Eliminating Unnecessary Requirements for Hog Carcass Cleaning, 22604-22607 [2018-10488]
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22604
Proposed Rules
Federal Register
Vol. 83, No. 95
Wednesday, May 16, 2018
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 310
[Docket No. FSIS–2018–0005]
RIN: 0583–AD68
Eliminating Unnecessary
Requirements for Hog Carcass
Cleaning
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is proposing
to amend the Federal meat inspection
regulations by removing the provision
requiring the cleaning of hog carcasses
before any incision is made preceding
evisceration. This provision, although
focusing on the presentation of carcass
dressing defects, impedes the adoption
of more efficient, effective procedures
under other regulations to ensure that
carcasses and parts are free of
contamination. Also, the provision is no
longer necessary because other
regulations require carcass cleaning, the
maintenance of sanitary conditions, and
the prevention of hazards reasonably
likely to occur in the slaughter process.
DATES: Comments must be received by
July 16, 2018.
ADDRESSES: FSIS invites interested
persons to submit comments on FSIS–
2018–0005. 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
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SUMMARY:
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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, FSIS; Telephone:
(202) 205–0495.
SUPPLEMENTARY INFORMATION:
Background
Under the Federal Meat Inspection
Act (21 U.S.C. 601–695), FSIS carries
out an inspection program to ensure that
carcasses, parts, and products of
amenable species of livestock are
wholesome, not adulterated, and
properly marked, labeled and packaged.
Among other provisions of the Act is a
requirement for post-mortem inspection
of livestock carcasses, including swine
carcasses (21 U.S.C. 604). This
inspection must be completed before the
carcasses or the meat or meat food
products derived from them are moved
to further processing (21 U.S.C. 605) and
preparation for commerce (also under
inspection) (21 U.S.C. 606(a)).
Under the Act, the Agency may
prescribe rules and regulations of
sanitation under which establishments
must be maintained (21 U.S.C. 608).
More generally, the Agency may issue
rules and regulations necessary for the
efficient execution of the Act’s
provisions (21 U.S.C. 621).
Accordingly, FSIS and its
predecessors have issued regulations
governing inspection. The regulations
include post-mortem inspection
requirements, criteria for determining
whether or not meat or meat food
products are adulterated, and
requirements for inspected
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establishments to develop and maintain
Hazard Analysis and Critical Control
Point (HACCP) plans and Sanitation
Standard Operating Procedures
(Sanitation SOPs).
Among the post-mortem inspection
regulations is one titled ‘‘Cleaning of
hog carcasses before incising’’ (9 CFR
310.11). This regulation states, ‘‘All
hair, scurf, and dirt, including all hoofs
and claws, shall be removed from hog
carcasses and the carcasses thoroughly
washed and cleaned, before any incision
is made for inspection or evisceration.’’
The carcass cleaning that the regulation
is referring to typically begins in an
official slaughter establishment after
stunning, bleeding, and scalding, and
continues after gambrelling 1 and
singeing, along with trimming of jowls,
lips, and eyelids, but before dropping of
the head. This regulation has helped to
ensure that carcasses are clean when
presented for post-mortem inspection.
Another post-mortem-inspection
regulation, 9 CFR 310.18, on
‘‘Contamination of carcasses, organs, or
other parts,’’ addresses the prevention
and removal of contamination from
carcasses (before or after incision),
organs, and other parts. Under this
regulation, any contamination
remaining post-incision or postevisceration is removed.
Regulations on Sanitation SOPs (9
CFR 304.3, 416.12–17) require
establishments to have written
procedures to ensure sanitary operating
conditions that will prevent
contamination and adulteration of
products. The HACCP regulations (9
CFR 304.3, and 417, particularly 9 CFR
417.2, and 417.4) require establishments
to have HACCP plans to prevent or
reduce to acceptable levels any hazards
reasonably likely to occur. These
include any contamination hazards that
are not already minimized through the
implementation of Sanitation SOPs or
other prerequisite programs. FSIS and
members of the regulated industry have
found that the regulation on cleaning
hog carcasses before incising, 9 CFR
310.11, may impede the application of
alternative, more efficient, procedures
for removing hair, scurf, and dirt after
the first incision preceding the dropping
of the head and evisceration.
