Mandatory Inspection of Fish of the Order Siluriformes and Products Derived From Such Fish, 75589-75630 [2015-29793]
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Vol. 80
Wednesday,
No. 231
December 2, 2015
Part III
Department of Agriculture
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Food Safety and Inspection Service
9 CFR Parts 300, 441, 530, et al.
Mandatory Inspection of Fish of the Order Siluriformes and Products
Derived From Such Fish; Final Rule
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Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations
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
Food Safety and Inspection
Service.
ACTION: Final rule.
AGENCY:
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.
SUMMARY:
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
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DATES:
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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
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‘‘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
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Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations
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 inspectedand-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 18month 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.
1 Annualized present value of average costs is at
a 7 percent discount rate over 10 years.
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TABLE 1—PROJECTED SUMMARY ADDITIONAL ANNUALIZED AVERAGE NET
DIRECT COSTS (DOMESTIC) OF THE
FINAL RULE
Affected sectors of
the domestic economy
Additional annualized
cost, over 10 years,
discounted
$thousands
7
percent
3
percent
Siluriformes Fish Industry ....................
Federal Government
Agencies ...............
$326.55
$317.78
1,114.40
1,097.22
Total ......................
1,440.95
1,414.99
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
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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
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Background
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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 https://
www.fsis.usda.gov/wps/wcm/connect/
eefd3e0d-ea69-4c75-b1acea4df9d133e4/Transcripts_05242011_
Catfish_meeting.pdf?MOD=AJPERES
and https://www.fsis.usda.gov/wps/wcm/
connect/ddb209ab-6aa3-4953-951470a8532d3348/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.
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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 https://
www.fsis.usda.gov/wps/portal/
informational/aboutfsis/food-safetyagencies/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
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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.
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
2 Integrated Taxonomic Information System (ITIS)
report on ‘‘Siluriformes.’’ At https://www.itis.gov.
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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.
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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
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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).
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
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
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).
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: https://
www.fsis.usda.gov/OPPDE/rdad/FRPubs/20070022P/610_Report_PR_HACCP.pdf.
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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: https://www.fsis.usda.gov/
wps/wcm/connect/63387be5-ca8e-442db047-f031f29a8a47/SilurifomesRA.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
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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.
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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 crossreferenced 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
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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 nonhousehold 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.
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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
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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.
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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
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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
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75595
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
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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 (https://www.fda.gov/food/
guidanceregulation/guidancedocuments
regulatoryinformation/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
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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, singleingredient products. The Agency
received no comments on this
provision, and it is adopted as
proposed.
J. Food Ingredients Permitted
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.
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: https://
www.fsis.usda.gov/wps/portal/fsis/
topics/regulations/directives/7000series. This final rule adopts the
requirement 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.
K. Ready-to-Eat and Canned Fish
Products: Control of Listeria
monocytogenes
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.
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.
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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.
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
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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
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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.
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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
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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.
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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
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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-inCharge 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
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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.
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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
https://www.fsis.usda.gov/wps/portal/
informational/aboutfsis/food-safetyagencies/mou.
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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
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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
7 U.S. Centers for Disease Control and Prevention
(CDC). (June 2009) Foodborne Disease Outbreak
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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.’’
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.
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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.
Surveillance Data. Atlanta, GA. Retrieved from
https://www.cdc.gov/foodsafety/fdoss/.
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.
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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
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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
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
9 Annualized present value of average costs is at
a 7 percent discount rate over 10 years.
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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
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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
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75601
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 noninspected 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 noninspected 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 crosscontamination that may occur through
these activities. FSIS does not believe
there is a meaningful distinction
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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.
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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
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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
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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 ‘‘wildcaught’’ 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-
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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, ‘‘farmraised’’ or ‘‘wild-caught,’’ be required on
the label. A similar comment requested
that ‘‘wild-caught’’ fish be labeled as
such to distinguish them from ‘‘farmraised’’ 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 farmraised).
