Proposed Rule2026-05746
Revising Establishment Size Definitions
Primary source
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Published
March 24, 2026
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
FSIS is considering revising how it defines establishment sizes for purposes of its oversight of meat and poultry establishments and egg products plants. Since 1996, FSIS has used Hazard Analysis and Critical Control Point (HACCP) size categories, which are based on employee count and annual sales, to analyze the impact of regulations and tailor assistance to small entities. More recently, FSIS has also applied volume-based thresholds to categorize establishments to analyze the impact of regulations and for establishing Agency sampling frequencies or setting sampling requirements for the regulated industry. This advance notice of proposed rulemaking (ANPR) requests stakeholder input on whether FSIS should update its establishment size definitions and, if so, how.
Full Text
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<title>Federal Register, Volume 91 Issue 56 (Tuesday, March 24, 2026)</title>
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[Federal Register Volume 91, Number 56 (Tuesday, March 24, 2026)]
[Proposed Rules]
[Pages 13979-13982]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05746]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Chapter III
[Docket No. FSIS-2026-0001]
RIN 0583-AE09
Revising Establishment Size Definitions
AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: FSIS is considering revising how it defines establishment
sizes for purposes of its oversight of meat and poultry establishments
and egg products plants. Since 1996, FSIS has used Hazard Analysis and
Critical Control Point (HACCP) size categories, which are based on
employee count and annual sales, to analyze the impact of regulations
and tailor assistance to small entities. More recently, FSIS has also
applied volume-based thresholds to categorize establishments to analyze
the impact of regulations and for establishing Agency sampling
frequencies or setting sampling requirements for the regulated
industry. This advance notice of proposed rulemaking (ANPR) requests
stakeholder input on whether FSIS should update its establishment size
definitions and, if so, how.
DATES: Submit comments on or before May 26, 2026.
ADDRESSES: FSIS invites interested persons to submit comments on this
document.
Comments may be submitted by one of the following methods:
<bullet> Federal eRulemaking Portal: This website provides the
ability to type short comments directly into the comment field on this
web page or attach a file for lengthier comments. Go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the on-line instructions at that site for
submitting comments.
<bullet> Mail: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 1400 Independence
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
<bullet> Hand- or Courier-Delivered Submittals: Deliver to 1400
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E,
Washington, DC 20250-3700. Instructions: All items submitted by mail or
electronic mail must include the Agency name and docket number FSIS-
2026-0001. Comments received in response to this docket will be made
available for public inspection and posted without change, including
any personal information, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Docket: For access to background documents or comments received,
call (202) 286-2255 to schedule a time to visit the FSIS Docket Room at
1400 Independence Avenue SW, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: April Regonlinski, Assistant
Administrator for the Office of Policy and Program Development, at
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
I. Background
FSIS is the public health agency within the USDA responsible for
providing inspection of establishments producing meat, poultry, and egg
products and verifying that these products are safe, wholesome, and
properly labeled and packaged. FSIS carries out this mission under the
Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and the Egg
Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.), which
authorize the Secretary to make rules and regulations necessary for
their efficient execution (21 U.S.C. 621, 463(b), and 1043).
FSIS is subject to the Regulatory Flexibility Act of 1980 (RFA) (5
U.S.C. 601-612), which requires federal agencies to consider the
economic impact of regulatory proposals on small businesses and
consider less burdensome alternatives. FSIS must also comply with the
Small Business Regulatory Enforcement Fairness Act of 1996,\1\ which
requires agencies to publish Small Entity Compliance Guides for any
final rule classified as ``major'' that is expected to significantly
affect a substantial number of small businesses.
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\1\ Public Law 104-121, title II, Sec. Sec. 201-224, Mar. 29,
1996, 110 Stat. 857-862, as amended by Public Law 110-28, title
VIII, Sec. 8302, May 25, 2007, 121 Stat. 204.
