Mandatory Inspection of Catfish and Catfish Products

Federal RegisterFeb 24, 2011

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 300, 441, 530-534, 537, 539-554, 544, 548, 550, 552, 555, 557, and 559-561

[Docket No. FSIS-2008-0031]

RIN 0583-AD36

Mandatory Inspection of Catfish and Catfish Products

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is proposing regulations requiring continuous inspection of catfish and catfish products. FSIS is proposing these regulations to implement provisions of the Food, Conservation, and Energy Act (Farm Bill) of 2008. The proposed regulations are intended to ensure that catfish products distributed in commerce are wholesome, not adulterated, and properly marked, labeled, and packaged.

DATES:

Comments must be received on or before June 24, 2011.

ADDRESSES:

FSIS invites interested persons to submit comments on this proposed rule. Comments may be submitted by either of the following methods:

•

Federal eRulemaking Portal:

This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to

http://www.regulations.gov.

Follow the online instructions at that Web site for submitting comments.

•

Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items:

Send to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, Room 2-2127 George Washington Carver Center, 5601 Sunnyside Avenue, Beltsville, MD 20705.

Instructions:

All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2008-0031. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to

http://www.regulations.gov.

Docket:

For access to background documents or comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Dr. Daniel Engeljohn, Assistant Administrator, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 350-E Whitten Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700; (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Table of Contents

Background

I. Farm Bill Mandate for Catfish Inspection

II. 2002 Farm Bill

III. 2008 Farm Bill

IV. Defining “Catfish”

V. Catfish Farming and Processing

VI. Current Inspection of Domestic and Imported Catfish

VII. Public Health Protection: Chemical and Microbiological Contaminants

VIII. Proposed Regulations Implementing Continuous Inspection of Catfish and Catfish Products

A. Coverage of the FMIA: provisions applicable to catfish and catfish products

B. Catfish and catfish product inspection regulations under the FMIA

IX. FSIS Implementation

X. Executive Order 12866 and Regulatory Flexibility Act

XI. Paperwork Reduction Act

XII. E-Government Act

XIII. Executive Order 12988, Civil Justice Reform

XIV. Expected Environmental Impact

XV. Executive Order 13175, USDA Nondiscrimination Statement, and Additional Public Notification

XVI. Proposed Regulations

Background

I. Farm Bill Mandate for Catfish Inspection

The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, § 10016(b)), known as the 2008 Farm Bill, amended the Federal Meat Inspection Act (FMIA) to provide that “catfish, as defined by the Secretary,” is an amenable species (21 U.S.C. 601 (w)(2)). Catfish and catfish products are therefore subject to continuous inspection under the FMIA, which FSIS administers. The definition of “catfish” determines the scope of the FSIS inspection program. FSIS considered two possible definitions: Fish belonging to the family Ictaluridae and, a broader definition, all fish of the order Siluriformes. If catfish are defined as all fish of the order Siluriformes, FSIS will inspect domestically produced and imported Siluriformes, including basa, swai, and others. If the term “catfish” is defined as fish of the family Ictaluridae, FSIS will inspect all domestically and foreign produced Ictaluridae, which would account for virtually all of domestically produced Siluriformes and approximately 20-25% of foreign produced Siluriformes. Such a rule would cover approximately 70% of Siluriformes consumed in the United States in recent years. This proposed rule is silent on the scope of the term “catfish”. USDA is asking for public comments on the scope of the definition and will fully define and describe the term in the final rule. For purposes of convenience, this proposed rule uses the term “catfish” to refer to all fish classified within the order of Siluriformes. The use of this term is not with prejudice to what fish FSIS will ultimately determine to be “catfish” for purposes of the final rule.

II. 2002 Farm Bill

Before 2002, various species of fish in the order Siluriformes were commonly labeled and sold as “catfish” in the United States. However, the Farm Security and Rural Investment Act of 2002, known as the 2002 Farm Bill, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a section declaring, for the purposes of the FD&C Act and notwithstanding any other provision of law, that the term “catfish” is the common or usual name (or part thereof) only of fish classified in the family Ictaluridae and permitting the labeling or advertising only for fish classified in that family to include the term “catfish” (21 U.S.C. 321d(a), 343(t); Pub. L. 107-171, Title X, § 10806, 116 Stat. 526).

Accordingly, non-Ictaluridae Siluriformes, such as fish belonging to the family of Pangasiidae that are produced in Asia (

e.g.,

basa, tra, and swai), could no longer be marketed as “catfish” in the United States. FDA advised importers to use alternative common or usual names for these non-Ictaluidae species that did not include the term “catfish,” and suggested ways of devising those names.

The FD&C Act, as amended, (21 U.S.C. 321

et seq.

) prohibits the adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce (21 U.S.C 331(b)). A food is considered misbranded if, among other circumstances of misbranding, its labeling is false or misleading (21 U.S.C. 343(a)(1)); it is offered for sale under the name of another food (21 U.S.C. 343(b)); if its label does not bear the common or usual name of the food, if there is any, or, if the food is made of two or more ingredients, the common or usual name of the ingredients (21 U.S.C. 343(i)); or if it purports to be or is represented as catfish, unless it is fish classified within the family Ictaluridae (21 U.S.C. 343(t)). The provision in 21 U.S.C. 321d, “Market names for catfish and ginseng,” on catfish labeling, states, “(a)(1) Notwithstanding any other provision of law, for the purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301

et seq.

)—(A) the term “catfish” may only be considered to be a common or usual name (or part thereof) for fish classified within the family Ictaluridae; and (B) only labeling or advertising for fish classified within that family may include the term “catfish.”

U.S. Department of Health and Human Services. Food and Drug Administration. February 28, 2003.

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

In the 2008 Farm Bill (the Food, Conservation, and Energy Act (Farm Bill) of 2008 (Pub. L. 110-246, § 11016(b)), Congress gave the Secretary of Agriculture and, by delegation, FSIS, the authority to determine to which fish the term “catfish” would apply.

III. 2008 Farm Bill

In amending the FMIA to make “catfish” an amenable species (21 U.S.C. 601(w)(2)), Congress recognized that there are differences in how catfish and the other species that are subject to the FMIA are slaughtered and processed. The Farm Bill added 21 U.S.C. 625, which provides that the sections of the FMIA dealing with ante-mortem and post-mortem inspection and humane slaughter (21 U.S.C. 603, 604), inspection of carcasses and parts before their entry into establishments or further-processing departments (21 U.S.C. 605), and exemptions from inspection for custom and farm slaughter and processing and other exemptions (21 U.S.C. 623), do not apply to catfish.

The 2008 Farm Bill also revised 21 U.S.C. 606, which requires the appointment of inspectors to examine and inspect all meat food products prepared for commerce, by designating the existing section as 21 U.S.C. 606(a) and adding a paragraph, 21 U.S.C. 606(b). This new paragraph provides that the examination and inspection of meat food products derived from catfish are to take into account the conditions under which catfish are raised and transported to processing establishments.

The 2008 Farm Bill provides that the amendments are not to apply until the date on which the Agency issues final regulations to carry out the amendments. The Bill instructs the Agency to consult with the FDA in issuing these final regulations.

IV. Defining “Catfish”

The definition of “catfish” is a threshold issue in this rulemaking as it determines the scope of the FSIS catfish inspection program. Before discussing the options for how to define “catfish”, it is first helpful to review the scientific classification, or taxonomy, of the catfishes.

Taxonomy of the Catfishes

Taxonomy is the science of classification. Seven major hierarchical groupings are used to classify all living organisms. These are kingdom, phylum, class, order, family, genus, and species. The kingdom is the broadest grouping. The kingdom Animalia, for example, includes all known animals. The kingdom is comprised of individual phyla, phyla of classes, classes of orders, orders of families, families of genera, and genera of species. In the taxonomy of the fishes, fish of the order Siluriformes are commonly and collectively known as “catfishes” (Table 1).

Table 1

—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 à labyrinths)

Family

Cranoglanididae (armorhead catfishes, armoured catfishes)

Family

Diplomystidae (diplomystid catfishes, velvet catfishes)

Family

Doradidae (bagres sierra, poissons-chats épineux, 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 American freshwater catfishes)

Family

Lacantuniidae

Family

Loricariidae (armored catfishes, loricariidés, plecoóstomas, 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 à longues moustaches)

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 family Ictaluridae, the North American catfish, to which belong the fork-tailed channel catfish (

Ictalurus punctatus

) and blue catfish (

I. furcatus

), the principal U.S. farm-raised species, and the flathead catfish (

Pylodictis olivaris

). Other species in the United States that are in the Ictaluridae family are the white catfish (

I. catus

), and the black, brown, and yellow bullhead (

I. melas, I. nebulosus,

and

I. natalis

). Also among the Siluriformes are the air-breathing catfishes of the Clariidae family, to which belongs

Clarias fuscus,

a Chinese species raised on a small scale in Hawaii.

Adapted from Integrated Taxonomic Information System (ITIS) report on “Siluriformes.” At

http://www.itis.gov

(accessed October 4, 2009).

Another family of Siluriformes, the Pangasiidae, the so-called “giant catfishes,”

includes the aquaculture species basa (

Pangasius bocourti),

and tra or swai (

Pangasius hypophthalmus;

synonym,

Pangasius sutchi

), raised principally in Southeast Asia for domestic consumption and export. Other catfish types commercially raised in Asia include the hybrid

Clarias macrocephalus

and North American channel catfish (

I. punctatus

ITIS report on “Siluriformes.” At

http://www.itis.gov

(accessed Jan. 26, 2009).

Options for Defining “Catfish”

The Agency settled on two options for defining “catfish” after reviewing the legislative and regulatory history and scientific classification system. One option, was a definition adopted by Congress in the 2002 Farm Bill that defined “catfish” to be only fish of the Ictaluridae family for marketing and labeling purposes under the FD&C Act. This is the current definition used by FDA in its seafood program. The other option was an order definition including all fish of the order Siluriformes. This definition was used by FDA prior to the 2002 Farm Bill, and would follow established scientific practice that defines “catfish” as all fish of the order Siluriformes.

The 2008 Farm Bill grants the Secretary of Agriculture the authority to define “catfish” anew for purposes of the 2008 amendments of the FMIA. The FMIA, like the FD&C Act, prohibits the adulteration and misbranding of foods that are subject to it. Accordingly, FSIS examined the available data in deciding how it could carry out the FMIA to the best effect.

Specifically, the Agency looked at data describing the presence of chemical residues in, and the presence of microorganisms on or in, catfish or catfish products, and the amount and types of catfish and catfish products consumed in the United States. Sparse information on the distribution of microbial contamination and chemical residues on catfish limit our ability to make strong statements about the baseline risk. Furthermore, the lack of experience in implementing continuous inspection programs in the context of aquaculture makes estimating the impact of such a program on risk difficult. However, the Agency has been able to conduct an illustrative assessment of potential human health risks associated with catfish consumption, using

Salmonella

as the example.

The Agency considered information about the extent of misbranding, and it evaluated outputs from its benefit-cost analysis for catfish inspection.

U.S. Department of Agriculture. Food Safety and Inspection Service. Office of Public Health Science. December 2010. Draft Risk Assessment of the Potential Human Health Effect of Applying Continuous Inspection to Catfish. Washington, DC.

USDA is requesting public comments on the scope of the definition of the term “catfish.”

V. Catfish Farming and Processing

Domestic Catfish Farming and Processing

The catfish growing process in the United States begins after eggs from breeding ponds are transferred to hatcheries. Hatchlings are reared in the hatcheries for several days before being placed in nursery or fry ponds, where they are raised until, as 3-inch to 8-inch fingerlings, they are transferred to grow-out ponds. There, the fish are fed a ration of pelletized floating feed made with soybean meal, fishmeal, corn, wheat, or other grains until they reach marketable size.

In some instances, medicated feeds containing antimicrobials may be fed to catfish for therapeutic treatment of bacterial infections. Also, pond water may be treated with chemicals to control algal growth and prevent off-flavor in the fish.

Catfish-raising ponds are generally of two types: Levee or delta ponds and watershed ponds. Levee ponds are built on flat land and filled with groundwater or surface water. In hilly areas, dams built across valleys and between hillsides capture runoff from rainfall to fill “watershed” ponds. Though water to fill and maintain watershed ponds usually comes from watershed runoff, wells are often necessary to supplement the watershed supply. Watershed ponds tend to be deeper than levee ponds and can efficiently nourish more fish per acre than levee ponds.

Water quality—proper temperature, pH, ammonia, nitrite, alkalinity, hardness, carbon dioxide, chloride, and oxygen—must be maintained to ensure fish health and maximize feed efficiency. Aerators are used to prevent oxygen depletion in the ponds. The oxygen levels are monitored regularly to ensure fish health and to help in limiting algal blooms.

When catfish reach marketable length and weight—optimally 9 to 12 inches and 0.75 to 1.5 pounds—they are collected with seines and put in aerated tanks mounted on trucks that then transport fish to the processing plant. A truck may carry from 4 to 10 of these vats, each loaded with about 3,000 pounds of water and catfish.

The following generally describes catfish processing in the United States. Individual operations may vary. At the processing plant, fish are unloaded into a holding vat and carried by conveyor to an electrical stunner. The fish are then sorted and sized. Fish of incorrect species, such as shad (used in the ponds

to reduce algae), or incorrect size are sorted out. Fish of the correct size are sent to the next operation where they are headed and gutted. Next, the fish are trimmed and mounted on conveyors and sent tail-first through filleting machinery. After further trimming, including removal of the belly flap, or “nugget,” fillets are skinned and sent through a chiller. Fillets are then prepared for packaging or freezing. Nuggets may be used in lower-grade edible product.

Most catfish fillets are shipped frozen. Preservatives, including sodium tripolyphosphate, may be used as humectants or to minimize oxidation and freezer burn. Some fillets are sold fresh; some marinated; and some breaded. Little if any U.S. farm-raised catfish undergoes complex processing. There are few multi-ingredient commercial catfish products. Fish too big for further processing with automated equipment are sent through a separate processing line to be hand-processed and sold as whole gutted fish (head on), mainly to restaurants and institutions.

Waste materials and byproducts from heading, gutting, and trimming are taken from the food processing area of the establishment to be separately processed or packaged and shipped. Muscle tissue separated from bones, called mince, may be processed into surimi (a white-fish food product). Other byproducts may be rendered to produce fish oils, or they may be used in animal feed manufacture, or processed into fishmeal or fertilizer. Fish heads may be sold as bait for commercial fishermen.

Foreign Catfish Farming and Processing

Foreign catfish farming and processing is done in a similar manner to that of the United States, but it may differ in specific methods. In general, it is more labor-intensive than U.S. farming and processing. It may involve the use of hatcheries and inland ponds. In some countries, however, catfish may be grown in net enclosures in rivers, in floating cages, sometimes alongside or under houseboats, or in “raceway” inlets fed by river waters.

