[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Rules and Regulations]
[Pages 9695-9698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04993]



Food Safety and Inspection Service

9 CFR Part 316

[Docket No. FSIS 2018-0019]
RIN 0583-AD69

Elimination of the Requirement That Livestock Carcasses Be Marked
"U.S. Inspected and Passed" at the Time of Inspection Within a
Slaughter Establishment for Carcasses To Be Further Processed Within
the Same Establishment

AGENCY: Food Safety and Inspection Service (FSIS), USDA.

ACTION: Final rule.


SUMMARY: FSIS is amending the Federal meat inspection regulations to
eliminate the requirement that livestock carcasses be marked with the
official inspection legend at the time of inspection in a slaughter
establishment, if the carcasses are to be further processed in the same

DATES: Effective April 17, 2019.

Administrator, Office of Policy and Program Development, Food Safety
and Inspection Service, U.S. Department of Agriculture; Telephone:
(202) 205-0495.



    In the past, slaughter establishments often would ship carcasses to
other establishments for further processing into primal, subprimal, and
other meat cuts and products. Today however, most establishments that
slaughter swine, cattle, sheep, or goats also fabricate the carcasses
into various primal and subprimal parts, as well as other meat
products. More specifically, after a carcass has passed inspection, the
slaughter establishment typically moves it, under control, to another
department in the same establishment for further processing. The
establishment then typically ships the resulting meat food products,
rather than marked carcasses, in fully labeled containers either for
further processing at other establishments or into commerce.

[[Page 9696]]

    FSIS regulations at Sec.  316.9(a) have required that all livestock
carcasses be marked with the inspection legend when they are inspected
and passed on the slaughter floor, even if they are to be further
processed within the same establishment. Numerous slaughter
establishments have requested and been granted waivers (Sec.  303.1(h))
from this requirement, as they further process the carcasses elsewhere
in the same establishment, after which the resulting products are
marked with the inspection legend. FSIS experience with establishments
operating under these waivers has shown that they have no difficulty
ensuring that only inspected, passed and properly marked parts enter
into commerce and also ensuring, when applicable, that only inspected,
passed and marked carcasses are shipped into commerce.
    Accordingly, on July 31, 2018, FSIS proposed that establishments no
longer be required to mark carcasses with the inspection legend on the
slaughter floor, if the carcasses are to be further processed in the
same establishment (83 FR 36794). The proposal did not change the
regulations that require that all primals, subprimals, parts and other
meat food products be properly labeled and bear the mark of inspection
before entering commerce (Sec.  316.9(b)). Under the proposed rule,
FSIS inspection personnel would verify whether the establishment is
shipping marked carcasses or whether the establishment is further
processing the carcasses in the establishment and marking the processed
parts appropriately before the parts leave the establishment.

Final Rule

    After consideration of all the comments, FSIS is finalizing the
provisions of the July 31, 2018, proposed rule with one change. The
final rule does not include the proposed requirement that
establishments have procedures in their HACCP plans, Sanitation SOPs,
or prerequisite programs to ensure that (1) unmarked carcasses are
further processed only in the slaughtering establishment; (2) unmarked
carcasses that, for any reason, are not further processed in the
slaughtering establishment do not leave the establishment unmarked; and
(3) unmarked and retained carcasses or parts remain under FSIS control
until the establishment makes any corrections that are necessary to
render the carcass or part eligible to bear the mark of inspection.

