Tell it to The Packer | Letter to the Editor
In the Aug. 22 article, “FDA fees may cause some sticker shock,” (Page A1) various industry officials offered their personal opinions and interpretations of the recently announced Food and Drug Administration fee schedule under the FDA Food Safety Modernization Act of 2011 (FSMA).
The comments in the article may have confused or misled Packer readers regarding the fee schedule and the work FDA must do in response to three specific instances of noncompliance as authorized under Section 107 of FSMA.
To clarify, the fee schedule that was announced in the Federal Register on Aug. 1 provides for the recovery of costs and applies only to those parties in the food and feed industry whose noncompliance requires FDA to conduct additional follow-up activities.
There are three instances for which FDA could assess fees related to non-compliance:
- Facility re-inspections to determine compliance has been achieved after finding a violation materially related to food safety requirements during a previous inspection;
- Food recall activities conducted by FDA as a result of noncompliance with a recall order; and
- Import re-inspections to determine compliance has been achieved after a previous examination identified a violation materially related to food safety requirements.
In addition, FDA recognizes that for some small businesses the full cost of re-inspection or recall oversight could impose a severe economic hardship.
Accordingly, FDA announced that, during fiscal 2012, the agency will consider on a case-by-case basis waiving in limited cases some or all of an invoiced fee based on a severe economic hardship, the nature of the underlying violation, and other relevant factors.
FDA is also seeking comment in a public docket on factors it should consider in developing the fee schedule in future years.
Although FDA officials have been consistent and public in stating that full implementation of FSMA will indeed require additional resources, the fee schedule for the compliance activities specified in FSMA Section 107 is separate from the overall issue of full implementation of FSMA.
Associate Commissioner for Food Protection
FDA Office of Foods