Fish may be fed homemade or pelleted feed. Homemade feed is composed of fishmeal, mixed with rice bran. (In the United States, only a very low percentage of catfish feed—zero to 3 percent—is fishmeal.) In some instances, pelleted feed can be a source of contamination with unapproved antimicrobials or chemical residues.

Some reports suggest that antimicrobials prohibited for extra-label use in food-producing animals in the United States (

e.g.,

fluoroquinolones) have been used in the raising of catfish in foreign countries.

Also, the quality of the river water is more difficult to control or less subject to control by fish farmers than is pond water.

U.S. Department of Health and Human Services. Food and Drug Administration. July 2007. Congressional Testimony: Safety of Chinese Imports. Washington, DC; U.S. Department of Health and Human Services. Food and Drug Administration. November 2008. Enhanced Aquaculture and Seafood Inspection—Report to Congress. Washington, DC.

VI. Current Inspection of Domestic and Imported Catfish

U.S. catfish processors, exporters, and importers are subject to the U.S. Food and Drug Administration's seafood Hazard Analysis Critical Control Point (HACCP) regulations (21 CFR 123) and to other requirements under the Food, Drug, and Cosmetic (FD&C) Act. FDA's regulations on current good manufacturing practices (cGMPs, at 21 CFR part 110) and on recordkeeping and registration requirements (21 CFR part 1, subpart H), issued under the Bioterrorism Act of 2002 (Pub. L. 107-188, Jun. 12, 2002) also apply to these establishments.

For imported products, FDA requires that the importer either (1) obtain fish or fish products from a country that has an active memorandum of understanding with FDA that covers the product and documents the equivalence or compliance of the foreign inspection system with that of the United States, or (2) have and implement written verification procedures for ensuring fish and fish products offered for import into the United States were processed in accordance with FDA regulations in 21 CFR part 123 (21 CFR 123.12).

The arrangement for imported fish products does not presuppose a regulatory finding by FDA that the foreign inspection system is equivalent to that of the United States, nor does FDA conduct continuous re-inspection of imported fish products as a condition of their entry into the United States.

In addition to FDA regulations, some U.S. catfish processing establishments have contracted for voluntary, fee-for-service inspection and certification programs administered by the Department of Commerce's National Marine Fisheries Service (NMFS)under the Agricultural Marketing Act (7 U.S.C. 1622, 1624) and implementing regulations (50 CFR 260). NMFS administers three levels of seafood inspection programs under authority of the Agricultural Marketing Act (7 U.S.C. 1622, 1624) and regulations implementing that act (50 CFR 260). These are: (1) A resident inspection program, which provides continuous inspection to qualifying establishments; (2) an integrated quality assurance program, under which an establishment operates an NMFS-approved quality assurance system and assists NMFS personnel in carrying out U.S. grading or specification regulations; and (3) a HACCP-Quality Management Program (QMP), under which the establishment's quality program is enhanced to meet the ISO 9001 quality management standards.

An establishment that participates in the continuous inspection program must agree to prepare products using only wholesome raw materials and to correctly label inspected items. The establishment must also agree to prior label approval by NMFS and to furnish the Agency with reports that the Agency may request on processing, packaging, grading, laboratory analysis, and production of inspected products. The establishment must provide facilities to NMFS inspectors and agree to conditions under which inspection may be suspended or terminated (50 CFR 260.97). The premises of the establishment must be free from conditions that may result in food contamination (50 CFR 260.98). Buildings and structures must be equipped with adequate lighting, ventilation, drains and gutters, and hot and cold water. Processing facilities must be of sound construction and capable of being efficiently and thoroughly cleaned. Animals and pests must be excluded. The use of chemical compounds, such as cleaning agents, insecticides, rodenticides, and bactericides must be limited to circumstances and conditions approved by NMFS (50 CFR 260.99).

An establishment participating in any of the NMFS inspection programs is expected to have organized food-safety management systems that are implemented through a combination of operational prerequisite programs that document how food safety hazards are to be controlled, and HACCP plans for each product processed by the establishment. The establishment must maintain documented Sanitation Standard Operating Procedures (Sanitation SOPs) and prerequisite programs. The programs must ensure the safety of processing water, ensure employee hygiene, prevent contamination of food-contact surfaces, and prevent cross-contamination generally in the establishment. The establishment is expected to document how it will control nonconforming products, handle recalls, and withdraw defective products from the market. All

HACCP-related records must be available to NMFS inspectors.

VII. Public Health Protection: Chemical and Microbiological Contaminants

FDA and the Centers for Disease Control and Prevention (CDC) consider commercially raised catfish to be a low-risk food. Even so, because catfish of domestic or foreign origin may be exposed to chemical and microbiological contaminants, it is incumbent on FSIS to consider the food safety hazards that might be presented by catfish in planning the Agency's regulatory approach.

Chemical Residues in Catfish

Most of the chemical residues identified in some domestic and foreign catfish fall into three main classes—heavy metals, pesticides, and antimicrobials.

Heavy Metals

At sufficient levels, these heavy metals are associated with ischemic heart disease, developmental abnormalities, decreased intelligent quotient (IQ) values, and other harmful effects in humans.

U.S. Centers for Disease Control and Prevention. Agency for Toxic Substances and Disease Registry. (1999). Toxicological Profile for Mercury.

U.S. Centers for Disease Control and Prevention. Agency for Toxic Substances and Disease Registry. (2007a). Toxicological Profile for Arsenic.

U.S. Centers for Disease Control and Prevention. Agency for Toxic Substances and Disease Registry. (2007b). Toxicological Profile for Lead.

FSIS tested 737 samples collected under a sampling plan representing catfish consumption in the United States during the course of one year, April 2008 through March 2009. Samples of seafood labeled as “catfish” were taken from the retail market system in the United States and were tested for the presence of arsenic, cadmium, lead, and mercury. Seventeen samples from among domestic and imported products had detectable heavy metal residues. Six domestic samples contained lead and cadmium. Four samples contained lead at a mean concentration of 43.48 parts per billion (ppb), with a range of 29.49 ppb to 76.92 ppb, while 2 samples contained cadmium at a mean concentration of 11.6 ppb, with a range of 10.9 ppb to 13.11 ppb. Twelve imported samples contained lead and arsenic. Ten samples contained lead at a mean concentration of 46.08 ppb, with a range of 27.96 ppb to 103.24 ppb, while 2 samples contained arsenic at a mean concentration of 1.34, with a range of 1.03 ppm to 1.64 ppm. We are unaware of regulatory action levels for arsenic, cadmium, and lead; the action level for mercury is 1,00 ppb.

U.S. Department of Agriculture. Food Safety and Inspection Service. 2010. Analysis of Heavy Metals and Veterinary Drugs found in 737 Catfish Samples from Retail Markets in the United States. Washington, DC.

In a 2001 study of 257 domestic catfish (

i.e.,

Ictaluridae) samples conducted by Santerre

et al.,

lead residues were detected in 11 percent, arsenic residues in 5 percent, and mercury residues in 83 percent.

Average metal residues detected in the study were lower than recommended safety limits, although it should be noted that the Environmental Protection Agency has not established a reference dose (maximum acceptable oral dose) for lead.

Santerre, C.R., P.B. Bush, D.H. Xu, G.W. Lewis, J.T. Davis, R.M. Grodner, R. Ingram, C.I. Wei, J.M. Hinshaw. 2001. Metal Residues in Farm-Raised Channel Catfish, Rainbow Trout, and Red Swamp Crayfish from the Southern U.S. Journal of Food Science. 66:270-273.

Pesticides

In 2008, the USDA Agricultural Marketing Service

tested 552 catfish samples collected under a sampling plan representing catfish consumption in the U.S. (including 435 samples of domestic and 108 samples of foreign catfish, as well as 9 samples of catfish of unknown origin) for pesticide residues.

Of note, chlorpyrifos

residues were detected in less than 1 percent of the domestic samples and in 32 percent of the import samples. DDE (p,p'- Dichlorodiphenyldichloroethylene), a metabolite of dichlorodiphenyltrichloroethane (DDT)

was detected in 97 percent of the domestic samples and 34 percent of imported samples at levels below regulatory concern; endosulfan

and its metabolites were detected in less than 1 percent of the domestic samples and in 27 percent of the import samples; and Toxaphene

was detected in 1 percent of the domestic samples and none of the import samples.

U.S. Department of Agriculture. Agriculture Marketing Service. December 2009. Pesticide Data Program Annual Report 2008. Washington, DC.

U.S. Department of Agriculture. Agriculture Marketing Service. December 2009. Pesticide Data Program annual Report 2008. Washington, DC.

An organophosphate insecticide linked to neurological and birth defects.

A synthetic organochlorine pesticide often used for mosquito control, DDT is a suspected carcinogen. Use of DDT was banned in the U.S. in 1972. Today it is banned in most developed countries. Because of its long half-life (ca. 25 years), DDT is classified as a persistent organic pollutant. This perhaps explains its presence in domestic and imported catfish samples.

An organochlorine insecticide with acute toxicity and high bioaccumulation potential, endosulfan is an endocrine disruptor.

Toxaphene is a mixture of approximately 200 organic compounds. Used as an insecticide in cotton and soybean growing areas of the United States, it was banned for use in 1986. Toxaphene is a carcinogen.

Unapproved Antimicrobials

If antimicrobials that are not approved by the FDA, such as malachite green and fluoroquinolones, are used in catfish production, they can result in the presence of chemical residues in edible tissue. Some research suggests that antimicrobial residues in food may hasten the development of antimicrobial-resistant infections in humans.

Exposure to high levels of malachite green and similar antimicrobials has been shown to be carcinogenic and mutagenic in rats. In 2006, the FDA found 15 imported catfish samples positive for malachite green and 2 for fluoroquinolones. In 2007, 868,000 lines of seafood fish and fishery products were submitted for import to the U.S.; FDA obtained samples from approximately 10,400 of those lines; and FDA tested 686 of those samples for antimicrobial residues. Meanwhile, about one percent of the 10.5 billion pounds of imported fish and fisheries products in 2007 were Siluriformes. In their 2008 report “Enhanced Aquaculture and Seafood Inspection—Report to Congress,” available at:

http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/SeafoodRegulatoryProgram/ucm150954.htm

. FDA reported that in 2007 it found 12 imported catfish samples positive for malachite green and 6 for fluoroquinolones. Since June 2008, FDA rejected 31 shipments of catfish imports for presence of unsafe animal drug residues.

Heuer, O.E. Kruse, H., Grave K., Karunasagar, I., & Angulo, F.J. (2009). Human Health Consequences of Use of Antimicrobial Agents in Aquaculture.

Clinical Infectious Diseases.

49:1248-1253.

Muller, L., Kasper, P. Kersten, B. & Zhang, J. (1998). Photochemical genotoxicity and photochemical carcinogenesis. Two Sides of a Coin?

Toxicology Letters.

102-103: 383-387.

Culp, S.J., Mellick, P.W., Trotter, R.W., Greenlees, K.J., Kodell, R.L., Beland, F.A. (2006). Carcinogenicity of Malachite Green Chloride and Leucomalachite Green in B6C3F1 Mice and F344 Rats. Food and Chemical Toxicology. 44:1204-1212.

There are three approved classes of antimicrobials for use in catfish: florfenicol, Romet 30 and TC, and several terramycin formulations.

See http://www.fda.gov/downloadsAnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/UCM109808.pdf

(Accessed Feb. 15, 2011).

In conjunction with the April 2008—March 2009 heavy metals survey, FSIS tested 733 catfish samples for the presence of chloramphenicol, gentian

violet, malachite green, and nitrofurans. (The number of samples tested for some chemicals differs slightly due to insufficient amount of material in some samples to do all of the tests.) A total of 10 samples were confirmed positive for nitrofurans (AOZ and AMOZ), gentian violet, and malachite green. Five domestic samples had confirmed positive results, 4 for gentian violet and 1 for malachite green. Five imported samples had confirmed positive results, each for AOZ and AMOZ, 2 for gentian violet, and 1 for malachite green. Detects were at levels below regulatory concern.

The foregoing shows that, while catfish may not frequently harbor residues of illegal drugs or other chemicals, the potential exists for such contamination. Because some shipments of imported catfish have been found with residues of drugs that FDA has banned and that are unsafe, FSIS proposes to conduct regular verification to ensure the safety of catfish and catfish products.

Microbial Pathogens in Catfish

The hazard identification component of the FSIS catfish risk assessment

identified certain microorganisms as higher-priority. The prioritization was based on association with catfish-related outbreaks and on the severity of resultant illness. The microorganisms identified included

Salmonella, Listeria monocytogenes,

and Enterotoxigenic

E. coli.

Salmonella

In a study by McCaskey and colleagues

reviewed by FSIS,

Salmonella

were found on 2 percent of 220 domestic catfish fillets. Among 136 imported catfish violations listed by FDA for 1998-2004, 42 percent were for

Salmonella.

It is difficult to compare prevalence values described here because the domestic fillets were sampled randomly, whereas the imported fillets were likely not sampled randomly.

McCaskey T, TC Hannah, T Lovell,

et al.

1998.

Safe and Delicious

study shows catfish is low risk for foodborne illness. Highlights of Agricultural Research. Vol. 45, No. 4. Available at

http://www.ag.auburn.edu/aaes/communications/highlights/winter98/catfish.html.

U.S. Department of Agriculture. Economic Research Service. 2009. Economic Research Service Staff Analysis of FDA Import Refusals for Catfish, 1998-2004. Washington, DC.

Because of this, the FSIS catfish draft risk assessment assumed that the prevalence of

Salmonella

on imported catfish was the same as that on domestic fish,

i.e.

2%.

Listeria

Though no catfish-borne listeriosis outbreaks have been identified, Chou

et al.

(2006) identified

L. monocytogenes

in 25-47% of raw catfish fillets at three U.S. processing plants.

Some isolates were persistently found in processed fillets, suggesting either that the sanitation was inadequate, or that these isolates originated from the natural habitats of the catfish. McCaskey

et al.

(1998) found a prevalence of 5.9% for

L. monocytogenes

on catfish fillets. Significant risk may exist if cross-contamination occurs between raw products and ready-to-eat (RTE) products (Fernandes

et al.

1998). Chou

et al.

(2006) found that

L. monocytogenes

was most commonly isolated from catfish in the winter with a prevalence rate of 51 percent, compared to 41 percent in the spring, 36.7 percent in the fall, and 19 percent in the summer. This finding may be attributable to the ability of

L. monocytogenes

to out-compete other bacterial species at lower temperatures.

Chou, C.H., Silva, J.L., & Wang, C. (2006). Prevalence and Typing of

Listeria monocytogenes

in Raw Catfish Fillets. Journal of Food Protection, 69, 815-819.