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To meet the RFA requirements, FSIS has historically categorized
establishments by HACCP size or production volume for regulatory
analysis and to tailor assistance for small and very small
establishments. Since 1996, FSIS has classified establishments as very
small (fewer than 10 employees or annual sales under $2.5 million),
small (10-499 employees), or large (500 or more employees) under
definitions established in the Pathogen Reduction/HACCP Systems final
rule (61 FR 38806, July 25, 1996). These size definitions are applied
to individual establishments and do not account for whether the
establishment is part of a larger corporate structure. As of December
2025, there are 2,961 very small, 2,847 small, and 508 large FSIS
regulated establishments.\2\
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\2\ USDA/FSIS, Meat, Poultry and Egg Product Inspection
Directory, <a href="https://www.fsis.usda.gov/inspection/establishments/meat-poultry-and-egg-product-inspection-directory">https://www.fsis.usda.gov/inspection/establishments/meat-poultry-and-egg-product-inspection-directory</a>.
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FSIS has used HACCP size categories to phase in requirements, such
as notification and documentation for adulterated or misbranded product
(77 FR 26929, May 8, 2012) and the regulations that prescribe
procedures for controlling contamination throughout the slaughter and
dressing process in 9 CFR 310.18(c) and recordkeeping requirements in 9
CFR 310.18(d) (84 FR 52300, October 1, 2019). FSIS also used these
categories to determine eligibility for reduced inspection fees (86 FR
37276, July 15, 2021). However, for reduced fees eligibility, FSIS
applied the terms ``small'' and ``very small'' only to establishments
unaffiliated with multiple or large businesses in a way that would
effectively place them within the large establishment definition (86 FR
37276, 37277).
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FSIS has also relied on various production volume thresholds. For
example, the Nutrition Labeling of Meat and Poultry Products final rule
included a phased implementation based on annual production volume and
the number of employees (58 FR 632, January 6, 1993). 9 CFR 317.400 and
381.500 also exempt small businesses from nutrition labeling of certain
meat and poultry products based on annual production volume and the
number of employees. In addition, FSIS exempts low-volume
establishments, defined as producing an average of 1 to 1,000 pounds
per day, from FSIS Salmonella sampling for certain raw pork products.
FSIS also bases certain requirements on production volume. For example,
FSIS requires different establishment sampling frequencies for very
low-volume poultry establishments operating under Traditional
Inspection (9 CFR 381.65(g)(2)) and very low-volume swine slaughter
establishments (9 CFR 310.18(c)(2)).
FSIS has explored other ways to group establishments. In the Meat,
Poultry, and Egg Product Inspection Directory Establishment Demographic
Data supplemental dataset,\3\ which provides additional information
about FSIS establishments, (e.g., establishment size, species
slaughtered, and aggregate categorical production information), FSIS
grouped establishments that produce processed products into five
categories based on aggregated volume of all processed products
estimated as total pounds per month. These categories are numbered 1-5
and are separated based on production volume. Category 1 is less than
10,000 lbs; Category 2 is greater than or equal to 10,000 lbs and less
than 100,000 lbs; Category 3 is greater than or equal to 100,000 lbs
and less than 1,000,000 lbs; Category 4 is greater than or equal to
1,000,000 lbs to 10,000,000 lbs; and Category 5 is greater than or
equal to 10,000,000 lbs. Similarly, FSIS grouped slaughter
establishments into five categories based on aggregated head
slaughtered for the last 360 days using head counts. Category 1 is less
than 1,000 head slaughtered; Category 2 is greater than or equal to
1,000 and less than 10,000; Category 3 is greater than or equal to
10,000 and less than 100,000; Category 4 is greater than or equal to
100,000 and less than 10,000,000; and Category 5 is greater than or
equal to 10,000,000 head slaughtered. These categorizations are
publicly posted on the Meat, Poultry and Egg Product Inspection (MPI)
Directory.\4\
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\3\ Dataset: Establishment Demographic Data, available at:
<a href="https://www.fsis.usda.gov/inspection/establishments/meat-poultry-and-egg-product-inspection-directory">https://www.fsis.usda.gov/inspection/establishments/meat-poultry-and-egg-product-inspection-directory</a>.
\4\ See FSIS Establishment Slaughter/Processing Data--MPI
Supplement--Data Documentation, pg 3, available at <a href="https://www.fsis.usda.gov/sites/default/files/media_file/documents/Data-Documentation-MPI-Directory-Establishment-Demographic-Documentation.pdf">https://www.fsis.usda.gov/sites/default/files/media_file/documents/Data-Documentation-MPI-Directory-Establishment-Demographic-Documentation.pdf</a>.
