10434 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules

DEPARTMENT OF AGRICULTURE Administrator, Office of Policy and produced Siluriformes. Such a rule Program Development, Food Safety and would cover approximately 70% of Food Safety and Inspection Service Inspection Service, U.S. Department of Siluriformes consumed in the United Agriculture, Room 350–E Whitten States in recent years. This proposed 9 CFR Parts 300, 441, 530–534, 537, Building, 1400 Independence Avenue, rule is silent on the scope of the term 539–554, 544, 548, 550, 552, 555, 557, SW., Washington, DC 20250–3700; (202) ‘‘catfish’’. USDA is asking for public and 559–561 205–0495. comments on the scope of the definition [Docket No. FSIS–2008–0031] SUPPLEMENTARY INFORMATION: and will fully define and describe the term in the final rule. For purposes of RIN 0583–AD36 Table of Contents convenience, this proposed rule uses the term ‘‘catfish’’ to refer to all fish Background Mandatory Inspection of Catfish and classified within the order of Catfish Products I. Farm Bill Mandate for Catfish Inspection Siluriformes. The use of this term is not II. 2002 Farm Bill with prejudice to what fish FSIS will AGENCY: Food Safety and Inspection III. 2008 Farm Bill Service, USDA. IV. Defining ‘‘Catfish’’ ultimately determine to be ‘‘catfish’’ for purposes of the final rule. ACTION: Proposed rule. V. Catfish Farming and Processing VI. Current Inspection of Domestic and II. 2002 Farm Bill SUMMARY: The Food Safety and Imported Catfish Inspection Service (FSIS) is proposing VII. Public Health Protection: Chemical and Before 2002, various species of fish in regulations requiring continuous Microbiological Contaminants the order Siluriformes were commonly inspection of catfish and catfish VIII. Proposed Regulations Implementing labeled and sold as ‘‘catfish’’ in the Continuous Inspection of Catfish and products. FSIS is proposing these United States. However, the Farm Catfish Products Security and Rural Investment Act of regulations to implement provisions of A. Coverage of the FMIA: provisions the Food, Conservation, and Energy Act 2002, known as the 2002 Farm Bill, applicable to catfish and catfish products amended the Federal Food, Drug, and (Farm Bill) of 2008. The proposed B. Catfish and catfish product inspection regulations are intended to ensure that regulations under the FMIA Cosmetic Act (FD&C Act) by adding a catfish products distributed in IX. FSIS Implementation section declaring, for the purposes of commerce are wholesome, not X. Executive Order 12866 and Regulatory the FD&C Act and notwithstanding any adulterated, and properly marked, Flexibility Act other provision of law, that the term XI. Paperwork Reduction Act ‘‘ ’’ labeled, and packaged. catfish is the common or usual name XII. E-Government Act (or part thereof) only of fish classified in DATES: Comments must be received on XIII. Executive Order 12988, Civil Justice the family Ictaluridae and permitting or before June 24, 2011. Reform the labeling or advertising only for fish ADDRESSES: FSIS invites interested XIV. Expected Environmental Impact XV. Executive Order 13175, USDA classified in that family to include the persons to submit comments on this term ‘‘catfish’’ (21 U.S.C. 321d(a), 343(t); proposed rule. Comments may be Nondiscrimination Statement, and Additional Public Notification Pub. L. 107–171, Title X, § 10806, 116 submitted by either of the following XVI. Proposed Regulations Stat. 526).1 Accordingly, non-Ictaluridae methods: Siluriformes, such as fish belonging to • Federal eRulemaking Portal: This Background the family of Pangasiidae that are Web site provides the ability to type produced in Asia (e.g., basa, tra, and short comments directly into the I. Farm Bill Mandate for Catfish Inspection swai), could no longer be marketed as comment field on this Web page or ‘‘catfish’’ in the United States. FDA attach a file for lengthier comments. Go The Food, Conservation, and Energy advised importers to use alternative to http://www.regulations.gov. Follow Act of 2008 (Pub. L. 110–246, common or usual names for these non- the online instructions at that Web site § 10016(b)), known as the 2008 Farm Ictaluidae species that did not include for submitting comments. Bill, amended the Federal Meat the term ‘‘catfish,’’ and suggested ways • Mail, including floppy disks or CD– Inspection Act (FMIA) to provide that of devising those names.2 ROMs, and hand- or courier-delivered ‘‘catfish, as defined by the Secretary,’’ is items: Send to Docket Clerk, U.S. an amenable species (21 U.S.C. 601 1 The FD&C Act, as amended, (21 U.S.C. 321 et Department of Agriculture (USDA), (w)(2)). Catfish and catfish products are seq.) prohibits the adulteration or misbranding of FSIS, Room 2–2127 George Washington therefore subject to continuous any food, drug, device, or cosmetic in interstate commerce (21 U.S.C 331(b)). A food is considered Carver Center, 5601 Sunnyside Avenue, inspection under the FMIA, which FSIS misbranded if, among other circumstances of Beltsville, MD 20705. administers. The definition of ‘‘catfish’’ misbranding, its labeling is false or misleading (21 Instructions: All items submitted by determines the scope of the FSIS U.S.C. 343(a)(1)); it is offered for sale under the mail or electronic mail must include the inspection program. FSIS considered name of another food (21 U.S.C. 343(b)); if its label does not bear the common or usual name of the Agency name and docket number FSIS– two possible definitions: Fish belonging food, if there is any, or, if the food is made of two 2008–0031. Comments received in to the family Ictaluridae and, a broader or more ingredients, the common or usual name of response to this docket will be made definition, all fish of the order the ingredients (21 U.S.C. 343(i)); or if it purports available for public inspection and to be or is represented as catfish, unless it is fish Siluriformes. If catfish are defined as all classified within the family Ictaluridae (21 U.S.C. posted without change, including any fish of the order Siluriformes, FSIS will 343(t)). The provision in 21 U.S.C. 321d, ‘‘Market personal information, to http:// inspect domestically produced and names for catfish and ginseng,’’ on catfish labeling, www.regulations.gov. imported Siluriformes, including basa, states, ‘‘(a)(1) Notwithstanding any other provision Docket: For access to background of law, for the purposes of the Federal Food, Drug, swai, and others. If the term ‘‘catfish’’ is and Cosmetic Act (21 U.S.C. 301 et seq.)—(A) the documents or comments received, go to defined as fish of the family Ictaluridae, term ‘‘catfish’’ may only be considered to be a the FSIS Docket Room at the address FSIS will inspect all domestically and common or usual name (or part thereof) for fish listed above between 8:30 a.m. and 4:30 foreign produced Ictaluridae, which classified within the family Ictaluridae; and (B) p.m., Monday through Friday. only labeling or advertising for fish classified would account for virtually all of within that family may include the term ‘‘catfish.’’ FOR FURTHER INFORMATION CONTACT: Dr. domestically produced Siluriformes and 2 U.S. Department of Health and Human Services. Daniel Engeljohn, Assistant approximately 20–25% of foreign Food and Drug Administration. February 28, 2003.

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In the 2008 Farm Bill (the Food, exemptions (21 U.S.C. 623), do not determines the scope of the FSIS catfish Conservation, and Energy Act (Farm apply to catfish. inspection program. Before discussing Bill) of 2008 (Pub. L. 110–246, The 2008 Farm Bill also revised 21 the options for how to define ‘‘catfish’’, § 11016(b)), Congress gave the Secretary U.S.C. 606, which requires the it is first helpful to review the scientific of Agriculture and, by delegation, FSIS, appointment of inspectors to examine classification, or taxonomy, of the the authority to determine to which fish and inspect all meat food products catfishes. the term ‘‘catfish’’ would apply. prepared for commerce, by designating the existing section as 21 U.S.C. 606(a) Taxonomy of the Catfishes III. 2008 Farm Bill and adding a paragraph, 21 U.S.C. 606(b). This new paragraph provides Taxonomy is the science of In amending the FMIA to make that the examination and inspection of classification. Seven major hierarchical ‘‘ ’’ catfish an amenable species (21 U.S.C. meat food products derived from catfish groupings are used to classify all living 601(w)(2)), Congress recognized that are to take into account the conditions organisms. These are kingdom, phylum, there are differences in how catfish and under which catfish are raised and class, order, family, genus, and species. the other species that are subject to the transported to processing The kingdom is the broadest grouping. FMIA are slaughtered and processed. establishments. The kingdom Animalia, for example, The Farm Bill added 21 U.S.C. 625, The 2008 Farm Bill provides that the includes all known animals. The which provides that the sections of the amendments are not to apply until the kingdom is comprised of individual FMIA dealing with ante-mortem and date on which the Agency issues final phyla, phyla of classes, classes of post-mortem inspection and humane regulations to carry out the orders, orders of families, families of slaughter (21 U.S.C. 603, 604), amendments. The Bill instructs the genera, and genera of species. In the inspection of carcasses and parts before Agency to consult with the FDA in taxonomy of the fishes, fish of the order their entry into establishments or issuing these final regulations. Siluriformes are commonly and further-processing departments (21 ‘‘ ’’ U.S.C. 605), and exemptions from IV. Defining ‘‘Catfish’’ collectively known as catfishes inspection for custom and farm The definition of ‘‘catfish’’ is a (Table 1). slaughter and processing and other threshold issue in this rulemaking as it

TABLE 1 3—TAXONOMY OF THE CATFISHES. THE ORDER SILURIFORMES, OR ‘‘CATFISHES,’’ INCLUDES THIRTY-SIX FAMILIES, COMMON NAMES OF WHICH ARE IN PARENTHESES

Order Siluriformes (catfishes [English], silures [French])

Family ...... Akysidae (stream catfishes) Family ...... Amblycipitidae (torrent catfishes) Family ...... Amphiliidae (loach catfishes) Family ...... Ariidae (bagres marinos, fork-tailed catfishes, poissonschats marins, sea catfishes) Family ...... Aspredinidae (banjo catfishes) Family ...... Astroblepidae (climbing catfishes, naked sucker-mouth catfishes) Family ...... Auchenipteridae (driftwood catfishes) Family ...... Bagridae (bagrid catfishes, naked catfishes) Family ...... Callichthyidae (armored catfishes, callichthyid armored catfishes, coridoras, mailed catfishes, plated catfishes, poissons-chats cuirasses) Family ...... Cetopsidae (whale catfishes, whalelike catfishes) Family ...... Chacidae (angler catfishes, frogmouth catfishes, squarehead catfishes) Family ...... Clariidae (airbreathing catfishes, bagres laberintos, labyrinth catfishes, poissons-chats a` labyrinths) Family ...... Cranoglanididae (armorhead catfishes, armoured catfishes) Family ...... Diplomystidae (diplomystid catfishes, velvet catfishes) Family ...... Doradidae (bagres sierra, poissons-chats e´pineux, thorny catfishes) Family ...... Erethistidae Family ...... Heptapteridae (heptapterids) Family ...... Heteropneustidae (airsac catfishes) Family ...... Hypophthalmidae (loweye catfishes) Family ...... Ictaluridae (bagres de agua dulce, barbottes, barbottes et barbues, barbues, bullhead catfishes, North American catfishes, North Amer- ican freshwater catfishes) Family ...... Lacantuniidae Family ...... Loricariidae (armored catfishes, loricariide´s, plecoo´stomas, suckermouth armored catfishes, suckermouth catfishes) Family ...... Malapteruridae (electric catfishes) Family ...... Mochokidae (naked catfishes, squeakers, upside-down catfishes) Family ...... Nematogenyidae (mountain catfishes) Family ...... Olyridae Family ...... Pangasiidae (giant catfishes) Family ...... Parakysidae Family ...... Pimelodidae (flat-hosed catfishes, juiles, long-whiskered catfishes, longwhiskered catfishes, poissonschats a` longues moustaches)

Memorandum ‘‘To All Interested Parties’’ on Ictaluridae and that were previously marketed with ‘‘market names for fish that are outside the family the term ‘catfish’ in their names.’’

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TABLE 1 3—TAXONOMY OF THE CATFISHES. THE ORDER SILURIFORMES, OR ‘‘CATFISHES,’’ INCLUDES THIRTY-SIX FAMILIES, COMMON NAMES OF WHICH ARE IN PARENTHESES—Continued

Order Siluriformes (catfishes [English], silures [French])

Family ...... Plotosidae (coral catfishes, eel catfishes, stinging catfishes) Family ...... Pseudopimelodidae (bumblebee catfishes, dwarf marbled catfishes) Family ...... Schilbeidae (glass catfishes, schilbid catfishes) Family ...... Scoloplacidae (spiny dwarf catfishes) Family ...... Siluridae (freshwater catfishes, sheatfishes) Family ...... Sisoridae (sisorid catfishes, sucker catfishes) Family ...... Trichomycteridae (parasitic catfishes, pencil catfishes)

The order Siluriformes includes the The 2008 Farm Bill grants the fingerlings, they are transferred to grow- family Ictaluridae, the North American Secretary of Agriculture the authority to out ponds. There, the fish are fed a catfish, to which belong the fork-tailed define ‘‘catfish’’ anew for purposes of the ration of pelletized floating feed made channel catfish (Ictalurus punctatus) 2008 amendments of the FMIA. The with soybean meal, fishmeal, corn, and blue catfish (I. furcatus), the FMIA, like the FD&C Act, prohibits the wheat, or other grains until they reach principal U.S. farm-raised species, and adulteration and misbranding of foods marketable size. the flathead catfish (Pylodictis olivaris). that are subject to it. Accordingly, FSIS In some instances, medicated feeds Other species in the United States that examined the available data in deciding containing antimicrobials may be fed to are in the Ictaluridae family are the how it could carry out the FMIA to the catfish for therapeutic treatment of white catfish (I. catus), and the black, best effect. bacterial infections. Also, pond water brown, and yellow bullhead (I. melas, I. Specifically, the Agency looked at may be treated with chemicals to nebulosus, and I. natalis). Also among data describing the presence of chemical control algal growth and prevent off- the Siluriformes are the air-breathing residues in, and the presence of flavor in the fish. catfishes of the Clariidae family, to microorganisms on or in, catfish or Catfish-raising ponds are generally of which belongs Clarias fuscus, a Chinese catfish products, and the amount and two types: Levee or delta ponds and species raised on a small scale in types of catfish and catfish products watershed ponds. Levee ponds are built Hawaii. consumed in the United States. Sparse on flat land and filled with groundwater Another family of Siluriformes, the information on the distribution of or surface water. In hilly areas, dams Pangasiidae, the so-called ‘‘giant microbial contamination and chemical built across valleys and between residues on catfish limit our ability to catfishes,’’ 4 includes the aquaculture hillsides capture runoff from rainfall to make strong statements about the species basa (Pangasius bocourti), and fill ‘‘watershed’’ ponds. Though water to baseline risk. Furthermore, the lack of tra or swai (Pangasius hypophthalmus; fill and maintain watershed ponds experience in implementing continuous synonym, Pangasius sutchi), raised usually comes from watershed runoff, inspection programs in the context of principally in Southeast Asia for wells are often necessary to supplement aquaculture makes estimating the domestic consumption and export. the watershed supply. Watershed ponds impact of such a program on risk Other catfish types commercially raised tend to be deeper than levee ponds and difficult. However, the Agency has been in Asia include the hybrid Clarias can efficiently nourish more fish per able to conduct an illustrative macrocephalus and North American acre than levee ponds. assessment of potential human health channel catfish (I. punctatus). Water quality—proper temperature, risks associated with catfish pH, ammonia, nitrite, alkalinity, Options for Defining ‘‘Catfish’’ consumption, using Salmonella as the hardness, carbon dioxide, chloride, and example.5 The Agency considered oxygen—must be maintained to ensure The Agency settled on two options for information about the extent of fish health and maximize feed defining ‘‘catfish’’ after reviewing the misbranding, and it evaluated outputs efficiency. Aerators are used to prevent legislative and regulatory history and from its benefit-cost analysis for catfish oxygen depletion in the ponds. The scientific classification system. One inspection. oxygen levels are monitored regularly to option, was a definition adopted by USDA is requesting public comments ensure fish health and to help in Congress in the 2002 Farm Bill that on the scope of the definition of the limiting algal blooms. defined ‘‘catfish’’ to be only fish of the term ‘‘catfish.’’ When catfish reach marketable length Ictaluridae family for marketing and and weight—optimally 9 to 12 inches labeling purposes under the FD&C Act. V. Catfish Farming and Processing and 0.75 to 1.5 pounds—they are This is the current definition used by Domestic Catfish Farming and collected with seines and put in aerated FDA in its seafood program. The other Processing tanks mounted on trucks that then option was an order definition The catfish growing process in the transport fish to the processing plant. A including all fish of the order United States begins after eggs from truck may carry from 4 to 10 of these Siluriformes. This definition was used breeding ponds are transferred to vats, each loaded with about 3,000 by FDA prior to the 2002 Farm Bill, and hatcheries. Hatchlings are reared in the pounds of water and catfish. would follow established scientific hatcheries for several days before being The following generally describes ‘‘ ’’ practice that defines catfish as all fish placed in nursery or fry ponds, where catfish processing in the United States. of the order Siluriformes. they are raised until, as 3-inch to 8-inch Individual operations may vary. At the processing plant, fish are unloaded into 3 Adapted from Integrated Taxonomic 5 U.S. Department of Agriculture. Food Safety and a holding vat and carried by conveyor Information System (ITIS) report on ‘‘Siluriformes.’’ Inspection Service. Office of Public Health Science. to an electrical stunner. The fish are At http://www.itis.gov (accessed October 4, 2009). December 2010. Draft Risk Assessment of the 4 ITIS report on ‘‘Siluriformes.’’ At http:// Potential Human Health Effect of Applying then sorted and sized. Fish of incorrect www.itis.gov (accessed Jan. 26, 2009). Continuous Inspection to Catfish. Washington, DC. species, such as shad (used in the ponds

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to reduce algae), or incorrect size are United States (e.g., fluoroquinolones) These are: (1) A resident inspection sorted out. Fish of the correct size are have been used in the raising of catfish program, which provides continuous sent to the next operation where they in foreign countries.6 Also, the quality inspection to qualifying establishments; are headed and gutted. Next, the fish are of the river water is more difficult to (2) an integrated quality assurance trimmed and mounted on conveyors control or less subject to control by fish program, under which an establishment and sent tail-first through filleting farmers than is pond water. operates an NMFS-approved quality machinery. After further trimming, assurance system and assists NMFS including removal of the belly flap, or VI. Current Inspection of Domestic and personnel in carrying out U.S. grading ‘‘nugget,’’ fillets are skinned and sent Imported Catfish or specification regulations; and (3) a through a chiller. Fillets are then U.S. catfish processors, exporters, and HACCP-Quality Management Program prepared for packaging or freezing. importers are subject to the U.S. Food (QMP), under which the establishment’s Nuggets may be used in lower-grade and Drug Administration’s seafood quality program is enhanced to meet the edible product. Hazard Analysis Critical Control Point ISO 9001 quality management Most catfish fillets are shipped frozen. (HACCP) regulations (21 CFR 123) and standards. Preservatives, including sodium to other requirements under the Food, An establishment that participates in tripolyphosphate, may be used as Drug, and Cosmetic (FD&C) Act. FDA’s the continuous inspection program must humectants or to minimize oxidation regulations on current good agree to prepare products using only and freezer burn. Some fillets are sold manufacturing practices (cGMPs, at 21 wholesome raw materials and to fresh; some marinated; and some CFR part 110) and on recordkeeping and correctly label inspected items. The breaded. Little if any U.S. farm-raised registration requirements (21 CFR part establishment must also agree to prior catfish undergoes complex processing. 1, subpart H), issued under the label approval by NMFS and to furnish There are few multi-ingredient Bioterrorism Act of 2002 (Pub. L. 107– the Agency with reports that the Agency commercial catfish products. Fish too 188, Jun. 12, 2002) also apply to these may request on processing, packaging, big for further processing with establishments. grading, laboratory analysis, and automated equipment are sent through a For imported products, FDA requires production of inspected products. The separate processing line to be hand- that the importer either (1) obtain fish establishment must provide facilities to processed and sold as whole gutted fish or fish products from a country that has NMFS inspectors and agree to (head on), mainly to restaurants and an active memorandum of conditions under which inspection may institutions. understanding with FDA that covers the be suspended or terminated (50 CFR Waste materials and byproducts from product and documents the equivalence 260.97). The premises of the heading, gutting, and trimming are or compliance of the foreign inspection establishment must be free from taken from the food processing area of system with that of the United States, or conditions that may result in food the establishment to be separately (2) have and implement written contamination (50 CFR 260.98). processed or packaged and shipped. verification procedures for ensuring fish Buildings and structures must be Muscle tissue separated from bones, and fish products offered for import into equipped with adequate lighting, called mince, may be processed into the United States were processed in ventilation, drains and gutters, and hot surimi (a white-fish food product). accordance with FDA regulations in 21 and cold water. Processing facilities Other byproducts may be rendered to CFR part 123 (21 CFR 123.12). must be of sound construction and produce fish oils, or they may be used The arrangement for imported fish capable of being efficiently and in animal feed manufacture, or products does not presuppose a thoroughly cleaned. Animals and pests processed into fishmeal or fertilizer. regulatory finding by FDA that the must be excluded. The use of chemical Fish heads may be sold as bait for foreign inspection system is equivalent compounds, such as cleaning agents, commercial fishermen. to that of the United States, nor does insecticides, rodenticides, and bactericides must be limited to Foreign Catfish Farming and Processing FDA conduct continuous re-inspection of imported fish products as a condition circumstances and conditions approved Foreign catfish farming and of their entry into the United States. by NMFS (50 CFR 260.99). processing is done in a similar manner In addition to FDA regulations, some An establishment participating in any to that of the United States, but it may U.S. catfish processing establishments of the NMFS inspection programs is differ in specific methods. In general, it have contracted for voluntary, fee-for- expected to have organized food-safety is more labor-intensive than U.S. service inspection and certification management systems that are farming and processing. It may involve programs administered by the implemented through a combination of the use of hatcheries and inland ponds. Department of Commerce’s National operational prerequisite programs that In some countries, however, catfish may Marine Fisheries Service (NMFS)under document how food safety hazards are be grown in net enclosures in rivers, in the Agricultural Marketing Act (7 U.S.C. to be controlled, and HACCP plans for floating cages, sometimes alongside or 1622, 1624) and implementing each product processed by the under houseboats, or in ‘‘raceway’’ inlets regulations (50 CFR 260). NMFS establishment. The establishment must fed by river waters. administers three levels of seafood maintain documented Sanitation Fish may be fed homemade or inspection programs under authority of Standard Operating Procedures pelleted feed. Homemade feed is the Agricultural Marketing Act (7 U.S.C. (Sanitation SOPs) and prerequisite composed of fishmeal, mixed with rice 1622, 1624) and regulations programs. The programs must ensure bran. (In the United States, only a very implementing that act (50 CFR 260). the safety of processing water, ensure low percentage of catfish feed—zero to employee hygiene, prevent 3 percent—is fishmeal.) In some 6 U.S. Department of Health and Human Services. contamination of food-contact surfaces, instances, pelleted feed can be a source Food and Drug Administration. July 2007. and prevent cross-contamination of contamination with unapproved Congressional Testimony: Safety of Chinese generally in the establishment. The antimicrobials or chemical residues. Imports. Washington, DC; U.S. Department of establishment is expected to document Health and Human Services. Food and Drug Some reports suggest that Administration. November 2008. Enhanced how it will control nonconforming antimicrobials prohibited for extra-label Aquaculture and Seafood Inspection—Report to products, handle recalls, and withdraw use in food-producing animals in the Congress. Washington, DC. defective products from the market. All