Comments and Responses

    FSIS received one comment from a trade association and five
comments from individuals in response to this rule. One individual and
the trade association generally supported the proposed changes. A
summary of comments and FSIS responses follows.
    Comment: A trade association representing members of the meat
industry stated that the economic impact analysis assumes that all
establishments that are currently marking carcasses will stop after the
implementation of the final rule. According to the trade association,
not all establishments will change their marking practices because some
establishments ship whole carcasses, some package primals in bulk
packaging (making the mark necessary to comply with regulation), and
some will not want to incorporate controls for unmarked carcasses into
their HACCP plans. The commenter also stated customer requirements,
production practices, and product mix can affect the marking of
carcasses. The trade association argued that the proposed rule does not
create a stronger incentive to discontinue carcass marking than the
waiver process.
    Response: The Agency agrees that it is likely that not all
establishments will stop marking carcasses after implementation of the
final rule. Establishments that ship whole carcasses will need to
continue to mark carcasses. However, FSIS believes that the advantage
to discontinuing the marking of carcasses is strong enough that most
establishments will do this after implementation of the final rule,
provided the establishment does not ship the carcass outside the
establishment for further processing. In response to the comment, FSIS
adjusted the expected post-rule percentage of carcasses that will not
be marked from 100 percent to 90-95 percent in the final rule economic
impact analyses. FSIS estimates that elimination of the requirement to
mark carcasses will yield an annual cost-saving of $0.82 million to
$0.93 million per year.
    Comment: The same trade association comment stated that because the
proposed rule would require establishments to incorporate unmarked
carcass procedures into the HACCP system, sanitation SOPs, or other
prerequisite programs, FSIS is just replacing one regulation with
another, and that the proposed rule is not a deregulatory action as
defined by E.O. 13771. The comment stated that other, existing
regulations require establishments to prevent uninspected or condemned
carcasses from entering commerce and that inspected and passed
carcasses and parts bear the mark before leaving the official
establishment. Further, the comment argued that HACCP controls are
specific to the establishment based on a thorough hazard analysis and
that only if the movement of unmarked carcasses poses a significant
food safety risk in the process should a control be put in place. The
comment stated that the movement of unmarked carcasses likely would not
pose a significant food safety risk at establishments.
    Response: FSIS agrees that requirements concerning the movement and
marking of carcasses already occur in other regulations: 9 CFR part
310, addresses the retaining of carcasses that may be unfit for human
consumption; 9 CFR part 314, addresses condemned and inedible product;
9 CFR part 316, addresses marking of products and containers; and 9 CFR
part 317, addresses labeling, marking devices, and containers.
Together, these existing regulations adequately require that
establishments control the movement of unmarked carcasses. Accordingly,
in the final provisions in Sec.  316.9(b), FSIS has removed the
requirement that establishments incorporate unmarked carcass procedures
into their HACCP plans, sanitation SOPs, or other prerequisite
    Comment: One individual questioned FSIS's regulatory authority to
deviate from the exact language in the Federal Meat Inspection Act
(FMIA) when changing the language in the regulations.
    Response: The FMIA requires that carcasses and parts (21 U.S.C.
604) and meat food products (21 U.S.C. 606) found not to be adulterated
be marked ``Inspected and passed'' by FSIS inspectors. The FMIA does
not require that this marking be done at a specific time or in a
specific location in the establishment, especially if carcasses are
being processed into parts or into meat food products within the same
establishment. The new regulations in 316.9(a) will ensure that the
specific intent of the FMIA marking requirements continue to be met in
the contemporary market, i.e., that carcasses, parts, and meat food
products found not adulterated by USDA inspectors enter commerce only
if marked ``Inspected and Passed.''
    Comment: One individual opposed the changes and questioned the risk
of a carcass leaving the facility unmarked under this rule. The
individual also questioned FSIS's oversight for establishments under
this new rule.
    Response: The new language at Sec.  316.9(a) states that ``Each
carcass that has been inspected and passed in an official establishment
must be marked at the time of inspection with the official

[[Page 9697]]

inspection legend containing the number of the official establishment,
if the carcass is to be shipped into commerce from the establishment
without further processing.'' Therefore, all carcasses not further
processed at the establishment must be marked with the official
inspection legend before entering commerce. FSIS will continue to
provide inspection at establishments to verify that establishments meet
this requirement, as well as to ensure that all meat food products are
properly marked and labeled before entering commerce.

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 final rule has been designated as a
``non-significant'' regulatory action under section 3(f) of E.O. 12866.
Accordingly, the final rule has not been reviewed by the Office of
Management and Budget (OMB) under E.O. 12866.

Economic Impact Analysis

    FSIS is removing the requirement for carcasses slaughtered in an
establishment to bear the mark of inspection after being inspected and
passed on the slaughter floor if the carcasses are to be further
processed in the same establishment. Since this requirement is no
longer necessary to prevent adulterated food product from entering
commerce (see explanation in the Background section above), removing it
will have no negative public health impact. Nor will it impose costs on
the industry or the Agency.
    Regarding benefits from the rulemaking, removing an unnecessary
requirement will allow establishments the flexibility to innovate and
to operate in the most efficient manner. In addition, it will also
allow FSIS to utilize its resources more appropriately by relieving
inspectors of unnecessary tasks. The expected benefits from this final
rule will accrue from time and resource savings. Inspected and passed
carcasses meant for further processing in the same establishment where
the animals were slaughtered will not have to wait for the mark of
inspection but can move directly to further processing. Thus,
establishments that slaughter livestock and process livestock carcasses
in the same facility will benefit from fewer delays in their operations
and greater flexibility to conduct processing operations on inspected
and passed carcasses.
    FSIS received only one comment on the proposed rule's economic
impact analysis. The comment, from the industry, argued that some
establishments will continue to mark the carcasses after the
implementation of the final rule. In response to this comment, FSIS
adjusted the expected post-rule percentage of carcasses processed
within the same establishment that will not be marked from 100 percent
to 90-95 percent.
    Agency data showed that there are approximately 797 meat
slaughtering establishments, and approximately 676 of them (~85
percent) do both slaughtering and processing.\1\ FSIS estimates that in
these 676 establishments, approximately 95 percent of the carcasses are
further processed in the same establishment. Given that the annual
production of meat by Federal inspected establishments is approximately
150 million heads,\2\ roughly 120.9 million carcasses are subject to
the requirements in Sec.  316.9 (150 million x 85 percent x 95
percent). Assuming that it takes establishment labor, on average, 3
seconds to mark each carcass, and that approximately half of the
establishments already have waivers from the requirement, and that an
additional 40-45 percent of the carcasses will not be marked after
implementation of this final rule, approximately 40,310 to 45,349
additional hours will be saved by this final rule. Most establishments
use hired workers to do the marking. If we assume that the average
hourly pay (salary plus benefits) is $20,\3\ then the time saved is
equivalent to approximately $0.81 to $0.91 million annually.

