The requirements of the PCAF rule can be different depending on facility size and operations. It can be difficult to read through the regulatory text to determine where exactly your facility fits in.

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 a qualified facility exemption through the U.S. Food and Drug Administration (FDA).

Use the new decision tree tool from NC State Extension to determine which parts of the Preventive Controls for Animal Food (PCAF) rule may apply to your facility.

For the best experience with the decision tree tool, download the PDF document and open it in your browser. You’ll be able to select responses to each question. Select answers to each question and follow the arrows until you reach a STOP.

The buttons within the tool function as links to more information in the appendices or to online resources.

Some of the regulatory text or questions are small. Use your browser to zoom in (hold down Ctrl and +) on the document to make the text larger.

You can also print the document and complete it offline.

This 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.

There are several components of the PCAF rule (21 CFR Part 507):

• Subpart A - General Provisions
• Subpart B - Current Good Manufacturing Practice
• Subpart C - Hazard Analysis and Risk-Based Preventive Controls
• Subpart D - Withdrawal of a Qualified Facility Exemption
• Subpart E - Supply-Chain Program
• Subpart F - Requirements Applying to Records That Must Be Established and Maintained

It is the responsibility of the owner, operator or agent in charge to ensure that their facility is in compliance with the applicable components of the rule with appropriate documentation, should the facility file a qualified facility attestation through the FDA.

Facility size and operations are important factors in determining which subparts apply for compliance. Depending on these factors, a facility may only be subject to subpart B or modified requirements. For assistance identifying potential exemptions, use the “Does PCAF Apply?” decision tree tool.

Qualified Facilities

If a facility meets the definition of a qualified facility, facility owners, operators or agents in charge have three (3) options for compliance:

1. Submit a qualified facility attestation and identify the potential hazards associated with the animal food being produced, implement preventive controls to address the hazards requiring preventive controls, and monitor any preventive controls to ensure their effectiveness; or

2. Submit a qualified facility attestation and be in compliance with state, local, county, tribal, or other applicable non-federal food safety laws; or

3. If the facility does not submit a qualified facility attestation to the FDA, regardless of status, they are subject to the full requirements of the rule.

In some instances, firms may choose to meet the full requirements of the PCAF rule instead of submitting a qualified facility attestation.

Warehouses

Warehouses storing animal food that requires time and temperature controls are exempt from the full requirements of subparts C and E, but are required to meet modified requirements.

Since the animal food requires time and temperature controls to remain safe, the facility storing the animal food must establish and implement controls to control pathogen or toxin growth.

The facility must maintain records for monitoring these controls, taking corrective actions when necessary, and verifying that the temperature controls are implemented consistently.

The FDA has provided several guidance documents that are also helpful in determining the compliance status of a facility. If you need additional information, these documents may help.

• Determination of Status as a Qualified Facility

• Application of the “Solely Engaged” Exemptions in Parts 117 and 507

• Ensuring Safety of Animal Feed Maintained and Fed On-Farm

• Registration of Food Facilities: What You Need to Know About the FDA Regulation

• Questions and Answers Regarding Food Facility Registration (Seventh Edition)

• Current Good Manufacturing Practice Requirements for Food for Animals

• Human Food By-Products For Use As Animal Food

• Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

The Food Safety Preventive Controls Alliance (FSPCA) and the NC State Feed Milling program also have free resources available online.

• FSPCA PCAF Participant Manual

• NC State CGMP checklist