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

1The 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.’’ 

2U.S. Department of Health and Human Services. 

Food and Drug Administration. February 28, 2003. 

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).1 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 nonIctaluidae species that did not include 

the term ‘‘catfish,’’ and suggested ways 

of devising those names.2


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10435 

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 3—TAXONOMY OF THE CATFISHES. THE ORDER SILURIFORMES, OR ‘‘CATFISHES,’’ INCLUDES THIRTY-SIX FAMILIES, 

COMMON NAMES OF WHICH ARE IN PARENTHESES

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

Family ....................................................................................................... Akysidae (stream catfishes) 

Family ....................................................................................................... Amblycipitidae (torrent catfishes) 

Family ....................................................................................................... Amphiliidae (loach catfishes) 

Family ....................................................................................................... Ariidae (bagres marinos, fork-tailed catfishes, poissonschats marins, 

sea catfishes) 

Family ....................................................................................................... Aspredinidae (banjo catfishes) 

Family ....................................................................................................... Astroblepidae (climbing catfishes, naked sucker-mouth catfishes) 

Family ....................................................................................................... Auchenipteridae (driftwood catfishes) 

Family ....................................................................................................... Bagridae (bagrid catfishes, naked catfishes) 

Family ....................................................................................................... Callichthyidae (armored catfishes, callichthyid armored catfishes, 

coridoras, mailed catfishes, plated catfishes, poissons-chats 

cuirasses) 

Family ....................................................................................................... Cetopsidae (whale catfishes, whalelike catfishes) 

Family ....................................................................................................... Chacidae (angler catfishes, frogmouth catfishes, squarehead catfishes) 

Family ....................................................................................................... Clariidae (airbreathing catfishes, bagres laberintos, labyrinth catfishes, 

poissons-chats a` labyrinths) 

Family ....................................................................................................... Cranoglanididae (armorhead catfishes, armoured catfishes) 

Family ....................................................................................................... Diplomystidae (diplomystid catfishes, velvet catfishes) 

Family ....................................................................................................... Doradidae (bagres sierra, poissons-chats e ́pineux, thorny catfishes) 

Family ....................................................................................................... Erethistidae 

Family ....................................................................................................... Heptapteridae (heptapterids) 

Family ....................................................................................................... Heteropneustidae (airsac catfishes) 

Family ....................................................................................................... Hypophthalmidae (loweye catfishes) 

Family ....................................................................................................... Ictaluridae (bagres de agua dulce, barbottes, barbottes et barbues, 

barbues, bullhead catfishes, North American catfishes, North American freshwater catfishes) 

Family ....................................................................................................... Lacantuniidae 

Family ....................................................................................................... Loricariidae (armored catfishes, loricariide ́s, plecoo ́stomas, 

suckermouth armored catfishes, suckermouth catfishes) 

Family ....................................................................................................... Malapteruridae (electric catfishes) 

Family ....................................................................................................... Mochokidae (naked catfishes, squeakers, upside-down catfishes) 

Family ....................................................................................................... Nematogenyidae (mountain catfishes) 

Family ....................................................................................................... Olyridae 

Family ....................................................................................................... Pangasiidae (giant catfishes) 

Family ....................................................................................................... Parakysidae 

Family ....................................................................................................... Pimelodidae (flat-hosed catfishes, juiles, long-whiskered catfishes, 

longwhiskered catfishes, poissonschats a` longues moustaches) 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10436 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

3Adapted from Integrated Taxonomic 

Information System (ITIS) report on ‘‘Siluriformes.’’ 

At http://www.itis.gov (accessed October 4, 2009). 

4 ITIS report on ‘‘Siluriformes.’’ At http:// 

www.itis.gov (accessed Jan. 26, 2009). 

5U.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. 

TABLE 1 3—TAXONOMY OF THE CATFISHES. THE ORDER SILURIFORMES, OR ‘‘CATFISHES,’’ INCLUDES THIRTY-SIX FAMILIES, 

COMMON NAMES OF WHICH ARE IN PARENTHESES—Continued 

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

Family ....................................................................................................... Plotosidae (coral catfishes, eel catfishes, stinging catfishes) 

Family ....................................................................................................... Pseudopimelodidae (bumblebee catfishes, dwarf marbled catfishes) 

Family ....................................................................................................... Schilbeidae (glass catfishes, schilbid catfishes) 

Family ....................................................................................................... Scoloplacidae (spiny dwarf catfishes) 

Family ....................................................................................................... Siluridae (freshwater catfishes, sheatfishes) 

Family ....................................................................................................... Sisoridae (sisorid catfishes, sucker catfishes) 

Family ....................................................................................................... Trichomycteridae (parasitic catfishes, pencil catfishes) 

The order Siluriformes includes the 

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. 

Another family of Siluriformes, the 

Pangasiidae, the so-called ‘‘giant 

catfishes,’’ 4 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). 

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.5 The Agency considered 

information about the extent of 

misbranding, and it evaluated outputs 

from its benefit-cost analysis for catfish 

inspection. 

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 growout 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 offflavor 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10437 

6U.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. 

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 handprocessed 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.6 Also, the quality 

of the river water is more difficult to 

control or less subject to control by fish 

farmers than is pond water. 

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-forservice 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10438 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

7U.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. 

8U.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. 

9Santerre, 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. 

10U.S. Department of Agriculture. Agriculture 

Marketing Service. December 2009. Pesticide Data 

Program Annual Report 2008. Washington, DC. 

11U.S. Department of Agriculture. Agriculture 

Marketing Service. December 2009. Pesticide Data 

Program annual Report 2008. Washington, DC. 

12An organophosphate insecticide linked to 

neurological and birth defects. 

13A 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. 

14An organochlorine insecticide with acute 

toxicity and high bioaccumulation potential, 

endosulfan is an endocrine disruptor. 

15Toxaphene 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. 

16Heuer, 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/downloads

AnimalVeterinary/ResourcesforYou/Animal

HealthLiteracy/UCM109808.pdf (Accessed Feb. 15, 

2011). 

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 lowrisk 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.7

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.8

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.9

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. 

Pesticides 

In 2008, the USDA Agricultural 

Marketing Service 10 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.11 Of note, chlorpyrifos 12

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) 13 was detected in 97 percent of 

the domestic samples and 34 percent of 

imported samples at levels below 

regulatory concern; endosulfan 14 and 

its metabolites were detected in less 

than 1 percent of the domestic samples 

and in 27 percent of the import samples; 

and Toxaphene 15 was detected in 1 

percent of the domestic samples and 

none of the import samples. 

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.16 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/ProductSpecificInformation/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. 

In conjunction with the April 2008— 

March 2009 heavy metals survey, FSIS 

tested 733 catfish samples for the 

presence of chloramphenicol, gentian 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10439 

17U.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. 

18McCaskey 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. 

19U.S. Department of Agriculture. Economic 

Research Service. 2009. Economic Research Service 

Staff Analysis of FDA Import Refusals for Catfish, 

1998–2004. Washington, DC. 20Because 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%. 21Chou, 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. 

22Beatty, M.E., Bopp, C.A., Wells, J.G., Greene, 

K.D., Puhr, N.D., & Mintz, E.D. (2004). Enterotoxinproducing Escherichia coli O169:H41, United 

States. Emerging Infectious Diseases. Retrieved from 

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

0268.htm Oct. 16, 2009. 

23 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. 

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 17

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 18 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.19 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.20

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.21 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 crosscontamination 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. 

Escherichia coli 

A 2003 outbreak linked catfish or 

coleslaw consumption to 41 cases of 

Enterotoxigenic E. coli (ETEC) 

O169:H41-related illness (Beatty, 

2004).22 However, FSIS is aware of no 

data to describe the occurrence of ETEC 

on catfish. 

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.23

Year State Setting Etiology Illnesses Hospitalizations Deaths 

1991 ....... NJ .......... Restaurant ...................... Salmonella ...................... 10 6 0 

1999 ....... FL ........... Private Home ................. Unknown ........................ 2 0 0 

1999 ....... FL ........... Restaurant/Deli ............... Unknown ........................ 5 0 0 

2000 ....... OH ......... Restaurant/Deli ............... Chemical ........................ 2 0 0 

2003 ....... TN .......... Workplace ...................... E. coli O169 ................... 41 2 0 

2003 ....... CO ......... Restaurant/Deli ............... Unknown ........................ 4 0 0 

2007 ....... FL ........... Private Home ................. Unknown ........................ 2 0 0 

In 1991, an illness outbreak occurred 

in New Jersey that affected ten casepatients. Nine stool specimens tested 

positive for Salmonella Hadar. Catfish 

was identified as a possible vehicle for 

illnesses. 

In 1991, an illness outbreak occurred 

in New Jersey that affected ten casepatients. 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10440 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

24U.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. 

25Food 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). 

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.24 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.25

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 costeffectiveness 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 inplant 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10441 

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, crossreferencing 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)). 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
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26The District Manager, in the current Agency 

organization, has absorbed functions of the former 

Area Supervisor, mentioned in 9 CFR 307.4. 

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 26 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. 

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 preharvest 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
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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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10444 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

27FSIS 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. 

28The program is explained at: http:// 

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

(Accessed 10/29/2008.) 

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).27 The FSIS National Residue 

Program determines whether there are 

violative concentrations of drug or other 

chemical residues in the products the 

Agency regulates.28 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. 

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10445 

29U.S. Department of Commerce. NIST Handbook 

133: Checking the Net Contents of Packaged Goods, 

Fourth Edition, January 2005. Washington, DC. 

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 safehandling 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 foodsafety 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 2.6.29 Interested 

persons may want to consult NIST 

Handbook 133 for maximum allowable 

variations. 

Nutrition Labeling Requirements 

Under the FMIA (21 U.S.C. 601(n)(1), 

621), FSIS is proposing to apply the 

nutrition labeling requirements to 


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10446 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

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 furtherprocessed 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_SeriesProcessed_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 foodcontact 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, crossreferencing to 9 CFR part 318, subpart 

G (§§ 318.300–318.311)). Domestic 

canned fish products currently are 

subject to FDA requirements for lowacid 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 


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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 


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‘‘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 


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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10449 

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-inCharge 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. 


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TABLE 5—RELATIONSHIP BETWEEN CATFISH AND CATFISH PRODUCT INSPECTION REGULATIONS IN SUBCHAPTER F AND

MEAT INSPECTION REGULATIONS IN SUBCHAPTER A OR SUBCHAPTER E—Continued 

Subject Subchapter F 

designation 

Corresponding Subchapter A or E part 

or section reference 

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. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10451 

TABLE 5—RELATIONSHIP BETWEEN CATFISH AND CATFISH PRODUCT INSPECTION REGULATIONS IN SUBCHAPTER F AND

MEAT INSPECTION REGULATIONS IN SUBCHAPTER A OR SUBCHAPTER E—Continued 

Subject Subchapter F 

designation 

Corresponding Subchapter A or E part 

or section reference 

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10452 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10453 

30A 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. 

