Industry is required to establish a compliant HAPRC food safety plan as of September 17, 2016, which was one year after the publication of the final rule. There are several exceptions. One big consideration is the size of the business. If the business’ number of full time employee equivalent does not exceed 500, or if the yearly market value of the foods it sells have not exceeded $1 million in recent years, then the compliance date is extended until 2018. Also, if the business is only a receiving facility, it will not be required to have a HARPC food safety plan in place until its supplier’s compliance dates.
Very Small Business means, for the purposes of the Human Food Preventative Control regulations, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale. That same term has an identical definition for the purposes of the Animal Food Preventative Control regulations, except the dollar threshold is higher at $2,500,000. Note: These were the baseline dollar amounts, which FDA is adjusting annually, see FSMA Inflation Adjusted Cut Offs for updated values.
