FDA updates cut-offs for FSMA exemptions

The FDA said that it is changing how it calculates a company’s sales, which affects whether or not some companies can be exempt from some requirements of the Food Safety Modernization Act (FSMA).

Most of the final rules implementing FSMA have compliance dates or exemptions that are based on annual sales averaged over the previous three-year period and adjusted for inflation. These baseline values were set in 2011, when FSMA became law, but have changed every year because of inflation. The FDA has updated the applicable inflation adjusted values for six of the FSMA regulations covering 2015-2017, the most recent three years for which these values are available.

“These values are particularly noteworthy for smaller businesses that may not be covered, may receive an exemption, or have later compliance dates based on their sales being less than the indicated value,” the FDA said.

The agency gave the example: farms or farm mixed-type facilities with an average annual monetary value of produce sold during the previous three-year period of $25,000 or less (adjusted for inflation) are not subject to the Produce Safety Rule. That number, $25,000, was set as the baseline in 2011; however, the three-year inflation-adjusted average from 2015-2017 is $26,999. Therefore, if a farm or farm mixed-type facility’s three-year average is $26,999 or less, it is not subject to the Produce Safety Rule.

Certain businesses subject to the Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Foreign Supplier Verification Programs, Sanitary Transportation and Intentional Adulteration Regulations should refer to the updated values at the FSMA Inflation Adjusted Cut Offs page to determine whether they meet the cut-off value for the applicable regulation.