The Food Safety Modernization Act (FSMA) that became law in January gives the U.S. Food and Drug Administration the authority to impose and collect fees from food producers when the agency has to reinspect food manufacturing or processing facilities and when inspectors must verify compliance following a food recall.
The agency has posted a notice in the Federal Register proposing fees of $224 an hour for work by its staff in domestic food facilities and $335 an hour at foreign facilities. The fees would be imposed if a previous inspection found significant problems and regulatory action was required to address them. The FDA said the rate was set to cover inspectors’ time at a facility, travel expenses, related administrative tasks and lab analysis.
Under some circumstances, if a company could show that its food was not adulterated or misbranded, fees would not be required for reinspections, the FDA said.
Comments on the fees will be accepted until October 31 this year, and the agency says those comments will also be considered when the fees are established for the following fiscal year.
The notice says the FDA is particularly interested in comments on whether the fees will be a burden to small businesses, how to define small businesses, and whether a reduction or waiver of the fees would be appropriate for small-scale food producers.
Each year 48 million people, or one in six Americans, are sickened, 128,000 are hospitalized and 3,000 die from foodborne illlness, according to the Centers for Disease Control and Prevention. Under FSMA, the FDA has new enforcement authority that is supposed to help it achieve higher rates of compliance with prevention- and risk-based standards to ensure the safety and security of the U.S. food supply.
Image of inspectors from the U.S. Food and Drug Administration