[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Rules and Regulations]
[Pages 2430-2433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01345]


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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: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat inspection regulations by removing the provision requiring 
the cleaning of hog carcasses before any incision is made preceding 
evisceration. Other regulations require carcass cleaning, the 
maintenance of sanitary conditions, and the prevention of hazards 
reasonably likely to occur in the slaughter process. Removal of this 
unnecessary provision will enable official establishments to adopt more 
efficient, effective procedures under other regulations to ensure that 
carcasses and parts are free of contamination.

DATES: Effective date: April 8, 2019.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and Program Development, FSIS; 
Telephone: (202)-205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    On May 16, 2018, FSIS proposed (83 FR 22604) to amend the Federal 
meat inspection regulations by removing from the post-mortem inspection 
regulations requirements for the cleaning of hog carcasses before 
incision for inspection or evisceration (9 CFR 310.11). FSIS noted that 
regulations on sanitation and standard operating procedures (9 CFR 
parts 304, 416), hazard analysis and critical control point (HACCP) 
systems (9 CFR part 417), and another post-mortem inspection regulation 
(9 CFR 310.18) require sanitary conditions for the handling of 
carcasses. The regulation at 9 CFR 310.18, in particular, addresses the 
prevention and removal of contamination from carcasses (before or after 
incision), organs, and other parts. The regulation requires the removal 
of any contamination remaining or occurring post-incision or post-
evisceration.
    After reviewing comments on the proposed rule, FSIS is finalizing 
it without changes.

Responses to Comments

    FSIS received nine comment letters on the proposed rule from 
industry and consumer-advocacy groups, as well as from individuals. The 
issues raised in the comments and the Agency responses are summarized 
below.

Pre-Incision Cleaning, APA Compliance, and Public Health Benefits

    Comment: A group advocating humane treatment of livestock stated 
that other current regulations do not obviate the need for 9 CFR 
310.11. According to the comment, this is the only regulation that 
addresses pre-incision cleaning, which is integral to preventing 
contamination of pig carcasses. Similarly, the comment stated that 
studies show that pre-incision cleaning is necessary to ensure food 
safety, and FSIS provides no evidence to the contrary. Pig carcasses 
are relatively smooth compared to beef and potentially more susceptible 
to external contamination. For this reason, pre-evisceration cleaning 
is even more necessary and more effective in removing bacteria from pig 
carcasses. Eliminating this requirement, therefore, does not have a 
scientific basis, would endanger food safety, and is arbitrary and 
capricious.
    Response: The regulations at 9 CFR 310.10, which remain, require 
the washing and cleaning of hide-on or skin-on livestock carcasses 
before incision for removal of any parts or for evisceration. 
Additionally, establishments commonly scald, dehair, and singe hog 
carcasses after bleed-out, before inspection. And, as explained 
elsewhere in this document, the removal of other trim defects on hog 
carcasses, such as hair, scurf, nails, and hooves, which 9 CFR 310.11 
addressed, is still required under 310.18 and can be completed in a 
different manner and at different points in the slaughter process. This 
can be done without creating insanitary conditions and before the 
product enters commerce. Under this final rule, an establishment will 
have to handle its carcasses and parts in a sanitary manner to prevent 
their contamination with hair, dirt, or foreign matter. The 
establishment will have to carry out all carcass dressing and further 
processing activities in a manner consistent with its Sanitation SOPs, 
other prerequisite programs, and its HACCP plan.
    Comment: Comments from consumer advocacy groups, an animal welfare 
organization, and individuals argued that the proposal would yield no 
public health benefits, just efficiency, and that industry efficiency 
is not a goal of the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 
et seq.). The animal welfare group went farther and argued that the 
proposed rule is arbitrary and capricious under the Administrative 
Procedure Act (APA, 5 U.S.C. Subchapter II) because, in constructing 
and making the proposal, the Agency relied on factors Congress did not 
intend it to consider, failed to consider an important aspect of the 
problem, and offered an implausible explanation running counter to 
evidence and not based on differences in expertise or viewpoints. 
According to the animal welfare group, the Agency proposed the rule to 
ensure the efficiency of establishment operations, but ensuring this 
efficiency is not a responsibility of FSIS. Therefore, according to the 
comment, the Agency relied on factors Congress did not intend it to 
consider, making the proposed regulation arbitrary and capricious. One 
consumer advocacy argued that the cost-benefit analysis was flawed 
because it did not address potential public health implications of 
removing 9 CFR 310.11.
    Response: Congress, through the FMIA, requires the Agency and its 
inspection program to address and

