[Federal Register Volume 80, Number 231 (Wednesday, December 2, 2015)]
[Rules and Regulations]
[Pages 75590-75630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29793]



[[Page 75589]]

Vol. 80

Wednesday,

No. 231

December 2, 2015

Part III





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 Fish of the Order Siluriformes and Products 
Derived From Such Fish; Final Rule

  Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / 
Rules and Regulations  

[[Page 75590]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 300, 441, 530, 531, 532, 533, 534, 537, 539, 540, 541, 
544, 548, 550, 552, 555, 557, 559, 560, and 561

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


Mandatory Inspection of Fish of the Order Siluriformes and 
Products Derived From Such Fish

AGENCY: Food Safety and Inspection Service.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 
regulations to establish a mandatory inspection program for fish of the 
order Siluriformes and products derived from these fish. These final 
regulations implement the provisions of the 2008 and 2014 Farm Bills, 
which amended the Federal Meat Inspection Act, mandating FSIS 
inspection of Siluriformes.

DATES: Effective Date: March 1, 2016.
    On the effective date (March 1, 2016), Siluriformes fish and fish 
products are under FSIS jurisdiction. By March 1, 2016, foreign 
countries seeking to continue exporting Siluriformes fish and fish 
products to the United States during the transitional period are 
required to submit lists of establishments (with the establishment name 
and number) that currently export and will continue to export 
Siluriformes fish and fish products to the United States. Foreign 
countries are also required to submit documentation showing that they 
currently have laws or other legal measures in place that provide 
authority to regulate the growing and processing of fish for human food 
and to assure compliance with the Food and Drug Administration's (FDA) 
regulatory requirements in 21 CFR part 123, Fish and Fishery Products.
    Transitional Period (transition to complete implementation): 
Beginning on March 1, 2016 and continuing until September 1, 2017, FSIS 
will conduct inspection and exercise broad enforcement discretion in 
domestic establishments that slaughter or slaughter and process and 
distribute Siluriformes fish and fish products. Foreign countries 
seeking to continue to export Siluriformes fish and fish products to 
the United States after the transitional period has expired are 
required to submit to FSIS by September 1, 2017 adequate documentation 
showing the equivalence of their Siluriformes inspection systems with 
that of the United States. Foreign countries submitting such 
documentation by the deadline are permitted to continue exporting 
Siluriformes fish and fish products to the United States while FSIS 
undertakes an evaluation as to equivalency.
    Date of Full Enforcement (September 1, 2017): FSIS will fully 
enforce these regulations in domestic Siluriformes fish products and 
fish processing establishments. Foreign countries seeking to continue 
exporting Siluriformes fish and fish products to the United States upon 
full enforcement are required to submit their documentation showing 
equivalence by this date.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Assistant 
Administrator, Office of Policy and Program Development, FSIS, U.S. 
Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 
20250-3700, (202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Executive Summary

    The 2008 Farm Bill amended the Federal Meat Inspection Act (FMIA), 
to make ``catfish'' a species amenable to the FMIA and, therefore, 
subject to FSIS inspection. In addition, the 2008 Farm Bill gave FSIS 
the authority to define the term ``catfish.''
    On February 24, 2011, FSIS published a proposed rule that outlined 
a mandatory catfish inspection program and presented two options for 
defining ``catfish'': One option was to define catfish narrowly as 
those fish belonging to the family Ictaluridae. The other option was a 
broader definition, all fish of the order Siluriformes (76 FR 10434). 
FSIS sought public comments on the scope of the definition in the 
proposed rule. The Agency proposed regulatory requirements for 
mandatory catfish inspection that were adapted from the meat inspection 
regulations.
    The 2014 Farm Bill, enacted on February 7, 2014, amended the FMIA 
to remove the term ``catfish'' and to make ``all fish of the order 
Siluriformes'' subject to FSIS jurisdiction and inspection. As a 
result, FSIS inspection of Siluriformes is mandated by law. This final 
rule adopts all the regulatory requirements outlined in the February 
2011 proposal, with the following changes:
     The term ``catfish'' defined in proposed 9 CFR part 531 
and used throughout the proposed regulatory text, is replaced in this 
final rule by the term ``fish of the order Siluriformes,'' 
``Siluriformes fish,'' or simply ``fish,'' understood to mean, for 
purposes of the final regulations, any fish of the order Siluriformes.
     The retail store exemption includes, as an exempt retail 
operation, the slaughter of fish at retail stores or restaurants for 
consumers who purchase the fish at those facilities, and in accordance 
with the consumers' request.
     Fish with unusual gross deformities caused by disease or 
chemical contamination (rather than merely with gross deformities) are 
not to be used for human food (9 CFR 539.1(d)).
     The labeling regulations (9 CFR 541.7) permit the use of 
the term ``catfish'' only on labels of fish classified within the 
family Ictaluridae, consistent with provisions of the Federal Food, 
Drug, and Cosmetic (FD&C) Act (21 U.S.C. 321d (a) and 343(t)). Fish of 
the order Siluriformes, from families other than Ictaluridae, must be 
labeled with an appropriate common or usual name.
     The labeling regulations (9 CFR 541.7) require packages of 
Siluriformes fish and fish products that are not ready-to-eat to bear 
safe-handling instructions to include ``fish'' in the rationale 
statement, i.e., ``This product was prepared from inspected and passed 
fish, ''and in the labeling statements, i.e., ``Keep raw fish from 
other foods. Wash working surfaces (including cutting boards), 
utensils, and hands after touching raw fish.''
     The labeling regulations (9 CFR 541.7) to clarify that the 
labeling of fish covered commodities sold by a retailer bear country of 
origin and method of production information, in compliance with the 
requirements in 7 CFR part 60, subpart A, Country of Origin Labeling 
for Fish and Shellfish.
     The import inspection regulations for Siluriformes fish 
and fish products (9 CFR part 557) to make them consistent with the 
September 19, 2014, rule amending the FSIS regulations for imported 
meat, poultry, and egg products (79 FR 56220).
     The regulations include provisions for State-Federal, 
Federal-State Cooperate Agreements; State Designations (9 CFR part 560) 
and authorize coordination with States that have fish inspection 
programs to select certain establishments to participate in an 
interstate shipment program. These changes reference regulations that 
took effect after the proposed rule on catfish inspection was 
published. The regulations incorporate requirements for establishments 
to maintain written recall plans (9 CFR 532.2) and to notify the FSIS 
District Office of any adulterated or misbranded product that

[[Page 75591]]

the establishment has received or shipped in commerce (9 CFR 537.3). 
These changes reference regulations that took effect after the proposed 
rule on catfish inspection was published.
     The regulations on official marks and devices for 
identifying inspected-and-passed fish and fish products (9 CFR 
541.2(d)) require whole, gutted fish carcasses to bear the official 
inspection legend or to be properly packaged in an immediate container 
marked with the official inspection legend, as well as all other 
required labeling features.
     The preamble discussion explains that the net weight for 
ice-glazed fish is determined on a rigid-state basis, as provided in 
the National Institute of Standards and Technology (NIST) Handbook 133, 
``Checking the Net Contents of Packaged Goods.''
     The regulatory requirements in this final rule will be 
effective 90 days after its publication. FSIS will implement the 
regulatory requirements during an 18-month timeframe.
     In addition, during the 18-month transitional period, 
foreign countries are to begin submitting to FSIS documentation 
demonstrating the equivalency of their inspection systems for 
Siluriformes fish and fish products.
    The annualized cost to the Siluriformes fish domestic industry is 
$326.55 thousand.\1\ This would be an additional annualized average net 
direct cost to this domestic fish industry of about $0.0008 per pound 
of processed Siluriformes fish and Siluriformes products. For 
comparison, the average price received by domestic processors for 
domestic catfish (of the order Siluriformes) products was considerably 
greater at $3.04 per pound, in 2013. Furthermore, the additional 
annualized average direct cost to FSIS is $2,604.4 thousand. On the 
other hand, the decreased annualized average direct cost to FDA and to 
the U.S. Department of Commerce's (USDC) National Oceanic and 
Atmospheric Administration (NOAA)/National Marine Fisheries Service 
(NMFS) is $1,490 thousand because of this final rule. The net 
difference of these annualized average direct costs to these three 
Federal government agencies is $1,114.40 thousand. Therefore, the 
annualized (at 7 percent) average net direct cost to the Siluriformes 
fish domestic industry and to the three affected Federal government 
agencies is $1,440.95 thousand.
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    \1\ Annualized present value of average costs is at a 7 percent 
discount rate over 10 years.

   Table 1--Projected Summary Additional Annualized Average Net Direct
                   Costs (Domestic) of the Final Rule
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                                                         Additional
                                                      annualized cost,
                                                       over 10 years,
                                                         discounted
     Affected sectors of the domestic economy            $thousands
                                                   ---------------------
                                                        7          3
                                                     percent    percent
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Siluriformes Fish Industry........................    $326.55    $317.78
Federal Government Agencies.......................   1,114.40   1,097.22
                                                   ---------------------
  Total...........................................   1,440.95   1,414.99
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Table of Contents

Background
I. 2008 Farm Bill
II. 2011 Proposed Rule
III. 2014 Farm Bill
IV. Use of the Terms ``Catfish'' and ``Fish'' in Preamble Discussion
V. Scientific Classification (Taxonomy) of the Catfishes
VI. Current Inspection of Domestic and Imported Catfish
VII. Public Health Considerations: Potential Chemical and 
Microbiological Contaminants
VIII. Summary of Proposed and Final Regulatory Requirements
    A. Organization of Inspection Operations
    B. Definitions
    C. Establishments Requiring Inspection; Grant and Approval of 
Inspection
    D. Facility Requirements for Inspection
    E. Pre-harvest and Transfer to Processing Establishment
    F. Sanitation and Hazard Analysis Critical Control Point (HACCP) 
System Requirements for Processing Facilities
    G. Mandatory Dispositions; Performance Standards Respecting 
Physical, Chemical, or Biological Contaminants
    H. Handling and Disposal of Condemned and Inedible Materials
    I. Marks, Marking, and Labeling of Products and Containers
    1. Official Marks and Devices
    2. Labeling Requirements; Prior Approval of Labeling
    3. Prevention of False or Misleading Labeling Practices
    4. Net Weight and Retained Water
    5. Nutrition Labeling Regulations
    J. Food Ingredients Permitted
    K. Ready-to-eat and Canned Fish Products: Control of Listeria 
monocytogenes
    L. Canned Products
    M. Accredited Laboratories
    N. Standards of Identity and Composition
    O. Exports
    P. Transportation in Commerce
    Q. Imported Products
    R. Demonstrating Equivalence of Foreign Systems
    1. Program Administration
    2. Legal Authority and Requirements Governing Catfish and 
Catfish Products Inspection
    3. Document Evaluation and System Review
    4. Maintenance of Standards
    S. Marking and Labeling of Imported Products
IX. Proposed Regulations Under Other FMIA Subchapters
    A. Rules of Practice; Reference to Rules of Practice
    B. Detention, and Seizure and Condemnation
    1. Detention
    2. Seizure and Condemnation
X. Records Required To Be Kept
XI. Comments and Responses
    A. General Opposition
    B. The Definition of Catfish
    C. Risk Assessment
    D. Cost and Benefits Analysis
    E. Trade Barriers and Agreements
    F. Equivalency and Implementation
    G. Facilities Requirements and Schedule of Operations
    H. Definitions
    1. ``Adulterated''
    2. ``Slaughter'' and ``Slaughterhouse''
    3. ``Farm-raised'' and ``Wild-Caught''
    I. Labeling
    1. Mark of Inspection
    2. Species Identification and Prevention of False or Misleading 
Labeling Practices
    3. Standards of Identity
    4. Percent Approved Substances
    5. Net Weight and Retained Water
    6. Safe Handling Instructions
    7. Country of Origin Labeling
    J. Pre-harvest and Transport Conditions
    K. Pathogen Reduction and Tolerances for Animal Drugs
    L. Limits for Retail Quantities
    M. Hard Copy Information
    N. Other Comments
    1. Exemptions and Periodic Auditing
    2. Use of Program Seals
    O. Cooperation With States
    P. Outreach and Training
XII. FSIS Implementation
XIII. Executive Orders 12866 and 13563 and Regulatory Flexibility 
Act
    A. Need for the Rule
    B. Baseline
    C. Catfish Consumption and Prices
    D. Alternative Regulatory Approaches Considered
    E. Expected Costs of the Final Rule
    F. Costs to Foreign Entities
    1. Foreign Governments
    2. Foreign Establishments
    G. Associated Costs to U.S. Consumers
    H. Expected Budgetary Impacts on FSIS and Other Government 
Agencies
    I. Break-Even Analysis
    1. Possible Health Benefits Assessment Break-Even Analysis
    2. Health Benefits--Removing Adulterated Products From the 
Market
    J. Regulatory Flexibility Act Assessment
XIV. Paperwork Reduction Act
XV. E-Government Act
XVI. Executive Order 12988, Civil Justice Reform
XVII. Expected Environmental Impact
XVIII. Executive Order 13175, Indian Tribal Government
XIX. USDA Non-Discrimination Statement
XX. Additional Public Notification

[[Page 75592]]

Background

I. 2008 Farm Bill

    The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, 
Section 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)). Therefore, 
the 2008 Farm Bill placed catfish and catfish products under FSIS 
jurisdiction and inspection. The 2008 Farm Bill also 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 
and 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. In 
addition, the 2008 Farm Bill revised 21 U.S.C. 606, which requires the 
appointment of inspectors to examine and inspect all meat food products 
prepared for commerce and provided 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 (21 U.S.C. 606(a) and (b)).

II. 2011 Proposed Rule

    On February 24, 2011, FSIS published the proposed rule, ``Mandatory 
Inspection of Catfish and Catfish Products,'' (76 FR 10434). The 
regulations proposed to implement the provisions of the 2008 Farm Bill. 
The proposed rule's comment period closed on June 24, 2011, 90 days 
after its publication.
    In May 2011, FSIS held two public meetings, in Washington, DC, and 
Stoneville, MS, to discuss the proposed rule. At those meetings, FSIS 
provided an overview of the proposed rule and provided the public with 
an opportunity to comment on the proposed regulation. Transcripts of 
the public meeting are available on the FSIS Web site at http://www.fsis.usda.gov/wps/wcm/connect/eefd3e0d-ea69-4c75-b1ac-ea4df9d133e4/Transcripts_05242011_Catfish_meeting.pdf?MOD=AJPERES and http://www.fsis.usda.gov/wps/wcm/connect/ddb209ab-6aa3-4953-9514-70a8532d3348/Transcripts_05262011_Catfish_meeting.pdf?MOD=AJPERES.

III. 2014 Farm Bill

    On February 7, 2014, the Agricultural Act of 2014 (Pub. L. 113-79, 
Sec. 12106), known as the 2014 Farm Bill, amended Section 1(w) of the 
FMIA to remove the phrase ``catfish, as defined by the Secretary,'' and 
replace it with ``all fish of the order Siluriformes,'' thus including 
these fish among the amenable species under FSIS jurisdiction and 
inspection (21 U.S.C. 601(w)(2)). The 2014 Farm Bill also amended the 
2008 Farm Bill instructing FSIS, in consultation with the Food and Drug 
Administration (FDA), to issue final regulations to carry out the 
amendments in a manner that ensures no duplication in inspection 
activities. In addition, the 2014 Farm Bill instructed FSIS to execute 
a Memorandum of Understanding (MOU) with FDA to improve interagency 
cooperation and to maximize the effectiveness of personnel and 
resources by ensuring that inspections are not duplicative, and that 
any information from the examination, testing, and inspections is 
considered in making risk-based determinations, including the 
establishment of inspection priorities. The MOU between FSIS and FDA 
was signed on April 30, 2014, and can be found on the FSIS Web site at 
http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/food-safety-agencies/mou.
    This final rule issues regulations in response to the 2014 Farm 
Bill mandate. In addition, this final rule includes a summary of the 
major issues raised by comments to the 2011 proposed rule and FSIS's 
responses to the comments, including changes made to the proposed 
regulations in response to comments.

IV. Use of the Terms ``Catfish'' and ``Fish'' in Preamble Discussion

    For purposes of convenience, the preamble discussion in this final 
rule will use the terms ``catfish'' and ``catfish products'' where 
appropriate when discussing and referencing the 2011 Proposed Rule, 
since those terms were used in the proposal. The preamble discussion of 
the final rule amendments will use the terms ``fish of the order 
Siluriformes'', ``Siluriformes fish,'' or ``fish.''

V. Scientific Classification (Taxonomy) of the Catfishes

    As discussed in the proposed rule (76 FR 10435), in the taxonomy of 
the fishes, fish of the order Siluriformes include the Ictaluridae, the 
North American catfish, to which family belong the fork-tailed channel 
catfish (Ictalurus punctatus) and blue catfish (I. furcatus), the 
principal United States 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 (Ameiurus catus, synonym 
I. catus), and the black, brown, and yellow bullhead (A. melas, syn. I. 
melas, A. nebulosus, syn. I. nebulosus, and A. natalis, syn.I. 
natalis). Also among the Siluriformes are the air-breathing catfishes 
of the Clariidae family, to which belongs Clarias fuscus, a species 
raised in the United States on a small scale in Hawaii.
    Another family of Siluriformes, the Pangasiidae, the so-called 
``giant catfishes,''\2\ includes the aquaculture species basa 
(Pangasius bocourti) and tra or swai (Pangasius hypophthalmus; syn., 
Pangasius sutchi), raised principally in Southeast Asia for domestic 
consumption and export. Other Siluriformes fish species raised in Asia 
include the hybrid Clarias macrocephalus and North American channel 
catfish (I. punctatus) that are raised for export to the United States.
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    \2\ Integrated Taxonomic Information System (ITIS) report on 
``Siluriformes.'' At http://www.itis.gov.
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VI. Current Inspection of Domestic and Imported Fish

    As discussed in the proposed rule, U.S. catfish processors, 
exporters, and importers have been subject to the U.S. Food and Drug 
Administration's (FDA) seafood Hazard Analysis Critical Control Point 
(HACCP) regulations (21 CFR 123) and to other requirements under the 
Food, Drug, and Cosmetic (FD&C) Act (76 FR 10437). FDA's regulations on 
current good manufacturing practices (cGMPs, at 21 CFR 110) and on 
recordkeeping and registration requirements (21 CFR part 1, subparts H 
and J) also apply to those establishments.
    For imported fish and fishery products, FDA requires the importer 
to 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).
    In addition to the FDA regulations, some United States catfish 
processing establishments contract 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

[[Page 75593]]

regulations (50 CFR part 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 
part 260). The three levels are: (1) A resident inspection program, 
which provides 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 assurance program is enhanced to meet the ISO 
9001 quality management standards.

VII. Public Health Considerations: Potential Chemical and 
Microbiological Contaminants

    As discussed in the proposed rule, because catfish of domestic or 
foreign origin may be exposed to chemical and microbiological 
contaminants, FSIS considered the food safety issues that might be 
presented by catfish in planning its regulatory approach (76 FR 10438).
    In the Hazard Identification section of its risk assessment, 
Assessment of the Potential Change in Human Health Risk Associated with 
Applying Inspection to Fish of the Order Siluriformes, the Agency 
discussed the three main classes of chemical residues identified in 
some domestic and foreign catfish--heavy metals, pesticides, and 
antimicrobials and the adverse health effects that have been associated 
with those chemicals. The assessment also summarized the results of 
FSIS, Agriculture Marketing Service (AMS) and FDA testing of the fish 
for these residues (76 FR 10438). The test results showed that, while 
catfish may not frequently harbor residues of illegal drugs or 
violative concentrations of other chemicals, the potential exists for 
such contamination. For example, 9% and 2% of imported catfish tested 
for malachite green and gentian violet, respectively, tested positive 
for those banned chemicals. Because some shipments of imported catfish 
have been found with residues of drugs that FDA has banned and that are 
unsafe, FSIS proposed to conduct regular residue sampling, as it does 
for imported meat products, to ensure the safety of imported catfish 
products (9 CFR 557.6(a)(3)).
    For microbial pathogens in catfish, the hazard identification 
component of the FSIS catfish risk assessment \3\ 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 (76 FR 10439).
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    \3\ 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 (as referenced in 
the proposed rule).
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    FSIS conducted an assessment of the potential risk to human health 
from consumption of fish of the order Siluriformes, using the example 
of Salmonella contamination. The Agency was particularly interested in 
Salmonella because the bacteria are the most frequently reported cause 
of foodborne illness in the United States. From a public health 
perspective, even a small decrease in the percentage of an illness that 
affects a large number of people can have a substantial effect of 
decreasing illness, and thus, improve public health. According to the 
Centers for Disease Control and Prevention (CDC), salmonellosis causes 
an estimated 1.4 million cases of foodborne illness and more than 400 
deaths annually in the United States.\4\ In addition, CDC lists catfish 
as the vehicle in at least one outbreak of human salmonellosis may have 
been related to catfish consumption.\5\ Salmonella is a useful model 
because its presence provides an indication of the sanitary conditions 
under which food is produced and, if considering illnesses rather than 
raw product, the way it is prepared. In addition, an approach that 
produces a reduction in Salmonella through improved process control can 
be effective in controlling for the presence of other microbial 
pathogens.\6\
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    \4\ Scallan, et al. Emerging Infectious Diseases, Vol. 17, No. 
1. January 2011.
    \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 (as referenced in 
the proposed rule).
    \6\ 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.
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    FSIS invited all interested stakeholders to submit additional data 
and scientific evidence specific to catfish food safety. USDA also 
sought public comment on the evidence regarding the public health 
benefits and cost-effectiveness to be achieved with the proposed 
program (76 FR 10440). FSIS received comments on these issues and its 
responses are included in Comments and Responses (Section XI), below.
    The FSIS risk assessment has been modified to move the hazard 
identification section to the body of the risk assessment document. In 
addition, an Addendum has been added to the risk assessment, which: (1) 
Summarizes potentially relevant research studies published since the 
draft risk assessment was conducted; (2) provides an update from CDC's 
outbreak database, stating that it does not indicate that any 
additional outbreaks have occurred recently; and (3) updates data on 
the results of analyses of pesticides from the Agricultural Marketing 
Service's Pesticide Data Program. The updated risk assessment (December 
2014) is posted on the FSIS Web site at: http://www.fsis.usda.gov/wps/wcm/connect/63387be5-ca8e-442d-b047-f031f29a8a47/Silurifomes-RA.pdf?MOD=AJPERES

VIII. Summary of Proposed and Final Regulatory Requirements

    FSIS proposed regulatory requirements for the inspection of catfish 
and catfish products adapted from the appropriate meat inspection 
regulations that prevent 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 ``meat'' (cattle, sheep, swine, 
goats, horses, mules or other equines), FSIS proposed some separate 
regulations for catfish establishments and products. In many cases, 
FSIS proposed to reference the existing regulations for meat and meat 
food products as applying to catfish.

