[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]]


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 http://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-
     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 http://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.

Administrator, Office of Policy and Program Development, FSIS;
Telephone: (202) 205-0495.



    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
    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.

    \1\ Suspending the carcass by the legs from a metal frame or
hanger--a gambrel.

    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

[[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

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).

    \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/

    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.

    \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.

    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.

    \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

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: http://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: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information,
regulations, directives, and notices. Customers can add or delete
subscriptions themselves, and have the option to password protect their

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

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:


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]

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]