Because the current regulation is
prescriptive and requires dehairing
1 Suspending the carcass by the legs from a metal
frame or hanger—a gambrel.
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before evisceration, the establishment
has limited flexibility. Removing the
regulation will enable an establishment
to remove hair, scurf, nails, and hooves
at other points in the process and to do
so in a way that may prove to be more
efficient. For example, removing hair
from the snout when the snout is on a
table, beyond the point where the first
incision is made, and the snout is also
not moving on the line is more efficient
than trying to remove the hair on a
moving carcass with the head still
attached.
These more efficient procedures also
ensure that carcasses will be free of
contamination when moved within an
establishment to, or shipped in
commerce for, further processing. The
alternative procedures can be
incorporated in a prerequisite program
aimed at preventing contamination.
When executed and documented, the
program can support an establishment’s
hazard analysis (as per 9 CFR
417.5(a)(1)) and HACCP plan. At times,
the Agency has, under an exemption
regulation, at 9 CFR 303.1(h), granted
waivers from the requirements of 9 CFR
310.11 to permit the use of the
alternative procedures.
For example, carcass defects and
blemishes too small to be detected
during slaughter can be removed during
off-line inspection or during further
processing. So, some establishments are
using alternative procedures for
removing, after carcass dressing, hairs
that are not readily visible. Such defects
may be regarded as finished carcass
defects and not as contamination or
sanitary dressing defects. Singed
eyelashes remaining on the carcass or
isolated, individual, hairs on the head
or face of the ham may be found after
the first incision. Such defects may be
removed effectively when pulling the
snout and when ‘‘facing’’ (trimming the
excess fat along the inside surfaces of)
hams in the cutting room, where
carcasses are broken down in a sanitary
manner into standard wholesale or retail
cuts. Remaining hoofs and claws (i.e.,
nails) can be removed after the first
incision or later in processing when feet
are discarded or not saved for food in
the cutting room. FSIS has found the
performance of establishments using the
alternative procedures to be satisfactory.
Establishments using the alternatives
are listed on the FSIS website at: https://
www.fsis.usda.gov/wps/wcm/connect/
188bf583-45c9-4837-920537e0eb1ba243/Waiver_
Table.pdf?MOD=AJPERES
By relying on the authority of 9 CFR
310.18 and the Sanitation SOP and
HACCP regulations, establishments
have the flexibility to implement these
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or other procedures to remove any
defects during the stages of slaughter
and further processing that follow
evisceration. They can make their
operations more efficient and effective
without compromising food safety.
Therefore, these other regulations, and
establishment compliance therewith,
make 9 CFR 310.11 unnecessary.
FSIS is therefore proposing to remove
9 CFR 310.11 from the regulations.
Modernization of Swine Slaughter
Inspection
On February 1, 2018, FSIS proposed
a new regulation to modernize swine
inspection (83 FR 4780). Among other
things, in this rule, FSIS is proposing to
require that all official swine slaughter
establishments develop, implement, and
maintain in their HACCP systems
written procedures to prevent the
contamination of carcasses and parts by
enteric pathogens, fecal material,
ingesta, and milk throughout the entire
slaughter and dressing operation. These
procedures must include sampling and
analysis for microbial organisms to
monitor process control for enteric
pathogens, as well as written procedures
to prevent visible fecal material, ingesta,
and milk contamination. In addition,
FSIS is proposing to require that all
official swine slaughter establishments
develop, implement, and maintain in
their HACCP systems written
procedures to prevent contamination of
the pre-operational environment by
enteric pathogens. Therefore, in the
modernization proposed rule, FSIS is
proposing additional requirements that,
if finalized, will further prevent
contamination of swine carcasses. If
finalized, this rule would provide more
support for eliminating section 310.11,
as is proposed above.
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.
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22605
Economic Analysis
Expected Cost Savings and Benefits
Associated With the Proposed Rule
This proposed rule is expected to
reduce swine slaughter labor costs by
approximately $11.81 million annually.
