Elimination of the Requirement That Livestock Carcasses Be Marked “U.S. Inspected and Passed” at the Time of Inspection Within a Slaughter Establishment for Carcasses to be Further Processed Within the Same Establishment, 36794-36797 [2018-16345]
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Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF AGRICULTURE
Roberta Wagner, Assistant
Administrator, Office of Policy and
Program Development, Food Safety and
Inspection Service, U.S. Department of
Agriculture; Telephone: (202) 205–0495.
SUPPLEMENTARY INFORMATION:
Food Safety and Inspection Service
9 CFR Part 316
[Docket No. FSIS 2018–0019]
RIN 0583–AD69
Elimination of the Requirement That
Livestock Carcasses Be Marked ‘‘U.S.
Inspected and Passed’’ at the Time of
Inspection Within a Slaughter
Establishment for Carcasses to be
Further Processed Within the Same
Establishment
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
FSIS is proposing to amend
the Federal meat inspection regulations
to eliminate the requirement that
livestock carcasses be marked with the
official inspection legend at the time of
inspection in a slaughter establishment,
if the carcasses are to be further
processed in the same establishment.
DATES: Comments must be received on
or before October 1, 2018.
ADDRESSES: FSIS invites interested
persons to submit comments on this
proposed rule. Comments may be
submitted by one of the following
methods:
• Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field on this web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov. Follow
the on-line instructions at that site for
submitting comments.
• Mail, including CD–ROMs: Send to
Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection
Service, 1400 Independence Avenue
SW, Mailstop 3758, Room 6065,
Washington, DC 20250–3700.
• Hand- or courier-delivered
submittals: Deliver to 1400
Independence Avenue SW, Room 6065,
Washington, DC 20250–3700.
• Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2018–0005. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov.
Docket: For access to background
documents or comments received, call
(202) 720–5627 to schedule a time to
visit the FSIS Docket Room at 1400
Independence Avenue SW, Room 6065,
Washington, DC 20250–3700.
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SUMMARY:
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Background
In the past, slaughter establishments
often would ship carcasses to other
establishments for further processing
into primal, subprimal, and other meat
cuts and products. Today however, most
establishments that slaughter swine,
cattle, or sheep also fabricate the
carcasses into various primal and
subprimal parts, as well as other meat
products. After a carcass has passed
inspection, the slaughter establishment
typically moves it, under control, to
another department in the same
establishment for further processing.
The establishment then typically ships
the resulting meat food products, rather
than marked carcasses, in fully labeled
containers either for further processing
at other establishments or into
commerce.
The Federal Meat Inspection Act
(FMIA) requires the inspection of all
livestock carcasses and parts of
livestock carcasses prepared in
slaughter establishments as articles of
commerce capable of use as human food
(21 U.S.C. 604). In this same provision,
the FMIA requires that such carcasses
and parts of carcasses found to be not
adulterated be stamped as ‘‘inspected
and passed’’ before they enter
commerce. The FMIA also gives FSIS
broad authority to promulgate rules and
regulations necessary to carry out its
provisions (21 U.S.C. 621).
The regulations at 9 CFR 316.9 set
forth more prescriptive, and partially
outdated, requirements for the marking
of inspected carcasses. Specifically, the
regulation at 9 CFR 316.9(a) requires
each carcass at an official establishment
to be marked at the time of inspection
with the official inspection legend. This
requirement is intended to prevent
uninspected carcasses from being
shipped in commerce from slaughter
establishments to processing
establishments or elsewhere. However,
given contemporary practices at
slaughter establishments, marking the
carcass on the slaughter floor is often
unnecessary, as the carcass will be
moved elsewhere in the same
establishment for further processing.
Requests To Move Carcasses and Parts
of Carcasses To Processing Without
Marking the Carcass
Numerous slaughter establishments
have requested waivers from the
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requirement in 9 CFR 316.9(a), i.e., that
the carcasses they further process inhouse not be required to be marked at
the time of inspection. The information
presented with these requests has
described the steps that establishments
would take to ensure that uninspected,
unmarked, or adulterated product does
not enter commerce. These steps
typically include: (1) Ensuring that all
carcasses inspected and passed by
USDA, but not marked on the slaughter
floor, are stored and processed in the
establishment; (2) ensuring that all
products shipped from the
establishment bear the mark of
inspection or are shipped in fully
labeled containers that bear the mark of
inspection; and (3) ensuring that FSIS
still maintains control over any
carcasses that do not pass inspection.
