[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Proposed Rules]
[Pages 10434-10469]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2011-3726]



[[Page 10433]]

Vol. 76

Thursday,

No. 37

February 24, 2011

Part II





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Parts 300, 441, 530, et al.



Mandatory Inspection of Catfish and Catfish Products; Proposed Rule

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

[[Page 10434]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

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

[Docket No. FSIS-2008-0031]
RIN 0583-AD36


Mandatory Inspection of Catfish and Catfish Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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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, 
Sec.  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, Sec.  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 non-Ictaluidae species that did not include the term 
``catfish,'' and suggested ways of devising those names.\2\
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    \1\ The FD&C Act, as amended, (21 U.S.C. 321 et seq.) prohibits 
the adulteration or misbranding of any food, drug, device, or 
cosmetic in interstate commerce (21 U.S.C 331(b)). A food is 
considered misbranded if, among other circumstances of misbranding, 
its labeling is false or misleading (21 U.S.C. 343(a)(1)); it is 
offered for sale under the name of another food (21 U.S.C. 343(b)); 
if its label does not bear the common or usual name of the food, if 
there is any, or, if the food is made of two or more ingredients, 
the common or usual name of the ingredients (21 U.S.C. 343(i)); or 
if it purports to be or is represented as catfish, unless it is fish 
classified within the family Ictaluridae (21 U.S.C. 343(t)). The 
provision in 21 U.S.C. 321d, ``Market names for catfish and 
ginseng,'' on catfish labeling, states, ``(a)(1) Notwithstanding any 
other provision of law, for the purposes of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.)--(A) the term ``catfish'' 
may only be considered to be a common or usual name (or part 
thereof) for fish classified within the family Ictaluridae; and (B) 
only labeling or advertising for fish classified within that family 
may include the term ``catfish.''
    \2\ U.S. Department of Health and Human Services. Food and Drug 
Administration. February 28, 2003. Memorandum ``To All Interested 
Parties'' on ``market names for fish that are outside the family 
Ictaluridae and that were previously marketed with the term 
`catfish' in their names.''

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[[Page 10435]]

    In the 2008 Farm Bill (the Food, Conservation, and Energy Act (Farm 
Bill) of 2008 (Pub. L. 110-246, Sec.  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
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                                             Siluriformes (catfishes
                 Order                     [English], silures [French])
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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 [agrave] labyrinths)
Family.................................  Cranoglanididae (armorhead
                                          catfishes, armoured catfishes)
Family.................................  Diplomystidae (diplomystid
                                          catfishes, velvet catfishes)
Family.................................  Doradidae (bagres sierra,
                                          poissons-chats [eacute]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,
                                          loricariid[eacute]s,
                                          pleco[oacute]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 [agrave] longues
                                          moustaches)

[[Page 10436]]

 
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.
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    \3\ Adapted from Integrated Taxonomic Information System (ITIS) 
report on ``Siluriformes.'' At http://www.itis.gov (accessed October 
4, 2009).
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    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).
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    \4\ ITIS report on ``Siluriformes.'' At http://www.itis.gov 
(accessed Jan. 26, 2009).
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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.
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    \5\ U.S. Department of Agriculture. Food Safety and Inspection 
Service. Office of Public Health Science. December 2010. Draft Risk 
Assessment of the Potential Human Health Effect of Applying 
Continuous Inspection to Catfish. Washington, DC.
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    USDA is requesting public comments on the scope of the definition 
of the term ``catfish.''

V. Catfish Farming and Processing

Domestic Catfish Farming and Processing

    The catfish growing process in the United States begins after eggs 
from breeding ponds are transferred to hatcheries. Hatchlings are 
reared in the hatcheries for several days before being placed in 
nursery or fry ponds, where they are raised until, as 3-inch to 8-inch 
fingerlings, they are transferred to grow-out ponds. There, the fish 
are fed a ration of pelletized floating feed made with soybean meal, 
fishmeal, corn, wheat, or other grains until they reach marketable 
size.
    In some instances, medicated feeds containing antimicrobials may be 
fed to catfish for therapeutic treatment of bacterial infections. Also, 
pond water may be treated with chemicals to control algal growth and 
prevent off-flavor in the fish.
    Catfish-raising ponds are generally of two types: Levee or delta 
ponds and watershed ponds. Levee ponds are built on flat land and 
filled with groundwater or surface water. In hilly areas, dams built 
across valleys and between hillsides capture runoff from rainfall to 
fill ``watershed'' ponds. Though water to fill and maintain watershed 
ponds usually comes from watershed runoff, wells are often necessary to 
supplement the watershed supply. Watershed ponds tend to be deeper than 
levee ponds and can efficiently nourish more fish per acre than levee 
ponds.
    Water quality--proper temperature, pH, ammonia, nitrite, 
alkalinity, hardness, carbon dioxide, chloride, and oxygen--must be 
maintained to ensure fish health and maximize feed efficiency. Aerators 
are used to prevent oxygen depletion in the ponds. The oxygen levels 
are monitored regularly to ensure fish health and to help in limiting 
algal blooms.
    When catfish reach marketable length and weight--optimally 9 to 12 
inches and 0.75 to 1.5 pounds--they are collected with seines and put 
in aerated tanks mounted on trucks that then transport fish to the 
processing plant. A truck may carry from 4 to 10 of these vats, each 
loaded with about 3,000 pounds of water and catfish.
    The following generally describes catfish processing in the United 
States. Individual operations may vary. At the processing plant, fish 
are unloaded into a holding vat and carried by conveyor to an 
electrical stunner. The fish are then sorted and sized. Fish of 
incorrect species, such as shad (used in the ponds

[[Page 10437]]

to reduce algae), or incorrect size are sorted out. Fish of the correct 
size are sent to the next operation where they are headed and gutted. 
Next, the fish are trimmed and mounted on conveyors and sent tail-first 
through filleting machinery. After further trimming, including removal 
of the belly flap, or ``nugget,'' fillets are skinned and sent through 
a chiller. Fillets are then prepared for packaging or freezing. Nuggets 
may be used in lower-grade edible product.
    Most catfish fillets are shipped frozen. Preservatives, including 
sodium tripolyphosphate, may be used as humectants or to minimize 
oxidation and freezer burn. Some fillets are sold fresh; some 
marinated; and some breaded. Little if any U.S. farm-raised catfish 
undergoes complex processing. There are few multi-ingredient commercial 
catfish products. Fish too big for further processing with automated 
equipment are sent through a separate processing line to be hand-
processed and sold as whole gutted fish (head on), mainly to 
restaurants and institutions.
    Waste materials and byproducts from heading, gutting, and trimming 
are taken from the food processing area of the establishment to be 
separately processed or packaged and shipped. Muscle tissue separated 
from bones, called mince, may be processed into surimi (a white-fish 
food product). Other byproducts may be rendered to produce fish oils, 
or they may be used in animal feed manufacture, or processed into 
fishmeal or fertilizer. Fish heads may be sold as bait for commercial 
fishermen.