Escherichia coli

A 2003 outbreak linked catfish or coleslaw consumption to 41 cases of Enterotoxigenic

E. coli

(ETEC) O169:H41-related illness (Beatty, 2004).

However, FSIS is aware of no data to describe the occurrence of ETEC on catfish.

Beatty, M.E., Bopp, C.A., Wells, J.G., Greene, K.D., Puhr, N.D., & Mintz, E.D. (2004). Enterotoxin-producing

Escherichia coli

O169:H41, United States. Emerging Infectious Diseases. Retrieved from

http://www.cdc.gov/ncidod/EID/vol10no3/03-0268.htm

Oct. 16, 2009.

Illness Outbreaks From Catfish

Cases of human illness have been linked to catfish consumption. Since 1990, the Centers for Disease Control and Prevention (CDC) have identified seven illness outbreaks where such catfish were consumed. In only one of these outbreaks was catfish specifically identified as possible vehicles of infection. These outbreaks, which are described below, have included 66 illnesses and 8 hospitalizations (Table 2).

Table 2—CDC Data on Outbreaks of Foodborne Illness in Which Catfish Was a Confirmed or Suspected Vehicle, 1991-2007, United States.

Year

State

Setting

Etiology

Illnesses

Hospitalizations

Deaths

1991

Restaurant

Salmonella

1999

Private Home

Unknown

1999

Restaurant/Deli

Unknown

2000

Restaurant/Deli

Chemical

2003

Workplace

E. coli

O169

2003

Restaurant/Deli

Unknown

2007

Private Home

Unknown

In 1991, an illness outbreak occurred in New Jersey that affected ten case-patients. Nine stool specimens tested positive for

Salmonella

Hadar. Catfish was identified as a possible vehicle for illnesses.

Data from the Centers for Disease Control and Prevention's (CDC) electronic Foodborne Disease Outbreak Reporting System (eFORS). Provided to FSIS by CDC, Sept. 15, 2008.

In 1991, an illness outbreak occurred in New Jersey that affected ten case-patients. Nine stool specimens tested positive for

Salmonella

Hadar. Catfish was identified as a possible vehicle for illnesses.

In 1999, two illness outbreaks occurred in Florida with undetermined etiology or causal agent. The first affected five case-patients, all reporting catfish consumption. Statistical evidence suggested catfish might be the vehicle, although the restaurant where case-patients dined had poor sanitation and inadequate refrigeration. The second affected two case-patients who experienced illnesses after preparing and consuming catfish and yellow rice

at home. Both foods were identified as implicated items.

In 2000, an Ohio illness outbreak was reported that affected two case-patients experiencing signs and symptoms suggestive of chemical contamination. Samples of raw and fried, farm-raised catfish were tested, and results indicated contamination with an unidentified chemical.

In 2003, two reported illness outbreaks identified catfish as an implicated food item. One outbreak occurred in Tennessee and included 41 illnesses and 12 confirmed cases of

E. coli

O169:H41. An epidemiologic study was conducted and identified multiple food items, including catfish. A food worker was suspected as the source of contamination. The second outbreak occurred in Colorado, and investigators reported that four out of five people became ill after eating catfish at a restaurant. The fifth, well person did not report eating catfish.

The most recent reported illness outbreak occurred in Florida in 2007. Two case-patients were identified after consuming in a private home catfish prepared at a grocery store. Improper cold storage and reheating practices at the food service facility (grocery store) were noted.

Table 2 shows that there has been one catfish-associated outbreak from

Salmonella

in the past twenty years. Because only a small proportion of all foodborne illnesses reported are identified as associated with outbreaks (

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5931a1.htm

), it is possible that there may be a low level of sporadic cases of salmonellosis associated with catfish that are not detected with current levels of surveillance. FSIS notes, however, that this case occurred before FDA's implementation of regulations (21 CFR part 123) that require processors of fish and fishery products to develop and implement HACCP systems for their operations. Since implementation, no cases of salmonellosis linked to catfish have been reported.

The FSIS Catfish Draft Risk Assessment

FSIS conducted an illustrative assessment of the potential risk to human health of catfish consumption, using the example of

Salmonella

contamination. We are particularly interested in

Salmonella

because the general burden of illness from this pathogen in the United States remains a concern and there is evidence that at least one outbreak of human salmonellosis may have been related to catfish consumption.

Salmonella

is a useful model because its presence provides an indication of the sanitary conditions under which food is produced, and because an approach that produces a reduction in

Salmonella

through improved process control is effective in controlling for the presence of other microbial pathogens.

Food Safety and Inspection Service. 2006. Review of the Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule pursuant to Section 610 of the Regulatory Flexibility Act, as Amended. Available at:

http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2007-0022P/610_Report_PR_HACCP.pdf

(Accessed Oct. 14, 2009).

With regard to the risk assessment for catfish, FSIS continues to evaluate the hazards, particularly Salmonella, associated with this fish. FSIS invites all interested stakeholders to submit additional data and scientific evidence specific to catfish food safety. FSIS will consider this information and other data in the development of a final risk assessment in this proceeding.

Further, USDA is seeking public comments on the evidence regarding the public health benefits and cost-effectiveness to be achieved with the proposed program.

VIII. Proposed Regulations Implementing Continuous Inspection of Catfish and Catfish Products

As stated above, this proposal implements provisions of the FMIA added by the 2008 Farm Bill respecting the amenable species “catfish, as defined by the Secretary” (21 U.S.C. 601(w)(2)). It is intended to prevent and eliminate any burdens on commerce imposed by adulterated or misbranded catfish or catfish products and to protect the health and welfare of consumers from such adulterated or misbranded catfish or catfish products (21 U.S.C. 602).

A. Coverage of the FMIA: Provisions Applicable to Catfish and Catfish Products

The FMIA (21 U.S.C. 601-695) requires FSIS to carry out a continuous inspection program for the species that are subject to this statute, which now includes catfish. FSIS inspects food products derived from those species, verifies that the products are prepared for commerce under sanitary conditions, and inspects products that are exported from or imported into the United States. The inspection may include testing for pathogens or for drug or other chemical residues. The FMIA also gives FSIS the authority to take action with respect to meat products in commerce that may be adulterated or misbranded. FSIS intends to apply to catfish and catfish products provisions of the FMIA that now apply to meat and meat food products, except for the provisions that the 2008 Farm Bill excludes from applicability to catfish.

B. Catfish and Catfish Product Inspection Regulations Under the FMIA

FSIS is proposing to establish regulatory requirements for the continuous inspection of catfish and catfish products. FSIS is adapting for use in the regulation and inspection of catfish and catfish products those meat inspection regulations that are appropriate in preventing the transportation, sale, offer for sale or transportation, or receipt for transportation, in commerce, of adulterated or misbranded products (21 U.S.C. 602, 610, 621). Because there are differences between fish and mammalian livestock species, some of the regulations for catfish will be separate within the Code of Federal Regulations from those for the inspection of meat and meat food products. Other regulations apply as written to catfish and will simply be cross-referenced.

Organization of Catfish Inspection

In general, the catfish regulations parallel the sequence of operations from the harvesting and delivery of the fish to the processing plant, through the in-plant operations, to transportation in commerce, specifying export and import requirements where appropriate.

After outlining the district-level supervision of catfish inspection in proposed 9 CFR 530.2, FSIS makes clear in proposed § 530.3 that, as provided in 9 CFR 300.6, persons that are subject to the FMIA, and specifically the catfish inspection provisions, are to grant authorized Agency or Department personnel access to establishments that process catfish and to other establishments in industries related to the catfish processing industry (21 U.S.C. 606, 642(a)).

Definitions

FSIS is proposing largely to use the same definitions for the catfish inspection regulations (proposed 9 CFR 531.1) as for the meat inspection regulations (9 CFR 301.2), which are incorporated into proposed 9 CFR 531.1 by reference. However, recognizing the differences between the commercial production and processing of catfish products, as opposed to other products

that are subject to the FMIA, the Agency is proposing to add definitions for “catfish,” “catfish product,” “catfish food product,” “farm-raised,” and some other terms. The Agency also is adapting certain terms used in the meat inspection regulations, such as “applicant” and “consumer package,” to apply in the context of catfish production and processing.

FSIS is proposing that the term “catfish”—aside from what animal species the term is to denote—mean the skeletal muscle tissue of catfish, the edible portion of the fish that is prepared for the consumer.

FSIS is proposing to define “catfish food product” to parallel the definition of “meat food product,” and “catfish product” to mean any catfish or catfish part, as well as any product made wholly or in part from any catfish or catfish part, except for products exempted from definition as a catfish product in the regulations. In the context of the proposed regulations, the term “catfish product” generally denotes an edible product.

The Agency is proposing to define “farm-raised,” as “grown under controlled conditions, within an enclosed space, as on a farm.” As indicated in earlier discussion, FSIS understands “farm-raised catfish” to be those that are typically raised in confinement from incubated eggs to harvest and fed commercial feed throughout the stages of production until harvested. Production schemes include culturing catfish in ponds and high-density culture systems that utilize tanks, raceways, and cages. The Agency recognizes that variations of these arrangements may be in use in the United States and in foreign countries. FSIS also recognizes that there are situations in which wild-caught catfish are processed for commercial distribution and requests comment on how the Agency should address these situations.

FSIS expects that, in general, catfish that will be subject to the proposed regulations will be grown as food for human consumption in a controlled environment by a commercial operator. Many of the remaining proposed definitions are adaptations from the definitions in the meat inspection regulations. For example, a “product” is any carcass, catfish, catfish product, or catfish food product that is capable of use as human food; an “official mark,” is a symbol to identify the status of any article, catfish, or catfish product under the FMIA; and such terms as “U.S. Condemned,” “U.S. Detained,” and “U.S. Retained,” are redefined to apply in situations involving catfish products.

Inasmuch as the ante-mortem inspection, post-mortem inspection, and humane slaughter provisions of the amended FMIA do not apply to catfish, there is little need for a definition or other requirements addressing slaughtering methods. However, the FMIA defines as adulterated a food product that is, in whole or in part, the product of an animal that has died otherwise than by slaughter (21 U.S.C. 601(m)(5)). In the view of FSIS, catfish that died under circumstances other than the controlled circumstances of commercial fish harvesting and processing would be adulterated under this provision of the FMIA and unacceptable for food. (For example, a fish that fell onto the pavement in the delivery area of a processing plant and lay there until it died would not be acceptable for human food.) Also, it may be necessary for the Agency to apply the detention, seizure, and condemnation provisions of the Act (21 U.S.C. 672, 673) in cases where the Agency finds dead, dying, or diseased catfish. It would then be necessary to distinguish catfish slaughtered for the purpose of being processed into human food from catfish that died from a disease, from accidental asphyxiation, from poisoning by environmental contaminants, or by any other cause that would render the catfish unacceptable for human food.

Moreover, the Agency has become aware of methods used in transporting catfish to, or in holding catfish at, processing establishments that involve holding the fish at so low a temperature that the catfish are intentionally killed before being delivered for processing for human food. To the extent that the methods are applied under controlled conditions in a manner that does not create a human food-safety hazard, FSIS would likely view these methods as constituting slaughter.

The question therefore arises whether the Agency should propose a definition of “slaughter” that would encompass various methods of killing catfish for food and that would ensure that catfish that died otherwise than by slaughter would not be used for food. FSIS's tentative view is that it should. Thus, it has proposed to define “slaughter,” with respect to catfish, as intentional killing under controlled conditions. FSIS requests comment on this proposed definition, and on whether there is a need for it.

Establishments Requiring Inspection; Grant and Approval of Inspection

In proposed 9 CFR part 532, FSIS identifies the classes of establishments that handle catfish that require inspection. Under this proposal, establishments that process catfish or catfish products for transportation or sale in commerce for use as human food will need to be under FSIS inspection. Also, the records not only of official catfish establishments but those of related businesses, including retail establishments that are exempt from continuous inspection, will be subject to periodic inspection.

FSIS is proposing requirements for catfish processing establishments to qualify for a grant of inspection that are similar to those that apply to meat processing establishments. These requirements cover facilities, potable water and water sanitation performance standards, Sanitation SOPs, and validated HACCP plans. FSIS intends to assign inspection personnel to catfish processing establishments.

Proposed 9 CFR 532.2 sets out the application procedures, cross-referencing the application procedures for, and grant and approval of, meat inspection in 9 CFR part 304 because the procedures for catfish establishments will be similar to those for meat establishments.

Establishments will have to complete an Application for Federal Inspection (currently, FSIS Form 5200-2, available from the appropriate District Office). In addition to completing the application, establishments will need to attach a description of the limits of the premises of the establishment that are to be under Federal inspection (Item No. 106 on the current application form). This description could be written, or it could be a drawing.

Under this proposal, a catfish establishment intending to conduct operations under an FSIS Grant of Inspection will be subject, consistent with 9 CFR 304.3, to the sanitation performance standard requirements (distinct from Sanitation SOPs) in 9 CFR part 416. After the establishment files its application with the appropriate District Office, FSIS will reserve an official plant number, in accordance with 9 CFR 305.1, that will identify all inspected and passed products prepared in an establishment and that must be printed on the label of any packaged product. All packaged catfish products also will have to bear the U.S. Inspection legend. All labeling material will have to be Federally approved and on-hand before inspection could be granted per 9 CFR 317.4.

Under the proposed regulations (requirements for sanitary operation under 21 U.S.C. 608 and 621), the establishment will have to have documentation supporting the potability of the water it uses for catfish (per 9 CFR and 416.2(g)).

FSIS also cross-references 9 CFR 305, on the assignment of establishment numbers and the inauguration of inspection, and 9 CFR 306, on the assignment and authorities of FSIS personnel, because they are essentially the same for meat and catfish inspection (proposed 9 CFR 532.2(c) and (d)). Before the inauguration of inspection, FSIS inspection personnel will examine the establishment and premises. If this examination shows that the facilities are satisfactory, FSIS will assign inspection personnel. No establishment operations may be conducted except under the supervision of an inspection program employee. FSIS provides inspection service to official establishments without charge, up to eight (8) consecutive hours per shift on consecutive days during the basic workweek. The regulations further provide that each official establishment is to submit a work schedule to the District Manager for approval (proposed 9 CFR 533.5; 9 CFR 307.4(d)(1)).

Any work conducted over the 8-hour shift, or any time past the initial 5-consecutive-day period, will be charged to the plant at the prevailing hourly overtime rate. If the operator of the establishment requests inspection during odd hours, a minimum of 2 hours will be charged to the plant at the above rate. This rate also is charged if the plant works on any Federal holiday.