FSIS has granted many of these
waivers, per the regulations at 9 CFR
303.1, thereby allowing inspected and
passed carcasses to move, without the
mark of inspection, from the slaughter
floor to processing departments in the
same establishment. At one point,
because of the high number of waivers
granted, FSIS issued an administrative
notice to inspectors (FSIS Notice 17–16)
with instructions for verification
activities at establishments that had
received a waiver from these
requirements. FSIS has allowed this
notice to expire, in anticipation of this
rulemaking. Further, based on
discussions with FSIS District Offices,
while a significant number of
establishments are currently operating
under such waivers, there are no reports
of unmarked carcasses being shipped
into commerce.
FSIS has carefully considered the
available information on allowing
establishments to move carcasses and
parts of carcasses to processing without
marking the carcass with the inspection
legend. From its experience with
establishments to which it has provided
waivers, the Agency has concluded that
controls that establishments have put in
place and Agency procedures to address
inspection of unmarked carcasses have
been successful in preventing unmarked
carcasses from leaving the establishment
for processing in an outside facility.
FSIS is thus proposing that
establishments not be required to mark
carcasses with the inspection legend
when the carcasses leave the slaughter
floor to be further processed within the
same establishment. However, all
primals, subprimals, parts and other
meat food products will have to be
properly labeled and bear the mark of
inspection before entering commerce.
Under the proposed rule, FSIS
inspection personnel will continue to
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Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules
verify that the establishment has in
place in its Hazard Analysis and Critical
Control Point (HACCP) plan, Sanitation
Standard Operating Procedures (SOPs),
or other prerequisite programs, controls
to ensure that unmarked carcasses are
further processed in the establishment
and that carcasses that are not further
processed in the establishment do not
leave the establishment unmarked.
Additionally, should this rule become
final, inspectors would verify through
records review or direct observation that
the establishment’s procedures ensure
that: (1) The establishment properly
identifies and handles carcasses or parts
eligible for the mark of inspection
through edible channels, so that only
edible, inspected and passed product
proceeds to fabrication; (2) the
establishment can account for the
number of carcasses it slaughters and
moves through its establishment and
that it correctly identifies the species
slaughtered on the final label; (3)
retained carcasses or parts remain under
FSIS control until the establishment
makes corrections that render the
carcass or part eligible to bear the mark
of inspection (e.g., carcasses retained for
residue sample or pending pathology
disposition are held in FSIS controlled
retained cages in the cooler); and (4)
whole carcasses transported to another
establishment bear the mark of
inspection.
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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
benefits, distributive impacts, and
equity). Executive Order (E.O.) 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This
proposed rule has been designated as a
‘‘non-significant’’ regulatory action
under section 3(f) of E.O. 12866.
Accordingly, the rule has not been
reviewed by the Office of Management
and Budget (OMB) under E.O. 12866.
Economic Impact Analysis
FSIS is proposing to remove the
requirement for carcasses slaughtered in
an establishment to bear the mark of
inspection after being inspected and
passed on the slaughter floor if the
carcasses are to be further processed in
the same establishment. Since this
requirement is no longer necessary to
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prevent adulterated food product from
entering commerce (see explanation in
the Background section above),
removing it will have no negative public
health impact. Nor will it impose costs
on the industry or the Agency.
In regard to benefits from the
rulemaking, removing an unnecessary
requirement will allow establishments
the flexibility to be innovative and to
operate in the most efficient manner. In
addition, it will also allow FSIS to
utilize its resources more appropriately
by relieving inspectors of unnecessary
tasks. The expected benefits from this
proposed rule would accrue from time
and resource savings. Inspected and
passed carcasses meant for further
processing would not have to wait for
the mark of inspection but could move
directly to further processing. Thus,
establishments that slaughter livestock
and process livestock carcasses in the
same facility would benefit from fewer
delays in their operations and greater
flexibility to conduct processing
operations on inspected and passed
carcasses.