Foreign Catfish Farming and Processing

    Foreign catfish farming and processing is done in a similar manner 
to that of the United States, but it may differ in specific methods. In 
general, it is more labor-intensive than U.S. farming and processing. 
It may involve the use of hatcheries and inland ponds. In some 
countries, however, catfish may be grown in net enclosures in rivers, 
in floating cages, sometimes alongside or under houseboats, or in 
``raceway'' inlets fed by river waters.
    Fish may be fed homemade or pelleted feed. Homemade feed is 
composed of fishmeal, mixed with rice bran. (In the United States, only 
a very low percentage of catfish feed--zero to 3 percent--is fishmeal.) 
In some instances, pelleted feed can be a source of contamination with 
unapproved antimicrobials or chemical residues.
    Some reports suggest that antimicrobials prohibited for extra-label 
use in food-producing animals in the United States (e.g., 
fluoroquinolones) have been used in the raising of catfish in foreign 
countries.\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.
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    \6\ U.S. Department of Health and Human Services. Food and Drug 
Administration. July 2007. Congressional Testimony: Safety of 
Chinese Imports. Washington, DC; U.S. Department of Health and Human 
Services. Food and Drug Administration. November 2008. Enhanced 
Aquaculture and Seafood Inspection--Report to Congress. Washington, 
DC.
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VI. Current Inspection of Domestic and Imported Catfish

    U.S. catfish processors, exporters, and importers are subject to 
the U.S. Food and Drug Administration's seafood Hazard Analysis 
Critical Control Point (HACCP) regulations (21 CFR 123) and to other 
requirements under the Food, Drug, and Cosmetic (FD&C) Act. FDA's 
regulations on current good manufacturing practices (cGMPs, at 21 CFR 
part 110) and on recordkeeping and registration requirements (21 CFR 
part 1, subpart H), issued under the Bioterrorism Act of 2002 (Pub. L. 
107-188, Jun. 12, 2002) also apply to these establishments.
    For imported products, FDA requires that the importer either (1) 
obtain fish or fish products from a country that has an active 
memorandum of understanding with FDA that covers the product and 
documents the equivalence or compliance of the foreign inspection 
system with that of the United States, or (2) have and implement 
written verification procedures for ensuring fish and fish products 
offered for import into the United States were processed in accordance 
with FDA regulations in 21 CFR part 123 (21 CFR 123.12).
    The arrangement for imported fish products does not presuppose a 
regulatory finding by FDA that the foreign inspection system is 
equivalent to that of the United States, nor does FDA conduct 
continuous re-inspection of imported fish products as a condition of 
their entry into the United States.
    In addition to FDA regulations, some U.S. catfish processing 
establishments have contracted for voluntary, fee-for-service 
inspection and certification programs administered by the Department of 
Commerce's National Marine Fisheries Service (NMFS)under the 
Agricultural Marketing Act (7 U.S.C. 1622, 1624) and implementing 
regulations (50 CFR 260). NMFS administers three levels of seafood 
inspection programs under authority of the Agricultural Marketing Act 
(7 U.S.C. 1622, 1624) and regulations implementing that act (50 CFR 
260). These are: (1) A resident inspection program, which provides 
continuous inspection to qualifying establishments; (2) an integrated 
quality assurance program, under which an establishment operates an 
NMFS-approved quality assurance system and assists NMFS personnel in 
carrying out U.S. grading or specification regulations; and (3) a 
HACCP-Quality Management Program (QMP), under which the establishment's 
quality program is enhanced to meet the ISO 9001 quality management 
standards.
    An establishment that participates in the continuous inspection 
program must agree to prepare products using only wholesome raw 
materials and to correctly label inspected items. The establishment 
must also agree to prior label approval by NMFS and to furnish the 
Agency with reports that the Agency may request on processing, 
packaging, grading, laboratory analysis, and production of inspected 
products. The establishment must provide facilities to NMFS inspectors 
and agree to conditions under which inspection may be suspended or 
terminated (50 CFR 260.97). The premises of the establishment must be 
free from conditions that may result in food contamination (50 CFR 
260.98). Buildings and structures must be equipped with adequate 
lighting, ventilation, drains and gutters, and hot and cold water. 
Processing facilities must be of sound construction and capable of 
being efficiently and thoroughly cleaned. Animals and pests must be 
excluded. The use of chemical compounds, such as cleaning agents, 
insecticides, rodenticides, and bactericides must be limited to 
circumstances and conditions approved by NMFS (50 CFR 260.99).
    An establishment participating in any of the NMFS inspection 
programs is expected to have organized food-safety management systems 
that are implemented through a combination of operational prerequisite 
programs that document how food safety hazards are to be controlled, 
and HACCP plans for each product processed by the establishment. The 
establishment must maintain documented Sanitation Standard Operating 
Procedures (Sanitation SOPs) and prerequisite programs. The programs 
must ensure the safety of processing water, ensure employee hygiene, 
prevent contamination of food-contact surfaces, and prevent cross-
contamination generally in the establishment. The establishment is 
expected to document how it will control nonconforming products, handle 
recalls, and withdraw defective products from the market. All

[[Page 10438]]

HACCP-related records must be available to NMFS inspectors.

VII. Public Health Protection: Chemical and Microbiological 
Contaminants

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

Chemical Residues in Catfish

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

Heavy Metals

    At sufficient levels, these heavy metals are associated with 
ischemic heart disease, developmental abnormalities, decreased 
intelligent quotient (IQ) values, and other harmful effects in 
humans.\7\
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    \7\ U.S. Centers for Disease Control and Prevention. Agency for 
Toxic Substances and Disease Registry. (1999). Toxicological Profile 
for Mercury.
    U.S. Centers for Disease Control and Prevention. Agency for 
Toxic Substances and Disease Registry. (2007a). Toxicological 
Profile for Arsenic.
    U.S. Centers for Disease Control and Prevention. Agency for 
Toxic Substances and Disease Registry. (2007b). Toxicological 
Profile for Lead.
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    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\
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    \8\ U.S. Department of Agriculture. Food Safety and Inspection 
Service. 2010. Analysis of Heavy Metals and Veterinary Drugs found 
in 737 Catfish Samples from Retail Markets in the United States. 
Washington, DC.
---------------------------------------------------------------------------

    In a 2001 study of 257 domestic catfish (i.e., Ictaluridae) samples 
conducted by Santerre et al., lead residues were detected in 11 
percent, arsenic residues in 5 percent, and mercury residues in 83 
percent.\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.
---------------------------------------------------------------------------

    \9\ Santerre, C.R., P.B. Bush, D.H. Xu, G.W. Lewis, J.T. Davis, 
R.M. Grodner, R. Ingram, C.I. Wei, J.M. Hinshaw. 2001. Metal 
Residues in Farm-Raised Channel Catfish, Rainbow Trout, and Red 
Swamp Crayfish from the Southern U.S. Journal of Food Science. 
66:270-273.
---------------------------------------------------------------------------

Pesticides

    In 2008, the USDA Agricultural Marketing Service \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.
---------------------------------------------------------------------------

    \10\ U.S. Department of Agriculture. Agriculture Marketing 
Service. December 2009. Pesticide Data Program Annual Report 2008. 
Washington, DC.
    \11\ U.S. Department of Agriculture. Agriculture Marketing 
Service. December 2009. Pesticide Data Program annual Report 2008. 
Washington, DC.
    \12\ An organophosphate insecticide linked to neurological and 
birth defects.
    \13\ A synthetic organochlorine pesticide often used for 
mosquito control, DDT is a suspected carcinogen. Use of DDT was 
banned in the U.S. in 1972. Today it is banned in most developed 
countries. Because of its long half-life (ca. 25 years), DDT is 
classified as a persistent organic pollutant. This perhaps explains 
its presence in domestic and imported catfish samples.
    \14\ An organochlorine insecticide with acute toxicity and high 
bioaccumulation potential, endosulfan is an endocrine disruptor.
    \15\ Toxaphene is a mixture of approximately 200 organic 
compounds. Used as an insecticide in cotton and soybean growing 
areas of the United States, it was banned for use in 1986. Toxaphene 
is a carcinogen.
---------------------------------------------------------------------------

