Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail
?
-

Resources for You

-

Fees

Information available related to Fees under the FDA Food Safety Modernization Act (FSMA).

Facility Reinspection and Recall User Fees Effective October 1, 2011

 

Importer Reinspection User Fees Postponed

 

FDA will not invoice for any fees prior to January 1, 2012. Agency to further evaluate import reinspection fees and notify the public prior to assessing these fees. For more information on FDA's proposed process for implementing FSMA user fees, visit: 
 

 

 

New Fees under the FDA Food Safety Modernization Act

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. FSMA specifically authorizes new fees to give FDA resources necessary to implement specific activities.

Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done. Congress has established specific implementation dates in the legislation. The funding the Agency gets each year, which affects staffing and vital operations, will affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders. 

 

Guidance and Rules

Frequently Asked Questions

General Questions on Fees

F.1.1 Is there a registration fee required under FSMA?
FSMA does not require a registration fee to be paid by registered facilities.

F.1.2 Will there be a fee associated with FDA inspections?
FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. There is no fee for an initial FDA inspection. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems.

F.1.3 Will there be any fees connected to the new recall authority FDA now has?
FDA has authority to assess and collect fees for food recall activities associated with a recall order when a domestic food facility or importer does not comply with such order.

F.1.4 What other fees are outlined in the new law?
There are also fees that can be collected for administrative costs of the voluntary qualified importer program, for costs associated with issuing food export certifications, for costs to establish and administer the third-party accreditation program.  With the exception of food export certificates, the law requires FDA to publish a notice of any new fees in the Federal Register no later than 60 days before the start of each fiscal year.

F.1.5 How much will the fees be?
The fiscal year 2012 fee schedule has been established for domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections (please see below section). The other fees are still to be determined. FDA will publish the fees each August with the methodology used to arrive at those fees.

Domestic and Foreign Facility Reinspections, Failure to Comply with Recall Orders, and Certain Importer Reinspections User Fee Rates for Fiscal Year 2012

F.2.1 What is FDA announcing?
On August 1, 2011, FDA announced the fiscal year (FY) 2012 fee schedule for certain domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections through a Federal Register Notice (Federal Register Correction Notice).

F.2.2 Why are these fees important? 
FSMA represents a critical step in strengthening the U.S. food safety system. The legislation significantly enhances FDA’s ability to oversee the millions of food products coming into the United States from other countries each year. However, there are challenges in and costs associated with achieving full implementation of FSMA. The fees announced today allow FDA to recover 100% of its costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and certain importer reinspections. Previously, FDA bore the burden of these costs.

F.2.3 Who is affected by these fees?
Only those parties in the food and feed industry whose non-compliance results in the following activities:

  • Facility reinspections – follow up inspections conducted by FDA subsequent to a previous inspection that found a violation materially related to food safety requirements. The reinspection must be conducted specifically to determine that compliance has been achieved.
  • Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.
  • Importer reinspections – follow up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that found a problem materially related to food safety requirements. The reinspection must be conducted specifically to determine that compliance has been achieved.

F.2.4 What are the FY 2012 fees?
The rates are as follows: $224 an hour if no foreign travel is required and $325 an hour if foreign travel is required.

F.2.5 Can small businesses have their fees waived?
The FY2012 fee schedule does not contain any reduced fee rate for small business. However, FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, and there may be unique circumstances in which some relief would be appropriate. Thus, during FY2012, FDA will consider waiving in limited cases some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.

F.2.6 How is FDA addressing the impact of these fees in future years on small businesses?
A separate Federal Register Notice is being issued that requests comments on the burden of the fees on small business. The notice is being published at the same time as the FY2012 fee schedule. The notice requests public input to help the agency understand what factors it should consider in developing guidelines in consideration of the burden of fees on such businesses in future years.

F.2.7 When do the FY2012 fees go into effect?
The fees are effective October 1, 2011 through September 30, 2012

F.2.8 Why are these fees being implemented now?
The FDA Food Safety Modernization Act (FSMA) instructs FDA to establish the fees for certain domestic and foreign facility reinspections, failure to comply with a recall order, and certain importer reinspections to be collected for each fiscal year and to publish the fees in a Federal Register notice not later than 60 days before the start of each fiscal year.

F.2.9 How does FDA plan to implement these fees?
The responsible party will be invoiced for the direct hours spent to perform the reinspection or recall at the appropriate hourly rate. Detailed payment information will be included in the invoice.

F.2.10 How long does the responsible party have to pay the fees?
Payment must be made within 30 days of the invoice date.

F.2.11 What happens if the responsible party does not pay?
Any fee that is not paid within 30 days after it is due shall be treated as a claim of the United States government subject to provisions of subchapter II of Chapter 37 of Title 31, United States Code.

F.2.12 What is the purpose of the November 25, 2011, Federal Register Notice titled "Agency Emergency Processing Under the Office of Management and Budget Review; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Food Safety Modernization Act: Economic Hardship Fee Reduction Guidance"?
The purpose of the FR Notice is to notify Industry and the public that FDA has requested permission to use emergency clearance procedures to obtain OMB approval of the information collection related to the Economic Hardship Fee Reduction Guidance. If FDA were to use the normal clearance procedures instead of emergency clearance procedures, the approval of the information collection would not be finalized in time to issue invoices for fees, as FDA intends, in January 2012.

F.2.13 When will the Guidance document be published for the Economic Hardship Fee Reduction?
FDA intends to publish this guidance document in the near future. The Economic Hardship Fee Reduction Guidance will provide information to firms who may wish to apply for a reduction in fees that have been invoiced in FY 2012.

F.2.14 Is the Economic Hardship Fee Reduction Guidance the same as the Small Business Guidelines?
No. During fiscal year 2012, FDA will consider waiving some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors. Independently, FSMA provides that FDA shall develop a proposed set of guidelines in consideration of the burden of fee amounts on small businesses. Currently, the Agency is reviewing the public comments received in response to the August 1, 2011, Federal Register notice seeking information to be used in developing these proposed guidelines, which FDA intends to publish for comment in fiscal year 2012.
 

    

Full Text of the Law Relating to Fees

 

Additional Resources

 

Presentations

  • Food Safety Modernization Act: FSMA Fees Discussion (PPT, 469KB)

 

-
-