Proposed Rule2026-18531
Modernization of Regulations Under 9 CFR Parts 101-118 and 123-124
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
September 11, 2026
Issuing agencies
Agriculture Department
Abstract
The U.S. Department of Agriculture (USDA) proffers this Request for Information (RFI) to solicit the public's input on regulatory considerations related to 9 CFR parts 101-118, 123-124. The regulations are issued primarily pursuant to Section 154 of the Virus- Serum-Toxin Act (VSTA). USDA intends to evaluate each part and subpart for its effectiveness at upholding the VSTA's statutory mandate to prohibit the preparation, sale, barter, or exchange of "worthless, contaminated, dangerous, or harmful" viruses, serums, toxins, or analogous products intended for the use in the treatment of domestic animals, i.e., all animals, other than man, including poultry. The current regulations reflect decades of incremental amendments, technical updates, and revisions adopted at different points in time to address specific scientific, operational, and/or programmatic needs; in recent history, USDA has not holistically reformed the regulations implementing the VSTA. Comprehensive modernization of the regulations will ensure that the framework remains coherent, consistent, and responsive to contemporary technologies, innovation, and practices while continuing to fulfill the statutory requirements of the VSTA.
Full Text
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<title>Federal Register, Volume 91 Issue 175 (Friday, September 11, 2026)</title>
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[Federal Register Volume 91, Number 175 (Friday, September 11, 2026)]
[Proposed Rules]
[Pages 57828-57829]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18531]
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DEPARTMENT OF AGRICULTURE
Office of the Secretary
9 CFR Parts 101 Through 118, 123, and 124
[Docket No: USDA-2026-0298]
Modernization of Regulations Under 9 CFR Parts 101-118 and 123-
124
AGENCY: Office of the Secretary, U.S. Department of Agriculture.
ACTION: Request for information.
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SUMMARY: The U.S. Department of Agriculture (USDA) proffers this
Request for Information (RFI) to solicit the public's input on
regulatory considerations related to 9 CFR parts 101-118, 123-124. The
regulations are issued primarily pursuant to Section 154 of the Virus-
Serum-Toxin Act (VSTA). USDA intends to evaluate each part and subpart
for its effectiveness at upholding the VSTA's statutory mandate to
prohibit the preparation, sale, barter, or exchange of ``worthless,
contaminated, dangerous, or harmful'' viruses, serums, toxins, or
analogous products intended for the use in the treatment of domestic
animals, i.e., all animals, other than man, including poultry. The
current regulations reflect decades of incremental amendments,
technical updates, and revisions adopted at different points in time to
address specific scientific, operational, and/or programmatic needs; in
recent history, USDA has not holistically reformed the regulations
implementing the VSTA. Comprehensive modernization of the regulations
will ensure that the framework remains coherent, consistent, and
responsive to contemporary technologies, innovation, and practices
while continuing to fulfill the statutory requirements of the VSTA.
DATES: We will consider all comments that we receive on or before
October 13, 2026.
ADDRESSES: USDA invites public comments on this RFI and encourages
stakeholders, including farmers, industry representatives, and state
and local governments, to provide input. You may submit comments,
identified by docket number USDA-2026-0298, in the Federal eRulemaking
Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the online instructions for
submitting comments. All comments will be posted without change and
will be publicly available on <a href="http://www.regulations.gov">www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: Michael Poe, Office of the General
Counsel, USDA, 1400 Independence Avenue SW, Washington, DC 20250-1400,
(202) 769-8247.
SUPPLEMENTARY INFORMATION:
Background
Within the United States Department of Agriculture (USDA), the
Animal and Plant Health Inspection Service (APHIS) Center for
Veterinary Biologics (CVB) regulates veterinary biologics under the
Virus-Serum-Toxin Act (VSTA).\1\ The VSTA prohibits the preparation,
sale, barter, exchange or shipment of ``worthless, contaminated,
dangerous, or harmful'' viruses, serums, toxins, or analogous
products.\2\ The VSTA authorizes the Secretary of Agriculture (the
Secretary) to examine and inspect all viruses, serums, toxins, and
analogous products for use in the treatment of domestic animals, if the
products are imported or offered for importation into the United
States, to determine if the products are prohibited by the VSTA, and if
they are, to deny entry. The VSTA further authorizes the Secretary to
promulgate regulations to prevent the preparation, sale, barter,
exchange, or shipment of such products. Within USDA, this authority has
been delegated to CVB. Regulations established under the VSTA are
contained in 9 CFR parts 101-118, 123-124.