Unapproved Antimicrobials

    If antimicrobials that are not approved by the FDA, such as 
malachite green and fluoroquinolones, are used in catfish production, 
they can result in the presence of chemical residues in edible tissue. 
Some research suggests that antimicrobial residues in food may hasten 
the development of antimicrobial-resistant infections in humans.\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/Product-SpecificInformation/Seafood/SeafoodRegulatoryProgram/ucm150954.htm. FDA reported that in 2007 it 
found 12 imported catfish samples positive for malachite green and 6 
for fluoroquinolones. Since June 2008, FDA rejected 31 shipments of 
catfish imports for presence of unsafe animal drug residues.
---------------------------------------------------------------------------

    \16\ Heuer, O.E. Kruse, H., Grave K., Karunasagar, I., & Angulo, 
F.J. (2009). Human Health Consequences of Use of Antimicrobial 
Agents in Aquaculture. Clinical Infectious Diseases. 49:1248-1253.
    Muller, L., Kasper, P. Kersten, B. & Zhang, J. (1998). 
Photochemical genotoxicity and photochemical carcinogenesis. Two 
Sides of a Coin? Toxicology Letters. 102-103: 383-387.
    Culp, S.J., Mellick, P.W., Trotter, R.W., Greenlees, K.J., 
Kodell, R.L., Beland, F.A. (2006). Carcinogenicity of Malachite 
Green Chloride and Leucomalachite Green in B6C3F1 Mice and F344 
Rats. Food and Chemical Toxicology. 44:1204-1212.
    There are three approved classes of antimicrobials for use in 
catfish: florfenicol, Romet 30 and TC, and several terramycin 
formulations. See http://www.fda.gov/downloadsAnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/UCM109808.pdf (Accessed Feb. 
15, 2011).
---------------------------------------------------------------------------

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

[[Page 10439]]

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.
---------------------------------------------------------------------------

    \17\ U.S. Department of Agriculture. Food Safety and Inspection 
Service. Office of Public Health Science. December 2010. Draft Risk 
Assessment of the Potential Human Health Effect of Applying 
Continuous Inspection to Catfish. Washington, DC.
---------------------------------------------------------------------------

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\
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    \18\ McCaskey T, TC Hannah, T Lovell, et al. 1998. Safe and 
Delicious study shows catfish is low risk for foodborne illness. 
Highlights of Agricultural Research. Vol. 45, No. 4. Available at 
http://www.ag.auburn.edu/aaes/communications/highlights/winter98/catfish.html.
    \19\ U.S. Department of Agriculture. Economic Research Service. 
2009. Economic Research Service Staff Analysis of FDA Import 
Refusals for Catfish, 1998-2004. Washington, DC.
    \20\ Because of this, the FSIS catfish draft risk assessment 
assumed that the prevalence of Salmonella on imported catfish was 
the same as that on domestic fish, i.e. 2%.
---------------------------------------------------------------------------

Listeria

    Though no catfish-borne listeriosis outbreaks have been identified, 
Chou et al. (2006) identified L. monocytogenes in 25-47% of raw catfish 
fillets at three U.S. processing plants.\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 cross-contamination occurs between raw products and 
ready-to-eat (RTE) products (Fernandes et al. 1998). Chou et al. (2006) 
found that L. monocytogenes was most commonly isolated from catfish in 
the winter with a prevalence rate of 51 percent, compared to 41 percent 
in the spring, 36.7 percent in the fall, and 19 percent in the summer. 
This finding may be attributable to the ability of L. monocytogenes to 
out-compete other bacterial species at lower temperatures.
---------------------------------------------------------------------------

    \21\ Chou, C.H., Silva, J.L., & Wang, C. (2006). Prevalence and 
Typing of Listeria monocytogenes in Raw Catfish Fillets. Journal of 
Food Protection, 69, 815-819.
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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.
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    \22\ Beatty, M.E., Bopp, C.A., Wells, J.G., Greene, K.D., Puhr, 
N.D., & Mintz, E.D. (2004). Enterotoxin-producing Escherichia coli 
O169:H41, United States. Emerging Infectious Diseases. Retrieved 
from http://www.cdc.gov/ncidod/EID/vol10no3/03-0268.htm Oct. 16, 
2009.
---------------------------------------------------------------------------

Illness Outbreaks From Catfish

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

         Table 2--CDC Data on Outbreaks of Foodborne Illness in Which Catfish Was a Confirmed or Suspected Vehicle, 1991-2007, United States.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 case-patients. Nine stool specimens tested positive for Salmonella 
Hadar. Catfish was identified as a possible vehicle for illnesses.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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

[[Page 10440]]

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\
---------------------------------------------------------------------------

    \24\ U.S. Department of Agriculture. Food Safety and Inspection 
Service. Office of Public Health Science. December 2010. Draft Risk 
Assessment of the Potential Human Health Effect of Applying 
Continuous Inspection to Catfish. Washington, DC.
    \25\ Food Safety and Inspection Service. 2006. Review of the 
Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems Final Rule pursuant to Section 610 of the Regulatory 
Flexibility Act, as Amended. Available at: http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2007-0022P/610_Report_PR_HACCP.pdf (Accessed 
Oct. 14, 2009).
---------------------------------------------------------------------------

    With regard to the risk assessment for catfish, FSIS continues to 
evaluate the hazards, particularly Salmonella, associated with this 
fish. FSIS invites all interested stakeholders to submit additional 
data and scientific evidence specific to catfish food safety. FSIS will 
consider this information and other data in the development of a final 
risk assessment in this proceeding.
    Further, USDA is seeking public comments on the evidence regarding 
the public health benefits and cost-effectiveness to be achieved with 
the proposed program.

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

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

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

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

B. Catfish and Catfish Product Inspection Regulations Under the FMIA

    FSIS is proposing to establish regulatory requirements for the 
continuous inspection of catfish and catfish products. FSIS is adapting 
for use in the regulation and inspection of catfish and catfish 
products those meat inspection regulations that are appropriate in 
preventing the transportation, sale, offer for sale or transportation, 
or receipt for transportation, in commerce, of adulterated or 
misbranded products (21 U.S.C. 602, 610, 621). Because there are 
differences between fish and mammalian livestock species, some of the 
regulations for catfish will be separate within the Code of Federal 
Regulations from those for the inspection of meat and meat food 
products. Other regulations apply as written to catfish and will simply 
be cross-referenced.
Organization of Catfish Inspection
    In general, the catfish regulations parallel the sequence of 
operations from the harvesting and delivery of the fish to the 
processing plant, through the in-plant operations, to transportation in 
commerce, specifying export and import requirements where appropriate.
    After outlining the district-level supervision of catfish 
inspection in proposed 9 CFR 530.2, FSIS makes clear in proposed Sec.  
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

[[Page 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, cross-
referencing the application procedures for, and grant and approval of, 
meat inspection in 9 CFR part 304 because the procedures for catfish 
establishments will be similar to those for meat establishments.
    Establishments will have to complete an Application for Federal 
Inspection (currently, FSIS Form 5200-2, available from the appropriate 
District Office). In addition to completing the application, 
establishments will need to attach a description of the limits of the 
premises of the establishment that are to be under Federal inspection 
(Item No. 106 on the current application form). This description could 
be written, or it could be a drawing.
    Under this proposal, a catfish establishment intending to conduct 
operations under an FSIS Grant of Inspection will be subject, 
consistent with 9 CFR 304.3, to the sanitation performance standard 
requirements (distinct from Sanitation SOPs) in 9 CFR part 416. After 
the establishment files its application with the appropriate District 
Office, FSIS will reserve an official plant number, in accordance with 
9 CFR 305.1, that will identify all inspected and passed products 
prepared in an establishment and that must be printed on the label of 
any packaged product. All packaged catfish products also will have to 
bear the U.S. Inspection legend. All labeling material will have to be 
Federally approved and on-hand before inspection could be granted per 9 
CFR 317.4.
    Under the proposed regulations (requirements for sanitary operation 
under 21 U.S.C. 608 and 621), the establishment will have to have 
documentation supporting the potability of the water it uses for 
catfish (per 9 CFR and 416.2(g)).

