Qualified facilities that began or will begin processing, packing, or holding food before September 17, 2018 must submit the relevant form by December 17, 2018. Facilities that will begin processing, packing, or holding food on or after September 17, 2018 must submit the relevant form before beginning operations. Facilities must re-submit attestation to FDA every two years during the biennial food facility registration renewal period, which begins on October 1st and ends on December 31st of each even numbered year.
A very small business that does not notify FDA of its status as a qualified facility is fully subject to the standard requirements of the Preventive Controls Rule and, generally, must develop and implement a written HARPC Food Safety Plan and Supply-Chain Program by September 17, 2018.
The Preventive Controls Rule compliance deadlines for facilities that do not meet the definition of a very small business have already passed. Thus, many food facilities that have not yet developed and implemented a written HARPC Food Safety Plan and Supply-Chain Program are likely to be in violation of FDA regulations.
Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses that do not meet the definition of a qualified facility or do not intend to notify FDA of their status as a qualified facility to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet regulatory requirements.
