The owner, operator, or agent in charge of each domestic or international food facility is required to develop an adequate HARPC plan for any facility that is subject to FDA food facility registration under The Bioterrorism Act. There are no substantive adulteration charges that apply to food manufactured in a facility that fails to comply with HARPC. Rather, failure to implement HARPC is defined by the FSMA as a “prohibited act”. Therefore, failure to comply could lead to criminal prosecution of the company (corporation, partnership, association, etc.) and / or the owner, operator or agent in charge of the facility.