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\1\ 21 U.S.C. 151-159 (2023).
\2\ 21 U.S.C. 151.
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The regulations in 9 CFR parts 101-118, 123-124 establish the
terminology, technical requirements, and enforcement practices for
CVB's administration of the VSTA. These parts collectively address a
range of activities associated with veterinary biological products,
including product and establishment licensing; \3\ the conditions
[[Page 57829]]
for importation and experimental use; \4\ and the procedures for
suspension or revocation of USDA licenses and authorizations.\5\ These
regulations also include requirements related to facility design and
operation,\6\ equipment sanitation,\7\ production controls,\8\ testing
and serial release procedures,\9\ packaging and labeling
specifications,\10\ and recordkeeping and reporting practices.\11\
Additional provisions address the management and use of animals at
licensed establishments,\12\ inspection authorities,\13\ and the
detention or disposition of non-compliant products.\14\ Over time CVB
has amended these regulations to incorporate updated laboratory methods
and production technologies, resulting in a patchwork of incremental
updates across multiple technical domains. The intent of this Request
for Information (RFI) is to gather information that would assist USDA
in modernizing 9 CFR parts 101-118, 123-124. Modifications will be
considered to encourage innovation, protect animal health, and improve
regulatory clarity, while ensuring fidelity to the text of the VSTA.
Based on this background information, we solicit public comments
regarding the following questions:
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\3\ See 9 CFR 102.
\4\ See 9 CFR 103-104.
\5\ See 9 CFR 105.
\6\ See 9 CFR 108.
\7\ See 9 CFR 109.
\8\ See 9 CFR 114.
\9\ See 9 CFR 113.
\10\ See 9 CFR 112.
\11\ See 9 CFR 116.
\12\ See 9 CFR 117.
\13\ See 9 CFR 115.
\14\ See 9 CFR 118.
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1. What modifications or streamlining of the regulations in 9 CFR
parts 101-118, 123-124 would best respond to modern research and
development (R&D), manufacturing, and distribution practices to improve
animal health outcomes?
2. Please describe your experiences with regulation under 9 CFR
parts 101-118, 123-124, including any areas that could be improved. In
your view, do any provisions hinder market efficiency or innovation,
and what costs do you incur when complying with or navigating the
regulatory requirements? Additionally, which aspects of 9 CFR parts
101-118, 123-124 function effectively as written?
3. How could CVB improve the clarity, organization, or
interpretation of the regulations in 9 CFR parts 101-118, 123-124 to
reduce ambiguity, enhance predictability, and support consistent
compliance across the industry?
4. How could 9 CFR parts 101-118, 123-124 better align with the
statutory authorities granted in the VSTA, particularly with respect to
animal testing and handling requirements, facility requirements, and
packaging and labeling requirements, among others?
5. Which regulatory processes within 9 CFR parts 101-118, 123-124,
such as licensing, production updates, facility approvals, inspections,
or reporting, could be streamlined to reduce administrative burden
while preserving product quality, availability, and effectiveness?
6. How could CVB better align 9 CFR parts 101-118, 123-124 with
international standards or regulatory frameworks to support and/or
preserve global market access, reduce duplicative requirements, or
improve regulatory harmonization? How could changes to 9 CFR parts 101-
118, 123-124 impact domestic manufacturers and producers' ability to
export to other markets?
7. How might CVB incorporate greater regulatory flexibility into 9
CFR parts 101-118, 123-124 to accommodate emerging technologies, novel
product categories, or evolving production systems without compromising
safety or effectiveness?
8. Are there any other specific issues or topics CVB should
consider in modifying and modernizing the regulatory framework outlined
in 9 CFR parts 101-118, 123-124?
We request that commentors:
1. Provide supporting data, case examples, or references that
substantiate your recommendations.
2. If applicable, indicate whether your comments reflect the
perspective of a manufacturer, distributor, veterinarian, academic/
research institution, trade association, state regulatory officials,
the public, or other stakeholder group.
When providing information to USDA, commenters must indicate what
information provided is confidential business information. USDA will
review this information to ensure that the provided information is not
information that the submitter would ordinarily disclose to the public.
USDA intends to protect confidential business information in accordance
with legal and regulatory obligations and practices.
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.3.
Andrew Perry,
Office of the General Counsel.
[FR Doc. 2026-18531 Filed 9-10-26; 8:45 am]
BILLING CODE 3410-14-P
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