A. Organization of Inspection Operations

    In general, the proposed regulations paralleled 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 the inspection in 
proposed 9 CFR 530.2, FSIS made it clear in proposed 9 CFR 530.3, that, 
as provided in 9 CFR 300.6, persons that are subject to the FMIA, as 
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

[[Page 75594]]

the catfish processing industry (for example, fish farms, fish 
hatcheries, fish feed mills, live-fish catchers/loaders and haulers, 
distributors, and brokers) (76 FR 10440).
    FSIS did not make any changes in the final regulations to the 
inspection operations provisions or to the access Agency or Department 
personnel have to establishments.

B. Definitions

    In proposed 9 CFR part 531, FSIS used the same definitions for the 
catfish inspection regulations as the meat inspection regulations (9 
CFR 301.2). The Agency proposed to add definitions for ``catfish,'' 
``catfish byproduct,'' ``catfish food product,'' ``catfish product,'' 
``farm-raised,'' and some other terms (76 FR 10441). The ante-mortem 
inspection, post-mortem inspection, and humane slaughter provisions of 
the amended FMIA do not apply to catfish, therefore, the Agency did not 
propose definitions for slaughtering methods. FSIS specifically 
requested comment on whether the term ``slaughter'' should be defined.
    The Agency received comments on some of the proposed regulatory 
definitions but, as explained in the Comments and Responses (Section 
XI) below, determined that it was not necessary to make changes to 
these definitions. The Agency received numerous comments on the 
``catfish'' species definition. However, as provided by the 2014 Farm 
Bill, FSIS has jurisdiction over all fish of the order Siluriformes. In 
this final rule, 9 CFR part 531 has been amended to delete the term 
``catfish,'' and its definition, and replace it with ``fish,'' defined 
as ``any fish of the order Siluriformes, whether live or dead.''

C. Establishments Requiring Inspection; Grant and Approval of 
Inspection

    In proposed 9 CFR part 532, FSIS identified the classes of catfish 
establishments that require inspection and outlined the requirements to 
qualify for a grant of inspection and the application procedures. FSIS 
also cross-referenced 9 CFR parts 305 and 306, on the assignment of 
establishment numbers and the assignment and authorities of FSIS 
personnel.
    As discussed in the proposed rule, the amended FMIA did not provide 
an exemption from inspection for custom catfish slaughter and 
processing facilities. FSIS did however, propose to provide an 
exemption for retail stores and restaurants in proposed 9 CFR 532.3 
(under 21 U.S.C. 661(c)(2), that parallels 9 CFR 303.1(d) and (e). FSIS 
also proposed exemptions for individual household (single-sale) 
purchases and non-household consumers based on the poultry exemptions 
in 9 CFR 381.10. FSIS solicited comment on the limits on retail sales 
to household or non-household consumers.
    In proposed 9 CFR 532.4, the Agency asserted 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 in proposed 9 CFR 532.4.
    In addition, the Agency proposed in 9 CFR 532.5 to exempt from 
inspection articles that do not contain a minimum amount of catfish (3 
percent raw or 2 percent cooked catfish) or are historically not 
regarded by consumers as products of the catfish food products 
industry.
    FSIS received a comment on the proposed limits on retail sales, 
discussed in Comments and Responses (Section XI) below. The Agency did 
not make any changes to the purchase quantity limits in the final 
regulations. However, in response to a comment on exemptions, the 
Agency has added language (in 9 CFR 532.3) defining as an exempt retail 
operation, the slaughter, by the operator of a retail store or 
restaurant, of live fish purchased by a consumer at the retail store or 
restaurant for the consumer and at the consumer's instructions.

D. Facility Requirements for Inspection

    In proposed 9 CFR part 533, FSIS set forth facility requirements 
for catfish processing establishments. The regulations proposed 
requirements for office space and furnishings for program employees, 
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. FSIS also proposed that 
establishments have to provide adequate facilities for the receipt and 
inspection of catfish and catfish products. The final regulations are 
consistent with those proposed.
    Under this final rule, FSIS will approve operating schedules for 
fish establishments (9 CFR 533.5) just as it does for official meat 
establishments. FSIS received comments on schedule of operations and 
addressed the comments in the Comments and Responses (Section XI), 
below. The final regulations are consistent with those proposed.

E. Pre-Harvest and Transport To Processing Establishment

    In proposed 9 CFR part 534, FSIS outlined the pre-harvest standards 
to be applied to catfish to ensure that the environmental conditions 
and source waters in which the catfish are grown will not render them 
unfit for food. FSIS also proposed general standards for the 
transportation of catfish to the processing plant. As discussed below, 
FSIS received comments on pre-harvest and transport issues and is 
clarifying comments raised in the responses to comments section below. 
However, the final provisions are consistent with those proposed.

F. Sanitation and Hazard Analysis and Critical Control Point (HACCP) 
System Requirements for Processing Facilities

    In proposed 9 CFR part 537, FSIS proposed to require that any 
official establishment that prepares or processes catfish or catfish 
products for human food comply with all of the sanitation requirements 
in 9 CFR part 416 and the HACCP requirements in 9 CFR part 417. In this 
final rule, FSIS is adopting 9 CFR part 537, which requires 
Siluriformes fish establishments to comply with the HACCP and 
sanitation requirements.

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

    In proposed 9 CFR part 539, FSIS listed the diseases or other 
conditions that would lead to condemnation of catfish carcasses or 
parts affected upon inspection. FSIS requested comment on the extent to 
which infection should result in condemnation and on whether there are 
other conditions found in catfish that require such disposition. FSIS 
received general comments to the effect that diseases should not 
automatically render catfish adulterated as discussed in Comments and 
Responses (Section XI) below. FSIS has not changed the proposed 
regulations in response to these comments. However, in section 539, for 
greater precision than in the proposed rule, FSIS is stating that 
``unusual gross deformities caused by disease or chemical 
contamination'' may not be used for human food.

H. Handling and Disposal of Condemned and Inedible Materials

    In 9 CFR part 540, FSIS proposed to require that a processor 
prevent catfish that have died otherwise than by slaughter from 
entering the official establishment. FSIS explained (in proposed 9 CFR 
540.1(b)) that the establishment would have to maintain physical 
separation between slaughtered catfish and those that died otherwise

[[Page 75595]]

than by slaughter to prevent commingling of edible and inedible product 
(76 FR 10444). In addition, FSIS explained that all condemned or 
otherwise inedible catfish parts would have to be conveyed from the 
official premises for further disposition at a rendering plant or other 
facility that handles inedible products. FSIS received some comments on 
these requirements, as discussed in Comments and Responses (Section XI) 
below; however, the Agency did not change the proposed provisions in 
response to the comments.

I. Marks, Marking, and Labeling of Products and Containers

1. Official Marks and Devices
    FSIS proposed to use certain official marks, devices, and 
certificates for the purpose of identifying inspected and passed 
catfish and catfish products and their status (9 CFR 541.1 through 
541.5).
    The Agency proposed in 9 CFR 541.2(a) to provide for an official 
inspection legend containing the number of the official establishment, 
and that the form of the official inspection legend will be that for 
meat products (9 CFR 312.2(b)(1)), or another form that the Agency 
would prescribe. FSIS requested comments and suggestions on alternative 
forms. There were no comments on the form of the official inspection 
legend. Therefore, the Agency is requiring 9 CFR 541.1 that the 
official inspection legend for fish and fish products be in the form of 
the meat products inspection legend (9 CFR 312.12) or another form 
determined by the Administrator to provide flexibility for future 
innovations in marking of product.
    FSIS proposed to require that whole, gutted catfish carcasses, 
inspected and passed at an official establishment and intended for sale 
as whole, gutted catfish, be marked or labeled with the official 
inspection legend containing the number of the establishment at the 
time of inspection (9 CFR 541.2(d)). The Agency requested comment on 
whether the marking is necessary, the form of the mark that would be 
satisfactory, and how the mark should be applied. FSIS received 
comments that applying the mark of inspection to all carcasses of 
whole, gutted fish may be impractical because of the size of the 
product. As discussed in the Comments and Responses (Section XI) below, 
the Agency recognizes that it may be impractical to physically apply 
the inspection legend to whole, gutted fish carcasses. Therefore, in 
this final rule, 9 CFR 541.2(d) provides that whole, gutted fish 
carcasses that have been inspected and passed at an official 
establishment, and that are intended for sale as whole, gutted catfish, 
must be stamped with the official inspection legend or properly 
packaged in an immediate container labeled with the official inspection 
legend, as well as all other required labeling features.
    All other official marks and devices labeling regulations (9 CFR 
541.1 through 541.5) are finalized without change.
2. Labeling Requirements; Prior Approval of Labeling
    The Agency proposed (9 CFR 541.7) to apply to catfish and catfish 
products many of the general meat labeling and label approval 
requirements in 9 CFR part 317, subpart A. The proposed labeling 
regulations govern 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. In the proposed rule, the Agency specifically noted that 
processors of catfish and catfish products will be able to use 
generically approved labeling if it meets the generic labeling 
requirements in 9 CFR 317.5 (76 FR 10445).
    As discussed in the Comments and Responses (Section XI) below, the 
final provisions in 9 CFR 541.7 include a paragraph (c), which modifies 
the safe handling instructions to make the rationale statement read, 
``This product was prepared from inspected and passed fish,'' and the 
labeling statements read, ``Keep raw fish from other foods. Wash 
working surfaces (including cutting boards), utensils, and hands after 
touching raw fish.''
    In addition, on November 7, 2013, FSIS published the final rule, 
``Prior Label Approval System: Generic Label Approval'' (78 FR 66826). 
In that final rule, the Agency consolidated the meat and poultry label 
approval regulations into a new part, 9 CFR part 412, Label Approval. 
Therefore, in this final rule, 9 CFR 541.7 includes a paragraph (g) 
that references 9 CFR 412 for label approval.
    This rule adopts the other proposed labeling and label approval 
regulations in 9 CFR 541.7 without change.
3. Prevention of False or Misleading Labeling Practices
    In the preamble of the proposed rule (76 FR 10445), FSIS explained 
that under its 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, work 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. In addition, 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).
    The Agency explained that 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). FSIS proposed that all these requirements, which apply to meat 
and meat food products, would apply to catfish and catfish products 
under the proposed rule (9 CFR 541.7(a)).
    In the preamble discussion on preventing false or misleading 
labeling practices, the Agency stated that, after a fish is processed, 
it is a major challenge for regulators and industry to visually 
identify the species of fish (76 FR 10445). 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 was considering various technological means to verify 
catfish species. The Agency requested comment and suggestions on 
species verification methods that the Agency might use.
    The Agency received several comments on the methods of speciation 
and country of origin labeling. The responses to these comments are 
discussed in the Comments and Responses (Section XI) below. This rule 
finalizes the prevention of false or misleading labeling regulations in 
9 CFR 541.7(a) (consistent with 9 CFR 317.8, 317.12, and 317.13 
specifically) and adds 9 CFR 541.7(b) to correct the reference to the 
AMS regulations for the country of origin labeling for fish (7 CFR, 
part 60, subpart A).
    In addition, under the Federal Food, Drug, and Cosmetic (FD&C) Act 
(21 U.S.C. 321d (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 only labeling or advertising for fish

[[Page 75596]]

classified within that family may include the term ``catfish.'' Also, a 
food is misbranded 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)). Therefore, in this final rule, FSIS has revised proposed 9 CFR 
541.7 to require that the term ``catfish'' be used only on labels and 
in labeling of fish within the family Ictaluridae and the products of 
those fish.
    The Agency is also requiring in 9 CFR 541.7 that fish and fish 
products in all other families in the order Siluriformes be labeled 
with appropriate common or usual names. Domestic and foreign fish 
establishments should consult FDA's ``Guidance for Industry: The 
Seafood List--FDA's Guide to Acceptable Market Names for Seafood Sold 
in Interstate Commerce,'' for appropriate common or usual names (http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm113260.htm.
4. Net Weight and Retained Water
    As discussed in the preamble, FSIS's labeling regulations on net 
weight of meat products incorporates by reference the National 
Institute of Standards and Technology's (NIST) Handbook 133 (76 FR 
10445). The Agency also explained that the net weight of catfish 
presents a specific challenge because of the frequent and varying use 
of ice-glazing to preserve the freshness of the product (76 FR 10445). 
The Agency proposed that packages of fresh or fresh-frozen catfish or 
parts must be labeled to reflect 100-percent net weight after thawing 
(9 CFR 541.7(b)(1)).
    To regulate the net weight for raw catfish products, FSIS proposed 
in 9 CFR 541.7(b) to apply the requirements for control of retained 
water from processing in raw meat and poultry products through 9 CFR 
part 441. Retained water--water remaining in raw product after it 
undergoes immersion chilling or a similar process--would not be 
permitted unless the official establishment could show that the 
retained water is an unavoidable consequence of the process (9 CFR 
441.10(a)). The establishment would have to label its product to state 
the maximum percentage of retained water.
    In response to comment, discussed further in Comments and Responses 
(Section XI) below, the Agency is clarifying that, according to NIST 
Handbook 133 net weight test procedures for ice-glazed fish products 
are ``deglazed'' by placing the product under a gentle spray of cold 
water, and the product should remain rigid. However, as proposed, the 
NIST Handbook 133, net weight test procedures for frozen or fresh-
frozen fish are determined on a thawed basis. The proposed net weight 
and retained water labeling regulations in 9 CFR 541.7 are adopted 
without change.
5. Nutrition Labeling Requirements
    In 9 CFR 541.7(c), the Agency proposed, under the FMIA (21 U.S.C. 
601(n)(1), 621) to apply the nutrition labeling requirements to catfish 
and catfish products that are not raw, single-ingredient products. The 
Agency received no comments on this provision, and it is adopted as 
proposed.

J. Food Ingredients Permitted

    FSIS proposed in 9 CFR part 544 to apply to catfish products the 
requirements in 9 CFR part 424 prohibiting a product from bearing or 
containing any food ingredient that would render it adulterated or 
misbranded.
    As discussed in the proposed rule, FSIS will make determinations on 
the safety and suitability of uses of food ingredients for Siluriformes 
products in consultation with FDA, as it does for all food ingredients 
(76 FR 10446). FSIS compiles safe and suitable uses, including limits 
and conditions of use, of food ingredients in these products and makes 
the information available in an instruction to its inspection force in 
FSIS Directive 7120.1. This directive is regularly updated and 
published on the Agency's Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/directives/7000-series. This final rule 
adopts the requirement as proposed.

K. Ready-to-Eat and Canned Fish Products: Control of Listeria 
monocytogenes

    As discussed in the proposed rule (76 FR 10446), ready-to-eat (RTE) 
catfish products, such as smoked catfish, would have to comply with 
appropriate performance standards if they are not to be considered 
adulterated under the FMIA (21 U.S.C. 601(m)). FSIS proposed to make 
post-lethality-exposed catfish products subject to the requirements in 
9 CFR part 430 (proposed 9 CFR 548.6). An RTE catfish product would be 
considered 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. The Agency is adopting this 
provision as proposed.

L. Canned Products

    As discussed in the proposed rule, FSIS is not aware of any canned 
catfish products processed in the U.S., but canned catfish soups are 
imported into this country (76 FR 10446). FSIS proposed (9 CFR 548.6) 
that any domestic canned catfish products that an official 
establishment manufactures will be subject to requirements similar to 
those for canning and canned meat products (9 CFR 318.300-318.311). As 
explained in the proposed rule, imported canned catfish products would 
have to be prepared under requirements that are equivalent to those 
applying to domestic products. FSIS is adopting this provision as 
proposed.

M. Accredited Laboratories

    FSIS proposed that catfish processing establishments, like other 
official establishments, may use a non-Federal analytical laboratory 
that meets the accreditation requirements in 9 CFR 439 instead of an 
FSIS laboratory to analyze official regulatory samples (proposed 9 CFR 
548.9). The Agency is adopting proposed 9 CFR 548.9 as final, without 
changes.

N. Standards of Identity and Composition

    In the preamble to the proposed rule, FSIS requested comment on 
whether the Agency should promulgate any standards of identity or 
composition for catfish products (76 FR 10446). The Agency received 
comments on catfish standards of identity, as discussed in Comments and 
Responses (Section XI) below, but is not promulgating standards of 
identity or composition in this final rule.

O. Exports

    The Agency proposed (9 CFR part 552) to adopt requirements for 
exported catfish and catfish products that are similar to those that 
apply to meat articles by cross-referencing the provision of 9 CFR part 
322. There are no changes to the proposed regulations in this final 
rule.

P. Transportation in Commerce

    FSIS proposed in 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. As discussed in the proposed rule, 
a transport conveyance intended to carry catfish products would be 
subject to FSIS inspection to determine its sanitary condition (76 FR 
10447). FSIS also explained that

[[Page 75597]]

products on an insanitary vehicle would have to be removed and either 
handled in accordance with the regulations on mandatory dispositions or 
on the handling of condemned and inedible materials (9 CFR part 539 or 
part 540).
    The Agency also discussed that it had 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 (9 CFR 555.3-555.8). The proposed regulations addressed 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. The Agency is adopting these proposed 
regulations as final.

Q. Imported Products

    As FSIS discussed in the proposed rule, under the FMIA, the 
provisions of the act governing imports apply to catfish and catfish 
products (76 FR 10447). FSIS proposed to apply the requirements for the 
inspection of imported meat products to imported catfish products (9 
CFR part 557, referencing 9 CFR part 327). Under the proposed rule and 
final rule, FSIS would have to find that the system of fish inspection 
maintained by any foreign country, with respect to establishments 
preparing products in such country for export to the United States, 
insures compliance of the establishments and their products with 
requirements equivalent to the inspection and other requirements of the 
FMIA and the regulations that implement it in the United States. When 
the Agency determines that a foreign country's inspection system for 
fish is equivalent to that operated by FSIS, the Agency would publish a 
proposed rule to list the country in the regulations as eligible to 
export Siluriformes fish and fish products to the U.S., and would 
provide an opportunity for public comment. Should the Agency decide to 
list the country's system as equivalent, FSIS would respond to comments 
in the final rule and list the name of the country in the regulations 
(9 CFR 557.2(b)). FSIS is adopting these proposed requirements as 
final, except for terminology changes to reflect that they apply to 
fish in the order Siluriformes.
    On September 19, 2014, FSIS published a final rule (79 FR 56220) 
amending its regulations for imported meat, poultry, and egg products 
to provide, among other things, for use of the Agency's electronic 
Public Health Information System (PHIS) import component. In addition 
to providing for the PHIS import component, the final rule deleted 
overly prescriptive formatting and narrative requirements for foreign 
establishments and inspection certificates, required additional 
information on the certificates, and made the requirements the same for 
imported meat, poultry, and egg products. The regulations in 9 CFR part 
557 adopted by this final rule on Siluriformes inspection reflect the 
amendments to accommodate the use of PHIS.

R. Demonstrating Equivalence of Foreign Systems

    FSIS proposed that countries will need to demonstrate that their 
inspection systems are equivalent to the U.S. system in the following 
respects:
    (1) Program administration. Under proposed 9 CFR 557.2 (referencing 
9 CFR 327.2) the foreign program for catfish would 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 (9 CFR 327.2(a)(2)(i)(B)). Qualified, competent 
inspection personnel must be employed in the food safety system (9 CFR 
327.2(a)(2)(i)(C)). National inspection officials would have to 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 would have to be adequate administrative and 
technical support and inspection, sanitation, quality, 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)). FSIS is adopting these requirements as proposed.
    (2) Legal authority and requirements governing catfish and catfish 
products inspection. Under proposed 9 CFR 557.3, to be considered 
eligible to export catfish products to the United States, foreign 
countries would 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)). In countries where 
catfish producers use floating cages on rivers and ``raceway ponds'' 
that are filled and emptied by the continuous flow of water from nearby 
rivers, under the proposed rule, the water quality, residue, and other 
standards would have to be equivalent to those applying to catfish 
raised in the United States.
    Also, under the proposed rule, eligible foreign countries would 
have to establish standards for, and maintain 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 
would need to be maintained throughout all certified establishments (9 
CFR 327.2(a)(ii)(E)). The country's requirements would 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)(ii)(F)-(I)).
    (3) Document evaluation and system review. Under the proposed rule, 
foreign countries seeking eligibility to export catfish and catfish 
products into the United States (9 CFR 557.2(a)) would also have to 
present to FSIS copies of laws, regulations, and other information 
pertaining to their system of catfish product inspection, just as 
countries now do when they seek eligibility to export products of other 
species amenable to the FMIA. FSIS estimates that it would take 
approximately 3 months per submission to evaluate this documentation. 
FSIS would determine 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 would 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 that FSIS 
eventually determines to be eligible to export catfish and catfish 
products into the United States would have to provide for periodic 
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 would have to be available 
to FSIS. The foreign program would 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 sampling and analytical techniques 
approved by FSIS (9 CFR 327.2(a)(2)(iv)(C)). The residue testing would 
have to be conducted on samples from catfish intended for export to the 
United States.
    Once FSIS has determined that countries maintain equivalent

[[Page 75598]]

inspection systems, only certified foreign catfish establishments, that 
is, establishments that foreign program officials have certified as 
complying with the requirements equivalent to United States 
requirements, would be eligible to export their catfish products to the 
United States. If FSIS found that a foreign establishment is not in 
compliance with United States requirements for imported products, FSIS 
would terminate the eligibility of the establishment. FSIS would 
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)).
    This final rule adopts these proposed regulations without change. 
However, to provide foreign countries with adequate time to transition 
to the final regulations, on the date that the rule becomes effective, 
March 1, 2016, foreign countries seeking to continue exporting 
Siluriformes fish and fish products to the United States during the 18-
month transitional period are permitted to do so, provided they submit 
(1) the list of establishments (with the establishment name and number) 
currently exporting Siluriformes fish and fish products to the United 
States and (2) adequate documentation demonstrating that the foreign 
country currently has laws or other legal measures in place that 
provide authority to regulate the growing and processing of fish for 
human food and to assure compliance with the Food and Drug 
Administration's (FDA) regulatory requirements in 21 CFR part 123, Fish 
and Fishery Products, which include requirements for good manufacturing 
practices, Hazard analysis and Hazard Analysis Critical Control Point 
(HACCP) plans, and sanitation control procedures. This initial 
documentation will not be used to establish equivalency.
    By the end of the 18-month transitional period, foreign countries 
seeking equivalency must submit documentation showing that they have 
systems for inspection of Siluriformes fish and fish products 
equivalent to FSIS's system. A country can continue to export fish 
products to the United States after the 18-month transitional period, 
if the country has submitted its documentation on equivalency by the 
start of full enforcement of this rule, September 1, 2017. See Section 
XII., ``FSIS Implemention,'' for more details.