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HACCP-related records must be cadmium, and lead; the action level for percent of the domestic samples and available to NMFS inspectors. mercury is 1,00 ppb.8 none of the import samples. In a 2001 study of 257 domestic VII. Public Health Protection: Chemical Unapproved Antimicrobials catfish (i.e., Ictaluridae) samples and Microbiological Contaminants conducted by Santerre et al., lead If antimicrobials that are not approved FDA and the Centers for Disease residues were detected in 11 percent, by the FDA, such as malachite green Control and Prevention (CDC) consider arsenic residues in 5 percent, and and fluoroquinolones, are used in commercially raised catfish to be a low- mercury residues in 83 percent.9 catfish production, they can result in risk food. Even so, because catfish of Average metal residues detected in the the presence of chemical residues in domestic or foreign origin may be study were lower than recommended edible tissue. Some research suggests exposed to chemical and safety limits, although it should be that antimicrobial residues in food may microbiological contaminants, it is noted that the Environmental Protection hasten the development of incumbent on FSIS to consider the food Agency has not established a reference antimicrobial-resistant infections in safety hazards that might be presented dose (maximum acceptable oral dose) humans.16 Exposure to high levels of by catfish in planning the Agency’s for lead. malachite green and similar regulatory approach. antimicrobials has been shown to be Pesticides carcinogenic and mutagenic in rats. In Chemical Residues in Catfish In 2008, the USDA Agricultural 2006, the FDA found 15 imported Most of the chemical residues Marketing Service 10 tested 552 catfish catfish samples positive for malachite identified in some domestic and foreign samples collected under a sampling green and 2 for fluoroquinolones. In catfish fall into three main classes— plan representing catfish consumption 2007, 868,000 lines of seafood fish and heavy metals, pesticides, and in the U.S. (including 435 samples of fishery products were submitted for antimicrobials. domestic and 108 samples of foreign import to the U.S.; FDA obtained catfish, as well as 9 samples of catfish samples from approximately 10,400 of Heavy Metals of unknown origin) for pesticide those lines; and FDA tested 686 of those At sufficient levels, these heavy residues.11 Of note, chlorpyrifos 12 samples for antimicrobial residues. metals are associated with ischemic residues were detected in less than 1 Meanwhile, about one percent of the heart disease, developmental percent of the domestic samples and in 10.5 billion pounds of imported fish and abnormalities, decreased intelligent 32 percent of the import samples. DDE fisheries products in 2007 were quotient (IQ) values, and other harmful (p,p’- Siluriformes. In their 2008 report effects in humans.7 Dichlorodiphenyldichloroethylene), a ‘‘Enhanced Aquaculture and Seafood FSIS tested 737 samples collected metabolite of Inspection—Report to Congress,’’ under a sampling plan representing dichlorodiphenyltrichloroethane available at: http://www.fda.gov/Food/ catfish consumption in the United (DDT) 13 was detected in 97 percent of FoodSafety/Product- States during the course of one year, the domestic samples and 34 percent of SpecificInformation/Seafood/ April 2008 through March 2009. imported samples at levels below SeafoodRegulatoryProgram/ Samples of seafood labeled as ‘‘catfish’’ regulatory concern; endosulfan 14 and ucm150954.htm. FDA reported that in were taken from the retail market its metabolites were detected in less 2007 it found 12 imported catfish system in the United States and were than 1 percent of the domestic samples samples positive for malachite green tested for the presence of arsenic, and in 27 percent of the import samples; and 6 for fluoroquinolones. Since June cadmium, lead, and mercury. Seventeen and Toxaphene 15 was detected in 1 2008, FDA rejected 31 shipments of samples from among domestic and catfish imports for presence of unsafe imported products had detectable heavy 8 U.S. Department of Agriculture. Food Safety and animal drug residues. metal residues. Six domestic samples Inspection Service. 2010. Analysis of Heavy Metals In conjunction with the April 2008— and Veterinary Drugs found in 737 Catfish Samples March 2009 heavy metals survey, FSIS contained lead and cadmium. Four from Retail Markets in the United States. samples contained lead at a mean Washington, DC. tested 733 catfish samples for the concentration of 43.48 parts per billion 9 Santerre, C.R., P.B. Bush, D.H. Xu, G.W. Lewis, presence of chloramphenicol, gentian (ppb), with a range of 29.49 ppb to 76.92 J.T. Davis, R.M. Grodner, R. Ingram, C.I. Wei, J.M. ppb, while 2 samples contained Hinshaw. 2001. Metal Residues in Farm-Raised cotton and soybean growing areas of the United Channel Catfish, Rainbow Trout, and Red Swamp cadmium at a mean concentration of States, it was banned for use in 1986. Toxaphene Crayfish from the Southern U.S. Journal of Food is a carcinogen. 11.6 ppb, with a range of 10.9 ppb to Science. 66:270–273. 16 Heuer, O.E. Kruse, H., Grave K., Karunasagar, 13.11 ppb. Twelve imported samples 10 U.S. Department of Agriculture. Agriculture I., & Angulo, F.J. (2009). Human Health contained lead and arsenic. Ten samples Marketing Service. December 2009. Pesticide Data Consequences of Use of Antimicrobial Agents in contained lead at a mean concentration Program Annual Report 2008. Washington, DC. Aquaculture. Clinical Infectious Diseases. 49:1248– 11 U.S. Department of Agriculture. Agriculture of 46.08 ppb, with a range of 27.96 ppb 1253. Marketing Service. December 2009. Pesticide Data Muller, L., Kasper, P. Kersten, B. & Zhang, J. to 103.24 ppb, while 2 samples Program annual Report 2008. Washington, DC. (1998). Photochemical genotoxicity and contained arsenic at a mean 12 An organophosphate insecticide linked to photochemical carcinogenesis. Two Sides of a concentration of 1.34, with a range of neurological and birth defects. Coin? Toxicology Letters. 102–103: 383–387. 1.03 ppm to 1.64 ppm. We are unaware 13 A synthetic organochlorine pesticide often Culp, S.J., Mellick, P.W., Trotter, R.W., Greenlees, used for mosquito control, DDT is a suspected K.J., Kodell, R.L., Beland, F.A. (2006). of regulatory action levels for arsenic, carcinogen. Use of DDT was banned in the U.S. in Carcinogenicity of Malachite Green Chloride and 1972. Today it is banned in most developed Leucomalachite Green in B6C3F1 Mice and F344 7 U.S. Centers for Disease Control and Prevention. countries. Because of its long half-life (ca. 25 years), Rats. Food and Chemical Toxicology. 44:1204– Agency for Toxic Substances and Disease Registry. DDT is classified as a persistent organic pollutant. 1212. (1999). Toxicological Profile for Mercury. This perhaps explains its presence in domestic and There are three approved classes of U.S. Centers for Disease Control and Prevention. imported catfish samples. antimicrobials for use in catfish: florfenicol, Romet Agency for Toxic Substances and Disease Registry. 14 An organochlorine insecticide with acute 30 and TC, and several terramycin formulations. (2007a). Toxicological Profile for Arsenic. toxicity and high bioaccumulation potential, See http://www.fda.gov/downloads U.S. Centers for Disease Control and Prevention. endosulfan is an endocrine disruptor. AnimalVeterinary/ResourcesforYou/Animal Agency for Toxic Substances and Disease Registry. 15 Toxaphene is a mixture of approximately 200 HealthLiteracy/UCM109808.pdf (Accessed Feb. 15, (2007b). Toxicological Profile for Lead. organic compounds. Used as an insecticide in 2011).

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violet, malachite green, and nitrofurans. resultant illness. The microorganisms products (Fernandes et al. 1998). Chou (The number of samples tested for some identified included Salmonella, Listeria et al. (2006) found that L. chemicals differs slightly due to monocytogenes, and Enterotoxigenic E. monocytogenes was most commonly insufficient amount of material in some coli. isolated from catfish in the winter with samples to do all of the tests.) A total a prevalence rate of 51 percent, Salmonella of 10 samples were confirmed positive compared to 41 percent in the spring, for nitrofurans (AOZ and AMOZ), In a study by McCaskey and 36.7 percent in the fall, and 19 percent gentian violet, and malachite green. Five colleagues 18 reviewed by FSIS, in the summer. This finding may be domestic samples had confirmed Salmonella were found on 2 percent of attributable to the ability of L. positive results, 4 for gentian violet and 220 domestic catfish fillets. Among 136 monocytogenes to out-compete other 1 for malachite green. Five imported imported catfish violations listed by bacterial species at lower temperatures. samples had confirmed positive results, FDA for 1998–2004, 42 percent were for each for AOZ and AMOZ, 2 for gentian Salmonella.19 It is difficult to compare Escherichia coli prevalence values described here violet, and 1 for malachite green. A 2003 outbreak linked catfish or because the domestic fillets were Detects were at levels below regulatory coleslaw consumption to 41 cases of sampled randomly, whereas the concern. Enterotoxigenic E. coli (ETEC) The foregoing shows that, while imported fillets were likely not sampled O169:H41-related illness (Beatty, catfish may not frequently harbor randomly.20 2004).22 However, FSIS is aware of no residues of illegal drugs or other Listeria data to describe the occurrence of ETEC chemicals, the potential exists for such on catfish. contamination. Because some shipments Though no catfish-borne listeriosis of imported catfish have been found outbreaks have been identified, Chou et Illness Outbreaks From Catfish with residues of drugs that FDA has al. (2006) identified L. monocytogenes banned and that are unsafe, FSIS in 25–47% of raw catfish fillets at three Cases of human illness have been proposes to conduct regular verification U.S. processing plants.21 Some isolates linked to catfish consumption. Since to ensure the safety of catfish and were persistently found in processed 1990, the Centers for Disease Control catfish products. fillets, suggesting either that the and Prevention (CDC) have identified sanitation was inadequate, or that these seven illness outbreaks where such Microbial Pathogens in Catfish isolates originated from the natural catfish were consumed. In only one of The hazard identification component habitats of the catfish. McCaskey et al. these outbreaks was catfish specifically of the FSIS catfish risk assessment 17 (1998) found a prevalence of 5.9% for L. identified as possible vehicles of identified certain microorganisms as monocytogenes on catfish fillets. infection. These outbreaks, which are higher-priority. The prioritization was Significant risk may exist if cross- described below, have included 66 based on association with catfish-related contamination occurs between raw illnesses and 8 hospitalizations outbreaks and on the severity of products and ready-to-eat (RTE) (Table 2).

TABLE 2—CDC DATA ON OUTBREAKS OF FOODBORNE ILLNESS IN WHICH CATFISH WAS A CONFIRMED OR SUSPECTED VEHICLE, 1991–2007, UNITED STATES.23

Year State Setting Etiology Illnesses Hospitalizations Deaths

1991 ...... NJ ...... Restaurant ...... Salmonella ...... 10 6 0 1999 ...... FL ...... Private Home ...... Unknown ...... 2 0 0 1999 ...... FL ...... Restaurant/Deli ...... Unknown ...... 5 0 0 2000 ...... OH ...... Restaurant/Deli ...... Chemical ...... 2 0 0 2003 ...... TN ...... Workplace ...... E. coli O169 ...... 41 2 0 2003 ...... CO ...... Restaurant/Deli ...... Unknown ...... 4 0 0 2007 ...... FL ...... Private Home ...... Unknown ...... 2 0 0

In 1991, an illness outbreak occurred patients. Nine stool specimens tested catfish consumption. Statistical in New Jersey that affected ten case- positive for Salmonella Hadar. Catfish evidence suggested catfish might be the patients. Nine stool specimens tested was identified as a possible vehicle for vehicle, although the restaurant where positive for Salmonella Hadar. Catfish illnesses. case-patients dined had poor sanitation was identified as a possible vehicle for In 1999, two illness outbreaks and inadequate refrigeration. The illnesses. occurred in Florida with undetermined second affected two case-patients who In 1991, an illness outbreak occurred etiology or causal agent. The first experienced illnesses after preparing in New Jersey that affected ten case- affected five case-patients, all reporting and consuming catfish and yellow rice

17 U.S. Department of Agriculture. Food Safety 19 U.S. Department of Agriculture. Economic 22 Beatty, M.E., Bopp, C.A., Wells, J.G., Greene, and Inspection Service. Office of Public Health Research Service. 2009. Economic Research Service K.D., Puhr, N.D., & Mintz, E.D. (2004). Enterotoxin- Science. December 2010. Draft Risk Assessment of Staff Analysis of FDA Import Refusals for Catfish, producing Escherichia coli O169:H41, United the Potential Human Health Effect of Applying 1998–2004. Washington, DC. States. Emerging Infectious Diseases. Retrieved from 20 Continuous Inspection to Catfish. Washington, DC. Because of this, the FSIS catfish draft risk http://www.cdc.gov/ncidod/EID/vol10no3/03- assessment assumed that the prevalence of 18 0268.htm Oct. 16, 2009. McCaskey T, TC Hannah, T Lovell, et al. 1998. Salmonella on imported catfish was the same as Safe and Delicious study shows catfish is low risk that on domestic fish, i.e. 2%. 23 Data from the Centers for Disease Control and for foodborne illness. Highlights of Agricultural 21 Chou, C.H., Silva, J.L., & Wang, C. (2006). Prevention’s (CDC) electronic Foodborne Disease Research. Vol. 45, No. 4. Available at http:// Prevalence and Typing of Listeria monocytogenes in Outbreak Reporting System (eFORS). Provided to www.ag.auburn.edu/aaes/communications/ Raw Catfish Fillets. Journal of Food Protection, 69, FSIS by CDC, Sept. 15, 2008. highlights/winter98/catfish.html. 815–819.

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at home. Both foods were identified as catfish consumption.24 Salmonella is a residues. The FMIA also gives FSIS the implicated items. useful model because its presence authority to take action with respect to In 2000, an Ohio illness outbreak was provides an indication of the sanitary meat products in commerce that may be reported that affected two case-patients conditions under which food is adulterated or misbranded. FSIS intends experiencing signs and symptoms produced, and because an approach that to apply to catfish and catfish products suggestive of chemical contamination. produces a reduction in Salmonella provisions of the FMIA that now apply Samples of raw and fried, farm-raised through improved process control is to meat and meat food products, except catfish were tested, and results effective in controlling for the presence for the provisions that the 2008 Farm indicated contamination with an of other microbial pathogens.25 Bill excludes from applicability to unidentified chemical. With regard to the risk assessment for catfish. catfish, FSIS continues to evaluate the In 2003, two reported illness B. Catfish and Catfish Product hazards, particularly Salmonella, outbreaks identified catfish as an Inspection Regulations Under the FMIA associated with this fish. FSIS invites all implicated food item. One outbreak interested stakeholders to submit FSIS is proposing to establish occurred in Tennessee and included 41 additional data and scientific evidence regulatory requirements for the illnesses and 12 confirmed cases of E. specific to catfish food safety. FSIS will continuous inspection of catfish and coli O169:H41. An epidemiologic study consider this information and other data catfish products. FSIS is adapting for was conducted and identified multiple in the development of a final risk use in the regulation and inspection of food items, including catfish. A food assessment in this proceeding. catfish and catfish products those meat worker was suspected as the source of Further, USDA is seeking public inspection regulations that are contamination. The second outbreak comments on the evidence regarding the appropriate in preventing the occurred in Colorado, and investigators public health benefits and cost- transportation, sale, offer for sale or reported that four out of five people effectiveness to be achieved with the transportation, or receipt for became ill after eating catfish at a proposed program. transportation, in commerce, of restaurant. The fifth, well person did adulterated or misbranded products (21 not report eating catfish. VIII. Proposed Regulations U.S.C. 602, 610, 621). Because there are The most recent reported illness Implementing Continuous Inspection of differences between fish and outbreak occurred in Florida in 2007. Catfish and Catfish Products mammalian livestock species, some of Two case-patients were identified after As stated above, this proposal the regulations for catfish will be consuming in a private home catfish implements provisions of the FMIA separate within the Code of Federal prepared at a grocery store. Improper added by the 2008 Farm Bill respecting Regulations from those for the cold storage and reheating practices at the amenable species ‘‘catfish, as inspection of meat and meat food the food service facility (grocery store) defined by the Secretary’’ (21 U.S.C. products. Other regulations apply as were noted. 601(w)(2)). It is intended to prevent and written to catfish and will simply be Table 2 shows that there has been one eliminate any burdens on commerce cross-referenced. catfish-associated outbreak from imposed by adulterated or misbranded Organization of Catfish Inspection Salmonella in the past twenty years. catfish or catfish products and to protect Because only a small proportion of all the health and welfare of consumers In general, the catfish regulations foodborne illnesses reported are from such adulterated or misbranded parallel the sequence of operations from identified as associated with outbreaks catfish or catfish products (21 U.S.C. the harvesting and delivery of the fish (http://www.cdc.gov/mmwr/preview/ 602). to the processing plant, through the in- mmwrhtml/mm5931a1.htm), it is plant operations, to transportation in A. Coverage of the FMIA: Provisions commerce, specifying export and import possible that there may be a low level Applicable to Catfish and Catfish of sporadic cases of salmonellosis requirements where appropriate. Products After outlining the district-level associated with catfish that are not supervision of catfish inspection in detected with current levels of The FMIA (21 U.S.C. 601–695) proposed 9 CFR 530.2, FSIS makes clear surveillance. FSIS notes, however, that requires FSIS to carry out a continuous in proposed § 530.3 that, as provided in this case occurred before FDA’s inspection program for the species that 9 CFR 300.6, persons that are subject to implementation of regulations (21 CFR are subject to this statute, which now the FMIA, and specifically the catfish part 123) that require processors of fish includes catfish. FSIS inspects food inspection provisions, are to grant and fishery products to develop and products derived from those species, authorized Agency or Department implement HACCP systems for their verifies that the products are prepared personnel access to establishments that operations. Since implementation, no for commerce under sanitary conditions, process catfish and to other cases of salmonellosis linked to catfish and inspects products that are exported establishments in industries related to have been reported. from or imported into the United States. The inspection may include testing for the catfish processing industry (21 The FSIS Catfish Draft Risk Assessment pathogens or for drug or other chemical U.S.C. 606, 642(a)). FSIS conducted an illustrative Definitions 24 U.S. Department of Agriculture. Food Safety assessment of the potential risk to and Inspection Service. Office of Public Health FSIS is proposing largely to use the human health of catfish consumption, Science. December 2010. Draft Risk Assessment of same definitions for the catfish using the example of Salmonella the Potential Human Health Effect of Applying inspection regulations (proposed 9 CFR contamination. We are particularly Continuous Inspection to Catfish. Washington, DC. 25 Food Safety and Inspection Service. 2006. 531.1) as for the meat inspection interested in Salmonella because the Review of the Pathogen Reduction; Hazard Analysis regulations (9 CFR 301.2), which are general burden of illness from this and Critical Control Point (HACCP) Systems Final incorporated into proposed 9 CFR 531.1 pathogen in the United States remains a Rule pursuant to Section 610 of the Regulatory by reference. However, recognizing the concern and there is evidence that at Flexibility Act, as Amended. Available at: http:// www.fsis.usda.gov/OPPDE/rdad/FRPubs/2007- differences between the commercial least one outbreak of human 0022P/610_Report_PR_HACCP.pdf (Accessed Oct. production and processing of catfish salmonellosis may have been related to 14, 2009). products, as opposed to other products

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that are subject to the FMIA, the Agency Inasmuch as the ante-mortem establishments that process catfish or is proposing to add definitions for inspection, post-mortem inspection, and catfish products for transportation or ‘‘catfish,’’ ‘‘catfish product,’’ ‘‘catfish food humane slaughter provisions of the sale in commerce for use as human food product,’’ ‘‘farm-raised,’’ and some other amended FMIA do not apply to catfish, will need to be under FSIS inspection. terms. The Agency also is adapting there is little need for a definition or Also, the records not only of official certain terms used in the meat other requirements addressing catfish establishments but those of inspection regulations, such as slaughtering methods. However, the related businesses, including retail ‘‘applicant’’ and ‘‘consumer package,’’ to FMIA defines as adulterated a food establishments that are exempt from apply in the context of catfish product that is, in whole or in part, the continuous inspection, will be subject to production and processing. product of an animal that has died periodic inspection. FSIS is proposing that the term otherwise than by slaughter (21 U.S.C. FSIS is proposing requirements for ‘‘catfish’’—aside from what animal 601(m)(5)). In the view of FSIS, catfish catfish processing establishments to species the term is to denote—mean the that died under circumstances other qualify for a grant of inspection that are skeletal muscle tissue of catfish, the than the controlled circumstances of similar to those that apply to meat edible portion of the fish that is commercial fish harvesting and processing establishments. These prepared for the consumer. processing would be adulterated under requirements cover facilities, potable FSIS is proposing to define ‘‘catfish this provision of the FMIA and water and water sanitation performance food product’’ to parallel the definition unacceptable for food. (For example, a standards, Sanitation SOPs, and of ‘‘meat food product,’’ and ‘‘catfish fish that fell onto the pavement in the validated HACCP plans. FSIS intends to product’’ to mean any catfish or catfish delivery area of a processing plant and assign inspection personnel to catfish part, as well as any product made lay there until it died would not be processing establishments. wholly or in part from any catfish or acceptable for human food.) Also, it may Proposed 9 CFR 532.2 sets out the catfish part, except for products be necessary for the Agency to apply the application procedures, cross- exempted from definition as a catfish detention, seizure, and condemnation referencing the application procedures product in the regulations. In the provisions of the Act (21 U.S.C. 672, for, and grant and approval of, meat context of the proposed regulations, the 673) in cases where the Agency finds inspection in 9 CFR part 304 because term ‘‘catfish product’’ generally denotes dead, dying, or diseased catfish. It the procedures for catfish an edible product. would then be necessary to distinguish establishments will be similar to those The Agency is proposing to define catfish slaughtered for the purpose of for meat establishments. ‘‘farm-raised,’’ as ‘‘grown under being processed into human food from Establishments will have to complete controlled conditions, within an catfish that died from a disease, from an Application for Federal Inspection enclosed space, as on a farm.’’ As accidental asphyxiation, from poisoning (currently, FSIS Form 5200–2, available indicated in earlier discussion, FSIS by environmental contaminants, or by from the appropriate District Office). In understands ‘‘farm-raised catfish’’ to be any other cause that would render the addition to completing the application, those that are typically raised in catfish unacceptable for human food. establishments will need to attach a confinement from incubated eggs to Moreover, the Agency has become description of the limits of the premises harvest and fed commercial feed aware of methods used in transporting of the establishment that are to be under throughout the stages of production catfish to, or in holding catfish at, Federal inspection (Item No. 106 on the until harvested. Production schemes processing establishments that involve current application form). This include culturing catfish in ponds and holding the fish at so low a temperature description could be written, or it could high-density culture systems that utilize that the catfish are intentionally killed be a drawing. tanks, raceways, and cages. The Agency before being delivered for processing for Under this proposal, a catfish recognizes that variations of these human food. To the extent that the establishment intending to conduct arrangements may be in use in the methods are applied under controlled operations under an FSIS Grant of United States and in foreign countries. conditions in a manner that does not Inspection will be subject, consistent FSIS also recognizes that there are create a human food-safety hazard, FSIS with 9 CFR 304.3, to the sanitation situations in which wild-caught catfish would likely view these methods as performance standard requirements are processed for commercial constituting slaughter. (distinct from Sanitation SOPs) in 9 CFR distribution and requests comment on The question therefore arises whether part 416. After the establishment files its how the Agency should address these the Agency should propose a definition application with the appropriate District situations. of ‘‘slaughter’’ that would encompass Office, FSIS will reserve an official FSIS expects that, in general, catfish various methods of killing catfish for plant number, in accordance with 9 CFR that will be subject to the proposed food and that would ensure that catfish 305.1, that will identify all inspected regulations will be grown as food for that died otherwise than by slaughter and passed products prepared in an human consumption in a controlled would not be used for food. FSIS’s establishment and that must be printed environment by a commercial operator. tentative view is that it should. Thus, it on the label of any packaged product. Many of the remaining proposed has proposed to define ‘‘slaughter,’’ with All packaged catfish products also will definitions are adaptations from the respect to catfish, as intentional killing have to bear the U.S. Inspection legend. definitions in the meat inspection under controlled conditions. FSIS All labeling material will have to be regulations. For example, a ‘‘product’’ is requests comment on this proposed Federally approved and on-hand before any carcass, catfish, catfish product, or definition, and on whether there is a inspection could be granted per 9 CFR catfish food product that is capable of need for it. 317.4. use as human food; an ‘‘official mark,’’ Under the proposed regulations is a symbol to identify the status of any Establishments Requiring Inspection; (requirements for sanitary operation article, catfish, or catfish product under Grant and Approval of Inspection under 21 U.S.C. 608 and 621), the the FMIA; and such terms as ‘‘U.S. In proposed 9 CFR part 532, FSIS establishment will have to have Condemned,’’ ‘‘U.S. Detained,’’ and ‘‘U.S. identifies the classes of establishments documentation supporting the potability Retained,’’ are redefined to apply in that handle catfish that require of the water it uses for catfish (per 9 situations involving catfish products. inspection. Under this proposal, CFR and 416.2(g)).