I. Labeling
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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 inprocess 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
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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 https://
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,
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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, crossreferencing 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 319that 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 furtherprocessed fish products produced
domestically (76 FR 10446), and FSIS is
not aware of any fish standard-ofidentity 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,
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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
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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
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production information (wild or farmraised) (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 preharvest 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
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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).
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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
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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 nonhousehold 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
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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 intraState. 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.
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.
mstockstill on DSK4VPTVN1PROD with RULES2
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 18month transitional period, the Agency is
providing establishments ample time to
prepare and comply with the final
regulations. In addition, during the 18month 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.
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 18month 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.
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
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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 18month 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.
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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.
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
10 https://docs.house.gov/billsthisweek/20140127/
CRPT-113hrpt-HR2642-SOM.pdf.
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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 18month 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
75607
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
Type of
sample
100 (at each laboratory).
50 (at each laboratory)
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Samples per year
Domestic ....................
Tests at eastern laboratory
Import .........................
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
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Jkt 238001
Salmonella,
Veterinary
Salmonella,
Veterinary
Speciation, Metals, Dyes, and
Drug Residures (MRM).
Speciation, Metals, Dyes, and
Drug Residues (MRM).
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
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Tests at western laboratory
Salmonella, Pesticides, Veterinary Drug Residues (MRM), and Nitrofurans.
Pesticides and Nitrofurans.
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:
InternationalEquivalence@fsis.usda.gov.
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,
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Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations
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: https://
www.fsis.usda.gov/wps/portal/fsis/
topics/international-affairs/importingproducts/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 18month 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
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13:52 Dec 01, 2015
Jkt 238001
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 18month 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.
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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
• 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.
In establishments that request
inspection services under the
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.
12 More additional information, see the FDA
Seafood HACCP regulations and guidance at
https://www.fda.gov/Food/GuidanceRegulation/
HACCP/ucm2006764.htm.
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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:
• 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
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).
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13:52 Dec 01, 2015
Jkt 238001
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
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75609
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).
D. Alternative Regulatory Approaches
Considered
Initially, FSIS considered two basic
regulatory approaches to Siluriformes
fish and Siluriformes fish products
inspection: (1) A more command-andcontrol 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-andcontrol 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
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.
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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.
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.
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 thirdparty 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
16 ‘‘Mandatory Inspection of Ratites and Squabs.’’
May 7, 2001 (66 FR 22899).
17 ‘‘Mandatory Inspection of Ratites and Squabs.’’
May 7, 2001 (66 FR 22899).
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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, feefor-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
18 For more information regarding the difference,
see the Proposed Regulatory Impact Analysis, Table
2.
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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.
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: https://www.fsis.usda.gov/
wps/wcm/connect/63387be5-ca8e-442db047-f031f29a8a47/SilurifomesRA.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
19 FDA
March 2011 Labeling Cost Model.
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.
20 Source:
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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).
These additional regulatory costs
compare to an estimated direct cost of
about $0.01 per pound of meat and
75611
poultry associated with the Pathogen
Reduction/Hazard Analysis and Critical
Control Points (PR/HACCP) rule of
1996.24
TABLE 3—SUMMARY, PROJECTED ADDITIONAL AVERAGE DIRECT COSTS a b TO THE DOMESTIC INDUSTRY OF THE FINAL
RULE MEASURES
New measure
Recurring
(savings)
One-time
Annualized total costs
(savings)
7 percent
Industry Costs:
Sanitation SOPs .......................................................................................
HACCP Plans—Validation ........................................................................
Pre-Harvest Actions—for Producers ........................................................
Pre-Harvest Actions—for Haulers ............................................................
Labels .......................................................................................................
Government Office Space and Equipment ...............................................
Re-inspection at Import Establishments ...................................................
Other—Reduced Payments ......................................................................
3 percent
........................
........................
$0
86,400
131,670
16,500
8,910
0
........................
........................
$60,971
18,355
13,398
7,200
27,477
(35,970)
$42,283
160,435
60,971
29,851
30,918
9,396
28,663
(35,970)
$42,122
156,512
60,971
28,189
28,384
9,078
28,492
(35,970)
Sub-Total Industries Costs ................................................................