[[Page 10442]]

    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.
---------------------------------------------------------------------------

    \26\ The District Manager, in the current Agency organization, 
has absorbed functions of the former Area Supervisor, mentioned in 9 
CFR 307.4.
---------------------------------------------------------------------------

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

Pre-Harvest and Transport to Processing Establishment

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

[[Page 10443]]

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

[[Page 10444]]

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.
---------------------------------------------------------------------------

    \27\ FSIS notes, in addition, that the FDA Compliance Policy 
Guide, Section 575.100, Pesticide Chemicals in Food--Enforcement 
Criteria, lists action levels for banned but persistent chlorinated 
pesticides. Most pesticides detected in catfish are listed in this 
guidance.
    \28\ The program is explained at: http://www.fsis.usda.gov/Science/Chemistry/index.asp (Accessed 10/29/2008.)
---------------------------------------------------------------------------

    With respect to microbiological contamination, FSIS plans to 
implement a pathogen reduction program for catfish that would be 
similar to that for other classes of raw product subject to the FMIA. 
After completing a study to determine the national baseline prevalence 
and levels of Salmonella on raw catfish, FSIS will conduct regular 
testing in processing establishments for the purpose of measuring 
industry performance against the baseline.

Handling and Disposal of Condemned and Inedible Materials

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

Marks, Marking, and Labeling of Products and Containers

Official Marks and Devices
    FSIS is proposing (under 21 U.S.C. 601(n)(12), 601(s)-(v), 606, 
611) to use certain official marks, devices, and certificates for the 
purpose of identifying inspected and passed catfish and catfish 
products and their status. FSIS is proposing to provide that an 
official inspection legend containing the number of the official 
establishment be shown on all labels of inspected and passed product (9 
CFR 541.2(a)). The form of the official legend will be that for meat 
products (9 CFR 312.2(b)(1), reproduced in proposed 9 CFR 541.2), or 
another form that the Agency would prescribe. Comments and suggestions 
on what an alternative form might be are welcome.
    FSIS is proposing to require that whole, gutted catfish carcasses 
that have been inspected and passed at an official establishment, and 
that are intended for sale as whole, gutted catfish, be marked or 
labeled with an official inspection legend containing the number of the 
establishment at the time of inspection (proposed 9 CFR 541.2(d)). The 
form of the inspection legend will be that in 9 CFR 312.2(a) and as 
illustrated in proposed 9 CFR 541.2(d) or as otherwise determined by 
the FSIS Administrator. The marking must ensure that the catfish will 
be identified as having been inspected and will not become misbranded 
while in commerce. Comments are welcome on whether marking is 
necessary, the form of the mark that would be satisfactory, and how the 
mark should be applied.
    In proposed 9 CFR 541.3, FSIS is providing that the official mark 
used in sealing railroad cars, cargo containers, or other transport 
conveyances, as prescribed in proposed 9 CFR part 555, be in the form 
of the inscription and serial number shown in 9 CFR 312.5 or in another 
form approved by FSIS. The Agency-approved seal will be an official 
device under the FMIA. The seal will have to be attached to the means 
of conveyance by an Agency employee.
    FSIS is also proposing (proposed 9 CFR 541.4) that the official 
export inspection mark for catfish (see proposed 9 CFR part 552) be 
that specified in 9 CFR 312.8(a), and that the export certificate for 
catfish and catfish products be the same as that prescribed in 9 CFR 
312.8(b) for meat and meat food products.
    FSIS also is proposing (proposed 9 CFR 541.5) that the official 
mark for shipments of articles and catfish that are officially detained 
be the designation ``U.S. Detained.'' The device for applying the mark 
would be the same ``U.S. Detained'' tag that FSIS uses for detained 
meat articles.

Labeling Requirements; Prior Approval of Labeling

    FSIS is proposing (proposed 9 CFR 541.7) to apply to catfish and 
catfish products many of the same labeling and label approval 
requirements as those for meat and meat food products in 9 CFR 317, 
Subpart A, except where those regulations apply specifically, or could 
only apply, to meat or meat food products (under 21 U.S.C. 607). The 
requirements that FSIS is proposing to apply to catfish address labels 
and labeling, the abbreviations of official marks, label approval, 
generically approved labeling, the use of approved labels, the labeling 
of products for foreign commerce, prohibited practices, the reuse of 
official inspection marks, filling of containers, relabeling of 
products, the storage and distribution of labels, and the requirements 
for packaging materials.
    Under this proposal, the basic requirements for a label (most, in 9 
CFR 317.2) will be similar in a number of respects to those that FDA 
requires for the label of food products under its jurisdiction. Unlike 
FDA, however, FSIS

[[Page 10445]]

requires that the label bear the official inspection legend. Also, 
unlike FDA, FSIS forbids any final labeling from being used on any 
product unless the sketch of the final labeling has been approved by 
the Agency.
    Another requirement that differs from the FDA requirements is the 
requirement for safe-handling labeling (9 CFR 317.2(l)) on products 
that are not ready-to-eat, that is, products that are raw or that 
undergo minimal treatment, such as heating, before being consumed. FSIS 
is proposing to require that safe-handling instructions appear on the 
label of every not-ready-to-eat catfish product that is destined for 
household consumers, hotels, restaurants, or similar institutions.

Generically Approved Labeling

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

Prevention of False or Misleading Labeling Practices

    Under the FSIS regulations, no product or any of its wrappers, 
packaging, or other containers may bear any false or misleading 
marking, label, or other labeling, and no statement, word, picture, 
design, or device that conveys any false impression or gives any false 
indication of origin or quality or that is otherwise false or 
misleading may appear in any marking or other labeling. No product may 
be enclosed wholly or partly in any wrapper, packaging, or other 
container that is made, formed, or filled in a manner that would make 
it misleading. (9 CFR 317.8.)
    To prevent the misuse of labeling, FSIS enforces regulations 
controlling the conditions under which product may be relabeled at a 
location other than an official establishment (9 CFR 317.12). The 
Agency also regulates the conditions under which labels, wrappers, or 
containers bearing official marks may be transported from one official 
establishment to another official establishment (9 CFR 317.13). All 
these requirements, which apply to meat and meat food products, will 
apply to catfish and catfish products under this proposed rule.
    A major challenge to the identification of processed fish products 
is the inability to visually identify the species of fish after 
processing. Because of the interest of the catfish products industry 
and consumers in ensuring that product labeling correctly represents 
the actual species of fish in the product, FSIS is considering the use 
of various technological means to verify catfish species. There is 
available chemical taxonomic information consisting of species-
characteristic biochemical patterns that may be compared quantitatively 
to patterns obtained by an appropriate laboratory analysis of the fish 
in question. These patterns include data from isoelectric focusing 
(IEF), a type of electrophoresis, and restriction fragment length 
polymorphism (RFLP) studies. RFLP is a technique in which organisms may 
be differentiated by analysis of patterns derived from cleavage of 
their DNA. If two organisms differ in the distance between sites of 
cleavage of a particular restriction endonuclease, the length of the 
fragments produced will differ when the DNA is digested with a 
restriction enzyme. The similarity of the patterns generated can be 
used to differentiate species (and even strains) from one another.
    In recent years, interest in another technique, known as ``DNA bar 
coding,'' has been growing. It involves the DNA sequencing of 
mitochondrial gene cytochrome c oxidase I (COI) in seafood tissue 
samples to obtain unique, species-specific identifications, or 
``barcodes.'' The method is considered robust and sensitive to small 
phylogenetic differences. FDA has been considering it as a replacement 
for IEF as that agency's standard for species identification and FSIS 
is considering this approach as well. FSIS welcomes comment and 
suggestions on species verification methods that the Agency might use.