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FSIS also cross-references 9 CFR 305, the catfish food products industry per 9 materials for the proper disposal of on the assignment of establishment CFR 301.2. The catfish ingredients of condemned articles, and docks and numbers and the inauguration of the exempt products will have to be receiving rooms for receipt and inspection, and 9 CFR 306, on the FSIS-inspected or inspected under an inspection of catfish and catfish assignment and authorities of FSIS equivalent foreign system (under 21 products (proposed 9 CFR 533.4). personnel, because they are essentially U.S.C. 601(j)). Also, the labels of these FSIS approves operating schedules for the same for meat and catfish inspection exempt products cannot represent the official meat establishments and is (proposed 9 CFR 532.2(c) and (d)). products as catfish products. Products proposing to require such approval for Before the inauguration of inspection, exempt from the definition of ‘‘catfish catfish processing establishments FSIS inspection personnel will examine product’’ will be subject to regulation (proposed 9 CFR 533.5, referencing 9 the establishment and premises. If this under the FD&C Act. CFR 307.4). This is necessary to ensure examination shows that the facilities are that the Agency can maintain an Facility Requirements for Catfish satisfactory, FSIS will assign inspection inspector presence during establishment Inspection personnel. No establishment operations operations. The proposed regulations may be conducted except under the In proposed part 533, FSIS sets out thus define a shift and the basic supervision of an inspection program facility requirements for catfish workweek for Program employees and employee. FSIS provides inspection processing establishments (under 21 require each official establishment to service to official establishments U.S.C. 608, 621). To ensure that sanitary submit a work schedule to the District without charge, up to eight (8) operating conditions are maintained, Manager 26 for approval. Under the consecutive hours per shift on official catfish processing proposed regulations, each official consecutive days during the basic establishments will have to be separate establishment will be required to workweek. The regulations further and distinct from any unofficial maintain a consistent work schedule provide that each official establishment establishment and separate from any and, except for minor deviations, will is to submit a work schedule to the other official establishment, except an not be allowed to change it without District Manager for approval (proposed establishment preparing products under submitting the proposed change to the 9 CFR 533.5; 9 CFR 307.4(d)(1)). the FMIA, the Poultry Products District Manager at least two weeks in Any work conducted over the 8-hour Inspection Act (PPIA), or the Egg advance. The Agency also is proposing shift, or any time past the initial 5- Products Inspection Act (EPIA) to require that official establishments consecutive-day period, will be charged (proposed 9 CFR 533.1). Common areas request inspection service outside the to the plant at the prevailing hourly for inspected and uninspected products regular workday as far as possible in overtime rate. If the operator of the may be used if the inspected product is advance of receiving the service. establishment requests inspection acceptably maintained and protected to FSIS offers overtime and holiday during odd hours, a minimum of 2 prevent product adulteration. inspection service for a fee. The FSIS hours will be charged to the plant at the FSIS is proposing to require that regulations list the Federal holidays (9 above rate. This rate also is charged if official catfish establishments provide CFR 307.5, referred to by proposed 9 the plant works on any Federal holiday. office space and furnishings for the CFR 533.6) and the terms of overtime Although there is no exemption from exclusive use of the inspector and other and holiday inspection (9 CFR 307.6, Program employees assigned to the inspection in the amended FMIA for referred to by proposed 9 CFR 533.7, establishment (proposed 9 CFR 533.3). custom catfish slaughter and processing and 9 CFR 391.3). facilities, FSIS is providing an This is essentially the same requirement exemption for retail stores and as that applying to establishments that Pre-Harvest and Transport to Processing restaurants in proposed 9 CFR 532.3 prepare other products under the FMIA. Establishment (under 21 U.S.C. 661(c)) and paralleling The space set aside for this purpose will In proposed 9 CFR part 534 (under 21 9 CFR 303.1(d) and (e)). FSIS is have to meet with the approval of U.S.C. 606(b)), FSIS outlines the pre- tentatively using the poultry exemption Agency supervisors. As the Agency does harvest standards to be applied to regulations set out in 9 CFR 381.10 as in the meat inspection program, FSIS catfish to ensure that the environmental a model in proposing a limit of 75 will exercise its discretion to determine conditions and source waters in which pounds for individual household whether small establishments requiring the fish are grown will not render the (single-sale) purchases of catfish to be the services of less than one full-time fish unfit for food. The Agency is deemed retail purchases; the quantity inspector will not have to furnish proposing to require that catfish for non-household consumers would be Government office space if adequate harvested for human food must not have 150 pounds. FSIS solicits comments on facilities exist in a nearby location. Each lived under conditions that would what the limits on retail sales to establishment, however, will have to render them unsound, unwholesome, household or non-household consumers provide laundry service for inspectors’ unhealthful, or otherwise unfit for ought to be. outer work clothing. human food (proposed 9 CFR 534.1)— Other facilities to be provided by an In proposed 9 CFR 532.4, the Agency that is, whether the fish would be official establishment include sufficient asserts Federal pre-emption of State or ‘‘adulterated’’ as the term is defined in lighting for the proper conduct of local authority with respect to premises, 21 U.S.C. 601(m)(3) in the FMIA. The inspection, facilities for performing facilities, and operations at an official Agency advises catfish producers to inspection, receptacles for diseased establishment, and with respect to monitor the water in which the fish are carcasses and parts, and materials for labeling, packaging, and ingredient raised for suspended solids, organic cleansing and disinfecting hands, for requirements (pursuant to 21 U.S.C. matter, nutrients, heavy metals, sterilizing instruments used in handling 678). antimicrobials, pesticides, fertilizers, diseased carcasses, and for cleaning and Finally, in proposed 9 CFR 532.5, and industrial chemicals that may sanitizing floors and other articles or FSIS exempts from inspection articles contaminate the fish. FSIS may take that do not contain a minimum amount places contaminated by diseased of catfish (3 percent raw or 2 percent carcasses (proposed 9 CFR 533.4). 26 The District Manager, in the current Agency cooked catfish) or historically are not Establishments will have to provide organization, has absorbed functions of the former regarded by consumers as products of adequate facilities, including denaturing Area Supervisor, mentioned in 9 CFR 307.4.

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samples of fish and water (proposed 9 receiving a grant of inspection. FSIS (21 CFR 123.6–123.10). The FSIS CFR 534.2) to assess whether the fish verifies the adequacy and effectiveness regulations include requirements that are being raised under conditions that of the Sanitation SOPs as part of its implement the principles of HACCP— will produce safe and wholesome inspection (9 CFR 416.17). hazard analysis, supporting product. Under the proposed rule, catfish documentation, decision-making The Agency reminds producers in establishments will be required to documents, critical control points, proposed 9 CFR 534.3 that only certain detail, in writing, the procedures that critical limits, monitoring, corrective new animal drugs are legally available they will carry out to prevent direct actions, verification, and recordkeeping for use in raising catfish for human contamination or adulteration of (9 CFR 417.1 to 417.5)—and require a food. Approved drugs and tolerances are product before and during operations (9 HACCP-trained individual to perform listed in the FDA regulations (21 CFR CFR 416.12(a)). Each catfish certain key functions (9 CFR 417.7). The parts 516, subpart E; 520; 524; 526; 529; establishment will be responsible for FSIS regulations also define an 556; and 558). evaluating the effectiveness of its inadequate HACCP system (9 CFR FSIS is proposing general standards Sanitation SOPs and for revising them 417.6); they require a review, preferably for the transportation of catfish to the as necessary to keep them effective and by a HACCP-trained individual, of processing plant (proposed 9 CFR 534.4, current with respect to changes in records associated with the production under 21 U.S.C. 606(b)). A vehicle used facilities, equipment, utensils, of a product before the product is to transport catfish to a processing operations, or personnel (9 CFR 416.14). shipped (‘‘pre-shipment review’’) (9 CFR establishment will need to contain Under the proposed regulations, 417.5(c)); and, of course, they provide sufficient water and oxygen to ensure catfish establishments will have to for Agency verification of HACCP plan that the catfish that arrive at the conduct the pre-operation procedures in adequacy (9 CFR 417.8). establishment are not adulterated per 9 the Sanitation SOPs before the start of The Agency’s verification includes a CFR 301.2(5) in that they have perished operations, conduct all other procedures review of the HACCP plan to determine by means other than slaughter. Any in the Sanitation SOPs at the that it meets regulatory requirements; a catfish that are dead or dying (otherwise frequencies specified, and monitor the review of Critical Control Point CCP than by slaughter), diseased, or daily implementation of the procedures records; a review and determination of contaminated with substances that in the Sanitation SOPs (9 CFR 416.13). the adequacy of corrective actions taken would adulterate catfish food products Establishments will be responsible for when there is a deviation from a critical are subject to condemnation at the taking and required to take appropriate limit; a review of the critical limits; establishment. (See also proposed 9 CFR corrective action when the Sanitation review of other records pertaining to the 555.11 and .12.) SOPs have failed to prevent direct HACCP plan or system; direct contamination or adulteration of Sanitation and HACCP Requirements observation or measurement at a CCP; product as detailed in 9 CFR 416.15(a). for Processing Facilities sample collection and analysis to Corrective actions include procedures to determine whether the product meets FSIS is proposing (under 21 U.S.C. ensure the appropriate disposition of all regulatory requirements respecting 608, 621) that catfish processing product that may be contaminated, to biological, chemical, or physical establishments will have to meet certain restore sanitary conditions, and to hazards; and on-site observations and basic requirements that parallel those prevent the recurrence of direct records review (9 CFR 417.8). The that meat establishments must meet and contamination or adulteration of frequency of FSIS verification activities those that seafood processing product. Corrective actions may also will vary, depending on a number of establishments are already required to need to include reevaluating and factors, such as the establishment’s past meet under FDA regulations. FSIS is modifying the Sanitation SOPs or performance, risk inherent in the proposing (proposed 9 CFR 537.1) to improving their execution (9 CFR processes or products, quantity of require that any official establishment 416.15(b)). product, and likely uses. that prepares or processes catfish or If this proposed rule is adopted, each FSIS is proposing, under 21 U.S.C. catfish products for human food comply catfish establishment will be required to 606(b), to require that a catfish with the sanitation requirements in 9 maintain a daily record of the actions it establishment’s hazard analysis take CFR 416. These requirements include takes that are prescribed in the into account the hazards that can occur the sanitation performance standards Sanitation SOPs and to make such before, during, and after the harvest of and the requirement that every official records available to Program employees catfish (proposed 9 CFR 537.2). meat (or poultry) establishment have for inspection and verification (9 CFR Moreover, FSIS provides that catfish written Sanitation SOPs. 416.16(a) and (c)). The establishment products not produced under a hazard The sanitation performance standards will be required, at a minimum, to analysis and HACCP plan that fully (9 CFR 416.1–416.6) resemble in some record deviations from the Sanitation complies with the regulations will be ways FDA’s current good manufacturing SOPs, along with corrective actions adulterated under the FMIA because practice regulations for buildings and taken—including procedures to prevent they will have been prepared and facilities (21 CFR part 110, subpart B) the direct contamination or adulteration packed under insanitary conditions that but provide for continuous FSIS of products—in conjunction with the may render them injurious to health (9 inspection. The sanitation performance monitoring of daily sanitation activities. CFR 537.2(b)). standards set forth requirements in The establishments will also be terms of an objective to be achieved but responsible for complying and will have Mandatory Dispositions; Performance do not prescribe the means to achieve to comply with the HACCP Standards Respecting Physical, the objective. To meet the performance requirements (proposed 9 CFR Chemical, or Biological Contaminants standards, establishments must develop 537.1(a)(1) cross-referencing to 9 CFR In proposed 9 CFR part 539, FSIS lists and employ sanitation or processing part 417; issued under 21 U.S.C. the diseases or other conditions that procedures customized to the nature 601(m)(1), 601(m)(3), 601(m)(4), 602, would lead to condemnation of catfish and volume of their production. 608, and 621). These requirements are carcasses or parts affected upon Compliance with FSIS’s Sanitation similar to the FDA requirements for inspection (under 21 U.S.C. 606). Both SOP requirement is a condition for processors of fish or fishery products zoonotic and non-zoonotic diseases are

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included because FSIS is required to standards will apply to imported as well proposed 9 CFR 541.2(d) or as otherwise ensure that the food products it as domestic catfish and catfish products. determined by the FSIS Administrator. regulates are not adulterated either for With respect to microbiological The marking must ensure that the food safety reasons, or because they are contamination, FSIS plans to implement catfish will be identified as having been unwholesome or otherwise unfit for a pathogen reduction program for inspected and will not become human food. Catfish and catfish catfish that would be similar to that for misbranded while in commerce. products affected by these diseases or other classes of raw product subject to Comments are welcome on whether conditions would be adulterated under the FMIA. After completing a study to marking is necessary, the form of the 21 U.S.C. 601(m)(3) in that they are determine the national baseline mark that would be satisfactory, and unsound, unwholesome, or otherwise prevalence and levels of Salmonella on how the mark should be applied. unfit for human food. raw catfish, FSIS will conduct regular In proposed 9 CFR 541.3, FSIS is testing in processing establishments for providing that the official mark used in The Agency intends to condemn, as the purpose of measuring industry sealing railroad cars, cargo containers, unwholesome or unfit for human food, performance against the baseline. or other transport conveyances, as carcasses or parts of catfish whose prescribed in proposed 9 CFR part 555, tissues are affected by abscesses or Handling and Disposal of Condemned be in the form of the inscription and lesions, and catfish tissues affected by and Inedible Materials serial number shown in 9 CFR 312.5 or non-zoonotic parasites such as cestodes, FSIS is proposing to require that a in another form approved by FSIS. The or by such parasites as digenean processor prevent catfish that have died Agency-approved seal will be an official trematodes, metacercaria (Bolbophorus otherwise than by slaughter from device under the FMIA. The seal will spp.), yellow grubs (Clinostomum spp.), entering the official establishment have to be attached to the means of or white grubs (Hysterbmorpha spp.). (under 21 U.S.C. 601(m)(3), 601(m)(4), conveyance by an Agency employee. FSIS also intends to condemn catfish 608, 621, 644) (proposed 9 CFR FSIS is also proposing (proposed 9 affected by Heterophyid intestinal 540.1(a)). The establishment will have CFR 541.4) that the official export flukes or Dictophymatidae nematodes, to maintain physical separation between inspection mark for catfish (see columnaris (infection by Flexibacter slaughtered catfish and those that have proposed 9 CFR part 552) be that columnaris), or enteric septicemia of died otherwise than by slaughter specified in 9 CFR 312.8(a), and that the catfish (ESC) (proposed 9 CFR 539.1). (proposed 9 CFR 540.1(b)) to prevent export certificate for catfish and catfish The Agency will condemn catfish commingling of edible and inedible products be the same as that prescribed carcasses, parts, or catfish products product. All condemned or otherwise in 9 CFR 312.8(b) for meat and meat found to be in a state of spoilage or inedible catfish parts will have to be food products. decomposition or that are otherwise conveyed from the official premises for FSIS also is proposing (proposed 9 unwholesome. FSIS requests comments further disposition at a rendering plant CFR 541.5) that the official mark for shipments of articles and catfish that are on what extent of columnaris or other or other facility that handles inedible officially detained be the designation infection should result in condemnation products (proposed 9 CFR 540.3). ‘‘U.S. Detained.’’ The device for applying and on whether there are other Marks, Marking, and Labeling of the mark would be the same ‘‘U.S. conditions found in catfish that require Products and Containers Detained’’ tag that FSIS uses for such disposition. Official Marks and Devices detained meat articles. Under proposed 9 CFR 539.2, catfish and catfish products that are FSIS is proposing (under 21 U.S.C. Labeling Requirements; Prior Approval contaminated with physical matter will 601(n)(12), 601(s)–(v), 606, 611) to use of Labeling be subject to retention by Program certain official marks, devices, and FSIS is proposing (proposed 9 CFR employees. Also, any antibiotic or other certificates for the purpose of 541.7) to apply to catfish and catfish drug residues or pesticide residues in identifying inspected and passed catfish products many of the same labeling and catfish tissues will have to be within and catfish products and their status. label approval requirements as those for applicable tolerances in the FDA or FSIS is proposing to provide that an meat and meat food products in 9 CFR Environmental Protection Agency official inspection legend containing the 317, Subpart A, except where those regulations (21 CFR part 556; 40 CFR number of the official establishment be regulations apply specifically, or could part 180).27 The FSIS National Residue shown on all labels of inspected and only apply, to meat or meat food Program determines whether there are passed product (9 CFR 541.2(a)). The products (under 21 U.S.C. 607). The violative concentrations of drug or other form of the official legend will be that requirements that FSIS is proposing to chemical residues in the products the for meat products (9 CFR 312.2(b)(1), apply to catfish address labels and Agency regulates.28 Catfish or catfish reproduced in proposed 9 CFR 541.2), labeling, the abbreviations of official products containing violative residues or another form that the Agency would marks, label approval, generically will not be eligible to bear the mark of prescribe. Comments and suggestions on approved labeling, the use of approved inspection because FSIS could not find what an alternative form might be are labels, the labeling of products for them to be not adulterated under 21 welcome. foreign commerce, prohibited practices, U.S.C. 601(m)(2)(A). The products will FSIS is proposing to require that the reuse of official inspection marks, be subject to condemnation. The residue whole, gutted catfish carcasses that have filling of containers, relabeling of been inspected and passed at an official products, the storage and distribution of establishment, and that are intended for labels, and the requirements for 27 FSIS notes, in addition, that the FDA Compliance Policy Guide, Section 575.100, sale as whole, gutted catfish, be marked packaging materials. Pesticide Chemicals in Food—Enforcement Criteria, or labeled with an official inspection Under this proposal, the basic lists action levels for banned but persistent legend containing the number of the requirements for a label (most, in 9 CFR chlorinated pesticides. Most pesticides detected in establishment at the time of inspection 317.2) will be similar in a number of catfish are listed in this guidance. respects to those that FDA requires for 28 The program is explained at: http:// (proposed 9 CFR 541.2(d)). The form of www.fsis.usda.gov/Science/Chemistry/index.asp the inspection legend will be that in 9 the label of food products under its (Accessed 10/29/2008.) CFR 312.2(a) and as illustrated in jurisdiction. Unlike FDA, however, FSIS

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requires that the label bear the official industry and consumers in ensuring that the product.) To regulate net weight for inspection legend. Also, unlike FDA, product labeling correctly represents the raw catfish products, FSIS is proposing FSIS forbids any final labeling from actual species of fish in the product, to apply to raw catfish the requirements being used on any product unless the FSIS is considering the use of various for control of retained water from sketch of the final labeling has been technological means to verify catfish processing in raw meat and poultry approved by the Agency. species. There is available chemical products through 9 CFR part 441 Another requirement that differs from taxonomic information consisting of (referenced in proposed 9 CFR 541.7(b)), the FDA requirements is the species-characteristic biochemical slightly amended to include raw catfish requirement for safe-handling labeling patterns that may be compared and catfish products. Retained water— (9 CFR 317.2(l)) on products that are not quantitatively to patterns obtained by an water remaining in raw product after it ready-to-eat, that is, products that are appropriate laboratory analysis of the undergoes immersion chilling or a raw or that undergo minimal treatment, fish in question. These patterns include similar process—will not be permitted such as heating, before being consumed. data from isoelectric focusing (IEF), a unless the official establishment is able FSIS is proposing to require that safe- type of electrophoresis, and restriction to show, with data collected under a handling instructions appear on the fragment length polymorphism (RFLP) written protocol, that the retained water label of every not-ready-to-eat catfish studies. RFLP is a technique in which is an unavoidable consequence of the product that is destined for household organisms may be differentiated by process used to meet applicable food- consumers, hotels, restaurants, or analysis of patterns derived from safety requirements (9 CFR 441.10(a)). similar institutions. cleavage of their DNA. If two organisms The establishment will have to label its Generically Approved Labeling differ in the distance between sites of products to state, besides net weight, the cleavage of a particular restriction maximum percentage of water retained Under this proposed rule, processors endonuclease, the length of the in the product from such processing as of catfish and catfish products will be fragments produced will differ when the chilling (e.g., up to X% retained water, able to use generically approved DNA is digested with a restriction less than X% water retained from labeling if the labeling meets the enzyme. The similarity of the patterns chilling). The protocol, to be maintained conditions for such labeling in 9 CFR generated can be used to differentiate in the establishment’s files, will have to 317.5. Generically approved labeling species (and even strains) from one explain how data will be collected and usually involves minor modifications of another. used to demonstrate that the amount of labeling that has been approved by In recent years, interest in another retained water in the product covered FSIS. technique, known as ‘‘DNA bar coding,’’ by the protocol is an unavoidable Prevention of False or Misleading has been growing. It involves the DNA consequence of the process used to meet Labeling Practices sequencing of mitochondrial gene specified food-safety requirements. The cytochrome c oxidase I (COI) in seafood establishment will have to notify FSIS Under the FSIS regulations, no tissue samples to obtain unique, product or any of its wrappers, as soon as it has a new or revised species-specific identifications, or protocol (9 CFR 441.10(c)). Expected packaging, or other containers may bear ‘‘ ’’ barcodes. The method is considered elements of the protocol are given in the any false or misleading marking, label, robust and sensitive to small or other labeling, and no statement, regulations (9 CFR 441.10(d)). phylogenetic differences. FDA has been FSIS also is proposing to apply to word, picture, design, or device that considering it as a replacement for IEF catfish and catfish products the conveys any false impression or gives as that agency’s standard for species requirements in part 442, subchapter E, any false indication of origin or quality identification and FSIS is considering governing quantity of contents labeling, or that is otherwise false or misleading this approach as well. FSIS welcomes the testing of scales, and the handling of may appear in any marking or other comment and suggestions on species product that is found to be out of labeling. No product may be enclosed verification methods that the Agency compliance with net weight wholly or partly in any wrapper, might use. requirements (referenced in proposed 9 packaging, or other container that is CFR 541.7(b)). made, formed, or filled in a manner that Net Weight and Retained Water FSIS is proposing, in particular, that would make it misleading. (9 CFR FSIS labeling regulations on net packages of fresh or fresh-frozen catfish 317.8.) weight of meat products incorporate by carcasses or parts be labeled to reflect To prevent the misuse of labeling, reference Handbook 133 of the National 100-percent net weight (gross weight FSIS enforces regulations controlling Institute of Standards and Technology less the weight of glaze) after thawing. the conditions under which product (NIST). These regulations include The de-glazed net weight must average may be relabeled at a location other than provisions for determining compliance 100 percent of the stated net weight of an official establishment (9 CFR 317.12). with net weight requirements and the frozen product when sampled and The Agency also regulates the prescribe the reasonable variations from weighed according to the method conditions under which labels, the declared net weight on the labels of prescribed in NIST Handbook 133 wrappers, or containers bearing official immediate containers of products (9 Chapter 2, Section 2.6.29 marks may be transported from one CFR 317.18–317.22). To ensure that Interested official establishment to another official there is compliance, the regulations persons may want to consult NIST establishment (9 CFR 317.13). All these prescribe requirements for scales to Handbook 133 for maximum allowable requirements, which apply to meat and determine accurate weights and for the variations. meat food products, will apply to catfish testing of scales (9 CFR 317.20–317.21). Nutrition Labeling Requirements FSIS has learned from FDA and and catfish products under this Under the FMIA (21 U.S.C. 601(n)(1), industry sources that catfish presents a proposed rule. 621), FSIS is proposing to apply the A major challenge to the specific challenge regarding net weight nutrition labeling requirements to identification of processed fish products because of the frequent and varying use is the inability to visually identify the of glazing. (A glaze is a thin coating of 29 U.S. Department of Commerce. NIST Handbook species of fish after processing. Because ice on a catfish or catfish product that 133: Checking the Net Contents of Packaged Goods, of the interest of the catfish products is intended to preserve the freshness of Fourth Edition, January 2005. Washington, DC.

