FDA announces reinspection fee rates under FMSA

By Caroline Scott-Thomas

- Last updated on GMT

FDA announces reinspection fee rates under FMSA

Related tags Safety modernization act Food safety modernization Food safety Food and drug administration

The Food and Drug Administration (FDA) has announced fee rates for food facility reinspections and non-compliance with recall orders, as authorized by the Food Safety Modernization Act (FMSA).

The hourly fees of $224, or $335 if foreign travel is required, apply to reinspections of domestic and foreign facilities as well as importer reinspections, and are due to come into effect on October 1. The FDA said that the fees would be collected in the case of reinspection after a previous inspection had been classified as Official Action Indicated, meaning inspectors found significant problems with the conditions or practices in a food facility, where regulatory action would be necessary to address the issue, and non-compliance was related to food safety requirements.

The fees would also apply for import reinspections following refusals related to food safety requirements.

However, fees would not apply in certain circumstances, such as if the company involved could present information indicating that the food was not adulterated or misbranded, the FDA said.

The rate has been set at a level intended to pay for 100 percent of the agency’s costs related to reinspections and non-compliance with recall orders. Calculation of the hours necessary to deal with reinspections would not only include the inspectors’ time at the plant, but also time spent on travel, related administrative tasks, and analyzing samples from the facility.

The FDA has also published a notice​ requesting comment on the burden of fees on small businesses and whether and how the FDA should alleviate that burden.

The fees are intended to pay for some of the additional responsibilities granted to the FDA under the Food Safety Modernization Act, which was signed into law in January this year. Its development was prompted by a spate of contaminated food recalls in recent years, some of which were fatal, including a nationwide recall of salmonella-tainted peanut products that killed at least nine at the beginning of 2009.

According to statistics from the Centers for Disease Control and Prevention, about 48m Americans get sick as a result of foodborne illness each year, and about 3,000 die. Former FDA economist Robert Scharff has estimated that foodborne illness costs the US economy about $152bn a year.

The FDA notice on reinspection user fee rates is available here​.

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1 comment

Importers to Bear Reinspection Costs

Posted by David Lennarz,

Your article failed to mention an important aspect of FDA's new reinspection fees. Reinspection fees must be paid by the United States Agent for each foreign facility (section 743(a)(1)(A) of the FD&C Act). In this case, "United States Agent" means the person or company listed as U.S. Agent on an exporter's Food Facility Registration Module (FFRM) Registration page. Typically, exporters list their U.S. importers as their U.S. Agent. This means that these importers will be responsible for paying the U.S. Government all fees related to FDA's reinspection of the foreign facility.

Since these fees could easily range from $30,000 to $50,000 per reinspection, it is easy to imagine that importers may have difficulty in getting some foreign manufacturers to reimburse them for the cost of reinspection - - leaving the importers to pay the entire cost. The financial risk to importers is enormous!

The only way to eliminate this risk is for importers to refuse to function as the U.S. Agent for any foreign manufacturer. Instead, importers should recommend that exporters use 3rd-party U.S. Agents, such as Registrar Corp. Registrar Corp's services are designed to help mitigate this risk by assisting foreign manufacturers in complying with U.S. FDA requirements.

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