Shutdown Deal Restricts Funds for FSMA 204, Produce Safety Rule Enforcement

The Fiscal Year (FY) 2026 appropriations bill approved by Senate on November 12—ending the longest government shutdown in U.S. history—includes language restricting the use of federal funds to enforce the U.S. Food and Drug Administration’s (FDA’s) Food Traceability Rule until its 2028 compliance date, as well as the Produce Safety Rule and Pre-Harvest Agricultural Water Rule for certain commodities.
The bill also specifies FDA’s FY 2026 funding for Human Foods Program activities, and mentions Listeria monocytogenes and pet food rulemaking. The full bill text can be read here.
FDA’s FY 2026 Budget for Human Foods Program and Food-Related Activities
The total amount appropriated to FDA Human Foods Program and related activities for FY 2026 is $1,171,319,000. This covers inspections, investigations, and import operations conducted by the Human Foods Program, the Office of Inspections and Investigations, or the Office of the Chief Scientist.
Of this amount, no less than $15,000,000 shall be used for inspections of foreign seafood manufacturers and field examinations of imported seafood.
Limitations to FSMA Enforcement
The bill restricts the use of federal funds to enforce the FSMA Produce Safety Rule and the Pre-Harvest Agricultural Water Rule for wine grapes, hops, pulse crops, or almonds. The bill states:
“None of the funds made available by this or any other act may be used to enforce the final rule promulgated by [FDA] entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption published on November 27, 2015, and the proposed rule issued by [FDA] pending at the Office of Management and Budget entitled Standards for the Growing, Harvesting, Packing, and Holding Produce for Human Consumption Related to Agricultural Water, with respect to the regulation of entities that grow, harvest, pack, or hold wine grapes, hops, pulse crops, or almonds.”
Regarding the Food Traceability Rule, which fulfills Section 204(d) of the Food Safety Modernization Act and for which the Trump Administration extended the compliance date until July 2028, the bill states, “No funds appropriated by this act may be used to administer or enforce the Requirements for Additional Traceability Records for Certain Foods, published on November 21, 2022, or any other rule promulgated in accordance with Section 204 of [FSMA], prior to July 20, 2028.
Also related to FSMA 204, the bill requires FDA to:
- “Engage quarterly with the regulated entities, including farms, restaurants, retail food establishments, and warehouses distributing to retail food establishments and restaurants, to identify and implement, as appropriate, additional flexibilities for satisfying the rule’s lot-level tracking requirement, such that regulated entities can comply with the November 21, 2022, rule consistent with Section 204(d)(1)(L)(iii), which prohibits the agency from requiring product tracking to the case level.”
- “Within 180 days of enactment of [the bill], provide industry stakeholders with recommendations for these additional flexibilities satisfying the rule’s lot-level tracking requirement, as appropriate.”
- “Provide assistance to industry regarding how to handle food waste recovery, reclamation, intra-company transfers, and customer returns under the rule, and initiate a series of hypothetical data intake exercises to test the capabilities of FDA’s Product Tracing System and, upon request and as resources allow, the covered entity systems, and identify any technical difficulties prior to full implementation.”
Listeria monocytogenes and Pet Food Rulemaking
The bill also restricts FDA’s ability to create new rules or guidelines related to Listeria monocytogenes in low-risk ready-to-eat (RTE) foods, stating:
“None of the funds appropriated or otherwise made available by this act may be used by [FDA] to issue or promote any new guidelines or regulations applicable to food manufacturers of low-risk RTE foods for [L. monocytogenes] until FDA considers the available new science in developing the Compliance Policy Guide (CPG), Guidance for FDA Staff, Section 555.320 Listeria monocytogenes regarding [L. monocytogenes] in low-risk foods, meaning foods that do not support the growth of [L. monocytogenes].”
Additionally, the bill requires FDA to take initial steps in the rulemaking process for pet and animal food labeling and ingredient regulation, stating:
“The Commissioner of [FDA] shall develop a report to determine the cost and any implications associated with efforts to issue a proposed rule and implement FDA guidance and enforcement for setting standards for pet and animal food labeling and ingredient regulation: Provided, that the report shall: 1) cover intent for harmonization across state and federal regulatory bodies for pet and animal food labeling and ingredients, 2) include timelines for developing guidelines, proposed regulations, resource and personnel needs to implement such standards, and where FDA would need additional authority to implement any proposed changes; and 3) be submitted to the House and Senate Committees on Appropriations within 120 days of enactment of this act.”
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