[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]


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DEPARTMENT OF AGRICULTURE

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.

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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 
establishment.

DATES: Effective April 17, 2019.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

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

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: 
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.

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:

PART 316--MARKING PRODUCTS AND THEIR CONTAINERS

0
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.


0
 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,
Administrator.
[FR Doc. 2019-04993 Filed 3-15-19; 8:45 am]
BILLING CODE 3410-DM-P