On September 11, 2026, the U.S. Department of Agriculture (USDA) issued a Request for Information (RFI) concerning the modernization of regulations found in 9 CFR parts 101-118 and 123-124. This significant move by the Office of the Secretary, identified by docket number USDA-2026-0298, invites public and stakeholder comments through October 13, 2026, to ensure that the regulatory framework governing veterinary biologics remains relevant and effective in an evolving scientific and industrial landscape. The RFI highlights USDA's intent to conduct a holistic reform of these rules, which have seen only incremental updates over decades.
Background and Statutory Mandate
At the core of these regulations is the Virus-Serum-Toxin Act (VSTA), codified at 21 U.S.C. 151-159. Enacted to protect animal health and commerce, the VSTA prohibits the preparation, sale, barter, or exchange of "worthless, contaminated, dangerous, or harmful" viruses, serums, toxins, or analogous products intended for use in domestic animals. This statutory authority grants the Secretary of Agriculture the power to examine and inspect such products, particularly those imported, and to promulgate regulations to prevent the distribution of non-compliant items. Within the USDA, the Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics (CVB) has been delegated the authority to administer and enforce the VSTA's provisions.
The existing regulations in 9 CFR parts 101-118, 123-124 establish the terminology, technical requirements, and enforcement practices critical to CVB's oversight. These encompass a broad spectrum of activities including product and establishment licensing, conditions for importation and experimental use, and procedures for suspending or revoking USDA licenses. Additionally, they cover essential operational aspects such as facility design and operation, equipment sanitation, production controls, testing and serial release procedures, packaging and labeling specifications, and recordkeeping requirements. Provisions also address the management of animals at licensed establishments, inspection authorities, and the handling of non-compliant products.
Rationale for Modernization
The USDA acknowledges that while these regulations have undergone various amendments over time to incorporate updated laboratory methods and production technologies, these changes have often resulted in a "patchwork" of updates across multiple technical domains. The current RFI signals a shift towards a comprehensive modernization effort. The primary objectives are to encourage innovation within the veterinary biologics industry, enhance the protection of animal health, and improve regulatory clarity. The USDA stresses that any modifications will be considered with an eye toward ensuring fidelity to the original text and intent of the VSTA, while simultaneously making the framework coherent, consistent, and responsive to contemporary technologies, innovation, and practices.
Key Areas for Public Comment
The RFI poses eight specific questions to solicit detailed feedback from stakeholders. These questions aim to gather insights on how the regulations can be improved across various dimensions:
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Modern Research and Development: What modifications would best support modern R&D, manufacturing, and distribution practices to improve animal health outcomes?
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Stakeholder Experiences and Challenges: What are common experiences with the current regulations, particularly regarding provisions that might hinder market efficiency or innovation, and what are the associated compliance costs? Conversely, which aspects function effectively?
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Clarity and Interpretation: How can CVB improve the clarity, organization, or interpretation of the regulations to reduce ambiguity, enhance predictability, and support consistent compliance?
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Alignment with VSTA Authorities: How can the regulations better align with the VSTA's statutory authorities, especially concerning animal testing, handling requirements, facility standards, and packaging and labeling?
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Streamlining Processes: Which regulatory processes, such as licensing, production updates, facility approvals, inspections, or reporting, could be streamlined to reduce administrative burden while maintaining product quality, availability, and effectiveness?
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International Harmonization: How can CVB better align the regulations with international standards or frameworks to support global market access, reduce duplicative requirements, or improve harmonization? What impact could changes have on domestic manufacturers' export capabilities?
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Regulatory Flexibility for Innovation: How might CVB incorporate greater flexibility to accommodate emerging technologies, novel product categories, or evolving production systems without compromising safety or effectiveness?
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Other Specific Issues: Are there any other specific issues or topics CVB should consider in modifying and modernizing the regulatory framework?
Commenters are specifically asked to provide supporting data, case examples, or references to substantiate their recommendations. Furthermore, they are encouraged to indicate their stakeholder group affiliation, such as manufacturer, veterinarian, academic institution, or trade association. The USDA has committed to protecting confidential business information in accordance with legal and regulatory obligations.
This RFI represents a critical opportunity for all interested parties to contribute to shaping the future of veterinary biologics regulation, ensuring that the rules effectively safeguard animal health while fostering innovation and efficiency within the industry.