S. Marking and Labeling of Imported Products

    The proposed regulations (9 CFR 557.14 and 557.15) reference the 
meat regulations (9 CFR 327.14 and 327.15) requiring the marking and 
labeling of immediate and outside containers of imported catfish and 
catfish products. There are no changes to these proposed regulations in 
this final rule.

IX. Proposed Regulations Under Other FMIA Subchapters

A. Rules of Practice; Reference to Rules of Practice

    FSIS proposed to apply its rules of practice (9 CFR part 500) in 
enforcing the proposed catfish inspection regulations (proposed 9 CFR 
561.1). Also, FSIS proposed 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. There are no changes to the proposed regulations in this 
final rule.

B. Detention, and Seizure and Condemnation

1. Detention
    FSIS proposed to 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 (proposed 9 CFR 559.1, referencing 9 CFR 329.1-
329.6). This final rule adopts these proposed regulations without 
change.
2. Seizure and Condemnation
    FSIS proposed 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. There are no changes to the proposed regulations in this 
final rule.

X. Records Required To Be Kept

    In proposed 9 CFR part 550, FSIS proposed to require persons and 
firms involved in processing, buying and selling, or rendering catfish 
or catfish products to keep records on their activities respecting 
catfish sold, transported, or offered for sale or transport, in 
commerce. The records they would be required to keep include sales 
records or invoices, shippers' certificates and required permits, 
records of seal numbers used in the sealed transport of inedible 
products, guaranties provided by suppliers of packaging materials, 
canning records as required by 9 CFR part 318, subpart G, nutrition 
labeling records, and records of all labeling, along with the 
formulation and processing procedures. In addition, the Agency proposed 
that persons and firms covered by the recordkeeping requirements would 
have to register with the FSIS Administrator, and asked for comment on 
a proposed time frame for completing this registration (76 FR 10449).
    FSIS also stated that it would require each official establishment 
to provide accurate information to FSIS employees so that they could 
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 (76 FR 10449). The Agency 
proposed that the operator of each establishment report quarterly on 
the number of pounds of catfish processed. The report has to be filed 
within 15 days after the end of each quarter. The establishment 
operator would also have to file other reports as FSIS might require 
from time to time under the FMIA (9 CFR 550.6).
    In addition, FSIS proposed to require that a consignee who refuses 
to accept delivery of a product bearing the mark of inspection because 
it is adulterated or misbranded notify the Inspector-in-Charge of the 
kind, quantity, source, and present location of the product (9 CFR 
550.7).
    There are no changes to the proposed regulations in this final 
rule.

XI. Comments and Responses

    FSIS received approximately 4,335 comments on the proposed rule. 
About 4,000 of the comments were form letters submitted as part of a 
write-in campaign initiated by a consumer advocacy organization. FSIS 
also received a separate petition signed by 41 private citizens, and a 
joint submission from 16 food and agricultural organizations and

[[Page 75599]]

companies. Almost all of the remaining comments were from private 
citizens; domestic and foreign catfish farmers; trade groups and 
associations representing the catfish and seafood industry (processing, 
manufacturing, storage, and distribution); the catfish processing 
industry; consumer advocacy groups; members of U.S. Congress; foreign 
government ministries of agriculture and rural development; foreign 
chambers of commerce; trade associations representing retail and 
restaurant industries; aquaculture industry advocacy associations; 
public policy organizations; U.S. State and county officials; 
aquaculture scientists; members of academia; restaurant consortiums; a 
foreign government; an organization of U.S. regulatory officials; and a 
small business advocacy association. The Agency's responses to comments 
on major issues concerning the proposed rule are discussed below.

A. General Opposition

    Comment: Some comments opposed the transfer of jurisdiction over 
catfish and catfish products to FSIS for a variety of reasons. The 
comments generally expressed the concern that the proposal was 
unnecessary, wasteful, unjustified, or redundant. Several commenters 
stated that both FDA and FSIS will regulate the same product. Many 
commenters also stated that FDA's current regulatory approach ensures 
the safety of domestically produced and imported seafood products, and 
that the catfish industry has a demonstrated track record of food 
safety.
    Response: Under the 2008 Farm Bill, FSIS was required to develop 
regulations, in consultation with FDA, to implement FSIS inspection of 
``catfish,'' as defined by its regulations. Under the 2014 Farm Bill, 
which amended the 2008 Farm Bill, all fish of the order Siluriformes 
are amenable species under the jurisdiction of FSIS. The 2014 Farm Bill 
requires FSIS to develop final regulations in consultation with FDA. 
FSIS consulted FDA during development of these final regulations. The 
legislation also requires FSIS and FDA to execute a Memorandum of 
Understanding (MOU) to improve interagency cooperation on food safety 
and fraud prevention and to maximize the effectiveness of limited 
personnel and resources. FDA and FSIS have agreed on this MOU. It is 
posted at http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/food-safety-agencies/mou.

B. The Definition of Catfish

    Comments: Many comments representing domestic groups, individuals, 
and numerous comments from members of the U.S. Congress, urged FSIS to 
define catfish as all species in the order Siluriformes, the broader 
definition. The commenters stated that the broader definition affords 
the greatest food safety protection for the entire ``catfish'' category 
of seafood; it is consistent with the science of taxonomy; and it would 
include all imported catfish.
    Foreign governments, foreign ministries of agriculture, foreign 
catfish farmers, and foreign industries supported defining catfish as 
only fish of the Ictaluridae family, stating that this definition is 
the current FDA regulatory definition, adopted by Congress in the 2002 
Farm Bill (21 U.S.C. 321d (a)), and that it would provide consistency 
and eliminate confusion among seafood exporters.
    Response: The 2014 Farm Bill settled this issue. It amended the 
FMIA to give FSIS jurisdiction over all establishments that slaughter 
or process ``all fish of the order Siluriformes.'' Many Siluriformes 
fish species are produced in foreign countries and are exported to the 
United States. To be eligible to be imported into the U.S., these 
products will have to be produced under inspection systems equivalent 
to the U.S. system and will be subject to reinspection in the U.S.
    For labeling or advertising purposes, the FD&C Act provides that 
the term ``catfish'' can only be used in labeling of fish classified 
within the family Ictaluridae. By removing the term ``catfish'' from 
the FMIA and using the term ``certain fish'' in its stead, Congress 
left FSIS free to use the FD&C Act's definition of ``catfish.'' 
Therefore, in this final rule, FSIS is modifying the labeling 
regulations that it proposed to permit the use of the term ``catfish'' 
only on labels of fish from the Ictaluridae family. Siluriformes fish, 
which includes families in addition to Ictaluridae, will need to be 
labeled with the appropriate common or usual name.

C. Risk Assessment

    Comments: Many comments asked for additional evidence to support 
the shift in jurisdiction for catfish and catfish products from FDA to 
FSIS. The comments also stated that the products of aquaculture are 
rarely involved in outbreaks of salmonellosis. Comments from a foreign 
government, a foreign country's chamber of commerce, members of the 
seafood industry, and trade policy organizations asked FSIS to explain 
how the proposed rule was consistent with its World Trade 
Organization's (WTO) Sanitary and Phytosanitary Measures (the ``SPS 
Agreement'') obligations. A domestic catfish processor expressed the 
need for a risk assessment associated with chemical contamination of 
catfish aquaculture based on the constantly changing quality of river 
water.
    Response: It is important to note that the risk assessment was not 
conducted ``to support the shift in jurisdiction for catfish and 
catfish products from FDA to FSIS.'' FSIS conducted a quantitative food 
safety risk assessment, in accordance with national and international 
guidelines, that included all four components of a standard risk 
assessment: (1) Hazard Identification, (2) Exposure Assessment, (3) 
Hazard Characterization, and (4) Risk Characterization. FSIS thoroughly 
reviewed the scientific literature and garnered input from scientists 
from other Federal agencies and academia in performing the Hazard 
Identification portion of the risk assessment. The risk assessment was 
also independently peer-reviewed in accordance with the Office of 
Management and Budget's Peer Review Guidelines, as required under the 
Information Quality Act (Pub. L. 106-554). The purpose of the risk 
assessment was to provide predictions of the public health benefits 
(e.g., reduction in foodborne illnesses) that might accompany the 
implementation of a mandatory inspection system. The risk assessment 
identified Salmonella as a hazard of primary concern because: (1) It is 
the foodborne pathogen associated with catfish (McCoy et. al., Journal 
of Food Protection 74(3):500-16, 2011); (2) there was more available 
data for assessing the risk of human illnesses associated with 
Salmonella and assessing the effectiveness of an FSIS regulatory 
strategy for this hazard; (3) its occurrence in domestic catfish 
processing facilities and retail catfish is documented; (4) its 
presence in catfish imported to the United States is documented; and 
(5) CDC identifies catfish as the vehicle associated with a 1991 
outbreak of Salmonella hadar.
    The estimates for human salmonellosis cases associated with catfish 
consumed in the United States (under current inspection programs) were 
supported by an FSIS Risk Assessment and Analytics Staff independent 
analysis (``attribution analysis'') on the basis of epidemiological 
data.7 8 The Centers for

[[Page 75600]]

Disease Control and Prevention (CDC) concurred with FSIS' findings and 
stated that FSIS may even have underestimated the number of human 
salmonellosis cases attributed to catfish by not considering outbreaks 
attributed to ``finfish,'' that may have been ``catfish.''
---------------------------------------------------------------------------

    \7\ U.S. Centers for Disease Control and Prevention (CDC). (June 
2009) Foodborne Disease Outbreak Surveillance Data. Atlanta, GA. 
Retrieved from http://www.cdc.gov/foodsafety/fdoss/index.html.
    \8\ Mead, P.S., Slutsker, L., Dietz, V., McCaig, L.F., Bresee, 
J.S., Shapiro, C., Griffin, P.M., & Tauxe, R.V. (1999). Food-Related 
Illness and Death in the United States. Emerging Infectious 
Diseases, 5,607-625.
---------------------------------------------------------------------------

    FSIS requirements are consistent with the WTO SPS Agreement on the 
Application of Sanitary and Phytosanitary Measures. Under the articles 
of the SPS Agreement, a measure can be taken when it is necessary to 
protect against a public health hazard and there is scientific support 
for the measure.
    Chemical contamination hazards are important to catfish food safety 
and FSIS anticipates generating chemical contamination data once it 
begins its inspection program. Any risks identified through FSIS's 
surveillance will be addressed to ensure food safety.

D. Cost and Benefits Analysis

    Comments: Several comments questioned FSIS's ``break-even'' 
analysis in light of the fact that, historically, so few salmonellosis 
illnesses have been associated with the consumption of contaminated 
catfish. A member of academia, however, stated that the benefits of 
implementing this rule would be far greater than those estimated 
because the calculations did not include the long-term public health 
benefits of preventing imported product contaminated with chemical 
residues, such as malachite green, from entering the United States. 
Other comments stated that the incremental cost increases associated 
with the rule would negatively affect the marketability of catfish and 
catfish products.
    Response: By focusing solely on Salmonella in the risk assessment 
and the subsequent break-even analysis, FSIS took a conservative 
approach to estimating the number of illnesses prevented needed to 
offset costs of implementing this rule. It is possible that the process 
steps needed to reduce Salmonella on fish will also result in the 
reduction of other pathogenic microorganisms, such as E. coli 
(enterohemorrhagic, Shigatoxigenic, enterotoxigenic, and 
enteropathogenic strains), Listeria monocytogenes, and Clostridium 
botulinum on raw and ready-to-eat (RTE) fish.
    Comment: Several comments questioned FSIS's relatively high Agency 
cost to implement and maintain the proposed mandatory catfish 
inspection program.
    Response: In the final rule costs analysis, FSIS lowered its 
estimated additional net direct costs to implement and continue the 
mandatory inspection of fish and fish products. These costs are lower 
than preliminary Regulatory Impact Analysis (RIA) estimates because the 
domestic fish industry is now more consolidated, contracted, and 
concentrated and will require fewer additional FSIS resources for 
inspection. Furthermore, the FSIS Office of Field Operations was 
recently consolidated and now we will use more of the existing OFO 
staff (with minimal new hires and relocations) in patrol assignments 
for the processing-only establishments. This recent consolidation 
transitioned the Office of Catfish Inspection Programs (OCIP) to OFO. 
Thus, this transition would eliminate permanent staff positions (such 
as for managers, supervisors, inspection program personnel, and 
technical staff) that would have been dedicated to the OCIP, as 
discussed in the PRIA (scenario 1) of the published Proposed Rule. The 
Agency cost estimate is in the full RIA of the final rule, in the 
Appendix material (FRIA Appendix A).
    Comment: A domestic catfish processor claimed that transferring 
catfish inspection to FSIS would give processors of all other non-FSIS 
inspected seafood an unfair cost advantage.
    Response: FSIS projects in its regulatory impact analysis that the 
final rule would increase domestic product average net direct cost of 
aggregate processed fish and fish food products by $0.0008 per pound. 
According to the USDA, National Agricultural Statistics Service (NASS), 
the average price received by domestic processors for domestic catfish 
products was $3.04 per pound in 2013. Thus, FSIS's projected additional 
net direct cost to the domestic fish processing industry is relatively 
small when compared to the average domestic price received.
    Comment: A domestic catfish processor claimed that transferring 
catfish inspection to FSIS would increase catfish processor's costs. 
The processor stated that the initial cost to house inspectors and for 
the industry to conduct laboratory analysis sufficiently rigorous to 
ensure compliance with FSIS requirements may be significant. In 
addition, the processor stated that the testing for drugs with 
sufficient rigor would likely cost several thousand dollars per year.
    Response: FSIS projected an additional average net direct cost of 
$0.0008 per pound of aggregated processed fish and fish products to the 
domestic processors. This additional average net direct cost includes 
expected capital costs including additional office space for 
inspectors. Furthermore, the Agency projected additional establishment 
testing costs for required validation and verification of HACCP 
processing plans at official establishments. FSIS found on site visits 
that many domestic processors already have available office space for 
inspectors. Furthermore, many of these domestic processors already test 
their fish and fish products for microorganisms and drugs, according to 
the FDA 2011 Report. Thus, some domestic processors would have little 
to no additional costs for inspector office space or for microbe and 
drug testing. The aggregate direct cost FSIS projects for the domestic 
activities is an annualized $326.55 thousand.\9\
---------------------------------------------------------------------------

    \9\ Annualized present value of average costs is at a 7 percent 
discount rate over 10 years.
---------------------------------------------------------------------------

    Comment: A domestic seafood distributor stated that the proposed 
rule regulatory impact analysis underestimated the number of catfish 
processors in the U.S. A public policy organization stated that the 
data presented in the regulatory impact analysis were not properly 
attributed to a source, that no specific market failure or major health 
problem was identified, and that the theory behind the assertions was 
not articulated. The commenter further added that the regulatory impact 
analysis calculates a salmonellosis illness baseline without 
considering whether poultry processors used voluntary (fee-for-service) 
inspection services at the time, and that the numbers cannot be 
compared to the catfish industry.
    Response: The commenter provided no estimate of the number of 
affected catfish processors in the United States. In the proposed rule, 
FSIS used data from its research and site visits to project the number 
of affected domestic processors and distributors. The proposed rule 
regulatory impact analysis (RIA) data sources are in footnotes, tables, 
a list of references, and exhibits. In the final rule analysis, FSIS 
used the best available data from the Food and Drug Administration 
(FDA); National Oceanic and Atmospheric Administration (NOAA)/National 
Marine Fisheries Service (NMFS); import records of the U.S. Department 
of Homeland Security (DHS/CBP); and

[[Page 75601]]

Dun and Bradstreet, and updated the presentation of summary data and 
its sources.
    As for the market failure, FSIS finds foodborne illness to be 
potentially consistent with an informational market failure; 
specifically, the market for food may be characterized by an asymmetry 
in which producers know more than consumers about the microbiologic 
status and chemical residue status of the foods they prepare and 
consume.
    While the proposed rule employed a risk assessment in its PRIA, the 
final rule employs a break-even analysis in its RIA. The break-even 
analysis was calculated using catfish data and did not incorporate 
findings from the risk assessment.
    Comment: A trade association stated that the proposed rule would 
deprive seafood processors of imported products that they need and 
would subject them to duplicative and costly regulation.
    Response: The 2014 Farm Bill amendments of the FMIA give FSIS 
jurisdiction over all Siluriformes fish and fish products, including 
Siluriformes fish and fish products imported from other countries. 
Through its planned outreach to affected entities, FSIS will address 
the continued importation of those fish species and will conduct 
records reviews and audits to verify that all countries that import 
those fish species to the U.S. maintain inspections systems and 
requirements that are equivalent to those of FSIS. See sections Q. 
Imported Products and R. Demonstrating Equivalence of Foreign Systems 
for additional discussion of how FSIS will evaluate the equivalence of 
these countries and conduct rulemaking to list these countries in the 
regulations.
    To prevent duplicative and costly regulation, the 2014 Farm Bill 
also instructed FSIS to execute a MOU with FDA to maximize the 
effectiveness of limited personnel and by ensuring that inspections of 
shipments and processing facilities are not duplicative, and that any 
information resulting from examination, testing, and inspections is 
considered in making risk-based determinations, including the 
establishment of inspection priorities.

E. Trade Barriers and Agreements

    Comments: A comment stated that the proposed rule violated the 
World Trade Organization (WTO) National Treatment Principle, which 
states that imported and locally-produced goods should be treated 
equally once they enter the market. Another comment stated that the 
proposal violated the WTO agreement on Technical Barriers to Trade 
because it may be considered a disguised restriction on international 
trade. Some comments stated that the United States could be subjected 
to WTO-sanctioned tariffs if the rule is found by the WTO dispute 
settlement body to be noncompliant with its WTO obligations. A comment 
from a foreign government stated that it had been exporting catfish to 
the U.S. for many years under a food and feed safety agreement protocol 
with FDA, and that it hoped that the protocol would continue.
    Response: As with all other products FSIS regulates under the FMIA, 
this final rule would ensure that equivalent regulatory standards are 
applied to imported and domestic fish of the order Siluriformes. 
Therefore, this rule is not a violation of WTO National Treatment 
Principles. Imported products must be produced under an inspection 
system equivalent to the domestic system.

F. Equivalency and Implementation

    Comment: Many domestic catfish farmers and processors and private 
citizens endorsed the concept of an exporting country's food safety 
system being held to equivalent standards that are applied to domestic 
production. A trade association strongly opposed phasing in the 
requirements because the phase-in jeopardizes the health and safety of 
consumers and is unnecessary because there has been ample time to 
comply. An aquaculture industry advocacy association stated that no 
catfish imports should enter the United States until the foreign system 
overseeing them is determined to be equivalent. The same association 
and a member of academia stated that requirements for domestic and 
foreign entities should have the same effective date. A foreign 
agricultural ministry requested that FSIS commit to a timeframe for 
equivalence determinations. Some commenters recommended possible 
timeframes for implementation.
    Response: The Agency has given the implementation of this final 
rule careful consideration and has outlined the Agency's implementation 
strategy in Section XII. Under this implementation plan, FSIS will 
begin implementing inspection of domestic Siluriformes producers and 
inspection of imported Siluriformes product at the same time, 90 days 
after the publication of this final rule. Siluriformes fish and fish 
products exported to the U.S. will be subject to species and residue 
testing. Also, at the start of implementation, 90 days after the 
publication of this final rule, foreign countries will have to submit 
written documentation identifying a list of establishments (with the 
establishment name and number) that currently export and will continue 
to export Siluriformes fish and Siluriformes fish products to the U.S., 
and demonstrating that they have laws or other legal measures in place 
that provide authority to regulate the growing and processing of fish 
for human food and to assure compliance with FDA's regulatory 
requirements. In addition, during the 18-month transitional period, 
foreign countries seeking to continue importing into the United States 
Siluriformes and products derived from these fish after the expiration 
of the transitional period are encouraged to start submitting their 
documentation demonstrating the equivalency of their Siluriformes fish 
and fish products inspection systems. In any event, such documentation 
must be submitted by the end of the transitional period.