Net Weight and Retained Water

    FSIS labeling regulations on net weight of meat products 
incorporate by reference Handbook 133 of the National Institute of 
Standards and Technology (NIST). These regulations include provisions 
for determining compliance with net weight requirements and prescribe 
the reasonable variations from the declared net weight on the labels of 
immediate containers of products (9 CFR 317.18-317.22). To ensure that 
there is compliance, the regulations prescribe requirements for scales 
to determine accurate weights and for the testing of scales (9 CFR 
317.20-317.21).
    FSIS has learned from FDA and industry sources that catfish 
presents a specific challenge regarding net weight because of the 
frequent and varying use of glazing. (A glaze is a thin coating of ice 
on a catfish or catfish product that is intended to preserve the 
freshness of the product.) To regulate net weight for raw catfish 
products, FSIS is proposing to apply to raw catfish the requirements 
for control of retained water from processing in raw meat and poultry 
products through 9 CFR part 441 (referenced in proposed 9 CFR 
541.7(b)), slightly amended to include raw catfish and catfish 
products. Retained water--water remaining in raw product after it 
undergoes immersion chilling or a similar process--will not be 
permitted unless the official establishment is able to show, with data 
collected under a written protocol, that the retained water is an 
unavoidable consequence of the process used to meet applicable food-
safety requirements (9 CFR 441.10(a)). The establishment will have to 
label its products to state, besides net weight, the maximum percentage 
of water retained in the product from such processing as chilling 
(e.g., up to X% retained water, less than X% water retained from 
chilling). The protocol, to be maintained in the establishment's files, 
will have to explain how data will be collected and used to demonstrate 
that the amount of retained water in the product covered by the 
protocol is an unavoidable consequence of the process used to meet 
specified food-safety requirements. The establishment will have to 
notify FSIS as soon as it has a new or revised protocol (9 CFR 
441.10(c)). Expected elements of the protocol are given in the 
regulations (9 CFR 441.10(d)).
    FSIS also is proposing to apply to catfish and catfish products the 
requirements in part 442, subchapter E, governing quantity of contents 
labeling, the testing of scales, and the handling of product that is 
found to be out of compliance with net weight requirements (referenced 
in proposed 9 CFR 541.7(b)).
    FSIS is proposing, in particular, that packages of fresh or fresh-
frozen catfish carcasses or parts be labeled to reflect 100-percent net 
weight (gross weight less the weight of glaze) after thawing. The de-
glazed net weight must average 100 percent of the stated net weight of 
the frozen product when sampled and weighed according to the method 
prescribed in NIST Handbook 133 Chapter 2, Section 2.6.\29\ Interested 
persons may want to consult NIST Handbook 133 for maximum allowable 
variations.
---------------------------------------------------------------------------

    \29\ U.S. Department of Commerce. NIST Handbook 133: Checking 
the Net Contents of Packaged Goods, Fourth Edition, January 2005. 
Washington, DC.
---------------------------------------------------------------------------

Nutrition Labeling Requirements

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

[[Page 10446]]

catfish and catfish products that are not raw, single-ingredient 
products (proposed 9 CFR 541.7(d)). The FSIS requirements for meat and 
meat food products (9 CFR 317.300-317.500) are similar to FDA's (21 CFR 
101.9 et seq.) in that a nutrition facts panel has to appear on the 
label. The FSIS nutrition facts panel includes information on serving 
size, servings per container, amount of calories per serving, and 
calories from fat. Also the panel includes amount and percent daily 
value of total fat and saturated fat, cholesterol, sodium, total 
carbohydrates, dietary fiber, sugar, and protein, as well as 
information on percent daily intake of vitamins and minerals. 
Processors may provide additional nutritional labeling that is not 
false or misleading.

Food Ingredients Permitted

    FSIS is proposing to apply to catfish products requirements in 9 
CFR part 424 prohibiting a product from bearing or containing any food 
ingredient that would render it adulterated or misbranded under 21 
U.S.C. 601(m)(2)(C) (proposed 9 CFR part 544). This prohibition is 
consistent with the current regulation of catfish products under the 
FD&C Act.
    Few further-processed catfish products are produced domestically; 
however, FSIS is aware of the use in some fresh-frozen catfish of 
sodium tripolyphosphate and other sodium phosphates as humectants. 
Also, marinade solutions and breading ingredients are used in the 
preparation of some catfish products. FDA has approved these various 
ingredients for uses that include catfish products or has determined 
them to be Generally Recognized As Safe (GRAS) for these uses.
    Under the FMIA, establishments will only be able to prepare a 
further-processed catfish product when the establishment is under 
inspection by an FSIS inspection program employee. Under 21 U.S.C. 601, 
606, and 608, preparation of edible product will have to be carried out 
in compliance with the sanitary and other requirements in the 
regulations (proposed 9 CFR 548.1(a)).
    Under this proposed rule, FSIS will make determinations on the 
safety and suitability of uses of food ingredients in catfish products 
in consultation and coordination with FDA, as it does for all food 
ingredients. FSIS will compile safe and suitable uses, including limits 
and conditions of use, of food ingredients in these products and make 
the information available in an instruction to its inspection force, 
FSIS Directive 7120.1. This directive is regularly updated and 
published on the Agency's Web site at: http://www.fsis.usda.gov/Regulations_&_Policies/7000_Series-Processed_Products/index.asp 
(accessed Feb. 15, 2011).

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

    Only a few ready-to-eat (RTE) catfish products, such as smoked 
catfish, are distributed in commerce. Under this proposed rule, these 
products will have to comply with appropriate performance standards, as 
must all RTE meat and poultry products if they are not to be considered 
adulterated under either the FMIA (21 U.S.C. 601(m)) or the PPIA (21 
U.S.C. 453(g). Any pathogen on an RTE product adulterates the product 
because RTE products are likely not to be cooked before consumption. 
Currently, there are requirements for the control of Listeria 
monocytogenes in RTE products that are exposed to the processing 
environment after undergoing a process that is lethal to L. 
monocytogenes. FSIS is proposing to make post-lethality-exposed catfish 
products subject to these requirements (proposed 9 CFR 548.6, 
referencing 9 CFR part 430).
    An RTE product is adulterated if it contains L. monocytogenes, or 
if it comes into direct contact with a food-contact surface that is 
contaminated with L. monocytogenes because it is likely to be consumed 
without further processing such as cooking. An RTE catfish product, as 
well as an RTE meat or poultry product, would be adulterated in either 
of these situations.