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-andcontrol, 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-andcontrol 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-andcontrol 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 $243,000.30 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. 

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10454 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

31A 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. 

32Wholesale price. Source: Catfish Market 

Statistics, NASS, USDA. 

33Wholesale price. Source: Catfish Monthly 

Summary, NASS, USDA. 

34Wholesale price. Source: Catfish Market 

Statistics Annual, NASS, USDA. 

35M. 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. 

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 $233,000.31 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,32 $1.14 per pound 

for frozen catfish fillets,33 and $0.402 

per pound for frozen catfish nuggets.34

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 1996.35 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. 

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. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10455 

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 importexport 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 importexport 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 EGovernment 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10456 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

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://originwww.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. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10457 

(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, 

transportation, offer for sale or 

transportation, or receipt for 

transportation. 

(b) Catfish as defined in this 

subchapter are amenable to the Act, 

including, as the Administrator may 

determine, to provisions of the Act in 

which other amenable species are 

named, except where the Act 

specifically excludes the provisions 

from applicability to catfish. 

§ 530.2 FSIS organization for inspection of 

catfish and catfish products. 

The Food Safety and Inspection 

Service, U.S. Department of Agriculture, 

administers a continuous inspection 

program for catfish and catfish products. 

The organization of FSIS and the 

principal offices of FSIS and their 

functions are described, and 

organizational terms defined, in 9 CFR 

part 300. Section 300.3 lists the FSIS 

district offices and the geographic areas 

of the districts. 

§ 530.3 Access to establishments. 

The provisions of 9 CFR 300.6 apply 

to catfish processing establishments and 

related industries as they do to other 

establishments subject to the FMIA. 

PART 531—DEFINITIONS 

Sec. 

531.1 Definitions. 

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. 

§ 531.1 Definitions. 

As used in this subchapter, unless 

otherwise required by the context, the 

following terms shall be construed, 

respectively, to mean: 

Act. The Federal Meat Inspection Act, 

as amended, (34 Stat. 1260, as amended, 

81 Stat. 584, 84 Stat. 438, 92 Stat. 1069, 

106 Stat. 4499, 119 Stat. 2166, 122 Stat. 

1369, 122 Stat. 2130, 21 U.S.C., sec. 601 

et seq.). 

Adulterated. This term applies to any 

carcass, part thereof, catfish or catfish 

food product under one or more of the 

following circumstances: 

(1) If it bears or contains any such 

poisonous or deleterious substance 

which may render it injurious to health; 

but in case the substance is not an 

added substance, such article shall not 

be considered adulterated under this 

clause if the quantity of such substance 

in or on such article does not ordinarily 

render it injurious to health; 

(2)(i) If it bears or contains (by reason 

of administration of any substance to 

the live animal or otherwise) any added 

poisonous or added deleterious 

substance, other than one which is: 

(A) A pesticide chemical in or on a 

raw agricultural commodity; 

(B) A food additive; or 

(C) A color additive which may, in the 

judgment of the 

Administrator, make such article unfit 

for human food; 

(ii) If it is, in whole or in part, a raw 

agricultural commodity and such 

commodity bears or contains a pesticide 

chemical which is unsafe within the 

meaning of section 408 of the Federal 

Food, Drug, and Cosmetic Act; 

(iii) If it bears or contains any food 

additive which is unsafe within the 

meaning of section 409 of the Federal 

Food, Drug, and Cosmetic Act; 

(iv) If it bears or contains any color 

additive which is unsafe within the 

meaning of section 706 of the Federal 

Food, Drug, and Cosmetic Act: 

Provided, That an article which is not 

deemed adulterated under paragraphs 

(2) (ii), (iii), or (iv) of this section shall 

nevertheless be deemed adulterated if 

use of the pesticide chemical food 

additive, or color additive in or on such 

article is prohibited by the regulations 

in this subchapter in official 

establishments; 

(3) If it consists in whole or in part of 

any filthy, putrid, or decomposed 

substance or is for any other reason 

unsound, unhealthful, unwholesome, or 

otherwise unfit for human food; 

(4) If it has been prepared, packed, or 

held under unsanitary conditions 

whereby it may have become 

contaminated with filth, or whereby it 

may have been rendered injurious to 

health; 

(5) If it is, in whole or in part, the 

product of an animal which has died 

otherwise than by slaughter; 

(6) If its container is composed, in 

whole or in part, of any poisonous or 

deleterious substance that may render 

the contents injurious to health; 

(7) If it has been intentionally 

subjected to radiation, unless the use of 

the radiation was in conformity with a 

regulation or exemption in effect 

pursuant to section 409 of the Federal 

Food, Drug, and Cosmetic Act; 

(8) If any valuable constituent has 

been in whole or in part omitted or 

abstracted therefrom; or if any substance 

has been substituted, wholly or in part 

therefor; or if damage or inferiority has 

been concealed in any manner; or if any 

substance has been added thereto or 

mixed or packed therewith so as to 

increase its bulk or weight, or reduce its 

quality or strength, or make it appear 

better or of greater value than it is. 

Amenable species. A species that is, 

and whose products are, subject to the 

Act and regulations promulgated under 

the Act, except as the Act may provide. 

Animal food. Any article intended for 

use as food for dogs, cats, or other 

animals, derived wholly, or in part, 

from the carcass or parts or products of 

the carcass of any amenable species, 

except that the term animal food as used 

herein does not include: 


emcdonald on DSK2BSOYB1PROD with PROPOSALS2
10458 Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 

(1) Processed dry animal food or 

(2) Feeds for amenable species 

manufactured from processed by 

products of amenable species. 

Applicant. Any person who requests 

inspection service, exemption, or other 

authorization under the regulations. 

Biological residue. Any substance, 

including metabolites, remaining in 

catfish at time of slaughter or in any of 

their tissues after slaughter as the result 

of treatment or exposure of the catfish 

to a pesticide, organic or inorganic 

compound, hormone, hormone like 

substance, antihelmintic, or other 

therapeutic or prophylactic agent. 

Capable of use as human food. This 

term applies to any carcass or part or 

product of a carcass of any catfish 

unless it is denatured or otherwise 

identified as required by section 540.3 

of this subchapter to deter its use as a 

human food, or it is naturally inedible 

by humans; e.g., barbels or fins in their 

natural state. 

Carcass. All parts, including viscera, 

of any slaughtered livestock. 

Catfish. The skeletal muscle tissue of 

catfish. As applied to products of catfish 

species, this term has a meaning 

comparable to that of ‘‘meat’’ in the meat 

inspection regulations (9 CFR 301.2). 

Catfish byproduct. Any catfish part 

capable of use as human food, other 

than the skeletal muscle tissue, that has 

been derived from one or more catfish. 

Catfish food product. Any article 

capable of use as human food that is 

made wholly or in part from any catfish 

or part thereof; or any product that is 

made wholly or in part from any catfish 

or part thereof, excepting those 

exempted from definition as a catfish 

product by the Administrator in specific 

cases or by a regulation in this 

subchapter; upon a determination that 

they contain catfish ingredients only in 

a relatively small proportion or 

historically have not been considered by 

consumers as products of the catfish 

food industry, and provided that they 

comply with any requirements that are 

imposed in such cases or regulations as 

conditions of such exemptions to ensure 

that the catfish meat or other portions of 

such carcasses contained in such 

articles are not adulterated, and that 

such articles are not represented as 

catfish food products. 

Catfish product. Any catfish or catfish 

part; or any product that is made wholly 

or in part from any catfish or catfish 

part, except for those exempted from 

definition as a catfish product by the 

Administrator in a regulation in this 

subchapter. Except where the context 

requires otherwise (e.g., in part 540 of 

this subchapter), this term is limited to 

articles capable of use as human food. 

Commerce. Commerce between any 

State, any Territory, or the District of 

Columbia, and any place outside 

thereof; or within any Territory not 

organized with a legislative body, or the 

District of Columbia. 

Consumer package. Any container in 

which a catfish product is enclosed for 

the purpose of display and sale to 

household consumers. 

Container. Any box, can, tin, cloth, 

plastic, or any other receptacle, 

wrapper, or cover. 

Dead catfish. The body of catfish that 

has died otherwise than by slaughter. 

Dying or diseased catfish. Catfish 

affected by any of the conditions for 

which the catfish are required to be 

condemned under part 539 or other 

regulations in this subchapter. 

Edible. Intended for use as human 

food. 

Farm-raised. Grown under controlled 

conditions, within an enclosed space, as 

on a farm. 

Federal Food, Drug, and Cosmetic 

Act. The Act so entitled, approved June 

25, 1938 (52 Stat. 1040), and Acts 

amendatory thereof or supplementary 

thereto. 

Firm. Any partnership, association, or 

other unincorporated business 

organization. 

Further processing. Smoking, cooking, 

canning, curing, refining, or rendering 

in an official establishment of product 

previously prepared in official 

establishments. 

Immediate container. The receptacle 

or other covering in which any product 

is directly contained or wholly or 

partially enclosed. 

Inedible. Adulterated, uninspected, or 

not intended for use as human food. 

‘‘Inspected and passed’’ or ‘‘U.S. 

Inspected and Passed’’ or ‘‘U.S. 

Inspected and Passed by Department of 

Agriculture’’ (or any authorized 

abbreviation thereof). This term means 

that the product so identified has been 

inspected and passed under the 

regulations in this subchapter, and at 

the time it was inspected, passed, and 

identified, it was found to be not 

adulterated. 

Label. A display of written, printed, 

or graphic matter upon the immediate 

container (not including package liners) 

of any article. 

Labeling. All labels and other written, 

printed, or graphic matter: 

(1) Upon any article or any of its 

containers or wrappers, or 

(2) Accompanying such article. 