Agency Costs:
Additional Costs to FSIS Inspection .........................................................
Reduced Costs to FDA ............................................................................
Reduced Costs to Commerce Dept NOAA NMFS ...................................
........................
........................
326,548
317,777
........................
........................
........................
........................
150,000
(1,340,000)
2,604,402
(150,000)
(1,340,000)
2,587,217
(150,000)
(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.
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.
b Because
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.
TABLE AA—TOTAL NUMBER OF SHIPMENTS TO THE UNITED STATES, SELECT TRADING PARTNERS, CY 2009—2013
Country of origin
2009
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CAMBODIA ......................................................................
CANADA ..........................................................................
CHINA ..............................................................................
INDONESIA .....................................................................
MALAYSIA .......................................................................
MEXICO ...........................................................................
SPAIN ..............................................................................
THAILAND .......................................................................
VIETNAM .........................................................................
125
265
538
19
24
33
13
349
2,603
2010
2011
53
232
434
8
12
30
17
204
3,094
2012
33
232
269
3
2
7
23
89
5,480
2013
3
205
200
....................
3
9
8
44
6,741
....................
151
353
....................
1
1
....................
48
6,556
Total #
shipments
214
1,085
1,794
30
42
80
61
734
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
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.
25 Customs and Border Protection, Data pulled for
OPPD by OFO/Recall Management and Technical
Analysis Staff on February 18, 2014.
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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.
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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
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 https://
www.inspection.gc.ca/food/fish-and-seafood/
imports/by-jurisdiction/eng/1373433337535/13734
33338754.
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 https://www.
fsis.usda.gov/wps/wcm/connect/8675a5cb-7bca4a8f-a563-7788adceb583/MOU-FSIS-FDA-FishProducts.pdf?MOD=AJPERES.
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. https://www.
fda.gov/Food/GuidanceRegulation/Guidance
DocumentsRegulatoryInformation/Seafood/
ucm150954.htm.
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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.
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
32 NOAA USDC Approved Establishments.
December 2014. https://www.seafood.nmfs.noaa.
gov/pdfs/participants_list14.pdf.
33 USITC. Certain Frozen Fish Fillets from
Vietnam. Investigation No. 731–TA–1012ITC, 2009.
Retrieved from https://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.
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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.
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.
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 https://www.usitc.gov/publications/
701_731/pub4083.pdf.
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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 FSISregulated 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 breakeven analysis, but we do not directly
use the findings of the risk assessment
to monetize the expected benefits of the
FSIS Siluriformes inspection system.
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
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38 CDC.
CDC Estimates of foodborne illness in the
United States. 2011. https://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.
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$1,440.95 thousand, at a 7-percent
discount rate over 10 years. At a 3percent 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.
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
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.
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75613
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
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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, over
10 years, discounted
$thousands
Affected sectors of the domestic economy
7 percent
3 percent
Assessment of Salmonellosis
illnesses reduced needed to
break even on annualized
costs, over 10 years and
discounted—in cases
averted annually
7 percent
3 percent
Siluriformes Fish Industry ................................................................................
Federal Government Agencies ........................................................................
$326.55
1,114.40
$317.78
1,097.22
135
460
131
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.
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
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.
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.
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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
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.
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75615
TABLE 5—PROJECTED NUMBER OF SILURIFORMES FISH AND SILURIFORMES FISH PRODUCTS ENTITIES IN THE DOMESTIC
SUPPLY CHAIN
Number of
establishments
(FRIA)
Siluriformes fish supply chain type
(NAICS code *)
Percent SBA
small
Slaughter and Primary Processors—Food Manufacturing (311712) ..................................................................
Further/Secondary Processors-only—Food Manufacturing (311711) .................................................................
Producers—Farms, Ponds & Fish Hatcheries (112511 ......................................................................................
Feed Mills (311119) .............................................................................................................................................
Loaders/Haulers(/Wholesalers)—Transporters Livestock Trucking (4842202) ...................................................