Agency data show that there are
approximately 797 meat slaughtering
establishments, and approximately 676
of them (∼85 percent) do both
slaughtering and processing.1 FSIS
estimates that approximately 644 of
these 676 establishments (∼95 percent)
further process the carcasses they
slaughter. Given that the annual
production of meat by Federal inspected
establishments is approximately 150
million heads,2 roughly 120.9 million
carcasses are subject to the requirements
in 9 CFR 316.9 (150 million × 85 percent
× 95 percent). Assuming that it takes
establishment labor, on average, 3
seconds to stamp each carcass, and that
approximately half of the
establishments already have waivers
from the requirement, approximately
50,417 additional hours would be saved.
Most establishments use hired workers
to do the stamping. If we assume the
average hourly pay (salary plus benefits)
is $20,3 then the time saved is
equivalent to approximately $1.01
million annually.
In addition, such establishments
would no longer need to replace the
broken or worn out stamps previously
1 Data source: Public Health Inspection System as
of June 2017, provided by FSIS’s Office of Data
Integration and Food Protection.
2 Livestock Slaughter 2016 Summary (April
2017). USDA, National Agricultural Statistics.
https://usda.mannlib.cornell.edu/usda/current/
LiveSlauSu/LiveSlauSu-04-19-2017.pdf, p.15.
accessed 06/01/2017.
3 Data source: Bureau of Labor Statistics (BLS)
most recent report of average wage of meat
slaughterers and packers. https://www.bls.gov/oes/
current/oes513023.htm/, accessed 06/2017.
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36795
used for marking carcasses on the
slaughter floor. Typically, a stamp
(usually made of bronze) costs $225 and
lasts 5 years.4 The annualized cost of
the stamp is $55 (if the interest rate is
7 percent) or $50 (if the interest rate is
3 percent). Assuming each
establishment (that does not already
have a waiver from the requirement)
uses one stamp per year, the annual
savings on these stamps would be
between $16,700 and $18,600.
Additionally, establishments would
no longer need to make written requests
for waivers from the requirement to
stamp carcasses further processed
within the same establishment and
would no longer need to wait to have
such requests approved. Further,
because FSIS inspectors would no
longer need to ensure that inspected and
passed carcasses bear the mark of
inspection before they are sent for
further processing, FSIS inspectors
would have greater flexibility to focus
on activities that are more important in
ensuring food safety, such as verifying
that establishments meet HACCP
regulations and collecting product
samples. However, the time needed for
submitting a written waiver request and
waiting for approval is minimal, and the
saving of that time would be offset by
the increase in time needed for
establishments to amend their HACCP
plans, Sanitation SOPs, or prerequisite
programs to add controls for the
movement of these unmarked carcasses
under this proposed rule. Similarly, the
time saved for FSIS inspectors to ensure
that inspected carcasses bear the mark
of inspection would be offset by the
increase in time to verify that
establishments meet HACCP
regulations.
There are no expected costs
associated with this proposed rule.
Establishments already operating under
a waiver will have procedures in their
HACCP plans, Sanitation SOPs, or
prerequisite programs that ensure that
carcasses that are not further processed
in the establishment do not leave the
establishment unmarked. Other
establishments will need to revise these
procedures. However, FSIS expects that
any costs associated with revising the
procedures would be offset by increased
flexibility allowed to those
establishments as discussed in the
foregoing section.
Regulatory Flexibility Act Assessment
The FSIS Administrator has made a
preliminary determination that this
4 Data from Ketchum Manufacturing Inc., a
manufacturer of meat stamps, through telephone
interview on 4/17/2017.
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Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules
proposed rule will not have a significant
economic impact on a substantial
number of small entities, as defined by
the Regulatory Flexibility Act (5 U.S.C.
601). The proposed rule will not
increase costs to the industry.
Executive Order 13771
Consistent with E.O. 13771 (82 FR
9339, February 3, 2017), FSIS has
estimated that this proposed rule would
yield cost savings. Therefore, if finalized
as proposed, this rule is expected to be
an E.O. 13771 deregulatory action.
Paperwork Reduction Act
There are no paperwork or
recordkeeping requirements associated
with this proposed rule under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520).
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.
require tribal consultation under E.O.
13175. If a Tribe requests consultation,
FSIS will work with the Office of Tribal
Relations to ensure meaningful
consultation is provided where changes,
additions and modifications identified
herein are not expressly mandated by
Congress.
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.