Misbranded. This term applies to any 

carcass, part thereof, meat or meat food 

product under one or more of the 

following circumstances: 

(1) If its labeling is false or misleading 

in any particular; 

(2) If it is offered for sale under the 

name of another food; 

(3) If it is an imitation of another food, 

unless its label bears, in type of uniform 

size and prominence, the word 

‘‘imitation’’ and immediately thereafter, 

the name of the food imitated; 

(4) If its container is so made, formed, 

or filled as to be misleading; 

(5) If in a package or other container 

unless it bears a label showing: 

(i) The name and place of business of 

the manufacturer, packer, or distributor; 

and 

(ii) An accurate statement of the 

quantity of the contents in terms of 

weight, measure, or numerical count; 

except as otherwise provided in part 

317 of this subchapter with respect to 

the quantity of contents; 

(6) If any word, statement, or other 

information required by or under 

authority of the Act to appear on the 

label or other labeling is not 

prominently placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use; 

(7) If it purports to be or is 

represented as a food for which a 

definition and standard of identity or 

composition has been prescribed by the 

regulations in part 319 of this 

subchapter unless: 

(i) It conforms to such definition and 

standard, and 

(ii) Its label bears the name of the food 

specified in the definition and standard 

and, insofar as may be required by such 

regulations, the common names of 

optional ingredients (other than spices, 

flavoring, and coloring) present in such 

food; 

(8) If it purports to be or is 

represented as a food for which a 

standard or standards of fill of container 

have been prescribed by the regulations 

in part 319 of this subchapter, and it 

falls below the standard of fill of 

container applicable thereto, unless its 

label bears, in such manner and form as 

such regulations specify, a statement 

that it falls below such standard; 

(9) If it is not subject to the provisions 

of paragraph (7)(ii) of this section unless 

its label bears: 

(i) The common or usual name of the 

food, if any there be, and 

(ii) In case it is fabricated from two or 

more ingredients, the common or usual 

name of each such ingredient, except as 

otherwise provided in part 317 of this 

subchapter; 

(10) If it purports to be or is 

represented for special dietary uses, 


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unless its label bears such information 

concerning its vitamin, mineral, and 

other dietary properties as is required by 

the regulations in part 317 of this 

subchapter. 

(11) If it bears or contains any 

artificial flavoring, artificial coloring, or 

chemical preservative, unless it bears a 

label stating that fact; except as 

otherwise provided by the regulations in 

part 317 of this subchapter; or 

(12) If it fails to bear, directly thereon 

or on its containers, when required by 

the regulations in part 316 or 317 of this 

subchapter, the inspection legend and, 

unrestricted by any of the foregoing, 

such other information as the 

Administrator may require in such 

regulations to assure that it will not 

have false or misleading labeling and 

that the public will be informed of the 

manner of handling required to 

maintain the article in a wholesome 

condition. 

Nonfood compound. Any substance 

proposed for use in official 

establishments, the intended use of 

which will not result, directly or 

indirectly, in the substance becoming a 

component or otherwise affecting the 

characteristics of meat food and meat 

products excluding labeling and 

packaging materials as covered in part 

541 of this subchapter. 

Official certificate. Any certificate 

prescribed by the regulations in this 

subchapter for issuance by an inspector 

or other person performing official 

functions under the Act. 

Official device. Any device prescribed 

by the regulations in part 312 of this 

subchapter for use in applying any 

official mark. 

Official establishment. Any 

slaughtering, cutting, boning, catfish 

product canning, curing, smoking, 

salting, packing, rendering, or similar 

establishment at which inspection is 

maintained under the regulations in this 

subchapter. 

Official import inspection 

establishment. This term means any 

establishment, other than an official 

establishment as defined in this section, 

where inspections are authorized to be 

conducted as prescribed in part 557 of 

this subchapter. 

Official inspection legend. Any 

symbol prescribed by the regulations in 

this subchapter showing that an article 

was inspected and passed in accordance 

with the Act. 

Official mark. The official inspection 

legend or any other symbol prescribed 

by the regulations in this subchapter to 

identify the status of any article, catfish, 

or catfish product under the Act. 

Packaging material. Any cloth, paper, 

plastic, metal, or other material used to 

form a container, wrapper, label, or 

cover for meat products. 

Person. Any individual, firm, or 

corporation. 

Pesticide chemical, food additive, 

color additive, raw agricultural 

commodity. These terms shall have the 

same meanings for purposes of the Act 

and the regulations in this subchapter as 

under the Federal, Drug, and Cosmetic 

Act. 

Prepared. Slaughtered, canned, salted, 

rendered, boned, cut up, or otherwise 

manufactured or processed. 

Process authority. A person or 

organization with expert knowledge in 

catfish production process control and 

relevant regulations. This definition 

does not apply to § 548.6 of this 

subchapter or to subpart G of part 318 

of this chapter. 

Process schedule. A written 

description of processing procedures, 

consisting of any number of specific, 

sequential operations directly under the 

control of the establishment employed 

in the manufacture of a specific product, 

including the control, monitoring, 

verification, validation, and corrective 

action activities associated with 

production. This definition does not 

apply to § 548.6 of this subchapter or to 

subpart G of part 318 of this chapter. 

Producer. Any person engaged in the 

business of growing farm-raised catfish. 

Product. Any carcass, catfish, catfish 

product, or catfish food product, 

capable of use as human food. 

Program. The organizational unit 

within the Department having the 

responsibility for carrying out the 

provisions of the Act. 

Program employee. Any inspector or 

other individual employed by the 

Department or any cooperating agency 

who is authorized by the Secretary to do 

any work or perform any duty in 

connection with the Program. 

Slaughter. With respect to catfish, 

intentional killing under controlled 

conditions. 

State. Any State of the United States 

or the Commonwealth of Puerto Rico. 

Territory. Guam, the Virgin Islands of 

the United States, American Samoa, and 

any other territory or possession of the 

United States. 

U.S. Condemned. This term means 

that the catfish, part, or product of 

catfish so identified was inspected and 

found to be adulterated and is 

condemned. 

U.S. Detained. This term applies to 

catfish, catfish products, and other 

articles which are held in official 

custody in accordance with section 402 

of the Act (21 U.S.C. 672), pending 

disposal as provided in the same section 

402. 

U.S. Retained. This term means that 

the catfish, part, or product of catfish so 

identified is held for further 

examination by an inspector at an 

official establishment to determine its 

disposal. 

United States. The States, the District 

of Columbia, and the Territories of the 

United States. 

PART 532—REQUIREMENTS FOR 

INSPECTION 

Sec. 

532.1 Establishments requiring inspection; 

other inspection. 

532.2 Application for inspection. 

532.3 Exemption of retail operations. 

532.4 Inspection at official establishments; 

relation to other authorities. 

532.5 Exemption from definition of catfish 

product of certain human food products 

containing catfish. 

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. 

§ 532.1 Establishments requiring 

inspection; other inspection. 

(a) No establishment may process or 

prepare catfish, catfish parts, or catfish 

products capable of use as human food, 

or sell, transport, or offer for sale or 

transportation in commerce any of these 

articles without continuous inspection 

under these regulations, except as 

expressly exempted in § 532.3. 

(b) Inspection under the regulations is 

required at: (1) Every establishment, 

except as provided in the regulation on 

exemption of retail operations (§ 532.3), 

in which any catfish or catfish products 

are wholly or in part, processed for 

transportation or sale in commerce, as 

articles intended for use as human food. 

(2) Every establishment, except as 

provided in the regulation on exemption 

of retail operations (§ 532.3), within any 

State or organized territory which is 

designated pursuant to section 301 of 

the Act (21 U.S.C. 661), at which any 

catfish or catfish products are processed 

for use as human food solely for 

distribution within that State or 

territory. 

(3) Except as provided in the 

regulation on exemption of retail 

operations (§ 532.3), every 

establishment designated by the 

administrator under section 301 of the 

Act (21 U.S.C. 661) as one producing 

adulterated catfish products which 

would clearly endanger the public 

health. 

(4) Coverage of catfish and catfish 

products processed in official 

establishments. All catfish and catfish 

products prepared in an official 

establishment must be inspected, 

handled, processed, marked, and 

labeled as required by the regulations. 


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(5) Other inspection. Periodic 

inspections may be made of: 

(i) The records of all persons engaged 

in the business of hatching, feeding, 

growing, or transporting catfish between 

premises where catfish are bred, 

hatcheries, and premises where catfish 

are grown, and from these premises to 

processing establishments. 

(ii) Exempted retail establishments to 

determine that those establishments are 

operating in accordance with these 

regulations. 

§ 532.2 Application for inspection. 

(a) Application for inspection is as 

required by 9 CFR 304.1. 

(b) Information to be furnished is as 

required by 9 CFR 304.2(a), (b), and 

(c)(1). Conditions for receiving 

inspection, including having written 

Sanitation SOPs and HACCP plans, are 

as required by 9 CFR 304.3. 

(c) Official numbers; inauguration of 

inspection; withdrawal of inspection; 

reports of violation. The requirements 

for assignment of official numbers, 

inauguration of inspection, withdrawal 

of inspection, and reports of violations 

at catfish processing establishments are 

as required by 9 CFR part 305 for meat 

establishments. 

(d) Assignment and authorities of 

program employees. The requirements 

concerning the assignment and 

authorities of Program employees at 

catfish processing establishments are as 

required by 9 CFR parts 306 and 307 

with respect to Program employees at 

meat establishments. 

§ 532.3 Exemption of retail operations. 

The exemption in 9 CFR 303.1(d) for 

operations of types traditionally and 

usually conducted at retail stores and 

restaurants applies with respect to 

catfish products as it does with respect 

to products of other amenable species 

under the FMIA. However, a retail 

quantity of catfish or catfish products 

sold to a household consumer is a 

normal retail quantity if it does not 

exceed 75 pounds and the quantity of 

catfish or catfish product sold by a retail 

supplier to a non-household consumer 

is a normal retail quantity if it does not 

exceed 150 pounds in the aggregate. 

§ 532.4 Inspection at official 

establishments; relation to other 

authorities. 

(a) Requirements within the scope of 

the Act with respect to premises, 

facilities, and operations of any official 

establishment that are in addition to or 

different than those made under this 

subchapter may not be imposed by any 

State or local jurisdiction except that the 

State or local jurisdiction may impose 

recordkeeping and other requirements 

within the scope of § 550.1 of this 

chapter, if consistent with those 

requirements, with respect to the 

establishment. 

(b) Labeling, packaging, or ingredient 

requirements in addition to or different 

than those made under this subchapter, 

the Federal Food, Drug, and Cosmetic 

Act and Fair Packaging and Labeling 

Act may not be imposed by any State or 

local jurisdiction with respect to any 

catfish or catfish products processed at 

any official establishment in accordance 

with the requirements under this 

subchapter and those Acts. 

§ 532.5 Exemption from definition of 

catfish product of certain human food 

products containing catfish. 

The following articles contain catfish 

ingredients only in a relatively small 

proportion or historically have not been 

considered by consumers as products of 

the catfish food products industry. 

Therefore, the articles are exempted 

from the definition of ‘‘catfish product’’ 

and the requirements of the Act and the 

regulations that apply to catfish 

products, if they comply with the 

conditions specified in this section. 

(a) Any human food product if: 

(1) It contains less than 3 percent raw 

or 2 percent cooked catfish; 

(2) The catfish ingredients used in the 

product were prepared under Federal 

inspection or were inspected under a 

foreign inspection system approved 

under § 557.2 of this chapter and 

imported in compliance with the Act 

and the regulations; 

(3) The immediate container of the 

product bears a label which shows the 

name of the product in accordance with 

this section; and 

(4) The product is not represented as 

a catfish product. The percentage of 

cooked catfish ingredients must be 

computed on the basis of the moist, 

deboned, cooked catfish in the ready-toserve product when prepared according 

to the serving directions on the 

consumer package. 