These savings are due to industry’s
practice of dedicating labor pre-incision,
solely to comply with 310.11. Under the
proposed rule, this labor would no
longer be needed because the work can
be accomplished by existing labor
located post-incision. FSIS’s labor cost
savings estimate assumes that the labor
affected by the proposed rule is
equivalent to that in the Bureau of Labor
Statistics’ (BLS’s) slaughtering and
meat-packing occupational category, for
which the industry annual wage is
$27,140.2 The Agency seeks comment
on this assumption. Applying a benefitsand-overhead factor of 2 brings this
occupation’s total annual labor costs per
position to $54,280 ($27,140 × 2).
The number of positions affected at
each establishment depends on the
establishment’s size, slaughter volume,
number of lines and shifts it operates,
and days of operation. Large 3 swine
establishments are thought to dedicate
from one to three full-time positions per
line and per shift to comply with 9 CFR
310.11; while small 4 high-volume 5
establishments dedicate between one
and two positions for the same purpose.
Small low-volume and very small 6
establishments are thought to dedicate
between one quarter-time and one fulltime position to compliance with this
regulation. The Agency seeks comment
on these labor-demand estimates.
According to data from the Agency’s
electronic Public Health Inspection
System (PHIS), 479 very small
establishments, 54 small low-volume
establishments, 51 small high-volume
establishments, and 23 7 large swine
2 BLS Occupational Employment Statistics (OES)
May 2016 National Industry-Specific Occupational
Employment and Wage Estimates for North
American Industrial Classification (NAICS) code
311600 (Animal Slaughtering and Processing)
https://www.bls.gov/oes/current/naics4_
311600.htm> Last Modified 3/31/2017 Accessed on
1/19/2018.
3 A large establishment has 500 or more
employees.
4 A small establishment has between 10 and 499
employees.
5 9 CFR 310.25(a)(2)(v) defines very low volume
swine slaughter establishments as slaughtering
20,000 head annually or fewer. For the purposes of
this analysis, FSIS has labeled swine establishments
that annually slaughter more than 20,000 head per
year as high-volume establishments.
6 A very small establishment has less than 10
employees or less than $2.5 million in annual sales.
7 While there are 28 large swine establishments,
five are operating under waivers from 9 CFR 310.11
and are not expected to experience a decrease in
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Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Proposed Rules
establishments would be affected by this
rule. This analysis takes into
consideration the fact that some large
and small high-volume establishments
operate multiple lines and multiple
shifts. This analysis assumes that all
other establishments operate one line
and one shift per day. Data from PHIS
also show that, on average, large
establishments annually operate 266
days, small high-volume establishments
239 days, small low-volume
establishments 95 days, and very small
establishments 67 days. The proposed
rule is expected to lead to a reduction
in industry positions at these
establishments; see table 1. Table 2
provides the estimated labor cost
savings from the proposed rule, given
the expected labor costs, number of
positions, and days of operation. The
annual cost savings range from $5.27
million to $19.03 million, with a midpoint of $11.81 million.
TABLE 1—ESTIMATED INDUSTRY LABOR REDUCTIONS FROM REMOVING 310.11
Number of
establishments *
Size of est
Large ................................................................................................................
Small High Volume ..........................................................................................
Small Low Volume ...........................................................................................
Very Small .......................................................................................................
Combined .........................................................................................................
Number of positions reduced
Low
23
51
54
479
607
Medium
37
26
14
120
196
High
74
77
27
240
417
111
102
54
479
746
* Public Health Information System (PHIS).
TABLE 2—LABOR WAGE COST (SAVINGS) FROM REMOVING 310.11, 2016
Number of
establishments *
Size of est
Large ................................................................................................................
Small High Volume ..........................................................................................
Small Low Volume ...........................................................................................
Very Small .......................................................................................................
Combined .........................................................................................................
23
51
54
479
612
Total annual labor costs (savings)
(M$) **
Low
Medium
High
($2.06)
(1.27)
(.27)
(1.68)
(5.27)
($4.11)
(3.82)
(.54)
(3.35)
(11.81)
($6.17)
(5.09)
(1.07)
(6.7)
(19.03)
(5.27)
(5.27)
(11.81)
(11.81)
(19.03)
(19.03)
Annualized Costs (Savings), Over 10 Years (M$)
Assuming a 3% Discount Rate ....................................................................................................