Canned Products

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

Accredited Laboratories

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

Standards of Identity and Composition

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

Exports

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

[[Page 10447]]

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

[[Page 10448]]

``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

[[Page 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-in-Charge of 
the kind, quantity, source, and present location of the product. The 
consignee also will have to report on the respects in which the product 
is adulterated or misbranded. Movement of the product, except back to 
the official establishment from where it came, is prohibited (proposed 
9 CFR 550.7), and if the product moves back to the originating 
establishment, the use of seals, documentation, or other conditions 
applies.

Summary of Proposed Regulations

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

    Table 5--Relationship Between Catfish and Catfish Product Inspection Regulations in Subchapter F and Meat
                             Inspection Regulations in Subchapter A or Subchapter E
----------------------------------------------------------------------------------------------------------------
                                                                                 Corresponding Subchapter A or E
                      Subject                         Subchapter F  designation     part or section reference
----------------------------------------------------------------------------------------------------------------
GENERAL REQUIREMENTS; DEFINITIONS..................  PART 530..................  Part 300.
General............................................  Sec.   530.1..............  Sec.   300.1, Sec.   300.2.
FSIS organization for inspection of catfish and      Sec.   530.2..............  Sec.   300.3.
 catfish products.
Access to establishments...........................  Sec.   530.3..............  Sec.   300.6.
DEFINITIONS........................................  PART 531..................  Part 301.
Definitions........................................  Sec.   531.1..............  Sec.   303.1.
REQUIREMENTS FOR INSPECTION........................  PART 532..................  Part 302, Part 304, Part 305.
Establishments requiring inspection; other           Sec.   532.1..............  Sec.   302.1.
 inspection.
Application for inspection, etc....................  Sec.   532.2..............  Sec.   304.1, Sec.   304.2,
                                                                                  Sec.   304.3.
Exemption of retail operations.....................  Sec.   532.3..............  Sec.   303.1.
Inspection at official establishments; relation to   Sec.   532.4..............  Sec.   302.2.
 other authorities.
Exemption from definition of catfish product of      Sec.   532.5..............
 certain human food products containing catfish.
SEPARATION OF ESTABLISHMENT; FACILITIES FOR          PART 533..................  Part 305, Part 306, Part 307.
 INSPECTION.
Separation of establishments.......................  Sec.   533.1..............  Sec.   305.2.
Facilities for Program employees...................  Sec.   533.3..............  Sec.   307.1.
Other facilities and conditions to be provided.....  Sec.   533.4..............  Sec.   307.2.
Schedule of operations.............................  Sec.   533.5..............  Sec.   307.4.
Overtime and holiday inspection service............  Sec.   533.6..............  Sec.   307.5.
Basis of billing for overtime and holiday services.  Sec.   533.7..............  Sec.   307.6.

[[Page 10450]]

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

[[Page 10451]]

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

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

[[Page 10452]]

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

[[Page 10453]]

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

Phase Two

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

Phase Three

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

Phase Four

     The transitional measures will expire. FSIS will require 
that all establishments that produce catfish and catfish products 
comply with all provisions of the final catfish inspection regulations.
     Foreign countries that export catfish products to the 
United States will be required to have implemented a catfish inspection 
program that is equivalent to the U.S. inspection program. To be 
eligible for the importation of their products into the United States, 
the countries will have to be listed in proposed 9 CFR part 557.

X. Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866, 
``Regulatory Planning and Review.'' FSIS would amend Title 9, Code of 
Federal Regulations, Chapter III by adding regulations on the mandatory 
inspection of catfish and catfish products. The regulations, if 
adopted, will continue to ensure that catfish and catfish products 
produced and sold in commerce for use as human food are safe, 
wholesome, and not adulterated. The regulations will also ensure that 
they are properly marked, labeled, and packaged. FSIS will verify that 
catfish are raised and transported to processing establishments under 
conditions that ensure that catfish products used for human food are 
not adulterated.
    The proposed regulations require establishments that process and 
prepare catfish to apply for FSIS inspection and meet the conditions 
for receiving inspection. Establishments will be required to meet 
sanitation performance standards, have written Sanitation SOPs, and 
operate validated HACCP systems. FSIS will verify the Sanitation SOPs 
and HACCP systems and will conduct other verification activities to 
ensure that the establishments are in compliance with the FMIA and 
regulatory requirements under the Act that apply to catfish and catfish 
products. The establishments will be subject to sampling as part of 
microbiological, chemical, and other testing by FSIS of catfish and 
catfish products. The labeling of inspected products will bear a 
distinctive mark or legend to reflect that the product has been 
inspected and passed by FSIS.
    The proposed regulations also require the listing in the 
regulations of foreign countries after their food safety systems for 
catfish have been found by FSIS to be equivalent to that of the United 
States. The equivalency determination and the listing in the 
regulations are necessary in order for the catfish products of these 
countries to be imported into the United States. The proposed 
regulations also require the inspection (actually, re-inspection) of 
catfish products offered for entry into this country.
    FSIS is proposing these regulations to carry out the requirements 
of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, 
Sec. 11016), known as the 2008 Farm Bill, that amended the FMIA to make 
catfish, as defined by the Secretary of Agriculture, an amenable 
species under the FMIA and subject to many of the requirements of the 
FMIA.

Regulatory Approaches Considered

    Regardless of the definition of catfish that is adopted an 
alternative to current FDA practices would be proposed.
    FSIS has considered two basic regulatory approaches to catfish 
inspection--a more command-and-control, traditional approach or an 
approach that focuses on the verification of an establishment's food 
safety system. Strictly in terms of implementing the FMIA with respect 
to catfish and catfish products, FSIS could take a prescriptive, 
command-and-control approach to inspection, as it has in the past with 
meat and poultry and currently does with egg products. Command-and-
control requirements specify, often in great detail, how an 
establishment is to achieve a particular food-safety objective. They 
may involve the use of specific techniques or processing parameters; 
the review and approval of equipment, establishment drawings and 
specifications; and the review and approval of particular process 
control programs. FSIS, however, rejected this command-and-control 
approach in 1996 with the adoption of the Pathogen Reduction/Hazard 
Analysis and Critical Control Points Systems final rule (61 FR 38806; 
July 25, 1996).
    Thus, the Agency is proposing to adopt, as it has for meat and 
poultry, an approach to inspection that focuses on the verification of 
an establishment's food safety system, which consists of an 
establishment's HACCP plan, Sanitation SOPs, and prerequisite programs. 
As mentioned elsewhere in this document, the FSIS HACCP requirements 
for meat and poultry establishments are in some ways similar to the FDA 
HACCP requirements for seafood processors (in 21 CFR 123), yet 
supported by much more intensive inspection by FSIS.
    USDA is requesting public comments on the approach.