G. Facilities Requirements and Schedule of Operations

    Comment: A domestic seafood processor stated that the proposed 
requirement (9 CFR 533.1) for separation of inspected and non-inspected 
facilities would make it impossible for them to operate because of a 
lack of space, resulting in huge hardship.
    Response: Consistent with meat regulations in 9 CFR 305.2(a), FSIS 
generally considers a separation in time or space between inspected and 
non-inspected facilities to be sufficient, under certain conditions, to 
meet the requirement for separation of facilities. Therefore, common 
areas for inspected and uninspected operations may be used if the 
inspected product is acceptably maintained and protected to prevent 
product adulteration.
    Comment: A trade association suggested that the proposed phrase 
``docks and receiving room'' (9 CFR 533.4(f)) be replaced with 
``existing plant receiving area'' because it would be cost prohibitive 
to retrofit existing fish processing plant designs to meet the meat and 
poultry plant models.
    Response: Consistent with the meat regulations in 9 CFR 307.2, 9 
CFR 533.4 requires the official Siluriformes establishment to provide 
docks and receiving rooms, designated by the operator of the official 
establishment, in consultation with the FSIS frontline supervisor, for 
the receipt and inspection of Siluriformes, Siluriformes products, and 
other products. These spaces are necessary to facilitate unloading and 
staging of products and to minimize the potential for cross-
contamination that may occur through these activities. FSIS does not 
believe there is a meaningful distinction

[[Page 75602]]

between ``docks and receiving rooms'' and ``plant receiving area'' and 
is not modifying the regulatory language in this final rule. The Agency 
does not anticipate that catfish plant designs will need to be 
significantly modified to comply with the regulations that contain this 
language.
    Comment: A trade association and a domestic processor asserted that 
the consistent work schedules and two weeks advance notice for schedule 
changes requirements, as proposed, will pose undue hardship on the 
catfish industry. The comments explained that operational hours 
necessarily fluctuate according to seasonal peaks, availability of 
fish, size of fish harvested, and other factors.
    Response: As proposed, the final regulations for a fish 
establishment's schedule of operations (9 CFR 533.5) cross-reference 
the meat regulations (9 CFR 307.4) that define a shift and the basic 
workweek and require each official establishment to submit a work 
schedule to their District Manager for approval. In addition, each 
official establishment will be required to maintain a consistent work 
schedule. Deviations from the work schedule must be submitted to the 
District Manager at least two weeks in advance. Establishments may also 
request overtime inspection, if needed; however, seasonal demands can 
only be met as resources allow. Consistent work schedules and prior 
notification for schedule changes are necessary to ensure that the 
Agency can maintain an inspector presence during establishment 
operations. However, the Agency does not want to pose undue hardships 
on establishments, and District Managers will take into consideration 
any work schedule change request.

H. Definitions

1. ``Adulterated''
    Comment: A domestic processor specifically requested that FSIS 
delete the phrase `` . . . an animal which has died otherwise than by 
slaughter,'' paragraph (5) under the proposed ``adulterated'' 
definition (9 CFR 531.1). In addition, a trade association suggested 
FSIS use the definition of ``adulterated'' to mean any food safety 
hazard as defined in 21 CFR part 123.
    Response: As discussed in the proposed rule (76 FR 10441), 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)), and the proposed ``adulterated'' definition in 9 CFR 
531.1 is the same as the definition in the meat regulations (9 CFR 
301.2). FSIS continues to view fish that died under circumstances other 
than the controlled circumstances of commercial fish harvesting and 
processing as adulterated under this provision of the FMIA and 
unacceptable for food. In cases where dead, dying, diseased, or 
otherwise unfit fish are in commerce, it may be necessary for the 
Agency to apply the detention, seizure, and condemnation provisions of 
the Act (21 U.S.C. 672, 673).
2. ``Slaughter'' and ``Slaughterhouse''
    Comments: Several comments suggested various definitions of the 
term ``slaughter.'' A consumer advocacy group urged FSIS to provide a 
clear definition of slaughter that listed various acceptable methods of 
slaughter. A domestic processor suggested that ``slaughter'' be defined 
as ``when the head is removed for processing.'' A trade association 
stated that the catfish industry recognizes that slaughter, under 
controlled conditions, occurs at the de-header machine within the 
processing facility.
    An organization of regulatory officials recommended that FSIS 
define ``slaughterhouse'' to include locations where catfish may have 
died under conditions other than the controlled circumstances of 
commercial processing. This comment further added that a definition for 
``slaughterhouse'' should also include locations where ``wild-caught'' 
catfish are processed.
    Response: After considering the comments, FSIS has concluded that 
the definition of ``slaughter'' as intentional killing under controlled 
conditions (9 CFR 531.1) is applicable to various slaughter methods, 
and it is not necessary to list all of the various methods in the 
regulations. In addition, the Agency does not see value in defining the 
term ``slaughterhouse,'' as the definition includes the phrase ``under 
controlled conditions.'' FSIS would consider fish that died under 
circumstances other than the controlled circumstances of commercial 
fish harvesting and processing to be adulterated under the FMIA and 
unacceptable for food, e.g., 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.
3. ``Farm-Raised'' and ``Wild-Caught''
    Comment: A trade association suggested that the proposed definition 
for ``farm-raised'' (9 CFR 531.1) be amended to require the control of 
enclosed bodies of water to prevent contamination. A domestic processor 
asked that the proposed definition be amended to include ``raised in an 
enclosed environment of a clean, private, controlled water source.''
    A comment from a foreign government described the proposed 
definition for ``farm-raised'' as unreasonable because it does not 
consider the diversity of raising methods (e.g., breeding in pools and 
floating cages) and is inconsistent with ``the actual growth situation 
of catfish'' in their country. The foreign country stated that the 
floating cage method is the general method used in their country, as 
well as other foreign countries.
    A member of academia stated that ``wild-caught'' catfish should be 
subjected to the same provisions of the rule as ``farm-raised'' 
catfish, including the testing requirements of the fish and water. A 
consumer advocacy group urged FSIS to require catfish establishments to 
segregate ``wild-caught'' fish from ``farm-raised'' fish during 
slaughter and processing. In addition, an aquaculture scientist stated 
that freshwater aquaculture needs an inspection and food safety system 
that differs from marine ``wild-caught'' seafood because hazards, their 
sources, and interventions differ significantly.
    Response: Proposed 9 CFR part 534 outlines the pre-harvest 
standards that FSIS will require to ensure that the environmental 
conditions and source waters in which the fish are grown will not 
render the fish unfit for food. These regulations require that fish 
harvested for human food, whether wild-caught or farm-raised, must not 
have lived under conditions that would render them unsound, 
unwholesome, unhealthful, or otherwise unfit for human food (9 CFR 
534.1) so the fish would not be ``adulterated'' as the term is defined 
in 21 U.S.C. 601(m)(3) in the FMIA. The definition of ``farm-raised'' 
in 9 CFR 531.1 of the regulations is intended to cover a variety of 
fish-raising methods, including methods that involve raising the fish 
in pools and floating cages.
    Although the domestic fish growing process primarily utilizes fish-
raising ponds, FSIS recognizes that wild-caught fish may be 
commercially processed. 9 CFR 534.2 states that farmers of fish should 
monitor the water in which the fish are raised for the presence of 
suspended solids, organic matter, nutrients, heavy metals, pesticides, 
fertilizers, and chemicals that may contaminate fish. FSIS will inspect 
wild-caught and farm-raised fish processed in official establishments 
and test them for metals, dyes, pesticides, and animal drug residues. 
The Agency does not see the need for requiring the segregation of 
``farm-raised'' and ``wild-

[[Page 75603]]

caught'' fish as they are processed in an official establishment.
    Comment: A consumer advocacy group requested that the manner by 
which the animal was raised, ``farm-raised'' or ``wild-caught,'' be 
required on the label. A similar comment requested that ``wild-caught'' 
fish be labeled as such to distinguish them from ``farm-raised'' fish.
    Response: FSIS is authorized under the FMIA to regulate the 
marking, labeling, and packaging of all Siluriformes products in 
commerce (21 U.S.C. 607). However, there is no statutory obligation to 
label fish with the raising claims ``farm-raised,'' or ``wild-caught.'' 
Establishments may choose to voluntarily label their finished product 
with such raising claims, if the claims are not false or misleading. 
Such claims for fish would not require FSIS approval as required by 9 
CFR 412.1(c)(3) and 541.7(g).
    As discussed below, the final rule (9 CFR 541.7(b)) requires that 
country of origin statements on the label of any covered commodity 
(fish, including fillets, steaks, nuggets, and any other flesh) sold by 
a retailer must comply with the AMS regulations (7 CFR 60.200 and 
60.300). For these products, the AMS regulations require method of 
production information (wild or farm-raised).

I. Labeling

1. Mark of Inspection
    Comment: Several domestic processors, a consumer advocacy group, 
and an organization of regulatory officials recommended that the 
Federal mark of inspection be similar to the current brand for meat, 
poultry, and egg products. Another comment requested that the official 
inspection legend for catfish be unique in design and applied only to 
all finished packaging and in-process transfer containers. One comment 
favored assigning a number to each catfish establishment. Several 
comments noted that it may be impractical to stamp all carcasses of 
whole, gutted fish due to the size of the product and suggested 
alternative measures be considered, such as branding shipping 
containers, affixing inspection tags to lots, or marking invoices that 
accompany any shipments.
    Response: Because all fish of the order Siluriformes are amenable 
species under the FMIA, FSIS will require the same inspection legend 
for those products as it does meat products (9 CFR 312.2, reproduced in 
9 CFR 541.2, respectively). This inspection legend includes the number 
of the establishment. FSIS recognizes that it may be impractical to 
physically apply the inspection legend to whole, gutted, fish 
carcasses. Therefore, whole, gutted fish carcasses that have been 
inspected and passed at an official establishment, and that are 
intended for sale as whole, gutted fish may be stamped with the 
official inspection legend or properly packaged in an immediate 
container and then labeled with the official inspection legend, as well 
as with all other required labeling features (9 CFR 317.2). For all 
other Siluriformes fish products, the inspection legend will be 
required on the immediate container.
2. Species Identification and Prevention of False or Misleading 
Labeling Practices
    Comment: One comment stated that FSIS should choose a rapid, 
accurate, and inexpensive method for catfish species identification. 
Another comment stated that FSIS should choose a method that provides 
accuracy at the species level. One comment stated that catfish products 
should be identified according to the species of fish throughout 
processing regardless of the final packing step location.
    Response: FSIS will determine fish speciation by appropriately 
validated methods which are published in the Chemistry Laboratory 
Guidebook on the FSIS Web site at http://www.fsis.usda.gov/Science/Chemistry_Lab_Guidebook/index.asp. The methods chosen by FSIS are 
state-of-the-art and appropriate for their purpose in determining fish 
species identification.
    The fish labeling regulations (9 CFR 541.7, cross-referencing part 
317, subpart A) require the name of the product on the label (9 CFR 
317.2(c)(1)). Product leaving an official Federal establishment for 
distribution in commerce for further processing would have to be 
properly identified with all applicable mandatory labeling features, 
including a product name. It would typically bear a statement of 
limited use, e.g., ``for further processing'' to limit distribution to 
another official Federal establishment. Because the product is intended 
for further processing, and not for retail sale, some labeling features 
would not be required because they would meet an existing exemption, 
e.g., nutrition labeling (317.400 (a)(3)), safe handling instructions 
(9 CFR 317.2(l)(4), and net weight (317.2(h)(1).
    Under the FD&C Act (21 U.S.C. 321d (a)), the term ``catfish'' is 
considered to be a common or usual name (or part thereof) only for fish 
classified within the family Ictaluridae; and labeling or advertising 
only for fish classified within that family may include the term 
``catfish.'' Species of Ictaluridae include, among others, Ictalurus 
punctatus, I. furcatus, and Pylodictis olivaris, which may be 
identified as ``channel catfish,'' ``blue catfish,'' and ``flat-head 
catfish,'' on the labeling, if it is not false or misleading (9 CFR 
541.7, cross-referencing part 317, subpart A, 9 CFR 317.8). Through 
fish speciation sampling and testing, FSIS will routinely verify that 
product is accurately labeled and not misbranded at official 
establishments and at import reinspection facilities.
3. Standards of Identity
    Comment: A domestic processor requested that all catfish products 
(as examples, formed nuggets, patties, cakes, gumbo) should contain at 
least 51 percent or more catfish.
    Response: Product standards are intended to ensure that products 
sold under particular names have the characteristics expected by 
consumers. FSIS will, if necessary and appropriate, apply any of the 
existing meat regulatory standards in 9 CFR part 319- that may be 
applicable, e.g., ``meat stew'' (9 CFR 319.304) to fish products. A 
mixture of Ictaluridae and other Siluriformes could be labeled with an 
accurate and truthful descriptive name identifying the Ictaluridae 
(catfish) and other species of the Siluriformes, e.g., ``Catfish and 
Basa.''
    As stated in the preamble of the proposed rule, there are few 
further-processed fish products produced domestically (76 FR 10446), 
and FSIS is not aware of any fish standard-of-identity issues that 
require rulemaking. However, as provided in 9 CFR part 392, any person 
can petition the Agency to issue a regulation for a standard of 
identity.
4. Percent Approved Substances
    Comment: A trade association asked that the percentage of sodium 
tripolyphosphate, where allowed in catfish products (generally 0.5 
percent by weight of the finished product), be explicitly addressed in 
the regulations to ensure that there is a uniform standard for domestic 
and foreign products.
    Response: 9 CFR 544 states that no fish product may bear or contain 
any food ingredient that would render it adulterated or misbranded or 
that is not approved in 9 CFR part 424 of subchapter E. 9 CFR 424.21 
lists food ingredients that are approved for use in the preparation of 
meat products if they are used for the purposes indicated, within the 
limit of the amounts stated, and under other conditions specified. FSIS 
will apply the purpose and amount of any food ingredients to fish 
products,

[[Page 75604]]

if appropriate, and in consultation with FDA. The purpose and amount of 
sodium tripolyphosphate listed in the table for meat food products that 
would be applicable to fish products is 0.5 percent in the meat food 
product to decrease the amount of cooked out juices.
5. Net Weight and Retained Water
    Comment: An aquaculture industry advocacy group stated that the net 
weight of Individually Quick Frozen (IQF) fish is not determined on a 
``thawed'' basis, as suggested in proposed 9 CFR 541.7(b)(1). The 
commenter stated that while it is correct that the deglazed net weight 
must be 100 percent of the stated net weight, the procedure to 
determine this weight, as found in the NIST Handbook 133, does not thaw 
the product but only requires the removal of the outer layer of ice, 
and that the product is maintained in a frozen state. Additionally, the 
commenter stated that the net weight for IQF seafood is determined on a 
frozen basis.
    A domestic seafood distributor requested additional clarification 
on the section related to product moisture content and labeling because 
the proposed language is unclear on how to measure and label products 
that have undergone any kind of further processing. A foreign country's 
chamber of commerce stated that it would be impractical and serve no 
legitimate end to require catfish processors to calculate how much 
retained water is included in the production process.
    Response: NIST Handbook 133 net weight test procedures for the ice-
glazed catfish products state that the products are ``deglazed'' by 
placing the product under a gentle spray of cold water, and that the 
product should remain rigid (Section 2.6.2.2). FSIS will follow this 
procedure for determining net-weight compliance for ice-glazed fish. 
However, the NIST Handbook 133 test procedure for Encased-in-Ice 
Product Only (Section 2.6.1.2), which includes frozen catfish, 
including IQF catfish, is to thaw the product before weighing.
    As explained in the proposed rule, the Agency proposed requirements 
for the control of retained water in catfish (76 FR 10445). FSIS will 
not permit retained water--water remaining in raw product after it 
undergoes immersion chilling or a similar process-- in the packaged 
product 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)). To determine the amount of water 
retained in the product retained from a chilling process, an 
establishment may use physical water pick-up tests, weighing the 
product before the chilling process, and again just prior to final 
packaging and labeling. This is necessary because the amount of water 
retained in the product in excess of naturally occurring moisture must 
be prominently declared on the label.
6. Safe Handling Instructions
    Comment: A comment suggested that, to avoid confusion, one of the 
statements required within the safe handling instructions (9 CFR 541.7, 
cross-referencing part 317, subpart A), ``This product was prepared 
from inspected and passed meat and/or poultry,'' be modified to include 
the word ``catfish'' along with ``meat and/or poultry.''
    Response: FSIS agrees that a safe handling statement referencing 
``meat and/or poultry'' may potentially confuse consumers. Therefore, 
in this final rule, FSIS has modified the proposed codified language (9 
CFR 541.7(a)) to require that the safe handling instructions rationale 
statement read, ``This product was prepared from inspected and passed 
fish,'' and the labeling statements read, ``Keep raw fish from other 
foods. Wash working surfaces (including cutting boards), utensils, and 
hands after touching raw fish.''
7. Country of Origin Labeling
    Comment: Several private citizens, trade groups, and domestic 
processors requested that FSIS require that the country in which the 
catfish was hatched and raised, as well as processed, appear on the 
finished product label.
    Response: All shipping containers and immediate containers, as 
defined in 9 CFR 301.2, containing meat, including fish, imported into 
the United States for human consumption, must bear the name of the 
country of origin (9 CFR 327.14, 327.15; 9 CFR 557.14, 557.15).
    The proposed labeling regulations (9 CFR 541.7, cross-referencing 9 
CFR, part 317, subpart A) require that catfish and catfish products be 
labeled in accordance with the Agricultural Marketing Service (AMS) 
country of origin notification labeling regulations in 7 CFR, part 65, 
subpart A (9 CFR 317.8(b)(40)). The AMS regulations require that 
covered commodities (as defined in 7 CFR 60.105) sold by a retailer, 
whether individually, in a bulk bin, display case, carton, crate, 
barrel, cluster, or consumer package contain country of origin and 
method of production information (wild or farm-raised) (7 CFR 60.200 
and 60.300). The proposed rule cross-referenced AMS' Country of Origin 
Labeling (COOL) requirements for meat commodities. In this final rule, 
the Agency is correcting the regulatory text, by adding a paragraph to 
9 CFR 541.7, to cite 7 CFR part 60, subpart A, ``Country of Origin 
Labeling for Fish and Shellfish.'' Establishments are not required to 
label their fish products with country of origin labeling. However, if 
an establishment chooses to place a label on a Siluriformes fish or 
fish product covered commodity with a country of origin statement, it 
must comply with the AMS regulations. Labels with country of origin 
claims can be generically approved, i.e., the labels can be prior-
approved by the Agency without submitting such labels to FSIS for 
sketch approval (9 CFR 412.2). Generic label approval requires that all 
mandatory label features be in conformance with FSIS regulations.

J. Pre-Harvest and Transport Conditions

    Comment: FSIS received several comments requesting that the final 
rule include performance standards for pre-harvest environmental and 
water conditions and transportation. A trade association stated that an 
FSIS monitoring program for water quality is unnecessary, and that 
water quality should be tested on a periodic basis, perhaps annually. 
Another trade association requested that any performance standards that 
the Agency develops should be clearly spelled out with adequate 
explanation for regulated parties to fully understand the new 
requirements.
    Response: The general pre-harvest requirements in 9 CFR part 534, 
require that fish harvested for use as human food must have grown and 
have lived under conditions that will not render them unsound, 
unwholesome, unhealthful, or otherwise unfit for human food. 9 CFR 
534.2 requires that farmers of catfish 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 will collect samples of 
feed, fish, and pond water on a case-by-case basis, for cause, i.e, if 
FSIS finds residues or diseases in tissue at slaughter. Establishments 
will be required address the hazards associated with ``wild-caught'' 
fish as part of their HACCP plans (9 CFR 417.2), and FSIS will verify 
that they carry out this monitoring.
    In addition, 9 CFR 534.4 requires that vats or other containers 
transporting fish

[[Page 75605]]

must be maintained in a sanitary condition, and that sufficient water 
and sufficient oxygen must be provided to the vats that hold the fish 
to ensure that the fish are delivered to the processing establishment 
not adulterated.
    Comment: Several commenters stated that the regulations must 
address the quality of water used in transport vehicles. One trade 
association stated that proposed 9 CFR 534.4 should be amended to 
include the phrase, ``. . . sufficient unpolluted and uncontaminated 
water and sufficient oxygen or aeration must be provided to the vats. . 
. .''
    Response: FSIS agrees with the comments but finds that no changes 
are necessary in response to the comments. In point of fact, the 
proposed regulations provided for the transport conditions the comments 
seek. Thus, the final regulation requires that sufficient water and 
oxygen be provided, and that vats or other containers be maintained in 
a sanitary condition, which includes the water in the vats (9 CFR 
534.4). In addition, the regulations require that fish harvested for 
use as human food have been grown and have lived under conditions that 
will not render them or the products made from them unsound, 
unwholesome, unhealthful, or otherwise unfit for human food (9 CFR 
534.1).
    Comment: A trade association and several domestic processors stated 
that it is not uncommon for live fish to come in contact with dead, 
dying, or diseased catfish during transport.
    Response: FSIS recognizes that live fish may, on occasion, come in 
contact with dead, dying, or diseased fish during transport. However, 
incidental contact during transport with dead, dying, or diseased fish 
would not automatically render an otherwise healthy fish adulterated. 
Under 9 CFR 548.2, adopted as proposed in this final rule, the 
establishment is required to prevent unsound, unhealthful, unwholesome, 
or otherwise unfit ingredients from being used in the preparation of 
products. 9 CFR 534.4 states that any fish that are dead, dying, 
diseased, or contaminated with substances that may adulterate catfish 
products are subject to condemnation at the official fish processing 
establishment. In cases where dead, dying, diseased, or otherwise unfit 
fish have entered commerce, it may be necessary for the Agency to apply 
the detention, seizure, and condemnation provisions of the Act (21 
U.S.C. 672, 673).

K. Pathogen Reduction and Tolerances for Animal Drugs

    Comment: FSIS received several comments requesting that the final 
rule include performance standards for pathogen reduction.
    Response: In the preamble of the proposed rule (76 FR 10444), FSIS 
stated that it planned 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. If, after 
observing the industry's performance, the Agency determines the need 
for performance standards, it will publish the planned standards in the 
Federal Register, for public comment.
    Comment: Several comments suggested that the Agency stipulate 
``zero tolerance'' for malachite green, crystal violet, enrofloxacin, 
ciprofloxacin, and other antimicrobials prohibited for use in the U.S. 
One comment requested that FSIS add regulatory requirements for 
appropriate disposition of catfish and lots of catfish found positive 
for these substances. Another comment asked that FSIS specify that only 
antibiotics approved for use in U.S farm-raised catfish be permitted 
for use in all catfish products sold in the United States, foreign or 
domestic.
    Response: The Environmental Protection Agency (EPA) and the Food 
and Drug Administration (FDA) have statutory authority for establishing 
antibiotic and other animal drug tolerances for meat, including fish. 
FSIS works with the EPA and the FDA to control drug, pesticide, and 
contaminant residues including antibiotics in meat products, including 
fish, by testing animal tissues to verify that tolerance levels are not 
violated. Fish or fish products and lots of fish containing violative 
residues of the drugs or other chemicals including those the commenters 
listed would be considered adulterated and subject to condemnation (9 
CFR 539.2).