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catfish and catfish products that are not Web site at: http://www.fsis.usda.gov/ Accredited Laboratories raw, single-ingredient products Regulations_&_Policies/7000_Series- _ Under this proposed rule, FSIS will (proposed 9 CFR 541.7(d)). The FSIS Processed Products/index.asp (accessed allow catfish processing establishments requirements for meat and meat food Feb. 15, 2011). to use third-party accredited products (9 CFR 317.300–317.500) are Ready-to-Eat and Canned Catfish laboratories instead of an FSIS similar to FDA’s (21 CFR 101.9 et seq.) laboratory to analyze official regulatory in that a nutrition facts panel has to Products: Control of Listeria Monocytogenes samples for residues (proposed 9 CFR appear on the label. The FSIS nutrition 548.9). This practice has been allowed facts panel includes information on Only a few ready-to-eat (RTE) catfish so as to provide an option for serving size, servings per container, establishments of receiving, at their own amount of calories per serving, and products, such as smoked catfish, are expense, sample results more quickly calories from fat. Also the panel distributed in commerce. Under this than would be the case with the limited includes amount and percent daily proposed rule, these products will have laboratory capacity of FSIS. An value of total fat and saturated fat, to comply with appropriate performance establishment that holds sampled cholesterol, sodium, total carbohydrates, standards, as must all RTE meat and product until the receipt of test results dietary fiber, sugar, and protein, as well poultry products if they are not to be might be especially interested in the as information on percent daily intake considered adulterated under either the availability of accredited laboratory of vitamins and minerals. Processors FMIA (21 U.S.C. 601(m)) or the PPIA (21 may provide additional nutritional U.S.C. 453(g). Any pathogen on an RTE services. Use of an accredited laboratory labeling that is not false or misleading. product adulterates the product because would always be at the establishment’s RTE products are likely not to be cooked discretion, and the establishment would Food Ingredients Permitted before consumption. Currently, there are have to pay for the service. The FSIS is proposing to apply to catfish requirements for the control of Listeria requirements for laboratory products requirements in 9 CFR part monocytogenes in RTE products that are accreditation are in 9 CFR part 439, 424 prohibiting a product from bearing exposed to the processing environment subchapter E. FSIS is proposing to bring catfish or containing any food ingredient that after undergoing a process that is lethal within the coverage of the accredited would render it adulterated or to L. monocytogenes. FSIS is proposing laboratory program for species misbranded under 21 U.S.C. to make post-lethality-exposed catfish identification—which would be a new 601(m)(2)(C) (proposed 9 CFR part 544). products subject to these requirements program service—as well as for residue This prohibition is consistent with the (proposed 9 CFR 548.6, referencing 9 detection. The Agency would amend the current regulation of catfish products CFR part 430). under the FD&C Act. accredited laboratory regulations as Few further-processed catfish An RTE product is adulterated if it necessary to include species products are produced domestically; contains L. monocytogenes, or if it identification methods in the program. however, FSIS is aware of the use in comes into direct contact with a food- Standards of Identity and Composition some fresh-frozen catfish of sodium contact surface that is contaminated tripolyphosphate and other sodium with L. monocytogenes because it is FSIS may promulgate standards of phosphates as humectants. Also, likely to be consumed without further composition for catfish products marinade solutions and breading processing such as cooking. An RTE composed of more than one ingredient. ingredients are used in the preparation catfish product, as well as an RTE meat A standard of composition prescribes of some catfish products. FDA has or poultry product, would be the minimum amount of catfish for a approved these various ingredients for adulterated in either of these situations. product to be called by a name that uses that include catfish products or has asserts that it was made with catfish. determined them to be Generally Canned Products The Agency also may prescribe standards of identity for catfish Recognized As Safe (GRAS) for these FSIS is not aware of any canned products. A standard of identity uses. catfish products that are processed in Under the FMIA, establishments will prescribes the specific ingredients or the United States for human only be able to prepare a further- components, and relative amounts, in a consumption, but canned catfish soups processed catfish product when the product that are necessary to meet are imported into this country. Under establishment is under inspection by an consumer expectations for the product. this proposed rule, any domestic canned FSIS inspection program employee. However, there is at present only a Under 21 U.S.C. 601, 606, and 608, catfish products that an official relatively small number of commercially preparation of edible product will have establishment manufactures will be distributed catfish products, and FSIS is to be carried out in compliance with the subject to requirements similar to those not aware of any product identity issues sanitary and other requirements in the for canning and canned meat products requiring a regulatory intervention. regulations (proposed 9 CFR 548.1(a)). (proposed 9 CFR 548.6, cross- Comments are welcome on whether Under this proposed rule, FSIS will referencing to 9 CFR part 318, subpart the Agency should promulgate any make determinations on the safety and G (§§ 318.300–318.311)). Domestic standards of identity or composition in suitability of uses of food ingredients in canned fish products currently are this rulemaking. This issue is separate catfish products in consultation and subject to FDA requirements for low- from the basic product identity issue of coordination with FDA, as it does for all acid canned foods (21 CFR 113) and what species of fish or catfish is actually food ingredients. FSIS will compile safe imported canned products are subject to in a product. and suitable uses, including limits and equivalency requirements for process conditions of use, of food ingredients in filing (21 CFR 108.35). Under the Exports these products and make the proposed rule, imported canned catfish FSIS is proposing (proposed 9 CFR information available in an instruction products will have to be produced 552, cross-referencing provisions of 9 to its inspection force, FSIS Directive under requirements that are equivalent CFR 322) to adopt requirements for 7120.1. This directive is regularly to those that would apply to domestic exported catfish and catfish products updated and published on the Agency’s products. that are similar to those that apply to

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meat articles under 9 CFR 322 (issued inedible materials (proposed 9 CFR 539 requirements for the inspection of under 21 U.S.C. 615–616). Some of the or 540). imported meat products (21 U.S.C. 620) meat regulations, e.g., those addressing FSIS has tentatively determined that to the inspection of imported catfish the transport of lard or tallow, are not other regulations on the transportation products (9 CFR part 557, referencing 9 applicable to catfish. The Agency is of meat and meat food products (in 9 CFR part 327). FSIS must find that a proposing to require that the outside CFR part 325) are appropriate for the foreign inspection system ensures container of any inspected and passed transportation of catfish products compliance of processing catfish product for export, with certain (proposed 9 CFR 555.3–555.8). These establishments and catfish products exceptions, bear an official export proposed regulations address: The with requirements that are equivalent to stamp, as depicted in the regulations (9 transportation of unmarked, inspected the inspection and other requirements CFR 312.8), that includes the number of product under FSIS affixed-seal; of the FMIA and the regulations that the export certificate. Under this product that may have become implement it that apply to official proposal, the FSIS inspector in charge at adulterated in transit or storage; catfish establishments in the United the official catfish establishment will be inedible products; the filing of original States. When the Agency determines authorized to issue official export certificates for unmarked inspected that a foreign country’s inspection certificates for shipments of inspected products; and the unloading of any system for catfish and catfish products and passed product to any foreign catfish product from an officially sealed is equivalent to that operated by FSIS, country. FSIS will expect that the conveyance or loading after the the Agency will give notice of that fact certificates will be issued at the time the conveyance has left the official (in the Federal Register) and will list products leave the official establishment. These regulations would the name of the country in the establishment. The certificates could be serve to prevent the diversion of regulations (in proposed 9 CFR issued at a later time only after adulterated catfish and catfish products 557.2(b)). identification and reinspection of the into food channels (proposed 9 CFR 555.9). Demonstrating Equivalence of Foreign products. Under the proposal, the Systems certification will have to show the Imported Products names of the exporter and consignee, FSIS is proposing that countries The FMIA prohibits the importation the destination, the number and types of demonstrate the equivalence of their of carcasses, parts, meat, or meat food packages, the shipping marks, the kinds inspection system to the U.S. system, in products of amenable species if these the following respects: of products, and the weight of the articles are adulterated or misbranded, (1) Program administration. Under products. and unless they comply with all the proposed 9 CFR 557.2 (under 21 U.S.C. Transportation in Commerce inspection, building, construction 620(a)), as must foreign programs for standards, and other provisions of the other species under the FMIA, the The FMIA gives FSIS the authority to FMIA and regulations applicable to the foreign program for catfish will have to regulate amenable products in products (21 U.S.C. 620). FSIS enforces be staffed in a way that will ensure commerce (21 U.S.C. 602). Since, under this provision through random uniform enforcement of the laws and the FMIA and this proposal, catfish and inspection for species verification and regulations. Ultimate control and catfish products are amenable to for residues, and through the random supervision must rest with the national inspection, no person may sell, sampling and testing of the tissues of government or employees of the system transport, offer for sale or amenable species by the exporting (9 CFR 327.2(a)(2)(i)(B)). Qualified, transportation, or receive for country. competent inspectors must be assigned transportation, in commerce, any catfish Each foreign country from which (9 CFR 327.2(a)(2)(i)(C)). National or catfish product that is capable of use products of amenable species are offered inspection officials must have the as human food if it is adulterated, for importation into the United States authority to enforce requisite laws and misbranded, or does not bear an official must obtain a certification from FSIS regulations and certify or refuse to inspection legend at the time of such stating that the country maintains a certify products intended for export (9 sale, transportation, offer, or receipt (21 program using reliable analytical CFR 327.2(a)(2)(i)(D)). There must be U.S.C. 610(c)). methods to ensure compliance with U.S. adequate administrative and technical Under the authority in 21 U.S.C. 610 standards for residues in those products. support and inspection, sanitation, and 621, FSIS is proposing (proposed 9 FSIS periodically reviews the quality, and species verification, residue CFR 555.1) to require that any catfish certifications and revokes any standards, and other regulatory product capable of use as human food certification if the Agency determines requirements that are equivalent to that is to be transported in commerce be that the country involved is not those of the United States (9 CFR properly handled and maintained to maintaining a program that uses reliable 327.2(a)(2)(i)(E)–(G)). ensure that it is not adulterated and is analytical methods to ensure (2) Legal authority and requirements properly marked and labeled. A compliance with U.S. standards for governing catfish and catfish products transport conveyance intended to carry residues in the products it exports. In inspection. To be considered eligible to catfish products will be subject to FSIS considering any application for export catfish products to the United inspection to determine its sanitary certification, FSIS takes into account States, foreign countries will have to condition. A transport conveyance that inspection at individual establishments enforce laws and regulations that is insanitary may cause contamination in order to ensure that the foreign address the conditions under which of catfish products and thus may not be country’s inspection program is meeting catfish are raised and transported to the used until the insanitary conditions are the United States standards (21 U.S.C. processing establishment (9 CFR corrected. Under these proposed 620(f)). 327.2(a)(2)(ii)(I); 21 U.S.C. 606(b), regulations, products on an insanitary As mentioned previously, under the 620(a); proposed 9 CFR 557.3). FSIS vehicle must be removed and either FMIA, as amended by the 2008 Farm recognizes that in some countries, in handled in accordance with the Bill, the provisions governing imports addition to having fish ponds like those regulations on mandatory dispositions apply to catfish and catfish products. in the United States, catfish producers or on the handling of condemned and FSIS is proposing to apply the use floating cages on rivers and

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‘‘raceway ponds’’ that are filled and from catfish intended for export to the to appeal enforcement decisions made emptied by the continuous flow of water United States. by inspection program personnel (9 CFR from nearby rivers. Under this proposed Under this proposal, only certified 306.5). rule, the water quality, residue, and foreign catfish establishments will be Detention, Seizure, Condemnation other standards applying in these eligible to export their catfish products catfish-raising situations will have to be to the United States. However, if a Detention equivalent to those applying to catfish foreign establishment is not in Under this proposal, FSIS will raised in the United States. compliance with U.S. requirements for exercise its detention authority under Also, eligible foreign countries will imported products, FSIS will terminate the FMIA upon finding that catfish or have to establish standards for, and the eligibility of the establishment. FSIS catfish products in commerce are maintain continuous official will provide reasonable notice to the adulterated, misbranded, or otherwise supervision of, preparation and foreign government of the proposed in violation of the Act or regulatory processing of product to ensure that termination of eligibility, unless delay requirements (21 U.S.C. 672, proposed 9 adulterated or misbranded product is in notification could result in the CFR 559.1, 9 CFR 329.1–329.6). The not prepared for export to the United importation of adulterated or FMIA authorizes detentions if the States (9 CFR 327.2(a)(ii)(D)). A single misbranded product. (9 CFR Secretary has reason to believe that the standard of inspection and sanitation 327.2(a)(3).) article is adulterated or misbranded and will need to be maintained throughout Marking and Labeling of Imported is capable of use as human food, or that all certified establishments (9 CFR Products it has not been inspected in violation of 327.2(a)(ii)(E)). The country’s the FMIA or of any other Federal or requirements will need to address The proposed regulations (proposed 9 CFR 557.14 and 557.15, under 21 U.S.C. State law. sanitary handling of product and Detained product may not be further provide for official controls over 620) will apply to catfish and catfish products the requirements in 9 CFR distributed or sold to consumers. condemned material; a HACCP system Detained product is either appropriately equivalent to that set forth in 9 CFR part 327.14 and 327.15 for the marking of catfish and catfish products and the disposed of by the product owner, 417; and other applicable controls under agent, or custodian (e.g., through the FMIA or implementing regulations labeling of immediate and outside containers of product that is imported. voluntary destruction, by personal use, (9 CFR 327.2(a)(2)(ii)(F)–(I)). donation, or other FSIS-acceptable (3) Document evaluation and system An imported catfish product will have to be marked ‘‘product of [country of option), or FSIS initiates an action to review. Foreign countries seeking seize the product. eligibility to export catfish and catfish origin]’’ under multiple authorities (7 products into the United States CFR part 60, under 7 U.S.C. Seizure and Condemnation 1638a(a)(3)), proposed 9 CFR 541.7, and (proposed 9 CFR 557.2(a)), under 21 When detained product is not 9 CFR 317.9(b)(9)(xxv), 317.8(b)(40), U.S.C. 620) will also have to present to destroyed or properly disposed of, it is under 21 U.S.C. 607, 620, 621). FSIS copies of laws, regulations, and subject to seizure and condemnation by other information pertaining to their 2. Proposed Regulations Under Other a U.S. District Court under Section 403 systems of catfish products inspection, FMIA Subchapters of the FMIA (21 U.S.C. 673). FSIS is just as countries now do when they seek proposing to apply the provisions for Rules of Practice; Reference To Rules of eligibility to export products of other seizure and condemnation in the meat Practice species amenable to the FMIA. FSIS will regulations (9 CFR 329.7–329.9) to make a determination of eligibility on FSIS is proposing to apply its rules of catfish (proposed 9 CFR 559.2). The the basis of a study of these documents practice (9 CFR part 500, under 21 regulations also address criminal and an on-site visit to the country of the U.S.C. 601, 606, 608, 610, 621, and 671)) offenses addressed in Sections 22 and system in operation by FSIS. FSIS will in enforcing the proposed catfish 405 of the FMIA (21 U.S.C. 622, 675), also conduct periodic reviews of foreign inspection regulations (proposed 9 CFR such as bribery of Program employees, catfish products inspection systems to 561.1). Also, FSIS is proposing to receipt of gifts by Program employees, determine their continued eligibility (9 provide establishments with an and assaults on, or other interference CFR 327.2(a)(3)). opportunity for presentation of views with, Program employees while engaged (4) Maintenance of standards. In (proposed 9 CFR 561.2, referencing 9 in, or on account of, the performance of addition, countries seeking eligibility to CFR part 335) before reporting their official duties under the Act. export catfish and catfish products into violations to the Department of Justice the United States will have to provide for criminal prosecution. The procedure Records Required To Be Kept for periodic supervisory visits to to be followed in a case relating to FSIS is proposing (under 21 U.S.C. certified establishments to ensure that catfish and catfish products inspection 642(b)) to require persons involved in U.S. requirements are being met and for would be the same as that followed in processing, buying and selling, or written reports on the supervisory visits a case relating to meat and meat food rendering catfish or catfish products to (proposed 9 CFR 557.2, under 21 U.S.C. products inspection. FSIS uses its rules keep records on their activities 620). The reports will have to be of practice for enforcement processes respecting catfish sold, transported, available to FSIS. The foreign program that may lead to such actions as offered for sale or transport, in will have to conduct random sampling withholding (refusing to allow the mark commerce. Under this proposal, the of catfish tissues and the testing of the of inspection to be applied to product) classes of records they will be required tissues for residues identified by FSIS or or suspension (withdrawing inspection to keep include sales records or by the foreign inspection authority as program employees from a facility) of invoices, shippers’ certificates and potential contaminants, in accordance inspection. The USDA uniform rules of required permits, records of seal with FSIS-approved sampling and practice (7 CFR 1.130–1.151) apply in numbers used in the sealed transport of analytical methods (9 CFR actions commenced pursuant to section inedible products, guaranties provided 327.2(a)(2)(iv)(C)). The residue testing 401 of the FMIA (21 U.S.C. 671). by suppliers of packaging materials, will have to be conducted on samples Establishment management has a right canning records as required by 9 CFR

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part 318, subpart G, nutrition labeling for the examination and sampling of end of each quarter. The establishment records, and records of all labeling, inventory (proposed 9 CFR 550.4). operator also will have to file other along with the formulation and Persons and firms covered by the reports as FSIS might require from time processing procedures (proposed 9 CFR recordkeeping requirements will have to to time under the FMIA (proposed 9 550.1). register with the FSIS Administrator CFR 550.6.) FSIS notes that production Under this proposal, persons subject using a form obtained from the Agency data from individual establishments is to these requirements will have to keep (proposed 9 CFR 550.5). FSIS is asking protected from disclosure under the the records and maintain them at the for comment on a proposed time frame Freedom of Information Act. The place where the business generating the for completion of this registration under Agency releases only aggregate data for records is conducted. In the case where ‘‘Proposed Phasing of Implementation’’. reporting purposes. one person or firm conducts catfish This registration requirement will apply Finally, FSIS is proposing to require operations at several establishments or to farms and transporters that supply that a consignee who refuses delivery of locations, the records could be kept at catfish to official processing a product bearing the mark of inspection a headquarters office (proposed 9 CFR establishments and will enable FSIS to because the product is adulterated or 550.2). The Agency is proposing to conduct sampling and other activities as misbranded notify the Inspector-in- require the records be retained for a necessary to account for the conditions Charge of the kind, quantity, source, and period of 2 years after December 31 of under which catfish are raised and present location of the product. The the year in which the transaction to transported to the processing consignee also will have to report on the which the record relates occurred establishment (under 21 U.S.C. 606(b)). respects in which the product is (proposed 9 CFR 550.3). The registration would have to be adulterated or misbranded. Movement Canning records will have to be updated whenever a change is made in of the product, except back to the maintained in accordance with current the name, address, or trade name under official establishment from where it requirements for records of the canning which the registrant operates. These came, is prohibited (proposed 9 CFR of meat food products. Processing and registration requirements would not 550.7), and if the product moves back to production records would have to be apply, however, to any person the originating establishment, the use of retained for at least 1 year at the canning conducting business only at an official seals, documentation, or other establishment and for an additional 2 establishment (proposed 9 CFR conditions applies. years at the establishment or other 550.5(c)). This registration requirement Summary of Proposed Regulations location from which the records could is similar to that with which food be made available to authorized FSIS establishments must already comply In general, FSIS has attempted to employees (proposed 9 CFR 550.3, 9 under FDA regulations. apply to catfish and catfish inspection, CFR 318.307(e)). Records of scheduled FSIS will require each official with some modifications, the processes will have to be maintained on establishment to provide accurate regulations governing the inspection of file at the processing establishment and information to FSIS employees so that other species under the FMIA. In many available to Program employees they can report on the amount of cases the proposed regulations merely (proposed 9 CFR 550.3, 9 CFR 318.302). products prepared or handled in the cross-reference the existing regulations Authorized representatives of the establishment, and on sanitation, for meat and meat food products. The Secretary will have to be afforded access microbiological testing, and other accompanying table shows how the to the businesses that would be subject aspects of the establishment’s catfish regulations in proposed to the recordkeeping requirements operations. FSIS is proposing that the Subchapter F correspond to the meat (under 21 U.S.C. 642(a)). They will have operator of each establishment report inspection regulations in Subchapter A to be afforded any necessary facilities, quarterly on the number of pounds of (9 CFR parts 300–335) or Subchapter E except reproduction equipment, for the catfish processed. The report would (9 CFR parts 416, 417, 424, 439, 441, examination and copying of records and have to be filed within 15 days after the 442).

TABLE 5—RELATIONSHIP BETWEEN CATFISH AND CATFISH PRODUCT INSPECTION REGULATIONS IN SUBCHAPTER F AND MEAT INSPECTION REGULATIONS IN SUBCHAPTER A OR SUBCHAPTER E

Subchapter F Corresponding Subchapter A or E part Subject designation or section reference

GENERAL REQUIREMENTS; DEFINITIONS ...... PART 530 ...... Part 300. General ...... § 530.1 ...... § 300.1, § 300.2. FSIS organization for inspection of catfish and catfish products ...... § 530.2 ...... § 300.3. Access to establishments ...... § 530.3 ...... § 300.6. DEFINITIONS ...... PART 531 ...... Part 301. Definitions ...... § 531.1 ...... § 303.1. REQUIREMENTS FOR INSPECTION ...... PART 532 ...... Part 302, Part 304, Part 305. Establishments requiring inspection; other inspection ...... § 532.1 ...... § 302.1. Application for inspection, etc...... § 532.2 ...... § 304.1, § 304.2, § 304.3. Exemption of retail operations ...... § 532.3 ...... § 303.1. Inspection at official establishments; relation to other authorities ...... § 532.4 ...... § 302.2. Exemption from definition of catfish product of certain human food products con- § 532.5. taining catfish. SEPARATION OF ESTABLISHMENT; FACILITIES FOR INSPECTION ...... PART 533 ...... Part 305, Part 306, Part 307. Separation of establishments ...... § 533.1 ...... § 305.2. Facilities for Program employees ...... § 533.3 ...... § 307.1. Other facilities and conditions to be provided ...... § 533.4 ...... § 307.2. Schedule of operations ...... § 533.5 ...... § 307.4. Overtime and holiday inspection service ...... § 533.6 ...... § 307.5. Basis of billing for overtime and holiday services ...... § 533.7 ...... § 307.6.

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TABLE 5—RELATIONSHIP BETWEEN CATFISH AND CATFISH PRODUCT INSPECTION REGULATIONS IN SUBCHAPTER F AND MEAT INSPECTION REGULATIONS IN SUBCHAPTER A OR SUBCHAPTER E—Continued

Subchapter F Corresponding Subchapter A or E part Subject designation or section reference

PRE-HARVEST STANDARDS AND TRANSPORTATION TO PROCESSING ES- PART 534. TABLISHMENT. General ...... § 534.1. Water quality for food fish ...... § 534.2. Standards for use of drugs and other chemicals in feed and in catfish growing § 534.3. ponds. Transportation to processing plant ...... § 534.4. SANITATION REQUIREMENTS AND HAZARD ANALYSIS AND CRITICAL PART 537 ...... Part 416, Part 417. CONTROL POINTS SYSTEMS. Basic requirements ...... § 537.1 ...... Part 416, Part 417. Hazard Analysis and HACCP plan ...... § 537.2 ...... Part 417, § 417.2. MANDATORY DISPOSITIONS; PERFORMANCE STANDARDS ...... PART 539 ...... Part 311. HANDLING AND DISPOSAL OF CONDEMNED AND OTHER INEDIBLE MATE- PART 540 ...... Part 314. RIALS. Dead catfish ...... § 540.1 ...... § 314.8. Specimens for educational, research, and other nonfood purposes; permits ...... § 540.2 ...... § 314.9. Handling and disposal of condemned or other inedible materials ...... § 540.3 ...... Part 314. MARKS, MARKING AND LABELING OF PRODUCTS AND CONTAINERS ...... PART 541 ...... Part 312, Part 316. General ...... § 541.1. Official marks and devices to identify inspected and passed catfish and catfish § 542.2 ...... § 312.2. products. Official seals for transportation of products ...... § 541.3 ...... § 312.5. Official export inspection marks, devices, and certificates ...... § 541.4 ...... § 312.8. Official detention marks and devices ...... § 541.5 ...... § 329.2. Labels required; supervision of a Program employee ...... § 541.7 ...... Part 317, Part 441, Part 442. FOOD INGREDIENTS PERMITTED ...... PART 544 ...... Part 424. Use of food ingredients ...... § 544.1 ...... Part 424. PREPARATION OF PRODUCTS ...... PART 548 ...... Part 318. Preparation of catfish products ...... § 548.1. Requirements concerning ingredients and other articles used in the preparation § 548.2 ...... § 318.6. of catfish products. Samples of products, water, dyes, chemicals to be taken for examination ...... § 548.3 ...... § 318.9. Mixtures containing product but not amenable to the Act ...... § 548.4 ...... § 318.13. Ready-to-eat catfish products ...... § 548.5 ...... Part 430. Canning and canned products ...... § 548.6 ...... Part 318, Subpart G (§§ 318.300– 318.311). Use of animal drugs ...... § 548.7. Polluted water contamination at establishment ...... § 548.8 ...... § 318.4. Accreditation of non-Federal chemistry laboratories ...... § 548.9 ...... Part 439. STANDARDS OF IDENTITY AND COMPOSITION ...... PART 549 (RE- Part 319. SERVED). RECORDS REQUIRED TO BE KEPT ...... PART 550 ...... Part 320. Records required to be kept ...... § 550.1 ...... § 320.1. Place of maintenance of records ...... § 550.2 ...... § 320.2. Record retention period ...... § 550.3 ...... § 320.3. Access to and inspection of records, facilities, and inventory; copying and sam- § 550.4 ...... § 320.4. pling. Registration ...... § 550.5 ...... § 320.5. Information and reports required from official establishment operators ...... § 550.6 ...... § 320.6. Reports by consignees of allegedly adulterated or misbranded products; sale or § 550.7 ...... § 320.7. transportation as violations. EXPORTS ...... PART 552 ...... Part 320. Affixing stamps and marking products for export; issuance of export certificates; § 552.1 ...... § 322.1, § 322.2, § 322.4. clearance of vessels and transportation. TRANSPORTATION OF CATFISH PRODUCTS IN COMMERCE ...... PART 555 ...... Part 325. Transportation of catfish products ...... § 555.1 ...... § 325.1. Catfish product transported within the United States as part of export movement § 555.2 ...... § 325.3. Unmarked, inspected catfish product transported under official seal between offi- § 555.3 ...... § 325.5. cial establishments for further processing. Handling of catfish products that may have become adulterated ...... § 555.4 ...... § 325.10. Transportation of inedible catfish product in commerce ...... § 555.5 ...... § 325.11. Certificates ...... § 555.6 ...... § 325.14. Official seals; forms, use, and breaking ...... § 555.7 ...... § 325.16. Loading or unloading of catfish products in sealed transport conveyances ...... § 555.8 ...... § 325.18. Diverting of shipments ...... § 555.9 ...... § 325.18. Provisions inapplicable to specimens for laboratory examination or to naturally § 555.10 ...... § 325.19. inedible articles. Transportation and other transactions concerning dead, dying, or diseased cat- § 555.11 ...... § 325.20. fish, and catfish or parts of catfish that died otherwise than by slaughter.