Although there is no exemption from inspection in the amended FMIA for custom catfish slaughter and processing facilities, FSIS is providing an exemption for retail stores and restaurants in proposed 9 CFR 532.3 (under 21 U.S.C. 661(c)) and paralleling 9 CFR 303.1(d) and (e)). FSIS is tentatively using the poultry exemption regulations set out in 9 CFR 381.10 as a model in proposing a limit of 75 pounds for individual household (single-sale) purchases of catfish to be deemed retail purchases; the quantity for non-household consumers would be 150 pounds. FSIS solicits comments on what the limits on retail sales to household or non-household consumers ought to be.

In proposed 9 CFR 532.4, the Agency asserts Federal pre-emption of State or local authority with respect to premises, facilities, and operations at an official establishment, and with respect to labeling, packaging, and ingredient requirements (pursuant to 21 U.S.C. 678).

Finally, in proposed 9 CFR 532.5, FSIS exempts from inspection articles that do not contain a minimum amount of catfish (3 percent raw or 2 percent cooked catfish) or historically are not regarded by consumers as products of the catfish food products industry per 9 CFR 301.2. The catfish ingredients of the exempt products will have to be FSIS-inspected or inspected under an equivalent foreign system (under 21 U.S.C. 601(j)). Also, the labels of these exempt products cannot represent the products as catfish products. Products exempt from the definition of “catfish product” will be subject to regulation under the FD&C Act.

Facility Requirements for Catfish Inspection

In proposed part 533, FSIS sets out facility requirements for catfish processing establishments (under 21 U.S.C. 608, 621). To ensure that sanitary operating conditions are maintained, official catfish processing establishments will have to be separate and distinct from any unofficial establishment and separate from any other official establishment, except an establishment preparing products under the FMIA, the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA) (proposed 9 CFR 533.1). Common areas for inspected and uninspected products may be used if the inspected product is acceptably maintained and protected to prevent product adulteration.

FSIS is proposing to require that official catfish establishments provide office space and furnishings for the exclusive use of the inspector and other Program employees assigned to the establishment (proposed 9 CFR 533.3). This is essentially the same requirement as that applying to establishments that prepare other products under the FMIA. The space set aside for this purpose will have to meet with the approval of Agency supervisors. As the Agency does in the meat inspection program, FSIS will exercise its discretion to determine whether small establishments requiring the services of less than one full-time inspector will not have to furnish Government office space if adequate facilities exist in a nearby location. Each establishment, however, will have to provide laundry service for inspectors' outer work clothing.

Other facilities to be provided by an official establishment include sufficient lighting for the proper conduct of inspection, facilities for performing inspection, receptacles for diseased carcasses and parts, and materials for cleansing and disinfecting hands, for sterilizing instruments used in handling diseased carcasses, and for cleaning and sanitizing floors and other articles or places contaminated by diseased carcasses (proposed 9 CFR 533.4). Establishments will have to provide adequate facilities, including denaturing materials for the proper disposal of condemned articles, and docks and receiving rooms for receipt and inspection of catfish and catfish products (proposed 9 CFR 533.4).

FSIS approves operating schedules for official meat establishments and is proposing to require such approval for catfish processing establishments (proposed 9 CFR 533.5, referencing 9 CFR 307.4). This is necessary to ensure that the Agency can maintain an inspector presence during establishment operations. The proposed regulations thus define a shift and the basic workweek for Program employees and require each official establishment to submit a work schedule to the District Manager

for approval. Under the proposed regulations, each official establishment will be required to maintain a consistent work schedule and, except for minor deviations, will not be allowed to change it without submitting the proposed change to the District Manager at least two weeks in advance. The Agency also is proposing to require that official establishments request inspection service outside the regular workday as far as possible in advance of receiving the service.

The District Manager, in the current Agency organization, has absorbed functions of the former Area Supervisor, mentioned in 9 CFR 307.4.

FSIS offers overtime and holiday inspection service for a fee. The FSIS regulations list the Federal holidays (9 CFR 307.5, referred to by proposed 9 CFR 533.6) and the terms of overtime and holiday inspection (9 CFR 307.6, referred to by proposed 9 CFR 533.7, and 9 CFR 391.3).

Pre-Harvest and Transport to Processing Establishment

In proposed 9 CFR part 534 (under 21 U.S.C. 606(b)), FSIS outlines the pre-harvest standards to be applied to catfish to ensure that the environmental conditions and source waters in which the fish are grown will not render the fish unfit for food. The Agency is proposing to require that catfish harvested for human food must not have lived under conditions that would render them unsound, unwholesome, unhealthful, or otherwise unfit for human food (proposed 9 CFR 534.1)—that is, whether the fish would be “adulterated” as the term is defined in 21 U.S.C. 601(m)(3) in the FMIA. The Agency advises catfish producers to monitor the water in which the fish are raised for suspended solids, organic matter, nutrients, heavy metals, antimicrobials, pesticides, fertilizers, and industrial chemicals that may contaminate the fish. FSIS may take

samples of fish and water (proposed 9 CFR 534.2) to assess whether the fish are being raised under conditions that will produce safe and wholesome product.

The Agency reminds producers in proposed 9 CFR 534.3 that only certain new animal drugs are legally available for use in raising catfish for human food. Approved drugs and tolerances are listed in the FDA regulations (21 CFR parts 516, subpart E; 520; 524; 526; 529; 556; and 558).

FSIS is proposing general standards for the transportation of catfish to the processing plant (proposed 9 CFR 534.4, under 21 U.S.C. 606(b)). A vehicle used to transport catfish to a processing establishment will need to contain sufficient water and oxygen to ensure that the catfish that arrive at the establishment are not adulterated per 9 CFR 301.2(5) in that they have perished by means other than slaughter. Any catfish that are dead or dying (otherwise than by slaughter), diseased, or contaminated with substances that would adulterate catfish food products are subject to condemnation at the establishment. (

See also

proposed 9 CFR 555.11 and .12.)

Sanitation and HACCP Requirements for Processing Facilities

FSIS is proposing (under 21 U.S.C. 608, 621) that catfish processing establishments will have to meet certain basic requirements that parallel those that meat establishments must meet and those that seafood processing establishments are already required to meet under FDA regulations. FSIS is proposing (proposed 9 CFR 537.1) to require that any official establishment that prepares or processes catfish or catfish products for human food comply with the sanitation requirements in 9 CFR 416. These requirements include the sanitation performance standards and the requirement that every official meat (or poultry) establishment have written Sanitation SOPs.

The sanitation performance standards (9 CFR 416.1-416.6) resemble in some ways FDA's current good manufacturing practice regulations for buildings and facilities (21 CFR part 110, subpart B) but provide for continuous FSIS inspection. The sanitation performance standards set forth requirements in terms of an objective to be achieved but do not prescribe the means to achieve the objective. To meet the performance standards, establishments must develop and employ sanitation or processing procedures customized to the nature and volume of their production.

Compliance with FSIS's Sanitation SOP requirement is a condition for receiving a grant of inspection. FSIS verifies the adequacy and effectiveness of the Sanitation SOPs as part of its inspection (9 CFR 416.17).

Under the proposed rule, catfish establishments will be required to detail, in writing, the procedures that they will carry out to prevent direct contamination or adulteration of product before and during operations (9 CFR 416.12(a)). Each catfish establishment will be responsible for evaluating the effectiveness of its Sanitation SOPs and for revising them as necessary to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel (9 CFR 416.14).

Under the proposed regulations, catfish establishments will have to conduct the pre-operation procedures in the Sanitation SOPs before the start of operations, conduct all other procedures in the Sanitation SOPs at the frequencies specified, and monitor the daily implementation of the procedures in the Sanitation SOPs (9 CFR 416.13). Establishments will be responsible for taking and required to take appropriate corrective action when the Sanitation SOPs have failed to prevent direct contamination or adulteration of product as detailed in 9 CFR 416.15(a). Corrective actions include procedures to ensure the appropriate disposition of product that may be contaminated, to restore sanitary conditions, and to prevent the recurrence of direct contamination or adulteration of product. Corrective actions may also need to include reevaluating and modifying the Sanitation SOPs or improving their execution (9 CFR 416.15(b)).

If this proposed rule is adopted, each catfish establishment will be required to maintain a daily record of the actions it takes that are prescribed in the Sanitation SOPs and to make such records available to Program employees for inspection and verification (9 CFR 416.16(a) and (c)). The establishment will be required, at a minimum, to record deviations from the Sanitation SOPs, along with corrective actions taken—including procedures to prevent the direct contamination or adulteration of products—in conjunction with the monitoring of daily sanitation activities.

The establishments will also be responsible for complying and will have to comply with the HACCP requirements (proposed 9 CFR 537.1(a)(1) cross-referencing to 9 CFR part 417; issued under 21 U.S.C. 601(m)(1), 601(m)(3), 601(m)(4), 602, 608, and 621). These requirements are similar to the FDA requirements for processors of fish or fishery products (21 CFR 123.6-123.10). The FSIS regulations include requirements that implement the principles of HACCP—hazard analysis, supporting documentation, decision-making documents, critical control points, critical limits, monitoring, corrective actions, verification, and recordkeeping (9 CFR 417.1 to 417.5)—and require a HACCP-trained individual to perform certain key functions (9 CFR 417.7). The FSIS regulations also define an inadequate HACCP system (9 CFR 417.6); they require a review, preferably by a HACCP-trained individual, of records associated with the production of a product before the product is shipped (“pre-shipment review”) (9 CFR 417.5(c)); and, of course, they provide for Agency verification of HACCP plan adequacy (9 CFR 417.8).

The Agency's verification includes a review of the HACCP plan to determine that it meets regulatory requirements; a review of Critical Control Point CCP records; a review and determination of the adequacy of corrective actions taken when there is a deviation from a critical limit; a review of the critical limits; review of other records pertaining to the HACCP plan or system; direct observation or measurement at a CCP; sample collection and analysis to determine whether the product meets all regulatory requirements respecting biological, chemical, or physical hazards; and on-site observations and records review (9 CFR 417.8). The frequency of FSIS verification activities will vary, depending on a number of factors, such as the establishment's past performance, risk inherent in the processes or products, quantity of product, and likely uses.

FSIS is proposing, under 21 U.S.C. 606(b), to require that a catfish establishment's hazard analysis take into account the hazards that can occur before, during, and after the harvest of catfish (proposed 9 CFR 537.2). Moreover, FSIS provides that catfish products not produced under a hazard analysis and HACCP plan that fully complies with the regulations will be adulterated under the FMIA because they will have been prepared and packed under insanitary conditions that may render them injurious to health (9 CFR 537.2(b)).

Mandatory Dispositions; Performance Standards Respecting Physical, Chemical, or Biological Contaminants

In proposed 9 CFR part 539, FSIS lists the diseases or other conditions that would lead to condemnation of catfish carcasses or parts affected upon inspection (under 21 U.S.C. 606). Both zoonotic and non-zoonotic diseases are

included because FSIS is required to ensure that the food products it regulates are not adulterated either for food safety reasons, or because they are unwholesome or otherwise unfit for human food. Catfish and catfish products affected by these diseases or conditions would be adulterated under 21 U.S.C. 601(m)(3) in that they are unsound, unwholesome, or otherwise unfit for human food.

The Agency intends to condemn, as unwholesome or unfit for human food, carcasses or parts of catfish whose tissues are affected by abscesses or lesions, and catfish tissues affected by non-zoonotic parasites such as cestodes, or by such parasites as digenean trematodes, metacercaria (

Bolbophorus

spp.), yellow grubs (

Clinostomum

spp.), or white grubs (

Hysterbmorpha

spp.). FSIS also intends to condemn catfish affected by Heterophyid intestinal flukes or

Dictophymatidae

nematodes, columnaris (infection by

Flexibacter columnaris

), or enteric septicemia of catfish (ESC) (proposed 9 CFR 539.1). The Agency will condemn catfish carcasses, parts, or catfish products found to be in a state of spoilage or decomposition or that are otherwise unwholesome. FSIS requests comments on what extent of columnaris or other infection should result in condemnation and on whether there are other conditions found in catfish that require such disposition.

Under proposed 9 CFR 539.2, catfish and catfish products that are contaminated with physical matter will be subject to retention by Program employees. Also, any antibiotic or other drug residues or pesticide residues in catfish tissues will have to be within applicable tolerances in the FDA or Environmental Protection Agency regulations (21 CFR part 556; 40 CFR part 180).

The FSIS National Residue Program determines whether there are violative concentrations of drug or other chemical residues in the products the Agency regulates.

Catfish or catfish products containing violative residues will not be eligible to bear the mark of inspection because FSIS could not find them to be not adulterated under 21 U.S.C. 601(m)(2)(A). The products will be subject to condemnation. The residue standards will apply to imported as well as domestic catfish and catfish products.

FSIS notes, in addition, that the FDA Compliance Policy Guide, Section 575.100, Pesticide Chemicals in Food—Enforcement Criteria, lists action levels for banned but persistent chlorinated pesticides. Most pesticides detected in catfish are listed in this guidance.

The program is explained at:

http://www.fsis.usda.gov/Science/Chemistry/index.asp

(Accessed 10/29/2008.)

With respect to microbiological contamination, FSIS plans to implement a pathogen reduction program for catfish that would be similar to that for other classes of raw product subject to the FMIA. After completing a study to determine the national baseline prevalence and levels of

Salmonella

on raw catfish, FSIS will conduct regular testing in processing establishments for the purpose of measuring industry performance against the baseline.

Handling and Disposal of Condemned and Inedible Materials

FSIS is proposing to require that a processor prevent catfish that have died otherwise than by slaughter from entering the official establishment (under 21 U.S.C. 601(m)(3), 601(m)(4), 608, 621, 644) (proposed 9 CFR 540.1(a)). The establishment will have to maintain physical separation between slaughtered catfish and those that have died otherwise than by slaughter (proposed 9 CFR 540.1(b)) to prevent commingling of edible and inedible product. All condemned or otherwise inedible catfish parts will have to be conveyed from the official premises for further disposition at a rendering plant or other facility that handles inedible products (proposed 9 CFR 540.3).

Marks, Marking, and Labeling of Products and Containers

Official Marks and Devices

FSIS is proposing (under 21 U.S.C. 601(n)(12), 601(s)-(v), 606, 611) to use certain official marks, devices, and certificates for the purpose of identifying inspected and passed catfish and catfish products and their status. FSIS is proposing to provide that an official inspection legend containing the number of the official establishment be shown on all labels of inspected and passed product (9 CFR 541.2(a)). The form of the official legend will be that for meat products (9 CFR 312.2(b)(1), reproduced in proposed 9 CFR 541.2), or another form that the Agency would prescribe. Comments and suggestions on what an alternative form might be are welcome.