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II. National Advisory Committee on Meat and Poultry Inspection (NACMPI)
Meeting and Recommendations
In September 2024, FSIS brought the issue of establishment size
classification to NACMPI (89 FR 66669, August 16, 2024). The Agency
asked the committee to review and advise FSIS on whether the Agency
should change its definitions for establishment size categories (i.e.,
large, small, and very small) \5\ to better assess and describe current
business operations as well as better determine the impact of FSIS
policies on different size establishments.\6\
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\5\ Large establishments have 500 or more employees; small
establishments have 10 or more employees, but fewer than 500; and
very small establishments have fewer than 10 employees or annual
sales of less than $2.5 million.
\6\ Specifically, the Agency asked the committee to consider the
following questions: (1) FSIS uses multiple size categories. Any
concerns with continuing with that approach?; (2) What metric should
FSIS use to define size categories for regulated establishments?;
(3) How should FSIS account for establishment ownership when
developing size categories?; (4) What size standards are commonly
used within the industry for defining small and very small?; (5) Are
there other applications for the current FSIS HACCP sizes outside of
FSIS, such as within the industry? Are there repercussions outside
of FSIS if establishment size classifications are changed?; (6) How
should FSIS obtain data to determine if the establishment is a small
entity under the Small Business Administration's size definitions?;
and (7) Are there sources of data, besides PHIS, that FSIS can use
to better identify establishment size and ownership structures?
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During the public meeting held on September 16-17, 2024, NACMPI
members discussed how FSIS defines very small, small, and large
establishments.\7\ They noted that the current definitions group
together businesses that operate at very different scales. For example,
an establishment with 11 employees and one with 499 employees are both
considered ``small,'' even though their resources and production
capacity may be vastly different. The committee also raised concerns
about establishments that are classified as small but are owned by
large firms, which may give them access to more support and funding
than truly independent small businesses.
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\7\ September 2024 NACMPI meeting transcript available at:
<a href="https://www.fsis.usda.gov/sites/default/files/media_file/documents/NACMPI_Plenary_Meeting_9-16-24_Transcript.pdf">https://www.fsis.usda.gov/sites/default/files/media_file/documents/NACMPI_Plenary_Meeting_9-16-24_Transcript.pdf</a>.
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In its meeting report on the establishment size questions,\8\
NACMPI recommended that FSIS continue to use multiple establishment
size classifications but also recommended that the Agency consider
using two separate metrics to define establishment size. According to
NACMPI, the primary metric should focus on production volume, which
could help FSIS establish and implement regulatory requirements more
effectively. The second metric should focus on business size (e.g.,
employee count, annual revenue, and corporate association), which could
be used for purposes such as determining eligibility for grants and
other support programs. The committee suggested that FSIS apply both
metrics to every establishment, so that FSIS would categorize
establishments based on product volume and based on business size. The
committee also recommended that, when determining an establishment's
eligibility for federal services and programs administered by other
agencies (e.g., Agricultural Marketing Service (AMS) commodity
contracts or other USDA assistance), FSIS or the applicable agency
should consider whether a small or very small establishment receives
significant support from a larger firm, such as an owner company. The
committee further recommended that FSIS create a cross-disciplinary
working group of legal and financial experts to advise on new
establishment size categories, consider requiring the disclosure of
corporate ownership structure information on all grant applications for
federal services and programs, including grants of inspection, and
conduct federal agency and stakeholder outreach to ensure any changes
are clearly communicated and consistently applied.
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\8\ September 2024 NACMPI committee report available at: <a href="https://www.fsis.usda.gov/news-events/publications/2024-nacmpi-reports">https://www.fsis.usda.gov/news-events/publications/2024-nacmpi-reports</a>.
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NACMPI also addressed the potential alignment of FSIS size
classifications with Small Business Administration (SBA) standards. SBA
establishes size standards that are used by other agencies to determine
which businesses qualify for federal assistance, including grants,
loans, and contracts (see 13 CFR part 121). Currently, SBA uses the
number of employees a firm has to define small businesses in the North
American Industry Classification System (NAICS) categories relevant to
FSIS-regulated industries: \9\
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\9\ United States Small Business Administration (SBA), Table of
Small Business Standards Matched to North American Industry
Classification System Codes. Effective January 1, 2022. Available at
<a href="https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf">https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf</a>.