    \1\ Data source: Public Health Information System as of June
2017, provided by FSIS's Office of Data Integration and Food
Protection (now the Office of Planning, Analysis and Risk
    \2\ Livestock Slaughter 2016 Summary (April 2017). USDA,
National Agricultural Statistics. http://usda.mannlib.cornell.edu/usda/nass/LiveSlauSu//2010s/2017/LiveSlauSu-04-19-2017.pdf, p.15,
accessed 11/16/2018.
    \3\ Data source: Bureau of Labor Statistics (BLS) report of
average wage of meat slaughterers and packers. https://www.bls.gov/oes/current/oes513023.htm/., accessed 06/2017.

    In addition, such establishments will no longer need to replace the
broken or worn out stamps previously used for marking carcasses on the
slaughter floor. Typically, a stamp (usually made of bronze) costs $225
and lasts 5 years.\4\ The annualized cost of the stamp is $55 (if the
interest rate is 7 percent) or $50 (if the interest rate is 3 percent).
Assuming each establishment (that does not already have a waiver from
the requirement to mark carcasses and is expected to stop marking
because of the final rule) uses one stamp per year, the annual savings
on these stamps will be between $13,300 and $16,700.

    \4\ Data from Ketchum Manufacturing Inc., a manufacturer of meat
stamps, through telephone interview on 4/17/2017.

    Additionally, establishments will no longer need to make written
requests for waivers from the requirement to mark carcasses further
processed within the same establishment and will no longer need to wait
to have such requests approved. Further, because FSIS inspected and
passed carcasses will no longer be required to bear the mark of
inspection if they are sent for further processing in the same
establishment, FSIS inspectors will no longer need to verify this mark,
and will have more time to focus on activities that are more important
in ensuring food safety, such as verifying that establishments meet
HACCP regulations and collecting product samples. These savings are
minimal and have not been quantified. There are no expected costs
associated with this rule.

Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a determination that this final
rule will not have a significant economic impact on a substantial
number of small entities, as defined by the Regulatory Flexibility Act
(5 U.S.C. 601). The final rule will not increase costs to the industry.

Executive Order 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS has
estimated that this final rule will yield cost savings. Therefore, this
rule is an E.O. 13771 deregulatory action.

Paperwork Reduction Act

    There are no new paperwork or recordkeeping requirements associated
with this final rule under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the internet and other information technologies
and providing increased opportunities for citizen

[[Page 9698]]

access to Government information and services, and for other purposes.

Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under E.O. 12988, Civil Justice
Reform. Under this rule: (1) All State and local laws and regulations
that are inconsistent with this rule will be preempted; (2) no
retroactive effect will be given to this rule; and (3) no
administrative proceedings will be required before parties may file
suit in court challenging this rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of
E.O. 13175, ``Consultation and Coordination with Indian Tribal
Governments.'' E.O. 13175 requires Federal agencies to consult and
coordinate with tribes on a government-to-government basis on policies
that have tribal implications, including regulations, legislative
comments or proposed legislation, and other policy statements or
actions that have substantial direct effects on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.
    FSIS has assessed the impact of this rule on Indian tribes and
determined that this rule does not, to our knowledge, have tribal
implications that require tribal consultation under E.O. 13175. If a
Tribe requests consultation, FSIS will work with the Office of Tribal
Relations to ensure meaningful consultation is provided where changes,
additions and modifications identified herein are not expressly
mandated by Congress.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at 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: 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).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication online through the FSIS web page located at:
    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.

List of Subjects in 9 CFR Part 316

    Food labeling, Food packaging, Meat inspection.

    For the reasons set forth in the preamble, FSIS is amending 9 CFR
part 316 as follows:


1. The authority citation for part 316 is revised to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.55.

 2. In Sec.  316.9, revise paragraph (a), redesignate paragraphs (b)
through (d) as paragraphs (c) through (e), respectively, and add a new
paragraph (b) to read as follows:

Sec.  316.9  Products to be marked with official marks.

    (a) Each carcass that has been inspected and passed in an official
establishment must be marked at the time of inspection with the
official inspection legend containing the number of the official
establishment, if the carcass is to be shipped into commerce from the
establishment without further processing.
    (b) A passed and inspected carcass that is to be further processed
in the slaughtering establishment need not be marked with the official
inspection legend at the time of inspection.
* * * * *

    Done in Washington, DC.
Carmen M. Rottenberg,
[FR Doc. 2019-04993 Filed 3-15-19; 8:45 am]