Costs and Benefits

Costs
Siluriformes
    If catfish are defined as members of the order Siluriformes, the 
mean total first-year and one-time cost to the catfish and catfish food 
products domestic supply chain industries of the proposed measures is 
projected to be about $306,000. The first year cost is projected to be 
about $543,000. For the catfish and catfish food product domestic 
industry, the mean annual cost is projected at $187,000. The projected 
mean estimated annualized cost is $240,000 (See Table 18 of the RIA 
Appendix). The projected lower bound (10th percentile) is $237,000, and 
the projected upper bound (90th percentile) is $243,000.\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.
---------------------------------------------------------------------------

    \30\ A stochastic simulation model was used to determine the 
distribution of values. Uncertainty analyses are conducted to 
estimate cost distributions for each of the alternatives for the 
proposed rule. The stochastic model uses @RISK (Version 4.5, 
Palisades Corp.) to examine the effects of uncertainty.
---------------------------------------------------------------------------

    For the domestic industry and the Government, the additional mean 
total first-year one-time cost to the catfish and catfish products 
supply chain industries and additional cost to the government of the 
proposed measures is projected at $1.3 million. The additional mean 
total first-year cost is projected at $15.4 million. Additional mean 
annual cost is projected at $14.0 million. The projected mean 
annualized cost is $14.2 million (See Table 18 of the RIA Appendix). 
The projected lower bound (10th percentile) is $14.1 million. The 
projected upper bound (90th percentile) is $14.3 million. The present 
value of

[[Page 10454]]

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.
---------------------------------------------------------------------------

    \31\ A stochastic simulation model was used to determine the 
distribution of values. Uncertainty analyses are conducted to 
estimate cost distributions for each of the alternatives for the 
proposed rule. The stochastic model uses @RISK (Version 4.5, 
Palisades Corp.) to examine the effects of uncertainty.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \32\ Wholesale price. Source: Catfish Market Statistics, NASS, 
USDA.
    \33\ Wholesale price. Source: Catfish Monthly Summary, NASS, 
USDA.
    \34\ Wholesale price. Source: Catfish Market Statistics Annual, 
NASS, USDA.
    \35\ M. Ollinger, V. Mueller. 2003. Managing for Safer Food: The 
Economics of Sanitation and Process Controls in Meat and Poultry 
Establishments. Agricultural Economics Report 817. Economics 
Research Service, U.S. Department of Agriculture. Washington, DC.
---------------------------------------------------------------------------

Break-Even Analysis

    FSIS anticipates that all catfish and catfish products 
establishments will be in compliance with the requirements for 
Sanitation SOPs and HACCP according to the yet-to-be-determined 
implementation schedule. From discussions with industry experts, FSIS 
believes that a significant share of the catfish and catfish products 
industry is compliant with many of the individual proposed measures; 
although, because of differences between FDA and FSIS regulations, FSIS 
believes the industry will need time to make adjustments. Even though 
compliance rates for some HACCP related activities may be relatively 
high, the performance of HACCP systems depends on how well all the 
elements--hazard analysis, monitoring of CCPs and critical limits, 
recordkeeping, verification--are being performed. FSIS conducted an 
illustrative assessment of the potential risk to human health of 
catfish consumption, using the example of Salmonella contamination. 
Thus, we use Salmonella to illustrate potential benefits in this break-
even analysis.
    Epidemiological evidence suggests that salmonellosis leads to both 
acute and chronic illnesses. The acute illness that accompanies 
salmonellosis generally causes gastrointestinal symptoms that can lead 
to lost productivity and medical expenses. In rare instances, 
salmonellosis may result in acute or chronic arthritis. Arthritis is 
characterized by limited mobility, pain and suffering, productivity 
losses, and medical expenditures. Finally, salmonellosis can result in 
death. The risk of death appears to be higher in the elderly, children, 
and people with compromised immune systems. FSIS has estimated the 
costs for each of these severity levels.
    Applying the same methodology as FDA in projecting a monetary value 
for each QALD, using the value of a statistical life (VSL); and the 
value of a statistical life year (VSLY), FSIS projects a mean 
annualized cost of about $18,000 per new average case of salmonellosis 
(FDA, 2009). Thus, under the proposed rule for catfish defined as 
Siluriformes, using the projected annualized cost of $14.2 million and 
the estimated mean annualized cost of an average case of Salmonella 
spp. of approximately $18,000 (at a 7 percent discount rate), if 
roughly 790 illnesses were averted, the benefits of the proposed rule 
would equal the additional costs.
    Under the proposed rule applied to the catfish family Ictaluridae, 
using the projected annualized cost of $10.6 million and the estimated 
mean annualized cost of an average case of Salmonella spp. of $18,000, 
roughly 590 illnesses would have to be averted for the benefits of the 
proposed rule to equal the additional costs.

Effects on Small Entities

    The Administrator has determined that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), this proposed rule will 
not have a significant economic impact on a substantial number of small 
entities in the United States. Catfish farms (about 1,300) and 
slaughtering and primary processing establishments (about 23), and as 
many as 116 further processing establishments, live-fish haulers, 
importers, and feed mills would be affected by the rule. Most of these 
plants meet the Small Business Administration (SBA) size criteria for 
small businesses in the food manufacturing classification or other 
categories, in that they have 500 or fewer employees. The action would 
affect a substantial number of these small entities because the 
requirements would apply to all processing establishments in the 
catfish processing industry that ship their products in interstate 
commerce and would to some extent pertain to fish-farming practices. 
However, this action may have a significant effect on a substantial 
number of businesses that import catfish because imported catfish will 
be required to be inspected under a foreign system that is equivalent 
to that of the United States and from establishments that the foreign 
inspection authority has certified as complying with United States 
requirements.
    The proposed rule would directly and indirectly affect multiple 
sectors of the U.S. economy, including numerous small firms, jobs 
(i.e., employment) and on the government (e.g., local, State, and 
Federal). Sectors likely to be affected (directly and indirectly), in 
addition to the types of entities already mentioned, include 
transportation firms, importing and exporting firms, food service and 
restaurant firms, domestic and international trade, consumers, and 
government agencies. The economic analysis of the effects of this 
proposed rule accompanying this document is available at: http://www.fsis.usda.gov/Regulations_&_Policies/Proposed_Rules/index.asp.

[[Page 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 
import-export brokers.
    For catfish defined as Ictaluridae, 51, including 23 catfish 
slaughter and processing establishments, at least 10 further processing 
establishments, and 11 transporters of catfish to processing plants, 
plus approximately 7 import-export brokers.
    Estimated Number of Responses per Respondent: 1,512.
    Estimated Total Annual Burden on Respondents: For catfish defined 
as Siluriformes: 47,350 hours.
    For catfish defined as Ictaluridae: 32,002.5 hours.
    Copies of this information collection assessment can be obtained 
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety 
and Inspection Service, USDA, Room 3532 South Agriculture Building, 
1400 Independence Avenue, SW., Washington, DC 20250.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; and (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; ways to 
minimize the burden of the collection of information on those who are 
to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques, 
or other forms of information technology. Comments may be sent to both 
John O'Connell, Paperwork Reduction Act Coordinator, at the address 
provided above, and the Desk Officer for Agriculture, Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Washington, DC 20253.
    All responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record.

XII. E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601 et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

XIII. Executive Order 12988, Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. States and local jurisdictions are preempted by 
the FMIA from imposing any marking, labeling, packaging, or ingredient 
requirements on Federally inspected catfish products that are in 
addition to, or different than, those imposed under the FMIA. States 
and local jurisdictions may, however, exercise concurrent jurisdiction 
over catfish products that are outside official establishments for the 
purpose of preventing the distribution of catfish products that are 
misbranded or adulterated under the FMIA or, in the case of imported 
articles that are not at such an establishment, after their entry into 
the United States. This proposed rule is not intended to have 
retroactive effect.
    Administrative proceedings would not be required before parties may 
file suit in court challenging this proposed rule. However, the 
administrative procedures specified in 9 CFR 306.5 would have to be 
exhausted before any judicial challenge of the application of the 
provisions of this final rule, if the challenge involved any decision 
of an FSIS employee relating to inspection services provided under the 
FMIA.