(Product) Wholesalers or Brokers, Importers and Exporters (424460) ..............................................................
18
10
624
14
11
165
78
100
100
86
100
100
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 EGovernment Act (44 U.S.C. 3601 et seq.)
by, among other things, promoting the
use of the Internet and other
information technologies and providing
increased opportunities for citizen
access to Government information and
services, and for other purposes.
mstockstill on DSK4VPTVN1PROD with RULES2
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
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13:52 Dec 01, 2015
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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,
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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 https://
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:
program.intake@usda.gov.
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: https://
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.
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Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations
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:
https://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 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.
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
9 CFR Part 550
Fish and fish products, Fish
inspection, Reporting and
recordkeeping requirements.
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
9 CFR Part 552
Fish and fish products, Fish
inspection, Exports.
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
4. In § 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).
■
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.
Fish and fish products, Fish
inspection.
9 CFR Part 531
Fish and fish products, Fish
inspection.
9 CFR Part 559
Fish and fish products, Fish
inspection, Crime, Seizures and
forfeitures.
9 CFR Part 532
Fish and fish products, Fish
inspection, Reporting and
recordkeeping requirements.
9 CFR Part 560
Fish and fish products, Fish
inspection, Intergovernmental relations.
9 CFR Part 533
Fish and fish products, Fish
inspection, Government employees.
PART 441—CONSUMER PROTECTION
STANDARDS: RAW PRODUCTS
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
531
532
533
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:
534
Fish and fish products, Fish
inspection, Hazard Analysis and Critical
Control Point (HACCP) Systems,
Sanitation, Reporting and recordkeeping
requirements.
Subchapter A—Agency Organization and
Terminology; Mandatory Meat and Poultry
Products Inspection and Voluntary
Inspection and Certification
539
9 CFR Part 539
PART 300—AGENCY MISSION AND
ORGANIZATION
Animal diseases, Fish and fish
products, Fish inspection.
■
9 CFR Part 534
Aquaculture, Fish and fish products,
Fish inspection.
9 CFR Part 537
1. The authority citation for part 300
continues to read as follows:
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9 CFR Part 540
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.
Fish and fish products, Fish
inspection.
Fish and fish products, Fish
inspection, Food labeling, Food
packaging, Nutrition, Reporting and
recordkeeping requirements, Signs and
symbols.
13:52 Dec 01, 2015
540
541
544
548
549
550
552
555
■
9 CFR Part 541
VerDate Sep<11>2014
2. Section 300.3(a) is revised as
follows:
537
Jkt 238001
§ 300.3
FSIS organization.
(a) General. The organization of FSIS
reflects the Agency’s primary regulatory
responsibilities: implementation of the
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557
559
560
561
General Requirements; Definitions
Definitions
Requirements for Inspection
Separation of Establishment; Facilities
for Inspection; Facilities for Program
Employees; Other Required Facilities
Pre-Harvest Standards and
Transportation to Processing
Establishment
Sanitation Requirements and Hazard
Analysis and Critical Control Points
Systems; Notification Regarding
Adulterated or Misbranded Products
Mandatory Dispositions; Performance
Standards Respecting Physical,
Chemical, or Biological Contaminants
Handling and Disposal of Condemned
and Other Inedible Materials
Marks, Marking and Labeling Of
Products and Containers
Food Ingredients Permitted
Preparation of Products
[Reserved]
Records Required to be Kept
Exports
Transportation of Fish Products in
Commerce
Importation
Detention, Seizure, Condemnation
State-Federal, Federal-State
Cooperative Agreements; State
Designations
Rules of Practice
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Federal Register / Vol. 80, No. 231 / Wednesday, December 2, 2015 / Rules and Regulations
Subchapter F—Mandatory Inspection of
Fish of the Order Siluriformes and Products
of Such Fish
PART 530—GENERAL
REQUIREMENTS; DEFINITIONS
Sec.
530.1
530.2
530.3
General.
FSIS organization for fish inspection.
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.
§ 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.
§ 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.
§ 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
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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.