Assuming a 7% Discount Rate ....................................................................................................
* Public Health Information System (PHIS).
** Wage estimates were sourced from BLS OES May 2016 National Industry-Specific Occupational Employment and Wage Estimates for
NAICS code 311600 Last Modified 3/31/2017. Accessed on 1/19/2018.
Expected Costs Associated With This
Action
as proposed, this rule is expected to be
an E.O. 13771 deregulatory action.
The proposed rule has no expected
costs associated with it.
Paperwork Reduction Act
No new paperwork requirements are
associated with this proposed rule.
Expected Effects on Small Entities
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The FSIS Acting Administrator has
made a preliminary determination that
this proposed rule will not have a
significant impact on a substantial
number of small entities, as defined by
the Regulatory Flexibility Act (5 U.S.C.
601). The expected labor cost reductions
associated with the proposed rule are
not likely to be large enough to
significantly impact an entity. Further,
the proposed rule does not have any
cost increases.
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
Executive Order 12988
This proposed rule has been reviewed
under E.O. 12988, Civil Justice Reform.
If this proposed rule is adopted: (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)
Administrative proceedings will not be
required before parties may file suit in
court challenging this rule.
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.
Additional Public Notification
FSIS will announce this proposal online through the FSIS web page located
at: https://www.fsis.usda.gov/
regulations_&_policies/Proposed_Rules/
index.asp. FSIS also will make copies of
this Federal Register publication
available through the FSIS Constituent
Update, which is used to provide
information regarding FSIS policies,
procedures, regulations, Federal
Register notices, FSIS public meetings,
and other types of information that
could affect or would be of interest to
our constituents and stakeholders. 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
their demand for labor resulting from
implementation of this proposed rule.
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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.
USDA Non-Discrimination Statement
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).
List of Subjects in 9 CFR 310
Animal diseases, Meat inspection.
For the reasons set out in the
preamble, FSIS is proposing to amend 9
CFR part 310 as follows:
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PART 310—POST-MORTEM
INSPECTION
1. The authority citation for part 310
continues to read as follows:
■
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
[Removed and reserved]
2. Section 310.11 is removed and
reserved.
■
VerDate Sep<11>2014
15:33 May 15, 2018
Dated: May 10, 2018.
Sterling J. Rideout,
Assistant Director, Program Support.
[FR Doc. 2018–10488 Filed 5–15–18; 8:45 am]
[FR Doc. 2018–10485 Filed 5–15–18; 8:45 am]
BILLING CODE 3410–DM–P
BILLING CODE 4310–05–P
DEPARTMENT OF INTERIOR
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
[PA–166–FOR; Docket ID: OSM–2017–0008
S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520]
Pennsylvania Regulatory Program;
Correction
Office of Surface Mining
Reclamation and Enforcement (OSMRE),
Interior.
AGENCY:
ACTION:
How To File a Complaint of
Discrimination
§ 310.11
Done, at Washington, DC.
Paul Kiecker
Acting Administrator.
30 CFR Part 938
No agency, officer, or employee of the
USDA, 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,
shall 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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22607
Proposed rule; correction.
We, the Office of Surface
Mining Reclamation and Enforcement
published a document in the Federal
Register on May 8, 2018, reopening the
comment period and announcing a
public hearing on an amendment to the
Pennsylvania Regulatory Program. The
document contained an incorrect date
for the public hearing.
SUMMARY:
Mr.
Ben Owens, Chief, Pittsburgh Field
Division, Telephone: (412) 937–2827.
Email: bowens@osmre.gov.
FOR FURTHER INFORMATION CONTACT:
Correction
In the proposed rule of May 8, 2018,
in FR Doc. 2018–09767, on page 20774
in the third column, correct the DATES
caption to read:
DATES: We will accept written comments
until 4 p.m., Eastern Standard Time (EST),
June 7, 2018. The public hearing will be held
on May 17, 2018, from 5:30 p.m. until 7:30
p.m. EST.
