Some facilities may be required to comply with none or only certain parts of the rules. Use these resources to help determine where your facility falls.
The basic PCAF rule states that facilities that have to register under the Bioterrorism Act of 2002 also have to comply with FSMA. As with many rules, there are exceptions to the Preventive Controls for Animal Food rule.
Establishments, including farms (see relevant definitions), that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) do not need to comply with any part of the rule. The FDA guidance document regarding food facility registration answers many questions regarding the FD&C Act.
Our new interactive decision tree, “Does PCAF Apply?” is a short, easy-to-use tool for answering this important question.
The tool is for informational purposes only; it does not take the place of independent legal advice, and it is not intended to be used as legal advice.
What are the PCAF exemptions?
As with many regulations, there are possible exemptions from all or parts of the PCAF rule. Exemptions exist for smaller facilities that don’t have a major impact on commerce, but food safety is still an expectation.
Even if a facility files a qualified facility attestation, the FDA could withdraw that attestation if the facility has a food safety violation or recall.
Subpart B (CGMP) does not apply to establishments solely engaged in
- the holding and/or transportation of raw agricultural commodities,
- hulling, shelling, drying, packing and/or holding nuts and hulls (without manufacturing/processing, such as grinding shells or roasting nuts), or
- cotton ginning (without manufacturing/processing, such as extracting oil from cottonseed).
Subparts C and E
Subparts C and E do not apply to
- activities subject to regulations for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (just those activities, not the whole facility),
- activities that are subject to Standards for Produce Safety Rule,
- qualified facilities (must follow modified requirements),
- small or very small businesses (Qualified Facilities) that are farm mixed-type facilities if the only packing or holding activities are specified low-risk packing or holding activity/animal food combinations, even if activities are for distribution into commerce, or
- facilities solely engaged in storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution of processing.
For additional information contact
Marissa Herchler Cohen
NC State University
Cooperative Extension Service
Prestage Department of Poultry Science
236 Scott Hall
Raleigh, NC 27695-7608