FSMA Fee Technical Corrections Act

Bill Number

S. 3252

Origin Chamber

Senate

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-11-20: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8277-8278)

Last Updated

2026-01-05T15:02:35Z

AI-Generated Summary

Purpose

The FSMA Fee Technical Corrections Act (S. 3252) aims to fix technical issues in the FDA Food Safety Modernization Act (FSMA) of 2011. These fixes enable the Food and Drug Administration (FDA) to properly assess and collect fees for reinspections (follow-up checks after finding problems) and recalls (actions to remove unsafe food from the market) related to human and animal food safety.

Key Provisions

• Short Title: The bill is named the "FSMA Fee Technical Corrections Act."
• Fee Structure and Amounts:
• Establishes base fees of $15,000 for reinspections of facilities, recalls, and certain importer activities, adjusted annually starting in fiscal year 2026 based on an inflation factor.
• Fees for the voluntary qualified importer program (a system for pre-approved safe imports) cover 100% of program costs.
• Small businesses (defined later) pay only one-third of the standard fee.
• Requires the FDA to publish a schedule of reduced fees annually and issue guidance within 270 days of enactment on how to request reductions, effective immediately.
• Accounts for over-collected fees from prior years by crediting them toward future needs and adjusts for small business reductions.
• Use of Collected Fees:
• Fees from reinspections, recalls, and importer oversight fund only FDA activities for monitoring domestic and foreign food facilities and importers.
• Fees from the voluntary importer program fund only that program's operations.
• Fee Limits:
• Raises the annual cap on reinspection and recall fees from $20 million to $25 million.
• Raises the cap on importer program fees from $25 million to $30 million.
• Definitions:
• Clarifies "reinspection" as one or more follow-up checks after an initial inspection finds serious noncompliance (classified as needing "official action"), to verify fixes for both facilities and importers.
• Defines "importer" as entities handling human or animal food under the foreign supplier verification program (rules ensuring imported food meets U.S. safety standards).
• Defines "small business" based on employee count (fewer than 500 full-time equivalents for facilities) or annual sales thresholds (under $1 million for human food importers, under $2.5 million for animal food importers, adjusted for inflation over three years, including certain non-sales activities like processing for fees).

Significant Changes to Existing Law

• Amends Section 743 of the Federal Food, Drug, and Cosmetic Act (the main U.S. law on food and drugs) to correct errors from FSMA that previously blocked full fee collection.
• Introduces small business fee reductions and guidance processes, which were not previously specified.
• Expands and clarifies definitions for reinspection, importer, and small business to include both domestic/foreign facilities and importers under the foreign supplier verification program.
• Increases fee caps to allow more revenue collection without needing new appropriations.
• Specifies exact uses for fees, ensuring they support targeted food safety oversight rather than general FDA operations.

Potential Impacts

• On Government Agencies: Enables the FDA to generate dedicated funding (up to $55 million annually across categories) for food safety inspections and programs, reducing reliance on taxpayer-funded budgets and potentially improving efficiency in monitoring high-risk facilities and imports.
• On Citizens: Enhances food safety by supporting more reinspections and recalls, which could reduce risks from contaminated human or animal food; however, fees may indirectly raise costs for food businesses, potentially affecting consumer prices.
• On International Relations: Strengthens U.S. oversight of foreign food suppliers and importers, promoting safer global food trade without direct diplomatic changes, but could increase compliance burdens for international exporters.

Main Stakeholders Affected

• FDA: Gains authority and revenue to fund safety enforcement.
• Food Facilities and Importers: Domestic and foreign entities handling human or animal food must pay fees for reinspections or recalls, with relief for small businesses; importers face new verification-related fees.
• Small Businesses in the Food Sector: Benefit from reduced fees (one-third rate) and guidance to apply for them, easing financial strain on smaller operations.
• Consumers and Animal Owners: Indirectly protected through improved FDA oversight of food supply chains.

Notable Legal, Constitutional, or Political Implications

• Legal: Provides clear statutory authority for fee collection, resolving ambiguities that could have led to legal challenges over FDA's enforcement powers; ensures compliance with administrative law by requiring public guidance and fee schedules.
• Constitutional: No apparent issues, as it involves Congress's power to regulate interstate commerce and fund agencies via user fees, without infringing on individual rights.
• Political: Supports ongoing FSMA implementation by addressing technical gaps, potentially appealing to bipartisan interests in food safety; may face debate over fee burdens on businesses versus public health benefits, but focuses on corrections rather than new mandates.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Durbin, Richard J. [D-IL]

Cosponsors (2)

Sen. Blumenthal, Richard [D-CT], Sen. Markey, Edward J. [D-MA]

Recent Actions

• 2025-11-20: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8277-8278)
• 2025-11-20: Introduced in Senate

Bill Versions

• FSMA Fee Technical Corrections Act — issued 2025-11-20 — PDF (8 pages)