The rules provide small businesses a longer timeframe than their larger counterparts to develop written Food Safety Plans required by the Preventive Controls Rules; however, the compliance deadlines for most food facilities have passed, and small animal food businesses only have until September 17, 2018 to comply with preventive control requirements.
Certain farms that engage in activities requiring FDA registration (e.g. processing) may be exempt from requirements under the rule if they are considered a small business, but large farms that engage in these activities are required to have Food Safety Plans in place.
Additionally, “very small businesses” (defined by the rules as averaging less than $1,000,000 per year in sold and unsold products during the preceding three-year calendar period) are required to submit a “Qualified Facility Attestation” to FDA. These facilities receive modified preventive controls requirements, including exemption from developing Food Safety Plans. Facilities who submit an attestation must ensure that the average value per year of their sold and unsold products does not exceed $1,000,000, or they may be providing false statements to FDA. Submitting false statements to a U.S. federal agency is a criminal offense.
It is wise for covered facilities to develop Food Safety Plans immediately. FDA may look for a Food Safety Plan as part of a routine facility inspection, and U.S. importers may request their suppliers’ Food Safety Plan as part of a required supplier approval process.
