SB376 inserts a new Section 425 into the Federal Food, Drug, and Cosmetic Act that lets the Secretary of Health and Human Services (acting through FDA) request access to concentrated animal feeding operations (CAFOs) to conduct microbial sampling when the Secretary determines such sampling is necessary to investigate a foodborne illness outbreak, find its root cause, or address other public health needs. The bill specifies the types of sampling the Secretary may perform (plants, animals, water, environment), allows CAFOs to impose ‘reasonable’ time/place/manner conditions that cannot delay meaningful sampling, and ties the statutory definition of CAFO to the existing Clean Water Act regulation at 40 C.F.R. §122.23(b).
The bill also amends the FD&C Act’s enforcement provisions to make a refusal to provide reasonable access for microbial sampling a prohibited act. It requires the FDA to share collected data with USDA and relevant state and federal public health agencies while preserving applicable FOIA exemptions.
For compliance officers, public-health planners, and producers, the bill creates a new, federally backed pathway for on-site environmental testing during investigations — and it introduces immediate questions about scope, timing, confidentiality, and interagency boundaries.
At a Glance
What It Does
The bill adds Section 425 to the FD&C Act letting the Secretary request access to CAFOs for microbial sampling when necessary for outbreak investigation, root-cause analysis, or other public health needs. It permits CAFOs to set reasonable conditions for sampling but makes refusal to grant reasonable access a prohibited act under Section 301.
Who It Affects
Primary targets are operators and owners of concentrated animal feeding operations as defined by 40 C.F.R. §122.23(b), and FDA investigators who will conduct on-site sampling. USDA, state public-health agencies, and laboratories that receive or analyze samples will be drawn into coordination and data-sharing roles.
Why It Matters
The bill gives FDA an explicit statutory tool for environmental and upstream-source testing during foodborne outbreak work — a power that can speed tracing and root-cause analysis. It also raises practical and legal issues about enforcement, interagency jurisdiction over foods under USDA statutes, and how confidential business information will be handled.
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What This Bill Actually Does
SB376 creates a discrete, new authority for FDA to seek on-site microbial samples from concentrated animal feeding operations. The authority is not unlimited: the Secretary must determine that sampling is necessary to facilitate a foodborne-illness outbreak investigation, determine the outbreak’s root cause, or meet other public-health needs.
If the Secretary makes that determination, FDA may request access and collect samples of plants, animals, water, and the surrounding environment.
The bill requires CAFOs to provide what it calls “reasonable access.” Operators can set reasonable time, place, and manner conditions for sampling — for example, requiring sampling at certain hours or specifying access routes — but they may not use conditions to prevent FDA from conducting appropriate sampling within a reasonable period of time. To give that access teeth, the bill amends the list of prohibited acts in Section 301 of the FD&C Act so that refusal to provide reasonable access for microbial sampling is itself a violation of the Act.SB376 tries to limit overlap with USDA by explicitly stating that it does not impose additional requirements beyond microbial sampling for foods that fall under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.
At the same time, the bill requires FDA to make data collected available to USDA and relevant State and Federal public-health agencies to facilitate detection, investigation, and prevention work, while preserving applicable exemptions under the Freedom of Information Act. The bill also anchors the statutory definition of a CAFO to the Clean Water Act regulation at 40 C.F.R. §122.23(b), tying the scope of FDA’s new authority to an existing regulatory definition.In practice, the provision will mean on-the-ground coordination between FDA investigators, CAFO operators, and potentially state inspectors or USDA staff.
Important operational details — how quickly FDA must act, what “reasonable” means in a range of scenarios, chain-of-custody procedures for samples, and how sample results will be used in enforcement or liability contexts — are not spelled out in the text and will need implementing guidance or interagency agreements.
The Five Things You Need to Know
The bill adds Section 425 to the Federal Food, Drug, and Cosmetic Act authorizing the Secretary to request access to CAFOs to conduct microbial sampling when necessary for outbreak investigations, root-cause analysis, or other public health needs.
CAFOs must provide ‘reasonable access’ for sampling of plants, animals, water, and the environment; they may impose time/place/manner conditions so long as those conditions do not prevent sampling within a reasonable period.
SB376 expressly states it does not create additional requirements from FDA regarding foods under USDA’s statutory jurisdiction (Federal Meat Inspection Act, Poultry Products Inspection Act, Egg Products Inspection Act) beyond microbial sampling.
The bill amends FD&C Act Section 301 by adding refusal to provide reasonable access for microbial sampling as a prohibited act—creating a statutory enforcement basis for compelled cooperation.
‘Concentrated animal feeding operation’ is defined by reference to 40 C.F.R. §122.23(b) (or successor regs), and the bill mandates that data collected be shared with USDA and relevant State and Federal public-health agencies while preserving FOIA exemptions.
