domestic producers would submit catfish product labels for prior approval, as required under the proposed rule. Foreign countries that export catfish to the United States would submit documentation to show that they have legal measures in place that provide authority to regulate the growing and processing of catfish as human food. Additionally, FSIS would begin on-site audits within these countries to verify that the foreign establishments are complying with the required transitional measures.
Phase Two: All parties that engage in the processing, storing, wholesale purchasing , and transporting of catfish and catfish products would be required to register with FSIS.
Phase Three: Domestic and foreign establishments would be required to comply with the sanitation requirements within the proposed rule.
Phase Four: All establishments that produce catfish would have to comply with all provisions of the final catfish inspection regulations. Further, foreign countries that export catfish products to the United States would have to implement a catfish inspection program that is equivalent to the U.S. inspection program.
The proposed rule represents a shift in the regulatory regime applied to commercial catfish production that will have a substantial impact on both domestic and foreign catfish and catfish product producers. As such, affected companies must prepare for a greater regulatory burden in the form of continuous inspection, new recordkeeping requirements, the pre-approval of labeling, and additional requirements for importers of foreign catfish. Affected companies are advised to evaluate the legal and business implications of the USDA proposal now, and bring issues and concerns to the attention of appropriate policymakers, including by submitting written comments to USDA on or before the June 24, 2011 deadline. Please contact any of the Kelley Drye attorneys listed below is you have questions concerning the USDA proposal or other matters.
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1Mandatory Inspection of Catfish and Catfish Products, 76 Fed. Reg. 10434 (Proposed Feb. 24, 2011) (to be codified at 9 C.F.R. Parts 300, 441, 530-534, 537, 539-555, 557, and 559-561).
2 SeafoodSource, U.S. Catfish Farmers Applaud USDA Rule (Feb. 22, 2011) ("We are extremely pleased that the USDA has recommended stricter regulation of catfish, which will mean greater protection for American consumers," said [Catfish Farmers of America] President Joey Lowrey. "The USDA has determined there is a clear need for a stronger catfish food-safety inspection system." available at http://www.seafoodsource. com/newsarticledetail.aspx?id=9336.
3 21 U.S.C. 601(w)(2).
4 21 C.F.R. Part 123.
6 76 Fed. Reg. at 10459 (to be codified at 9 C.F.R. § 531.1) (note that the FDA Seafood HACCP applies to all seafood processors, defined at 21 C.F.R. § 123.3(l) as "any person engaged in commercial, customer, or institutional processing of fish or fishery products, either in the United States or in a foreign country. A processing includes any person
7 9 C.F.R. Part 320 (2010)(meat products); 21 C.F.R. Part 123 (2010) (fish and fishery products).