Correction
In the proposed rule of May 8, 2018,
in FR Doc. 2018–09767, on page 20775
in the first column, correct the ‘‘Public
Hearing’’ caption to read:
Public Hearing: The public hearing will be
held at the Double Tree by Hilton PittsburghGreen Tree, 500 Mansfield Avenue,
Pittsburgh, Pennsylvania 15205; phone
number: 412–922–8400, on Thursday, May
17, 2018, from 5:30 p.m. to 7:30 p.m. EST.
Those wishing to provide oral testimony
need to register between 5:00 p.m. and 5:30
p.m.
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Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 938
[SATS No. PA–165–FOR; Docket ID: OSM–
2016–0013; S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520]
Pennsylvania Abandoned Mine Land
Reclamation Program
Office of Surface Mining
Reclamation and Enforcement (OSMRE),
Interior.
ACTION: Proposed rule; public comment
period and opportunity for public
hearing on proposed amendment.
AGENCY:
We, the Office of Surface
Mining Reclamation and Enforcement
(OSMRE), are announcing receipt of a
proposed amendment to the
Pennsylvania Abandoned Mine Land
Reclamation (AMLR) Plan (hereinafter,
the Plan) under the Surface Mining
Control and Reclamation Act of 1977
(SMCRA or the Act). Through this
proposed amendment, Pennsylvania
would modify its AMLR Plan by adding
Reclamation Plan Amendment No. 3, to
allow the Pennsylvania Department of
Environmental Protection (PADEP) to
administer a State Emergency Program
under Title IV of the Surface Mining
Control and Reclamation Act of 1977.
The plan covers coordination of
emergency reclamation work between
the Commonwealth and the OSMRE as
well as procedures for implementing the
National Environmental Policy Act and
other Commonwealth procedures.
This document gives the locations
and times where the Pennsylvania
AMLR Plan documents and this
proposed amendment to that Plan are
available for your inspection,
establishes the comment period during
which you may submit written
comments on the amendment, and
describes the procedures we will follow
for the public hearing, if one is
requested.
SUMMARY:
We will accept written
comments on this amendment until 4:00
p.m., Eastern Standard Time (e.s.t.),
June 15, 2018. If requested, we will hold
a public hearing about the amendment
on June 11, 2018. We will accept
DATES:
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Agencies
[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Proposed Rules]
[Pages 22604-22607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10488]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 /
Proposed Rules
[[Page 22604]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 310
[Docket No. FSIS-2018-0005]
RIN: 0583-AD68
Eliminating Unnecessary Requirements for Hog Carcass Cleaning
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat inspection regulations by removing the provision
requiring the cleaning of hog carcasses before any incision is made
preceding evisceration. This provision, although focusing on the
presentation of carcass dressing defects, impedes the adoption of more
efficient, effective procedures under other regulations to ensure that
carcasses and parts are free of contamination. Also, the provision is
no longer necessary because other regulations require carcass cleaning,
the maintenance of sanitary conditions, and the prevention of hazards
reasonably likely to occur in the slaughter process.
DATES: Comments must be received by July 16, 2018.
ADDRESSES: FSIS invites interested persons to submit comments on FSIS-
2018-0005. 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.
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, FSIS;
Telephone: (202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
Under the Federal Meat Inspection Act (21 U.S.C. 601-695), FSIS
carries out an inspection program to ensure that carcasses, parts, and
products of amenable species of livestock are wholesome, not
adulterated, and properly marked, labeled and packaged. Among other
provisions of the Act is a requirement for post-mortem inspection of
livestock carcasses, including swine carcasses (21 U.S.C. 604). This
inspection must be completed before the carcasses or the meat or meat
food products derived from them are moved to further processing (21
U.S.C. 605) and preparation for commerce (also under inspection) (21
U.S.C. 606(a)).
Under the Act, the Agency may prescribe rules and regulations of
sanitation under which establishments must be maintained (21 U.S.C.
608). More generally, the Agency may issue rules and regulations
necessary for the efficient execution of the Act's provisions (21
U.S.C. 621).
Accordingly, FSIS and its predecessors have issued regulations
governing inspection. The regulations include post-mortem inspection
requirements, criteria for determining whether or not meat or meat food
products are adulterated, and requirements for inspected establishments
to develop and maintain Hazard Analysis and Critical Control Point
(HACCP) plans and Sanitation Standard Operating Procedures (Sanitation
SOPs).
