This bill would amend the Federal Food, Drug, and Cosmetic Act to authorize the FDA to request access to concentrated animal feeding operations (CAFOs) for microbial sampling when needed to facilitate a foodborne illness outbreak investigation, determine root causes, or address other public health needs. It sets a process for granting reasonable access, clarifies coordination with the USDA, and preserves existing rights under FOIA.
Enforcement is added to penalize refusals to provide access under the new section.
At a Glance
What It Does
Adds new Section 425 to authorize the FDA to request access to CAFOs to conduct microbial sampling of plants, animals, water, and the surrounding environment when necessary for outbreak investigations or public health needs. It allows CAFOs to set reasonable time, place, and manner conditions, provided sampling proceeds in a timely manner.
Who It Affects
Directly affects CAFO operators and their management, along with FDA investigators and other public health agencies (state and federal) coordinating outbreak responses. It also implicates the broader agricultural and food safety ecosystem that relies on CAFO-derived products.
Why It Matters
Establishing a formal mechanism for access to CAFOs aims to shorten outbreak response times, improve the accuracy of root-cause determinations, and enhance data sharing across agencies to prevent future incidents. It does so while attempting to limit disruption to operations and preserve existing USDA authorities over meat, poultry, and egg products.
More articles like this one.
A weekly email with all the latest developments on this topic.
What This Bill Actually Does
The Expanded Food Safety Investigation Act of 2025 would add a new authority to the FD&C Act that lets the FDA request access to a concentrated animal feeding operation (CAFO) to conduct microbial sampling if needed to investigate a foodborne illness outbreak, determine the root cause, or address other public health needs. The sampling can cover samples from plants, animals, water, and the surrounding environment, and the CAFO may set reasonable conditions on when and how sampling occurs, as long as these do not hinder the investigation.
Importantly, this authority does not expand USDA’s requirements beyond microbial sampling for foods under USDA’s jurisdiction, ensuring existing meat, poultry, and egg programs remain separate. Data collected under this section must be shared with the Secretary of Agriculture and relevant state and federal public health agencies to support detection, investigation, and prevention efforts, while respecting rights under the FOIA.
The term CAFO is defined by existing regulatory language to ensure clarity.
The Five Things You Need to Know
The bill creates Section 425 in the FD&C Act to authorize FDA microbial sampling at CAFOs during outbreak investigations.
CAFO operators must provide reasonable access, but can impose time, place, and manner conditions that do not block sampling.
Sampling scope includes plants, animals, water, and environmental contexts as determined appropriate by the Secretary.
Data from sampling must be shared with USDA and state/federal public health agencies to support investigations and prevention.
Refusal to provide access for sampling under 425 becomes enforceable under a new subsection (jjj) to FD&C Act Sec. 301.
Section-by-Section Breakdown
Every bill we cover gets an analysis of its key sections.
Microbial Sampling on CAFOs
The bill adds a new authority allowing the Secretary to request access to a CAFO to conduct microbial sampling when it is necessary to facilitate a foodborne illness outbreak investigation, determine root causes, or address other public health needs. It requires CAFOs to provide reasonable access and permits the Secretary to determine the sampling scope (plants, animals, water, and environment) as appropriate. The section also clarifies that, beyond microbial sampling, there are no new USDA mandates on foods under USDA jurisdiction, and it mandates coordination with other public health data sources to support investigations.
Enforcement for Access Refusal
This amendment adds a new enforcement hook to the FD&C Act: refusal to provide reasonable access for microbial sampling under Section 425 is itself an enforceable issue under Section 301. This ensures that the access provision has real, actionable consequences for noncompliance and ties the sampling authority to FDA enforcement tools.
This bill is one of many.
Codify tracks hundreds of bills on Healthcare across all five countries.
Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- FDA outbreak investigation teams gain a clear statutory basis to collect microbial samples at CAFOs, enabling faster identification of outbreak sources and root causes.
- State and local public health agencies benefit from shared data and coordinated sampling results, improving detection and response at the community level.
- Public health researchers and epidemiologists gain access to samples and associated data to study transmission pathways, contamination sources, and prevention strategies.
Who Bears the Cost
- CAFO operators bear the costs of permitting access and potentially adjusting operations to accommodate sampling, including time and resource coordination.
- FDA and state public health agencies incur costs for field sampling, personnel, data management, and cross-agency coordination.
- Industry groups and smaller producers may face increased compliance considerations and potential reputational risk associated with sampling activities.
Key Issues
The Core Tension
The central dilemma is balancing the need for rapid, thorough sampling to protect public health with the rights and operational realities of CAFOs, including property rights and business confidentiality.
The bill creates a mechanism intended to speed up outbreak investigations by granting FDA access to CAFOs for microbial sampling, but this raises tensions between public health imperatives and private property/operational concerns. The requirement to share data with the USDA and other public health bodies must be balanced against confidentiality and the protection of sensitive business information.
While the act preserves existing rights under FOIA, it also raises questions about how data collected in private facilities will be stored, shared, and used, and how duplicative sampling across agencies will be avoided. Implementation will hinge on how 'reasonable access' is negotiated in practice and how timelines and conditions are enforced across diverse farming operations.
Try it yourself.
Ask a question in plain English, or pick a topic below. Results in seconds.