§ 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,
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13:52 Dec 01, 2015
Jkt 238001
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;
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75617
(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 § 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.
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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.
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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:
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(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
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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 § 548.6 of this
subchapter or to subpart G of part 318
of this chapter.
Process schedule. A written
description of processing procedures,
consisting of any number of specific,
sequential operations directly under the
control of the establishment employed
in the manufacture of a specific product,
including the control, monitoring,
verification, validation, and corrective
action activities associated with
production. This definition does not
apply to § 548.6 of this subchapter or to
subpart G of part 318 of this chapter.
Producer. Any person engaged in the
business of growing farm-raised fish.
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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.
§ 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
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regulations, except as expressly
exempted in § 532.3.
(b) Inspection under the regulations is
required at:
(1) Every establishment, except as
provided in the regulation on exemption
of retail operations (§ 532.3), in which
any 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 (§ 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 (§ 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.
§ 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,
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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.
§ 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.
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§ 532.4 Inspection at official
establishments; relation to other
authorities.
(a) Requirements within the scope of
the Act with respect to premises,
facilities, and operations of any official
establishment that are in addition to or
different than those made under this
subchapter may not be imposed by any
State or local jurisdiction except that the
State or local jurisdiction may impose
recordkeeping and other requirements
within the scope of § 550.1 of this
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.
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§ 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 § 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.
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§ 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.
§ 533.2
[Reserved]
§ 533.3
Facilities for Program employees.
Office space, including necessary
furnishings, light, heat, and janitor
service, must be provided by official
establishments, rent free, for the
exclusive use for official purposes of the
inspector and other Program employees
assigned thereto. The space set aside for
this purpose shall meet with approval of
the District Manager or the frontline
supervisor and must be conveniently
located, properly ventilated, and
provided with lockers suitable for the
protection and storage of Program
supplies and with facilities suitable for
Program employees to change clothing if
such facilities are deemed necessary by
the frontline supervisor. At the
discretion of the Administrator, small
establishments requiring the services of
less than one full-time inspector need
not furnish facilities for Program
employees as prescribed in this section,
where adequate facilities exist in a
nearby convenient location. Laundry
service for inspectors’ outer work
clothing must be provided by each
establishment.
§ 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;
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(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.
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.
§ 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.
§ 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.
§ 534.3 Standards for use of drugs in the
raising of fish.
The requirements governing the
schedule of operations for fish
processing establishments are as
required by 9 CFR 307.4 for meat
establishments.
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.
§ 533.6 Overtime and holiday inspection
service.
§ 534.4
plant.
§ 533.5
Schedule of operations.
The requirements governing overtime
and holiday inspection service in 9 CFR
307.5 apply to fish processing
establishments.
§ 533.7 Basis of billing for overtime and
holiday services.
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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.
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Transportation to processing
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.
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PART 537—SANITATION
REQUIREMENTS AND HAZARD
ANALYSIS AND CRITICAL CONTROL
POINTS SYSTEMS; NOTIFICATION
REGARDING ADULTERATED OR
MISBRANDED PRODUCTS
Sec.
537.1
537.2
537.3
Basic requirements.
Hazard analysis and HACCP plan.
Notification.
Authority: 21 U.S.C. 21 U.S.C. 601–602,
606–622, 624–695; 7 CFR 2.7, 2.18, 2.53.
§ 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.
§ 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.
§ 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.
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§ 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.
§ 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.
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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.
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§ 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.
§ 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.
Authority: 21 U.S.C. 21 U.S.C. 601–602,
606–622, 624–695; 7 CFR 2.7, 2.18, 2.53.
§ 541.1
General.
The marks, devices, and certificates
prescribed or referenced in this part are
official marks, devices, and certificates
for the purposes of the Act respecting
fish and fish products. The marks,
devices, and certificates shall be used
only in accordance with the regulations
in this part.
§ 541.2 Official marks and devices to
identify inspected and passed 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:
§ 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 nonfood use. If not decharacterized by use
of approved denaturants or colorings,
the inedible materials shall be enclosed
in containers that are conspicuously
marked to indicate that the contents are
condemned or otherwise inedible. The
materials may be shipped under
company or official seal to a rendering
facility or for other inedible processing.