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TABLE 5—RELATIONSHIP BETWEEN CATFISH AND CATFISH PRODUCT INSPECTION REGULATIONS IN SUBCHAPTER F AND MEAT INSPECTION REGULATIONS IN SUBCHAPTER A OR SUBCHAPTER E—Continued

Subchapter F Corresponding Subchapter A or E part Subject designation or section reference

Means of conveyance in which dead, dying, or diseased catfish or parts of cat- § 555.12 ...... § 325.21. fish must be transported. IMPORTATION ...... PART 557 ...... Part 327. Definitions; application of provisions ...... § 557.1 ...... § 327.1. Eligibility of foreign countries for importation of catfish products into the United § 557.2 ...... § 327.2. States. No catfish product to be imported without compliance with applicable regulations § 557.3 ...... § 327.3. Imported catfish products; foreign certificates required ...... § 557.4 ...... § 327.4. Importer to make application for inspection of catfish products for entry ...... § 557.5 ...... § 327.5. Catfish products for importation; program inspection, time and place; application § 557.6 ...... § 327.6. for approval of facilities as official import inspection establishment. Import catfish products; equipment and means of conveyance used in handling § 557.8 ...... § 327.8. to be maintained in sanitary condition. [Reserved] ...... § 557.9 ...... § 327.9. Samples; inspection of consignments; refusal of entry; marking ...... § 557.10 ...... § 327.10. Receipts to importers for import catfish product samples ...... § 557.11 ...... § 327.11. Foreign canned or packaged catfish products bearing trade labels; sampling and § 557.12 ...... § 327.12. inspection. Foreign catfish products offered for importation; reporting of findings to Customs § 557.13 ...... § 327.13. Marking of catfish products and labeling of immediate containers thereof for im- § 557.14 ...... § 327.14. portation. Outside containers of foreign catfish products; marking and labeling; application § 557.15 ...... § 327.15. of official inspection legend. Small importations for importer’s own consumption; requirements ...... § 557.16 ...... § 327.16. Returned U.S. inspected and marked catfish products ...... § 557.17 ...... § 327.17. Catfish products offered for entry and entered ...... § 557.18 ...... § 327.18. Specimens for laboratory examination and similar purposes ...... § 557.19 ...... § 327.19. [Reserved] ...... § 557.20 [Re- served]. [Reserved] ...... § 557.21 [Re- served]. [Reserved] ...... § 557.22 [Re- served]. [Reserved] ...... § 557.23 [Re- served]. Appeals; how made ...... § 557.24 ...... § 327.24. Disposition procedures for catfish product condemned or ordered destroyed § 557.25 ...... § 327.25. under import inspection. Official import inspection marks and devices ...... § 557.26 ...... § 327.26. DETENTION, SEIZURE, CONDEMNATION ...... PART 559 ...... Part 329. Catfish and other articles subject to administrative detention ...... § 559.1 ...... §§ 329.1, 329.2, 329.3, 329.4, 329.5. Articles or catfish subject to judicial seizure and condemnation ...... § 559.2 ...... §§ 329.6, 329.7, 329.8. Criminal offenses ...... § 559.3 ...... § 329.9. STATE–FEDERAL, FEDERAL–STATE COOPERATIVE AGREEMENTS; STATE PART 560 ...... Part 321, Part 331. DESIGNATIONS. Cooperation with States and Territories ...... § 560.1 ...... § 321.1. Cooperation of States in Federal programs ...... § 560.2 ...... § 321.2. Designation of States under the FMIA ...... § 560.3 ...... Part 331, § 331.3, § 331.5, § 331.6. RULES OF PRACTICE ...... PART 561 ...... Part 335. Rules of practice governing inspection actions ...... § 561.1 ...... Part 500. Rules of practice governing proceedings under the FMIA for criminal violations ... § 561.2 ...... Part 335.

IX. FSIS Implementation 123.11). FDA has recommended that 9 CFR part 416 for sanitation. The Farm-raised catfish establishments each processor develop and implement establishments will have to meet the have been operating under the FDA written Sanitation SOPs for each facility FSIS sanitation performance standards. Seafood HACCP Regulations (21 CFR where fish and fishery products are To meet the standards, establishments part 123). The Seafood HACCP produced. The provisions on sanitation may develop and employ sanitation or Regulations describe procedures for the control procedures are in 21 CFR processing procedures customized to safe and sanitary processing of fish and 123.11. the nature and volume of their fish products. The FDA regulations FSIS anticipates that moving the production. require all processors of fish and fishery catfish industry from FDA’s regulatory A catfish processing establishment products to develop HACCP programs regime to the FSIS inspection system will have the flexibility to innovate in when necessary and to meet the will have some impact on the industry. facility design, construction, and requirements of 21 CFR part 110 as they If this proposed rule is adopted, all operations. The establishment, however, relate to the eight key sanitation areas catfish processing establishments will will have to continue to operate under defined in the regulations (21 CFR be required to follow the regulations in sanitary conditions in a manner that

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ensures that the product is not Proposed Phasing of Implementation compliance dates that affected adulterated and that does not interfere To provide for an orderly transition establishments will be required to meet with FSIS inspection and its from FDA’s regulatory program to FSIS’s for each of the following phases until enforcement of such standards. continuous inspection program, FSIS is the final rule is fully implemented: In its catfish products inspection, proposing a four-phase approach to Phase One FSIS intends to focus on verification of implementation of the final rule that • FSIS will deploy inspection Sanitation SOPs and HACCP plans. establishes the new catfish inspection personnel to domestic catfish processing Under the proposed Sanitation SOPs, program. The Agency requests comment establishments. FSIS inspection program personnel will on the implementation time frame. • Domestic establishments will be verify that plant management is During the transition period to full required to continue to comply with the conducting its operations in a sanitary implementation, FSIS plans to provide requirements of 21 CFR part 123 until environment and manner. establishments and foreign countries FSIS sanitation procedures (under that will be subject to the final rule with Catfish processing establishments will proposed 9 CFR part 537) are in place. the opportunity to train their personnel be able to include elements of their The regulations in 21 CFR part 123 and to bring their operations into Sanitation SOPs in their HACCP plans. require processors to monitor conditions compliance with the new regulations. Sanitation activities that directly affect and practices to ensure conformity with FSIS is aware that Ictaluridae, Pangasius FDA’s current Good Manufacturing the control of a processing hazard will and species of other families are be evaluated in the hazard analysis. Practices in 21 CFR part 110. imported into the United States. • Foreign countries that are exporting Where appropriate, the activities could Although a determination as to the catfish to the United States at the time be identified as CCPs in the HACCP definition of ‘‘catfish’’ has not yet been the final rule is published and that plan. Sanitation activities not identified made, any foreign producers or intend to continue to do so will need to as a CCP in the HACCP plan could processors handling catfish, as defined submit documentation to demonstrate remain in the Sanitation SOPs or in by a final rule, will be subject to FSIS that they have a law or other another prerequisite program for which processes and procedures. appropriate legal measure in place that the hazard analysis accounts. Any FSIS is proposing a phased provides authority to regulate the sanitation activity incorporated into a implementation of the final catfish growing and processing of catfish for HACCP plan as a CCP could be removed inspection rule to provide a reasonable human food. At this phase of from the facility’s Sanitation SOPs or timeframe for countries to develop and implementation, FSIS will accept other prerequisite program. FSIS will implement equivalent catfish inspection written documentation that countries verify the activity’s effectiveness, programs. FSIS intends to work with have provided to importers pursuant to whether as an element of the Sanitation exporting countries to ensure that the FDA’s regulations in 21 CFR SOPs or as a CCP in a HACCP plan. catfish products exported to the United 123.12(a)(2)(ii)(B) as evidence of a FSIS will also verify (under 9 CFR States during the phase-in period country’s authority to regulate the 417.8) that HACCP plans comply with achieve an equivalent level of sanitary production of catfish products and to the requirements of part 417 and have protection as catfish products produced assure compliance with the been validated by the establishment in in domestic establishments. requirements of 21 CFR part 123. FSIS accordance with 9 CFR 417.4. Potential The following is FSIS’s proposed will post a list on its Web site of verification activities by FSIS include, timeline for implementing the final rule countries that have met this initial, but would not be limited to, sampling requiring continuous inspection of minimum requirement. FSIS will activities (targeted and non-targeted, catfish and catfish products. The recognize current arrangements under marketplace, rapid screening tests for Agency is proposing to allow exporting 21 CFR part 123, including certification chemical residues); hands-on establishments to operate under FSIS’s of foreign facilities by competent third verification (organoleptic inspection, transitional requirements until the final parties, until complete implementation use of temperature or other monitoring rule is fully implemented. It is also of the final rule or FSIS determines devices); and review of establishment proposing to permit exporting whether foreign inspection systems are monitoring records. establishments in foreign countries to equivalent to that of the United States. continue to export their products during • FSIS will begin a series of on-site In addition to verifying Sanitation the phased implementation if they audits of foreign countries that export SOPs and HACCP systems, FSIS intends comply with the transitional catfish products to the United States to to verify establishment compliance with requirements. verify that establishments that produce the other regulatory requirements that The proposed phase-in will not, catfish products for export to the United become part of the final rule. As however, preclude establishments that States are complying with the required previously noted, the frequency of FSIS are prepared to bring their operations transitional measures. verification activities will vary, into full compliance with the final rule • Domestic producers will be depending on such factors as the before the final implementation date required to begin to submit the labels of establishment’s past performance, the from operating under the new catfish products to FSIS for prior risk inherent in processes or products, inspection program. Such approval. Labels will have to meet the quantity of product, and likely uses of establishments will need to work with requirements in proposed 9 CFR 541.7. the product. FSIS also will verify the their District Office to obtain the • Labels of catfish products produced conditions under which catfish are necessary inspection services. in foreign establishments will be raised and transported to the The proposed phasing of required, at a minimum, to bear the establishment, both as a check on the implementation will begin on the basic labeling features prescribed in effectiveness of the establishment’s effective date of the final rule, 90 days proposed 9 CFR 541.7. These features HACCP plan and to provide additional after publication in the Federal include the product name, handling assurance that only safe, wholesome Register. FSIS is requesting comment on statement, net weight statement, raw materials are processed for human what the duration of each of the ingredients statement, address line, and food. following phases should be, and on the nutrition facts panel. The labels will

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also need to include safe handling regulatory requirements under the Act approach to inspection that focuses on instructions as well as the inspection that apply to catfish and catfish the verification of an establishment’s legend and establishment number by the products. The establishments will be food safety system, which consists of an final implementation date. subject to sampling as part of establishment’s HACCP plan, Sanitation microbiological, chemical, and other SOPs, and prerequisite programs. As Phase Two testing by FSIS of catfish and catfish mentioned elsewhere in this document, • Persons and firms covered by the products. The labeling of inspected the FSIS HACCP requirements for meat recordkeeping requirements in proposed products will bear a distinctive mark or and poultry establishments are in some 9 CFR 550.5 will have to register with legend to reflect that the product has ways similar to the FDA HACCP FSIS. been inspected and passed by FSIS. requirements for seafood processors (in The proposed regulations also require Phase Three 21 CFR 123), yet supported by much the listing in the regulations of foreign more intensive inspection by FSIS. • Domestic and foreign countries after their food safety systems USDA is requesting public comments establishments will be required to for catfish have been found by FSIS to on the approach. comply with the sanitation be equivalent to that of the United requirements in 9 CFR part 416 States. The equivalency determination Costs and Benefits (proposed 9 CFR part 537). and the listing in the regulations are Costs Phase Four necessary in order for the catfish Siluriformes products of these countries to be • The transitional measures will imported into the United States. The If catfish are defined as members of expire. FSIS will require that all proposed regulations also require the the order Siluriformes, the mean total establishments that produce catfish and inspection (actually, re-inspection) of first-year and one-time cost to the catfish products comply with all catfish products offered for entry into catfish and catfish food products provisions of the final catfish inspection this country. domestic supply chain industries of the regulations. FSIS is proposing these regulations to proposed measures is projected to be • Foreign countries that export catfish carry out the requirements of the Food, about $306,000. The first year cost is products to the United States will be Conservation, and Energy Act of 2008 projected to be about $543,000. For the required to have implemented a catfish (Pub. L. 110–246, Sec. 11016), known as catfish and catfish food product inspection program that is equivalent to the 2008 Farm Bill, that amended the domestic industry, the mean annual cost the U.S. inspection program. To be FMIA to make catfish, as defined by the is projected at $187,000. The projected eligible for the importation of their Secretary of Agriculture, an amenable mean estimated annualized cost is products into the United States, the species under the FMIA and subject to $240,000 (See Table 18 of the RIA countries will have to be listed in many of the requirements of the FMIA. Appendix). The projected lower bound proposed 9 CFR part 557. (10th percentile) is $237,000, and the Regulatory Approaches Considered X. Executive Order 12866 and projected upper bound (90th percentile) Regardless of the definition of catfish 30 Regulatory Flexibility Act is $243,000. The present value of the that is adopted an alternative to current mean cost, using a 7-percent discount This proposed rule has been reviewed FDA practices would be proposed. rate over 10 years is projected at $1.7 under Executive Order 12866, FSIS has considered two basic million. The projected additional mean ‘‘Regulatory Planning and Review.’’ FSIS regulatory approaches to catfish total annualized cost to the catfish and would amend Title 9, Code of Federal inspection—a more command-and- catfish food products supply chain Regulations, Chapter III by adding control, traditional approach or an industries of the provisions of the regulations on the mandatory inspection approach that focuses on the proposal analyzed is about $0.0008 per of catfish and catfish products. The verification of an establishment’s food pound ($240,000/285 million pounds, regulations, if adopted, will continue to safety system. Strictly in terms of in 2007) of aggregate processed catfish ensure that catfish and catfish products implementing the FMIA with respect to and catfish food products. produced and sold in commerce for use catfish and catfish products, FSIS could For the domestic industry and the as human food are safe, wholesome, and take a prescriptive, command-and- Government, the additional mean total not adulterated. The regulations will control approach to inspection, as it has first-year one-time cost to the catfish also ensure that they are properly in the past with meat and poultry and and catfish products supply chain marked, labeled, and packaged. FSIS currently does with egg products. industries and additional cost to the will verify that catfish are raised and Command-and-control requirements government of the proposed measures is transported to processing specify, often in great detail, how an projected at $1.3 million. The additional establishments under conditions that establishment is to achieve a particular mean total first-year cost is projected at ensure that catfish products used for food-safety objective. They may involve $15.4 million. Additional mean annual human food are not adulterated. the use of specific techniques or cost is projected at $14.0 million. The The proposed regulations require processing parameters; the review and projected mean annualized cost is $14.2 establishments that process and prepare approval of equipment, establishment million (See Table 18 of the RIA catfish to apply for FSIS inspection and drawings and specifications; and the Appendix). The projected lower bound meet the conditions for receiving review and approval of particular (10th percentile) is $14.1 million. The inspection. Establishments will be process control programs. FSIS, projected upper bound (90th percentile) required to meet sanitation performance however, rejected this command-and- is $14.3 million. The present value of standards, have written Sanitation control approach in 1996 with the SOPs, and operate validated HACCP adoption of the Pathogen Reduction/ 30 A stochastic simulation model was used to systems. FSIS will verify the Sanitation Hazard Analysis and Critical Control determine the distribution of values. Uncertainty SOPs and HACCP systems and will Points Systems final rule (61 FR 38806; analyses are conducted to estimate cost distributions for each of the alternatives for the conduct other verification activities to July 25, 1996). proposed rule. The stochastic model uses @RISK ensure that the establishments are in Thus, the Agency is proposing to (Version 4.5, Palisades Corp.) to examine the effects compliance with the FMIA and adopt, as it has for meat and poultry, an of uncertainty.

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the mean total cost, using a 7-percent projected at $10.5 million. The Salmonella spp. of approximately discount rate over 10 years is projected projected mean annualized cost is $10.6 $18,000 (at a 7 percent discount rate), if at $100.0 million. million. The projected lower bound roughly 790 illnesses were averted, the (10th percentile) is $10.3 million. The benefits of the proposed rule would Ictaluridae projected upper bound (90th percentile) equal the additional costs. For catfish defined as Ictaluridae, the is $10.9 million. The present value of Under the proposed rule applied to mean total first-year and one-time cost the mean total cost, using a 7-percent the catfish family Ictaluridae, using the to the catfish and catfish food products discount rate over 10 years is projected projected annualized cost of $10.6 domestic supply chain industries of the at $74.8 million. million and the estimated mean proposed measures is projected to be annualized cost of an average case of about $286,000. The first year cost is Break-Even Analysis Salmonella spp. of $18,000, roughly 590 projected at about $516,000. For the FSIS anticipates that all catfish and illnesses would have to be averted for catfish and catfish food product catfish products establishments will be the benefits of the proposed rule to domestic industry, the mean annual cost in compliance with the requirements for equal the additional costs. is projected at $181,000. The projected Sanitation SOPs and HACCP according mean estimated annualized cost is to the yet-to-be-determined Effects on Small Entities $230,000. The projected lower bound implementation schedule. From The Administrator has determined (10th percentile) is $227,000, and the discussions with industry experts, FSIS that, for the purposes of the Regulatory projected upper bound (90th percentile) believes that a significant share of the Flexibility Act (5 U.S.C. 601–602), this is $233,000.31 The present value of the catfish and catfish products industry is proposed rule will not have a significant mean cost, using a 7 percent discount compliant with many of the individual economic impact on a substantial rate over 10 years is projected at $1.6 proposed measures; although, because number of small entities in the United million. of differences between FDA and FSIS States. Catfish farms (about 1,300) and The projected mean total annualized regulations, FSIS believes the industry slaughtering and primary processing cost to the catfish and catfish food will need time to make adjustments. establishments (about 23), and as many products supply chain industries of the Even though compliance rates for some as 116 further processing provisions of the proposal analyzed is HACCP related activities may be establishments, live-fish haulers, about $0.0011 per pound ($230,000/204 relatively high, the performance of importers, and feed mills would be million pounds, in 2007) of aggregate HACCP systems depends on how well affected by the rule. Most of these plants processed catfish and catfish food all the elements—hazard analysis, meet the Small Business Administration products. monitoring of CCPs and critical limits, (SBA) size criteria for small businesses The cost of the provisions to the recordkeeping, verification—are being in the food manufacturing classification catfish and catfish food products performed. FSIS conducted an or other categories, in that they have 500 industry compares to a 2006–2008 illustrative assessment of the potential or fewer employees. The action would average price of $0.83 per pound for risk to human health of catfish affect a substantial number of these frozen whole catfish,32 $1.14 per pound consumption, using the example of small entities because the requirements for frozen catfish fillets,33 and $0.402 Salmonella contamination. Thus, we would apply to all processing per pound for frozen catfish nuggets.34 use Salmonella to illustrate potential establishments in the catfish processing These costs compare to an estimated benefits in this break-even analysis. industry that ship their products in cost of about 1 cent per pound of meat Epidemiological evidence suggests interstate commerce and would to some and poultry associated with the that salmonellosis leads to both acute extent pertain to fish-farming practices. Pathogen Reduction/Hazard Analysis and chronic illnesses. The acute illness However, this action may have a and Critical Control Points (PR/HACCP) that accompanies salmonellosis significant effect on a substantial rule of 1996.35 For the domestic generally causes gastrointestinal number of businesses that import catfish industry and the Government, the mean symptoms that can lead to lost because imported catfish will be total first-year one-time cost to the productivity and medical expenses. In required to be inspected under a foreign catfish and catfish products supply rare instances, salmonellosis may result system that is equivalent to that of the chain industries and cost to the in acute or chronic arthritis. Arthritis is United States and from establishments Government of the proposed measures characterized by limited mobility, pain that the foreign inspection authority has is projected at $1.2 million. The mean and suffering, productivity losses, and certified as complying with United total first-year cost is projected at $11.8 medical expenditures. Finally, States requirements. million. The mean annual cost is salmonellosis can result in death. The The proposed rule would directly and risk of death appears to be higher in the indirectly affect multiple sectors of the 31 A stochastic simulation model was used to elderly, children, and people with U.S. economy, including numerous determine the distribution of values. Uncertainty compromised immune systems. FSIS small firms, jobs (i.e., employment) and analyses are conducted to estimate cost has estimated the costs for each of these on the government (e.g., local, State, and distributions for each of the alternatives for the proposed rule. The stochastic model uses @RISK severity levels. Federal). Sectors likely to be affected (Version 4.5, Palisades Corp.) to examine the effects Applying the same methodology as (directly and indirectly), in addition to of uncertainty. FDA in projecting a monetary value for the types of entities already mentioned, 32 Wholesale price. Source: Catfish Market each QALD, using the value of a include transportation firms, importing Statistics, NASS, USDA. statistical life (VSL); and the value of a and exporting firms, food service and 33 Wholesale price. Source: Catfish Monthly Summary, NASS, USDA. statistical life year (VSLY), FSIS projects restaurant firms, domestic and 34 Wholesale price. Source: Catfish Market a mean annualized cost of about $18,000 international trade, consumers, and Statistics Annual, NASS, USDA. per new average case of salmonellosis government agencies. The economic 35 M. Ollinger, V. Mueller. 2003. Managing for (FDA, 2009). Thus, under the proposed analysis of the effects of this proposed Safer Food: The Economics of Sanitation and rule for catfish defined as Siluriformes, rule accompanying this document is Process Controls in Meat and Poultry using the projected annualized cost of available at: http://www.fsis.usda.gov/ Establishments. Agricultural Economics Report 817. _ _ Economics Research Service, U.S. Department of $14.2 million and the estimated mean Regulations & Policies/ Agriculture. Washington, DC. annualized cost of an average case of Proposed_Rules/index.asp.