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Executive Order 12988, Civil Justice
Reform
This proposed rule has been reviewed
under E.O. 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.
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).
Executive Order 13175
This rule has been reviewed in
accordance with the requirements of
E.O. 13175, ‘‘Consultation and
Coordination with Indian Tribal
Governments.’’ E.O. 13175 requires
Federal agencies to consult and
coordinate with tribes on a governmentto-government basis on policies that
have tribal implications, including
regulations, legislative comments or
proposed legislation, and other policy
statements or actions that have
substantial direct effects on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
FSIS has assessed the impact of this
rule on Indian tribes and determined
that this rule does not, to our
knowledge, have tribal implications that
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.
Constituent updates are 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
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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 in 9 CFR Part 316
Food labeling, Food packaging, Meat
inspection.
For the reasons set forth in the
preamble, FSIS is proposing to amend 9
CFR part 316 as follows:
PART 316—MARKING PRODUCTS
AND THEIR CONTAINERS
1. The authority citation for part 316
is revised to read as follows:
■
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.55.
2. In § 316.9, revise paragraph (a),
redesignate paragraphs (b) through (d)
as paragraphs (c) through (e),
respectively, and add a new paragraph
(b) to read as follows:
■
§ 316.9 Products to be marked with official
marks.
(a) Each carcass that has been
inspected and passed in an official
establishment must be marked at the
time of inspection with the official
inspection legend containing the
number of the official establishment, if
the carcass is to be shipped into
commerce from the establishment
without further processing.
(b) A passed and inspected carcass
that is to be further processed in the
slaughtering establishment need not be
marked with the official inspection
legend at the time of inspection,
provided the establishment develops
and implements, as part of a HACCP
plan, Sanitation SOPs, or other
prerequisite program, procedures to
ensure that:
(1) Unmarked carcasses are further
processed only in the slaughtering
establishment;
(2) Unmarked carcasses that, for any
reason, are not further processed in the
establishment do not leave the
establishment unmarked; and
(3) Unmarked and retained carcasses
or parts remain under FSIS control until
the establishment makes any corrections
that are necessary to render the carcass
or part eligible to bear the mark of
inspection.
*
*
*
*
*
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Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules
Done in Washington, DC.
Paul Kiecker,
Acting Administrator.
Docket: For access to background
documents or comments received, call
(202) 720–5627 to schedule a time to
visit the FSIS Docket Room at 1400
Independence Avenue SW, Room 6065,
Washington, DC 20250–3700.
FOR FURTHER INFORMATION CONTACT:
Roberta Wagner, Assistant
Administrator, Office of Policy and
Program Development; Telephone: (202)
205–0495.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–16345 Filed 7–30–18; 8:45 am]
BILLING CODE 3410–DM–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 318 and 381
[Docket No. FSIS 2016–0032]
Background
RIN 0583–AD66
FSIS regulations at 9 CFR 318.12 and
381.152 govern the manufacture of pet
food and other uninspected, inedible
products in official meat and poultry
establishments. These regulations set
forth prescriptive requirements
intended to prevent the creation of
insanitary conditions in official
establishments, the commingling of
inedible and edible meat and poultry
products, and the movement of inedible
meat and poultry products into
commerce as human food. They also
require that pet food and other inedible
products be manufactured in official
establishments only when an FSIS
inspector is on premises.
These prescriptive requirements for
the production of pet food and other
inedible products (e.g., inedible
rendered fats, lungs, lung lobes, and
experimental products) are
incompatible with the Hazard Analysis
and Critical Control Point (HACCP)
regulations at 9 CFR part 417 and the
related sanitation regulations at 9 CFR
part 416. Under the HACCP regulations,
establishments are responsible for
developing and implementing HACCP
plans incorporating the controls
determined by the establishment to be
necessary and appropriate to produce
safe, unadulterated products.
Specifically under HACCP, official
establishments must determine the food
safety hazards reasonably likely to occur
in the production process; institute
controls necessary to prevent those
hazards from occurring or keeping them
within acceptable limits; monitor the
performance of controls and verify the
HACCP system is working as intended;
and maintain required HACCP records.
HACCP is a flexible system that
appropriately places the responsibility
for food safety on establishments and
enables them to tailor their control
systems to the needs of specific
processes and operating conditions.