FSIS is proposing to require that whole, gutted catfish carcasses that have been inspected and passed at an official establishment, and that are intended for sale as whole, gutted catfish, be marked or labeled with an official inspection legend containing the number of the establishment at the time of inspection (proposed 9 CFR 541.2(d)). The form of the inspection legend will be that in 9 CFR 312.2(a) and as illustrated in proposed 9 CFR 541.2(d) or as otherwise determined by the FSIS Administrator. The marking must ensure that the catfish will be identified as having been inspected and will not become misbranded while in commerce. Comments are welcome on whether marking is necessary, the form of the mark that would be satisfactory, and how the mark should be applied.

In proposed 9 CFR 541.3, FSIS is providing that the official mark used in sealing railroad cars, cargo containers, or other transport conveyances, as prescribed in proposed 9 CFR part 555, be in the form of the inscription and serial number shown in 9 CFR 312.5 or in another form approved by FSIS. The Agency-approved seal will be an official device under the FMIA. The seal will have to be attached to the means of conveyance by an Agency employee.

FSIS is also proposing (proposed 9 CFR 541.4) that the official export inspection mark for catfish (

see

proposed 9 CFR part 552) be that specified in 9 CFR 312.8(a), and that the export certificate for catfish and catfish products be the same as that prescribed in 9 CFR 312.8(b) for meat and meat food products.

FSIS also is proposing (proposed 9 CFR 541.5) that the official mark for shipments of articles and catfish that are officially detained be the designation “U.S. Detained.” The device for applying the mark would be the same “U.S. Detained” tag that FSIS uses for detained meat articles.

Labeling Requirements; Prior Approval of Labeling

FSIS is proposing (proposed 9 CFR 541.7) to apply to catfish and catfish products many of the same labeling and label approval requirements as those for meat and meat food products in 9 CFR 317, Subpart A, except where those regulations apply specifically, or could only apply, to meat or meat food products (under 21 U.S.C. 607). The requirements that FSIS is proposing to apply to catfish address labels and labeling, the abbreviations of official marks, label approval, generically approved labeling, the use of approved labels, the labeling of products for foreign commerce, prohibited practices, the reuse of official inspection marks, filling of containers, relabeling of products, the storage and distribution of labels, and the requirements for packaging materials.

Under this proposal, the basic requirements for a label (most, in 9 CFR 317.2) will be similar in a number of respects to those that FDA requires for the label of food products under its jurisdiction. Unlike FDA, however, FSIS

requires that the label bear the official inspection legend. Also, unlike FDA, FSIS forbids any final labeling from being used on any product unless the sketch of the final labeling has been approved by the Agency.

Another requirement that differs from the FDA requirements is the requirement for safe-handling labeling (9 CFR 317.2(l)) on products that are not ready-to-eat, that is, products that are raw or that undergo minimal treatment, such as heating, before being consumed. FSIS is proposing to require that safe-handling instructions appear on the label of every not-ready-to-eat catfish product that is destined for household consumers, hotels, restaurants, or similar institutions.

Generically Approved Labeling

Under this proposed rule, processors of catfish and catfish products will be able to use generically approved labeling if the labeling meets the conditions for such labeling in 9 CFR 317.5. Generically approved labeling usually involves minor modifications of labeling that has been approved by FSIS.

Prevention of False or Misleading Labeling Practices

Under the FSIS regulations, no product or any of its wrappers, packaging, or other containers may bear any false or misleading marking, label, or other labeling, and no statement, word, picture, design, or device that conveys any false impression or gives any false indication of origin or quality or that is otherwise false or misleading may appear in any marking or other labeling. No product may be enclosed wholly or partly in any wrapper, packaging, or other container that is made, formed, or filled in a manner that would make it misleading. (9 CFR 317.8.)

To prevent the misuse of labeling, FSIS enforces regulations controlling the conditions under which product may be relabeled at a location other than an official establishment (9 CFR 317.12). The Agency also regulates the conditions under which labels, wrappers, or containers bearing official marks may be transported from one official establishment to another official establishment (9 CFR 317.13). All these requirements, which apply to meat and meat food products, will apply to catfish and catfish products under this proposed rule.

A major challenge to the identification of processed fish products is the inability to visually identify the species of fish after processing. Because of the interest of the catfish products industry and consumers in ensuring that product labeling correctly represents the actual species of fish in the product, FSIS is considering the use of various technological means to verify catfish species. There is available chemical taxonomic information consisting of species-characteristic biochemical patterns that may be compared quantitatively to patterns obtained by an appropriate laboratory analysis of the fish in question. These patterns include data from isoelectric focusing (IEF), a type of electrophoresis, and restriction fragment length polymorphism (RFLP) studies. RFLP is a technique in which organisms may be differentiated by analysis of patterns derived from cleavage of their DNA. If two organisms differ in the distance between sites of cleavage of a particular restriction endonuclease, the length of the fragments produced will differ when the DNA is digested with a restriction enzyme. The similarity of the patterns generated can be used to differentiate species (and even strains) from one another.

In recent years, interest in another technique, known as “DNA bar coding,” has been growing. It involves the DNA sequencing of mitochondrial gene cytochrome c oxidase I (COI) in seafood tissue samples to obtain unique, species-specific identifications, or “barcodes.” The method is considered robust and sensitive to small phylogenetic differences. FDA has been considering it as a replacement for IEF as that agency's standard for species identification and FSIS is considering this approach as well. FSIS welcomes comment and suggestions on species verification methods that the Agency might use.

Net Weight and Retained Water

FSIS labeling regulations on net weight of meat products incorporate by reference Handbook 133 of the National Institute of Standards and Technology (NIST). These regulations include provisions for determining compliance with net weight requirements and prescribe the reasonable variations from the declared net weight on the labels of immediate containers of products (9 CFR 317.18-317.22). To ensure that there is compliance, the regulations prescribe requirements for scales to determine accurate weights and for the testing of scales (9 CFR 317.20-317.21).

FSIS has learned from FDA and industry sources that catfish presents a specific challenge regarding net weight because of the frequent and varying use of glazing. (A glaze is a thin coating of ice on a catfish or catfish product that is intended to preserve the freshness of the product.) To regulate net weight for raw catfish products, FSIS is proposing to apply to raw catfish the requirements for control of retained water from processing in raw meat and poultry products through 9 CFR part 441 (referenced in proposed 9 CFR 541.7(b)), slightly amended to include raw catfish and catfish products. Retained water—water remaining in raw product after it undergoes immersion chilling or a similar process—will not be permitted unless the official establishment is able to show, with data collected under a written protocol, that the retained water is an unavoidable consequence of the process used to meet applicable food-safety requirements (9 CFR 441.10(a)). The establishment will have to label its products to state, besides net weight, the maximum percentage of water retained in the product from such processing as chilling (

e.g.,

up to X% retained water, less than X% water retained from chilling). The protocol, to be maintained in the establishment's files, will have to explain how data will be collected and used to demonstrate that the amount of retained water in the product covered by the protocol is an unavoidable consequence of the process used to meet specified food-safety requirements. The establishment will have to notify FSIS as soon as it has a new or revised protocol (9 CFR 441.10(c)). Expected elements of the protocol are given in the regulations (9 CFR 441.10(d)).

FSIS also is proposing to apply to catfish and catfish products the requirements in part 442, subchapter E, governing quantity of contents labeling, the testing of scales, and the handling of product that is found to be out of compliance with net weight requirements (referenced in proposed 9 CFR 541.7(b)).

FSIS is proposing, in particular, that packages of fresh or fresh-frozen catfish carcasses or parts be labeled to reflect 100-percent net weight (gross weight less the weight of glaze) after thawing. The de-glazed net weight must average 100 percent of the stated net weight of the frozen product when sampled and weighed according to the method prescribed in NIST Handbook 133 Chapter 2, Section 2.6.

Interested persons may want to consult NIST Handbook 133 for maximum allowable variations.

U.S. Department of Commerce. NIST Handbook 133: Checking the Net Contents of Packaged Goods, Fourth Edition, January 2005. Washington, DC.

Nutrition Labeling Requirements

Under the FMIA (21 U.S.C. 601(n)(1), 621), FSIS is proposing to apply the nutrition labeling requirements to

catfish and catfish products that are not raw, single-ingredient products (proposed 9 CFR 541.7(d)). The FSIS requirements for meat and meat food products (9 CFR 317.300-317.500) are similar to FDA's (21 CFR 101.9

et seq.

) in that a nutrition facts panel has to appear on the label. The FSIS nutrition facts panel includes information on serving size, servings per container, amount of calories per serving, and calories from fat. Also the panel includes amount and percent daily value of total fat and saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugar, and protein, as well as information on percent daily intake of vitamins and minerals. Processors may provide additional nutritional labeling that is not false or misleading.

Food Ingredients Permitted

FSIS is proposing to apply to catfish products requirements in 9 CFR part 424 prohibiting a product from bearing or containing any food ingredient that would render it adulterated or misbranded under 21 U.S.C. 601(m)(2)(C) (proposed 9 CFR part 544). This prohibition is consistent with the current regulation of catfish products under the FD&C Act.

Few further-processed catfish products are produced domestically; however, FSIS is aware of the use in some fresh-frozen catfish of sodium tripolyphosphate and other sodium phosphates as humectants. Also, marinade solutions and breading ingredients are used in the preparation of some catfish products. FDA has approved these various ingredients for uses that include catfish products or has determined them to be Generally Recognized As Safe (GRAS) for these uses.

Under the FMIA, establishments will only be able to prepare a further-processed catfish product when the establishment is under inspection by an FSIS inspection program employee. Under 21 U.S.C. 601, 606, and 608, preparation of edible product will have to be carried out in compliance with the sanitary and other requirements in the regulations (proposed 9 CFR 548.1(a)).

Under this proposed rule, FSIS will make determinations on the safety and suitability of uses of food ingredients in catfish products in consultation and coordination with FDA, as it does for all food ingredients. FSIS will compile safe and suitable uses, including limits and conditions of use, of food ingredients in these products and make the information available in an instruction to its inspection force, FSIS Directive 7120.1. This directive is regularly updated and published on the Agency's Web site at:

http://www.fsis.usda.gov/Regulations_&_Policies/7000_Series-Processed_Products/index.asp

(accessed Feb. 15, 2011).

Ready-to-Eat and Canned Catfish Products: Control of Listeria Monocytogenes

Only a few ready-to-eat (RTE) catfish products, such as smoked catfish, are distributed in commerce. Under this proposed rule, these products will have to comply with appropriate performance standards, as must all RTE meat and poultry products if they are not to be considered adulterated under either the FMIA (21 U.S.C. 601(m)) or the PPIA (21 U.S.C. 453(g). Any pathogen on an RTE product adulterates the product because RTE products are likely not to be cooked before consumption. Currently, there are requirements for the control of

Listeria monocytogenes

in RTE products that are exposed to the processing environment after undergoing a process that is lethal to

L. monocytogenes.

FSIS is proposing to make post-lethality-exposed catfish products subject to these requirements (proposed 9 CFR 548.6, referencing 9 CFR part 430).

An RTE product is adulterated if it contains

L. monocytogenes,

or if it comes into direct contact with a food-contact surface that is contaminated with

L. monocytogenes

because it is likely to be consumed without further processing such as cooking. An RTE catfish product, as well as an RTE meat or poultry product, would be adulterated in either of these situations.

Canned Products

FSIS is not aware of any canned catfish products that are processed in the United States for human consumption, but canned catfish soups are imported into this country. Under this proposed rule, any domestic canned catfish products that an official establishment manufactures will be subject to requirements similar to those for canning and canned meat products (proposed 9 CFR 548.6, cross-referencing to 9 CFR part 318, subpart G (§§ 318.300-318.311)). Domestic canned fish products currently are subject to FDA requirements for low-acid canned foods (21 CFR 113) and imported canned products are subject to equivalency requirements for process filing (21 CFR 108.35). Under the proposed rule, imported canned catfish products will have to be produced under requirements that are equivalent to those that would apply to domestic products.

Accredited Laboratories

Under this proposed rule, FSIS will allow catfish processing establishments to use third-party accredited laboratories instead of an FSIS laboratory to analyze official regulatory samples for residues (proposed 9 CFR 548.9). This practice has been allowed so as to provide an option for establishments of receiving, at their own expense, sample results more quickly than would be the case with the limited laboratory capacity of FSIS. An establishment that holds sampled product until the receipt of test results might be especially interested in the availability of accredited laboratory services. Use of an accredited laboratory would always be at the establishment's discretion, and the establishment would have to pay for the service. The requirements for laboratory accreditation are in 9 CFR part 439, subchapter E.

FSIS is proposing to bring catfish within the coverage of the accredited laboratory program for species identification—which would be a new program service—as well as for residue detection. The Agency would amend the accredited laboratory regulations as necessary to include species identification methods in the program.

Standards of Identity and Composition

FSIS may promulgate standards of composition for catfish products composed of more than one ingredient. A standard of composition prescribes the minimum amount of catfish for a product to be called by a name that asserts that it was made with catfish. The Agency also may prescribe standards of identity for catfish products. A standard of identity prescribes the specific ingredients or components, and relative amounts, in a product that are necessary to meet consumer expectations for the product. However, there is at present only a relatively small number of commercially distributed catfish products, and FSIS is not aware of any product identity issues requiring a regulatory intervention.

Comments are welcome on whether the Agency should promulgate any standards of identity or composition in this rulemaking. This issue is separate from the basic product identity issue of what species of fish or catfish is actually in a product.

Exports

FSIS is proposing (proposed 9 CFR 552, cross-referencing provisions of 9 CFR 322) to adopt requirements for exported catfish and catfish products that are similar to those that apply to

meat articles under 9 CFR 322 (issued under 21 U.S.C. 615-616). Some of the meat regulations,

e.g.,

those addressing the transport of lard or tallow, are not applicable to catfish. The Agency is proposing to require that the outside container of any inspected and passed catfish product for export, with certain exceptions, bear an official export stamp, as depicted in the regulations (9 CFR 312.8), that includes the number of the export certificate. Under this proposal, the FSIS inspector in charge at the official catfish establishment will be authorized to issue official export certificates for shipments of inspected and passed product to any foreign country. FSIS will expect that the certificates will be issued at the time the products leave the official establishment. The certificates could be issued at a later time only after identification and reinspection of the products. Under the proposal, the certification will have to show the names of the exporter and consignee, the destination, the number and types of packages, the shipping marks, the kinds of products, and the weight of the products.

Transportation in Commerce

The FMIA gives FSIS the authority to regulate amenable products in commerce (21 U.S.C. 602). Since, under the FMIA and this proposal, catfish and catfish products are amenable to inspection, no person may sell, transport, offer for sale or transportation, or receive for transportation, in commerce, any catfish or catfish product that is capable of use as human food if it is adulterated, misbranded, or does not bear an official inspection legend at the time of such sale, transportation, offer, or receipt (21 U.S.C. 610(c)).