L. Limits for Retail Quantities

    Comment: A domestic processor stated that a retail purchase is 
generally less than 30 pounds, and non-household consumers would 
purchase 60 pounds or more. An organization of regulatory officials 
remarked that the retail purchase limits stated in the proposal seemed 
reasonable, although difficult to verify.
    Response: FSIS is providing an exemption for retail stores and 
restaurants (9 CFR 532.3, paralleling 9 CFR 303.1(d) and (e)), using 
the poultry exemption regulations set out in 9 CFR 381.10 as a model. 
The final regulations provide a limit of 75 lbs. (single-sale) for an 
individual household purchase of fish to be considered a retail 
purchase; the corresponding limit for a non-household consumer would be 
150 lb. Historically, these limits have been accepted as realistic, 
and, therefore, FSIS is not changing the limits in this final rule.

M. Hard Copy Information

    Comment: A domestic food processor requested that FSIS simplify and 
minimize the collection and transfer of hard copy information.
    Response: FSIS is taking steps to minimize the use of hard copy. 
Inspection assignments in the fish inspection program will be 
incorporated into FSIS's computerized PHIS, as appropriate. 
Establishments have access to PHIS. The Application for Federal 
Inspection (FSIS Form 5200-2) and the Application for Label Approval 
and Instructions (FSIS Form 7234.1) are available in fillable Portable 
Document Format (PDF) on the FSIS Web site. The electronic Label 
Submission and Approval System (LSAS) is also available to fish 
establishments that do not or cannot have their labels generically 
approved.
    FSIS will provide for the electronic submission of information that 
it collects from entities that will come under its fish inspection 
regulations, where applicable. The Agency will continue to work to 
enhance its capacity for the electronic collection of information.

N. Other Comments

1. Exemptions and Periodic Auditing
    Comment: A small domestic catfish processor requested that 
establishments that process less than 10,000 lb. of catfish products 
per week be exempted from the day-to-day FSIS mandatory inspection 
requirements. Additionally, the comment deemed a periodic audit system 
more appropriate for small scale operations than a mandatory inspection 
system. A similar comment suggested that the size of the catfish farm 
be taken into consideration when determining which farms are to be 
inspected.
    Response: The FMIA does not provide an exemption for fish 
processors that produce less than a specified amount of product. In 
addition, the exemptions for

[[Page 75606]]

custom and farm slaughter and processing or other exemptions do not 
apply to fish (21 U.S.C. 623). The FMIA provides for the examination 
and inspection of conditions under which fish are raised. This 
requirement applies to all farms that supply fish to Federal 
establishments, regardless of the size of the farm.
    However, as discussed in Section XII, ``FSIS Implementation,'' 
through its 18-month transitional period, the Agency is providing 
establishments ample time to prepare and comply with the final 
regulations. In addition, during the 18-month transitional period, the 
Agency will exercise broad enforcement discretion, focusing 
particularly on preventing adulterated or misbranded Siluriformes fish 
and fish products from entering commerce. After the 18-month 
transitional period, FSIS will fully enforce all of the final 
regulations.
2. Use of Program Seals
    Comment: Some domestic processors and a trade association claimed 
that requiring a program employee to affix a seal to any means of 
conveyance will cause processors undue hardship, especially if program 
employees are unavailable during shipping times. Commenters contend 
that it is unnecessary and impractical to require the sealing of 
trucks, since the boxes of product inside the truck are inspected and 
sealed and are delivered to multiple locations.
    Response: A means of conveyance (e.g., a truck) transporting 
inspected and passed fish products and bearing the official inspection 
legend (9 CFR 541.2; 9 CFR 325.5) is not required to be sealed by FSIS. 
The requirement for sealing railroad cars, motortrucks, or other means 
of conveyance applies when inspected and passed fish products are being 
transported from one official establishment to another, and the 
products are ``unmarked'', i.e., they do not contain the official mark 
of inspection. Shipping inspected and passed, and properly marked, 
product does not require FSIS inspection and typically occurs outside 
the hours of inspection. FSIS did not change these provisions because 
establishments have flexibility in timing the application of seals to 
shipments.

O. Cooperation With States

    Comment: An organization of regulatory officials requested that 
FSIS develop cooperative agreements with States for the inspection of 
catfish and catfish products.
    Response: Under 9 CFR 560.1, FSIS may cooperate with any State in 
developing and administering a fish inspection program that has 
requirements that are ``at least equal to'' the requirements of the 
FSIS inspection program. When resources allow, FSIS will enter into new 
State-Federal Cooperative Agreements under which the Agency will 
cooperate with, and provide assistance to, States carrying out 
inspection programs for fish and fish products that are to be sold 
intra-State. In addition, selected fish establishments in States that 
have and continue to maintain an ``at least equal to'' State meat 
inspection program will be eligible to ship their fish products across 
State lines and export them to foreign countries. In this final rule, 
FSIS is amending 9 CFR part 560 to include a paragraph specifically 
referencing 9 CFR 321.3, for the Cooperation of States for the 
Interstate Shipment of Carcasses, Parts of Carcasses, Meat, and Meat 
Food Products.

P. Outreach and Training

    Comment: A trade association representing the storage industry 
asked that FSIS initiate substantial industry outreach to ensure 
regulated parties fully understand any new requirements and the phased-
in implementation.
    Response: FSIS intends to develop necessary outreach materials and 
hold sessions to inform and educate fish establishment owners and 
operators of the regulatory requirements contained in the final rule. 
The timing of the 18-month transitional period is based in part on the 
need to ensure that domestic as well as foreign regulated parties 
understand FSIS's requirements. The implementation strategy is 
discussed in Section XII, and implementation information will also be 
posted on the FSIS Web site.

XII. FSIS Implementation

    FSIS proposed a four-phase approach to implementing the catfish 
inspection rule, but did not provide timeframes for implementation (76 
FR 10452). The final rule provides an effective date, 90 days after its 
publication, and an 18-month transitional period until the regulations 
are fully enforced.
    FSIS has given careful consideration in determining the nature of 
the inspection coverage that it will provide during the 18-month 
transitional period and once the rule is fully effective. In the 
proposed rule, FSIS used the term ``continuous inspection,'' but did 
not define what this would mean. The Egg Products Inspection Act uses 
the term ``continuous inspection'' (21 U.S.C. 1034(a)), and FSIS has 
interpreted it to mean that the Agency must have an inspector at an egg 
products plant whenever the plant is processing eggs. FSIS does not 
believe that Congress intended FSIS to provide this level of inspection 
coverage in establishments that slaughter and slaughter and process 
fish. Congress provided for inspection of fish in Section 606 of the 
FMIA (21 U.S.C. 606(b)). FSIS's longstanding and well-known 
interpretation of Section 606 is that it only requires inspection once 
per shift. If Congress had intended something different, it is 
reasonable to presume that it would have put the provision for 
inspection of fish in a different section. Second, the 2014 Farm Bill 
Joint Explanatory Statement of the Committee Conference'' \10\ states: 
``There exists scientific evidence that demonstrates that the use of 
substances such as malachite green, nitrofurans, fluoroquinolones, and 
gentian violet during the stages of production can result in continued 
presence in edible Siluriformes products. The managers believe that 
continuous inspection of farm-raised species is a legitimate tool to 
address concerns.'' In this statement, it is pretty clear that Congress 
was using ``continuous'' in its ordinary meaning of uninterrupted. 
Congress was saying that the FSIS model of performing inspection on an 
ongoing basis of once per shift is more consistent with the type of 
inspection necessary than the FDA model of sporadic inspection (once 
per year or more). Thus, FSIS believes that it will be providing the 
coverage that Congress intended and that it is not necessary to use 
``continuous'' in the regulations.
---------------------------------------------------------------------------

    \10\ http://docs.house.gov/billsthisweek/20140127/CRPT-113hrpt-HR2642-SOM.pdf.
---------------------------------------------------------------------------

    Following its interpretation of the language in the Farm Bills, the 
2014 Farm Bill Joint Explanatory Statement of the Committee of 
Conference and the FMIA, FSIS will, at the start of implementation, 
assign inspection program personnel to be present during all hours of 
operation on a daily basis at domestic establishments that slaughter 
and slaughter and process Siluriformes fish and fish products. At the 
start of implementation, FSIS will assign inspection program personnel 
to conduct inspection at processing-only facilities at least quarterly.
    At the end of the 18-month transitional period, inspection program 
personnel will continue to be assigned to conduct inspection during all 
hours of operation at slaughter and slaughter and processing 
establishments for some period of time. Based on FSIS's findings during 
and after the transitional period, it may adjust inspection frequency 
in slaughter and slaughter and processing establishments in the future. 
FSIS will establish criteria it will follow in

[[Page 75607]]

determining how inspection will be adjusted at these establishments and 
will make these criteria available to the public. At the end of the 18-
month transitional period, inspection program personnel will be 
assigned at least once per day per shift at processing only 
establishments.
    During initial implementation, FSIS will provide domestic 
Siluriformes fish and fish products establishments with guidance to 
ensure that they understand the new requirements. During the 18-month 
transitional period, if FSIS finds that an establishment has produced 
adulterated product (e.g., product that contains a violative residue or 
other adulterant or has been produced under insanitary conditions that 
result in direct product contamination) or has misbranded product by 
labeling it ``Catfish'' when the product does not contain fish of the 
family Ictaluridae or intentionally over-declaring the net weight, FSIS 
will prevent the product from going into commerce or will take action 
to ensure that it is removed from commerce. If FSIS finds any other 
noncompliance with these regulations, FSIS will document its finding 
and work with the establishment to address the problem in a timely 
manner.
    FSIS will conduct sampling and testing of Siluriformes fish and 
fish products for species and residues to ensure that product is not 
adulterated or misbranded. FSIS has developed a testing program that 
currently includes the capacity to test for malachite green, 
nitrofurans, veterinary drug residues (including some floroquinolones), 
gentian violet, metals, and pesticides(See Table 2, below). Also during 
the first 18 months, as noted in the Comment and Responses (Section 
XI), FSIS plans to commence collection of Salmonella data to determine 
the national baseline prevalence and levels of Salmonella on raw 
Siluriformes fish.

                                   Table 2--Projected FSIS Fish Sampling Plan
----------------------------------------------------------------------------------------------------------------
                                                                Tests at eastern            Tests at western
         Samples per year              Type of  sample             laboratory                  laboratory
----------------------------------------------------------------------------------------------------------------
100 (at each laboratory)..........  Domestic.............  Salmonella, Speciation,     Salmonella, Pesticides,
                                                            Metals, Dyes, and           Veterinary Drug Residues
                                                            Veterinary Drug Residures   (MRM), and Nitrofurans.
                                                            (MRM).
50 (at each laboratory)...........  Import...............  Salmonella, Speciation,     Pesticides and
                                                            Metals, Dyes, and           Nitrofurans.
                                                            Veterinary Drug Residues
                                                            (MRM).
----------------------------------------------------------------------------------------------------------------

    By the effective date of this final rule, March 1, 2016, foreign 
countries with establishments that are exporting Siluriformes fish and 
fish products to the United States, and that wish to continue to do so, 
are required to submit written documentation identifying a list of 
establishments (with the establishment name and number) that currently 
export and will continue to export Siluriformes fish and Siluriformes 
fish products. Foreign countries must also provide written 
documentation to demonstrate that they currently have laws or other 
legal measures in place that provide authority to regulate the growing 
and processing of fish for human food, and to assure compliance with 
FDA's good manufacturing practices, Hazard analysis and Hazard Analysis 
and Critical Control Point (HACCP) plans, sanitation control 
procedures, and other regulatory requirements in 21 CFR part 123, Fish 
and Fishery Products. This initial documentation will not be evaluated 
to determine the equivalency of the foreign country's inspection system 
to that of the United States, but to establish that the Siluriformes 
fish and fish products exported to the United States are produced under 
a foreign country's authority and meet FDA's regulatory requirements. A 
foreign country may provide FSIS with any of the following written 
documentation:

--pursuant to 21 CFR 123.12(a)(2)(ii)(B), copies of foreign inspection 
continuing or lot-by-lot certificates that the imported fish products 
are or were processed in accordance with requirements in 21 CFR part 
123; or
--pursuant to 21 CFR 123.12(a)(1), an active memorandum of 
understanding (MOU) or similar agreement between the foreign country 
and FDA that covers Siluriformes fish or fish products and documents 
the equivalence or compliance of the inspection system of the foreign 
country with the U.S. system, accurately reflects the current situation 
between the signing parties, and is functioning and enforceable in its 
entirety; or
--an active memorandum of understanding (MOU) or similar agreement 
between the foreign country and FDA that covers the food safety of its 
products; or
--a checklist of the country's regulatory control system, procedures, 
to demonstrate the competent authority's control and ability to enforce 
a HACCP-based control program; or
--a side-by-side comparison of the country's or each processor's HACCP 
program with 21 CFR part 123; or
--a side-by-side comparison of the country's or each processor's 
sanitation program with FDA's GMP for sanitation at 21 CFR part 110; or
--for canned fish, a comparison of the country's or each processor's 
low-acid canned food and acidified food program with FDA's (at 21 CFR 
parts 108, 113, and 114); or
--a third-party certification of the country's or each processor's 
compliance with FDA requirements; or
--data and information that foreign countries submitted in response to 
any FDA Import Alert.

    The initial documentation can be submitted to: Food Safety and 
Inspection Service, OPPD/International Equivalence Staff, 1400 
Independence Avenue SW., Room 2145, South Building, Washington, DC 
20250-3700.
    After a foreign country submits its documentation, FSIS will 
evaluate its acceptability and notify the foreign country if any 
clarifications or additional documentation are necessary. For 
additional information and guidance on the initial documentation 
requirements, foreign countries are encouraged to contact FSIS's, 
Office of Policy and Program Development's International Equivalence 
Staff at the address above, by phone (202) 720-0082, by Fax: (202) 720-
7990, or Email: [email protected].
    Starting on the effective date of the rule, March 1, 2016, or 
within a reasonable amount of time thereafter, FSIS will maintain a 
list on its Web site of foreign countries that have provided the list 
of establishments and met the initial documentation requirement. During 
the 18-month transitional period, Siluriformes fish and fish products 
exported to the United States from foreign counties that have not met 
the initial documentation requirement will be refused entry. If, during 
the transitional period, a foreign country wants to add establishments 
to its list,

[[Page 75608]]

it must notify FSIS using the contact information above. The foreign 
country should explain the circumstances behind adding the 
establishment and provide assurances that the facility conducts 
sanitary operations and produces wholesome product. FSIS will make 
determinations on adding establishments on a case-by-case basis, taking 
into account the information submitted.
    FSIS will recognize the initial documentation foreign countries 
submit, until full enforcement of the rule, at the end of the 18-month 
transitional period, September 1, 2017, or FSIS determines whether the 
foreign inspection systems are equivalent to that of the United States, 
whichever occurs first. Foreign countries seeking to continue exporting 
Siluriformes fish and fish products to the United States after the 18-
month transitional period, September 1, 2017, are advised to start 
submitting their documentation showing that they have an equivalent 
inspection system as soon as possible during the transitional period. 
The FSIS equivalency process is described fully on the FSIS Web site 
at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence. In any event, foreign countries 
must submit this information no later than the date of full 
enforcement, at the end of the 18 month transitional period, September 
1, 2017. If foreign countries have done so, they may continue to export 
until such time that FSIS makes a determination with respect to the 
equivalency documentation submitted by the foreign country, and FSIS's 
determination is negative (i.e., FSIS determines that the foreign 
inspection systems are not equivalent to that of the United States). If 
FSIS determination is positive, trade can continue.
    On the effective date, March 1, 2016, at each official import 
inspection establishment, imported Siluriformes fish and fish product 
shipments will be reinspected and subjected to species and residue 
testing on at least a quarterly basis. At the end of the 18-month 
transitional period, on the date of full enforcement (September 1, 
2017), all imported Siluriformes fish and fish product shipments will 
be reinspected, just as all imported meat and poultry products from 
equivalent countries that export product to the United states are 
reinspected.
    By the end of the 18-month transitional period, foreign countries 
must apply, under FSIS' regulations, for equivalency determinations. If 
a country does not initiate a request for equivalency and provide 
documentation showing its system is equivalent by the end of the 18-
month transitional period, i.e., the date of full enforcement, 
September 1, 2017, FSIS will refuse entry to Siluriformes fish and fish 
products exported from that country. When a foreign country initiates a 
request for equivalency and provides documentation during the 18-month 
transitional period, if additional information is required, FSIS will 
request that the foreign country respond or resubmit complete 
equivalence documentation within 90 day of receiving FSIS's request. 
If, after the 18-month transitional period, the foreign country has 
failed to respond to FSIS's request within 90 days of receiving the 
request, FSIS will refuse entry to Siluriformes fish and fish products 
exported from that country. Based on its review of the information and 
documentation that the country submits, FSIS will tentatively decide 
whether the foreign country's inspection system and requirements are 
equivalent to FSIS', and if so, will plan an on-site audit of the 
country's Siluriformes fish and fish products inspection system. If 
FSIS also tentatively finds the foreign country's inspection system 
equivalent based on the audit, FSIS will publish a proposed rule in the 
Federal Register announcing the results of the document review and on-
site audit, proposing to add the country to its list of eligible 
exporting countries (9 CFR 557.2(b)). After analysis of public 
comments, FSIS will publish a final rule announcing its determination 
on the country's eligibility.

XIII. Executive Orders 12866 and 13563 and the Regulatory Flexibility 
Act

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This final rule has been designated an ``economically 
significant'' regulatory action under section 3(f) of Executive Order 
(E.O.) 12866. Accordingly, the rule has been reviewed by the Office of 
Management and Budget under E.O. 12866. The Regulatory Flexibility Act 
requires an assessment of the effects of the final rule on small 
entities. This assessment is in this Section XIII, part J., below.
    FSIS is adopting, with changes, the preliminary regulatory impact 
analysis (PRIA) Scenario #1 alternative, published in the proposed 
rule, as the final regulatory impact analysis (FRIA) in this final 
rule. The changes to the PRIA are the result of the 2014 Agricultural 
Act amendments to the FMIA mandating that ``all fish of the order 
Siluriformes are amenable species,'' public comments, and updates that 
include more current costs, prices, fish consumption data, fish demand 
data, fish supply data, fish exports, fish imports, and the changing 
structure of the Siluriformes fish industry. These include:
     Updated baseline information to reflect changes in the 
industry.
     Updated costs and prices for the more current markets.
     Updated assessment of the potential public health benefits 
of the final rule, in the break-even analysis, to reflect a lower 
average direct cost of $2,423 (in 2010 dollars) for a clinical case of 
salmonellosis.\11\
---------------------------------------------------------------------------

    \11\ The FSIS estimate for the average cost of salmonellosis 
illnesses ($2,423 per case--2010 dollars) was developed using the 
USDA, ERS Foodborne Illness Costs Calculator: Salmonella (June 
2011). FSIS updated the ERS calculator to include Scallan case 
distribution for Salmonella. Scallan, E., Hoekstra, R., Angulo, F., 
et al. (2011). Foodborne Illness Acquired in the United States--
Major Pathogens. Emerging Infectious Diseases, 17 (1), pp.7-15.
---------------------------------------------------------------------------

     Updated FSIS implementation schedule (see section XII, 
above).

A. Need for the Rule

    FSIS inspection of Siluriformes is mandated by law and non-
discretionary.

B. Baseline

    Mandatory inspection of Siluriformes fish and Siluriformes fish 
products is a new program for FSIS. Currently, FDA does require a 
Seafood HACCP plan \12\ for establishments that process seafood, 
including Siluriformes fish and Siluriformes fish products. A Seafood 
HACCP plan requires covered establishments to have completed a hazard 
analysis, be able to take corrective actions, conduct on-going 
verification activities, review records, conduct training, and 
establish and implement sanitation control procedures. In the preamble 
of the proposed rule and the PRIA, Table 2, FSIS provided an overview 
comparison of the FSIS, FDA and USDC/NMFS/NOAA inspection system 
requirements.
---------------------------------------------------------------------------

    \12\ More additional information, see the FDA Seafood HACCP 
regulations and guidance at http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006764.htm.
---------------------------------------------------------------------------

    In establishments that request inspection services under the

[[Page 75609]]

Agricultural Marketing Act of 1946, USDC/NOAA/NMFS routinely inspects 
domestic seafood, including Siluriformes fish and Siluriformes fish 
products, on a fee-for-service basis. On average, domestic Siluriformes 
fish establishments' contract with NMFS for that service annually for 
an annual cost of $1,340.00 thousand. See the NMFS.gov Web site for 
more information on that service. However, neither FDA nor USDC/NOAA/
NMFS inspects Siluriformes fish production facilities (fish farms); or 
transporters of live Siluriformes fish. Also, the USDC/NOAA/NMFS does 
not inspect commercial feed mills that manufacture fish feed products 
or rations for Siluriformes fish farms.