Similarly, the Sanitation Performance
Standards (SPS) and requirements for
Sanitation Standard Operating
Procedures (SOPs) at 9 CFR part 416 set
forth sanitation objectives to be
Preparation of Uninspected Products
Outside of the Hours of Inspectional
Supervision
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
FSIS is proposing to amend
the Federal meat and poultry products
inspection regulations to eliminate
prescriptive requirements governing the
manufacture of uninspected products,
such as pet food, in edible product areas
of official establishments and to allow
official establishments to manufacture
such products outside the hours of
inspection.
DATES: To receive full consideration,
comments should be received by August
30, 2018.
ADDRESSES: FSIS invites interested
persons to submit comments on this
proposed rule. Comments may be
submitted by one of the following
methods:
• Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field on this web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov. Follow
the on-line instructions at that site for
submitting comments.
• Mail, including CD–ROMs, etc.:
Send to Docket Clerk, U.S. Department
of Agriculture, Food Safety and
Inspection Service, 1400 Independence
Avenue SW, Mailstop 3758, Room 6065,
Washington, DC 20250–3700.
• Hand- or courier-delivered
submittals: Deliver to 1400
Independence Avenue SW, Room 6065,
Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2018–0005. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov.
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SUMMARY:
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36797
achieved, while allowing establishments
to develop and employ innovative and
effective sanitation procedures
customized to the nature of their
operations. Under the Sanitation SOP
regulations, FSIS requires that all
inspected establishments develop and
implement written Sanitation SOPs to
prevent direct contamination or
adulteration of product before and
during operations. An establishment’s
Sanitation SOP typically covers the
scheduled, daily pre-operational and
operational cleaning and sanitation of
equipment and surfaces that may
contact product directly. Under the SPS
regulations, establishments must
address all of the other aspects of
establishment sanitation that can affect
food safety, e.g., pest control, adequate
ventilation, lighting, and plumbing
systems.
Under the HACCP and sanitation
requirements, an establishment that
produces both edible and inedible meat
and poultry products must develop and
implement the controls and procedures
necessary to prevent the adulteration of
edible products by insanitary conditions
and product commingling, as well as the
movement of inedible products into
commerce as human food. FSIS
inspectors verify the implementation
and effectiveness of these controls
through inspection, records review and,
as necessary, product sampling. Thus,
FSIS inspectors do not need to be
present in an official establishment
when it manufactures inedible products
in order to verify that edible products
are not adulterated as a result.
Proposed Changes
FSIS is proposing to eliminate the
prescriptive regulatory requirements at
9 CFR 318.12 and 381.152 governing the
manufacture of uninspected, inedible
products, such as pet food, and
restricting the hours during which such
products may be prepared in an official
establishment. Specifically, these
regulations set forth specific
requirements regarding the sanitary
handling of inedible products and their
separation from edible products, as well
as the placement, movement and
cleaning of equipment in areas where
inedible product is manufactured. They
also require that the manufacture of
uninspected, inedible products be
conducted only during those hours in
which the establishment operates under
inspectional supervision. These
regulations were issued before FSIS
published its HACCP and Sanitation
SOP regulations, when prescriptive
regulatory requirements were deemed
necessary to prevent the adulteration of
meat and poultry products by the
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]]>Agencies
[Federal Register Volume 83, Number 147 (Tuesday, July 31, 2018)]
[Proposed Rules]
[Pages 36794-36797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16345]
[[Page 36794]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 316
[Docket No. FSIS 2018-0019]
RIN 0583-AD69
Elimination of the Requirement That Livestock Carcasses Be Marked
``U.S. Inspected and Passed'' at the Time of Inspection Within a
Slaughter Establishment for Carcasses to be Further Processed Within
the Same Establishment
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: FSIS is proposing to amend the Federal meat inspection
regulations to eliminate the requirement that livestock carcasses be
marked with the official inspection legend at the time of inspection in
a slaughter establishment, if the carcasses are to be further processed
in the same establishment.
DATES: Comments must be received on or before October 1, 2018.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by one of the following
methods:
Federal eRulemaking Portal: This website provides the
ability to type short comments directly into the comment field on this
web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail, including CD-ROMs: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, 1400
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
Hand- or courier-delivered submittals: Deliver to 1400
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic
mail must include the Agency name and docket number FSIS-2018-0005.
