Resources for You
Information available related to Fees under the FDA Food Safety Modernization Act (FSMA).
- New Fees under the FDA Food Safety Modernization Act
- Guidance, Rules, and Notices
- Frequently Asked Questions
- Sections of the Law Relating to Fees
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 for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
Docket Number: FDA-2011-D-0721, comments can be submitted anytime
Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business
Docket Number: FDA-2011-N-0529,
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?
There is no fee for an initial FDA inspection. FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems. See the Assessment of Reinspection and Recall Fees by the FDA for more information.
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, and for costs to establish and administer the third-party accreditation program.
F.1.5 What fees have been established?
For each fiscal year since FY2012, a fee schedule has been established for domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections (please see section below). FDA publishes the fee schedule 60 days before the start of each fiscal year along with the methodology used to formulate those fees. The other fees (see F.1.4) will be established as the programs develop.
Domestic and Foreign Facility Reinspections, Failure to Comply with Recall Orders, and Certain Importer Reinspections User Fee Rates for Fiscal Year 2014
F.2.1 What is FDA announcing?
On August 2, 2013, FDA announced in a Federal Register notice the fiscal year FY 2014 fee schedule for certain domestic and foreign facility reinspections, importer reinspections, and failure to comply with recall orders.
F.2.2 Will importer reinspection fees be assessed and collected in FY 2014?
FDA is in the process of considering various issues associated with the assessment and collection of importer reinspection fees as stated in the Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act. Recognizing the particular complexities involved in these issues, FDA is not in a position to assess importer reinspection fees until the agency has resolved these issues and will not assess importer reinspection fees until the agency notifies the public. However, the fee rates set forth in the notice for FY 2014 will be used to determine any importer reinspection fees assessed in FY 2014 once the Agency begins to assess such fees.
F.2.3 What are the FY 2014 fees?
The rates are as follows: $237 an hour if no foreign travel is required and $302 an hour if foreign travel is required.
F.2.4 When do the FY 2014 fees go into effect?
The fees are effective October 1, 2013 through September 30, 2014. As stated in FDA’s September 2011 Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act, because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms. FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.
F.2.5 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 facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (the Act). 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 identified noncompliance materially related to a food safety requirement of the Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency.
F.2.6 Why are these fees important?
FSMA represents a critical step in strengthening the U.S. food safety system. However, there are challenges and costs associated with achieving the full implementation of FSMA. The fees allow FDA to recover costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and certain importer reinspections. Prior to FSMA, FDA bore the entire burden of these costs.
F.2.7 How does FDA plan to charge these fees?
For facility reinspection fees, FDA will invoice theresponsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For recall order fees, FDA will invoice the responsible party for each domestic facility or an importer who does not comply with a recall order under sections 423 or 412 of the Act for the hours spent to cover food recall activities associated with such order. For importer reinspection fees, FDA will invoice the importer for the direct hours spent to perform the reinspection including travel. Detailed payment information will be included in the invoice.
F.2.8 Why is there only one foreign travel fee rate? Shouldn’t it be a different rate for each country depending on the distance from the U.S? For example, traveling to Canada or Mexico from the U.S. should cost less than traveling to China.
Fees are charged on an hourly basis, thus the cost of traveling to a country closer to the U.S. will take less travel time, and therefore, will account for the distance variations and costs associated. Please see the FY 2014 Fee Rate Federal Register notice for explanation of the methodology used to determine the fee rate for foreign travel.
F.2.9 Which fiscal year rate will be charged if a reinspection occurs during one fiscal year and the invoice is sent out in the next fiscal year?
The fiscal year in which the reinspection occurs dictates the fee rate to be applied. For example, if a reinspection was conducted in September, 2012 and the invoice was issued in October, 2012, the fee rate to be applied would be the FY 2012 rate. The invoice clearly itemizes the fiscal year, hours and rate used to calculate the total invoice amount.
F.2.10 Can small businesses have their fees waived?
The FY 2014 fee schedule does not contain any reduced fee rate for small business. However, as stated in F.2.4, FDA does not intend to issue invoices for reinspection or recall order fees until a guidance document to outline the process through which firms may request a reduction of fees has been published. Once published, invoices will be issued and firms can apply for reductions as outlined in the guidance.
F.2.11 How is FDA addressing the impact of these fees in future years on small businesses?
A Federal Register notice was issued on August 1, 2011, that requested comments on the burden of the fees on small business. The notice requested 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.2.12 Will States conduct FSMA-related reinspections?
Generally, FDA intends to conduct all reinspections that could result in the assessment of fees under FSMA, even in the case where an initial inspection was conducted under state contract.
F.2.13 How long does the responsible party have to pay the fees?
Payment must be made within 90 days of the invoice date.
F.2.14 What happens if the responsible party or U.S. Agent 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.