A qualified facility is exempt from subparts C (Requirements for Hazard Analysis and Risk-Based Preventive Controls) and G (Requirements for a Supply-Chain Program) of the preventive controls for human food rule. However, a qualified facility is subject to modified requirements. It must submit two attestations to FDA: (1) an attestation that it is a qualified facility and (2) either an attestation that it has identified potential hazards, is implementing preventive controls to address the hazards, and is monitoring performance of the preventive controls or an attestation that the facility is in compliance with non-federal food safety laws and regulations. Further, a consumer notification requirement may be applicable, depending on which attestation a qualified facility provides.
The compliance date for a business meeting the definition of a “qualified facility” (including a “very small business”) is September 17, 2018. However, there is an earlier compliance date of January 1, 2016 for a facility to maintain (but not submit) financial records to support its status as a qualified facility.
The rule also establishes two additional compliance dates applicable to qualified facilities. First, it establishes December 17, 2018 as the compliance date for (1) the initial submission of the attestation by a facility that it is a qualified facility and (2) the attestation by a qualified facility about its food safety practices or that it is in compliance with non-federal food safety law. Second, it establishes January 1, 2020, as the compliance date for the consumer notification requirement. The consumer notification requirement applies to a qualified facility that submits an attestation that it is in compliance with applicable non-federal food safety law and requires such a facility to notify consumers as to the name and complete business address of the facility where the food was manufactured or processed.