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XI. Paperwork Reduction Act Estimated Total Annual Burden on are outside official establishments for Title: Mandatory Inspection of Catfish Respondents: For catfish defined as the purpose of preventing the and Catfish Products. Siluriformes: 47,350 hours. distribution of catfish products that are Type of Collection: Sanitation SOPs; For catfish defined as Ictaluridae: misbranded or adulterated under the HACCP Plans; Applications for Grants 32,002.5 hours. FMIA or, in the case of imported articles of Inspection; Applications for labeling Copies of this information collection that are not at such an establishment, approval; various records required to be assessment can be obtained from John after their entry into the United States. kept. O’Connell, Paperwork Reduction Act This proposed rule is not intended to Abstract: FSIS has reviewed the Coordinator, Food Safety and Inspection have retroactive effect. paperwork and recordkeeping Service, USDA, Room 3532 South Administrative proceedings would requirements in this proposed rule in Agriculture Building, 1400 not be required before parties may file accordance with the Paperwork Independence Avenue, SW., suit in court challenging this proposed Reduction Act. Under this proposed Washington, DC 20250. rule. However, the administrative rule, FSIS is requiring an information Comments are invited on: (a) Whether procedures specified in 9 CFR 306.5 collection associated with the the proposed collection of information would have to be exhausted before any inspection of catfish. is necessary for the proper performance judicial challenge of the application of FSIS would require an official catfish of FSIS’s functions, including whether the provisions of this final rule, if the processing establishment to maintain the information will have practical challenge involved any decision of an HACCP plans and records, Sanitation utility; (b) the accuracy of FSIS’s FSIS employee relating to inspection SOPs, and other prerequisite program estimate of the burden of the proposed services provided under the FMIA. collection of information, including the records, and conduct and keep records XIV. Expected Environmental Impact for microbiological testing. Currently, validity of the methodology and catfish establishments must have a assumptions used; and (c) ways to FSIS has tentatively determined that HACCP plan and records and this enhance the quality, utility, and clarity this proposed rule would not have a information collection burden is of the information to be collected; ways significant individual or cumulative reported by FDA. Once this information to minimize the burden of the collection effect on the human environment. collection is approved by OMB, the FDA of information on those who are to Therefore, this proposed action would seafood information collection burden respond, including through the use of be appropriately subject to the will be reduced appropriately. Catfish appropriate automated, electronic, categorical exclusion from the establishments will have to develop, mechanical, or other technological preparation of an environmental submit, and maintain records of labels collection techniques, or other forms of assessment or environmental impact for their catfish products. In addition, information technology. Comments may statement provided under 7 CFR 1b.4(6) they will have to develop nutrition be sent to both John O’Connell, of the U.S. Department of Agriculture labels for their catfish products. There is Paperwork Reduction Act Coordinator, regulations. also a requirement for a consignee of at the address provided above, and the XV. Executive Order 13175, USDA any inspected catfish product who Desk Officer for Agriculture, Office of Nondiscrimination Statement, and refuses to accept delivery of the product Information and Regulatory Affairs, Additional Public Notification because it is adulterated or misbranded Office of Management and Budget, to notify the FSIS Inspector in Charge of Washington, DC 20253. Executive Order 13175 the establishment that prepared the All responses to this notice will be The policies contained in this product. summarized and included in the request proposed rule do not have Tribal In addition, transporters of live catfish for OMB approval. All comments will Implications that preempt Tribal Law. would have to register with the Agency. also become a matter of public record. USDA Nondiscrimination Statement This estimate does not include XII. E-Government Act collections of information that are a The U.S. Department of Agriculture usual and customary part of business’ FSIS and USDA are committed to (USDA) prohibits discrimination in all normal activities. achieving the purposes of the E- its programs and activities on the basis Estimate of Burden: An average of Government Act (44 U.S.C. 3601 et seq.) of race, color, national origin, gender, 0.25 hours per response. by, among other things, promoting the religion, age, disability, political beliefs, Respondents: Official establishments use of the Internet and other sexual orientation, and marital or family that process catfish, catfish importers, information technologies and providing status. (Not all prohibited bases apply to and transporters of live catfish. increased opportunities for citizen all programs.) Persons with disabilities Estimated Number of Respondents: access to Government information and who require alternative means for For catfish defined as Siluriformes, 230: services, and for other purposes. communication of program information There are 23 catfish slaughter and XIII. Executive Order 12988, Civil (Braille, large print, or audiotape) primary processing establishments, 10 Justice Reform should contact USDA’s Target Center at further processing establishments, and 202–720–2600 (voice and TTY). 11 transporters of catfish to processing This proposed rule has been reviewed To file a written complaint of plants, plus approximately 80 import- under Executive Order 12988, Civil discrimination, write USDA, Office of export brokers. Justice Reform. States and local the Assistant Secretary for Civil Rights, For catfish defined as Ictaluridae, 51, jurisdictions are preempted by the 1400 Independence Avenue, SW., including 23 catfish slaughter and FMIA from imposing any marking, Washington, DC 20250–9410 or call processing establishments, at least 10 labeling, packaging, or ingredient 202–720–5964 (voice and TTY). USDA further processing establishments, and requirements on Federally inspected is an equal opportunity provider and 11 transporters of catfish to processing catfish products that are in addition to, employer. plants, plus approximately 7 import- or different than, those imposed under export brokers. the FMIA. States and local jurisdictions Additional Public Notification Estimated Number of Responses per may, however, exercise concurrent Public awareness of all segments of Respondent: 1,512. jurisdiction over catfish products that rulemaking and policy development is

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important. Consequently, in an effort to XVI. Proposed Regulations 9 CFR Part 552 ensure that the public and in particular List of Subjects Catfish and catfish products, Catfish minorities, women, and persons with inspection, Exports. disabilities, are aware of this proposed 9 CFR Part 300 9 CFR Part 555 rule, FSIS will announce it on-line Meat inspection. through the FSIS Web page located at Catfish and catfish products, Catfish http://www.fsis.usda.gov/ 9 CFR Part 441 inspection, Reporting and regulations_&_policies/Proposed_Rules/ Consumer protection standards, Meat recordkeeping requirements, index.asp. and meat products, Poultry products, Transportation. The Regulations.gov Web site is the Catfish and catfish products. central on-line rulemaking portal of the 9 CFR Part 557 United States Government. It is offered 9 CFR Part 530 Catfish and catfish products, Catfish as a public service to increase Catfish and catfish products, Catfish inspection, Food labeling, Food participation in the Federal inspection. packaging, Imports. Government’s regulatory activities. FSIS 9 CFR Part 531 9 CFR Part 559 participates in Regulations.gov and will accept comments about documents Catfish and catfish products, Catfish Catfish and catfish products, Catfish published on the site. The site allows inspection. inspection, Crime, Seizures and forfeitures. visitors to search by keyword or 9 CFR Part 532 Department or Agency for rulemakings 9 CFR Part 560 that provide for public comment. Each Catfish and catfish products, Catfish entry provides a quick link to a inspection, Reporting and Catfish and catfish products, Catfish comment form so that visitors can type recordkeeping requirements. inspection, Intergovernmental relations. in their comments and submit them to 9 CFR Part 533 9 CFR Part 561 FSIS. The Web site is located at Catfish and catfish products, Catfish Administrative practice and http://www.regulations.gov/. inspection, Government employees. procedure, Catfish and catfish products, FSIS also will make copies of this Catfish inspection, Crime, Government 9 CFR Part 534 Federal Register publication available employees. through the FSIS Constituent Update, Aquaculture, Catfish and catfish For the reasons set forth in the which is used to provide information products, Catfish inspection. preamble, 9 CFR chapter III is proposed regarding FSIS policies, procedures, to be amended as follows: regulations, Federal Register notices, 9 CFR Part 537 public meetings, recalls, and other types Catfish and catfish products, Catfish Subchapter A—Agency Organization and of information that could affect, or inspection, Hazard Analysis and Critical Terminology; Mandatory Meat and Poultry would be of interest to, our constituents Control Point (HACCP) Systems, Products Inspection and Voluntary and stakeholders. The update is Sanitation. Inspection and Certification communicated via Listserv, a free e-mail 9 CFR Part 539 PART 300—AGENCY MISSION AND subscription service consisting of ORGANIZATION industry, trade, and farm groups, Animal diseases, Catfish and catfish consumer interest groups, allied health products, Catfish inspection. 1. The authority citation for 9 CFR professionals, scientific professionals, 9 CFR Part 540 part 300 continues to read as follows: and other individuals who have Catfish and catfish products, Catfish Authority: 21 U.S.C. 450–471, 601–695, requested to be included. The update 1031–1056; 7 U.S.C. 138–138i, 450, 1621– also is available on the FSIS Web page inspection. 1627, 1901–1906; 7 CFR 2.7, 2.18, 2.53. at http://www.fsis.usda.gov/ 9 CFR Part 541 2. Section 300.3 is amended by News_&_Events/Constituent_Update/ Catfish and catfish products, Catfish revising paragraphs (a), (b) introductory index.asp. Through Listserv and the inspection, Food labeling, Food text, and (b)(1) to read as follows: Web page, FSIS is able to provide packaging, Nutrition, Reporting and information to a much broader, more § 300.3 FSIS organization. recordkeeping requirements, Signs and diverse audience. symbols. (a) General. The organization of FSIS In addition, FSIS offers an e-mail reflects the Agency’s primary regulatory subscription service which provides an 9 CFR Part 544 responsibilities: implementation of the automatic and customized notification Catfish and catfish products, Catfish FMIA, including catfish, the PPIA, and when popular pages are updated, inspection, Food additives, Food the EPIA. FSIS implements the including Federal Register publications packaging, Laboratories, Reporting and inspection provisions of the FMIA, the and related documents. This service is recordkeeping requirements. PPIA, and the EPIA through its field available at http://origin- structure. www.fsis.usda.gov/News_&_Events/ 9 CFR Part 548 (b) Headquarters. FSIS has ten EmailEmail_Subscription/index.asp and Catfish and catfish products, Catfish principal components or offices, each of allows FSIS customers to sign up for inspection, Food additives, Food which is under the direction of an subscription options in eight categories. packaging, Laboratories, Reporting and Assistant Administrator. The Assistant The subscription options categories recordkeeping requirements, Signs and Administrators, along with their staffs, include recalls, export information, symbols. and the Administrator, along with the regulations, directives, and notices. Office of the Administrator and ten staff Customers can add or delete 9 CFR Part 550 offices that report to the Administrator, subscriptions themselves and have the Catfish and catfish products, Catfish are located at U.S. Department of option to password protect their inspection, Reporting and Agriculture headquarters in accounts. recordkeeping requirements. Washington, DC.

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(1) Program Offices. FSIS’s determine, to provisions of the Act in (ii) If it is, in whole or in part, a raw headquarters offices are the Office of which other amenable species are agricultural commodity and such Public Health Science; the Office of named, except where the Act commodity bears or contains a pesticide Management; the Office of Policy and specifically excludes the provisions chemical which is unsafe within the Program Development; the Office of from applicability to catfish. meaning of section 408 of the Federal Field Operations; the Office of Data Food, Drug, and Cosmetic Act; Integration and Food Protection; the § 530.2 FSIS organization for inspection of (iii) If it bears or contains any food catfish and catfish products. Office of Program Evaluation, additive which is unsafe within the Enforcement, and Review; the Office of The Food Safety and Inspection meaning of section 409 of the Federal Public Affairs and Consumer Education; Service, U.S. Department of Agriculture, Food, Drug, and Cosmetic Act; the Office of Outreach, Employee administers a continuous inspection (iv) If it bears or contains any color Education, and Training; the Office of program for catfish and catfish products. additive which is unsafe within the International Affairs; and the Office of The organization of FSIS and the meaning of section 706 of the Federal Catfish Inspection Programs. principal offices of FSIS and their Food, Drug, and Cosmetic Act: functions are described, and * * * * * Provided, That an article which is not organizational terms defined, in 9 CFR deemed adulterated under paragraphs Subchapter E—Regulatory Requirements part 300. Section 300.3 lists the FSIS (2) (ii), (iii), or (iv) of this section shall under the Federal Meat Inspection Act and district offices and the geographic areas nevertheless be deemed adulterated if the Poultry Products Inspection Act of the districts. use of the pesticide chemical food PART 441—CONSUMER PROTECTION § 530.3 Access to establishments. additive, or color additive in or on such STANDARDS: RAW PRODUCTS article is prohibited by the regulations The provisions of 9 CFR 300.6 apply in this subchapter in official 3. The authority citation for 9 CFR to catfish processing establishments and establishments; part 441 continues to read as follows: related industries as they do to other (3) If it consists in whole or in part of establishments subject to the FMIA. Authority: 21 U.S.C. 451–470, 601–695; 7 any filthy, putrid, or decomposed U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53 PART 531—DEFINITIONS substance or is for any other reason unsound, unhealthful, unwholesome, or § 441.10 [Amended] Sec. otherwise unfit for human food; 4. In § 441.10, remove the term ‘‘Raw 531.1 Definitions. (4) If it has been prepared, packed, or livestock and poultry’’ and add in its held under unsanitary conditions place the term ‘‘Raw livestock, poultry, Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 601–602, 606–622, 624–695; 7 CFR whereby it may have become and catfish’’ at the beginning of the first 2.7, 7 CFR 2.18, 2.53. contaminated with filth, or whereby it sentence of paragraph (a) and at the may have been rendered injurious to beginning of the first sentence of § 531.1 Definitions. health; paragraph (b). As used in this subchapter, unless (5) If it is, in whole or in part, the 5. A new Subchapter F, consisting of otherwise required by the context, the product of an animal which has died Parts 530 to 561, is added to Chapter III following terms shall be construed, otherwise than by slaughter; to read as follows: respectively, to mean: (6) If its container is composed, in Subchapter F—Mandatory Inspection of Act. The Federal Meat Inspection Act, whole or in part, of any poisonous or Catfish and Catfish Products as amended, (34 Stat. 1260, as amended, deleterious substance that may render 81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, the contents injurious to health; PART 530—GENERAL 106 Stat. 4499, 119 Stat. 2166, 122 Stat. (7) If it has been intentionally REQUIREMENTS; DEFINITIONS 1369, 122 Stat. 2130, 21 U.S.C., sec. 601 subjected to radiation, unless the use of et seq.). the radiation was in conformity with a Sec. Adulterated. This term applies to any regulation or exemption in effect 530.1 General. 530.2 FSIS organization for inspection of carcass, part thereof, catfish or catfish pursuant to section 409 of the Federal catfish and catfish products. food product under one or more of the Food, Drug, and Cosmetic Act; 530.3 Access to establishments. following circumstances: (8) If any valuable constituent has been in whole or in part omitted or Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 (1) If it bears or contains any such U.S.C. 601–602, 606–622, 624–695; 7 CFR poisonous or deleterious substance abstracted therefrom; or if any substance 2.7, 7 CFR 2.18, 2.53. which may render it injurious to health; has been substituted, wholly or in part but in case the substance is not an therefor; or if damage or inferiority has § 530.1 General. added substance, such article shall not been concealed in any manner; or if any (a) The regulations in this subchapter be considered adulterated under this substance has been added thereto or provide for the inspection of catfish and clause if the quantity of such substance mixed or packed therewith so as to catfish products. The inspection and in or on such article does not ordinarily increase its bulk or weight, or reduce its regulations are intended to prevent the render it injurious to health; quality or strength, or make it appear sale, transportation, offer for sale or (2)(i) If it bears or contains (by reason better or of greater value than it is. transportation, or receipt for of administration of any substance to Amenable species. A species that is, transportation, in commerce of any the live animal or otherwise) any added and whose products are, subject to the catfish or catfish product that is capable poisonous or added deleterious Act and regulations promulgated under of use as human food and is adulterated substance, other than one which is: the Act, except as the Act may provide. or misbranded at the time of the sale, (A) A pesticide chemical in or on a Animal food. Any article intended for transportation, offer for sale or raw agricultural commodity; use as food for dogs, cats, or other transportation, or receipt for (B) A food additive; or animals, derived wholly, or in part, transportation. (C) A color additive which may, in the from the carcass or parts or products of (b) Catfish as defined in this judgment of the the carcass of any amenable species, subchapter are amenable to the Act, Administrator, make such article unfit except that the term animal food as used including, as the Administrator may for human food; herein does not include:

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(1) Processed dry animal food or Commerce. Commerce between any (2) If it is offered for sale under the (2) Feeds for amenable species State, any Territory, or the District of name of another food; manufactured from processed by Columbia, and any place outside (3) If it is an imitation of another food, products of amenable species. thereof; or within any Territory not unless its label bears, in type of uniform Applicant. Any person who requests organized with a legislative body, or the size and prominence, the word inspection service, exemption, or other District of Columbia. ‘‘imitation’’ and immediately thereafter, authorization under the regulations. Consumer package. Any container in the name of the food imitated; Biological residue. Any substance, which a catfish product is enclosed for (4) If its container is so made, formed, including metabolites, remaining in the purpose of display and sale to or filled as to be misleading; catfish at time of slaughter or in any of household consumers. (5) If in a package or other container their tissues after slaughter as the result Container. Any box, can, tin, cloth, unless it bears a label showing: of treatment or exposure of the catfish plastic, or any other receptacle, (i) The name and place of business of to a pesticide, organic or inorganic wrapper, or cover. the manufacturer, packer, or distributor; compound, hormone, hormone like Dead catfish. The body of catfish that and substance, antihelmintic, or other has died otherwise than by slaughter. (ii) An accurate statement of the therapeutic or prophylactic agent. Dying or diseased catfish. Catfish quantity of the contents in terms of Capable of use as human food. This affected by any of the conditions for weight, measure, or numerical count; term applies to any carcass or part or which the catfish are required to be except as otherwise provided in part product of a carcass of any catfish condemned under part 539 or other 317 of this subchapter with respect to unless it is denatured or otherwise regulations in this subchapter. the quantity of contents; identified as required by section 540.3 Edible. Intended for use as human (6) If any word, statement, or other of this subchapter to deter its use as a food. information required by or under human food, or it is naturally inedible Farm-raised. Grown under controlled authority of the Act to appear on the by humans; e.g., barbels or fins in their conditions, within an enclosed space, as label or other labeling is not natural state. on a farm. prominently placed thereon with such Carcass. All parts, including viscera, Federal Food, Drug, and Cosmetic conspicuousness (as compared with of any slaughtered livestock. Act. The Act so entitled, approved June other words, statements, designs, or Catfish. The skeletal muscle tissue of 25, 1938 (52 Stat. 1040), and Acts devices, in the labeling) and in such catfish. As applied to products of catfish amendatory thereof or supplementary terms as to render it likely to be read species, this term has a meaning thereto. and understood by the ordinary Firm. Any partnership, association, or comparable to that of ‘‘meat’’ in the meat individual under customary conditions other unincorporated business inspection regulations (9 CFR 301.2). of purchase and use; organization. Catfish byproduct. Any catfish part (7) If it purports to be or is Further processing. Smoking, cooking, capable of use as human food, other represented as a food for which a canning, curing, refining, or rendering than the skeletal muscle tissue, that has definition and standard of identity or been derived from one or more catfish. in an official establishment of product previously prepared in official composition has been prescribed by the Catfish food product. Any article regulations in part 319 of this capable of use as human food that is establishments. Immediate container. The receptacle subchapter unless: made wholly or in part from any catfish (i) It conforms to such definition and or part thereof; or any product that is or other covering in which any product is directly contained or wholly or standard, and made wholly or in part from any catfish (ii) Its label bears the name of the food or part thereof, excepting those partially enclosed. Inedible. Adulterated, uninspected, or specified in the definition and standard exempted from definition as a catfish not intended for use as human food. and, insofar as may be required by such product by the Administrator in specific ‘‘Inspected and passed’’ or ‘‘U.S. regulations, the common names of cases or by a regulation in this Inspected and Passed’’ or ‘‘U.S. optional ingredients (other than spices, subchapter; upon a determination that Inspected and Passed by Department of flavoring, and coloring) present in such they contain catfish ingredients only in Agriculture’’ (or any authorized food; a relatively small proportion or abbreviation thereof). This term means (8) If it purports to be or is historically have not been considered by that the product so identified has been represented as a food for which a consumers as products of the catfish inspected and passed under the standard or standards of fill of container food industry, and provided that they regulations in this subchapter, and at have been prescribed by the regulations comply with any requirements that are the time it was inspected, passed, and in part 319 of this subchapter, and it imposed in such cases or regulations as identified, it was found to be not falls below the standard of fill of conditions of such exemptions to ensure adulterated. container applicable thereto, unless its that the catfish meat or other portions of Label. A display of written, printed, label bears, in such manner and form as such carcasses contained in such or graphic matter upon the immediate such regulations specify, a statement articles are not adulterated, and that container (not including package liners) that it falls below such standard; such articles are not represented as of any article. (9) If it is not subject to the provisions catfish food products. Labeling. All labels and other written, of paragraph (7)(ii) of this section unless Catfish product. Any catfish or catfish printed, or graphic matter: its label bears: part; or any product that is made wholly (1) Upon any article or any of its (i) The common or usual name of the or in part from any catfish or catfish containers or wrappers, or food, if any there be, and part, except for those exempted from (2) Accompanying such article. (ii) In case it is fabricated from two or definition as a catfish product by the Misbranded. This term applies to any more ingredients, the common or usual Administrator in a regulation in this carcass, part thereof, meat or meat food name of each such ingredient, except as subchapter. Except where the context product under one or more of the otherwise provided in part 317 of this requires otherwise (e.g., in part 540 of following circumstances: subchapter; this subchapter), this term is limited to (1) If its labeling is false or misleading (10) If it purports to be or is articles capable of use as human food. in any particular; represented for special dietary uses,

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unless its label bears such information form a container, wrapper, label, or U.S. Retained. This term means that concerning its vitamin, mineral, and cover for meat products. the catfish, part, or product of catfish so other dietary properties as is required by Person. Any individual, firm, or identified is held for further the regulations in part 317 of this corporation. examination by an inspector at an subchapter. Pesticide chemical, food additive, official establishment to determine its (11) If it bears or contains any color additive, raw agricultural disposal. artificial flavoring, artificial coloring, or commodity. These terms shall have the United States. The States, the District chemical preservative, unless it bears a same meanings for purposes of the Act of Columbia, and the Territories of the label stating that fact; except as and the regulations in this subchapter as United States. otherwise provided by the regulations in under the Federal, Drug, and Cosmetic part 317 of this subchapter; or Act. PART 532—REQUIREMENTS FOR (12) If it fails to bear, directly thereon Prepared. Slaughtered, canned, salted, INSPECTION or on its containers, when required by rendered, boned, cut up, or otherwise Sec. the regulations in part 316 or 317 of this manufactured or processed. 532.1 Establishments requiring inspection; subchapter, the inspection legend and, Process authority. A person or other inspection. unrestricted by any of the foregoing, organization with expert knowledge in 532.2 Application for inspection. such other information as the catfish production process control and 532.3 Exemption of retail operations. Administrator may require in such relevant regulations. This definition 532.4 Inspection at official establishments; regulations to assure that it will not does not apply to § 548.6 of this relation to other authorities. subchapter or to subpart G of part 318 532.5 Exemption from definition of catfish have false or misleading labeling and product of certain human food products that the public will be informed of the of this chapter. containing catfish. manner of handling required to Process schedule. A written maintain the article in a wholesome description of processing procedures, Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 consisting of any number of specific, U.S.C. 601–602, 606–622, 624–695; 7 CFR condition. 2.7, 7 CFR 2.18, 2.53. Nonfood compound. Any substance sequential operations directly under the proposed for use in official control of the establishment employed § 532.1 Establishments requiring establishments, the intended use of in the manufacture of a specific product, inspection; other inspection. which will not result, directly or including the control, monitoring, (a) No establishment may process or indirectly, in the substance becoming a verification, validation, and corrective prepare catfish, catfish parts, or catfish component or otherwise affecting the action activities associated with products capable of use as human food, characteristics of meat food and meat production. This definition does not or sell, transport, or offer for sale or products excluding labeling and apply to § 548.6 of this subchapter or to transportation in commerce any of these packaging materials as covered in part subpart G of part 318 of this chapter. articles without continuous inspection 541 of this subchapter. Producer. Any person engaged in the under these regulations, except as Official certificate. Any certificate business of growing farm-raised catfish. expressly exempted in § 532.3. prescribed by the regulations in this Product. Any carcass, catfish, catfish (b) Inspection under the regulations is subchapter for issuance by an inspector product, or catfish food product, required at: (1) Every establishment, or other person performing official capable of use as human food. except as provided in the regulation on functions under the Act. Program. The organizational unit exemption of retail operations (§ 532.3), Official device. Any device prescribed within the Department having the in which any catfish or catfish products by the regulations in part 312 of this responsibility for carrying out the are wholly or in part, processed for subchapter for use in applying any provisions of the Act. transportation or sale in commerce, as official mark. Program employee. Any inspector or articles intended for use as human food. Official establishment. Any other individual employed by the (2) Every establishment, except as slaughtering, cutting, boning, catfish Department or any cooperating agency provided in the regulation on exemption product canning, curing, smoking, who is authorized by the Secretary to do of retail operations (§ 532.3), within any salting, packing, rendering, or similar any work or perform any duty in State or organized territory which is establishment at which inspection is connection with the Program. designated pursuant to section 301 of maintained under the regulations in this Slaughter. With respect to catfish, the Act (21 U.S.C. 661), at which any subchapter. intentional killing under controlled catfish or catfish products are processed Official import inspection conditions. for use as human food solely for establishment. This term means any State. Any State of the United States distribution within that State or establishment, other than an official or the Commonwealth of Puerto Rico. territory. establishment as defined in this section, Territory. Guam, the Virgin Islands of (3) Except as provided in the where inspections are authorized to be the United States, American Samoa, and regulation on exemption of retail conducted as prescribed in part 557 of any other territory or possession of the operations (§ 532.3), every this subchapter. United States. establishment designated by the Official inspection legend. Any U.S. Condemned. This term means administrator under section 301 of the symbol prescribed by the regulations in that the catfish, part, or product of Act (21 U.S.C. 661) as one producing this subchapter showing that an article catfish so identified was inspected and adulterated catfish products which was inspected and passed in accordance found to be adulterated and is would clearly endanger the public with the Act. condemned. health. Official mark. The official inspection U.S. Detained. This term applies to (4) Coverage of catfish and catfish legend or any other symbol prescribed catfish, catfish products, and other products processed in official by the regulations in this subchapter to articles which are held in official establishments. All catfish and catfish identify the status of any article, catfish, custody in accordance with section 402 products prepared in an official or catfish product under the Act. of the Act (21 U.S.C. 672), pending establishment must be inspected, Packaging material. Any cloth, paper, disposal as provided in the same section handled, processed, marked, and plastic, metal, or other material used to 402. labeled as required by the regulations.