XIV. Expected Environmental Impact

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

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

Executive Order 13175

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

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.) Persons with disabilities who require 
alternative means for communication of program information (Braille, 
large print, or audiotape) should contact USDA's Target Center at 202-
720-2600 (voice and TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, 
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is

[[Page 10456]]

important. Consequently, in an effort to ensure that the public and in 
particular minorities, women, and persons with disabilities, are aware 
of this proposed rule, FSIS will announce it on-line through the FSIS 
Web page located at http://www.fsis.usda.gov/regulations_&_policies/
Proposed_Rules/index.asp.
    The Regulations.gov Web site is the central on-line rulemaking 
portal of the United States Government. It is offered as a public 
service to increase participation in the Federal Government's 
regulatory activities. FSIS participates in Regulations.gov and will 
accept comments about documents published on the site. The site allows 
visitors to search by keyword or Department or Agency for rulemakings 
that provide for public comment. Each entry provides a quick link to a 
comment form so that visitors can type in their comments and submit 
them to FSIS. The Web site is located at http://www.regulations.gov/.
    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, public meetings, recalls, and other types of 
information that could affect, or would be of interest to, our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS Web page at 
http://www.fsis.usda.gov/News_&_Events/Constituent_Update/index.asp. 
Through Listserv and the Web page, FSIS is able to provide information 
to a much broader, more diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides an automatic and customized notification when popular pages 
are updated, including Federal Register publications and related 
documents. This service is available at http://origin-www.fsis.usda.gov/News_&_Events/EmailEmail_Subscription/index.asp 
and allows FSIS customers to sign up for subscription options in eight 
categories. The subscription options categories include recalls, export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves and have the option to password protect 
their accounts.

XVI. Proposed Regulations

List of Subjects

9 CFR Part 300

    Meat inspection.

9 CFR Part 441

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

9 CFR Part 530

    Catfish and catfish products, Catfish inspection.

9 CFR Part 531

    Catfish and catfish products, Catfish inspection.

9 CFR Part 532

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

9 CFR Part 533

    Catfish and catfish products, Catfish inspection, Government 
employees.

9 CFR Part 534

    Aquaculture, Catfish and catfish products, Catfish inspection.

9 CFR Part 537

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

9 CFR Part 539

    Animal diseases, Catfish and catfish products, Catfish inspection.

9 CFR Part 540

    Catfish and catfish products, Catfish inspection.

9 CFR Part 541

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

9 CFR Part 544

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

9 CFR Part 548

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

9 CFR Part 550

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

9 CFR Part 552

    Catfish and catfish products, Catfish inspection, Exports.

9 CFR Part 555

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

9 CFR Part 557

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

9 CFR Part 559

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

9 CFR Part 560

    Catfish and catfish products, Catfish inspection, Intergovernmental 
relations.

9 CFR Part 561

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

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

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

PART 300--AGENCY MISSION AND ORGANIZATION

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

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

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


Sec.  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.

[[Page 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


Sec.  441.10  [Amended]

    4. In Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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:

[[Page 10458]]

    (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,

[[Page 10459]]

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 Sec.  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 Sec.  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.


Sec.  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 Sec.  532.3.
    (b) Inspection under the regulations is required at: (1) Every 
establishment, except as provided in the regulation on exemption of 
retail operations (Sec.  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 (Sec.  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 (Sec.  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.

[[Page 10460]]

    (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.


Sec.  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.


Sec.  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.


Sec.  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 Sec.  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.


Sec.  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 Sec.  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-to-serve 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.


Sec.  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.


Sec.  533.2  [Reserved]


Sec.  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.

[[Page 10461]]

Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.

[[Page 10462]]

Sec.  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, non-zoonotic 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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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 non-food 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.


Sec.  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.


Sec.  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:
[GRAPHIC] [TIFF OMITTED] TP24FE11.000

    (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

[[Page 10463]]

commerce. The official inspection legend used for this purpose must be 
in the form illustrated below or in another form determined by the 
Administrator:
[GRAPHIC] [TIFF OMITTED] TP24FE11.001

Sec.  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).


Sec.  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.


Sec.  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.


Sec.  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\
---------------------------------------------------------------------------

    \36\ U.S. Department of Commerce. NIST Handbook 133: Checking 
the Net Contents of Packaged Goods, Fourth Edition, January 2005. 
Washington, DC.
---------------------------------------------------------------------------

    (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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  548.4  [Reserved]


Sec.  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.

[[Page 10464]]

Sec.  548.6  Canning and canned products.

    The requirements for canning and canned products in 9 CFR part 318, 
subpart G (Sec. Sec.  318.300-318.311) apply to catfish products that 
are canned.


Sec.  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.


Sec.  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 Sec.  318.4 of subchapter A 
of this chapter.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  550.3  Record retention period.

    The record retention requirements in 9 CFR 320.3 apply to records 
required to be kept under this part.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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 Sec.  322.1(a) of this chapter.
    (b) The requirements for the issuance of export certificates are as 
prescribed in Sec.  322.2 of this chapter.
    (c) The requirements for clearing vessels and other transportation 
vehicles are set out in Sec.  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.


Sec.  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 Sec.  
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

[[Page 10465]]

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 Sec.  540.3 of this 
subchapter.


Sec.  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.


Sec.  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 Sec.  325.5 of this chapter that apply to unmarked inspected meat 
products.


Sec.  555.4  Handling of catfish products that may have become 
adulterated.

    The provisions of Sec.  325.10 regarding the handling of products 
that may have become adulterated or misbranded apply to catfish and 
catfish products.


Sec.  555.5  Transportation of inedible catfish product in commerce.

    The provisions in Sec.  325.11(e) of this chapter regarding the 
transportation of inedible livestock products apply to the 
transportation of inedible catfish parts or products.


Sec.  555.6  Certificates.

    The provisions in Sec.  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.


Sec.  555.7  Official seals; forms, use, and breaking.

    The official seals required by this part are those prescribed in 
Sec.  541.3 and Sec.  312.5 of this chapter.


Sec.  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.


Sec.  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 Sec.  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.


Sec.  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 Sec.  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 Sec.  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.


Sec.  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,

[[Page 10466]]

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.


Sec.  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 Sec.  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.


Sec.  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 Sec.  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.


Sec.  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.


Sec.  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

[[Page 10467]]

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.


Sec.  557.4  Imported catfish products; foreign certificates required.

    Except as provided in Sec.  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.


Sec.  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 Sec. Sec.  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 Sec.  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.


Sec.  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 Sec. Sec.  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 re-inspection 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 Sec. Sec.  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 Sec. Sec.  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 Sec.  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

[[Page 10468]]

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 Sec.  
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 
Sec.  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.


Sec.  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.


Sec.  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.


Sec.  557.9  [Reserved]


Sec.  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 
pre-stamping of shipments of meat and meat food products apply with 
respect to catfish and catfish products.


Sec.  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 
Sec.  327.11 of this chapter.


Sec.  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 Sec.  541.7 of this subchapter 
are to be sampled and inspected in the same manner as provided by Sec.  
327.12 of this chapter for foreign canned meat food products.


Sec.  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 Sec.  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 Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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 Sec.  
327.19.


Sec.  557.20-557.23  [Reserved]


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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

[[Page 10469]]

livestock apply also with respect to the carcasses, parts, and products 
of catfish.


Sec.  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.


Sec.  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.


Sec.  560.1  Cooperation with States and Territories.

    The provisions in Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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.


Sec.  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