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FDA announces new fees

Published by Steve Coleman on August 03, 2011

The Food and Drug Administration has just announced the fiscal year 2012 fee rates that will begin on Oct. 1, 2011 for certain import re-inspections, domestic and foreign facility re-inspections, and failure to comply with a recall order, as mandated by the FDA Food Safety Modernization Act.

The hourly fee rates are quite high, depending on the travel required, and will reimburse FDA for the time it spends on various instances of noncompliance, including follow up inspections, reconditioning of food, etc.

Changes include:

G.7 How does this Act change the way FDA regulates foods? 

This new law puts prevention up front for FDA. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply.  Under the Act, implementation of mandatory preventive controls for food facilities and compliance with mandatory produce safety standards will be required.  FDA is in the process of developing a proposed rule that will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and will address soil amendments, worker health and hygiene, packaging, temperature controls, water, and other issues.  Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls, and specify the corrective actions the facility will take when necessary. I have cut and pasted from the FDA website for posting on ours and circulation to members

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 re-inspections. There is no fee for an initial FDA inspection. The fee for re-inspection is to cover re-inspection-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. 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.

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 re-inspections, failure to comply with recall orders, and certain importer re-inspections.

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 re-inspections, failure to comply with a recall order, and certain importer re-inspections. 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 re-inspections - follow up inspections conducted by FDA subsequent to a previous inspection that found a violation materially related to food safety requirements. The re-inspection 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 re-inspections - 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 re-inspection 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 re-inspection 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 theFY2012 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 re-inspections, failure to comply with a recall order, and certain importer re-inspections 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 re-inspection 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.
http://www.fda.gov/Food/FoodSafety/FSMA/ucm257982.htm

 

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