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Fees- 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
- Frequently Asked Questions
- Sections of the Law Relating to Fees
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.
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 and 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?
That is still to be determined. FDA
will publish the fees each August with the methodology used to arrive at those
fees.
Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012
F.2.1 What is FDA announcing?
FDA is publishing through a Federal
Register Notice the fiscal year (FY) 2012 fee schedule for certain domestic and
foreign facility reinspections, failure to comply with recall orders, and
certain importer reinspections.
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 $335 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
(insert link to 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.
Full Text of the Law Relating to Fees
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