Section-by-Section Breakdown
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Short title
Formal one-line provision giving the Act its name, the ‘‘Expanded Food Safety Investigation Act of 2025.’
Authority to request on-site microbial sampling at CAFOs
This provision inserts a new Section 425 into Chapter IV of the FD&C Act. It authorizes the Secretary to request access to a CAFO to conduct microbial sampling when the Secretary determines sampling is necessary for outbreak investigation, root-cause analysis, or other public-health needs. The text specifies sample targets (plants, animals, water, environment) and establishes the triggering standard — the Secretary’s determination of necessity — rather than a lower probable-cause threshold or warrant requirement.
Access mechanics, interstate jurisdiction, and data sharing
Subsection (b) requires CAFOs to provide ‘reasonable access’ and allows them to impose reasonable conditions (time, place, manner) that cannot prevent FDA from completing appropriate sampling within a reasonable timeframe. Subsection (c) limits FDA from imposing additional requirements on USDA-regulated foods beyond sampling. Subsection (d) requires FDA to make collected data available to USDA and relevant state and federal public-health agencies and preserves rights/exemptions under FOIA (5 U.S.C. §552). Subsection (e) imports the regulatory definition of CAFO from 40 C.F.R. §122.23(b).
Enforcement — refusal to permit sampling
This amendment adds a new paragraph to Section 301 of the FD&C Act making refusal to provide reasonable access for microbial sampling a prohibited act. The statutory insertion creates an enforcement hook—meaning FDA can pursue remedies tied to prohibited acts (injunctions, seizures, penalties under existing FD&C frameworks)—but the bill does not specify a novel penalty structure or process for resolving disputes about what constitutes ‘reasonable’ access.
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Who Benefits
- State and federal public-health agencies: Gain improved environmental and upstream data during outbreak investigations, helping to accelerate source attribution and root-cause analysis.
- Consumers and public health: Faster and more targeted sampling can shorten outbreak investigations and inform corrective actions that reduce illness risk.
- FDA investigators and epidemiologists: Obtain statutory backing to request on-site samples from CAFOs, reducing procedural friction when environmental evidence is important.
- USDA and its technical programs: Benefit from shared data that can complement FSIS and APHIS investigations, improving cross-agency situational awareness.
- Academic researchers and public-health laboratories: May gain access to additional isolates and environmental data valuable for surveillance, research, and method development.
Who Bears the Cost
- CAFO owners and operators: Face operational disruption, compliance costs for coordinating sampling and accommodating inspectors, and potential legal exposure from sample results.
- FDA (agency budget): Must absorb costs for travel, field staff time, sample collection, laboratory analysis, and legal processes unless new funding is provided.
- State health departments and laboratories: May incur costs to receive, analyze, or act on additional data and to coordinate with federal investigators.
- Private processors and downstream buyers: Could face supply-chain interruptions or liability exposure if upstream sampling identifies contamination sources linked to their products.
- Producers’ legal and compliance teams: Will face increased demand for negotiating reasonable access terms, handling confidentiality concerns, and contesting enforcement actions.
Key Issues
The Core Tension
The central tension is between rapid, on-site environmental sampling needed to protect public health and the rights and practical interests of producers and agencies: timely sampling can materially improve outbreak response, but it can also disrupt operations, implicate privacy and trade-secret concerns, and collide with USDA jurisdictional boundaries—creating a trade-off with no single clean policy solution.
SB376 grants an investigatory tool but leaves several operational and legal details unresolved. ‘Reasonable access’ and a ‘reasonable period of time’ are not defined; those ambiguous standards will determine how much leverage FDA has in practice and how disruptive sampling will be to operations. The bill also adds refusal as a prohibited act but does not specify the remedy ladder (administrative penalties, injunctive relief, criminal penalties) or a structured dispute-resolution process for contested access requests, so implementation may require additional rulemaking or interagency memoranda to avoid litigation.
The statute tries to thread a needle with USDA jurisdiction by saying it will not impose additional requirements for USDA-covered foods beyond sampling, yet sampling of animals and environments on a farm can produce data that have direct regulatory consequences for meat, poultry, and egg producers. How USDA and FDA will coordinate inspections, evidence-sharing, and follow-on enforcement is not prescribed and could produce jurisdictional friction.
Confidentiality and business-competitive concerns also remain under-specified: the bill preserves FOIA exemptions but does not establish explicit safeguards for trade secrets, farm-level biosecurity information, or contracts tied to sample results. Finally, the law ties the CAFO definition to a Clean Water Act regulation, which may create edge cases where an operation meets one agency’s regulatory definition but not another’s, complicating decisions about when FDA authority applies.
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