C. Catfish Consumption and Prices

    Data on Siluriformes supply and demand is limited. Recently, the 
U.S. Farm-Raised Catfish Industry 2013 Review and 2014 Outlook \13\ 
provided industry statistics for the Siluriformes Industry:
---------------------------------------------------------------------------

    \13\ Hanson, T and D. Sites. ``2013 U.S. Catfish Database''. 
Fisheries and Allied Aquacultures Department Series No. 1. Alabama 
Agricultural Experiment Station. Auburn University. Auburn, Alabama. 
April 2014. Sources: USDA National Agricultural Statistics Service 
(NASS) and Mississippi Agricultural Statistics Service (MASS).
---------------------------------------------------------------------------

     U.S. farm-raised catfish consumption of the order 
Siluriformes was 0.5 pounds per person in the 2012 ``Top 10'' fish and 
seafood consumption list for Americans, who consumed 14.6 pounds of 
fish and seafood per year in total. In 2004, catfish consumption was 
1.1 pounds when total seafood consumption for Americans was 16.6 
pounds. The U.S. catfish industry has been on a contracting course 
since a high mark in 2003 when 662 million pounds of round weight 
(i.e., live weight) catfish were processed. In 2013, 334 million pounds 
were processed, up 33.4 million pounds (11 percent) from 300 million 
pounds processed in 2012; but a 50 percent decrease since the 2003 
peak.
     In 2002 there were more than 2200 catfish operations with 
sales and distribution. By 2012, that number was down by nearly 50 
percent to about 1200 operations (NASS). There were 624 domestic 
producers reported by NASS in January 2013 down from 718 in 2012 and 
down from more than 1800 in 1989. Low prices and prior years of reduced 
production and processing have led to hatchery operators reducing their 
number of fingerlings and broodstock in stock.
     Imports of frozen Siluriformes fish fillets increased by 
44 million pounds (18 percent) to 281 million pounds in 2013; and 
imports now account for 75 percent of all U.S. sales of frozen 
Siluriformes fish fillet product.
     There were 71,725 acres of water in U.S. catfish 
production in January 2014, down 14 percent from 2013. Current 
production acreage for the top three catfish producing states, Alabama, 
Arkansas and Mississippi, was down 10,925 acres (15 percent) to 64,075 
acres. There were 196,760 acres of water in U.S. catfish production in 
January 2002 (NASS).
     The average price received by domestic producers was 
$0.974 per pound in 2013, down $0.002 per pound from the 2012 average 
price of $0.976 per pound. In 2013 there was a $0.294 per pound 
difference between high (November, $1.113 per pound) and low (January, 
$0.819 per pound) pond bank prices received during the year.
     Domestic in-pond inventories of foodsize fish in January 
2014 were down 10 percent from January 2013 levels. Stocker inventory 
was down 14 percent from January 2013 levels. Fingerling weight (and 
number) inventory was up 4 percent (and down 21 percent) from January 
2013 levels. Broodfish pounds were up 5 percent.
     Domestic catfish feed prices (32 percent protein) in 2013 
averaged $483/ton, up $14/ton (3 percent) over the 2012 average feed 
price of $469/ton. Of note, 2013 feed prices peaked in July ($494/ton) 
while the lowest feed price in 2013 occurred in November ($425/ton).
     The average wholesale price received by domestic catfish 
processors was $3.04 per pound in 2013, down $0.04 per pound from the 
2012 average price of $3.08 per pound. In 2013 there was a $0.60 per 
pound difference between high (October, $3.36 per pound) and low 
(January, $2.76 per pound) prices received during the year.
    For the affected United States domestic industry, FSIS projects 
that there are 624 operating Siluriformes fish farms and fish 
hatcheries; 18 establishments that slaughter and conduct primary 
processing of Siluriformes fish and Siluriformes fish products; and 200 
establishments that are (1) further or secondary processors of only 
Siluriformes fish and Siluriformes fish products, (2) live-fish 
loaders/haulers/wholesalers of Siluriformes fish, (3) wholesalers/
brokers/importers/exporters of Siluriformes fish and Siluriformes fish 
products, and (4) Siluriformes fish feed mills. In 2012 the number of 
catfish operations with sales and distribution numbered 1200. In 2013, 
the number of catfish operations with sales and distribution numbered 
842. See Table 5, below, for details.
    The Agency based those projections on the USDA National 
Agricultural Statistics Service (NASS) (2013-2014 Catfish Production 
Report); Food and Drug Administration (FDA) (2014); \14\ the Dun and 
Bradstreet (DNB) business database (2014); import records of the U.S. 
Department of Homeland Security (DHS) Customs and Border Protection 
(CBP) (2009-2013); \15\ and the U.S. Census Bureau Economic Census 
(2012).
---------------------------------------------------------------------------

    \14\ Email correspondence between the U.S. Food and Drug 
Administration and the Food Safety and Inspection Service. February 
26, 2014.
    \15\ U.S. Department of Homeland Security (DHS) Customs and 
Border Protection (CBP) import records of 2009 through 2013.
---------------------------------------------------------------------------

D. Alternative Regulatory Approaches Considered

    Initially, FSIS considered two basic regulatory approaches to 
Siluriformes fish and Siluriformes fish products inspection: (1) A more 
command-and-control approach, or (2) the Pathogen Reduction/Hazard 
Analysis and Critical Control Points Systems (PR/HACCP) approach the 
Agency adopted in 1996 (61 FR 38806; July 25, 1996). FSIS, however, 
rejected the command-and-control approach in 1996 with the adoption of 
the Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/
HACCP) Systems final rule (61 FR 38806; Jul. 25, 1996). Moreover, 
command-and-control approaches are generally disfavored, while less 
burdensome, more flexible approaches are generally preferred, under 
Executive Order 12866 and OMB Circular A-4.
    For the final rule, the Agency is adopting for Siluriformes fish 
and Siluriformes fish products, as it has for meat and poultry 
products, the PR/HACCP approach to inspection which focuses on the 
verification of an establishment's food safety system, which consists 
of an establishment's HACCP plan, Sanitation SOPs, and prerequisite 
programs.
    Further, FSIS considered two regulatory alternatives for the PR/
HACCP approach:
    1. The first alternative considered is the same as the final rule 
except the Agency implements this alternative with additional 
assignments of inspection program personnel (IPP) at fish ponds, fish 
hatcheries, fish feed mills, processing-only establishments, and for 
live-fish capturing/loading/transporting to the slaughter 
establishments. Under this alternative, FSIS would implement the 
regulation in a manner consistent with previous

[[Page 75610]]

rulemaking proposals.\16\ The additional cost of this alternative to 
the Agency would be as outlined in the published PRIA (scenario 1) of 
the Proposed Rule, and would add approximately $13 million annualized 
cost (7 percent interest over 10 years)) to the final rule. We would 
not expect additional potential benefits of increased FSIS inspection 
on reducing illnesses, beyond those additional potential benefits from 
the implementation of the final rule.
---------------------------------------------------------------------------

    \16\ ``Mandatory Inspection of Ratites and Squabs.'' May 7, 2001 
(66 FR 22899).
---------------------------------------------------------------------------

    2. The second alternative considered is the same as the final rule 
except the Agency implements the final rule in three phases of 18 
months for each phase, over a total of 4.5 years. Under this 
alternative, FSIS would implement the regulation in a manner consistent 
with previous rulemaking proposals.\17\ Presumably that would limit the 
prevention of salmonellosis cases in the first three years relative to 
the first alternative.
---------------------------------------------------------------------------

    \17\ ``Mandatory Inspection of Ratites and Squabs.'' May 7, 2001 
(66 FR 22899).
---------------------------------------------------------------------------

    That delay in implementation would have additional direct costs to 
the domestic industry of paying for contracted certification of fish 
and fish products for some of the affected facilities in order to meet 
stipulations in purchase contracts, such as with large grocery chains. 
The industry may be asked to initiate and maintain third-party 
inspection/auditing services (e.g., USDC/NOAA/NMFS) for a period of 
time until FSIS IPP are deployed, and, therefore, accruing additional 
costs (i.e., not accruing the projected cost-savings that would result 
from an earlier implementation of the final rule), such as for these 
third-party inspection/auditing services. The additional cost of this 
alternative to the industry and the Agency would be as outlined in the 
proposed rule (scenario 1), and would add approximately $0.03 million 
annualized cost (7 percent interest over 10 years) to the final rule. 
It may also delay the potential benefits of increased FSIS inspection 
and detection on reducing illnesses. An extended transitional period 
may reduce the expected minimal costs to foreign entities. Foreign 
producers do not need to gather and submit information to FSIS. Rather, 
at the beginning of the transitional period foreign governments that 
wish to continue exporting Siluriformes products to the United States 
will have to submit documentation showing that they are compliant with 
FDA requirements and a list of establishments that currently export 
Siluriformes products to this country. By the end of the transitional 
period, they will need to submit information to FSIS showing that they 
maintain an equivalent inspection system for such product. This 
transitional period will provide FSIS more time to work with these 
governments to provide guidance on what they need to submit. In 
addition, FSIS will have time to follow up with the country, if FSIS 
has questions or needs additional information. FSIS's efforts should 
lessen the possibility of trade disruptions, thereby minimizing the 
costs to foreign producers and any effects on the availability of 
product.

E. Expected Cost of the Final Rule

    The final rule establishes all fish of the order Siluriformes as an 
amenable species. This is Scenario #1 in the proposed rule. The final 
rule, however, is to be implemented in 18 months, as outlined above in 
Section XII.
    In the proposed rule, the Agency discussed that, since the domestic 
fish industry, including Siluriformes, must comply with the Food and 
Drug Administration's Seafood Hazard Analysis Critical Control Point 
(HACCP) and other regulatory requirements, and that some of the 
domestic establishments that slaughter fish of the order Siluriformes 
contract with the USDC/NOAA/NMFS for voluntary, fee-for-service 
inspection and certification program, the Agency thinks, from 
observations during site visits, that many of the domestic Siluriformes 
fish and Siluriformes fish products industry would be compliant with 
many of the proposed requirements.
    FSIS projects that all domestic Siluriformes fish and Siluriformes 
fish products establishments will be in compliance with the 
requirements for Sanitation SOPs and HACCP according to the 
implementation schedule of the final rule. From discussions with 
industry experts in the Cooperative Extension Services and USDC/NOAA/
NMFS, FSIS believes that a significant share of the domestic 
Siluriformes fish and Siluriformes fish products industry is compliant 
with many of the individual final rule measures.\18\ 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 critical control points and 
critical limits, recordkeeping, process control testing, and 
verification--are being performed. In addition, the provisions of the 
final rule have additional costs to the domestic industry such as for 
meeting sanitation requirements (SSOP), new training, new labels \19\ 
for Siluriformes fish and Siluriformes fish products, new government 
office space and equipment, new equipment and operating costs for live 
fish transportation/hauling, and for new reinspection at import 
establishments.
---------------------------------------------------------------------------

    \18\ For more information regarding the difference, see the 
Proposed Regulatory Impact Analysis, Table 2.
    \19\ FDA March 2011 Labeling Cost Model.
---------------------------------------------------------------------------

    The details of projected additional direct costs to the domestic 
industry, including the annual cost-savings of reduced payments of 
inspection fees to USDC/NMFS because of the implementation of the final 
rule are available at: http://www.fsis.usda.gov/wps/wcm/connect/63387be5-ca8e-442d-b047-f031f29a8a47/Silurifomes-RA.pdf?MOD=AJPERES. A 
summary table of the costs is included in Table 3 (below). FSIS 
projects that the annualized cost to these domestic industries is 
$326.55 thousand, at a 7 percent discount over 10 years. The projected 
additional annualized cost to these domestic industries is $317.78 
thousand, at a 3 percent discount over 10 years.
    At a 7-percent discount rate over 10 years, the projected 
additional annualized average net direct cost of the final rule 
provisions to the Siluriformes fish and Siluriformes food products 
domestic supply-chain industries is $0.0008 ($326.55 thousand/388,000 
thousand pounds) per pound of aggregate Siluriformes fish and 
Siluriformes fish food products processed, on average yearly, in 2011, 
2012, and 2013 (the last 3-year average of domestic and imported 
Siluriformes fish products), according to the USDA National 
Agricultural Statistics Service (NASS),20 21 22 and the 
import records of the U.S. Department of Homeland Security (DHS).\23\ 
The additional average net direct cost of the provisions to the 
Siluriformes fish food products domestic industry compares to the

[[Page 75611]]

average price received by domestic processors for domestic aggregate 
catfish (of the order Siluriformes) food products that was $3.04 per 
pound, in 2013, according to the NASS publication (2013).
---------------------------------------------------------------------------

    \20\ Source: Catfish Processing Reports, NASS, USDA. 2011-2013.
    \21\ Hanson, T and D. Sites. ``2012 U.S. Catfish Database''. 
Fisheries and Allied Aquacultures Department Series No. 1. Alabama 
Agricultural Experiment Station. Auburn University. Auburn, Alabama. 
March 2013. Sources: USDA National Agricultural Statistics Service 
(NASS) and Mississippi Agricultural Statistics Service (MASS).
    \22\ Hanson, T and D. Sites. ``2013 U.S. Catfish Database''. 
Fisheries and Allied Aquacultures Department Series No. 1. Alabama 
Agricultural Experiment Station. Auburn University. Auburn, Alabama. 
April 2014. Sources: USDA National Agricultural Statistics Service 
(NASS) and Mississippi Agricultural Statistics Service (MASS).
    \23\ U.S. Department of Homeland Security (DHS) CBP import 
records of 2009 through 2013.
---------------------------------------------------------------------------

    These additional regulatory costs compare to an estimated direct 
cost of about $0.01 per pound of meat and poultry associated with the 
Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/
HACCP) rule of 1996.\24\
---------------------------------------------------------------------------

    \24\ 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, D.C.

   Table 3--Summary, Projected Additional Average Direct Costs a b to the Domestic Industry of the Final Rule
                                                    Measures
----------------------------------------------------------------------------------------------------------------
                                                                                      Annualized total costs
                                                                     Recurring               (savings)
                   New measure                       One-time        (savings)   -------------------------------
                                                                                     7 percent       3 percent
----------------------------------------------------------------------------------------------------------------
Industry Costs:
    Sanitation SOPs.............................  ..............  ..............         $42,283         $42,122
    HACCP Plans--Validation.....................  ..............  ..............         160,435         156,512
    Pre-Harvest Actions--for Producers..........              $0         $60,971          60,971          60,971
    Pre-Harvest Actions--for Haulers............          86,400          18,355          29,851          28,189
    Labels......................................         131,670          13,398          30,918          28,384
    Government Office Space and Equipment.......          16,500           7,200           9,396           9,078
    Re-inspection at Import Establishments......           8,910          27,477          28,663          28,492
    Other--Reduced Payments.....................               0        (35,970)        (35,970)        (35,970)
                                                 ---------------------------------------------------------------
        Sub-Total Industries Costs..............  ..............  ..............         326,548         317,777
Agency Costs:
    Additional Costs to FSIS Inspection.........  ..............  ..............       2,604,402       2,587,217
    Reduced Costs to FDA........................  ..............         150,000       (150,000)       (150,000)
    Reduced Costs to Commerce Dept NOAA NMFS....  ..............     (1,340,000)     (1,340,000)     (1,340,000)
                                                 ---------------------------------------------------------------
        Sub-Total Agency Additional Costs.......  ..............  ..............       1,114,402       1,097,217
                                                 ---------------------------------------------------------------
        Total Net Costs.........................  ..............  ..............       1,440,949       1,414,995
----------------------------------------------------------------------------------------------------------------
\a\ Numbers in the table are rounded. Therefore, a total may not equal the sum of its parts.
\b\ Because the fish covered by this rulemaking present a new area of inspection for FSIS, there is a potential
  for the costs that the Agency is projecting to change during implementation. While FSIS believes that it can
  absorb at least some of the work for processing plants within existing patrol assignments, FSIS will not be
  able to completely validate this judgment until inspectors begin performing the inspections, and the agency is
  able to evaluate the workload that results. The Agency will not be able to make this final assessment until
  completion of the implementation phase.

F. Costs to Foreign Entities

1. Foreign Governments
    In order for a foreign establishment to be eligible to export 
Siluriformes fish products to the United States, FSIS must first 
determine if the regulatory system under which the foreign 
establishment operates is equivalent to the United States regulatory 
system. FSIS used U.S. Customs and Border Protection entry data from 
the period of January 1, 2009 to December 31, 2013 \25\ to assess the 
number of countries currently exporting Siluriformes products to the 
United States. During that time period, 35 countries exported 
Siluriformes products to the United States. Of those, 26 registered 
fewer than 15 entries into the United States during that same period. 
The remaining nine countries (Table AA) registered between 30 and 
24,474 shipments.
---------------------------------------------------------------------------

    \25\ Customs and Border Protection, Data pulled for OPPD by OFO/
Recall Management and Technical Analysis Staff on February 18, 2014.

        Table AA--Total Number of Shipments to the United States, Select Trading Partners, CY 2009--2013
----------------------------------------------------------------------------------------------------------------
                                                                                                       Total #
         Country of origin              2009         2010         2011         2012         2013      shipments
----------------------------------------------------------------------------------------------------------------
CAMBODIA..........................          125           53           33            3  ...........          214
CANADA............................          265          232          232          205          151        1,085
CHINA.............................          538          434          269          200          353        1,794
INDONESIA.........................           19            8            3  ...........  ...........           30
MALAYSIA..........................           24           12            2            3            1           42
MEXICO............................           33           30            7            9            1           80
SPAIN.............................           13           17           23            8  ...........           61
THAILAND..........................          349          204           89           44           48          734
VIETNAM...........................        2,603        3,094        5,480        6,741        6,556       24,474
----------------------------------------------------------------------------------------------------------------

    The cost to a country of maintaining an equivalent inspection 
system as a result of any incremental change to its existing regulatory 
framework is likely to be minimal for several reasons. First, several 
of the governments currently exporting to the United States maintain a 
meat or poultry inspection system equivalent to that of the United 
States

[[Page 75612]]

and are therefore aware of FSIS requirements.\26\ Second, many foreign 
governments maintain inspection systems similar to that required by the 
FSIS in order to have access to other markets, e.g. European Union \27\ 
and Canadian markets.\28\ Third, FSIS has outlined a plan for phased 
implementation to mitigate disruptions. Finally, FSIS and FDA have 
established a Memorandum of Understanding \29\ to assist our trading 
partners with the transition.
---------------------------------------------------------------------------

    \26\ At present Canada, China, Mexico, and Spain have equivalent 
status for at least one FSIS regulated product.
    \27\ The EU has approved importation of fish products from 
Vietnam, China, Canada, Thailand, Mexico, Spain, Malaysia, and 
Indonesia. This approval was granted after each country and its 
competent authority were evaluated for meeting specific requirements 
including residue monitoring and Salmonella spp. controls.
    \28\ Canada Food Inspection Agency, Import Information By 
Jurisdiction, Retrieved from http://www.inspection.gc.ca/food/fish-and-seafood/imports/by-jurisdiction/eng/1373433337535/1373433338754.
    \29\ Memorandum of Understanding Between The Food Safety and 
Inspection Service United States Department of Agriculture And The 
Food and Drug Administration United States Department of Health and 
Human Services. Retrieved from http://www.fsis.usda.gov/wps/wcm/connect/8675a5cb-7bca-4a8f-a563-7788adceb583/MOU-FSIS-FDA-Fish-Products.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

2. Foreign Establishments
    Due to limitations in the data, FSIS ability to estimate the number 
of manufacturers shipping Siluriformes products to the United States is 
limited. In order to assess the impact on foreign establishments, FSIS 
queried the U.S. Customs and Border Protection, FDA, and NOAA for data 
related to the number of manufacturers currently exporting Siluriformes 
products to the United States. Based on the previously cited U.S. 
Customs and Border Protection entry data, there are an estimated 314 
manufactures from the nine countries mentioned above that export 
Siluriformes products to the United States.\30\ However, it is unclear 
from the data source mentioned above if these manufacturers exclusively 
ship Siluriformes products. Based on a FDA report to Congress,\31\ in 
2008 there were approximately 14,900 foreign seafood firms registered 
to export product to the U.S. However, it is impossible to discern 
which of these firms deal with Siluriformes. While NOAA provided its 
December 2014 USDC Approved Establishments publication,\32\ due to data 
limitations it is impossible to determine which, if any, of these 
facilities export Siluriformes products to the United States. Even so, 
because foreign producers are currently meeting FDA standards, FSIS 
assumes that all establishments will continue to export Siluriformes 
product to the United State through the recognition of their respective 
national inspection systems and that the incremental costs to these 
establishments associated with this rule will be minimal. In addition, 
FSIS considered potential costs associated with reinspection at import 
facilities and has determined that it is not expected to cause an 
increase in spoilage because of the time needed to conduct the 
reinspection. The product arrives and is kept frozen.
---------------------------------------------------------------------------

    \30\ Customs and Border Protection, Data pulled for OPPD by OFO/
Recall Management and Technical Analysis Staff on February 18, 2014.
    \31\ FDA Report to Congress. 20 November 2008. The Secretary's 
Report to Congress on Enhanced Aquaculture and Seafood Inspection. 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm150954.htm.
    \32\ NOAA USDC Approved Establishments. December 2014. http://www.seafood.nmfs.noaa.gov/pdfs/participants_list14.pdf.
---------------------------------------------------------------------------

G. Associated Costs to U.S. Consumers

    FSIS has assumed that the transitional costs to foreign governments 
and producers are minimal. However, the Agency has also considered the 
possibility that any costs to these entities could be passed along to 
consumers. A review of the demand and supply literatures for 
Siluriformes yields ambiguous results. To start, given the numerous 
substitutes for Siluriformes filets, U.S. consumer demand for 
Siluriformes is expected to be elastic,\33\ indicating downward 
pressure on price. On the supply side, the United States International 
Trade Commission (USITC) determined the domestic supply of frozen 
Siluriformes filets to be elastic.\34\ Thus, any increase in price 
would be outpaced by an increase in domestic supply. This relationship 
puts downward pressure on price. Both volume-sold and retail-price data 
for 2005-2010 indicate that tilapia, pollock, and whiting, are 
competitive substitutes for both domestic and foreign Siluriformes. 
Competition for market share between these substitutes is expected to 
put downward pressure on retail prices.\35\ Further, because foreign 
producers derive a competitive advantage through charging low prices, 
they are disincentivized from increasing the price they seek.\36\ On 
the supply side, the United States International Trade Commission 
(USITC) determined the domestic supply of frozen Siluriformes filets, a 
substitute for imported Siluriformes filets, to be elastic, indicating 
that domestic processors have the flexibility to response to a change 
in demand brought about by a change in imports.\37\ As such, any 
increase in price of imported Siluriformes would be curtailed by an 
increase in domestic supply. All else held equal, higher elasticity of 
supply leads to a greater portion of regulatory costs being borne by 
consumers (in the form of price increases) than by producers (in the 
form of decreases in profit). However, the combination of elastic 
demand and elastic supply suggests that any regulatory cost burdens 
will be shared between consumers and producers. Elastic demand, the 
presence of many substitutes, and the fact that foreign suppliers 
depend on low market prices for competitive advantage indicate that 
domestic Siluriformes prices are not expected to increase, whereas 
elastic supply would offset this increase to an undetermined degree.
---------------------------------------------------------------------------

    \33\ USITC. Certain Frozen Fish Fillets from Vietnam. 
Investigation No. 731-TA-1012ITC, 2009. Retrieved from http://www.usitc.gov/publications/701_731/pub4083.pdf.
    \34\ Ibid.
    \35\ Dey, M.M., A.G. Rabbani, K. Singh, and C.R. Engle. 2014. 
Determinants of Retail Price and Sales Volume of Catfish Products in 
the United States: An Application of Retail Scanner Data, 
Aquaculture Economics & Management, 18:2, 120-148.
    \36\ Singh, K and M.M. Dey. 2011. International competitiveness 
of catfish in the U.S. market: A constant market share analysis. 
Aquaculture Economics & Management. 15:3, 214-229.
    \37\ USITC. Certain Frozen Fish Fillets from Vietnam. 
Investigation No. 731-TA-1012ITC, 2009. Retrieved from http://www.usitc.gov/publications/701_731/pub4083.pdf.
---------------------------------------------------------------------------

H. Expected Budgetary Impacts on FSIS and Other Government Agencies

    For the Government agencies, Table 3 shows the expected budgetary 
impacts that are the additional annualized average direct costs to FSIS 
and the reduced annualized average direct costs (i.e., a direct cost 
savings benefit) to FDA and the United States Department of Commerce's 
National Oceanic and Atmospheric Administration/National Marine 
Fisheries Service (USDC/NOAA/NMFS) with the implementation of the final 
rule.
    The annualized cost to the Government Agencies is $1,114.40 
thousand, at a 7 percent discount over 10 years. The projected 
annualized cost to the government is $1,097.22 thousand, at a 3 percent 
discount over 10 years.

