Rule2025-12212
Removal of Pumped Bacon Sampling Regulations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 1, 2025
Effective
July 1, 2025
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
FSIS is amending the Federal meat inspection regulations to remove the provisions providing for FSIS' sampling and testing of pumped bacon for nitrosamines. FSIS stopped sampling for nitrosamines in 1998.
Full Text
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<title>Federal Register, Volume 90 Issue 124 (Tuesday, July 1, 2025)</title>
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[Federal Register Volume 90, Number 124 (Tuesday, July 1, 2025)]
[Rules and Regulations]
[Pages 27973-27975]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12212]
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Rules and Regulations
Federal Register
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having general applicability and legal effect, most of which are keyed
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Federal Register / Vol. 90, No. 124 / Tuesday, July 1, 2025 / Rules
and Regulations
[[Page 27973]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 424
[Docket No. FSIS-2025-0017]
RIN 0583-AE07
Removal of Pumped Bacon Sampling Regulations
AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Final rule.
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SUMMARY: FSIS is amending the Federal meat inspection regulations to
remove the provisions providing for FSIS' sampling and testing of
pumped bacon for nitrosamines. FSIS stopped sampling for nitrosamines
in 1998.
DATES: The final rule is effective on July 1, 2025.
FOR FURTHER INFORMATION CONTACT: Denise Eblen, Acting Deputy Under
Secretary for the Office of Food Safety, at (202) 205-0495 or
<a href="/cdn-cgi/l/email-protection#9cf8f3fff7f9e8fff0f9eef7dce9eff8fdb2fbf3ea"><span class="__cf_email__" data-cfemail="1a7e7579717f6e79767f68715a6f697e7b347d756c">[email protected]</span></a> with a subject line of ``Docket No. FSIS-2025-
0017.'' Individuals in the United States who are deaf, deafblind, hard
of hearing, or have a speech disability may dial 711 (TTY, TDD, or
TeleBraille) to access telecommunications relay services. Individuals
outside the United States should use the relay services offered within
their country to make international calls to the point-of-contact in
the United States.
SUPPLEMENTARY INFORMATION: In 1978, USDA codified provisions for an
Agency sampling and testing program (hereinafter the ``nitrosamine
sampling program'') for pumped bacon, consisting of analysis of the
product for nitrosamines (43 FR 20992; May 16, 1978; 9 CFR
424.22(b)(1)(i) (previously 9 CFR 318.7(b)(2))). Test results also
could be furnished by establishments (43 FR 32136; July 25, 1978). The
Agency later provided alternative procedures for controlling the levels
of nitrite added to bacon (51 FR 21731; June 16, 1986) and, in doing
so, modified sample selection procedures under the nitrosamine sampling
program (9 CFR 424.22(b)(1)(ii)(C) (previously 9 CFR 318.7(b)(4))).
FSIS stopped collecting samples of pumped bacon under the
nitrosamine sampling program on October 23, 1998, in part because the
program identified very few samples of pumped bacon that contained
confirmable levels of volatile nitrosamines. For example, FSIS
conducted 174 initial screenings for nitrosamines in pumped bacon from
1994 to 1998. Of these, only 9 samples were presumptively positive for
nitrosamines. Only one sample was confirmed positive.
The Agency also stopped administering the program in 1998 because
the codified testing methods had become antiquated. The formation of
nitrosamines in products depends on several factors, including the
cooking method. The regulations provide that all testing for
nitrosamines be made on pumped bacon fried at 340 [deg]F for 3 minutes
on each side (9 CFR 424.22(b)(1)(i)). However, since the regulations
were implemented, greater variability in cooking methods for bacon
(e.g., microwave cooking, oven cooking) and greater use of ready-to-eat
bacon, meant the codified testing procedures did not necessarily
reflect how consumers would actually prepare the product.
Additionally, the nitrosamine sampling program is no longer
necessary, given other regulatory requirements control the formation of
nitrosamines in pumped bacon. The use of nitrate or nitrite to cure
pumped bacon can cause the formation of nitrosamines in the cooked
product. As such, FSIS regulations prohibit the use of nitrate in such
products and limit the amount of ingoing nitrite to 120 parts per
million (9 CFR 424.21 and 9 CFR 424.22). The regulations also require
the use of sodium ascorbate or sodium erythorbate in pumped bacon
because these substances are curing accelerators and reduce the amount
of residual nitrite in the finished product, thus reducing the
likelihood of the formation of nitrosamines in the product. Inspectors
can verify that establishments meet the requirements for the use of
nitrate, nitrite, and curing accelerators without collecting samples
for testing. Therefore, the nitrosamine testing program is no longer
necessary.
Given FSIS ended its nitrosamines sampling program and can verify
that establishments meet the requirements for pumped bacon through
other means, the Agency is removing the program's implementing
regulations at 9 CFR 424.22(b)(1)(i) and (ii)(C). This final rule is
solely an administrative change to Agency procedure or practice related
to its obsolete nitrosamine sampling program. It is therefore excluded
from the requirement for notice and comment under the Administrative
Procedure Act (5 U.S.C. 553(b)(B)). FSIS regulations will continue to
require the use of curing accelerators, prohibit the use of nitrate,
and limit the use of nitrite in pumped bacon, which is consistent with
FSIS' Hazard Analysis and Critical Control Point requirements (9 CFR
part 417), as well as the conditions set out in 9 CFR 424.21 and
424.22.
Executive Orders (E.O.s) 12866, 13563, 14215, and 14192
Executive Order (E.O.) 12866 provides that the Office of
Information and Regulatory Affairs (OIRA) in the Office of Management
and Budget will determine whether a regulatory action is significant as
defined by E.O. 12866 and will review significant regulatory actions.