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<bullet> NAICS 311615--Poultry Processing: 1,250 or fewer
employees.
<bullet> NAICS 311611--Animal (except Poultry) Slaughtering: 1,150
or fewer employees.
<bullet> NAICS 311612--Meat Processed from Carcasses: 1,000 or
fewer employees.
<bullet> NAICS 311710--Seafood Product Preparation and Packing: 750
or fewer employees.
<bullet> NAICS 311999--All Other Miscellaneous Food Manufacturing
(includes egg processors): 700 or fewer employees.
The committee discouraged FSIS from adopting SBA standards,
expressing concern that certain establishments might gain unfair
advantages if FSIS were to apply SBA standards. Specifically, NACMPI
was wary of exclusively using employee count or revenue to define
establishment sizes, arguing that these metrics may not accurately
reflect operational scale or ownership structures. Through this ANPR,
FSIS is seeking broader stakeholder input to better understand the
range of perspectives on how establishment sizes should be defined.
III. Requests for Comments and Data
FSIS is seeking public input to help inform potential changes to
how the Agency defines establishment sizes to better reflect how
establishments operate and are structured. FSIS invites comments on the
following questions. Please explain your reasoning and include any
supporting data, studies, or examples. To help FSIS review comments
efficiently, please identify the question to which you are responding
by its associated number and letter (e.g., ``2'') or whether you are
commenting on a topic not listed below.
1. How are establishments economically impacted by their current
HACCP size determination?
2. How would a change in HACCP size classifications, or the
implementation of a new classification system, impact an establishment?
3. What impact would there be on establishment if FSIS aligns its
size classifications with the current SBA standards?
4. What factors should FSIS consider when determining whether size
categories apply at the individual establishment level or the corporate
ownership level?
5. Should FSIS create additional size categories? If so, how should
additional size categories be defined and for what purposes?
a. What impact would it have on establishments if FSIS created
additional size categories based on production and slaughter volume and
product classification (e.g., HACCP category or slaughter class)? For
example, FSIS currently categorizes establishments into five categories
based on processing or slaughter volume in the MPI Directory (see
above).
b. What impact would it have on establishments if FSIS established
size categories for processing based on product characteristics other
than HACCP category--for example, packaging type, intended use, target
customer, or specific attributes such as Ready-to-Eat products that are
post-lethality exposed?
c. What impact would it have on establishments if FSIS created
additional size categories based on business size (e.g., employee
count, annual revenue, or corporate association)? If company structure
(e.g. corporate association, partnership, co-op, etc.) is taken into
consideration, how should it be considered?
d. What single variable or combination of variables should FSIS
consider in additional size categories (e.g., shift, operating days,
type of products, slaughter class, building square footage)?
6. How do other organizations (e.g. Federal Agencies, state and
local governments, businesses, or consumer groups) use FSIS HACCP size
determinations?
7. What would be the least burdensome way for FSIS to collect and
maintain records on establishment size?
a. How often should FSIS verify updates (e.g., quarterly or
annually)?
b. How should the information be collected (e.g., self-reported or
collected by an inspector)?
c. How should FSIS verify accuracy of the information provided?
8. How do various size metrics and categories impact industry,
consumers, and other government entities, particularly regarding: (a)
Data sources that FSIS can use to better identify establishment size
(b) Data on corporate ownership of FSIS inspected establishments and
(c) Potential industry costs or benefits by aligning the HACCP size
classifications with the SBA size classifications?
IV. 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#59292b363e2b38347730372d38323c192c2a3d38773e362f"><span class="__cf_email__" data-cfemail="1d6d6f727a6f7c70337473697c76785d686e797c337a726b">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
V. 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
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information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves and have the option to password protect
their accounts.
Jeremy T. Reed,
Chief Operating Officer.
[FR Doc. 2026-05746 Filed 3-23-26; 8:45 am]
BILLING CODE 3410-DM-P
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