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NC State Extension

PCAF: Exemptions

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.

animated demo of selecting buttons in the "Does PCAF Apply" interactive document

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.

Extension Factsheet attach_file

FSMA Preventive Controls for Animal Food (PCAF) Exemption Decision Tree Tool

The NC State Feed Milling and Animal Food Safety programs have developed a decision tree tool to help guide facilities through the exemption determination process and the requirements for obtaining …

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

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

For additional information contact

Marissa Herchler
NC State University
Cooperative Extension Service
Prestage Department of Poultry Science
236 Scott Hall
Raleigh, NC 27695-7608

E-mail: marissa_herchler@ncsu.edu
Phone: +1 919.515.5396