PART 541—MARKS, MARKING AND
LABELING OF PRODUCTS AND
CONTAINERS
Sec.
541.1 General.
541.2 Official marks and devices to identify
inspected and passed 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.
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(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
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§ 541.3 Official seals for transportation of
products.
The official mark for use in sealing
railroad cars, cargo containers, or other
means of conveyance as prescribed in
part 555 of this subchapter must be the
inscription and serial number shown in
9 CFR 312.5 or another official mark
approved by the Administrator. Any
seal approved by the Administrator for
applying the official mark is an official
device for the purposes of the Act. The
seal must be attached to the means of
conveyance only by a Program
employee, who shall also affix a
‘‘Warning Tag’’ (Form MP–408–3 or
similar official form).
§ 541.4 Official export inspection marks,
devices, and certificates.
(a) The official export inspection mark
for 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.
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§ 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.
§ 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
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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
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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
(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.
§ 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.
§ 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
1 U.S. Department of Commerce. NIST Handbook
133: Checking the Net Contents of Packaged Goods,
2013. Washington, DC.
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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:
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or consists of operations that are
exempted from inspection under 9 CFR
303.1. No fixtures or appliances, such as
tables, trucks, trays, tanks, vats,
machines, implements, cans, or
containers of any kind, shall be used
unless they are of such materials and
construction as will not contaminate or
otherwise adulterate the product and are
clean and sanitary. All steps in the
preparation of edible products shall be
conducted carefully and with strict
cleanliness in rooms or compartments
separate from those used for inedible
products.
(b) It shall be the responsibility of the
operator of every official establishment
to comply with the Act and the
regulations in this subchapter. To carry
out this responsibility effectively, the
operator of the establishment shall
institute appropriate measures to ensure
the maintenance of the establishment
and the preparation, marking, labeling,
packaging and other handling of its
products strictly in accordance with the
sanitary and other requirements of this
subchapter.
§ 548.2 Requirements concerning
ingredients and other articles used in the
preparation of 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.
because they bear or contain a new
animal drug that is unsafe within the
meaning of section 512 of the Federal
Food, Drug, and Cosmetic Act.
§ 548.8 Polluted water contamination at
establishment
§ 550.5
§ 548.9 Accreditation of non-Federal
chemistry laboratories.
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.
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
Samples of products, water, dyes,
chemicals, preservatives, spices, or
other articles in any official
establishment shall be taken, without
cost to the Program, for examination, as
often as may be deemed necessary for
the efficient conduct of the inspection.
§ 548.4
[Reserved]
Authority: 21 U.S.C. 601–602, 606–622,
624–695; 7 CFR 2.7, 2.18, 2.53.
§ 548.5
Ready-to-eat fish products.
§ 550.1
Ready-to-eat fish products are subject
to the requirements in part 430 of this
chapter.
§ 548.6
Canning and canned products.
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The requirements for canning and
canned products in 9 CFR part 318,
subpart G (§§ 318.300–318.311) apply to
fish products that are canned.
§ 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
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The provisions of 9 CFR 320.4 apply
to businesses dealing in fish and fish
products.
In the event that there is polluted
water (including but not limited to flood
water) in an official establishment, all
products and ingredients for use in the
preparation of the products that have
been rendered adulterated by the water
must be condemned. After the polluted
water has receded from the
establishment, the establishment must
follow the cleaning and sanitizing
procedures in § 318.4 of this chapter.
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.
§ 548.3 Samples of products, water, dyes,
chemicals, etc. to be taken for examination.
§ 550.4 Access to and inspection of
records, facilities and inventory; copying
and sampling.
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.
§ 550.2
Record retention period.
The record retention requirements in
9 CFR 320.3 apply to records required
to be kept under this part.
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§ 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.
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.
§ 552.1 Affixing stamps and marking
products for export; issuance of export
certificates; clearance of vessels and
transportation.