(b) A product exempted under this 

section will be deemed to be 

represented as a catfish product if the 

term ‘‘catfish’’ or a term representing a 

fish species that is covered by the 

definition of ‘‘catfish’’ in part 531 of this 

subchapter is used in the product name 

of the product without appropriate 

qualification. 

(c) A product exempted under this 

section is subject to the requirements of 

the Federal Food, Drug, and Cosmetic 

Act. 

PART 533—SEPARATION OF 

ESTABLISHMENT; FACILITIES FOR 

INSPECTION; FACILITIES FOR 

PROGRAM EMPLOYEES; OTHER 

REQUIRED FACILITIES 

Sec. 

533.1 Separation of establishments. 

533.2 [Reserved] 

533.3 Facilities for Program employees. 

533.4 Other facilities and conditions to be 

provided. 

533.5 Schedule of operations. 

533.6 Overtime and holiday inspection 

service. 

533.7 Basis of billing for overtime and 

holiday services. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 533.1 Separation of establishments. 

Each official establishment shall be 

separate and distinct from any unofficial 

establishment and from any other 

official establishment, except an 

establishment preparing products under 

the FMIA, the PPIA, or the EPIA, or 

under State catfish inspection 

requirements and authorities that are 

deemed to be at least equal to those 

provided under the FMIA. Further, 

doorways, or other openings, may be 

permitted between establishments at the 

discretion of the Administrator and 

under such conditions as he may 

prescribe. An official establishment that 

is not separate and distinct from another 

official or unofficial establishment must 

ensure that no sanitary hazards are 

created by the lack of separation. 

§ 533.2 [Reserved] 

§ 533.3 Facilities for Program employees. 

Office space, including necessary 

furnishings, light, heat, and janitor 

service, must be provided by official 

establishments, rent free, for the 

exclusive use for official purposes of the 

inspector and other Program employees 

assigned thereto. The space set aside for 

this purpose shall meet with approval of 

the District Manager or the frontline 

supervisor and must be conveniently 

located, properly ventilated, and 

provided with lockers suitable for the 

protection and storage of Program 

supplies and with facilities suitable for 

Program employees to change clothing if 

such facilities are deemed necessary by 

the frontline supervisor. At the 

discretion of the Administrator, small 

establishments requiring the services of 

less than one full-time inspector need 

not furnish facilities for Program 

employees as prescribed in this section, 

where adequate facilities exist in a 

nearby convenient location. Laundry 

service for inspectors’ outer work 

clothing must be provided by each 

establishment. 


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§ 533.4 Other facilities and conditions to 

be provided. 

When required by the District 

Manager or the frontline supervisor, 

each official establishment must provide 

the following facilities and conditions, 

and such others as may be found to be 

essential to efficient conduct of 

inspection and maintenance of sanitary 

conditions: 

(a) Sufficient light to be adequate for 

the proper conduct of inspection; 

(b) Tables, benches, and other 

equipment on which inspection is to be 

performed, of such design, material, and 

construction as to enable Program 

employees to conduct their inspection 

in a ready, efficient and clean manner; 

(c) Receptacles for holding and 

handling diseased carcasses and parts, 

so constructed as to be readily cleaned 

and to be marked in a conspicuous 

manner with the phrase ‘‘U.S. 

Condemned’’ in letters not less than 2 

inches high, and, when required by the 

frontline supervisor, to be equipped in 

a way that allows the receptacles to be 

locked or sealed; 

(d) Adequate arrangements, including 

liquid soap and cleansers, for cleansing 

and disinfecting hands, for sterilizing all 

implements used in handling diseased 

carcasses, for cleaning and sanitizing 

floors, and such other articles and 

places as may be contaminated by 

diseased carcasses or otherwise; 

(e) Adequate facilities, including 

denaturing materials, for the proper 

disposal of condemned articles in 

accordance with the regulations in this 

subchapter; 

(f) Docks and receiving rooms, to be 

designated by the operator of the official 

establishment, with the frontline 

supervisor, for the receipt and 

inspection of catfish, catfish products, 

or other products. 

(g) Suitable lockers in which brands 

bearing the official inspection legend 

and other official devices (excluding 

labels) can be stored. Official certificates 

shall be kept when not in use in suitable 

file cabinets. All such lockers and file 

cabinets shall be equipped for sealing or 

locking with locks or seals to be 

supplied by the Department. The keys of 

such locks shall not leave the custody 

of Program employees. 

§ 533.5 Schedule of operations. 

The requirements governing the 

schedule of operations for catfish 

processing establishments are as 

required by 9 CFR 307.4 for meat 

establishments. 

§ 533.6 Overtime and holiday inspection 

service. 

The requirements governing overtime 

and holiday inspection service in 9 CFR 

307.5 apply to catfish processing 

establishments. 

§ 533.7 Basis of billing for overtime and 

holiday services. 

The requirements for billing and 

overtime and holiday inspection 

services are as required by 9 CFR 307.6. 

PART 534—PRE–HARVEST 

STANDARDS AND TRANSPORTATION 

TO PROCESSING ESTABLISHMENT. 

Sec. 

534.1 General. 

534.2 Water quality for food fish. 

534.3 Standards for use of drugs in the 

raising of catfish. 

534.4 Transportation to processing plant. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 534.1 General. 

Catfish that are harvested for use as 

human food must have grown and lived 

under conditions that will not render 

the catfish or their products unsound, 

unwholesome, unhealthful, or otherwise 

unfit for human food. 

§ 534.2 Water quality for food fish. 

Producers of catfish should monitor 

the water in which the fish are raised for 

the presence of suspended solids, 

organic matter, nutrients, heavy metals, 

pesticides, fertilizers, and industrial 

chemicals that may contaminate fish. 

FSIS will collect samples of feed, fish, 

and pond water from producers, at 

intervals to be determined by the 

Administrator, for the purpose of 

verifying that catfish are being raised 

under conditions that will yield safe, 

wholesome products. 

§ 534.3 Standards for use of drugs in the 

raising of catfish. 

New animal drugs that are the subject 

of an approved new animal drug 

application (NADA) or abbreviated new 

animal drug application (ANADA) 

under section 512 of the Federal Food, 

Drug, and Cosmetic Act (the Act) [21 

USC 360b], or a conditional approval 

under section 571 of the Act [21 USC 

360ccc], or an investigational exemption 

under section 512(j) of the Act [21 

U.S.C. 360b(j)] may be used in the 

raising of catfish. New animal drugs 

approved under section 512 of the Act 

may be used in an extra-label manner if 

such use complies with section 

512(a)(4) of the Act and FDA regulations 

found at 21 CFR part 530. 

§ 534.4 Transportation to processing 

plant. 

A vehicle used to transport catfish 

from a producer’s premises to a 

processing establishment must be 

equipped with vats or other containers 

for holding the catfish. The vats or other 

containers must be maintained in a 

sanitary condition. Sufficient water and 

sufficient oxygen must be provided to 

the vats that hold the catfish to ensure 

that catfish delivered to the processing 

establishment will not be adulterated. 

Any catfish that are dead, dying, 

diseased, or contaminated with 

substances that may adulterate catfish 

products are subject to condemnation at 

the official catfish processing 

establishments. 

PART 537—SANITATION 

REQUIREMENTS AND HAZARD 

ANALYSIS AND CRITICAL CONTROL 

POINTS SYSTEMS 

Sec. 

537.1 Basic requirements. 

537.2 Hazard analysis and HACCP plan. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 537.1 Basic requirements. 

(a) Any official establishment that 

prepares or processes catfish or catfish 

products for human food must comply 

with the requirements contained in 9 

CFR parts 416 and 417, except as 

otherwise provided in this subchapter. 

(b) For the purposes of 9 CFR parts 

416, 417, and 500, an ‘‘official 

establishment’’ or ‘‘establishment’’ 

includes a plant that prepares or 

processes catfish or catfish products. 

§ 537.2 Hazard analysis and HACCP plan. 

(a) A catfish establishment’s hazard 

analysis shall take into account the food 

safety hazards that can occur before, 

during, and after harvest. 

(b) The failure of an establishment to 

develop and implement a hazard 

analysis and a HACCP plan that comply 

with this part or to operate in 

accordance with the requirements of 9 

CFR chapter III, subchapter E, will 

render the products produced under 

these conditions adulterated. 

PART 539—MANDATORY 

DISPOSITIONS; PERFORMANCE 

STANDARDS RESPECTING PHYSICAL, 

CHEMICAL, OR BIOLOGICAL 

CONTAMINANTS 

Sec. 

539.1 Disposal of diseased or otherwise 

adulterated catfish carcasses and parts or 

catfish products. 

539.2 Physical, chemical, or biological 

contaminants. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 


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§ 539.1 Disposal of diseased or otherwise 

adulterated catfish carcasses and parts or 

catfish products. 

(a)(1) Carcasses or parts of catfish 

affected by abscesses or lesions, nonzoonotic parasites such as cestodes, or 

such parasites as digenean trematodes, 

metacercaria (Bolbophorus spp.), yellow 

grubs (Clinostomum spp.), or white 

grubs (Hysterbmorpha spp.) are subject 

to condemnation unless properly 

disposed of by the establishment to 

prevent their use as human food. 

(2) Catfish affected by Heterophyid 

intestinal flukes or Dictophymatidae 

nematodes are subject to condemnation 

unless properly disposed of by the 

establishment. 

(b) Catfish affected by diseases, 

including columnaris (infection by 

Flexibacter columnaris) and enteric 

septicemia of catfish (ESC), are subject 

to condemnation unless properly 

disposed of by the establishment to 

prevent their use as human food. 

(c) Catfish carcasses or parts or catfish 

products that are found to be in a state 

of spoilage or decomposition are subject 

to condemnation unless properly 

disposed of by the establishment to 

prevent their use as human food. 

(d) Grossly deformed fish may not be 

used for human food. 

§ 539.2 Physical, chemical, or biological 

contaminants. 

(a) Catfish and catfish products that 

are contaminated with physical matter 

are subject to official retention and 

condemnation. 

(b) Antibiotic or other drug residues 

in catfish tissues must be within 

applicable tolerances in 21 CFR part 

556. 

(c) Pesticide residues in catfish tissues 

must be within applicable tolerances in 

40 CFR part 180. 

(d) Catfish or catfish products 

containing violative concentrations of 

drugs or other chemicals are subject to 

condemnation. 

PART 540—HANDLING AND 

DISPOSAL OF CONDEMNED AND 

OTHER INEDIBLE MATERIALS 

Sec. 

540.1 Dead catfish. 

540.2 Specimens for educational, research, 

and other nonfood purposes; permits. 

540.3 Handling and disposal of condemned 

or other inedible materials. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 540.1 Dead catfish. 

(a) With the exception of dead catfish 

that have died en route to an official 

establishment that have been received 

with live catfish at the official 

establishment, and that are subject to 

sorting and disposal at the official 

establishment, no catfish or part of the 

carcass of catfish that died otherwise 

than by slaughter may be brought onto 

the premises of an official establishment 

without advance permission from the 

FSIS frontline supervisor. 