Among the post-mortem inspection regulations is one titled
``Cleaning of hog carcasses before incising'' (9 CFR 310.11). This
regulation states, ``All hair, scurf, and dirt, including all hoofs and
claws, shall be removed from hog carcasses and the carcasses thoroughly
washed and cleaned, before any incision is made for inspection or
evisceration.'' The carcass cleaning that the regulation is referring
to typically begins in an official slaughter establishment after
stunning, bleeding, and scalding, and continues after gambrelling \1\
and singeing, along with trimming of jowls, lips, and eyelids, but
before dropping of the head. This regulation has helped to ensure that
carcasses are clean when presented for post-mortem inspection.
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\1\ Suspending the carcass by the legs from a metal frame or
hanger--a gambrel.
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Another post-mortem-inspection regulation, 9 CFR 310.18, on
``Contamination of carcasses, organs, or other parts,'' addresses the
prevention and removal of contamination from carcasses (before or after
incision), organs, and other parts. Under this regulation, any
contamination remaining post-incision or post-evisceration is removed.
Regulations on Sanitation SOPs (9 CFR 304.3, 416.12-17) require
establishments to have written procedures to ensure sanitary operating
conditions that will prevent contamination and adulteration of
products. The HACCP regulations (9 CFR 304.3, and 417, particularly 9
CFR 417.2, and 417.4) require establishments to have HACCP plans to
prevent or reduce to acceptable levels any hazards reasonably likely to
occur. These include any contamination hazards that are not already
minimized through the implementation of Sanitation SOPs or other
prerequisite programs. FSIS and members of the regulated industry have
found that the regulation on cleaning hog carcasses before incising, 9
CFR 310.11, may impede the application of alternative, more efficient,
procedures for removing hair, scurf, and dirt after the first incision
preceding the dropping of the head and evisceration.
Because the current regulation is prescriptive and requires
dehairing
[[Page 22605]]
before evisceration, the establishment has limited flexibility.
Removing the regulation will enable an establishment to remove hair,
scurf, nails, and hooves at other points in the process and to do so in
a way that may prove to be more efficient. For example, removing hair
from the snout when the snout is on a table, beyond the point where the
first incision is made, and the snout is also not moving on the line is
more efficient than trying to remove the hair on a moving carcass with
the head still attached.
These more efficient procedures also ensure that carcasses will be
free of contamination when moved within an establishment to, or shipped
in commerce for, further processing. The alternative procedures can be
incorporated in a prerequisite program aimed at preventing
contamination. When executed and documented, the program can support an
establishment's hazard analysis (as per 9 CFR 417.5(a)(1)) and HACCP
plan. At times, the Agency has, under an exemption regulation, at 9 CFR
303.1(h), granted waivers from the requirements of 9 CFR 310.11 to
permit the use of the alternative procedures.
For example, carcass defects and blemishes too small to be detected
during slaughter can be removed during off-line inspection or during
further processing. So, some establishments are using alternative
procedures for removing, after carcass dressing, hairs that are not
readily visible. Such defects may be regarded as finished carcass
defects and not as contamination or sanitary dressing defects. Singed
eyelashes remaining on the carcass or isolated, individual, hairs on
the head or face of the ham may be found after the first incision. Such
defects may be removed effectively when pulling the snout and when
``facing'' (trimming the excess fat along the inside surfaces of) hams
in the cutting room, where carcasses are broken down in a sanitary
manner into standard wholesale or retail cuts. Remaining hoofs and
claws (i.e., nails) can be removed after the first incision or later in
processing when feet are discarded or not saved for food in the cutting
room. FSIS has found the performance of establishments using the
alternative procedures to be satisfactory.
Establishments using the alternatives are listed on the FSIS
website at: https://www.fsis.usda.gov/wps/wcm/connect/188bf583-45c9-4837-9205-37e0eb1ba243/Waiver_Table.pdf?MOD=AJPERES
By relying on the authority of 9 CFR 310.18 and the Sanitation SOP
and HACCP regulations, establishments have the flexibility to implement
these or other procedures to remove any defects during the stages of
slaughter and further processing that follow evisceration. They can
make their operations more efficient and effective without compromising
food safety. Therefore, these other regulations, and establishment
compliance therewith, make 9 CFR 310.11 unnecessary.