(a) The manner of affixing stamps and
marking products for export is that
prescribed in § 322.1(a) of this chapter.
(b) The requirements for the issuance
of export certificates are as prescribed in
§ 322.2 of this chapter.
(c) The requirements for clearing
vessels and other transportation
vehicles are set out in § 322.4 of this
chapter.
Place of maintenance of records.
The requirements in 9 CFR 320.2 for
the place where records are to be
maintained apply in the keeping of
records under this part.
§ 550.3
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.
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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
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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.
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§ 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 § 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.
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(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 § 540.3 of
this subchapter.
§ 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.
§ 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 § 325.5 of this chapter
that apply to unmarked inspected meat
products.
§ 555.4 Handling of fish products that may
have become adulterated.
The provisions of § 325.10 of this
chapter regarding the handling of
products that may have become
adulterated or misbranded apply to fish
and fish products.
§ 555.5 Transportation of inedible fish
product in commerce.
The provisions in § 325.11(e) of this
chapter regarding the transportation of
inedible livestock products apply to the
transportation of inedible fish parts or
products.
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§ 555.6
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Certificates.
The provisions in § 325.14 of this
chapter regarding the filing of original
certificates of unmarked inspected meat
products delivered to carriers applies
with respect to fish and fish products.
§ 555.7 Official seals; forms, use, and
breaking.
The official seals required by this part
are those prescribed in § 541.3 and
§ 312.5 of this chapter.
§ 555.8 Loading or unloading of 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.
§ 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 § 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.
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§ 555.10 Provisions inapplicable to
specimens for laboratory examination, etc.,
or to naturally inedible articles.
The provisions of this part do not
apply:
(a) To specimens of product sent to or
by the Department of Agriculture or
divisions thereof in Washington, DC, or
elsewhere, for laboratory examination,
exhibition purposes, or other official
use;
(b) To material released for
educational, research, and other
nonfood purposes, as prescribed in
§ 540.2 of this subchapter;
(c) To tissues for use in preparing
pharmaceutical, organotherapeutic, or
technical products and not used for
human food, as described in § 540.2 of
this subchapter;
(d) To material or specimens of
product for laboratory examination,
research, or other nonhuman food
purposes, when authorized by the
Administrator, and under conditions
prescribed by him in specific cases; and
(e) To articles that are naturally
inedible by humans.
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§ 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;
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(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.
§ 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
§ 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.
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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.
§ 557.1 Definitions; application of
provisions.
(a) When used in this part, the
following terms shall be construed to
mean:
(1) Import. To bring within the
territorial limits of the United States
whether that arrival is accomplished by
land, air, or water.
(2) Offer for entry. Presentation of the
imported product by the importer to the
Program for reinspection.
(3) Entry. The point at which
imported product offered for entry
receives reinspection and is marked
with the official mark of inspection in
accordance with § 557.26 of this
subchapter.
(b) The provisions of this part shall
apply to 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
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with applicable requirements under
other laws, including the provisions in
part 94 of chapter I of this title.
§ 557.2 Eligibility of foreign countries for
importation of 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 § 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.
§ 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.
certificate was produced in accordance
with the regulatory requirements in
§ 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.
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§ 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.
(a) Except as provided in § 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
(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.
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(c) The provisions of this section do
not apply to products that are exempted
from inspection by §§ 557.16 and
557.17.
§ 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 §§ 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
§§ 304.1 and 304.2 of this chapter. Also,
before approval is granted, the
establishment must have developed
written Sanitation Standard Operating
Procedures in accordance with part 416
of this chapter.
(e) Owners or operators of
establishments at which import
inspections of product are to be made
shall furnish adequate sanitary facilities
and equipment for examination of such
product. The requirements of §§ 307.1,
307.2(b), (d), (f), (h), (k), and (l) and
416.1 through 416.6 of this chapter shall
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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
§ 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
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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 § 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
§ 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.
§ 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.
§ 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
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into the United States, shall be
maintained in a sanitary condition.
