2026-18531Proposed RuleWallet

USDA tweaks rules for worthless animal viruses and toxins?

Published Date: 9/11/2026

Proposed Rule

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.

Analyzed Economic Effects

5 provisions identified: 4 benefits, 0 costs, 1 mixed.

USDA plans broad regulatory modernization

USDA is asking for public input to modernize the rules in 9 CFR parts 101-118 and 123-124 that implement the Virus-Serum-Toxin Act (VSTA). The agency says it may update these rules to encourage innovation, protect animal health, and improve regulatory clarity while staying true to the VSTA; comments are due by October 13, 2026.

Possible streamlining of licensing and approvals

USDA asks how processes such as licensing, production updates, facility approvals, inspections, or reporting could be streamlined in parts 101-118 and 123-124 to reduce administrative burden while preserving product quality, availability, and effectiveness. The agency specifically solicits examples of costs incurred when complying with current requirements.

Alignment with international standards considered

USDA asks how 9 CFR parts 101-118 and 123-124 could better align with international standards to support or preserve global market access, reduce duplicative requirements, and improve harmonization. The agency asks commenters to say how changes could impact domestic manufacturers' ability to export to other markets.

Potential flexibility for emerging technologies

USDA asks for input on how to incorporate greater regulatory flexibility into parts 101-118 and 123-124 to accommodate emerging technologies, novel product categories, or evolving production systems without compromising safety or effectiveness. The request explicitly mentions accommodating new R&D, manufacturing, and distribution practices.

Modernization could change technical compliance rules

The regulations being reviewed currently include rules on facility design and operation, equipment sanitation, production controls, testing and serial release, packaging and labeling, recordkeeping, animal management, inspection authorities, and detention or disposition of non-compliant products. USDA's RFI signals these technical requirements are candidates for modification as part of modernization.

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Key Dates

Published Date
Comments Due
9/11/2026
10/13/2026

Department and Agencies

Department
Independent Agency
Agency
Agriculture Department
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