(b) The official establishment shall 

maintain physical separation between 

slaughtered catfish and the edible parts 

or products of slaughtered catfish and 

any catfish or parts of catfish that have 

died otherwise than by slaughter. 

Catfish or any parts of catfish that have 

died otherwise than by slaughter shall 

be excluded from any room or 

compartment in which edible product is 

prepared, handled, or stored. 

§ 540.2 Specimens for educational, 

research, and other nonfood purposes; 

permits. 

The requirements of 9 CFR 314.9 

apply to the handling and release of 

specimens of condemned or other 

inedible catfish materials. 

§ 540.3 Handling and disposal of 

condemned or other inedible materials. 

Condemned or other inedible catfish 

and catfish parts shall be separated from 

edible catfish. If not disposed of on the 

premises of the establishment, the 

condemned and inedible catfish parts 

shall be conveyed from the official 

establishment for disposition at a 

rendering plant, an animal feed 

manufacturing establishment, or at 

another establishment for other nonfood use. If not decharacterized by use 

of approved denaturants or colorings, 

the inedible materials shall be enclosed 

in containers that are conspicuously 

marked to indicate that the contents are 

condemned or otherwise inedible. The 

materials may be shipped under 

company or official seal to a rendering 

facility or for other inedible processing. 

PART 541—MARKS, MARKING AND 

LABELING OF PRODUCTS AND 

CONTAINERS 

Sec. 

541.1 General. 

541.2 Official marks and devices to identify 

inspected and passed catfish and catfish 

products. 

541.3 Official seals for transportation of 

products. 

541.4 Official export inspection marks, 

devices, and certificates. 

541.5 Official detention marks and devices. 

541.7 Labels required; supervision of a 

Program employee. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 541.1 General. 

The marks, devices, and certificates 

prescribed or referenced in this part are 

official marks, devices, and certificates 

for the purposes of the Act respecting 

catfish and catfish products. The marks, 

devices, and certificates shall be used 

only in accordance with the regulations 

in this part. 

§ 541.2 Official marks and devices to 

identify inspected and passed catfish and 

catfish products. 

(a)(1) The official inspection legend 

required by this part must be shown on 

all labels for inspected and passed 

catfish and catfish products and must be 

in the following form prescribed in 9 

CFR 312.2(b)(1) for inspected and 

passed products of cattle, sheep, swine, 

and goats, or in another form to be 

prescribed by the Administrator, except 

that it need not be of the size illustrated, 

if it is of a sufficient size and color to 

be conspicuously displayed, and readily 

legible, and in the same proportions of 

letter size and boldness are maintained 

as illustrated: 

(2) The official inspection legend 

shall contain the words ‘‘U.S. Inspected 

and Passed’’ or an abbreviation of those 

words approved by the Administrator. 

(b) This official mark must be applied 

by mechanical means and must not be 

applied by a hand stamp. 

(c)(1) The official inspection legend, 

or the approved abbreviation of the 

legend, must be printed on consumer 

packages and other immediate 

containers of inspected and passed 

catfish products or on labels to be 

securely affixed to the containers of the 

products and may be printed or 

stenciled on the containers but must not 

be applied by rubber stamping. 

(2) The official inspection legend may 

also be used for the purposes of marking 

shipping containers, band labels, and 

other articles with the approval of the 

Administrator. 

(d) Whole gutted catfish carcasses that 

have been inspected and passed in an 

official establishment and are intended 

for sale as whole gutted catfish must be 

marked or labeled in a manner that will 

ensure that the catfish carcasses are 

identified as ‘‘Inspected and Passed’’ and 

will not become misbranded while in 


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36U.S. Department of Commerce. NIST Handbook 

133: Checking the Net Contents of Packaged Goods, 

Fourth Edition, January 2005. Washington, DC. 

commerce. The official inspection 

legend used for this purpose must be in 

the form illustrated below or in another 

form determined by the Administrator: 

§ 541.3 Official seals for transportation of 

products. 

The official mark for use in sealing 

railroad cars, cargo containers, or other 

means of conveyance as prescribed in 

part 555 of this subchapter must be the 

inscription and serial number shown in 

9 CFR 312.5 or another official mark 

approved by the Administrator. Any 

seal approved by the Administrator for 

applying the official mark is an official 

device for the purposes of the Act. The 

seal must be attached to the means of 

conveyance only by a Program 

employee, who shall also affix a 

‘‘Warning Tag’’ (Form MP–408–3 or 

similar official form). 

§ 541.4 Official export inspection marks, 

devices, and certificates. 

(a) The official export inspection mark 

for catfish required by part 552 of this 

subchapter must be in the same form as 

that specified in 9 CFR 312.8(a) or 

otherwise as prescribed by the 

Administrator. 

(b) The official export certificate for 

catfish and catfish products required by 

part 552 of this subchapter must be in 

the same form as that prescribed for 

meat and meat food products in 9 CFR 

312.8(b) or otherwise as prescribed by 

the Administrator. 

§ 541.5 Official detention marks and 

devices. 

The official mark for shipments of 

articles and catfish detained under this 

subchapter is the designation ‘‘U.S. 

Detained,’’ and the official device for 

applying the mark is the official ‘‘U.S. 

Detained’’ tag (FSIS Form 8400–2) as 

prescribed in 9 CFR 329.2 or otherwise 

by the Administrator. 

§ 541.7 Labels required; supervision of a 

Program employee. 

(a) General labeling requirements. The 

requirements in part 317, subpart A, of 

this chapter, governing labels and 

labeling, safe-handling labeling, 

abbreviations of official marks, labeling 

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, 

apply to catfish and catfish products. 

(b) The requirements in part 441, 

subchapter E, governing water retained 

from processing in raw meat and 

poultry, apply to retained water in 

catfish. 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, apply to catfish 

and catfish products. 

(1) Packages of frozen or fresh-frozen 

catfish carcasses or parts must be 

labeled to reflect 100-percent net weight 

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 National Institute 

of Standards and Technology (NIST) 

Handbook 133 Chapter 2, Section 2.6.36

(2) [Reserved] 

(c) Nutrition labeling. The 

requirements for nutrition labeling of 

meat and meat food products in part 

317, subpart B, of this chapter, also 

apply to the labeling of catfish and 

catfish food products. 

PART 544—FOOD INGREDIENTS 

PERMITTED 

Sec. 

544.1 Use of food ingredients. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 544.1 Use of food ingredients. 

(a) No catfish product may bear or 

contain any food ingredient that would 

render it adulterated or misbranded or 

that is not approved in part 424 of 

subchapter E, or in this part or 

elsewhere in this subchapter, or by the 

Administrator in specific cases. 

(b) (Reserved) 

PART 548—PREPARATION OF 

PRODUCTS 

Sec. 

548.1 Preparation of catfish products. 

548.2 Requirements concerning ingredients 

and other articles used in the preparation 

of catfish products. 

548.3 Samples of products, water, dyes, 

chemicals, etc. to be taken for 

examination. 

548.4 Mixtures containing product but not 

amenable to the Act. 

548.5 Ready-to-eat catfish products. 

548.6 Canning and canned products. 

548.7 Use of animal drugs. 

548.8 Polluted water contamination at 

establishment. 

548.9 Accreditation of non-Federal 

chemistry laboratories. 

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. 

§ 548.1 Preparation of catfish products. 

(a) All processes used in preparing 

any catfish product in official 

establishments shall be subject to 

inspection by Program employees 

unless such preparation is conducted as 

or consists of operations that are 

exempted from inspection under 9 CFR 

303.1. No fixtures or appliances, such as 

tables, trucks, trays, tanks, vats, 

machines, implements, cans, or 

containers of any kind, shall be used 

unless they are of such materials and 

construction as will not contaminate or 

otherwise adulterate the product and are 

clean and sanitary. All steps in the 

preparation of edible products shall be 

conducted carefully and with strict 

cleanliness in rooms or compartments 

separate from those used for inedible 

products. 

(b) It shall be the responsibility of the 

operator of every official establishment 

to comply with the Act and the 

regulations in this subchapter. To carry 

out this responsibility effectively, the 

operator of the establishment shall 

institute appropriate measures to ensure 

the maintenance of the establishment 

and the preparation, marking, labeling, 

packaging and other handling of its 

products strictly in accordance with the 

sanitary and other requirements of this 

subchapter. 

§ 548.2 Requirements concerning 

ingredients and other articles used in the 

preparation of catfish products. 

All ingredients and other articles used 

in the preparation of any catfish product 

must be clean, sound, healthful, 

wholesome, and otherwise such as will 

not result in the product’s being 

adulterated. 

§ 548.3 Samples of products, water, dyes, 

chemicals, etc. to be taken for examination. 

Samples of products, water, dyes, 

chemicals, preservatives, spices, or 

other articles in any official 

establishment shall be taken, without 

cost to the Program, for examination, as 

often as may be deemed necessary for 

the efficient conduct of the inspection. 

§ 548.4 [Reserved] 

§ 548.5 Ready-to-eat catfish products. 

Ready-to-eat catfish products are 

subject to the requirements in part 430, 

subchapter E, of this chapter. 


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§ 548.6 Canning and canned products. 

The requirements for canning and 

canned products in 9 CFR part 318, 

subpart G (§§ 318.300–318.311) apply to 

catfish products that are canned. 

§ 548.7 Use of animal drugs. 

Edible tissues of catfish with residues 

exceeding tolerance levels specified in 

21 CFR part 556 are adulterated within 

the meaning of section 402(a)(2)(C)(ii) of 

the Federal Food, Drug, and Cosmetic 

Act because they bear or contain a new 

animal drug that is unsafe within the 

meaning of section 512 of the Federal 

Food, Drug, and Cosmetic Act. 

§ 548.8 Polluted water contamination at 

establishment. 

In the event that there is polluted 

water (including but not limited to flood 

water) in an official establishment, all 

products and ingredients for use in the 

preparation of the products that have 

been rendered adulterated by the water 

must be condemned. After the polluted 

water has receded from the 

establishment, the establishment must 

follow the cleaning and sanitizing 

procedures in § 318.4 of subchapter A of 

this chapter. 

§ 548.9 Accreditation of non-Federal 

chemistry laboratories. 

A non-Federal analytical laboratory 

that has met the requirements for 

accreditation specified in 9 CFR 439 and 

hence, at an establishment’s discretion, 

may be used in lieu of an FSIS 

laboratory for analyzing official 

regulatory samples. Payment for the 

analysis of regulatory samples is to be 

made by the establishment using the 

accredited laboratory. 

PART 549—[RESERVED] 

PART 550—RECORDS REQUIRED TO 

BE KEPT 

Sec. 