[[Page 2431]]

prevent the distribution in commerce of meat and meat food products 
that are adulterated (21 U.S.C. 602). Congress empowered the Agency to 
promulgate regulations for the efficient execution of the Federal Meat 
Inspection Act (21 U.S.C. 621). The elimination of unnecessary 
regulations creates efficiencies for both FSIS inspection and industry.
    Specifically, since FSIS made final its HACCP regulations in 1996, 
appropriately shifting the full responsibility for producing safe meat 
and poultry products to the regulated industry, the Agency has revised 
many of its prescriptive food safety regulations to give industry more 
flexibility to customize processes under HACCP. This flexibility often 
results in greater efficiencies for regulated establishments, but also 
allows them to fully employ HACCP to better ensure the production of 
safe meat and poultry products. The proposal to remove the requirements 
for hog carcass cleaning before incision for evisceration is part of 
these continuing efforts and was promulgated in accordance with the APA 
procedures.
    Removing a regulation that other requirements for sanitation and 
the prevention of adulteration have made redundant, will make the 
enforcement of the Act more efficient. This change will not negatively 
affect public health because, as explained above, establishments are 
still required to remove contamination from carcasses and to produce 
products that are safe, wholesome, and not adulterated.

New Swine Inspection System

    Comment: A consumer advocacy organization, an animal welfare 
organization, and an individual stated that the proposal assumes the 
implementation of the new swine inspection system.
    Response: The scurf proposal cites the future implementation of the 
new swine inspection system as more support for eliminating Sec.  
310.11, ``if finalized'' (83 FR 22605).

Industry Non-Compliance, Need for the Regulation

    Comment: One consumer advocacy group stated that FSIS inspection 
program personnel (IPP) are still issuing noncompliance records (NRs) 
for 9 CFR 310.11 violations; hence, the regulation is not redundant.
    Response: In the proposal, the Agency explained that the 
requirement in 9 CFR 310.11 is not needed because compliance with other 
regulations and accompanying procedures achieve its objective, i.e., 
clean hog carcasses and parts. Further, that this prescriptive 
regulation is cited in NRs does not show that it is in fact needed to 
ensure to ensure the production of safe food.

Regulatory Waivers

    Comment: Comments from consumer advocacy groups stated that the 
Agency seems to be basing the proposal on the five regulatory waivers 
granted to a major processor. The commenters were concerned that FSIS 
was relying on a small sample to justify removing 9 CFR 310.11.
    Response: Information from establishments that operated under 
waivers from this specific regulation shows that they operated without 
jeopardizing food safety and supports the removal of the specific 
requirement.

Relation of HACCP to the Proposal

    Comment: Comments from consumer advocacy groups stated that HACCP 
plans are doubtful substitutes for the requirements of 9 CFR 310.11.
    Response: Based on FSIS and establishment testing data, HACCP has 
proven to be an effective system for reducing or eliminating food 
safety hazards, and establishments may elect to clean hog carcasses 
before incision as a part of a HACCP system. Establishments also may 
elect to clean hog carcasses through a Sanitation SOP or other 
prerequisite program. And, notably, establishments must continue to 
comply with the regulations at 9 CFR 310.18, which require that 
livestock carcasses be cleaned of contamination to the satisfaction of 
FSIS.

Administration Support for the Proposal

    Comment: One consumer advocacy organization stated that the 
proposed rule is without adequate support in the Trump Administration. 
According to the commenter, at a June 27, 2018, House Oversight and 
Government Reform Committee hearing on the proposed Government 
reorganization, a Member asked an OMB official about the Agency's 
proposed repeal of the hog carcass cleaning regulation and how this 
deregulation would protect consumers or whether it was proposed at the 
behest of slaughterhouse operators. The OMB official said she was 
unfamiliar with the proposed rule.
    Response: This rulemaking has been listed in the Unified Agenda of 
Regulatory and Deregulatory Actions, reviewed and published by OMB, 
since Fall 2017.

