US: Food Safety Modernization Act exemptions
Certain farms that grow produce and food processors can be exempt from the rules depending on how much they sell and to whom they sell. Producers may either be completely exempt from compliance with the new requirements, or “qualified exempt” and eligible for modified requirements. To determine exemption, there are sales thresholds that apply to each category; sales thresholds can vary depending on whether the operator is a produce farmer or running a food facility. Regardless of the type of operation, however, sales thresholds or cutoffs are supposed to be based on an average of the past three years’ worth of sales and adjusted for inflation.
This clarification regarding inflation adjustment is important because the qualified exemption in the Produce Rule applies to farms with less than $500,000 in food sales (averaged over three years’ worth of sales), where the majority of those sales are direct to qualified end users. However, it is important to note that when adjusted for inflation, the dollar cutoff is actually higher than $500,000. The same is true for the $25,000 “de minimis” exemption.
FDA’s website provides the inflation-adjusted values relevant to all of the FSMA rules that have these kinds of sales thresholds or cutoffs, and will be updated in March of each year to reflect the most recent inflation-adjusted values. For 2015-2017 sales (and 2018 compliance purposes), the inflation-adjusted average value is $539,982 for the qualified exemption and $26,999 for the de minimis exemption.
Read more at NSAC