550.1 Records required to be kept. 

550.2 Place of maintenance of records. 

550.3 Record retention period. 

550.4 Access to and inspection of records, 

facilities and inventory; copying and 

sampling. 

550.5 Registration. 

550.6 Information and reports required 

from official establishment operators. 

550.7 Reports by consignees of allegedly 

adulterated or misbranded products; sale 

or transportation as violations. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 550.1 Records required to be kept. 

The requirements in 9 CFR 320.1 for 

records to be kept apply to persons that 

engage in businesses relating to catfish 

and catfish products as they do to 

persons that engage in businesses 

relating to the carcasses, parts, or 

products of other species amenable to 

the FMIA. 

§ 550.2 Place of maintenance of records. 

The requirements in 9 CFR 320.2 for 

the place where records are to be 

maintained apply in the keeping of 

records under this part. 

§ 550.3 Record retention period. 

The record retention requirements in 

9 CFR 320.3 apply to records required 

to be kept under this part. 

§ 550.4 Access to and inspection of 

records, facilities and inventory; copying 

and sampling. 

The provisions of 9 CFR 320.4 apply 

to businesses dealing in catfish and 

catfish products. 

§ 550.5 Registration. 

The registration requirements in 9 

CFR 320.5 apply to persons engaging in 

businesses, in or for commerce, relating 

to catfish and catfish products as they 

do to persons engaging in businesses 

relating to the carcasses, parts, and 

products, or any livestock, of other 

animal species that are amenable to the 

FMIA. 

§ 550.6 Information and reports required 

from official establishment operators. 

The information and reporting 

requirements in 9 CFR 320.6 for 

operators of official establishments 

apply with respect to catfish and catfish 

products as they do with respect to 

other species amenable to the FMIA. 

§ 550.7 Reports by consignees of allegedly 

adulterated or misbranded products; sale or 

transportation as violations. 

The requirements in 9 CFR 320.7 for 

reports by consignees of allegedly 

adulterated or misbranded products 

apply with respect to catfish and catfish 

products as they do with respect to 

products of other species amenable to 

the Act. 

PART 552—EXPORTS 

Sec. 

552.1 Affixing stamps and marking 

products for export; issuance of export 

certificates; clearance of vessels and 

transportation. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 552.1 Affixing stamps and marking 

products for export; issuance of export 

certificates; clearance of vessels and 

transportation. 

(a) The manner of affixing stamps and 

marking products for export is that 

prescribed in § 322.1(a) of this chapter. 

(b) The requirements for the issuance 

of export certificates are as prescribed in 

§ 322.2 of this chapter. 

(c) The requirements for clearing 

vessels and other transportation 

vehicles are set out in § 322.4 of this 

chapter. 

PART 555—TRANSPORTATION OF 

CATFISH PRODUCTS IN COMMERCE 

Sec. 

555.1 Transportation of catfish products. 

555.2 Catfish product transported within 

the United States as part of export 

movement. 

555.3 Unmarked, inspected catfish product 

transported under official seal between 

official establishments for further 

processing; certificate. 

555.4 Handling of catfish products that may 

have become adulterated. 

555.5 Transportation of inedible catfish 

product in commerce. 

555.6 Certificates. 

555.7 Official seals; forms, use, and 

breaking. 

555.8 Loading or unloading of catfish 

products in sealed transport 

conveyances. 

555.9 Diverting of shipments. 

555.10 Provisions inapplicable to 

specimens for laboratory examination, 

etc., or to naturally inedible articles. 

555.11 Transportation and other 

transactions concerning dead, dying, or 

diseased catfish, and catfish or parts of 

catfish that died otherwise than by 

slaughter. 

555.12 Means of conveyance in which 

dead, dying, or diseased catfish or parts 

of catfish must be transported. 

Authority: 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. 

§ 555.1 Transportation of catfish products. 

(a) 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 

being used as human food and is 

adulterated or fails to bear an official 

inspection legend or is otherwise 

misbranded at the time of such sale, 

transportation, offer or receipt, except 

otherwise provided in this paragraph or 

in part 557 of this chapter. 

(b) No person, engaged in the business 

of buying, selling, freezing, storing, or 

transporting, in or for commerce, catfish 

products capable of use as human food, 

or importing such articles, shall 

transport, offer for transportation, or 

receive for transportation, in commerce 

or in any State designated under § 560.3 

of this subchapter, any catfish product 

which is capable of use as human food 

and is not wrapped, packaged, or 

otherwise enclosed to prevent 

adulteration by airborne contaminants, 

unless the railroad car, truck, or other 


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means of conveyance in which the 

product is contained or transported is 

completely enclosed with tight fitting 

doors or other covers for all openings. 

In all cases, the means of conveyance 

shall be reasonably free of foreign matter 

(such as dust, dirt, rust, or other articles 

or residues), and free of chemical 

residues, so that product placed therein 

will not become adulterated. 

(c) Any cleaning compound, lye, soda 

solution, or other chemical used in 

cleaning the means of conveyance must 

be thoroughly removed from the means 

of conveyance prior to its use. Such 

means of conveyance onto which 

product is loaded, being loaded, or 

intended to be loaded, shall be subject 

to inspection by an inspector at any 

official establishment. 

(d) The decision whether or not to 

inspect a means of conveyance in a 

specific case, and the type and extent of 

such inspection shall be at the Agency’s 

discretion and shall be adequate to 

determine if catfish product in such 

conveyance is, or when moved could 

become, adulterated. 

(e) Circumstances of transport that 

can be reasonably anticipated shall be 

considered in making said 

determination. These include, but are 

not limited to, weather conditions, 

duration and distance of trip, nature of 

product covering, and effect of 

restowage at stops en route. Any means 

of conveyance found upon such 

inspection to be in such condition that 

catfish product placed therein could 

become adulterated shall not be used 

until such condition which could cause 

adulteration is corrected. 

(f) Catfish product placed in any 

means of conveyance that is found by 

the inspector to be in such condition 

that the catfish product may have 

become adulterated shall be removed 

from the means of conveyance and 

handled in accordance with part 539 or 

§ 540.3 of this subchapter. 

§ 555.2 Catfish product transported within 

the United States as part of export 

movement. 

When any shipment of any catfish 

product is offered to any carrier for 

transportation within the United States 

as a part of an export movement, the 

same certificate shall be required as if 

the shipment were destined to a point 

within the United States. 

§ 555.3 Unmarked, inspected catfish 

product transported under official seal 

between official establishments for further 

processing; certificate. 

The requirements governing 

transportation of catfish product that 

has been inspected and passed, but not 

so marked, from one official 

establishment to another official 

establishment are the same as those in 

§ 325.5 of this chapter that apply to 

unmarked inspected meat products. 

§ 555.4 Handling of catfish products that 

may have become adulterated. 

The provisions of § 325.10 regarding 

the handling of products that may have 

become adulterated or misbranded 

apply to catfish and catfish products. 

§ 555.5 Transportation of inedible catfish 

product in commerce. 

The provisions in § 325.11(e) of this 

chapter regarding the transportation of 

inedible livestock products apply to the 

transportation of inedible catfish parts 

or products. 

§ 555.6 Certificates. 

The provisions in § 325.14 of this 

chapter regarding the filing of original 

certificates of unmarked inspected meat 

products delivered to carriers applies 

with respect to catfish and catfish 

products. 

§ 555.7 Official seals; forms, use, and 

breaking. 

The official seals required by this part 

are those prescribed in § 541.3 and 

§ 312.5 of this chapter. 

§ 555.8 Loading or unloading of catfish 

products in sealed transport conveyances. 

The requirements in 9 CFR 325.18 

governing the unloading of any meat or 

meat food product from an officially 

sealed railroad car, truck, or other 

means of conveyance containing any 

unmarked product or loading any means 

of conveyance after the product leaves 

an official establishment are applicable 

to catfish and catfish products. 

§ 555.9 Diverting of shipments. 

(a) Shipments of inspected and passed 

catfish products that bear the inspection 

legend may be diverted from the 

original destination without a 

reinspection of the articles if the 

waybills, transfer bills, running slips, 

conductor’s card, or other papers 

accompanying the shipments are 

marked, stamped, or have attached 

thereto signed statements in accordance 

with § 325.15. 

(b) In case of a wreck or similar 

extraordinary emergency, the 

Department seals on a railroad car or 

other means of conveyance containing 

any inspected and passed product may 

be broken by the carrier, and if 

necessary, the articles may be reloaded 

into another means of conveyance, or 

the shipment may be diverted from the 

original destination, without another 

shipper’s certificate; but in all such 

cases the carrier must immediately 

report the facts by telephone or 

telegraph to the District Manager in the 

area in which the emergency occurs. 

The report must include the following 

information: 

(1) Nature of the emergency. 

(2) Place where seals were broken. 

(3) Original points of shipment and 

destination. 

(4) Number and initial of the original 

car or truck. 

(5) Number and initials of the car or 

truck into which the articles are 

reloaded. 

(6) New destination of the shipment. 

(7) Kind and amount of articles. 

§ 555.10 Provisions inapplicable to 

specimens for laboratory examination, etc., 

or to naturally inedible articles. 

The provisions of this part do not 

apply: 

(a) To specimens of product sent to or 

by the Department of Agriculture or 

divisions thereof in Washington, DC, or 

elsewhere, for laboratory examination, 

exhibition purposes, or other official 

use; 

(b) To material released for 

educational, research, and other 

nonfood purposes, as prescribed in 

§ 540.2 of this subchapter; 

(c) To tissues for use in preparing 

pharmaceutical, organotherapeutic, or 

technical products and not used for 

human food, as described in § 540.2 of 

this subchapter; 

(d) To material or specimens of 

product for laboratory examination, 

research, or other nonhuman food 

purposes, when authorized by the 

Administrator, and under conditions 

prescribed by him in specific cases; and 

(e) To articles that are naturally 

inedible by humans. 

§ 555.11 Transportation and other 

transactions concerning dead, dying, or 

diseased catfish, and catfish or parts of 

catfish that died otherwise than by 

slaughter. 