I. Break-Even Analysis

1. Possible Health Benefits--Assessment Break-Even Analysis
    FSIS conducted an assessment of the potential risk to human health 
of Siluriformes fish consumption, using the example of Salmonella spp.

[[Page 75613]]

contamination. It focuses on exposure to Salmonella spp. because a 
broad hazard identification identified Salmonella spp. as one of the 
few potential hazards that there was sufficient data to assess in 
Siluriformes. The risk assessment provides different scenarios for the 
benefits that might result from an inspection system in Siluriformes 
similar to FSIS's inspection system for poultry.
    In addition, FSIS is particularly interested in Salmonella spp. 
because, among foodborne pathogens in FSIS-regulated products, it is 
the most common cause of hospitalizations and fatalities, and therefore 
a serious concern in the United States.\38\ We also note that there is 
evidence that at least one outbreak of human salmonellosis may have 
been related to Siluriformes consumption. FSIS acknowledges, however, 
that applying its empirical evidence describing the effectiveness of an 
FSIS inspection program for Salmonella spp. control in another 
regulated species (i.e., poultry) carries with it significant 
limitations. Therefore, we use Salmonella spp. to present potential 
benefits in this break-even analysis, but we do not directly use the 
findings of the risk assessment to monetize the expected benefits of 
the FSIS Siluriformes inspection system.
---------------------------------------------------------------------------

    \38\ CDC. CDC Estimates of foodborne illness in the United 
States. 2011. http://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html. 
     Batz, M. B., S. Hoffmann, and J. G. Morris, Jr. 2012. Ranking 
the disease burden of 14 pathogens in food sources in the United 
States using attribution data from outbreak investigations and 
expert elicitation. Journal of Food Protection. V75. 7. P1278-1291 
and Scharff, R. L. 2012. Economic burden from health losses due to 
foodborne illness in the United States. Journal of Food Protection. 
V75. 1. P123-131.
---------------------------------------------------------------------------

    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 of these severity levels.
    In summary, in Table 4 (below), for the final rule, FSIS projects 
the additional annualized average net direct cost to the domestic 
supply industry and the Government. The annualized cost to the industry 
and Government is $1,440.95 thousand, at a 7-percent discount rate over 
10 years. At a 3-percent discount rate over 10 years, the annualized 
cost to the industry and Government is $1,414.99 thousand.
    Applying the methodology of the USDA Economic Research Service 
(ERS) in projecting a monetary value for each case, FSIS uses an 
annualized average direct cost of $2,423 (in 2010 dollars) per new 
average case of salmonellosis.\39\ Thus, under the final rule for all 
fish of the order Siluriformes, using the projected annualized cost of 
$1,440.95 thousand (at a 7 percent discount rate over 10 years), and 
the estimated average direct cost of an average case of salmonellosis 
of $2,423 (in 2010 dollars), if an average of 595 domestic cases were 
averted, the additional annualized average direct costs would be equal 
to the additional annualized average public health benefits 
(salmonellosis domestic cases averted) of the final rule. At a 3-
percent discount rate over 10 years, using the projected annualized 
cost of $1,414.99 thousand and the average direct cost of an average 
case of salmonellosis of $2,423 (in 2010 dollars), if an average of 
about 584 cases were averted, the additional annualized average total 
net direct costs would be equal to the additional annualized average 
total public health benefits (salmonellosis illnesses averted) of the 
final rule. The assessment of the potential public health benefit of 
the final rule is from the FSIS Risk Assessment (December 2014). That 
illness estimate includes illnesses from consumption of both domestic 
and imported Siluriformes.
---------------------------------------------------------------------------

    \39\ FSIS assumes that the average cost of illness is $2,423 for 
a clinical case of salmonellosis, according to the USDA Economic 
Research Service (ERS) cost-calculator: The average direct cost of 
salmonellosis illnesses. ($2,423 per case in 2010 dollars) was 
developed using the USDA, ERS Foodborne Illness Costs Calculator: 
Salmonella (June 2011). FSIS updated the ERS calculator to include 
Scallan case distribution for salmonellosis. Scallan, E., Hoekstra, 
R., Angulo, F., et al. (2011). Foodborne Illness Acquired in the 
United States--Major Pathogens. Emerging Infectious Diseases, 17 
(1), pp. 7-15.
---------------------------------------------------------------------------

    Because of data limitations, this RIA does not factor in the cost 
to foreign entities in a quantitative analysis. A qualitative analysis 
of market elasticities, foreign entities competitive advantages, and 
substitute goods, however, indicates that the cost to foreign entities 
is not expected to affect the break even analysis.
    FSIS's primary cost estimate, used in the calculation above, 
includes zero costs to foreign establishments (and zero pass-through of 
foreign costs to U.S. consumers). If this estimate is correct, it is an 
indication that foreign establishments will not change their practices 
as a result of this rule, and thus there will be no health benefits to 
U.S. consumers of imported Siluriformes; in other words, all the 
illness avoidance in the break-even result would need to be associated 
with consumption of domestic Siluriformes. If the zero foreign cost 
assumption is incorrect, then the level of illness avoidance that would 
be necessary for the rule to break even would be higher--and 
potentially much higher--than the estimates shown in this section. Of 
course, once the program is implemented, FSIS will have better data on 
true illness avoidance and on potential reductions in chemical residue 
hazards.
    There is another reason to believe the break-even level of illness 
avoidance is higher than shown here. The actions assessed in the cost 
analysis are mostly related to knowledge of potential hazards, rather 
than the actual addressing of the hazards (for example, by discarding 
bad fish or taking a corrective action when an establishment that is 
newly monitoring a critical control point detects a deviation from an 
established critical limit). The latter is necessary for achieving 
health benefits and thus there are either costs--specifically, the 
costs of addressing hazards--currently omitted from the break-even 
calculation or the rule will not achieve the previously-calculated 
break-even point due to yielding negligible benefits. There are also 
benefits to establishments and consumers that FSIS cannot quantify at 
this time. For example, we cannot quantify the gains in consumer 
confidence that may result from better quality product, more accurate 
labeling, or better control over pathogens or residues.
    The assessment of the potential public health benefit of the final 
rule is from the FSIS Risk Assessment (December 2014). However, we note 
that under FSIS HACCP inspection as described in the risk assessment, 
Salmonella prevalence domestically has varied over time within meat and 
poultry product classes and among classes and establishment sizes. In a 
minority of cases, Salmonella prevalence has proved resistant to 
improvement. Therefore, the difference in Salmonella prevalence 
witnessed between the 1994-95 and 2007-08 microbiological baselines for 
broilers may not be indicative of the future trends in the 
microbiological quality of catfish, and substantial time and 
adaptations may be required before improvements are realized. However, 
even if the estimated public health benefits do not achieve

[[Page 75614]]

the break-even point, FSIS inspection of Siluriformes is mandated by 
law and non-discretionary.

       Table 4--Projected Summary Additional Annualized Average Net Direct Costs and Break-Even Assessment
----------------------------------------------------------------------------------------------------------------
                                                    Additional annualized cost,     Assessment of Salmonellosis
                                                     over 10 years, discounted      illnesses reduced needed to
                                                            $thousands               break even on annualized
                                                 --------------------------------    costs, over 10 years and
    Affected sectors of the domestic economy                                       discounted--in cases  averted
                                                                                             annually
                                                     7 percent       3 percent   -------------------------------
                                                                                     7 percent       3 percent
----------------------------------------------------------------------------------------------------------------
Siluriformes Fish Industry......................         $326.55         $317.78             135             131
Federal Government Agencies.....................        1,114.40        1,097.22             460             453
                                                 ---------------------------------------------------------------
    Total.......................................        1,440.95        1,414.99             595             584
----------------------------------------------------------------------------------------------------------------
Footnotes: The FSIS estimate for the average cost of Salmonellosis illnesses ($2,423 per case--in 2010 dollars)
  was developed using the USDA, ERS Foodborne Illness Costs Calculator: Salmonella (June 2011). FSIS updated the
  ERS calculator to include Scallan case distribution for salmonellosis. Scallan, E., Hoekstra, R., Angulo, F.,
  et al. (2011). Foodborne Illness Acquired in the United States--Major Pathogens. Emerging Infectious Diseases,
  17 (1), pp. 7-15.

2. Health Benefits--Removing Adulterated Products From the Market
    Furthermore, as outlined in the hazard analysis section of the FSIS 
risk assessment, there is the potential for hazardous chemicals to be 
present in Siluriformes. For example, in 2008, 9% of 150 and 2% of 53 
imported catfish samples tested by FDA tested positive for malachite 
green and gentian violet, respectively. There is evidence that those 
chemical are mutagenic or carcinogenic, and FDA has banned the use of 
both of those chemicals as aquaculture drugs or pesticides. The FSIS 
National Residue Program will target chemical hazards (identified as 
hazards of concern in the hazard identification of the FSIS risk 
assessment) and conduct testing with the goal of removing adulterated 
products from the market. As a result, although the number of illnesses 
that could be avoided by removing Siluriformes adulterated with illegal 
or violative concentrations of chemicals could not be quantified--the 
fish consuming public may accrue additional unquantified public health 
benefits from the removal of those products from the market.

J. Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), the final rule will not 
have a significant impact on a substantial number of small entities in 
the United States.
    For the 842 affected entities of the U.S. domestic industry, we 
project an average of 624 fish farms and fish hatcheries; 18 
establishments that slaughter and conduct primary processing of 
Siluriformes fish and Siluriformes fish products; and 200 facilities 
that are for (1) further/secondary processing-only of Siluriformes fish 
and Siluriformes fish products, (2) live-fish loaders/haulers/
wholesalers of Siluriformes fish, (3) wholesalers/brokers/importers/
exporters of Siluriformes fish, and (4) Siluriformes fish feed mills.
    We based this on USDA NASS statistics (2013), Food and Drug 
Administration (FDA) (2014), import records of the U.S. Department of 
Homeland Security (DHS) (2009-2013),\40\ Dun and Bradstreet (DNB) 
business database (2014), and the United States Census Bureau Economic 
Census (2012). See Table 5 for the details. Most of these 
establishments or entities 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 final rule would affect a substantial number of these 
small entities because the requirements would apply to all processing 
establishments in the Siluriformes fish and Siluriformes fish food 
processing industry that ship their products in interstate commerce and 
would to some extent pertain to fish-farming practices. As stated above 
in the cost section, the projected annualized cost to the domestic 
Siluriformes fish supply chain industries of the provisions of the 
final rule is $0.0008 per pound of aggregate processed Siluriformes 
fish and Siluriformes fish food products. The additional average direct 
cost per pound of the provisions to the Siluriformes fish and 
Siluriformes fish food products domestic industry compares to the 
average wholesale net price per pound received by domestic processors 
for frozen and fresh catfish food products that was $3.04 per pound, in 
2013, according to the USDA, National Agricultural Statistical Service 
(NASS).\41\
---------------------------------------------------------------------------

    \40\ U.S. Department of Homeland Security (DHS) Custom and 
Border Protection (CBP) import records of 2009 through 2013.
    \41\ Wholesale price, gross value FOB plant. Source: Catfish 
Processing Reports, NASS, USDA. 2009-2013.
---------------------------------------------------------------------------

    Furthermore, this final rule will likely not have a significant 
effect on a substantial number of businesses that import Siluriformes 
fish and Siluriformes fish products. FSIS projects that those companies 
will continue to import quantities of Siluriformes fish and 
Siluriformes fish products. Nevertheless, for the final rule, imported 
Siluriformes fish and Siluriformes fish products will be required to be 
inspected under a foreign system that is equivalent to that of the 
United States and be processed at establishments that the foreign 
inspection authority has certified as complying with United States 
requirements.

[[Page 75615]]



  Table 5--Projected Number of Siluriformes Fish and Siluriformes Fish
             Products Entities in the Domestic Supply Chain
------------------------------------------------------------------------
                                           Number of
  Siluriformes fish supply chain type    establishments    Percent SBA
            (NAICS code *)                   (FRIA)           small
------------------------------------------------------------------------
Slaughter and Primary Processors--Food               18               78
 Manufacturing (311712)...............
Further/Secondary Processors-only--                  10              100
 Food Manufacturing (311711)..........
Producers--Farms, Ponds & Fish                      624              100
 Hatcheries (112511...................
Feed Mills (311119)...................               14               86
Loaders/Haulers(/Wholesalers)--                      11              100
 Transporters Livestock Trucking
 (4842202)............................
(Product) Wholesalers or Brokers,                   165              100
 Importers and Exporters (424460).....
                                       ---------------------------------
    Total.............................              842  ...............
------------------------------------------------------------------------
a. The Small Business Administration defines a small business in food
  manufacturing classification processing as an entity that is
  independently owned and operated, is organized for profit, is not
  dominant, and has 500 or fewer employees.
* North American Industry Classification System (NAICS) code, NAICS
  Association, 2002
Sources: National Agricultural Statistics Service (NASS) (2013), NASS
  Census of Agriculture 2014, US Food and Drug Administration (FDA)
  (2014), Dun and Bradstreet (DNB) (2014), US Census Bureau Economic
  Census (2012), Customs and Border Protection (CBP) import records of
  the U.S. Department of Homeland Security (DHS) (2009-2013), and
  catfish experts from the cooperative extension service and the catfish
  industry.

XIV. Paperwork Reduction Act

    As provided by the 2014 Farm Bill (Section 12106(b)(3)), 
referencing Section 1601(c)(2), FSIS is exempt from filing an 
information collection request under the Paper Work Reduction Act of 
1995 (44 U.S.C. 3501, et seq.)

XV. 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.

XVI. Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

XVII. Expected Environmental Impact

    Each USDA agency is required to comply with 7 CFR part 1b of the 
Departmental regulations, which supplements the National Environmental 
Policy Act (NEPA) regulations published by the Council on Environmental 
Quality. Under these regulations, actions of certain USDA agencies and 
agency units are categorically excluded from the preparation of an 
Environmental Assessment (EA) or an Environmental Impact Statement 
(EIS) unless the agency head determines that an action may have a 
significant environmental effect (7 CFR 1b.4(b)). FSIS is among the 
agencies categorically excluded from the preparation of an EA or EIS (7 
CFR 1b.4(b)(6)).
    Currently, fish establishments are required to meet all local, 
State, and Federal environmental requirements. Under this final rule, 
fish establishments will still be required to meet all local, State and 
Federal environmental requirements. Thus, FSIS has determined that this 
final rule will not have significant individual or cumulative effect on 
the human health environment. Therefore, this regulatory action is 
appropriately subject to the categorical exclusion from the preparation 
of an EA or EIS provided under 7 CFR 1b.4(b)(6) of the USDA 
regulations. In accordance with 7 CFR 1b.3(c), FSIS will continue to 
scrutinize its activities to determine continued eligibility for 
categorical exclusion.

XVIII. Executive Order 13175 Indian Tribal Governments

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, Consultation and Coordination with Indian Tribal 
Governments. The review reveals that this regulation will not have 
substantial and direct effects on Tribal governments and will not have 
significant Tribal implications.

XIX. USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How to File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, 
Fax: (202) 690-7442, Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

XX. Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders.

[[Page 75616]]

The Update is available on the FSIS Web page. Through the Web page, 
FSIS is able to provide information to a much broader, more diverse 
audience. In addition, FSIS offers an email subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

List of Subjects

9 CFR Part 300

    Meat inspection.

9 CFR Part 441

    Consumer protection standards, Meat and meat products, Poultry 
products, Fish and fish products.

9 CFR Part 530

    Fish and fish products, Fish inspection.

9 CFR Part 531

    Fish and fish products, Fish inspection.

9 CFR Part 532

    Fish and fish products, Fish inspection, Reporting and 
recordkeeping requirements.

9 CFR Part 533

    Fish and fish products, Fish inspection, Government employees.

9 CFR Part 534

    Aquaculture, Fish and fish products, Fish inspection.

9 CFR Part 537

    Fish and fish products, Fish inspection, Hazard Analysis and 
Critical Control Point (HACCP) Systems, Sanitation, Reporting and 
recordkeeping requirements.

9 CFR Part 539

    Animal diseases, Fish and fish products, Fish inspection.

9 CFR Part 540

    Fish and fish products, Fish inspection.

9 CFR Part 541

    Fish and fish products, Fish inspection, Food labeling, Food 
packaging, Nutrition, Reporting and recordkeeping requirements, Signs 
and symbols.

9 CFR Part 544

    Fish and fish products, Fish inspection, Food additives, Food 
packaging, Laboratories, Reporting and recordkeeping requirements.

9 CFR Part 548

    Fish and fish products, Fish inspection, Food additives, Food 
packaging, Laboratories, Reporting and recordkeeping requirements, 
Signs and symbols.

9 CFR Part 550

    Fish and fish products, Fish inspection, Reporting and 
recordkeeping requirements.

9 CFR Part 552

    Fish and fish products, Fish inspection, Exports.

9 CFR Part 555

    Fish and fish products, Fish inspection, Reporting and 
recordkeeping requirements, Transportation.

9 CFR Part 557

    Fish and fish products, Fish inspection, Food labeling, Food 
packaging, Imports.

9 CFR Part 559

    Fish and fish products, Fish inspection, Crime, Seizures and 
forfeitures.

9 CFR Part 560

    Fish and fish products, Fish inspection, Intergovernmental 
relations.

9 CFR Part 561

    Administrative practice and procedure, Fish and fish products, Fish 
inspection, Government employees.

    For the reasons set forth in the preamble, 9 CFR chapter III is 
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

0
1. The authority citation for 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.


0
2. Section 300.3(a) is revised 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 fish 
of the order Siluriformes, the PPIA, and the EPIA. FSIS implements the 
inspection provisions of the FMIA, the PPIA, and the EPIA through its 
field structure.
* * * * *

SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION 
ACT AND THE POULTRY PRODUCTS INSPECTION ACT

PART 441--CONSUMER PROTECTION STANDARDS: RAW PRODUCTS

0
3. The authority citation for 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

0
4. In Sec.  441.10, remove the term ``Raw livestock and poultry'' and 
add in its place the term ``Raw livestock, poultry, and fish'' at the 
beginning of the first sentence of paragraph (a) and at the beginning 
of the first sentence of paragraph (b).

0
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 Fish of the Order Siluriformes 
and Products of Such Fish

Part

Sec.
530 General Requirements; Definitions
531 Definitions
532 Requirements for Inspection
533 Separation of Establishment; Facilities for Inspection; 
Facilities for Program Employees; Other Required Facilities
534 Pre-Harvest Standards and Transportation to Processing 
Establishment
537 Sanitation Requirements and Hazard Analysis and Critical Control 
Points Systems; Notification Regarding Adulterated or Misbranded 
Products
539 Mandatory Dispositions; Performance Standards Respecting 
Physical, Chemical, or Biological Contaminants
540 Handling and Disposal of Condemned and Other Inedible Materials
541 Marks, Marking and Labeling Of Products and Containers
544 Food Ingredients Permitted
548 Preparation of Products
549 [Reserved]
550 Records Required to be Kept
552 Exports
555 Transportation of Fish Products in Commerce
557 Importation
559 Detention, Seizure, Condemnation
560 State-Federal, Federal-State Cooperative Agreements; State 
Designations
561 Rules of Practice

[[Page 75617]]

Subchapter F--Mandatory Inspection of Fish of the Order Siluriformes 
and Products of Such Fish

PART 530--GENERAL REQUIREMENTS; DEFINITIONS

Sec.
530.1 General.
530.2 FSIS organization for fish inspection.
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, 2.18, 2.53.


Sec.  530.1  General.

    (a) The regulations in this subchapter provide for the inspection 
of Siluriformes fish and fish 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 fish 
or fish 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) Fish 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 fish.


Sec.  530.2  FSIS organization for inspection of fish and fish 
products.

    The Food Safety and Inspection Service, U.S. Department of 
Agriculture, administers an inspection program for fish and fish 
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, subchapter A of this chapter. 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 fish 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, 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, fish 
or fish 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 definition 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 therefore; 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:
    (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 fish at time of slaughter or in any of their tissues after slaughter 
as the result of treatment or exposure of the fish to a pesticide, 
organic or inorganic compound, hormone, hormone like substance, 
anthelmintic, 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 fish unless it is denatured or 
otherwise identified as required by Sec.  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.
    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 fish 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 fish. The body of a fish that has died otherwise than by 
slaughter.

[[Page 75618]]

    Dying or diseased fish. Fish affected by any of the conditions for 
which the fish 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.
    Fish. (1) For the purposes of this subchapter, any fish of the 
order Siluriformes, whether live or dead.
    (2) The skeletal muscle tissue of fish. As applied to products of 
fish of the order Siluriformes, this term has a meaning comparable to 
that of ``meat'' in the meat inspection regulations (9 CFR 301.2).
    Fish byproduct. Any fish part capable of use as human food, other 
than the skeletal muscle tissue, that has been derived from one or more 
fish.
    Fish food product. Any article capable of use as human food that is 
made wholly or in part from any fish or part thereof; or any product 
that is made wholly or in part from any fish or part thereof, excepting 
those exempted from definition as a fish product by the Administrator 
in specific cases or by a regulation in this subchapter; upon a 
determination that they contain fish ingredients only in a relatively 
small proportion or historically have not been considered by consumers 
as products of the fish 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 fish meat or other 
portions of such carcasses contained in such articles are not 
adulterated, and that such articles are not represented as fish food 
products.
    Fish product. Any fish or fish part; or any product that is made 
wholly or in part from any fish or fish part, except for those exempted 
from definition as a fish 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.
    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, fish or 
fish 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 definition 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, 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 fish food and fish 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

[[Page 75619]]

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, fish 
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, fish, or fish product under the Act.
    Packaging material. Any cloth, paper, plastic, metal, or other 
material used to form a container, wrapper, label, or cover for fish 
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 fish 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 
fish.
    Product. Any carcass, fish, fish product, or fish 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 fish, 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 fish, part, or product of 
fish so identified was inspected and found to be adulterated and is 
condemned.
    U.S. Detained. This term applies to fish, fish 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 fish, part, or product of 
fish 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.
532.2 Application for inspection; information to be furnished; grant 
or refusal of Inspection; conditions for receiving inspection; 
official numbers and inspection; assignment and authorities of 
Program employees.
532.3 Exemption of retail operations.
532.4 Inspection at official establishments; relation to other 
authorities.
532.5 Exemption from definition of fish product of certain human 
food products containing fish.