§ 557.9
[Reserved]
§ 557.10 Samples; inspection of
consignments; refusal of entry; marking.
The provisions in 9 CFR 327.10
governing the taking of samples, the
inspection of consignments, the refusal
of entry, and the controlled prestamping of shipments of meat and meat
food products apply with respect to fish
and fish products.
§ 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 § 327.11 of this chapter.
§ 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
§ 541.7 of this subchapter are to be
sampled and inspected in the same
manner as provided by § 327.12 of this
chapter for foreign canned meat food
products.
§ 557.13 Foreign 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 § 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 § 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.
§ 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.
§ 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
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food products apply also with respect to
fish and fish products.
§ 557.16 Small importations for importer’s
own consumption; requirements.
The exemption in 9 CFR 327.16 for
small importations of meat or meat food
products for the importer’s own
consumption applies with respect to
fish or fish products.
§ 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.
§ 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.
§ 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 § 327.19 of this
chapter.
§ 557.20–557.23
§ 557.24
[Reserved]
Appeals; how made.
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An appeal from a decision of any
Program employee is to be made as
provided by 9 CFR 327.24.
§ 557.25 Disposition procedures for 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.
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§ 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.
75629
Territory apply with respect to fish and
fish products inspection.
§ 560.2 Cooperation of States in Federal
programs.
Under the ‘‘Talmadge-Aiken Act’’ of
September 28, 1962 (7 U.S.C. 450), the
Administrator is authorized to utilize
employees and facilities of any State in
carrying out Federal functions under the
FMIA, including functions relating to
the inspection of fish and fish products.
A cooperative program for this purpose
is called a Federal-State program.
§ 560.3 Cooperation of States for the
Interstate Shipment of Fish and Fish
Products.
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.
The provisions in § 321.3 authorizing
the Administrator to coordinate with
States that have meat inspection
programs as provided in § 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.
§ 559.2 Articles or fish subject to judicial
seizure and condemnation.
§ 560.4 Designation of States under the
Federal Meat Inspection Act.
§ 559.1 Fish and other articles subject to
administrative detention.
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.
§ 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.
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.
Authority: 7 U.S.C. 450; 21 U.S.C. 601–
602, 606–622, 624–695; 7 CFR 2.7, 2.18, 2.53.
§ 561.1 Rules of practice governing
inspection actions.
§ 560.1 Cooperation with States and
Territories.
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.
The provisions in § 321.1 of this
chapter authorizing the Administrator to
cooperate with any State (including
Puerto Rico) or any organized Territory
in developing and administering a meat
inspection program for the State or
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§ 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]
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Agencies
[Federal Register Volume 80, Number 231 (Wednesday, December 2, 2015)]
[Rules and Regulations]
[Pages 75589-75630]
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
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7 3
percent percent
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Siluriformes Fish Industry........................ $326.55 $317.78
Federal Government Agencies....................... 1,114.40 1,097.22
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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 https://www.fsis.usda.gov/wps/wcm/connect/eefd3e0d-ea69-4c75-b1ac-ea4df9d133e4/Transcripts_05242011_Catfish_meeting.pdf?MOD=AJPERES and https://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
https://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 https://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: https://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: https://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 (https://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: https://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 https://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.''
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\7\ U.S. Centers for Disease Control and Prevention (CDC). (June
2009) Foodborne Disease Outbreak Surveillance Data. Atlanta, GA.
Retrieved from https://www.cdc.gov/foodsafety/fdoss/.
\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.
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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\
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\9\ Annualized present value of average costs is at a 7 percent
discount rate over 10 years.
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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 https://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.
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\10\ https://docs.house.gov/billsthisweek/20140127/CRPT-113hrpt-HR2642-SOM.pdf.
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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: InternationalEquivalence@fsis.usda.gov.
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: https://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 https://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006764.htm.
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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: https://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 https://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 https://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.
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm150954.htm.
\32\ NOAA USDC Approved Establishments. December 2014. https://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 https://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 https://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. https://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 https://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: program.intake@usda.gov.
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:
https://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: https://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