No person engaged in the business of 

buying, selling, or transporting in 

commerce, or importing any dead, 

dying, or diseased catfish or parts of 

catfish that died otherwise than by 

slaughter shall: 

(a) Sell, transport, offer for sale or 

transportation, or receive for 

transportation, in commerce, any dead, 

dying, or diseased catfish or parts of 

catfish that died otherwise than by 

slaughter, unless the catfish and parts 

are consigned and delivered, without 

avoidable delay, to establishments of 

animal food manufacturers, renderers, 

or collection stations that are registered 

as required by part 550 of this 

subchapter, or to official establishments 

that operate under Federal inspection, 


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or to establishments that operate under 

a State or Territorial inspection system 

approved by FSIS as one that imposes 

requirements at least equal to the 

Federal requirements for purposes of 

paragraph 301(c) of the Act; 

(b) Buy in commerce or import any 

dead, dying, or diseased catfish or parts 

of catfish that died otherwise than by 

slaughter, unless he is an animal food 

manufacturer or renderer and is 

registered as required by part 550 of this 

subchapter, or is the operator of an 

establishment inspected as required by 

paragraph (a) of this section and such 

catfish or parts of catfish are to be 

delivered to establishments eligible to 

receive them under paragraph (a) of this 

section; 

(c) Unload en route to any 

establishment eligible to receive them 

under paragraph (a) of this section, any 

dead, dying, or diseased catfish or parts 

of catfish that died otherwise than by 

slaughter, which are transported in 

commerce or imported by any such 

person: Provided, That any such dead, 

dying, or diseased catfish, or parts of 

catfish may be unloaded from a means 

of conveyance en route where necessary 

in case of a wreck or otherwise 

extraordinary emergency, and may be 

reloaded into another means of 

conveyance; but in all such cases, the 

carrier must immediately report the 

facts by telephone or other electrical or 

electronic means to the Office of 

Program Evaluation, Enforcement, and 

Review, Food Safety and Inspection 

Service, U.S. Department of Agriculture, 

Washington, DC 20250. 

(d) Load into any means of 

conveyance containing any dead, dying, 

or diseased catfish, or parts of catfish 

that died otherwise than by slaughter, 

while in the course of importation or 

other transportation in commerce any 

catfish or parts of catfish not within the 

foregoing description or any other 

products or other commodities. 

§ 555.12 Means of conveyance in which 

dead, dying, or diseased catfish or parts of 

catfish must be transported. 

All vehicles and other means of 

conveyance used by persons subject to 

§ 555.11 for transporting in commerce or 

importing, any dead, dying, or diseased 

catfish or parts of catfish that died 

otherwise by slaughter must be leak 

proof and so constructed and equipped 

as to permit thorough cleaning and 

sanitizing. The means of conveyance 

used in conveying the catfish or parts of 

catfish must be cleaned and disinfected 

before being used in the transportation 

of any product intended for use as 

human food. The cleaning procedure 

must include the complete removal 

from the means of conveyance of any 

fluid, parts, or product of dead, dying, 

or diseased catfish and the thorough 

application of a disinfectant approved 

by the Administrator to the interior 

surfaces of the cargo space. 

PART 557—IMPORTATION 

Sec. 

557.1 Definitions; application of 

provisions. 

557.2 Eligibility of foreign countries for 

importation of catfish products into the 

United States. 

557.3 No catfish product to be imported 

without compliance with applicable 

regulations. 

557.4 Imported catfish products; foreign 

certificates required. 

557.5 Importer to make application for 

inspection of catfish products for entry. 

557.6 Catfish products for importation; 

program inspection, time and place; 

application for approval of facilities as 

official import inspection establishment; 

refusal or withdrawal of approval; 

official numbers. 

557.7 Products for importation; movement 

prior to inspection; handling; bond; 

assistance. 

557.8 Import catfish products; equipment 

and means of conveyance used in 

handling to be maintained in sanitary 

condition. 

557.9 [Reserved] 

557.10 Samples; inspection of 

consignments; refusal of entry; marking. 

557.11 Receipts to importers for import 

catfish products samples. 

557.12 Foreign canned or packaged catfish 

products bearing trade labels; sampling 

and inspection. 

557.13 Foreign catfish products offered for 

importation; reporting of findings to 

Customs. 

557.14 Marking of catfish products and 

labeling of immediate containers thereof 

for importation. 

557.15 Outside containers of foreign 

products; marking and labeling; 

application of official inspection legend. 

557.16 Small importations for importer’s 

own consumption; requirements. 

557.17 Returned U.S. inspected and marked 

catfish products. 

557.18 Catfish products offered for entry 

and entered to be handled and 

transported as domestic; exception. 

557.19 Specimens for laboratory 

examination and similar purposes. 

557.20–557.23 [Reserved] 

557.24 Appeals; how made. 

557.25 Disposition procedures for catfish 

product condemned or ordered 

destroyed under import inspection. 

557.26 Official import inspection marks 

and devices. 

Authority: 21 U.S.C. 601–602, 606–622, 

624–695; 7 CFR 2.7, 7 CFR 2.18, 2.53. 

§ 557.1 Definitions; application of 

provisions. 

(a) When used in this part, the 

following terms shall be construed to 

mean: 

(1) Import. To bring within the 

territorial limits of the United States 

whether that arrival is accomplished by 

land, air, or water. 

(2) Offer for entry. Presentation of the 

imported product by the importer to the 

Program for reinspection. 

(3) Entry. The point at which 

imported product offered for entry 

receives reinspection and is marked 

with the official mark of inspection in 

accordance with § 557.26 of this 

subchapter. 

(b) The provisions of this part shall 

apply to catfish and catfish products 

that are capable of use as human food. 

Compliance with the conditions for 

importation of products under this part 

does not excuse the need for compliance 

with applicable requirements under 

other laws, including the provisions in 

part 94 of chapter I of this title. 

§ 557.2 Eligibility of foreign countries for 

importation of catfish products into the 

United States. 

(a) The requirements in 9 CFR 

327.2(a)(1), 327.2(a)(2)(i), 

327.2(a)(2)(ii)(C)–(I), 327.2(a)(2)(iii)–(iv), 

and 327.2(a)(3), for determining the 

acceptability of foreign meat inspection 

systems for the importation of meat and 

meat food products into the United 

States, apply in determining the 

acceptability of foreign catfish 

inspection systems for the importation 

of catfish and catfish products into the 

United States. In determining the 

acceptability of these systems, the 

Agency will evaluate the manner in 

which they take into account the 

conditions under which catfish are 

raised and transported to a processing 

establishment. 

(b)(1) It has been determined that 

catfish and catfish products from the 

following countries covered by foreign 

inspection certificates of the country of 

origin as required by 9 CFR 557.4, are 

eligible under the regulations in this 

subchapter for entry into the United 

States after inspection and marking as 

required by the applicable provisions of 

this part: (None listed as of 

[PUBLICATION DATE OF FINAL 

RULE]). 

(2) Persons interested in having the 

most recent list of eligible countries and 

establishments may contact the Office of 

International Affairs, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, Washington, DC 20250. 

§ 557.3 No catfish product to be imported 

without compliance with applicable 

regulations. 

No catfish or catfish product offered 

for importation from any foreign 

country shall be admitted into the 


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United States if it is adulterated or 

misbranded or does not comply with all 

the requirements of this subchapter that 

would apply to it if it were a domestic 

product. 

§ 557.4 Imported catfish products; foreign 

certificates required. 

Except as provided in § 557.16, each 

consignment containing any catfish or 

catfish products consigned to the United 

States from a foreign country must be 

accompanied by a foreign inspection 

certificate for catfish and catfish 

products. The certificate, in paper or 

electronic format, must contain those 

data elements that the Administrator 

may prescribe to carry out the intent of 

this section. 

§ 557.5 Importer to make application for 

inspection of catfish products for entry. 

(a) Each importer must apply for 

inspection of any catfish product offered 

for entry (See Sec. 301.2(yyy)). 

(b) The application should be made as 

long as possible in advance of the 

anticipated arrival of each consignment 

into the United States, except in case of 

consignments of products expressly 

exempted from inspection by §§ 557.16 

and 557.17. 

(c) Each application must state the 

approximate date on which the 

consignment is due to arrive at such 

port in the United States, the name of 

the ship or other carrier transporting it, 

the name of the country from which the 

product was, or is to be, shipped, the 

place where inspection is desired in 

accordance with § 557.6, the quantity 

and kind of product, and whether it is 

fresh, cured, canned or otherwise 

prepared. In case of consignments 

arriving in the United States by water, 

the application must state the port of 

first arrival in the United States. 

§ 557.6 Catfish products for importation; 

program inspection, time and place; 

application for approval of facilities as 

official import inspection establishment; 

refusal or withdrawal of approval; official 

numbers. 

(a)(1) Except as provided in §§ 557.16 

and 557.17, all catfish products offered 

for entry from any foreign country shall 

be reinspected by a Program inspector 

before they shall be allowed entry into 

the United States. 

(2) Every lot of product shall routinely 

be given visual inspection by a Program 

import inspector for appearance and 

condition, and checked for certification 

and label compliance. 

(3) FSIS operates an electronic system 

to provide reinspection instructions. 

The electronic system assigns reinspection levels and procedures that 

are based on established sampling plans 

or established sampling plans and 

established product, country, and plant 

history. 

(4) When the inspector deems it 

necessary, the inspector may sample 

and inspect lots not designated by the 

electronic system. 

(b) Catfish and catfish products 

required by this part to be inspected 

must be inspected only at an official 

establishment or at an official import 

inspection establishment approved by 

the Administrator as provided in this 

section. 

(c) Owners or operators of 

establishments, other than official 

establishments, who want to have 

import inspections made at their 

establishments, shall apply to the 

Administrator for approval of their 

establishments for such purpose. 

Application must be made on a form 

furnished by the Program, Food Safety 

and Inspection Service, U.S. Department 

of Agriculture, Washington, DC, 20250, 

and must include all information called 

for by that form. 

(d) Approval for Federal import 

inspection must be in accordance with 

§§ 304.1 and 304.2 of this chapter. Also, 

before approval is granted, the 

establishment must have developed 

written Sanitation Standard Operating 

Procedures in accordance with part 416 

of this chapter. 

(e) Owners or operators of 

establishments at which import 

inspections of product are to be made 

shall furnish adequate sanitary facilities 

and equipment for examination of such 

product. The requirements of §§ 307.1, 

307.2 (b), (d), (f), (h), (k), and (l) and 

416.1 through 416.6 of this chapter shall 

apply as conditions for approval of 

establishments as official import 

inspection establishments to the same 

extent and in the same manner as they 

apply with respect to official 

establishments. 

(f) The Administrator is authorized to 

approve any establishment as an official 

import inspection establishment 

provided that an application has been 

filed in accordance with the 

requirements of paragraphs (c) and (d) 

of this section and he determines that 

such establishment meets the 

requirements under paragraph (e) of this 

section. Any application for inspection 

under this section may be denied or 

refused in accordance with the rules of 

practice in part 500 of this chapter. 

(g) Approval of an official import 

inspection establishment may be 

withdrawn in accordance with 

applicable rules of practice if it is 

determined that the sanitary conditions 

are such that the product is rendered 

adulterated, that such action is 

authorized by section 21(b) of the 

Federal Water Pollution Control Act, as 

amended (84 Stat. 91), or that the 

requirements of paragraph (e) of this 

section were not complied with. 

Approval may be withdrawn in 

accordance with section 401 of the Act 

and applicable rules of practice. 

(h) A special official number shall be 

assigned to each official import 

inspection establishment. Such number 

shall be used to identify all products 

inspected and passed for entry at the 

establishment. 