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(5) Other inspection. Periodic recordkeeping and other requirements PART 533—SEPARATION OF inspections may be made of: within the scope of § 550.1 of this ESTABLISHMENT; FACILITIES FOR (i) The records of all persons engaged chapter, if consistent with those INSPECTION; FACILITIES FOR in the business of hatching, feeding, requirements, with respect to the PROGRAM EMPLOYEES; OTHER growing, or transporting catfish between establishment. REQUIRED FACILITIES premises where catfish are bred, (b) Labeling, packaging, or ingredient hatcheries, and premises where catfish Sec. requirements in addition to or different 533.1 Separation of establishments. are grown, and from these premises to than those made under this subchapter, 533.2 [Reserved] processing establishments. the Federal Food, Drug, and Cosmetic 533.3 Facilities for Program employees. (ii) Exempted retail establishments to Act and Fair Packaging and Labeling 533.4 Other facilities and conditions to be determine that those establishments are Act may not be imposed by any State or provided. operating in accordance with these local jurisdiction with respect to any 533.5 Schedule of operations. regulations. 533.6 Overtime and holiday inspection catfish or catfish products processed at service. § 532.2 Application for inspection. any official establishment in accordance 533.7 Basis of billing for overtime and with the requirements under this (a) Application for inspection is as holiday services. subchapter and those Acts. required by 9 CFR 304.1. Authority: 21 U.S.C. 601–602, 606–622, (b) Information to be furnished is as § 532.5 Exemption from definition of 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. required by 9 CFR 304.2(a), (b), and catfish product of certain human food § 533.1 Separation of establishments. (c)(1). Conditions for receiving products containing catfish. Each official establishment shall be inspection, including having written The following articles contain catfish separate and distinct from any unofficial Sanitation SOPs and HACCP plans, are ingredients only in a relatively small establishment and from any other as required by 9 CFR 304.3. proportion or historically have not been official establishment, except an (c) Official numbers; inauguration of considered by consumers as products of establishment preparing products under inspection; withdrawal of inspection; the catfish food products industry. the FMIA, the PPIA, or the EPIA, or reports of violation. The requirements Therefore, the articles are exempted under State catfish inspection for assignment of official numbers, from the definition of ‘‘catfish product’’ requirements and authorities that are inauguration of inspection, withdrawal and the requirements of the Act and the deemed to be at least equal to those of inspection, and reports of violations regulations that apply to catfish provided under the FMIA. Further, at catfish processing establishments are products, if they comply with the doorways, or other openings, may be as required by 9 CFR part 305 for meat conditions specified in this section. permitted between establishments at the establishments. (a) Any human food product if: discretion of the Administrator and (d) Assignment and authorities of under such conditions as he may program employees. The requirements (1) It contains less than 3 percent raw prescribe. An official establishment that concerning the assignment and or 2 percent cooked catfish; is not separate and distinct from another authorities of Program employees at (2) The catfish ingredients used in the official or unofficial establishment must catfish processing establishments are as product were prepared under Federal ensure that no sanitary hazards are required by 9 CFR parts 306 and 307 inspection or were inspected under a created by the lack of separation. with respect to Program employees at foreign inspection system approved meat establishments. under § 557.2 of this chapter and § 533.2 [Reserved] § 532.3 Exemption of retail operations. imported in compliance with the Act § 533.3 Facilities for Program employees. and the regulations; The exemption in 9 CFR 303.1(d) for Office space, including necessary operations of types traditionally and (3) The immediate container of the furnishings, light, heat, and janitor usually conducted at retail stores and product bears a label which shows the service, must be provided by official restaurants applies with respect to name of the product in accordance with establishments, rent free, for the catfish products as it does with respect this section; and exclusive use for official purposes of the to products of other amenable species (4) The product is not represented as inspector and other Program employees under the FMIA. However, a retail a catfish product. The percentage of assigned thereto. The space set aside for quantity of catfish or catfish products cooked catfish ingredients must be this purpose shall meet with approval of sold to a household consumer is a computed on the basis of the moist, the District Manager or the frontline normal retail quantity if it does not deboned, cooked catfish in the ready-to- supervisor and must be conveniently exceed 75 pounds and the quantity of serve product when prepared according located, properly ventilated, and catfish or catfish product sold by a retail to the serving directions on the provided with lockers suitable for the supplier to a non-household consumer consumer package. protection and storage of Program supplies and with facilities suitable for is a normal retail quantity if it does not (b) A product exempted under this exceed 150 pounds in the aggregate. Program employees to change clothing if section will be deemed to be such facilities are deemed necessary by § 532.4 Inspection at official represented as a catfish product if the the frontline supervisor. At the establishments; relation to other term ‘‘catfish’’ or a term representing a discretion of the Administrator, small authorities. fish species that is covered by the establishments requiring the services of (a) Requirements within the scope of definition of ‘‘catfish’’ in part 531 of this less than one full-time inspector need the Act with respect to premises, subchapter is used in the product name not furnish facilities for Program facilities, and operations of any official of the product without appropriate employees as prescribed in this section, establishment that are in addition to or qualification. where adequate facilities exist in a different than those made under this (c) A product exempted under this nearby convenient location. Laundry subchapter may not be imposed by any section is subject to the requirements of service for inspectors’ outer work State or local jurisdiction except that the the Federal Food, Drug, and Cosmetic clothing must be provided by each State or local jurisdiction may impose Act. establishment.

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§ 533.4 Other facilities and conditions to 307.5 apply to catfish processing for holding the catfish. The vats or other be provided. establishments. containers must be maintained in a When required by the District sanitary condition. Sufficient water and § 533.7 Basis of billing for overtime and Manager or the frontline supervisor, sufficient oxygen must be provided to each official establishment must provide holiday services. The requirements for billing and the vats that hold the catfish to ensure the following facilities and conditions, that catfish delivered to the processing and such others as may be found to be overtime and holiday inspection services are as required by 9 CFR 307.6. establishment will not be adulterated. essential to efficient conduct of Any catfish that are dead, dying, inspection and maintenance of sanitary PART 534—PRE–HARVEST diseased, or contaminated with conditions: (a) Sufficient light to be adequate for STANDARDS AND TRANSPORTATION substances that may adulterate catfish the proper conduct of inspection; TO PROCESSING ESTABLISHMENT. products are subject to condemnation at the official catfish processing (b) Tables, benches, and other Sec. equipment on which inspection is to be 534.1 General. establishments. performed, of such design, material, and 534.2 Water quality for food fish. construction as to enable Program 534.3 Standards for use of drugs in the PART 537—SANITATION employees to conduct their inspection raising of catfish. REQUIREMENTS AND HAZARD in a ready, efficient and clean manner; 534.4 Transportation to processing plant. ANALYSIS AND CRITICAL CONTROL (c) Receptacles for holding and Authority: 21 U.S.C. 601–602, 606–622, POINTS SYSTEMS handling diseased carcasses and parts, 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. so constructed as to be readily cleaned Sec. and to be marked in a conspicuous § 534.1 General. 537.1 Basic requirements. manner with the phrase ‘‘U.S. Catfish that are harvested for use as 537.2 Hazard analysis and HACCP plan. Condemned’’ in letters not less than 2 human food must have grown and lived Authority: 21 U.S.C. 601–602, 606–622, inches high, and, when required by the under conditions that will not render 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. frontline supervisor, to be equipped in the catfish or their products unsound, a way that allows the receptacles to be unwholesome, unhealthful, or otherwise § 537.1 Basic requirements. locked or sealed; unfit for human food. (a) Any official establishment that (d) Adequate arrangements, including § 534.2 Water quality for food fish. prepares or processes catfish or catfish liquid soap and cleansers, for cleansing products for human food must comply and disinfecting hands, for sterilizing all Producers of catfish should monitor with the requirements contained in 9 implements used in handling diseased the water in which the fish are raised for CFR parts 416 and 417, except as carcasses, for cleaning and sanitizing the presence of suspended solids, floors, and such other articles and organic matter, nutrients, heavy metals, otherwise provided in this subchapter. places as may be contaminated by pesticides, fertilizers, and industrial (b) For the purposes of 9 CFR parts diseased carcasses or otherwise; chemicals that may contaminate fish. 416, 417, and 500, an ‘‘official (e) Adequate facilities, including FSIS will collect samples of feed, fish, establishment’’ or ‘‘establishment’’ denaturing materials, for the proper and pond water from producers, at includes a plant that prepares or disposal of condemned articles in intervals to be determined by the processes catfish or catfish products. accordance with the regulations in this Administrator, for the purpose of subchapter; verifying that catfish are being raised § 537.2 Hazard analysis and HACCP plan. (f) Docks and receiving rooms, to be under conditions that will yield safe, (a) A catfish establishment’s hazard designated by the operator of the official wholesome products. analysis shall take into account the food establishment, with the frontline § 534.3 Standards for use of drugs in the safety hazards that can occur before, supervisor, for the receipt and raising of catfish. inspection of catfish, catfish products, during, and after harvest. New animal drugs that are the subject or other products. (b) The failure of an establishment to of an approved new animal drug (g) Suitable lockers in which brands develop and implement a hazard application (NADA) or abbreviated new bearing the official inspection legend analysis and a HACCP plan that comply animal drug application (ANADA) and other official devices (excluding with this part or to operate in labels) can be stored. Official certificates under section 512 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 accordance with the requirements of 9 shall be kept when not in use in suitable CFR chapter III, subchapter E, will file cabinets. All such lockers and file USC 360b], or a conditional approval under section 571 of the Act [21 USC render the products produced under cabinets shall be equipped for sealing or these conditions adulterated. locking with locks or seals to be 360ccc], or an investigational exemption under section 512(j) of the Act [21 supplied by the Department. The keys of PART 539—MANDATORY U.S.C. 360b(j)] may be used in the such locks shall not leave the custody DISPOSITIONS; PERFORMANCE of Program employees. raising of catfish. New animal drugs approved under section 512 of the Act STANDARDS RESPECTING PHYSICAL, § 533.5 Schedule of operations. may be used in an extra-label manner if CHEMICAL, OR BIOLOGICAL The requirements governing the such use complies with section CONTAMINANTS schedule of operations for catfish 512(a)(4) of the Act and FDA regulations Sec. processing establishments are as found at 21 CFR part 530. 539.1 Disposal of diseased or otherwise required by 9 CFR 307.4 for meat adulterated catfish carcasses and parts or establishments. § 534.4 Transportation to processing plant. catfish products. § 533.6 Overtime and holiday inspection A vehicle used to transport catfish 539.2 Physical, chemical, or biological service. from a producer’s premises to a contaminants. The requirements governing overtime processing establishment must be Authority: 21 U.S.C. 601–602, 606–622, and holiday inspection service in 9 CFR equipped with vats or other containers 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53.

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§ 539.1 Disposal of diseased or otherwise establishment, and that are subject to § 541.1 General. adulterated catfish carcasses and parts or sorting and disposal at the official The marks, devices, and certificates catfish products. establishment, no catfish or part of the prescribed or referenced in this part are (a)(1) Carcasses or parts of catfish carcass of catfish that died otherwise official marks, devices, and certificates affected by abscesses or lesions, non- than by slaughter may be brought onto for the purposes of the Act respecting zoonotic parasites such as cestodes, or the premises of an official establishment catfish and catfish products. The marks, such parasites as digenean trematodes, without advance permission from the devices, and certificates shall be used metacercaria (Bolbophorus spp.), yellow FSIS frontline supervisor. only in accordance with the regulations grubs (Clinostomum spp.), or white (b) The official establishment shall in this part. grubs (Hysterbmorpha spp.) are subject maintain physical separation between to condemnation unless properly § 541.2 Official marks and devices to slaughtered catfish and the edible parts identify inspected and passed catfish and disposed of by the establishment to or products of slaughtered catfish and catfish products. prevent their use as human food. (2) Catfish affected by Heterophyid any catfish or parts of catfish that have (a)(1) The official inspection legend intestinal flukes or Dictophymatidae died otherwise than by slaughter. required by this part must be shown on nematodes are subject to condemnation Catfish or any parts of catfish that have all labels for inspected and passed unless properly disposed of by the died otherwise than by slaughter shall catfish and catfish products and must be establishment. be excluded from any room or in the following form prescribed in 9 (b) Catfish affected by diseases, compartment in which edible product is CFR 312.2(b)(1) for inspected and including columnaris (infection by prepared, handled, or stored. passed products of cattle, sheep, swine, Flexibacter columnaris) and enteric and goats, or in another form to be § 540.2 Specimens for educational, prescribed by the Administrator, except septicemia of catfish (ESC), are subject research, and other nonfood purposes; that it need not be of the size illustrated, to condemnation unless properly permits. if it is of a sufficient size and color to disposed of by the establishment to be conspicuously displayed, and readily prevent their use as human food. The requirements of 9 CFR 314.9 legible, and in the same proportions of (c) Catfish carcasses or parts or catfish apply to the handling and release of letter size and boldness are maintained products that are found to be in a state specimens of condemned or other as illustrated: of spoilage or decomposition are subject inedible catfish materials. to condemnation unless properly § 540.3 Handling and disposal of disposed of by the establishment to condemned or other inedible materials. prevent their use as human food. (d) Grossly deformed fish may not be Condemned or other inedible catfish used for human food. and catfish parts shall be separated from edible catfish. If not disposed of on the § 539.2 Physical, chemical, or biological premises of the establishment, the contaminants. condemned and inedible catfish parts (a) Catfish and catfish products that shall be conveyed from the official are contaminated with physical matter establishment for disposition at a are subject to official retention and rendering plant, an animal feed condemnation. manufacturing establishment, or at (2) The official inspection legend (b) Antibiotic or other drug residues another establishment for other non- shall contain the words ‘‘U.S. Inspected in catfish tissues must be within food use. If not decharacterized by use and Passed’’ or an abbreviation of those applicable tolerances in 21 CFR part of approved denaturants or colorings, words approved by the Administrator. 556. the inedible materials shall be enclosed (b) This official mark must be applied (c) Pesticide residues in catfish tissues in containers that are conspicuously by mechanical means and must not be must be within applicable tolerances in marked to indicate that the contents are applied by a hand stamp. 40 CFR part 180. condemned or otherwise inedible. The (c)(1) The official inspection legend, (d) Catfish or catfish products materials may be shipped under or the approved abbreviation of the containing violative concentrations of company or official seal to a rendering legend, must be printed on consumer drugs or other chemicals are subject to facility or for other inedible processing. packages and other immediate condemnation. containers of inspected and passed PART 541—MARKS, MARKING AND catfish products or on labels to be PART 540—HANDLING AND LABELING OF PRODUCTS AND securely affixed to the containers of the DISPOSAL OF CONDEMNED AND CONTAINERS products and may be printed or OTHER INEDIBLE MATERIALS stenciled on the containers but must not Sec. Sec. be applied by rubber stamping. 541.1 General. (2) The official inspection legend may 540.1 Dead catfish. 541.2 Official marks and devices to identify 540.2 Specimens for educational, research, also be used for the purposes of marking inspected and passed catfish and catfish and other nonfood purposes; permits. shipping containers, band labels, and 540.3 Handling and disposal of condemned products. other articles with the approval of the or other inedible materials. 541.3 Official seals for transportation of Administrator. products. (d) Whole gutted catfish carcasses that Authority: 21 U.S.C. 601–602, 606–622, 541.4 Official export inspection marks, 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. have been inspected and passed in an devices, and certificates. official establishment and are intended § 540.1 Dead catfish. 541.5 Official detention marks and devices. for sale as whole gutted catfish must be (a) With the exception of dead catfish 541.7 Labels required; supervision of a marked or labeled in a manner that will that have died en route to an official Program employee. ensure that the catfish carcasses are establishment that have been received Authority: 21 U.S.C. 601–602, 606–622, identified as ‘‘Inspected and Passed’’ and with live catfish at the official 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. will not become misbranded while in

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commerce. The official inspection inspection marks, filling of containers, 548.8 Polluted water contamination at legend used for this purpose must be in relabeling of products, the storage and establishment. the form illustrated below or in another distribution of labels, and the 548.9 Accreditation of non-Federal form determined by the Administrator: requirements for packaging materials, chemistry laboratories. apply to catfish and catfish products. Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 (b) The requirements in part 441, U.S.C. 601–602, 606–622, 624–695; 7 CFR subchapter E, governing water retained 2.7, 7 CFR 2.18, 2.53. from processing in raw meat and § 548.1 Preparation of catfish products. poultry, apply to retained water in catfish. The requirements in part 442, (a) All processes used in preparing subchapter E, governing quantity of any catfish product in official contents labeling, the testing of scales, establishments shall be subject to and the handling of product that is inspection by Program employees found to be out of compliance with net unless such preparation is conducted as § 541.3 Official seals for transportation of weight requirements, apply to catfish or consists of operations that are products. and catfish products. exempted from inspection under 9 CFR The official mark for use in sealing (1) Packages of frozen or fresh-frozen 303.1. No fixtures or appliances, such as railroad cars, cargo containers, or other catfish carcasses or parts must be tables, trucks, trays, tanks, vats, means of conveyance as prescribed in labeled to reflect 100-percent net weight machines, implements, cans, or part 555 of this subchapter must be the after thawing. The de-glazed net weight containers of any kind, shall be used inscription and serial number shown in must average 100 percent of the stated unless they are of such materials and 9 CFR 312.5 or another official mark net weight of the frozen product when construction as will not contaminate or approved by the Administrator. Any sampled and weighed according to the otherwise adulterate the product and are seal approved by the Administrator for method prescribed in National Institute clean and sanitary. All steps in the applying the official mark is an official of Standards and Technology (NIST) preparation of edible products shall be device for the purposes of the Act. The Handbook 133 Chapter 2, Section 2.6.36 conducted carefully and with strict seal must be attached to the means of (2) [Reserved] cleanliness in rooms or compartments conveyance only by a Program (c) Nutrition labeling. The separate from those used for inedible employee, who shall also affix a requirements for nutrition labeling of products. ‘‘Warning Tag’’ (Form MP–408–3 or meat and meat food products in part (b) It shall be the responsibility of the similar official form). 317, subpart B, of this chapter, also operator of every official establishment § 541.4 Official export inspection marks, apply to the labeling of catfish and to comply with the Act and the devices, and certificates. catfish food products. regulations in this subchapter. To carry out this responsibility effectively, the (a) The official export inspection mark PART 544—FOOD INGREDIENTS operator of the establishment shall for catfish required by part 552 of this PERMITTED subchapter must be in the same form as institute appropriate measures to ensure that specified in 9 CFR 312.8(a) or Sec. the maintenance of the establishment otherwise as prescribed by the 544.1 Use of food ingredients. and the preparation, marking, labeling, Administrator. Authority: 21 U.S.C. 601–602, 606–622, packaging and other handling of its (b) The official export certificate for 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. products strictly in accordance with the catfish and catfish products required by sanitary and other requirements of this part 552 of this subchapter must be in § 544.1 Use of food ingredients. subchapter. the same form as that prescribed for (a) No catfish product may bear or § 548.2 Requirements concerning meat and meat food products in 9 CFR contain any food ingredient that would render it adulterated or misbranded or ingredients and other articles used in the 312.8(b) or otherwise as prescribed by preparation of catfish products. the Administrator. that is not approved in part 424 of subchapter E, or in this part or All ingredients and other articles used § 541.5 Official detention marks and elsewhere in this subchapter, or by the in the preparation of any catfish product devices. Administrator in specific cases. must be clean, sound, healthful, The official mark for shipments of (b) (Reserved) wholesome, and otherwise such as will articles and catfish detained under this not result in the product’s being subchapter is the designation ‘‘U.S. PART 548—PREPARATION OF adulterated. Detained,’’ and the official device for PRODUCTS applying the mark is the official ‘‘U.S. § 548.3 Samples of products, water, dyes, Sec. chemicals, etc. to be taken for examination. Detained’’ tag (FSIS Form 8400–2) as 548.1 Preparation of catfish products. prescribed in 9 CFR 329.2 or otherwise 548.2 Requirements concerning ingredients Samples of products, water, dyes, by the Administrator. and other articles used in the preparation chemicals, preservatives, spices, or of catfish products. other articles in any official § 541.7 Labels required; supervision of a 548.3 Samples of products, water, dyes, establishment shall be taken, without Program employee. chemicals, etc. to be taken for cost to the Program, for examination, as (a) General labeling requirements. The examination. often as may be deemed necessary for 548.4 Mixtures containing product but not requirements in part 317, subpart A, of the efficient conduct of the inspection. this chapter, governing labels and amenable to the Act. labeling, safe-handling labeling, 548.5 Ready-to-eat catfish products. § 548.4 [Reserved] abbreviations of official marks, labeling 548.6 Canning and canned products. 548.7 Use of animal drugs. approval, generically approved labeling, § 548.5 Ready-to-eat catfish products. the use of approved labels, the labeling 36 U.S. Department of Commerce. NIST Handbook Ready-to-eat catfish products are of products for foreign commerce, 133: Checking the Net Contents of Packaged Goods, subject to the requirements in part 430, prohibited practices, the reuse of official Fourth Edition, January 2005. Washington, DC. subchapter E, of this chapter.

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§ 548.6 Canning and canned products. persons that engage in businesses (b) The requirements for the issuance The requirements for canning and relating to the carcasses, parts, or of export certificates are as prescribed in canned products in 9 CFR part 318, products of other species amenable to § 322.2 of this chapter. subpart G (§§ 318.300–318.311) apply to the FMIA. (c) The requirements for clearing catfish products that are canned. vessels and other transportation § 550.2 Place of maintenance of records. vehicles are set out in § 322.4 of this § 548.7 Use of animal drugs. The requirements in 9 CFR 320.2 for chapter. Edible tissues of catfish with residues the place where records are to be exceeding tolerance levels specified in maintained apply in the keeping of PART 555—TRANSPORTATION OF 21 CFR part 556 are adulterated within records under this part. CATFISH PRODUCTS IN COMMERCE the meaning of section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic § 550.3 Record retention period. Sec. The record retention requirements in 555.1 Transportation of catfish products. Act because they bear or contain a new 555.2 Catfish product transported within animal drug that is unsafe within the 9 CFR 320.3 apply to records required the United States as part of export meaning of section 512 of the Federal to be kept under this part. movement. Food, Drug, and Cosmetic Act. § 550.4 Access to and inspection of 555.3 Unmarked, inspected catfish product transported under official seal between § 548.8 Polluted water contamination at records, facilities and inventory; copying and sampling. official establishments for further establishment. processing; certificate. In the event that there is polluted The provisions of 9 CFR 320.4 apply 555.4 Handling of catfish products that may water (including but not limited to flood to businesses dealing in catfish and have become adulterated. water) in an official establishment, all catfish products. 555.5 Transportation of inedible catfish products and ingredients for use in the product in commerce. § 550.5 Registration. preparation of the products that have 555.6 Certificates. been rendered adulterated by the water The registration requirements in 9 555.7 Official seals; forms, use, and CFR 320.5 apply to persons engaging in breaking. must be condemned. After the polluted 555.8 Loading or unloading of catfish water has receded from the businesses, in or for commerce, relating to catfish and catfish products as they products in sealed transport establishment, the establishment must conveyances. follow the cleaning and sanitizing do to persons engaging in businesses 555.9 Diverting of shipments. procedures in § 318.4 of subchapter A of relating to the carcasses, parts, and 555.10 Provisions inapplicable to this chapter. products, or any livestock, of other specimens for laboratory examination, animal species that are amenable to the etc., or to naturally inedible articles. § 548.9 Accreditation of non-Federal FMIA. 555.11 Transportation and other chemistry laboratories. transactions concerning dead, dying, or A non-Federal analytical laboratory § 550.6 Information and reports required diseased catfish, and catfish or parts of from official establishment operators. that has met the requirements for catfish that died otherwise than by accreditation specified in 9 CFR 439 and The information and reporting slaughter. 555.12 Means of conveyance in which hence, at an establishment’s discretion, requirements in 9 CFR 320.6 for operators of official establishments dead, dying, or diseased catfish or parts may be used in lieu of an FSIS of catfish must be transported. laboratory for analyzing official apply with respect to catfish and catfish regulatory samples. Payment for the products as they do with respect to Authority: 7 U.S.C. 450; 21 U.S.C. 601– other species amenable to the FMIA. 602, 606–622, 624–695; 7 CFR 2.7, 7 CFR analysis of regulatory samples is to be 2.18, 2.53. made by the establishment using the § 550.7 Reports by consignees of allegedly accredited laboratory. adulterated or misbranded products; sale or § 555.1 Transportation of catfish products. transportation as violations. (a) No person may sell, transport, offer PART 549—[RESERVED] The requirements in 9 CFR 320.7 for for sale or transportation, or receive for reports by consignees of allegedly transportation, in commerce, any catfish PART 550—RECORDS REQUIRED TO or catfish product that is capable of BE KEPT adulterated or misbranded products apply with respect to catfish and catfish being used as human food and is Sec. products as they do with respect to adulterated or fails to bear an official 550.1 Records required to be kept. products of other species amenable to inspection legend or is otherwise 550.2 Place of maintenance of records. the Act. misbranded at the time of such sale, 550.3 Record retention period. transportation, offer or receipt, except 550.4 Access to and inspection of records, PART 552—EXPORTS otherwise provided in this paragraph or facilities and inventory; copying and in part 557 of this chapter. sampling. Sec. (b) No person, engaged in the business 550.5 Registration. 552.1 Affixing stamps and marking of buying, selling, freezing, storing, or 550.6 Information and reports required products for export; issuance of export from official establishment operators. certificates; clearance of vessels and transporting, in or for commerce, catfish 550.7 Reports by consignees of allegedly transportation. products capable of use as human food, adulterated or misbranded products; sale or importing such articles, shall Authority: 21 U.S.C. 601–602, 606–622, or transportation as violations. transport, offer for transportation, or 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. Authority: 21 U.S.C. 601–602, 606–622, receive for transportation, in commerce 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. § 552.1 Affixing stamps and marking or in any State designated under § 560.3 products for export; issuance of export of this subchapter, any catfish product § 550.1 Records required to be kept. certificates; clearance of vessels and which is capable of use as human food The requirements in 9 CFR 320.1 for transportation. and is not wrapped, packaged, or records to be kept apply to persons that (a) The manner of affixing stamps and otherwise enclosed to prevent engage in businesses relating to catfish marking products for export is that adulteration by airborne contaminants, and catfish products as they do to prescribed in § 322.1(a) of this chapter. unless the railroad car, truck, or other