OIRA has determined that this final rule is not significant as defined
by E.O. 12866. E.O. 13563 reaffirms the principles of E.O. 12866 while
calling for improvements in the Nation's regulatory system to promote
predictability, to reduce uncertainty, and to use the best, most
innovative, and least burdensome tools for achieving regulatory ends.
E.O. 14215 amends E.O. 12866 to ensure Presidential supervision and
control of the entire executive branch and to require that all
executive departments and agencies submit for review all proposed and
final significant regulatory actions to OIRA before publication in the
Federal Register. The Department has developed the final rule
consistent with E.O. 13563 and E.O. 14215.
This final rule is considered an E.O. 14192 deregulatory action.
Congressional Review Act
Pursuant to Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (known as the
[[Page 27974]]
Congressional Review Act) (5 U.S.C. 801 et seq.), OIRA has designated
this final rule as not a major rule as defined by 5 U.S.C. 804(2).
Regulatory Flexibility Act
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) (as
amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) of 1996; Pub. L. 104-121, 110 Stat. 857), agencies must
prepare and make available for public comment a regulatory flexibility
analysis that describes the effect of the rule on small entities (i.e.,
small businesses, small organizations, and small government
jurisdictions). No regulatory flexibility analysis is required,
however, if the head of an agency or an appropriate designee certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. FSIS has concluded and hereby
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities; therefore, an
analysis is not included. The final rule is an administrative change
that merely updates the meat product inspection regulations to remove
obsolete Agency sampling procedures and practices that have not been
implemented since 1998. Because the final rule does not impose any new
requirements or restrict production, it is not expected to have any
adverse economic effect on small or very small establishments.
Executive Order 13175
Executive Order 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 final rule on Indian tribes and determined that this rule would
not have tribal implications that require consultation under Executive
Order 13175.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520), FSIS has reviewed the final rule. The Administrator has
determined that this rulemaking would not impact information
collection, paperwork, or recordkeeping activities.
E-Government Act Compliance
The Department is committed to complying with the E-Government Act
of 2002 to promote the use of the internet and other information
technologies to provide increased opportunities for citizen access to
Government information and services, and for other purposes.
E.O. 13132; Federalism Summary Impact Statement
The final rule has no effect on States and local governments;
accordingly, FSIS anticipates that this rule will not have implications
for federalism. Therefore, under Section 6(b) of the E.O., a federalism
summary is not required.
Environmental Impact
This final rule will not have a reasonably foreseeable significant
effect on the quality of the human environment. The rule is an
administrative change that merely updates the meat product inspection
regulations to remove obsolete Agency sampling procedures and practices
that have not been implemented since 1998. Accordingly, this action is
appropriately subject to the categorical exclusion from the preparation
of an Environmental Assessment or an Environmental Impact Statement as
authorized under 7 CFR 1b.4 of the USDA regulations.
USDA Non-Discrimination Statement
In accordance with Federal civil rights law and USDA civil rights
regulations and policies, the USDA, its Agencies, offices, and
employees, and institutions participating in or administering USDA
programs are prohibited from discriminating based on race, color,
national origin, religion, sex, disability, age, marital status,
family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Persons with disabilities who require alternative means of
communication for program information (e.g., Braille, large print,
audiotape, American Sign Language, etc.) should contact the State or
local Agency that administers the program or contact USDA through the
Telecommunications Relay Service at 711 (voice and TTY). Additionally,
program information may be made available in languages other than
English.
To file a program discrimination complaint, complete the USDA
Program Discrimination Complaint Form, AD-3027, found online at How to
File a Program Discrimination Complaint and at any USDA office or write
a letter addressed to USDA and provide in the letter all of the
information requested in the form. To request a copy of the complaint
form, call (866) 632-9992. Submit your completed form or letter to USDA
by: (1) mail: U.S. Department of Agriculture, Office of the Assistant
Secretary for Civil Rights, 1400 Independence Avenue SW, Mail Stop
9410, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email:
<a href="/cdn-cgi/l/email-protection#8cfcfee3ebfeede1a2e5e2f8ede7e9ccf9ffe8eda2ebe3fa"><span class="__cf_email__" data-cfemail="fb8b89949c899a96d592958f9a909ebb8e889f9ad59c948d">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
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:
<a href="https://www.fsis.usda.gov/federal-register">https://www.fsis.usda.gov/federal-register</a>. 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: <a href="http://www.fsis.usda.gov/subscribe">http://www.fsis.usda.gov/subscribe</a>. 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.
Lists of Subjects in 9 CFR Part 424
Food additives, Food packaging, Meat inspection, Poultry and
poultry products.
For the reasons discussed in the preamble, FSIS is amending 9 CFR
Chapter III as follows:
[[Page 27975]]
PART 424--PREPARATION AND PROCESSING OPERATIONS
0
1. The authority citation for part 424 continues to read as follows:
Authority: 7 U.S.C. 1633, 1901-1906; 21 U.S.C. 451-472, 601-
695; 7 CFR 2.18, 2.53.
0
2. Amend Sec. 424.22 by
0
a. Removing and reserving paragraph (b)(1)(i);
0
b. Revising paragraph (b)(1)(ii) introductory text; and
0
c. Removing paragraph (b)(1)(ii)(C).
The revision reads as follows:
Sec. 424.22 Certain other permitted uses.
* * * * *
(b) * * *
(1) * * *
(ii) Sodium nitrite may be used at:
* * * * *
Done in Washington, DC.
Denise Eblen,
Acting Deputy Under Secretary for the Office of Food Safety.
[FR Doc. 2025-12212 Filed 6-30-25; 8:45 am]
BILLING CODE 3410-DM-P
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