[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
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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,
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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) ($6.17)
Small High Volume............................... 51 (1.27) (3.82) (5.09)
Small Low Volume................................ 54 (.27) (.54) (1.07)
Very Small...................................... 479 (1.68) (3.35) (6.7)
Combined........................................ 607 (5.27) (11.81) (19.03)
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Annualized Costs (Savings), Over 10 Years (M$):
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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