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means of conveyance in which the establishment to another official report the facts by telephone or product is contained or transported is establishment are the same as those in telegraph to the District Manager in the completely enclosed with tight fitting § 325.5 of this chapter that apply to area in which the emergency occurs. doors or other covers for all openings. unmarked inspected meat products. The report must include the following In all cases, the means of conveyance information: shall be reasonably free of foreign matter § 555.4 Handling of catfish products that (1) Nature of the emergency. may have become adulterated. (such as dust, dirt, rust, or other articles (2) Place where seals were broken. or residues), and free of chemical The provisions of § 325.10 regarding (3) Original points of shipment and residues, so that product placed therein the handling of products that may have destination. will not become adulterated. become adulterated or misbranded (4) Number and initial of the original (c) Any cleaning compound, lye, soda apply to catfish and catfish products. car or truck. solution, or other chemical used in (5) Number and initials of the car or § 555.5 Transportation of inedible catfish truck into which the articles are cleaning the means of conveyance must product in commerce. be thoroughly removed from the means reloaded. of conveyance prior to its use. Such The provisions in § 325.11(e) of this (6) New destination of the shipment. means of conveyance onto which chapter regarding the transportation of (7) Kind and amount of articles. inedible livestock products apply to the product is loaded, being loaded, or § 555.10 Provisions inapplicable to intended to be loaded, shall be subject transportation of inedible catfish parts or products. specimens for laboratory examination, etc., to inspection by an inspector at any or to naturally inedible articles. official establishment. § 555.6 Certificates. The provisions of this part do not (d) The decision whether or not to The provisions in § 325.14 of this apply: inspect a means of conveyance in a chapter regarding the filing of original (a) To specimens of product sent to or specific case, and the type and extent of certificates of unmarked inspected meat by the Department of Agriculture or such inspection shall be at the Agency’s products delivered to carriers applies divisions thereof in Washington, DC, or discretion and shall be adequate to with respect to catfish and catfish elsewhere, for laboratory examination, determine if catfish product in such products. exhibition purposes, or other official conveyance is, or when moved could use; become, adulterated. § 555.7 Official seals; forms, use, and (b) To material released for (e) Circumstances of transport that breaking. can be reasonably anticipated shall be educational, research, and other The official seals required by this part nonfood purposes, as prescribed in considered in making said are those prescribed in § 541.3 and determination. These include, but are § 540.2 of this subchapter; § 312.5 of this chapter. (c) To tissues for use in preparing not limited to, weather conditions, pharmaceutical, organotherapeutic, or duration and distance of trip, nature of § 555.8 Loading or unloading of catfish product covering, and effect of products in sealed transport conveyances. technical products and not used for human food, as described in § 540.2 of restowage at stops en route. Any means The requirements in 9 CFR 325.18 this subchapter; of conveyance found upon such governing the unloading of any meat or (d) To material or specimens of inspection to be in such condition that meat food product from an officially product for laboratory examination, catfish product placed therein could sealed railroad car, truck, or other research, or other nonhuman food become adulterated shall not be used means of conveyance containing any purposes, when authorized by the until such condition which could cause unmarked product or loading any means Administrator, and under conditions adulteration is corrected. of conveyance after the product leaves prescribed by him in specific cases; and (f) Catfish product placed in any an official establishment are applicable (e) To articles that are naturally means of conveyance that is found by to catfish and catfish products. the inspector to be in such condition inedible by humans. § 555.9 Diverting of shipments. that the catfish product may have § 555.11 Transportation and other become adulterated shall be removed (a) Shipments of inspected and passed transactions concerning dead, dying, or from the means of conveyance and catfish products that bear the inspection diseased catfish, and catfish or parts of handled in accordance with part 539 or legend may be diverted from the catfish that died otherwise than by § 540.3 of this subchapter. original destination without a slaughter. reinspection of the articles if the No person engaged in the business of § 555.2 Catfish product transported within waybills, transfer bills, running slips, buying, selling, or transporting in the United States as part of export movement. conductor’s card, or other papers commerce, or importing any dead, accompanying the shipments are dying, or diseased catfish or parts of When any shipment of any catfish marked, stamped, or have attached catfish that died otherwise than by product is offered to any carrier for thereto signed statements in accordance slaughter shall: transportation within the United States with § 325.15. (a) Sell, transport, offer for sale or as a part of an export movement, the (b) In case of a wreck or similar transportation, or receive for same certificate shall be required as if extraordinary emergency, the transportation, in commerce, any dead, the shipment were destined to a point Department seals on a railroad car or dying, or diseased catfish or parts of within the United States. other means of conveyance containing catfish that died otherwise than by § 555.3 Unmarked, inspected catfish any inspected and passed product may slaughter, unless the catfish and parts product transported under official seal be broken by the carrier, and if are consigned and delivered, without between official establishments for further necessary, the articles may be reloaded avoidable delay, to establishments of processing; certificate. into another means of conveyance, or animal food manufacturers, renderers, The requirements governing the shipment may be diverted from the or collection stations that are registered transportation of catfish product that original destination, without another as required by part 550 of this has been inspected and passed, but not shipper’s certificate; but in all such subchapter, or to official establishments so marked, from one official cases the carrier must immediately that operate under Federal inspection,

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or to establishments that operate under from the means of conveyance of any (1) Import. To bring within the a State or Territorial inspection system fluid, parts, or product of dead, dying, territorial limits of the United States approved by FSIS as one that imposes or diseased catfish and the thorough whether that arrival is accomplished by requirements at least equal to the application of a disinfectant approved land, air, or water. Federal requirements for purposes of by the Administrator to the interior (2) Offer for entry. Presentation of the paragraph 301(c) of the Act; surfaces of the cargo space. imported product by the importer to the (b) Buy in commerce or import any Program for reinspection. dead, dying, or diseased catfish or parts PART 557—IMPORTATION (3) Entry. The point at which of catfish that died otherwise than by Sec. imported product offered for entry slaughter, unless he is an animal food 557.1 Definitions; application of receives reinspection and is marked manufacturer or renderer and is provisions. with the official mark of inspection in registered as required by part 550 of this 557.2 Eligibility of foreign countries for accordance with § 557.26 of this subchapter, or is the operator of an importation of catfish products into the subchapter. establishment inspected as required by United States. (b) The provisions of this part shall paragraph (a) of this section and such 557.3 No catfish product to be imported apply to catfish and catfish products catfish or parts of catfish are to be without compliance with applicable regulations. that are capable of use as human food. delivered to establishments eligible to 557.4 Imported catfish products; foreign Compliance with the conditions for receive them under paragraph (a) of this certificates required. importation of products under this part section; 557.5 Importer to make application for does not excuse the need for compliance (c) Unload en route to any inspection of catfish products for entry. with applicable requirements under establishment eligible to receive them 557.6 Catfish products for importation; other laws, including the provisions in under paragraph (a) of this section, any program inspection, time and place; part 94 of chapter I of this title. dead, dying, or diseased catfish or parts application for approval of facilities as of catfish that died otherwise than by official import inspection establishment; § 557.2 Eligibility of foreign countries for slaughter, which are transported in refusal or withdrawal of approval; importation of catfish products into the official numbers. United States. commerce or imported by any such 557.7 Products for importation; movement person: Provided, That any such dead, prior to inspection; handling; bond; (a) The requirements in 9 CFR dying, or diseased catfish, or parts of assistance. 327.2(a)(1), 327.2(a)(2)(i), catfish may be unloaded from a means 557.8 Import catfish products; equipment 327.2(a)(2)(ii)(C)–(I), 327.2(a)(2)(iii)–(iv), of conveyance en route where necessary and means of conveyance used in and 327.2(a)(3), for determining the in case of a wreck or otherwise handling to be maintained in sanitary acceptability of foreign meat inspection extraordinary emergency, and may be condition. systems for the importation of meat and 557.9 [Reserved] meat food products into the United reloaded into another means of 557.10 Samples; inspection of conveyance; but in all such cases, the consignments; refusal of entry; marking. States, apply in determining the carrier must immediately report the 557.11 Receipts to importers for import acceptability of foreign catfish facts by telephone or other electrical or catfish products samples. inspection systems for the importation electronic means to the Office of 557.12 Foreign canned or packaged catfish of catfish and catfish products into the Program Evaluation, Enforcement, and products bearing trade labels; sampling United States. In determining the Review, Food Safety and Inspection and inspection. acceptability of these systems, the 557.13 Foreign catfish products offered for Service, U.S. Department of Agriculture, Agency will evaluate the manner in importation; reporting of findings to which they take into account the Washington, DC 20250. Customs. (d) Load into any means of 557.14 Marking of catfish products and conditions under which catfish are conveyance containing any dead, dying, labeling of immediate containers thereof raised and transported to a processing or diseased catfish, or parts of catfish for importation. establishment. that died otherwise than by slaughter, 557.15 Outside containers of foreign (b)(1) It has been determined that while in the course of importation or products; marking and labeling; catfish and catfish products from the other transportation in commerce any application of official inspection legend. following countries covered by foreign 557.16 Small importations for importer’s inspection certificates of the country of catfish or parts of catfish not within the own consumption; requirements. foregoing description or any other 557.17 Returned U.S. inspected and marked origin as required by 9 CFR 557.4, are products or other commodities. catfish products. eligible under the regulations in this 557.18 Catfish products offered for entry subchapter for entry into the United § 555.12 Means of conveyance in which and entered to be handled and States after inspection and marking as dead, dying, or diseased catfish or parts of transported as domestic; exception. required by the applicable provisions of catfish must be transported. 557.19 Specimens for laboratory this part: (None listed as of All vehicles and other means of examination and similar purposes. [PUBLICATION DATE OF FINAL 557.20–557.23 [Reserved] conveyance used by persons subject to RULE]). § 555.11 for transporting in commerce or 557.24 Appeals; how made. 557.25 Disposition procedures for catfish (2) Persons interested in having the importing, any dead, dying, or diseased most recent list of eligible countries and catfish or parts of catfish that died product condemned or ordered destroyed under import inspection. establishments may contact the Office of otherwise by slaughter must be leak 557.26 Official import inspection marks International Affairs, Food Safety and proof and so constructed and equipped and devices. Inspection Service, U.S. Department of as to permit thorough cleaning and Authority: 21 U.S.C. 601–602, 606–622, Agriculture, Washington, DC 20250. sanitizing. The means of conveyance 624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. used in conveying the catfish or parts of § 557.3 No catfish product to be imported catfish must be cleaned and disinfected § 557.1 Definitions; application of without compliance with applicable before being used in the transportation provisions. regulations. of any product intended for use as (a) When used in this part, the No catfish or catfish product offered human food. The cleaning procedure following terms shall be construed to for importation from any foreign must include the complete removal mean: country shall be admitted into the

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United States if it is adulterated or or established sampling plans and authorized by section 21(b) of the misbranded or does not comply with all established product, country, and plant Federal Water Pollution Control Act, as the requirements of this subchapter that history. amended (84 Stat. 91), or that the would apply to it if it were a domestic (4) When the inspector deems it requirements of paragraph (e) of this product. necessary, the inspector may sample section were not complied with. and inspect lots not designated by the Approval may be withdrawn in § 557.4 Imported catfish products; foreign electronic system. accordance with section 401 of the Act certificates required. (b) Catfish and catfish products and applicable rules of practice. Except as provided in § 557.16, each required by this part to be inspected (h) A special official number shall be consignment containing any catfish or must be inspected only at an official assigned to each official import catfish products consigned to the United establishment or at an official import inspection establishment. Such number States from a foreign country must be inspection establishment approved by shall be used to identify all products accompanied by a foreign inspection the Administrator as provided in this inspected and passed for entry at the certificate for catfish and catfish section. establishment. products. The certificate, in paper or (c) Owners or operators of (i) A product examination must be electronic format, must contain those establishments, other than official made, as provided in paragraph (a) of data elements that the Administrator establishments, who want to have this section, of a foreign catfish or may prescribe to carry out the intent of import inspections made at their catfish product, including defrosting if this section. establishments, shall apply to the necessary to determine its condition. Administrator for approval of their Inspection standards for foreign chilled § 557.5 Importer to make application for establishments for such purpose. inspection of catfish products for entry. fresh or frozen fresh catfish shall be the Application must be made on a form same as those used for domestic catfish (a) Each importer must apply for furnished by the Program, Food Safety or catfish products. Samples may be inspection of any catfish product offered and Inspection Service, U.S. Department collected at no cost to FSIS and for entry (See Sec. 301.2(yyy)). of Agriculture, Washington, DC, 20250, submitted to an FSIS laboratory for (b) The application should be made as and must include all information called analysis (See § 557.18). long as possible in advance of the for by that form. anticipated arrival of each consignment (d) Approval for Federal import (j) Imported canned products are into the United States, except in case of inspection must be in accordance with required to be sound, healthful, consignments of products expressly §§ 304.1 and 304.2 of this chapter. Also, properly labeled, wholesome, and exempted from inspection by §§ 557.16 before approval is granted, the otherwise not adulterated at the time the and 557.17. establishment must have developed products are offered for importation into (c) Each application must state the written Sanitation Standard Operating the United States. Provided other approximate date on which the Procedures in accordance with part 416 requirements of this part are met, the consignment is due to arrive at such of this chapter. determination of the acceptability of the port in the United States, the name of (e) Owners or operators of product and the condition of the the ship or other carrier transporting it, establishments at which import containers shall be based on the results the name of the country from which the inspections of product are to be made of an examination of a statistical sample product was, or is to be, shipped, the shall furnish adequate sanitary facilities drawn from the consignment as place where inspection is desired in and equipment for examination of such provided in paragraph (a) of this accordance with § 557.6, the quantity product. The requirements of §§ 307.1, section. If the inspector determines, on and kind of product, and whether it is 307.2 (b), (d), (f), (h), (k), and (l) and the basis of the sample examination, fresh, cured, canned or otherwise 416.1 through 416.6 of this chapter shall that the product does not meet the prepared. In case of consignments apply as conditions for approval of requirements of the Act and regulations arriving in the United States by water, establishments as official import thereunder, the consignment shall be the application must state the port of inspection establishments to the same refused entry. However, a consignment first arrival in the United States. extent and in the same manner as they rejected for container defects but apply with respect to official otherwise acceptable may be reoffered § 557.6 Catfish products for importation; for inspection under the following program inspection, time and place; establishments. application for approval of facilities as (f) The Administrator is authorized to conditions: official import inspection establishment; approve any establishment as an official (1) If the defective containers are not refusal or withdrawal of approval; official import inspection establishment indicative of an unsafe and unstable numbers. provided that an application has been product as determined by the (a)(1) Except as provided in §§ 557.16 filed in accordance with the Administrator; and 557.17, all catfish products offered requirements of paragraphs (c) and (d) (2) If the number and kinds of for entry from any foreign country shall of this section and he determines that container defects found in the original be reinspected by a Program inspector such establishment meets the sample do not exceed the limits before they shall be allowed entry into requirements under paragraph (e) of this specified for this purpose in FSIS the United States. section. Any application for inspection guidelines; and (2) Every lot of product shall routinely under this section may be denied or (3) If the defective containers in the be given visual inspection by a Program refused in accordance with the rules of consignment have been sorted out and import inspector for appearance and practice in part 500 of this chapter. exported or destroyed under the condition, and checked for certification (g) Approval of an official import supervision of an inspector. and label compliance. inspection establishment may be (k) Program inspectors or Customs (3) FSIS operates an electronic system withdrawn in accordance with officers at border or seaboard ports shall to provide reinspection instructions. applicable rules of practice if it is report the sealing of cars, trucks, or The electronic system assigns re- determined that the sanitary conditions other means of conveyance, and the inspection levels and procedures that are such that the product is rendered sealing or identification of containers of are based on established sampling plans adulterated, that such action is foreign product to Program personnel at

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points where such product is to be containers trade labels that have or have § 557.18 Catfish products offered for entry inspected. not been approved in accordance with and entered to be handled and transported (l) Representative samples of canned the regulations in § 541.7 of this as domestic; exception. product designated by the subchapter are to be sampled and The regulations in 9 CFR 327.18 Administrator in instructions to inspected in the same manner as governing the offer for entry into the inspectors shall be incubated under provided by § 327.12 of this chapter for United States of meat and meat food supervision of such inspectors in foreign canned meat food products. products apply with respect to catfish accordance with § 318.309(d)(1)(ii), and catfish products. Products that fail (d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), § 557.13 Foreign catfish products offered to meet these regulatory requirements (d)(1)(vii) and (d)(1)(viii) of this for importation; reporting of findings to are subject to penalties as administered subchapter. The importer or his/her Customs. by the U.S. Port Director of Customs and Border Protection. Likewise, the agent shall provide the necessary Program inspectors are to report their products may be subject to detention incubation facilities in accordance with findings as to any catfish product that § 318.309(d)(1)(i) of this subchapter. and to being proceeded against as (m) Sampling plans and acceptance has been inspected in accordance with determined by the Administrator. levels as prescribed in paragraphs (j) this part in the same manner as that provided by § 327.13 of this chapter for § 557.19 Specimens for laboratory and (l) of this section may be obtained, examination and similar purposes. upon request, from the Office of meat products. Catfish products that are International Affairs, Food Safety and refused entry are to be handled in the Importation of catfish or catfish Inspection Service, U.S. Department of same manner as provided by § 327.13 product samples for trade show Agriculture, Washington, DC 20250. for meat products that are refused entry. exhibition, laboratory examination, Import personnel will identify to the research, evaluative testing, trade show § 557.7 Products for importation; Port Director of U.S. Customs and exhibition, or other scientific purposes movement prior to inspection; handling; Border Protection and the Importer of are subject to the same conditions as bond; assistance. record any products refused entry into imported meat or meat product The requirements in 9 CFR 327.7 the United States. specimens under § 327.19. respecting the movement or conveyance § 557.20–557.23 [Reserved] from any port, or delivery to the § 557.14 Marking of catfish products and consignee, of any product required to be labeling of immediate containers thereof for § 557.24 Appeals; how made. inspected under part 327, apply to importation. An appeal from a decision of any catfish and catfish products. The regulations in 9 CFR 327.14 Program employee is to be made as § 557.8 Import catfish products; governing the marking of meat and meat provided by 9 CFR 327.24. equipment and means of conveyance used food products and the labeling of § 557.25 Disposition procedures for in handling to be maintained in sanitary immediate containers of those products catfish product condemned or ordered condition. for importation apply with respect to destroyed under import inspection. Compartments of ocean vessels, catfish and catfish products. Disposition procedures for railroad cars, and other means of condemned catfish or catfish products conveyance transporting any catfish or § 557.15 Outside containers of foreign ordered destroyed under import products; marking and labeling; application catfish product to the United States, and inspection are as those for carcasses, of official inspection legend. all trucks, chutes, platforms, racks, parts, meat, and meat food products tables, tools, utensils, and all other The requirements in 9 CFR 327.15 under 9 CFR 327.25. devices used in moving and handling governing the marking and labeling of any catfish or catfish product offered for § 557.26 Official import inspection marks outside containers of meat and meat importation into the United States, shall and devices. food products apply also with respect to be maintained in a sanitary condition. The official inspection legend and catfish and catfish products. other marks to be applied to imported § 557.9 [Reserved] § 557.16 Small importations for importer’s catfish and catfish products are as § 557.10 Samples; inspection of own consumption; requirements. required by 9 CFR 327.26 for meat food consignments; refusal of entry; marking. products prepared from cattle, sheep, The exemption in 9 CFR 327.16 for The provisions in 9 CFR 327.10 swine, and goats. small importations of meat or meat food governing the taking of samples, the products for the importer’s own PART 559—DETENTION, SEIZURE, inspection of consignments, the refusal CONDEMNATION of entry, and the controlled pre- consumption applies with respect to catfish or catfish products. stamping of shipments of meat and meat Sec. food products apply with respect to § 557.17 Returned U.S. inspected and 559.1 Catfish and other articles subject to catfish and catfish products. marked catfish products. administrative detention. 559.2 Articles or catfish subject to judicial § 557.11 Receipts to importers for import U.S. inspected and passed and so seizure and condemnation. catfish product samples. marked catfish products exported to and 559.3 Criminal offenses. FSIS will issue to importers official returned from foreign countries will be Authority: 7 U.S.C. 450; 21 U.S.C. 601–602, receipts for samples of foreign products admitted into the United States without 606–622, 624–695; 7 CFR 2.7, 7 CFR 2.18, collected for laboratory analysis, as compliance with this part upon 2.53. provided in § 327.11 of this chapter. notification of and approval by the § 559.1 Catfish and other articles subject § 557.12 Foreign canned or packaged Assistant Administrator, Office of to administrative detention. catfish products bearing trade labels; International Affairs, Food Safety and The provisions of 9 CFR 329.1 sampling and inspection. Inspection Service, U.S. Department of through 329.5 governing the Foreign canned or packaged catfish Agriculture, Washington, DC 20250, in administrative detention of carcasses, products bearing on their immediate specific cases. parts, meat, and meat food products of

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livestock apply also with respect to the cooperate with any State (including PART 561—RULES OF PRACTICE carcasses, parts, and products of catfish. Puerto Rico) or any organized Territory in developing and administering a meat Sec. § 559.2 Articles or catfish subject to inspection program for the State or 561.1 Rules of practice governing judicial seizure and condemnation. Territory apply with respect to catfish inspection actions. 561.2 Rules of practice governing The provisions of 9 CFR 329.6 products inspection. through 329.8 governing the judicial proceedings under the Federal Meat Inspection Act. seizure and condemnation of carcasses, § 560.2 Cooperation of States in Federal parts, meat, and meat food products of programs. Authority: 7 U.S.C. 450; 21 U.S.C. 601– livestock apply also with respect to the Under the ‘‘Talmadge-Aiken Act’’ of 602, 606–622, 624–695; 7 CFR 2.7, 7 CFR carcasses, parts, and products of catfish. September 28, 1962 (7 U.S.C. 450), the 2.18, 2.53. Administrator is authorized to utilize § 559.3 Criminal offenses. § 561.1 Rules of practice governing employees and facilities of any State in inspection actions. The criminal provisions of the Act carrying out Federal functions under the apply with respect to the inspection of FMIA, including functions relating to The rules of practice in part 500 of catfish and catfish products as they do the inspection of catfish and catfish this chapter, governing inspection with respect to the inspection of other products. A cooperative program for this actions taken by FSIS with respect to food products subject to the Act. purpose is called a Federal-State establishments and products, apply to program. actions taken with respect to catfish PART 560—STATE–FEDERAL, processing establishments, catfish, and FEDERAL–STATE COOPERATIVE § 560.3 Designation of States under the catfish products regulated under this AGREEMENTS; STATE Federal Meat Inspection Act subchapter. DESIGNATIONS The requirements in part 331 of this chapter apply with respect to catfish § 561.2 Rules of practice governing Sec. and catfish products inspection, proceedings under the Federal Meat Inspection Act. 560.1 Cooperation with States and including: Territories. 560.2 Cooperation of States in Federal (a) The requirements in 9 CFR 331.3 The procedures that the Agency must programs. governing the designation of States for follow before reporting a violation of the 560.3 Designation of States under the Federal inspection under section 301(c) Federal Meat Inspection Act for Federal Meat Inspection Act. of the Act (21 U.S.C. 661(c)); prosecution by the Department of (b) The requirements in 9 CFR 331.5 Authority: 7 U.S.C. 450; 21 U.S.C. 601–602, Justice are given in part 335, subchapter 606–622, 624–695; 7 CFR 2.7, 7 CFR 2.18, governing the designation under section A of this chapter. 2.53. 301(c) of the Act of establishments whose operations would clearly Done, at Washington, DC. § 560.1 Cooperation with States and endanger the public health; and Alfred V. Almanza, Territories. (c) The requirements in 9 CFR 331.6 Administrator. The provisions in § 321.1 of this governing the designation of States [FR Doc. 2011–3726 Filed 2–18–11; 8:45 am] chapter authorizing the Administrator to under paragraph 205 of the Act. BILLING CODE 3410–DM–P

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