FSIS is therefore proposing to remove 9 CFR 310.11 from the
regulations.
Modernization of Swine Slaughter Inspection
On February 1, 2018, FSIS proposed a new regulation to modernize
swine inspection (83 FR 4780). Among other things, in this rule, FSIS
is proposing to require that all official swine slaughter
establishments develop, implement, and maintain in their HACCP systems
written procedures to prevent the contamination of carcasses and parts
by enteric pathogens, fecal material, ingesta, and milk throughout the
entire slaughter and dressing operation. These procedures must include
sampling and analysis for microbial organisms to monitor process
control for enteric pathogens, as well as written procedures to prevent
visible fecal material, ingesta, and milk contamination. In addition,
FSIS is proposing to require that all official swine slaughter
establishments develop, implement, and maintain in their HACCP systems
written procedures to prevent contamination of the pre-operational
environment by enteric pathogens. Therefore, in the modernization
proposed rule, FSIS is proposing additional requirements that, if
finalized, will further prevent contamination of swine carcasses. If
finalized, this rule would provide more support for eliminating section
310.11, as is proposed above.
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 Analysis
Expected Cost Savings and Benefits Associated With the Proposed Rule
This proposed rule is expected to reduce swine slaughter labor
costs by approximately $11.81 million annually. These savings are due
to industry's practice of dedicating labor pre-incision, solely to
comply with 310.11. Under the proposed rule, this labor would no longer
be needed because the work can be accomplished by existing labor
located post-incision. FSIS's labor cost savings estimate assumes that
the labor affected by the proposed rule is equivalent to that in the
Bureau of Labor Statistics' (BLS's) slaughtering and meat-packing
occupational category, for which the industry annual wage is
$27,140.\2\ The Agency seeks comment on this assumption. Applying a
benefits-and-overhead factor of 2 brings this occupation's total annual
labor costs per position to $54,280 ($27,140 x 2).
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\2\ BLS Occupational Employment Statistics (OES) May 2016
National Industry-Specific Occupational Employment and Wage
Estimates for North American Industrial Classification (NAICS) code
311600 (Animal Slaughtering and Processing) https://www.bls.gov/oes/current/naics4_311600.htm> Last Modified 3/31/2017 Accessed on 1/19/
2018.
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The number of positions affected at each establishment depends on
the establishment's size, slaughter volume, number of lines and shifts
it operates, and days of operation. Large \3\ swine establishments are
thought to dedicate from one to three full-time positions per line and
per shift to comply with 9 CFR 310.11; while small \4\ high-volume \5\
establishments dedicate between one and two positions for the same
purpose. Small low-volume and very small \6\ establishments are thought
to dedicate between one quarter-time and one full-time position to
compliance with this regulation. The Agency seeks comment on these
labor-demand estimates.
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\3\ A large establishment has 500 or more employees.
\4\ A small establishment has between 10 and 499 employees.
\5\ 9 CFR 310.25(a)(2)(v) defines very low volume swine
slaughter establishments as slaughtering 20,000 head annually or
fewer. For the purposes of this analysis, FSIS has labeled swine
establishments that annually slaughter more than 20,000 head per
year as high-volume establishments.
\6\ A very small establishment has less than 10 employees or
less than $2.5 million in annual sales.
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According to data from the Agency's electronic Public Health
Inspection System (PHIS), 479 very small establishments, 54 small low-
volume establishments, 51 small high-volume establishments, and 23 \7\
large swine
[[Page 22606]]
establishments would be affected by this rule. This analysis takes into
consideration the fact that some large and small high-volume
establishments operate multiple lines and multiple shifts. This
analysis assumes that all other establishments operate one line and one
shift per day. Data from PHIS also show that, on average, large
establishments annually operate 266 days, small high-volume
establishments 239 days, small low-volume establishments 95 days, and
very small establishments 67 days. The proposed rule is expected to
lead to a reduction in industry positions at these establishments; see
table 1. Table 2 provides the estimated labor cost savings from the
proposed rule, given the expected labor costs, number of positions, and
days of operation. The annual cost savings range from $5.27 million to
$19.03 million, with a mid-point of $11.81 million.