Under the authority in 21 U.S.C. 610 and 621, FSIS is proposing (proposed 9 CFR 555.1) to require that any catfish product capable of use as human food that is to be transported in commerce be properly handled and maintained to ensure that it is not adulterated and is properly marked and labeled. A transport conveyance intended to carry catfish products will be subject to FSIS inspection to determine its sanitary condition. A transport conveyance that is insanitary may cause contamination of catfish products and thus may not be used until the insanitary conditions are corrected. Under these proposed regulations, products on an insanitary vehicle must be removed and either handled in accordance with the regulations on mandatory dispositions or on the handling of condemned and inedible materials (proposed 9 CFR 539 or 540).

FSIS has tentatively determined that other regulations on the transportation of meat and meat food products (in 9 CFR part 325) are appropriate for the transportation of catfish products (proposed 9 CFR 555.3-555.8). These proposed regulations address: The transportation of unmarked, inspected product under FSIS affixed-seal; product that may have become adulterated in transit or storage; inedible products; the filing of original certificates for unmarked inspected products; and the unloading of any catfish product from an officially sealed conveyance or loading after the conveyance has left the official establishment. These regulations would serve to prevent the diversion of adulterated catfish and catfish products into food channels (proposed 9 CFR 555.9).

Imported Products

The FMIA prohibits the importation of carcasses, parts, meat, or meat food products of amenable species if these articles are adulterated or misbranded, and unless they comply with all the inspection, building, construction standards, and other provisions of the FMIA and regulations applicable to the products (21 U.S.C. 620). FSIS enforces this provision through random inspection for species verification and for residues, and through the random sampling and testing of the tissues of amenable species by the exporting country.

Each foreign country from which products of amenable species are offered for importation into the United States must obtain a certification from FSIS stating that the country maintains a program using reliable analytical methods to ensure compliance with U.S. standards for residues in those products. FSIS periodically reviews the certifications and revokes any certification if the Agency determines that the country involved is not maintaining a program that uses reliable analytical methods to ensure compliance with U.S. standards for residues in the products it exports. In considering any application for certification, FSIS takes into account inspection at individual establishments in order to ensure that the foreign country's inspection program is meeting the United States standards (21 U.S.C. 620(f)).

As mentioned previously, under the FMIA, as amended by the 2008 Farm Bill, the provisions governing imports apply to catfish and catfish products. FSIS is proposing to apply the requirements for the inspection of imported meat products (21 U.S.C. 620) to the inspection of imported catfish products (9 CFR part 557, referencing 9 CFR part 327). FSIS must find that a foreign inspection system ensures compliance of processing establishments and catfish products with requirements that are equivalent to the inspection and other requirements of the FMIA and the regulations that implement it that apply to official catfish establishments in the United States. When the Agency determines that a foreign country's inspection system for catfish and catfish products is equivalent to that operated by FSIS, the Agency will give notice of that fact (in the

Federal Register

) and will list the name of the country in the regulations (in proposed 9 CFR 557.2(b)).

Demonstrating Equivalence of Foreign Systems

FSIS is proposing that countries demonstrate the equivalence of their inspection system to the U.S. system, in the following respects:

(1)

Program administration.

Under proposed 9 CFR 557.2 (under 21 U.S.C. 620(a)), as must foreign programs for other species under the FMIA, the foreign program for catfish will have to be staffed in a way that will ensure uniform enforcement of the laws and regulations. Ultimate control and supervision must rest with the national government or employees of the system (9 CFR 327.2(a)(2)(i)(B)). Qualified, competent inspectors must be assigned (9 CFR 327.2(a)(2)(i)(C)). National inspection officials must have the authority to enforce requisite laws and regulations and certify or refuse to certify products intended for export (9 CFR 327.2(a)(2)(i)(D)). There must be adequate administrative and technical support and inspection, sanitation, quality, and species verification, residue standards, and other regulatory requirements that are equivalent to those of the United States (9 CFR 327.2(a)(2)(i)(E)-(G)).

(2)

Legal authority and requirements governing catfish and catfish products inspection.

To be considered eligible to export catfish products to the United States, foreign countries will have to enforce laws and regulations that address the conditions under which catfish are raised and transported to the processing establishment (9 CFR 327.2(a)(2)(ii)(I); 21 U.S.C. 606(b), 620(a); proposed 9 CFR 557.3). FSIS recognizes that in some countries, in addition to having fish ponds like those in the United States, catfish producers use floating cages on rivers and

“raceway ponds” that are filled and emptied by the continuous flow of water from nearby rivers. Under this proposed rule, the water quality, residue, and other standards applying in these catfish-raising situations will have to be equivalent to those applying to catfish raised in the United States.

Also, eligible foreign countries will have to establish standards for, and maintain continuous official supervision of, preparation and processing of product to ensure that adulterated or misbranded product is not prepared for export to the United States (9 CFR 327.2(a)(ii)(D)). A single standard of inspection and sanitation will need to be maintained throughout all certified establishments (9 CFR 327.2(a)(ii)(E)). The country's requirements will need to address sanitary handling of product and provide for official controls over condemned material; a HACCP system equivalent to that set forth in 9 CFR part 417; and other applicable controls under the FMIA or implementing regulations (9 CFR 327.2(a)(2)(ii)(F)-(I)).

(3)

Document evaluation and system review.

Foreign countries seeking eligibility to export catfish and catfish products into the United States (proposed 9 CFR 557.2(a)), under 21 U.S.C. 620) will also have to present to FSIS copies of laws, regulations, and other information pertaining to their systems of catfish products inspection, just as countries now do when they seek eligibility to export products of other species amenable to the FMIA. FSIS will make a determination of eligibility on the basis of a study of these documents and an on-site visit to the country of the system in operation by FSIS. FSIS will also conduct periodic reviews of foreign catfish products inspection systems to determine their continued eligibility (9 CFR 327.2(a)(3)).

(4)

Maintenance of standards.

In addition, countries seeking eligibility to export catfish and catfish products into the United States will have to provide for periodic supervisory visits to certified establishments to ensure that U.S. requirements are being met and for written reports on the supervisory visits (proposed 9 CFR 557.2, under 21 U.S.C. 620). The reports will have to be available to FSIS. The foreign program will have to conduct random sampling of catfish tissues and the testing of the tissues for residues identified by FSIS or by the foreign inspection authority as potential contaminants, in accordance with FSIS-approved sampling and analytical methods (9 CFR 327.2(a)(2)(iv)(C)). The residue testing will have to be conducted on samples from catfish intended for export to the United States.

Under this proposal, only certified foreign catfish establishments will be eligible to export their catfish products to the United States. However, if a foreign establishment is not in compliance with U.S. requirements for imported products, FSIS will terminate the eligibility of the establishment. FSIS will provide reasonable notice to the foreign government of the proposed termination of eligibility, unless delay in notification could result in the importation of adulterated or misbranded product. (9 CFR 327.2(a)(3).)

Marking and Labeling of Imported Products

The proposed regulations (proposed 9 CFR 557.14 and 557.15, under 21 U.S.C. 620) will apply to catfish and catfish products the requirements in 9 CFR 327.14 and 327.15 for the marking of catfish and catfish products and the labeling of immediate and outside containers of product that is imported. An imported catfish product will have to be marked “product of [country of origin]” under multiple authorities (7 CFR part 60, under 7 U.S.C. 1638a(a)(3)), proposed 9 CFR 541.7, and 9 CFR 317.9(b)(9)(xxv), 317.8(b)(40), under 21 U.S.C. 607, 620, 621).

2. Proposed Regulations Under Other FMIA Subchapters

Rules of Practice; Reference To Rules of Practice

FSIS is proposing to apply its rules of practice (9 CFR part 500, under 21 U.S.C. 601, 606, 608, 610, 621, and 671)) in enforcing the proposed catfish inspection regulations (proposed 9 CFR 561.1). Also, FSIS is proposing to provide establishments with an opportunity for presentation of views (proposed 9 CFR 561.2, referencing 9 CFR part 335) before reporting violations to the Department of Justice for criminal prosecution. The procedure to be followed in a case relating to catfish and catfish products inspection would be the same as that followed in a case relating to meat and meat food products inspection. FSIS uses its rules of practice for enforcement processes that may lead to such actions as withholding (refusing to allow the mark of inspection to be applied to product) or suspension (withdrawing inspection program employees from a facility) of inspection. The USDA uniform rules of practice (7 CFR 1.130-1.151) apply in actions commenced pursuant to section 401 of the FMIA (21 U.S.C. 671). Establishment management has a right to appeal enforcement decisions made by inspection program personnel (9 CFR 306.5).

Detention, Seizure, Condemnation

Detention

Under this proposal, FSIS will exercise its detention authority under the FMIA upon finding that catfish or catfish products in commerce are adulterated, misbranded, or otherwise in violation of the Act or regulatory requirements (21 U.S.C. 672, proposed 9 CFR 559.1, 9 CFR 329.1-329.6). The FMIA authorizes detentions if the Secretary has reason to believe that the article is adulterated or misbranded and is capable of use as human food, or that it has not been inspected in violation of the FMIA or of any other Federal or State law.

Detained product may not be further distributed or sold to consumers. Detained product is either appropriately disposed of by the product owner, agent, or custodian (

e.g.,

through voluntary destruction, by personal use, donation, or other FSIS-acceptable option), or FSIS initiates an action to seize the product.

Seizure and Condemnation

When detained product is not destroyed or properly disposed of, it is subject to seizure and condemnation by a U.S. District Court under Section 403 of the FMIA (21 U.S.C. 673). FSIS is proposing to apply the provisions for seizure and condemnation in the meat regulations (9 CFR 329.7-329.9) to catfish (proposed 9 CFR 559.2). The regulations also address criminal offenses addressed in Sections 22 and 405 of the FMIA (21 U.S.C. 622, 675), such as bribery of Program employees, receipt of gifts by Program employees, and assaults on, or other interference with, Program employees while engaged in, or on account of, the performance of their official duties under the Act.

Records Required To Be Kept

FSIS is proposing (under 21 U.S.C. 642(b)) to require persons involved in processing, buying and selling, or rendering catfish or catfish products to keep records on their activities respecting catfish sold, transported, offered for sale or transport, in commerce. Under this proposal, the classes of records they will be required to keep include sales records or invoices, shippers' certificates and required permits, records of seal numbers used in the sealed transport of inedible products, guaranties provided by suppliers of packaging materials, canning records as required by 9 CFR

part 318, subpart G, nutrition labeling records, and records of all labeling, along with the formulation and processing procedures (proposed 9 CFR 550.1).

Under this proposal, persons subject to these requirements will have to keep the records and maintain them at the place where the business generating the records is conducted. In the case where one person or firm conducts catfish operations at several establishments or locations, the records could be kept at a headquarters office (proposed 9 CFR 550.2). The Agency is proposing to require the records be retained for a period of 2 years after December 31 of the year in which the transaction to which the record relates occurred (proposed 9 CFR 550.3).

Canning records will have to be maintained in accordance with current requirements for records of the canning of meat food products. Processing and production records would have to be retained for at least 1 year at the canning establishment and for an additional 2 years at the establishment or other location from which the records could be made available to authorized FSIS employees (proposed 9 CFR 550.3, 9 CFR 318.307(e)). Records of scheduled processes will have to be maintained on file at the processing establishment and available to Program employees (proposed 9 CFR 550.3, 9 CFR 318.302).

Authorized representatives of the Secretary will have to be afforded access to the businesses that would be subject to the recordkeeping requirements (under 21 U.S.C. 642(a)). They will have to be afforded any necessary facilities, except reproduction equipment, for the examination and copying of records and for the examination and sampling of inventory (proposed 9 CFR 550.4).

Persons and firms covered by the recordkeeping requirements will have to register with the FSIS Administrator using a form obtained from the Agency (proposed 9 CFR 550.5). FSIS is asking for comment on a proposed time frame for completion of this registration under “Proposed Phasing of Implementation”. This registration requirement will apply to farms and transporters that supply catfish to official processing establishments and will enable FSIS to conduct sampling and other activities as necessary to account for the conditions under which catfish are raised and transported to the processing establishment (under 21 U.S.C. 606(b)). The registration would have to be updated whenever a change is made in the name, address, or trade name under which the registrant operates. These registration requirements would not apply, however, to any person conducting business only at an official establishment (proposed 9 CFR 550.5(c)). This registration requirement is similar to that with which food establishments must already comply under FDA regulations.

FSIS will require each official establishment to provide accurate information to FSIS employees so that they can report on the amount of products prepared or handled in the establishment, and on sanitation, microbiological testing, and other aspects of the establishment's operations. FSIS is proposing that the operator of each establishment report quarterly on the number of pounds of catfish processed. The report would have to be filed within 15 days after the end of each quarter. The establishment operator also will have to file other reports as FSIS might require from time to time under the FMIA (proposed 9 CFR 550.6.) FSIS notes that production data from individual establishments is protected from disclosure under the Freedom of Information Act. The Agency releases only aggregate data for reporting purposes.

Finally, FSIS is proposing to require that a consignee who refuses delivery of a product bearing the mark of inspection because the product is adulterated or misbranded notify the Inspector-in-Charge of the kind, quantity, source, and present location of the product. The consignee also will have to report on the respects in which the product is adulterated or misbranded. Movement of the product, except back to the official establishment from where it came, is prohibited (proposed 9 CFR 550.7), and if the product moves back to the originating establishment, the use of seals, documentation, or other conditions applies.

Summary of Proposed Regulations

In general, FSIS has attempted to apply to catfish and catfish inspection, with some modifications, the regulations governing the inspection of other species under the FMIA. In many cases the proposed regulations merely cross-reference the existing regulations for meat and meat food products. The accompanying table shows how the catfish regulations in proposed Subchapter F correspond to the meat inspection regulations in Subchapter A (9 CFR parts 300-335) or Subchapter E (9 CFR parts 416, 417, 424, 439, 441, 442).

Table 5—Relationship Between Catfish and Catfish Product Inspection Regulations in Subchapter F and Meat Inspection Regulations in Subchapter A or Subchapter E

Subject

Subchapter F

designation

Corresponding Subchapter A or E part 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 containing catfish

§ 532.5

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.

PRE-HARVEST STANDARDS AND TRANSPORTATION TO PROCESSING ESTABLISHMENT

PART 534

General

§ 534.1

Water quality for food fish

§ 534.2

Standards for use of drugs and other chemicals in feed and in catfish growing ponds

§ 534.3

Transportation to processing plant

§ 534.4

SANITATION REQUIREMENTS AND HAZARD ANALYSIS AND CRITICAL CONTROL POINTS SYSTEMS

PART 537

Part 416, Part 417.

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 MATERIALS

PART 540

Part 314.