(i) A product examination must be 

made, as provided in paragraph (a) of 

this section, of a foreign catfish or 

catfish product, including defrosting if 

necessary to determine its condition. 

Inspection standards for foreign chilled 

fresh or frozen fresh catfish shall be the 

same as those used for domestic catfish 

or catfish products. Samples may be 

collected at no cost to FSIS and 

submitted to an FSIS laboratory for 

analysis (See § 557.18). 

(j) Imported canned products are 

required to be sound, healthful, 

properly labeled, wholesome, and 

otherwise not adulterated at the time the 

products are offered for importation into 

the United States. Provided other 

requirements of this part are met, the 

determination of the acceptability of the 

product and the condition of the 

containers shall be based on the results 

of an examination of a statistical sample 

drawn from the consignment as 

provided in paragraph (a) of this 

section. If the inspector determines, on 

the basis of the sample examination, 

that the product does not meet the 

requirements of the Act and regulations 

thereunder, the consignment shall be 

refused entry. However, a consignment 

rejected for container defects but 

otherwise acceptable may be reoffered 

for inspection under the following 

conditions: 

(1) If the defective containers are not 

indicative of an unsafe and unstable 

product as determined by the 

Administrator; 

(2) If the number and kinds of 

container defects found in the original 

sample do not exceed the limits 

specified for this purpose in FSIS 

guidelines; and 

(3) If the defective containers in the 

consignment have been sorted out and 

exported or destroyed under the 

supervision of an inspector. 

(k) Program inspectors or Customs 

officers at border or seaboard ports shall 

report the sealing of cars, trucks, or 

other means of conveyance, and the 

sealing or identification of containers of 

foreign product to Program personnel at 


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points where such product is to be 

inspected. 

(l) Representative samples of canned 

product designated by the 

Administrator in instructions to 

inspectors shall be incubated under 

supervision of such inspectors in 

accordance with § 318.309(d)(1)(ii), 

(d)(1)(iii), (d)(1)(iv)(c), (d)(1)(v), 

(d)(1)(vii) and (d)(1)(viii) of this 

subchapter. The importer or his/her 

agent shall provide the necessary 

incubation facilities in accordance with 

§ 318.309(d)(1)(i) of this subchapter. 

(m) Sampling plans and acceptance 

levels as prescribed in paragraphs (j) 

and (l) of this section may be obtained, 

upon request, from the Office of 

International Affairs, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, Washington, DC 20250. 

§ 557.7 Products for importation; 

movement prior to inspection; handling; 

bond; assistance. 

The requirements in 9 CFR 327.7 

respecting the movement or conveyance 

from any port, or delivery to the 

consignee, of any product required to be 

inspected under part 327, apply to 

catfish and catfish products. 

§ 557.8 Import catfish products; 

equipment and means of conveyance used 

in handling to be maintained in sanitary 

condition. 

Compartments of ocean vessels, 

railroad cars, and other means of 

conveyance transporting any catfish or 

catfish product to the United States, and 

all trucks, chutes, platforms, racks, 

tables, tools, utensils, and all other 

devices used in moving and handling 

any catfish or catfish product offered for 

importation into the United States, shall 

be maintained in a sanitary condition. 

§ 557.9 [Reserved] 

§ 557.10 Samples; inspection of 

consignments; refusal of entry; marking. 

The provisions in 9 CFR 327.10 

governing the taking of samples, the 

inspection of consignments, the refusal 

of entry, and the controlled prestamping of shipments of meat and meat 

food products apply with respect to 

catfish and catfish products. 

§ 557.11 Receipts to importers for import 

catfish product samples. 

FSIS will issue to importers official 

receipts for samples of foreign products 

collected for laboratory analysis, as 

provided in § 327.11 of this chapter. 

§ 557.12 Foreign canned or packaged 

catfish products bearing trade labels; 

sampling and inspection. 

Foreign canned or packaged catfish 

products bearing on their immediate 

containers trade labels that have or have 

not been approved in accordance with 

the regulations in § 541.7 of this 

subchapter are to be sampled and 

inspected in the same manner as 

provided by § 327.12 of this chapter for 

foreign canned meat food products. 

§ 557.13 Foreign catfish products offered 

for importation; reporting of findings to 

Customs. 

Program inspectors are to report their 

findings as to any catfish product that 

has been inspected in accordance with 

this part in the same manner as that 

provided by § 327.13 of this chapter for 

meat products. Catfish products that are 

refused entry are to be handled in the 

same manner as provided by § 327.13 

for meat products that are refused entry. 

Import personnel will identify to the 

Port Director of U.S. Customs and 

Border Protection and the Importer of 

record any products refused entry into 

the United States. 

§ 557.14 Marking of catfish products and 

labeling of immediate containers thereof for 

importation. 

The regulations in 9 CFR 327.14 

governing the marking of meat and meat 

food products and the labeling of 

immediate containers of those products 

for importation apply with respect to 

catfish and catfish products. 

§ 557.15 Outside containers of foreign 

products; marking and labeling; application 

of official inspection legend. 

The requirements in 9 CFR 327.15 

governing the marking and labeling of 

outside containers of meat and meat 

food products apply also with respect to 

catfish and catfish products. 

§ 557.16 Small importations for importer’s 

own consumption; requirements. 

The exemption in 9 CFR 327.16 for 

small importations of meat or meat food 

products for the importer’s own 

consumption applies with respect to 

catfish or catfish products. 

§ 557.17 Returned U.S. inspected and 

marked catfish products. 

U.S. inspected and passed and so 

marked catfish products exported to and 

returned from foreign countries will be 

admitted into the United States without 

compliance with this part upon 

notification of and approval by the 

Assistant Administrator, Office of 

International Affairs, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, Washington, DC 20250, in 

specific cases. 

§ 557.18 Catfish products offered for entry 

and entered to be handled and transported 

as domestic; exception. 

The regulations in 9 CFR 327.18 

governing the offer for entry into the 

United States of meat and meat food 

products apply with respect to catfish 

and catfish products. Products that fail 

to meet these regulatory requirements 

are subject to penalties as administered 

by the U.S. Port Director of Customs and 

Border Protection. Likewise, the 

products may be subject to detention 

and to being proceeded against as 

determined by the Administrator. 

§ 557.19 Specimens for laboratory 

examination and similar purposes. 

Importation of catfish or catfish 

product samples for trade show 

exhibition, laboratory examination, 

research, evaluative testing, trade show 

exhibition, or other scientific purposes 

are subject to the same conditions as 

imported meat or meat product 

specimens under § 327.19. 

§ 557.20–557.23 [Reserved] 

§ 557.24 Appeals; how made. 

An appeal from a decision of any 

Program employee is to be made as 

provided by 9 CFR 327.24. 

§ 557.25 Disposition procedures for 

catfish product condemned or ordered 

destroyed under import inspection. 

Disposition procedures for 

condemned catfish or catfish products 

ordered destroyed under import 

inspection are as those for carcasses, 

parts, meat, and meat food products 

under 9 CFR 327.25. 

§ 557.26 Official import inspection marks 

and devices. 

The official inspection legend and 

other marks to be applied to imported 

catfish and catfish products are as 

required by 9 CFR 327.26 for meat food 

products prepared from cattle, sheep, 

swine, and goats. 

PART 559—DETENTION, SEIZURE, 

CONDEMNATION 

Sec. 

559.1 Catfish and other articles subject to 

administrative detention. 

559.2 Articles or catfish subject to judicial 

seizure and condemnation. 

559.3 Criminal offenses. 

Authority: 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. 

§ 559.1 Catfish and other articles subject 

to administrative detention. 

The provisions of 9 CFR 329.1 

through 329.5 governing the 

administrative detention of carcasses, 

parts, meat, and meat food products of 


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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules 10469 

livestock apply also with respect to the 

carcasses, parts, and products of catfish. 

§ 559.2 Articles or catfish subject to 

judicial seizure and condemnation. 

The provisions of 9 CFR 329.6 

through 329.8 governing the judicial 

seizure and condemnation of carcasses, 

parts, meat, and meat food products of 

livestock apply also with respect to the 

carcasses, parts, and products of catfish. 

§ 559.3 Criminal offenses. 

The criminal provisions of the Act 

apply with respect to the inspection of 

catfish and catfish products as they do 

with respect to the inspection of other 

food products subject to the Act. 

PART 560—STATE–FEDERAL, 

FEDERAL–STATE COOPERATIVE 

AGREEMENTS; STATE 

DESIGNATIONS 

Sec. 

560.1 Cooperation with States and 

Territories. 

560.2 Cooperation of States in Federal 

programs. 

560.3 Designation of States under the 

Federal Meat Inspection Act. 

Authority: 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. 

§ 560.1 Cooperation with States and 

Territories. 

The provisions in § 321.1 of this 

chapter authorizing the Administrator to 

cooperate with any State (including 

Puerto Rico) or any organized Territory 

in developing and administering a meat 

inspection program for the State or 

Territory apply with respect to catfish 

products inspection. 

§ 560.2 Cooperation of States in Federal 

programs. 

Under the ‘‘Talmadge-Aiken Act’’ of 

September 28, 1962 (7 U.S.C. 450), the 

Administrator is authorized to utilize 

employees and facilities of any State in 

carrying out Federal functions under the 

FMIA, including functions relating to 

the inspection of catfish and catfish 

products. A cooperative program for this 

purpose is called a Federal-State 

program. 

§ 560.3 Designation of States under the 

Federal Meat Inspection Act 

The requirements in part 331 of this 

chapter apply with respect to catfish 

and catfish products inspection, 

including: 

(a) The requirements in 9 CFR 331.3 

governing the designation of States for 

Federal inspection under section 301(c) 

of the Act (21 U.S.C. 661(c)); 

(b) The requirements in 9 CFR 331.5 

governing the designation under section 

301(c) of the Act of establishments 

whose operations would clearly 

endanger the public health; and 

(c) The requirements in 9 CFR 331.6 

governing the designation of States 

under paragraph 205 of the Act. 

PART 561—RULES OF PRACTICE 

Sec. 

561.1 Rules of practice governing 

inspection actions. 

561.2 Rules of practice governing 

proceedings under the Federal Meat 

Inspection Act. 

Authority: 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. 

§ 561.1 Rules of practice governing 

inspection actions. 

The rules of practice in part 500 of 

this chapter, governing inspection 

actions taken by FSIS with respect to 

establishments and products, apply to 

actions taken with respect to catfish 

processing establishments, catfish, and 

catfish products regulated under this 

subchapter. 

§ 561.2 Rules of practice governing 

proceedings under the Federal Meat 

Inspection Act. 

The procedures that the Agency must 

follow before reporting a violation of the 

Federal Meat Inspection Act for 

prosecution by the Department of 

Justice are given in part 335, subchapter 

A of this chapter. 

Done, at Washington, DC. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. 2011–3726 Filed 2–18–11; 8:45 am] 

BILLING CODE 3410–DM–P 


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