S. 3252: FSMA Fee Technical Corrections Act

This bill, known as the FSMA Fee Technical Corrections Act, proposes a series of technical amendments related to the Food Safety Modernization Act (FSMA). The key aspects of the bill include:

Food-related Fees

The bill outlines how the Food and Drug Administration (FDA) can assess and collect fees related to food reinspection and food recall:

• It establishes that fees for reinspection and recall shall be set at $15,000 for each fiscal year, adjusted annually based on a specific calculation method.
• The fees can be reduced for small businesses, defined as businesses with fewer than 500 employees. In this case, the fee would be one-third of the standard amount.
• The FDA Secretary is required to publish guidelines for small businesses to request fee reductions and to specify the criteria for these adjustments.
• Fees for the Voluntary Qualified Importer Program will be determined based on the number of importers participating in the program.
• Any over-collection of fees in previous years can be credited against future collections, potentially lowering the fee amount in subsequent years.

Use of Fees

The bill specifies how the collected fees can be used:

• Fees from reinspection and related activities will be restricted exclusively for the FDA’s oversight activities of food facilities and importers.
• Fees collected for the Voluntary Qualified Importer Program will only be utilized for costs associated with operating that specific program.

Limitations on Fee Amounts

The bill states adjustments to the maximum annual fee limits:

• The fee ceiling for certain activities, previously capped at $20 million, will be increased to $25 million.
• A specific fee category limit will also increase from $25 million to $30 million.

Definitions

The bill refines definitions used in previous legislation:

• It clarifies the term reinspection to include inspections following prior inspections that identified noncompliance.
• The term importer is further defined to include those importing human or animal food that must comply with certain regulations.
• It provides a detailed definition of small business relating to employment numbers and revenue thresholds, with specific criteria for both human and animal food importers.

Implementation Timeline

The Secretary of the FDA is required to publish guidance to facilitate the fee reduction process within 270 days after the bill’s enactment, emphasizing a swift and effective implementation for those eligible.

Relevant Companies

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