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 products

§ 542.2

§ 312.2.

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 of catfish products

§ 548.2

§ 318.6.

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 (RESERVED)

Part 319.

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 sampling

§ 550.4

§ 320.4.

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 transportation as violations

§ 550.7

§ 320.7.

EXPORTS

PART 552

Part 320.

Affixing stamps and marking products for export; issuance of export certificates; clearance of vessels and transportation

§ 552.1

§ 322.1, § 322.2, § 322.4.

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 official establishments for further processing

§ 555.3

§ 325.5.

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 inedible articles

§ 555.10

§ 325.19.

Transportation and other transactions concerning dead, dying, or diseased catfish, and catfish or parts of catfish that died otherwise than by slaughter

§ 555.11

§ 325.20.

Means of conveyance in which dead, dying, or diseased catfish or parts of catfish must be transported

§ 555.12

§ 325.21.

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 States

§ 557.2

§ 327.2.

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 for approval of facilities as official import inspection establishment

§ 557.6

§ 327.6.

Import catfish products; equipment and means of conveyance used in handling to be maintained in sanitary condition

§ 557.8

§ 327.8.

[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 inspection

§ 557.12

§ 327.12.

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 importation

§ 557.14

§ 327.14.

Outside containers of foreign catfish products; marking and labeling; application of official inspection legend

§ 557.15

§ 327.15.

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 [Reserved]

[Reserved]

§ 557.21 [Reserved]

[Reserved]

§ 557.22 [Reserved]

[Reserved]

§ 557.23 [Reserved]

Appeals; how made

§ 557.24

§ 327.24.

Disposition procedures for catfish product condemned or ordered destroyed under import inspection

§ 557.25

§ 327.25.

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 DESIGNATIONS

PART 560

Part 321, Part 331.

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

Farm-raised catfish establishments have been operating under the FDA Seafood HACCP Regulations (21 CFR part 123). The Seafood HACCP Regulations describe procedures for the safe and sanitary processing of fish and fish products. The FDA regulations require all processors of fish and fishery products to develop HACCP programs when necessary and to meet the requirements of 21 CFR part 110 as they relate to the eight key sanitation areas defined in the regulations (21 CFR 123.11). FDA has recommended that each processor develop and implement written Sanitation SOPs for each facility where fish and fishery products are produced. The provisions on sanitation control procedures are in 21 CFR 123.11.

FSIS anticipates that moving the catfish industry from FDA's regulatory regime to the FSIS inspection system will have some impact on the industry. If this proposed rule is adopted, all catfish processing establishments will be required to follow the regulations in 9 CFR part 416 for sanitation. The establishments will have to meet the FSIS sanitation performance standards. To meet the standards, establishments may develop and employ sanitation or processing procedures customized to the nature and volume of their production.

A catfish processing establishment will have the flexibility to innovate in facility design, construction, and operations. The establishment, however, will have to continue to operate under sanitary conditions in a manner that

ensures that the product is not adulterated and that does not interfere with FSIS inspection and its enforcement of such standards.

In its catfish products inspection, FSIS intends to focus on verification of Sanitation SOPs and HACCP plans. Under the proposed Sanitation SOPs, FSIS inspection program personnel will verify that plant management is conducting its operations in a sanitary environment and manner.

Catfish processing establishments will be able to include elements of their Sanitation SOPs in their HACCP plans. Sanitation activities that directly affect the control of a processing hazard will be evaluated in the hazard analysis. Where appropriate, the activities could be identified as CCPs in the HACCP plan. Sanitation activities not identified as a CCP in the HACCP plan could remain in the Sanitation SOPs or in another prerequisite program for which the hazard analysis accounts. Any sanitation activity incorporated into a HACCP plan as a CCP could be removed from the facility's Sanitation SOPs or other prerequisite program. FSIS will verify the activity's effectiveness, whether as an element of the Sanitation SOPs or as a CCP in a HACCP plan.

FSIS will also verify (under 9 CFR 417.8) that HACCP plans comply with the requirements of part 417 and have been validated by the establishment in accordance with 9 CFR 417.4. Potential verification activities by FSIS include, but would not be limited to, sampling activities (targeted and non-targeted, marketplace, rapid screening tests for chemical residues); hands-on verification (organoleptic inspection, use of temperature or other monitoring devices); and review of establishment monitoring records.

In addition to verifying Sanitation SOPs and HACCP systems, FSIS intends to verify establishment compliance with the other regulatory requirements that become part of the final rule. As previously noted, the frequency of FSIS verification activities will vary, depending on such factors as the establishment's past performance, the risk inherent in processes or products, quantity of product, and likely uses of the product. FSIS also will verify the conditions under which catfish are raised and transported to the establishment, both as a check on the effectiveness of the establishment's HACCP plan and to provide additional assurance that only safe, wholesome raw materials are processed for human food.

Proposed Phasing of Implementation

To provide for an orderly transition from FDA's regulatory program to FSIS's continuous inspection program, FSIS is proposing a four-phase approach to implementation of the final rule that establishes the new catfish inspection program. The Agency requests comment on the implementation time frame. During the transition period to full implementation, FSIS plans to provide establishments and foreign countries that will be subject to the final rule with the opportunity to train their personnel and to bring their operations into compliance with the new regulations. FSIS is aware that Ictaluridae, Pangasius and species of other families are imported into the United States. Although a determination as to the definition of “catfish” has not yet been made, any foreign producers or processors handling catfish, as defined by a final rule, will be subject to FSIS processes and procedures.

FSIS is proposing a phased implementation of the final catfish inspection rule to provide a reasonable timeframe for countries to develop and implement equivalent catfish inspection programs. FSIS intends to work with exporting countries to ensure that the catfish products exported to the United States during the phase-in period achieve an equivalent level of sanitary protection as catfish products produced in domestic establishments.

The following is FSIS's proposed timeline for implementing the final rule requiring continuous inspection of catfish and catfish products. The Agency is proposing to allow exporting establishments to operate under FSIS's transitional requirements until the final rule is fully implemented. It is also proposing to permit exporting establishments in foreign countries to continue to export their products during the phased implementation if they comply with the transitional requirements.

The proposed phase-in will not, however, preclude establishments that are prepared to bring their operations into full compliance with the final rule before the final implementation date from operating under the new inspection program. Such establishments will need to work with their District Office to obtain the necessary inspection services.

The proposed phasing of implementation will begin on the effective date of the final rule, 90 days after publication in the

Federal Register

. FSIS is requesting comment on what the duration of each of the following phases should be, and on the compliance dates that affected establishments will be required to meet for each of the following phases until the final rule is fully implemented:

Phase One

• FSIS will deploy inspection personnel to domestic catfish processing establishments.

• Domestic establishments will be required to continue to comply with the requirements of 21 CFR part 123 until FSIS sanitation procedures (under proposed 9 CFR part 537) are in place. The regulations in 21 CFR part 123 require processors to monitor conditions and practices to ensure conformity with FDA's current Good Manufacturing Practices in 21 CFR part 110.

• Foreign countries that are exporting catfish to the United States at the time the final rule is published and that intend to continue to do so will need to submit documentation to demonstrate that they have a law or other appropriate legal measure in place that provides authority to regulate the growing and processing of catfish for human food. At this phase of implementation, FSIS will accept written documentation that countries have provided to importers pursuant to FDA's regulations in 21 CFR 123.12(a)(2)(ii)(B) as evidence of a country's authority to regulate the production of catfish products and to assure compliance with the requirements of 21 CFR part 123. FSIS will post a list on its Web site of countries that have met this initial, minimum requirement. FSIS will recognize current arrangements under 21 CFR part 123, including certification of foreign facilities by competent third parties, until complete implementation of the final rule or FSIS determines whether foreign inspection systems are equivalent to that of the United States.

• FSIS will begin a series of on-site audits of foreign countries that export catfish products to the United States to verify that establishments that produce catfish products for export to the United States are complying with the required transitional measures.

• Domestic producers will be required to begin to submit the labels of catfish products to FSIS for prior approval. Labels will have to meet the requirements in proposed 9 CFR 541.7.

• Labels of catfish products produced in foreign establishments will be required, at a minimum, to bear the basic labeling features prescribed in proposed 9 CFR 541.7. These features include the product name, handling statement, net weight statement, ingredients statement, address line, and nutrition facts panel. The labels will

also need to include safe handling instructions as well as the inspection legend and establishment number by the final implementation date.

Phase Two

• Persons and firms covered by the recordkeeping requirements in proposed 9 CFR 550.5 will have to register with FSIS.

Phase Three

• Domestic and foreign establishments will be required to comply with the sanitation requirements in 9 CFR part 416 (proposed 9 CFR part 537).

Phase Four

• The transitional measures will expire. FSIS will require that all establishments that produce catfish and catfish products comply with all provisions of the final catfish inspection regulations.

• Foreign countries that export catfish products to the United States will be required to have implemented a catfish inspection program that is equivalent to the U.S. inspection program. To be eligible for the importation of their products into the United States, the countries will have to be listed in proposed 9 CFR part 557.

X. Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866, “Regulatory Planning and Review.” FSIS would amend Title 9, Code of Federal Regulations, Chapter III by adding regulations on the mandatory inspection of catfish and catfish products. The regulations, if adopted, will continue to ensure that catfish and catfish products produced and sold in commerce for use as human food are safe, wholesome, and not adulterated. The regulations will also ensure that they are properly marked, labeled, and packaged. FSIS will verify that catfish are raised and transported to processing establishments under conditions that ensure that catfish products used for human food are not adulterated.

The proposed regulations require establishments that process and prepare catfish to apply for FSIS inspection and meet the conditions for receiving inspection. Establishments will be required to meet sanitation performance standards, have written Sanitation SOPs, and operate validated HACCP systems. FSIS will verify the Sanitation SOPs and HACCP systems and will conduct other verification activities to ensure that the establishments are in compliance with the FMIA and regulatory requirements under the Act that apply to catfish and catfish products. The establishments will be subject to sampling as part of microbiological, chemical, and other testing by FSIS of catfish and catfish products. The labeling of inspected products will bear a distinctive mark or legend to reflect that the product has been inspected and passed by FSIS.

The proposed regulations also require the listing in the regulations of foreign countries after their food safety systems for catfish have been found by FSIS to be equivalent to that of the United States. The equivalency determination and the listing in the regulations are necessary in order for the catfish products of these countries to be imported into the United States. The proposed regulations also require the inspection (actually, re-inspection) of catfish products offered for entry into this country.

FSIS is proposing these regulations to carry out the requirements of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, Sec. 11016), known as the 2008 Farm Bill, that amended the FMIA to make catfish, as defined by the Secretary of Agriculture, an amenable species under the FMIA and subject to many of the requirements of the FMIA.

Regulatory Approaches Considered

Regardless of the definition of catfish that is adopted an alternative to current FDA practices would be proposed.

FSIS has considered two basic regulatory approaches to catfish inspection—a more command-and-control, traditional approach or an approach that focuses on the verification of an establishment's food safety system. Strictly in terms of implementing the FMIA with respect to catfish and catfish products, FSIS could take a prescriptive, command-and-control approach to inspection, as it has in the past with meat and poultry and currently does with egg products. Command-and-control requirements specify, often in great detail, how an establishment is to achieve a particular food-safety objective. They may involve the use of specific techniques or processing parameters; the review and approval of equipment, establishment drawings and specifications; and the review and approval of particular process control programs. FSIS, however, rejected this command-and-control approach in 1996 with the adoption of the Pathogen Reduction/Hazard Analysis and Critical Control Points Systems final rule (61 FR 38806; July 25, 1996).

Thus, the Agency is proposing to adopt, as it has for meat and poultry, an approach to inspection that focuses on the verification of an establishment's food safety system, which consists of an establishment's HACCP plan, Sanitation SOPs, and prerequisite programs. As mentioned elsewhere in this document, the FSIS HACCP requirements for meat and poultry establishments are in some ways similar to the FDA HACCP requirements for seafood processors (in 21 CFR 123), yet supported by much more intensive inspection by FSIS.

USDA is requesting public comments on the approach.

Costs and Benefits

Costs

Siluriformes

If catfish are defined as members of the order Siluriformes, the mean total first-year and one-time cost to the catfish and catfish food products domestic supply chain industries of the proposed measures is projected to be about $306,000. The first year cost is projected to be about $543,000. For the catfish and catfish food product domestic industry, the mean annual cost is projected at $187,000. The projected mean estimated annualized cost is $240,000 (

See

Table 18 of the RIA Appendix). The projected lower bound (10th percentile) is $237,000, and the projected upper bound (90th percentile) is $243,000.

The present value of the mean cost, using a 7-percent discount rate over 10 years is projected at $1.7 million. The projected additional mean total annualized cost to the catfish and catfish food products supply chain industries of the provisions of the proposal analyzed is about $0.0008 per pound ($240,000/285 million pounds, in 2007) of aggregate processed catfish and catfish food products.

A stochastic simulation model was used to determine the distribution of values. Uncertainty analyses are conducted to estimate cost distributions for each of the alternatives for the proposed rule. The stochastic model uses @RISK (Version 4.5, Palisades Corp.) to examine the effects of uncertainty.

For the domestic industry and the Government, the additional mean total first-year one-time cost to the catfish and catfish products supply chain industries and additional cost to the government of the proposed measures is projected at $1.3 million. The additional mean total first-year cost is projected at $15.4 million. Additional mean annual cost is projected at $14.0 million. The projected mean annualized cost is $14.2 million (

See

Table 18 of the RIA Appendix). The projected lower bound (10th percentile) is $14.1 million. The projected upper bound (90th percentile) is $14.3 million. The present value of

the mean total cost, using a 7-percent discount rate over 10 years is projected at $100.0 million.

Ictaluridae

For catfish defined as Ictaluridae, the mean total first-year and one-time cost to the catfish and catfish food products domestic supply chain industries of the proposed measures is projected to be about $286,000. The first year cost is projected at about $516,000. For the catfish and catfish food product domestic industry, the mean annual cost is projected at $181,000. The projected mean estimated annualized cost is $230,000. The projected lower bound (10th percentile) is $227,000, and the projected upper bound (90th percentile) is $233,000.

The present value of the mean cost, using a 7 percent discount rate over 10 years is projected at $1.6 million.

The projected mean total annualized cost to the catfish and catfish food products supply chain industries of the provisions of the proposal analyzed is about $0.0011 per pound ($230,000/204 million pounds, in 2007) of aggregate processed catfish and catfish food products.

The cost of the provisions to the catfish and catfish food products industry compares to a 2006-2008 average price of $0.83 per pound for frozen whole catfish,

$1.14 per pound for frozen catfish fillets,

and $0.402 per pound for frozen catfish nuggets.

These costs compare to an estimated cost of about 1 cent per pound of meat and poultry associated with the Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/HACCP) rule of 1996.