Comments received in response to this docket will be made available for
public inspection and posted without change, including any personal
information, to https://www.regulations.gov.
Docket: For access to background documents or comments received,
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant
Administrator, Office of Policy and Program Development, Food Safety
and Inspection Service, U.S. Department of Agriculture; Telephone:
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
In the past, slaughter establishments often would ship carcasses to
other establishments for further processing into primal, subprimal, and
other meat cuts and products. Today however, most establishments that
slaughter swine, cattle, or sheep also fabricate the carcasses into
various primal and subprimal parts, as well as other meat products.
After a carcass has passed inspection, the slaughter establishment
typically moves it, under control, to another department in the same
establishment for further processing. The establishment then typically
ships the resulting meat food products, rather than marked carcasses,
in fully labeled containers either for further processing at other
establishments or into commerce.
The Federal Meat Inspection Act (FMIA) requires the inspection of
all livestock carcasses and parts of livestock carcasses prepared in
slaughter establishments as articles of commerce capable of use as
human food (21 U.S.C. 604). In this same provision, the FMIA requires
that such carcasses and parts of carcasses found to be not adulterated
be stamped as ``inspected and passed'' before they enter commerce. The
FMIA also gives FSIS broad authority to promulgate rules and
regulations necessary to carry out its provisions (21 U.S.C. 621).
The regulations at 9 CFR 316.9 set forth more prescriptive, and
partially outdated, requirements for the marking of inspected
carcasses. Specifically, the regulation at 9 CFR 316.9(a) requires each
carcass at an official establishment to be marked at the time of
inspection with the official inspection legend. This requirement is
intended to prevent uninspected carcasses from being shipped in
commerce from slaughter establishments to processing establishments or
elsewhere. However, given contemporary practices at slaughter
establishments, marking the carcass on the slaughter floor is often
unnecessary, as the carcass will be moved elsewhere in the same
establishment for further processing.
Requests To Move Carcasses and Parts of Carcasses To Processing Without
Marking the Carcass
Numerous slaughter establishments have requested waivers from the
requirement in 9 CFR 316.9(a), i.e., that the carcasses they further
process in-house not be required to be marked at the time of
inspection. The information presented with these requests has described
the steps that establishments would take to ensure that uninspected,
unmarked, or adulterated product does not enter commerce. These steps
typically include: (1) Ensuring that all carcasses inspected and passed
by USDA, but not marked on the slaughter floor, are stored and
processed in the establishment; (2) ensuring that all products shipped
from the establishment bear the mark of inspection or are shipped in
fully labeled containers that bear the mark of inspection; and (3)
ensuring that FSIS still maintains control over any carcasses that do
not pass inspection.
FSIS has granted many of these waivers, per the regulations at 9
CFR 303.1, thereby allowing inspected and passed carcasses to move,
without the mark of inspection, from the slaughter floor to processing
departments in the same establishment. At one point, because of the
high number of waivers granted, FSIS issued an administrative notice to
inspectors (FSIS Notice 17-16) with instructions for verification
activities at establishments that had received a waiver from these
requirements. FSIS has allowed this notice to expire, in anticipation
of this rulemaking. Further, based on discussions with FSIS District
Offices, while a significant number of establishments are currently
operating under such waivers, there are no reports of unmarked
carcasses being shipped into commerce.
FSIS has carefully considered the available information on allowing
establishments to move carcasses and parts of carcasses to processing
without marking the carcass with the inspection legend. From its
experience with establishments to which it has provided waivers, the
Agency has concluded that controls that establishments have put in
place and Agency procedures to address inspection of unmarked carcasses
have been successful in preventing unmarked carcasses from leaving the
establishment for processing in an outside facility. FSIS is thus
proposing that establishments not be required to mark carcasses with
the inspection legend when the carcasses leave the slaughter floor to
be further processed within the same establishment. However, all
primals, subprimals, parts and other meat food products will have to be
properly labeled and bear the mark of inspection before entering
commerce.