Need for Microbiological Performance Standards

    Comment: One consumer advocacy organization remarked that, 
according to the 1995 HACCP notice of proposed rulemaking, ``Science-
based process control . . . and appropriate performance standards are 
inextricably intertwined in the Agency's regulatory strategy for 
improving food safety'' (60 FR 6774, 6786; Feb. 3, 1995). The commenter 
also stated that the 1996 HACCP final rule established Salmonella 
performance standards for pork carcasses, but in 2011 FSIS stopped 
testing to ensure compliance with the standard, reasoning that 
violation rates were too low to justify the effort. The commenter 
questioned the wisdom of the Agency's decision, noting that the 
performance standards of the 1990's were intended to be a first step 
toward broader reliance on pathogen-specific performance standards. The 
commenter recommended that FSIS update the performance standards for 
whole carcasses, develop alternative standards for pork parts, or 
implement other performance standards to reduce Salmonella in pork 
products.
    Response: The Government Accountability Office (GAO), in a recent 
review of FSIS efforts to control pathogens in meat and poultry 
products,\1\ recommended that the Agency set timeframes for determining 
what pathogen standards or additional policies might be needed to 
address pathogens in beef carcasses, ground beef, port cuts, and ground 
pork. As indicated in the GAO's review report, FSIS concurred with the 
recommendation and is continuing its sampling and testing raw pork cuts 
and pork comminuted products for Salmonella under its exploratory 
study.
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    \1\ U.S. Govt. Accountability Office, GAO-18-272, Food Safety: 
USDA Should Take Further Action to Reduce Pathogens in Meat and 
Poultry Products (March 2018). https://www.gao.gov/assets/700/690709.pdf (Accessed Oct. 22, 2018).
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    As FSIS stated in its response to GAO, in 2019, the Agency will use 
the data from the exploratory study to determine whether standards or 
additional policies (e.g., training, guidance to industry, or 
instructions to field personnel) are needed to address Salmonella in 
pork products. If the Agency decides to institute new standards, it 
will collect and evaluate data to determine whether establishments meet 
the standards.

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

    Executive Orders (E.O.) 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,

[[Page 2432]]

environmental, public health and safety effects, distributive impacts, 
and equity). E.O. 13563 emphasizes the importance of quantifying both 
costs and benefits, of reducing costs, of harmonizing rules, and of 
promoting flexibility. This final rule has been designated 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 under E.O. 12866.

Economic Analysis

    FSIS is adopting the preliminary regulatory impact analysis (PRIA) 
published in the proposed rule as the final regulatory impact analysis 
(FRIA) in this final rule, without change.

Expected Cost Savings and Benefits Associated With the Final Rule

    This final 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 9 CFR 310.11. Under the final rule, this labor will 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 final 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 
sought, but did not receive, 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 
comply with this regulation. The Agency sought, but did not receive, 
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 
Information System (PHIS), 479 very small establishments, 54 small low-
volume establishments, 51 small high-volume establishments, and 23 \7\ 
large swine establishments will 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 final 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 final 
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 final rule.

                     Table 1--Estimated Industry Labor Reductions From Removing 9 CFR 310.11
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                                                     Number of                Number of positions **
                  Size of Est.                    establishments -----------------------------------------------
                                                         *              Low           Medium           High
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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
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* Public Health Information System (PHIS).
** Note, the totals may not equal the sum due to rounding.


                       Table 2--Labor Wage Cost (Savings) From Removing 9 CFR 310.11, 2016
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                                                     Number of    Total annual labor costs (Savings) ** (M$) ***
                  Size of Est.                    establishments -----------------------------------------------
                                                         *              Low           Medium           High
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Large...........................................              23         ($2.06)         ($4.11)         ($6.17)
Small High Volume...............................              51          (1.27)          (3.82)          (5.09)
Small Low Volume................................              54           (.27)           (.54)          (1.07)
Very Small......................................             479          (1.68)          (3.35)           (6.7)
Combined........................................             607          (5.27)         (11.81)         (19.03)
                                                 ---------------------------------------------------------------
Annualized Costs (Savings), Over 10 Years (M$):
    Assuming a 3% Discount Rate.................  ..............          (5.27)         (11.81)         (19.03)

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    Assuming a 7% Discount Rate.................  ..............          (5.27)         (11.81)         (19.03)
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* Public Health Information System (PHIS).
** Note, the totals may not equal the sum due to rounding.
*** 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#51-0000. Last Modified
  3/31/2017. Accessed on 11/26/2018.

Expected Costs Associated With This Action

    The final rule has no expected costs associated with it.

Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will not 
have a significant impact on a substantial number of small entities in 
the United States. The expected labor cost reductions associated with 
the final rule are not likely to be large enough to significantly 
impact an entity. Further, the final 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 final rule will yield cost savings. Therefore, this 
final rule is an E.O. 13771 deregulatory action.

Paperwork Reduction Act

    No new paperwork requirements are associated with this final rule.

Executive Order 12988

    This final rule has been reviewed under E.O. 12988, Civil Justice 
Reform. Upon the effective date of this final 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) 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

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Constituent Update is available on the FSIS web page. 
Through the web page, FSIS is able to provide information to a much 
broader, more diverse audience. In addition, FSIS offers an email 
subscription service which provides automatic and customized access to 
selected food safety news and information. This service is available 
at: http://www.fsis.usda.gov/subscribe. Options range from recalls to 
export information, regulations, directives, and notices. Customers can 
add or delete subscriptions themselves, and have the option to password 
protect their accounts.

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 Part 310

    Animal diseases, Meat inspection.

    For the reasons set out in the preamble, FSIS is amending 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.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-01345 Filed 2-6-19; 8:45 am]
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