For the domestic industry and the Government, the mean total first-year one-time cost to the catfish and catfish products supply chain industries and cost to the Government of the proposed measures is projected at $1.2 million. The mean total first-year cost is projected at $11.8 million. The mean annual cost is projected at $10.5 million. The projected mean annualized cost is $10.6 million. The projected lower bound (10th percentile) is $10.3 million. The projected upper bound (90th percentile) is $10.9 million. The present value of the mean total cost, using a 7-percent discount rate over 10 years is projected at $74.8 million.

Wholesale price. Source: Catfish Market Statistics, NASS, USDA.

Wholesale price. Source: Catfish Monthly Summary, NASS, USDA.

Wholesale price. Source: Catfish Market Statistics Annual, NASS, USDA.

M. Ollinger, V. Mueller. 2003. Managing for Safer Food: The Economics of Sanitation and Process Controls in Meat and Poultry Establishments. Agricultural Economics Report 817. Economics Research Service, U.S. Department of Agriculture. Washington, DC.

Break-Even Analysis

FSIS anticipates that all catfish and catfish products establishments will be in compliance with the requirements for Sanitation SOPs and HACCP according to the yet-to-be-determined implementation schedule. From discussions with industry experts, FSIS believes that a significant share of the catfish and catfish products industry is compliant with many of the individual proposed measures; although, because of differences between FDA and FSIS regulations, FSIS believes the industry will need time to make adjustments. Even though compliance rates for some HACCP related activities may be relatively high, the performance of HACCP systems depends on how well all the elements—hazard analysis, monitoring of CCPs and critical limits, recordkeeping, verification—are being performed. FSIS conducted an illustrative assessment of the potential risk to human health of catfish consumption, using the example of

Salmonella

contamination. Thus, we use

Salmonella

to illustrate potential benefits in this break-even analysis.

Epidemiological evidence suggests that salmonellosis leads to both acute and chronic illnesses. The acute illness that accompanies salmonellosis generally causes gastrointestinal symptoms that can lead to lost productivity and medical expenses. In rare instances, salmonellosis may result in acute or chronic arthritis. Arthritis is characterized by limited mobility, pain and suffering, productivity losses, and medical expenditures. Finally, salmonellosis can result in death. The risk of death appears to be higher in the elderly, children, and people with compromised immune systems. FSIS has estimated the costs for each of these severity levels.

Applying the same methodology as FDA in projecting a monetary value for each QALD, using the value of a statistical life (VSL); and the value of a statistical life year (VSLY), FSIS projects a mean annualized cost of about $18,000 per new average case of salmonellosis (FDA, 2009). Thus, under the proposed rule for catfish defined as Siluriformes, using the projected annualized cost of $14.2 million and the estimated mean annualized cost of an average case of

Salmonella

spp. of approximately $18,000 (at a 7 percent discount rate), if roughly 790 illnesses were averted, the benefits of the proposed rule would equal the additional costs.

Under the proposed rule applied to the catfish family Ictaluridae, using the projected annualized cost of $10.6 million and the estimated mean annualized cost of an average case of

Salmonella

spp. of $18,000, roughly 590 illnesses would have to be averted for the benefits of the proposed rule to equal the additional costs.

Effects on Small Entities

The Administrator has determined that, for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602), this proposed rule will not have a significant economic impact on a substantial number of small entities in the United States. Catfish farms (about 1,300) and slaughtering and primary processing establishments (about 23), and as many as 116 further processing establishments, live-fish haulers, importers, and feed mills would be affected by the rule. Most of these plants meet the Small Business Administration (SBA) size criteria for small businesses in the food manufacturing classification or other categories, in that they have 500 or fewer employees. The action would affect a substantial number of these small entities because the requirements would apply to all processing establishments in the catfish processing industry that ship their products in interstate commerce and would to some extent pertain to fish-farming practices. However, this action may have a significant effect on a substantial number of businesses that import catfish because imported catfish will be required to be inspected under a foreign system that is equivalent to that of the United States and from establishments that the foreign inspection authority has certified as complying with United States requirements.

The proposed rule would directly and indirectly affect multiple sectors of the U.S. economy, including numerous small firms, jobs (

i.e.,

employment) and on the government (

e.g.,

local, State, and Federal). Sectors likely to be affected (directly and indirectly), in addition to the types of entities already mentioned, include transportation firms, importing and exporting firms, food service and restaurant firms, domestic and international trade, consumers, and government agencies. The economic analysis of the effects of this proposed rule accompanying this document is available at:

http://www.fsis.usda.gov/Regulations_&_Policies/Proposed_Rules/index.asp

XI. Paperwork Reduction Act

Title:

Mandatory Inspection of Catfish and Catfish Products.

Type of Collection:

Sanitation SOPs; HACCP Plans; Applications for Grants of Inspection; Applications for labeling approval; various records required to be kept.

Abstract:

FSIS has reviewed the paperwork and recordkeeping requirements in this proposed rule in accordance with the Paperwork Reduction Act. Under this proposed rule, FSIS is requiring an information collection associated with the inspection of catfish.

FSIS would require an official catfish processing establishment to maintain HACCP plans and records, Sanitation SOPs, and other prerequisite program records, and conduct and keep records for microbiological testing. Currently, catfish establishments must have a HACCP plan and records and this information collection burden is reported by FDA. Once this information collection is approved by OMB, the FDA seafood information collection burden will be reduced appropriately. Catfish establishments will have to develop, submit, and maintain records of labels for their catfish products. In addition, they will have to develop nutrition labels for their catfish products. There is also a requirement for a consignee of any inspected catfish product who refuses to accept delivery of the product because it is adulterated or misbranded to notify the FSIS Inspector in Charge of the establishment that prepared the product.

In addition, transporters of live catfish would have to register with the Agency.

This estimate does not include collections of information that are a usual and customary part of business' normal activities.

Estimate of Burden:

An average of 0.25 hours per response.

Respondents:

Official establishments that process catfish, catfish importers, and transporters of live catfish.

Estimated Number of Respondents:

For catfish defined as Siluriformes, 230: There are 23 catfish slaughter and primary processing establishments, 10 further processing establishments, and 11 transporters of catfish to processing plants, plus approximately 80 import-export brokers.

For catfish defined as Ictaluridae, 51, including 23 catfish slaughter and processing establishments, at least 10 further processing establishments, and 11 transporters of catfish to processing plants, plus approximately 7 import-export brokers.

Estimated Number of Responses per Respondent:

1,512.

Estimated Total Annual Burden on Respondents:

For catfish defined as Siluriformes: 47,350 hours.

For catfish defined as Ictaluridae: 32,002.5 hours.

Copies of this information collection assessment can be obtained from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety and Inspection Service, USDA, Room 3532 South Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 20250.

Comments are invited on:

(a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; and (c) ways to enhance the quality, utility, and clarity of the information to be collected; ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both John O'Connell, Paperwork Reduction Act Coordinator, at the address provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

XII. E-Government Act

FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601

et seq.

) by, among other things, promoting the use of the Internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes.

XIII. Executive Order 12988, Civil Justice Reform

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. States and local jurisdictions are preempted by the FMIA from imposing any marking, labeling, packaging, or ingredient requirements on Federally inspected catfish products that are in addition to, or different than, those imposed under the FMIA. States and local jurisdictions may, however, exercise concurrent jurisdiction over catfish products that are outside official establishments for the purpose of preventing the distribution of catfish products that are misbranded or adulterated under the FMIA or, in the case of imported articles that are not at such an establishment, after their entry into the United States. This proposed rule is not intended to have retroactive effect.

Administrative proceedings would not be required before parties may file suit in court challenging this proposed rule. However, the administrative procedures specified in 9 CFR 306.5 would have to be exhausted before any judicial challenge of the application of the provisions of this final rule, if the challenge involved any decision of an FSIS employee relating to inspection services provided under the FMIA.

XIV. Expected Environmental Impact

FSIS has tentatively determined that this proposed rule would not have a significant individual or cumulative effect on the human environment. Therefore, this proposed action would be appropriately subject to the categorical exclusion from the preparation of an environmental assessment or environmental impact statement provided under 7 CFR 1b.4(6) of the U.S. Department of Agriculture regulations.

XV. Executive Order 13175, USDA Nondiscrimination Statement, and Additional Public Notification

Executive Order 13175

The policies contained in this proposed rule do not have Tribal Implications that preempt Tribal Law.

USDA Nondiscrimination Statement

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, or audiotape) should contact USDA's Target Center at 202-720-2600 (voice and TTY).

To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). USDA is an equal opportunity provider and employer.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is

important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this proposed rule, FSIS will announce it on-line through the FSIS Web page located at

http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.

The Regulations.gov Web site is the central on-line rulemaking portal of the United States Government. It is offered as a public service to increase participation in the Federal Government's regulatory activities. FSIS participates in Regulations.gov and will accept comments about documents published on the site. The site allows visitors to search by keyword or Department or Agency for rulemakings that provide for public comment. Each entry provides a quick link to a comment form so that visitors can type in their comments and submit them to FSIS. The Web site is located at

http://www.regulations.gov/.

FSIS also will make copies of this

Federal Register

publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,

Federal Register

notices, public meetings, recalls, and other types of information that could affect, or would be of interest to, our constituents and stakeholders. The update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS Web page at

http://www.fsis.usda.gov/News_&_Events/Constituent_Update/index.asp

. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience.

In addition, FSIS offers an e-mail subscription service which provides an automatic and customized notification when popular pages are updated, including

Federal Register

publications and related documents. This service is available at

http://origin-www.fsis.usda.gov/News_&_Events/EmailEmail_Subscription/index.asp

and allows FSIS customers to sign up for subscription options in eight categories. The subscription options categories include recalls, export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

XVI. Proposed Regulations

List of Subjects

9 CFR Part 300

Meat inspection.

9 CFR Part 441

Consumer protection standards, Meat and meat products, Poultry products, Catfish and catfish products.

9 CFR Part 530

Catfish and catfish products, Catfish inspection.

9 CFR Part 531

Catfish and catfish products, Catfish inspection.

9 CFR Part 532

Catfish and catfish products, Catfish inspection, Reporting and recordkeeping requirements.

9 CFR Part 533

Catfish and catfish products, Catfish inspection, Government employees.

9 CFR Part 534

Aquaculture, Catfish and catfish products, Catfish inspection.

9 CFR Part 537

Catfish and catfish products, Catfish inspection, Hazard Analysis and Critical Control Point (HACCP) Systems, Sanitation.

9 CFR Part 539

Animal diseases, Catfish and catfish products, Catfish inspection.

9 CFR Part 540

Catfish and catfish products, Catfish inspection.

9 CFR Part 541

Catfish and catfish products, Catfish inspection, Food labeling, Food packaging, Nutrition, Reporting and recordkeeping requirements, Signs and symbols.

9 CFR Part 544

Catfish and catfish products, Catfish inspection, Food additives, Food packaging, Laboratories, Reporting and recordkeeping requirements.

9 CFR Part 548

Catfish and catfish products, Catfish inspection, Food additives, Food packaging, Laboratories, Reporting and recordkeeping requirements, Signs and symbols.

9 CFR Part 550

Catfish and catfish products, Catfish inspection, Reporting and recordkeeping requirements.

9 CFR Part 552

Catfish and catfish products, Catfish inspection, Exports.

9 CFR Part 555

Catfish and catfish products, Catfish inspection, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 557

Catfish and catfish products, Catfish inspection, Food labeling, Food packaging, Imports.

9 CFR Part 559

Catfish and catfish products, Catfish inspection, Crime, Seizures and forfeitures.

9 CFR Part 560

Catfish and catfish products, Catfish inspection, Intergovernmental relations.

9 CFR Part 561

Administrative practice and procedure, Catfish and catfish products, Catfish inspection, Crime, Government employees.

For the reasons set forth in the preamble, 9 CFR chapter III is proposed to be amended as follows:

Subchapter A—Agency Organization and Terminology; Mandatory Meat and Poultry Products Inspection and Voluntary Inspection and Certification

PART 300—AGENCY MISSION AND ORGANIZATION

1. The authority citation for 9 CFR part 300 continues to read as follows:

Authority:

21 U.S.C. 450-471, 601-695, 1031-1056; 7 U.S.C. 138-138i, 450, 1621-1627, 1901-1906; 7 CFR 2.7, 2.18, 2.53.

2. Section 300.3 is amended by revising paragraphs (a), (b) introductory text, and (b)(1) to read as follows:

§ 300.3

FSIS organization.

(a)

General.

The organization of FSIS reflects the Agency's primary regulatory responsibilities: implementation of the FMIA, including catfish, the PPIA, and the EPIA. FSIS implements the inspection provisions of the FMIA, the PPIA, and the EPIA through its field structure.

(b)

Headquarters.

FSIS has ten principal components or offices, each of which is under the direction of an Assistant Administrator. The Assistant Administrators, along with their staffs, and the Administrator, along with the Office of the Administrator and ten staff offices that report to the Administrator, are located at U.S. Department of Agriculture headquarters in Washington, DC.

(1)

Program Offices.

FSIS's headquarters offices are the Office of Public Health Science; the Office of Management; the Office of Policy and Program Development; the Office of Field Operations; the Office of Data Integration and Food Protection; the Office of Program Evaluation, Enforcement, and Review; the Office of Public Affairs and Consumer Education; the Office of Outreach, Employee Education, and Training; the Office of International Affairs; and the Office of Catfish Inspection Programs.

Subchapter E—Regulatory Requirements under the Federal Meat Inspection Act and the Poultry Products Inspection Act

PART 441—CONSUMER PROTECTION STANDARDS: RAW PRODUCTS

3. The authority citation for 9 CFR part 441 continues to read as follows:

Authority:

21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906; 7 CFR 2.18, 2.53

§ 441.10

[Amended]

4. In § 441.10, remove the term “Raw livestock and poultry” and add in its place the term “Raw livestock, poultry, and catfish” at the beginning of the first sentence of paragraph (a) and at the beginning of the first sentence of paragraph (b).

5. A new Subchapter F, consisting of Parts 530 to 561, is added to Chapter III to read as follows:

Subchapter F—Mandatory Inspection of Catfish and Catfish Products

PART 530—GENERAL REQUIREMENTS; DEFINITIONS

Sec.

530.1

General.

530.2

FSIS organization for inspection of catfish and catfish products.

530.3

Access to establishments.

Authority:

7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 7 CFR 2.18, 2.53.

§ 530.1

General.

(a) The regulations in this subchapter provide for the inspection of catfish and catfish products. The inspection and regulations are intended to prevent the sale, transportation, offer for sale or transportation, or receipt for transportation, in commerce of any catfish or catfish product that is capable of use as human food and is adulterated or misbranded at the time of the sale

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