Under the proposed rule, FSIS inspection personnel will continue to
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verify that the establishment has in place in its Hazard Analysis and
Critical Control Point (HACCP) plan, Sanitation Standard Operating
Procedures (SOPs), or other prerequisite programs, controls to ensure
that unmarked carcasses are further processed in the establishment and
that carcasses that are not further processed in the establishment do
not leave the establishment unmarked. Additionally, should this rule
become final, inspectors would verify through records review or direct
observation that the establishment's procedures ensure that: (1) The
establishment properly identifies and handles carcasses or parts
eligible for the mark of inspection through edible channels, so that
only edible, inspected and passed product proceeds to fabrication; (2)
the establishment can account for the number of carcasses it slaughters
and moves through its establishment and that it correctly identifies
the species slaughtered on the final label; (3) retained carcasses or
parts remain under FSIS control until the establishment makes
corrections that render the carcass or part eligible to bear the mark
of inspection (e.g., carcasses retained for residue sample or pending
pathology disposition are held in FSIS controlled retained cages in the
cooler); and (4) whole carcasses transported to another establishment
bear the mark of inspection.
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 benefits, distributive impacts, and equity).
Executive Order (E.O.) 13563 emphasizes the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. This proposed rule has been designated as a
``non-significant'' regulatory action under section 3(f) of E.O. 12866.
Accordingly, the rule has not been reviewed by the Office of Management
and Budget (OMB) under E.O. 12866.
Economic Impact Analysis
FSIS is proposing to remove the requirement for carcasses
slaughtered in an establishment to bear the mark of inspection after
being inspected and passed on the slaughter floor if the carcasses are
to be further processed in the same establishment. Since this
requirement is no longer necessary to prevent adulterated food product
from entering commerce (see explanation in the Background section
above), removing it will have no negative public health impact. Nor
will it impose costs on the industry or the Agency.
In regard to benefits from the rulemaking, removing an unnecessary
requirement will allow establishments the flexibility to be innovative
and to operate in the most efficient manner. In addition, it will also
allow FSIS to utilize its resources more appropriately by relieving
inspectors of unnecessary tasks. The expected benefits from this
proposed rule would accrue from time and resource savings. Inspected
and passed carcasses meant for further processing would not have to
wait for the mark of inspection but could move directly to further
processing. Thus, establishments that slaughter livestock and process
livestock carcasses in the same facility would benefit from fewer
delays in their operations and greater flexibility to conduct
processing operations on inspected and passed carcasses.
Agency data show that there are approximately 797 meat slaughtering
establishments, and approximately 676 of them (~85 percent) do both
slaughtering and processing.\1\ FSIS estimates that approximately 644
of these 676 establishments (~95 percent) further process the carcasses
they slaughter. Given that the annual production of meat by Federal
inspected establishments is approximately 150 million heads,\2\ roughly
120.9 million carcasses are subject to the requirements in 9 CFR 316.9
(150 million x 85 percent x 95 percent). Assuming that it takes
establishment labor, on average, 3 seconds to stamp each carcass, and
that approximately half of the establishments already have waivers from
the requirement, approximately 50,417 additional hours would be saved.
Most establishments use hired workers to do the stamping. If we assume
the average hourly pay (salary plus benefits) is $20,\3\ then the time
saved is equivalent to approximately $1.01 million annually.
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\1\ Data source: Public Health Inspection System as of June
2017, provided by FSIS's Office of Data Integration and Food
Protection.
\2\ Livestock Slaughter 2016 Summary (April 2017). USDA,
National Agricultural Statistics. https://usda.mannlib.cornell.edu/usda/current/LiveSlauSu/LiveSlauSu-04-19-2017.pdf, p.15. accessed
06/01/2017.
\3\ Data source: Bureau of Labor Statistics (BLS) most recent
report of average wage of meat slaughterers and packers. https://www.bls.gov/oes/current/oes513023.htm/, accessed 06/2017.
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In addition, such establishments would no longer need to replace
the broken or worn out stamps previously used for marking carcasses on
the slaughter floor. Typically, a stamp (usually made of bronze) costs
$225 and lasts 5 years.\4\ The annualized cost of the stamp is $55 (if
the interest rate is 7 percent) or $50 (if the interest rate is 3
percent). Assuming each establishment (that does not already have a
waiver from the requirement) uses one stamp per year, the annual
savings on these stamps would be between $16,700 and $18,600.
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\4\ Data from Ketchum Manufacturing Inc., a manufacturer of meat
stamps, through telephone interview on 4/17/2017.