    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, 2.18, 2.53.


Sec.  532.1  Establishments requiring inspection; other inspection.

    (a) No establishment may process or prepare fish, fish parts, or 
fish products capable of use as human food, or sell, transport, or 
offer for sale or transportation in commerce any of these articles 
without 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 fish or fish 
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 fish or fish 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 fish products which would clearly endanger the 
public health.
    (4) Coverage of fish and fish products processed in official 
establishments. All fish and fish products prepared in an official 
establishment must be inspected, handled, processed, marked, and 
labeled as required by the regulations.
    (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 fish between premises where fish are 
bred, hatcheries, and premises where fish 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; information to be furnished; 
grant or refusal of Inspection; conditions for receiving inspection; 
official numbers and inspection; assignment and authorities of Program 
employees.

    (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, HACCP plans and written recall procedures, 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,

[[Page 75620]]

inauguration of inspection, withdrawal of inspection, and reports of 
violations at fish processing establishments are as required by part 
305 of this chapter for meat establishments.
    (d) Assignment and authorities of program employees. The 
requirements concerning the assignment and authorities of Program 
employees at fish processing establishments are as required by parts 
306 and 307 of this chapter with respect to Program employees at meat 
establishments.


Sec.  532.3  Exemption of retail operations.

    (a) 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 fish products as it does with respect to 
products of other amenable species under the FMIA.
    (b) The exemption also applies to the slaughtering of fish 
conducted at and by the operator of a retail store or restaurant, with 
respect to live fish purchased by a consumer at the retail store or 
restaurant, in accordance with the consumer's instructions.
    (c) A retail quantity of fish or fish products sold to a household 
consumer is a normal retail quantity if it does not exceed 75 pounds 
and the quantity of fish or fish 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 subchapter, 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 fish or 
fish products processed at any official establishment in accordance 
with the requirements under this subchapter and those Acts.


Sec.  532.5  Exemption from definition of fish product of certain human 
food products containing fish.

    The following articles contain fish ingredients only in a 
relatively small proportion or historically have not been considered by 
consumers to be products of the fish food products industry. Therefore, 
the articles are exempted from the definition of ``fish product'' and 
the requirements of the Act and the regulations that apply to fish 
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 fish;
    (2) The fish 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 subchapter 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 fish product. The 
percentage of cooked fish ingredients must be computed on the basis of 
the moist, deboned, cooked fish 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 fish product if the term ``fish'' or a term 
representing a fish species that is covered by the definition of 
``fish'' 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, 
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 fish 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.


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;

[[Page 75621]]

    (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 fish, fish 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 fish 
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 fish 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 fish.
534.4 Transportation to processing plant.

    Authority:  21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 
2.18, 2.53.


Sec.  534.1  General.

    Fish that are harvested for use as human food must have grown and 
lived under conditions that will not render the fish or their products 
unsound, unwholesome, unhealthful, or otherwise unfit for human food.


Sec.  534.2  Water quality for food fish.

    Farmers of fish 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 
water from producers, at intervals to be determined by the 
Administrator, for the purpose of verifying that fish are being raised 
under conditions that will yield safe, wholesome products.


Sec.  534.3  Standards for use of drugs in the raising of fish.

    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 U.S.C. 360b), or a conditional approval under section 571 
of the Act (21 U.S.C. 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 fish. 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 fish from a producer's premises to a 
processing establishment must be equipped with vats or other containers 
for holding the fish. 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 fish to ensure that fish delivered 
to the processing establishment will not be adulterated. Any fish that 
are dead, dying, diseased, or contaminated with substances that may 
adulterate fish products are subject to condemnation at the official 
fish processing establishments.

PART 537--SANITATION REQUIREMENTS AND HAZARD ANALYSIS AND CRITICAL 
CONTROL POINTS SYSTEMS; NOTIFICATION REGARDING ADULTERATED OR 
MISBRANDED PRODUCTS

Sec.
537.1 Basic requirements.
537.2 Hazard analysis and HACCP plan.
537.3 Notification.

    Authority:  21 U.S.C. 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 
2.7, 2.18, 2.53.


Sec.  537.1  Basic requirements.

    (a)(1) Any official establishment that prepares or processes fish 
or fish products for human food must comply with the requirements 
contained in 9 CFR parts 416, Sanitation and 417, Hazard Analysis and 
Critical Control Point (HACCP) Systems, except as otherwise provided in 
this subchapter.
    (2) For the purposes of 9 CFR part 416, Sanitation; 9 CFR part 417, 
Hazard Analysis and Critical Control Point (HACCP) Systems; and 9 CFR 
part 500, Rules of Practice, an ``official establishment'' or 
``establishment'' includes a plant that prepares or processes fish or 
fish products.


Sec.  537.2  Hazard analysis and HACCP plan.

    (a) A fish 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.


Sec.  537.3  Notification.

    Each official establishment must promptly notify the local FSIS 
District Office within 24 hours of learning or determining that an 
adulterated or misbranded fish product received by or originating from 
the official establishment has entered commerce, in accordance with the 
requirements of 9 CFR part 418.

PART 539--MANDATORY DISPOSITIONS; PERFORMANCE STANDARDS RESPECTING 
PHYSICAL, CHEMICAL, OR BIOLOGICAL CONTAMINANTS

Sec.
539.1 Disposal of diseased or otherwise adulterated fish carcasses 
and parts or fish products.
539.2 Physical, chemical, or biological contaminants.

    Authority:  21 U.S.C. 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 
2.7, 2.18, 2.53.

[[Page 75622]]

Sec.  539.1  Disposal of diseased or otherwise adulterated fish 
carcasses and parts or fish products.

    (a)(1) Carcasses or parts of fish affected by abscesses or lesions, 
zoonotic and non-zoonotic parasites such as cestodes, or such parasites 
as digenean trematodes, metacercaria (Bolbophorus spp.), yellow grubs 
(Clinostomum spp.), or white grubs (Hysteromorpha spp.) are subject to 
condemnation unless properly disposed of by the establishment to 
prevent their use as human food.
    (2) Fish affected by Heterophyid intestinal flukes or 
Dictophymatidae nematodes are subject to condemnation unless properly 
disposed of by the establishment.
    (b) Fish affected by diseases, including columnaris (infection by 
Flavobacterium columnare/Flexibacter columnaris) and enteric septicemia 
of fish (ESC), are subject to condemnation unless properly disposed of 
by the establishment to prevent their use as human food.
    (c) Fish carcasses or parts or fish 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) Fish with unusual gross deformities caused by disease or 
chemical contamination may not be used for human food.


Sec.  539.2  Physical, chemical, or biological contaminants.

    (a) Fish and fish products that are contaminated with physical 
matter are subject to official retention and condemnation.
    (b) Antibiotic or other drug residues in fish tissues must be 
within applicable tolerances in 21 CFR part 556 or within an applicable 
import tolerance established under 21 U.S.C. 360b(a)(6).
    (c) Pesticide residues in fish tissues must be within applicable 
tolerances in 40 CFR part 180.
    (d) Fish or fish 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 fish.
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. 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 
2.7, 2.18, 2.53.


Sec.  540.1  Dead fish.

    (a) With the exception of dead fish that have died en route to an 
official establishment that have been received with live fish at the 
official establishment, and that are subject to sorting and disposal at 
the official establishment, no fish or part of the carcass of fish 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 fish and the edible parts or products of 
slaughtered fish and any fish or parts of fish that have died otherwise 
than by slaughter. Fish or any parts of fish 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 fish materials.


Sec.  540.3  Handling and disposal of condemned or other inedible 
materials.

    Condemned or other inedible fish and fish parts shall be separated 
from edible fish. If not disposed of on the premises of the 
establishment, the condemned and inedible fish 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 
fish and fish 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. 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 
2.7, 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 fish and fish 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 fish and fish products.

    (a)(1) The official inspection legend required by this part must be 
shown on all labels for inspected and passed fish and fish 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] TR02DE15.000

    (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 fish 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 fish carcasses that have been inspected and passed 
in an official establishment and are intended for sale as whole gutted 
fish must be marked with the official inspection

[[Page 75623]]

legend or properly packaged in an immediate container labeled with the 
official inspection legend and all other required labeling features, 
that will ensure that the fish carcasses are identified as ``Inspected 
and Passed'' and will not become misbranded while in 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] TR02DE15.001

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 fish 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 fish and fish products 
required by part 552 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 fish 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, 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 fish and 
fish products.
    (b) A country of origin statement on the label of any fish 
``covered commodity'' as defined in 7 CFR part 60, subpart A, that is 
sold by a ``retailer,'' as defined in 7 CFR 60.124, must comply with 
the requirements of 7 CFR 60.200 and 60.300.
    (c) The safe handling instructions required on labels of fish and 
fish products specified in paragraph (a) of this section shall replace 
statements that include the terms ``meat'' and ``poultry'' with the 
following:
    (1) In the rationale statement, ``This product was prepared from 
inspected and passed fish. Some food products may contain bacteria that 
could cause illness if the product is mishandled and cooked improperly. 
For your protection, follow these safe handling instructions.'' This 
statement shall be placed immediately after the heading and before the 
safe handling statements.
    (2) In the labeling statements, ``Keep raw fish separate from other 
foods. Wash working surfaces (including cutting boards), utensils, and 
hands after touching raw fish. (A graphic illustration of soapy hands 
under a faucet shall be displayed next to statement.)''
    (d)(1) Labels and labeling of fish in the order Siluriformes and 
the products of those fish must bear the appropriate common or usual 
names of the fish. For example, among fish in the family Pangasiidae, 
the labels and labeling for fish of the species Pangasius bocourti must 
bear the term ``basa''; for the species Pangasius hypophthalmus or 
Pangasionodon hypophthalmus, ``swai,'' ``tra,'' or ``sutchi.''
    (2) The labels and labeling only of fish and fish products within 
the family Icataluridae may bear the term ``catfish.''
    (e) The requirements in part 441 of this chapter, governing water 
retained from processing in raw meat and poultry, apply to retained 
water in fish. The requirements in part 442 of this chapter, 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 fish and fish products.
    (1) Packages of frozen or fresh-frozen fish 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.\1\
---------------------------------------------------------------------------

    \1\ U.S. Department of Commerce. NIST Handbook 133: Checking the 
Net Contents of Packaged Goods, 2013. Washington, DC.
---------------------------------------------------------------------------

    (2) [Reserved]
    (f) 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 fish and fish food products.
    (g) Label approval. The requirements for the label approval of meat 
and meat food products in part 412 of this chapter, also apply to the 
labeling of fish and fish 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, 2.18, 
2.53.


Sec.  544.1  Use of food ingredients.

    (a) No fish product may bear or contain any food ingredient that 
would render it adulterated or misbranded or that is not approved in 
part 424 of this chapter, 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 fish products.
548.2 Requirements concerning ingredients and other articles used in 
the preparation of fish products.
548.3 Samples of products, water, dyes, chemicals, etc. to be taken 
for examination.
548.4 [Reserved]
548.5 Ready-to-eat fish products.
548.6 Canning and canned products.
548.7 Use of new 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, 2.18, 2.53.


Sec.  548.1  Preparation of fish products.

    (a) All processes used in preparing any fish product in official 
establishments shall be subject to inspection by Program employees 
unless such preparation is conducted as

[[Page 75624]]

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 fish products.

    All ingredients and other articles used in the preparation of any 
fish 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 fish products.

    Ready-to-eat fish products are subject to the requirements in part 
430 of this chapter.


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 fish products that are 
canned.


Sec.  548.7  Use of new animal drugs.

    Edible tissues of fish with residues exceeding tolerance levels 
specified in 21 CFR part 556 or established in an import tolerance 
under 21 U.S.C. 360b(a)(6) 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 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 part 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, 
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 fish and fish 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 fish 
and fish 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 fish and fish 
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 fish and 
fish 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 fish 
and fish 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, 
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 FISH PRODUCTS IN COMMERCE

Sec.
555.1 Transportation of fish products.
555.2 Fish product transported within the United States as part of 
export movement.
555.3 Unmarked, inspected fish product transported under official 
seal between

[[Page 75625]]

official establishments for further processing; certificate.
555.4 Handling of fish products that may have become adulterated.
555.5 Transportation of inedible fish product in commerce.
555.6 Certificates.
555.7 Official seals; forms, use, and breaking.
555.8 Loading or unloading of fish 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 fish, and fish or parts of fish that died otherwise than 
by slaughter.
555.12 Means of conveyance in which dead, dying, or diseased fish or 
parts of fish must be transported.

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


Sec.  555.1  Transportation of fish products.

    (a) No person may sell, transport, offer for sale or 
transportation, or receive for transportation, in commerce, any fish or 
fish 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 subchapter.
    (b) No person, engaged in the business of buying, selling, 
freezing, storing, or transporting, in or for commerce, fish 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 fish 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 
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 fish 
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 fish product placed therein could become adulterated 
shall not be used until such condition which could cause adulteration 
is corrected.
    Fish product placed in any means of conveyance that is found by the 
inspector to be in such condition that the fish 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  Fish product transported within the United States as part 
of export movement.

    When any shipment of any fish 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 fish product transported under 
official seal between official establishments for further processing; 
certificate.

    The requirements governing transportation of fish 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 fish products that may have become 
adulterated.

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


Sec.  555.5  Transportation of inedible fish 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 fish 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 fish and fish 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 fish products in sealed transport 
conveyances.

    The requirements in 9 CFR 325.17 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 fish and fish products.


Sec.  555.9  Diverting of shipments

    (a) Shipments of inspected and passed fish 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 of this chapter.
    (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.

[[Page 75626]]

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 fish, and fish or parts of fish 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 
fish or parts of fish 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 fish or 
parts of fish that died otherwise than by slaughter, unless the fish 
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, 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 
section 301(c) of the Act;
    (b) Buy in commerce or import any dead, dying, or diseased fish or 
parts of fish 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 fish or 
parts of fish 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 fish 
or parts of fish 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 fish, or parts of fish 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 Investigation, Enforcement and Audit, 
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 fish, or parts of fish that died otherwise than by 
slaughter, while in the course of importation or other transportation 
in commerce any fish or parts of fish not within the foregoing 
description or any other products or other commodities.


Sec.  555.12  Means of conveyance in which dead, dying, or diseased 
fish or parts of fish 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 fish or parts of fish 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 fish or parts of fish 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 fish 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 fish and 
fish products into the United States.
557.3 No fish or fish product to be imported without compliance with 
applicable regulations.
557.4 Imported fish and fish products; foreign certificates 
required.
557.5 Importer to make application for inspection of fish and fish 
products for entry.
557.6 Fish and fish 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 fish and fish 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 fish and fish products 
samples.
557.12 Foreign canned or packaged fish and fish products bearing 
trade labels; sampling and inspection.
557.13 Foreign fish and fish products offered for importation; 
reporting of findings to Customs.
557.14 Marking of fish 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 fish and fish products.
557.18 Fish and fish 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 fish and fish 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, 
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 fish and fish 
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

[[Page 75627]]

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 fish 
and fish products into the United States.

    (a) The requirements in 9 CFR 327.2(a)(1), (a)(2)(i), 
(a)(2)(ii)(C)-(I), (a)(2)(iii)-(iv), and (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 fish inspection systems for 
the importation of fish and fish 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 fish are raised and transported to a processing 
establishment.
    (b)(1) It has been determined that fish and fish products from the 
following countries covered by foreign inspection certificates of the 
country of origin as required by Sec.  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 December 2, 2015).
    (2) Persons interested in having the most recent list of eligible 
countries and establishments may contact the Office of Policy and 
Program Development, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250.


Sec.  557.3  No fish or fish product to be imported without compliance 
with applicable regulations.

    No fish or fish product offered for importation from any foreign 
country shall be admitted into the 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 fish and fish products; foreign certificates 
required.

    (a) Except as provided in Sec.  557.16, each consignment containing 
any fish or fish products consigned to the United States from a foreign 
country must be accompanied by an electronic foreign inspection 
certificate or a paper foreign inspection certificate for fish and fish 
products. The certificate must have been issued by an official of the 
foreign government agency responsible for the inspection and 
certification.
    (b) An official of the foreign government must certify that any 
fish or fish product described on any official certificate was produced 
in accordance with the regulatory requirements in Sec.  557.2.
    (c) The electronic foreign inspection certification must be in 
English, be transmitted directly to FSIS before the product's arrival 
at the official import inspection establishment, and be available to 
import inspection personnel.
    (d) The paper foreign inspection certificate must accompany each 
consignment; be submitted to import inspection personnel at the 
official import inspection establishment; be in English; bear the 
official seal of the foreign government responsible for the inspection 
of the product, and the name, title, and signature of the official 
authorized to issue inspection certificates for products imported to 
the United States.
    (e) The electronic foreign inspection certification and paper 
foreign inspection certificate must contain:
    (1) The date;
    (2) The foreign country of export and the producing foreign 
establishment number;
    (3) The species used to produce the product and the source country 
and foreign establishment number, if the source materials originate 
from a country other than the exporting country;
    (4) The product's description, including the process category, the 
product category, and the product group;
    (5) The name and address of the importer or consignee;
    (6) The name and address of the exporter or consignor;
    (7) The number of units (pieces or containers) and the shipping or 
identification;
    (8) The net weight of each lot;
    (9) Any additional information the Administrator requests to 
determine whether the product is eligible to be imported into the 
United States.


Sec.  557.5  Importer to make application for inspection of fish and 
fish products for entry.

    (a) Applicants must submit an import inspection application, to 
apply for the inspection of any product offered for entry. Applicants 
may apply for inspection using a paper or electronic application form.
    (b) Import inspection applications for each consignment must be 
submitted, electronically or on paper, to FSIS in advance of the 
shipment's arrival at the official import establishment where the 
product will be reinspected, but no later than when the entry is filed 
with U.S. Customs and Border Protection.
    (c) The provisions of this section do not apply to products that 
are exempted from inspection by Sec. Sec.  557.16 and 557.17.


Sec.  557.6  Fish and fish 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 fish 
and fish 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) The electronic inspection system will be consulted for 
reinspection instructions. The electronic inspection system will assign 
reinspection levels and procedures based on established sampling plans 
and established product and plant history.
    (4) When the inspector deems it necessary, the inspector may sample 
and inspect lots not designated by the electronic system.
    (b) Fish and fish 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

[[Page 75628]]

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 fish or fish product, including 
defrosting if necessary to determine its condition. Inspection 
standards for foreign chilled fresh or frozen fresh fish shall be the 
same as those used for domestic fish or fish 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 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 chapter. The importer or his/her agent shall 
provide the necessary incubation facilities in accordance with Sec.  
318.309(d)(1)(i) of this chapter.
    (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 Field Operations, 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 fish and fish 
products.


Sec.  557.8  Import fish and fish 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 fish or fish product to the United States, 
and all trucks, chutes, platforms, racks, tables, tools, utensils, and 
all other devices used in moving and handling any fish or fish 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 fish and fish products.


Sec.  557.11  Receipts to importers for import fish 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 fish and fish products bearing 
trade labels; sampling and inspection.

    Foreign canned or packaged fish and fish 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 fish and fish products offered for importation; 
reporting of findings to Customs.

    Program inspectors are to report their findings as to any fish or 
fish products that have been inspected in accordance with this part in 
the same manner as that provided by Sec.  327.13 of this chapter for 
meat products. Fish and fish products that are refused entry are to be 
handled in the same manner as provided by Sec.  327.13 of this chapter 
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 fish and fish 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 fish and fish 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

[[Page 75629]]

food products apply also with respect to fish and fish 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 fish or fish products.


Sec.  557.17  Returned U.S. inspected and marked fish and fish 
products.

    U.S. inspected and passed and so marked fish 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 Field Operations, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250, in specific cases.


Sec.  557.18  Fish or fish 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 
fish and fish 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 fish or fish 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 of this chapter.


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 fish and fish products 
condemned or ordered destroyed under import inspection.

    Disposition procedures for condemned fish or fish 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 fish and fish 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 Fish and other articles subject to administrative detention.
559.2 Articles or fish 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, 2.18, 2.53.


Sec.  559.1  Fish 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 livestock apply also with respect to the carcasses, parts, 
and products of fish.


Sec.  559.2  Articles or fish 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 fish.


Sec.  559.3  Criminal offenses.

    The criminal provisions of the Act apply with respect to the 
inspection of fish and fish 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 Cooperation of States for the Interstate Shipment of Fish and 
Fish Products.
560.4 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, 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 
fish and fish 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 fish and fish 
products. A cooperative program for this purpose is called a Federal-
State program.


Sec.  560.3  Cooperation of States for the Interstate Shipment of Fish 
and Fish Products.

    The provisions in Sec.  321.3 authorizing the Administrator to 
coordinate with States that have meat inspection programs as provided 
in Sec.  321.1 of this chapter to select certain establishments 
operating under these programs to participate in a cooperative program 
to ship products in interstate commerce apply with respect to fish and 
fish products inspection.


Sec.  560.4  Designation of States under the Federal Meat Inspection 
Act.

    The requirements in part 331 of this chapter apply with respect to 
fish and fish 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 section 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, 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 fish slaughter, fish 
processing, fish, and fish products regulated under this subchapter.

[[Page 75630]]

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 of this chapter.

    Done, at Washington, DC: November 18, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-29793 Filed 11-30-15; 4:15 pm]
 BILLING CODE 3410-DM-P