Very Small Businesses: Businesses (including all subsidiaries and affiliates collectively) that have averaged less than $1,000,000 (adjusted for inflation) in global sales of food for human consumption plus the market value of unsold food inventory per year during the previous three calendar years.
Other Qualified Facilities: Though FDA has stated that it expects most facilities that qualify for the exemption to be very small businesses, other facilities qualify if they possess both of the two following characteristics:
- Over the past three years, they have averaged annual sales of food for human consumption below $500,000 (adjusted for inflation)
- At least half of their food sales over the previous three years have been directly to local consumers, restaurants, or retail establishments that are located in the same state, same Indian reservation, or within 275 miles of the food facility in question.