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Additionally, establishments would no longer need to make written
requests for waivers from the requirement to stamp carcasses further
processed within the same establishment and would no longer need to
wait to have such requests approved. Further, because FSIS inspectors
would no longer need to ensure that inspected and passed carcasses bear
the mark of inspection before they are sent for further processing,
FSIS inspectors would have greater flexibility to focus on activities
that are more important in ensuring food safety, such as verifying that
establishments meet HACCP regulations and collecting product samples.
However, the time needed for submitting a written waiver request and
waiting for approval is minimal, and the saving of that time would be
offset by the increase in time needed for establishments to amend their
HACCP plans, Sanitation SOPs, or prerequisite programs to add controls
for the movement of these unmarked carcasses under this proposed rule.
Similarly, the time saved for FSIS inspectors to ensure that inspected
carcasses bear the mark of inspection would be offset by the increase
in time to verify that establishments meet HACCP regulations.
There are no expected costs associated with this proposed rule.
Establishments already operating under a waiver will have procedures in
their HACCP plans, Sanitation SOPs, or prerequisite programs that
ensure that carcasses that are not further processed in the
establishment do not leave the establishment unmarked. Other
establishments will need to revise these procedures. However, FSIS
expects that any costs associated with revising the procedures would be
offset by increased flexibility allowed to those establishments as
discussed in the foregoing section.
Regulatory Flexibility Act Assessment
The FSIS Administrator has made a preliminary determination that
this
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proposed rule will not have a significant economic impact on a
substantial number of small entities, as defined by the Regulatory
Flexibility Act (5 U.S.C. 601). The proposed rule will not increase
costs to the industry.
Executive Order 13771
Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS has
estimated that this proposed rule would yield cost savings. Therefore,
if finalized as proposed, this rule is expected to be an E.O. 13771
deregulatory action.
Paperwork Reduction Act
There are no paperwork or recordkeeping requirements associated
with this proposed rule under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
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.
Executive Order 12988, Civil Justice Reform
This proposed rule has been reviewed under E.O. 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.
Executive Order 13175
This rule has been reviewed in accordance with the requirements of
E.O. 13175, ``Consultation and Coordination with Indian Tribal
Governments.'' E.O. 13175 requires Federal agencies to consult and
coordinate with tribes on a government-to-government basis on policies
that have tribal implications, including regulations, legislative
comments or proposed legislation, and other policy statements or
actions that have substantial direct effects on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.
FSIS has assessed the impact of this rule on Indian tribes and
determined that this rule does not, to our knowledge, have tribal
implications that require tribal consultation under E.O. 13175. If a
Tribe requests consultation, FSIS will work with the Office of Tribal
Relations to ensure meaningful consultation is provided where changes,
additions and modifications identified herein are not expressly
mandated by Congress.
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: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.), should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
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. Constituent updates are 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 in 9 CFR Part 316
Food labeling, Food packaging, Meat inspection.
For the reasons set forth in the preamble, FSIS is proposing to
amend 9 CFR part 316 as follows:
PART 316--MARKING PRODUCTS AND THEIR CONTAINERS
0
1. The authority citation for part 316 is revised to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.55.
0
2. In Sec. 316.9, revise paragraph (a), redesignate paragraphs (b)
through (d) as paragraphs (c) through (e), respectively, and add a new
paragraph (b) to read as follows:
Sec. 316.9 Products to be marked with official marks.
(a) Each carcass that has been inspected and passed in an official
establishment must be marked at the time of inspection with the
official inspection legend containing the number of the official
establishment, if the carcass is to be shipped into commerce from the
establishment without further processing.
(b) A passed and inspected carcass that is to be further processed
in the slaughtering establishment need not be marked with the official
inspection legend at the time of inspection, provided the establishment
develops and implements, as part of a HACCP plan, Sanitation SOPs, or
other prerequisite program, procedures to ensure that:
(1) Unmarked carcasses are further processed only in the
slaughtering establishment;
(2) Unmarked carcasses that, for any reason, are not further
processed in the establishment do not leave the establishment unmarked;
and
(3) Unmarked and retained carcasses or parts remain under FSIS
control until the establishment makes any corrections that are
necessary to render the carcass or part eligible to bear the mark of
inspection.
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Done in Washington, DC.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-16345 Filed 7-30-18; 8:45 am]
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