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\7\ While there are 28 large swine establishments, five are
operating under waivers from 9 CFR 310.11 and are not expected to
experience a decrease in their demand for labor resulting from
implementation of this proposed rule.
Table 1--Estimated Industry Labor Reductions From Removing 310.11
----------------------------------------------------------------------------------------------------------------
Number of Number of positions reduced
Size of est establishments -----------------------------------------------
* Low Medium High
----------------------------------------------------------------------------------------------------------------
Large........................................... 23 37 74 111
Small High Volume............................... 51 26 77 102
Small Low Volume................................ 54 14 27 54
Very Small...................................... 479 120 240 479
Combined........................................ 607 196 417 746
----------------------------------------------------------------------------------------------------------------
* Public Health Information System (PHIS).
Table 2--Labor Wage Cost (Savings) From Removing 310.11, 2016
----------------------------------------------------------------------------------------------------------------
Number of Total annual labor costs (savings) (M$) **
Size of est establishments -----------------------------------------------
* Low Medium High
----------------------------------------------------------------------------------------------------------------
Large........................................... 23 ($2.06) ($4.11) ($6.17)
Small High Volume............................... 51 (1.27) (3.82) (5.09)
Small Low Volume................................ 54 (.27) (.54) (1.07)
Very Small...................................... 479 (1.68) (3.35) (6.7)
Combined........................................ 612 (5.27) (11.81) (19.03)
----------------------------------------------------------------------------------------------------------------
Annualized Costs (Savings), Over 10 Years (M$)
----------------------------------------------------------------------------------------------------------------
Assuming a 3% Discount Rate..................................... (5.27) (11.81) (19.03)
Assuming a 7% Discount Rate..................................... (5.27) (11.81) (19.03)
----------------------------------------------------------------------------------------------------------------
* Public Health Information System (PHIS).
** Wage estimates were sourced from BLS OES May 2016 National Industry-Specific Occupational Employment and Wage
Estimates for NAICS code 311600 <https://www.bls.gov/oes/current/naics4_311600.htm> Last Modified 3/31/2017.
Accessed on 1/19/2018.
Expected Costs Associated With This Action
The proposed rule has no expected costs associated with it.
Expected Effects on Small Entities
The FSIS Acting Administrator has made a preliminary determination
that this proposed rule will not have a significant impact on a
substantial number of small entities, as defined by the Regulatory
Flexibility Act (5 U.S.C. 601). The expected labor cost reductions
associated with the proposed rule are not likely to be large enough to
significantly impact an entity. Further, the proposed rule does not
have any cost increases.
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
No new paperwork requirements are associated with this proposed
rule.
Executive Order 12988
This proposed rule has been reviewed under E.O. 12988, Civil
Justice Reform. If this proposed rule is adopted: (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) Administrative proceedings will not be required before parties may
file suit in court challenging this rule.
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.
Additional Public Notification
FSIS will announce this proposal on-line through the FSIS web page
located at: https://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp. FSIS also will make copies of this Federal
Register publication available through the FSIS Constituent Update,
which is used to provide information regarding FSIS policies,
procedures, regulations, Federal Register notices, FSIS public
meetings, and other types of information that could affect or would be
of interest to our constituents and stakeholders. 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
[[Page 22607]]
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.
USDA Non-Discrimination Statement
No agency, officer, or employee of the USDA, 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,
shall 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).
List of Subjects in 9 CFR 310
Animal diseases, Meat inspection.
For the reasons set out in the preamble, FSIS is proposing to amend
9 CFR part 310 as follows:
PART 310--POST-MORTEM INSPECTION
0
1. The authority citation for part 310 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 310.11 [Removed and reserved]
0
2. Section 310.11 is removed and reserved.
Done, at Washington, DC.
Paul Kiecker
Acting Administrator.
[FR Doc. 2018-10488 Filed 5-15-18; 8:45 am]
BILLING CODE 3410-DM-P