PCAF: Food Safety Plan
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Collapse ▲Food safety plans (FSPs) are also new requirements for many facilities. Find out what an FSP should (& shouldn’t) contain and see example plans as they become available. If you’re not sure if you need a food safety plan, use our “Does PCAF Apply?” decision tree tool.
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 a qualified facility exemption through the U.S. Food and Drug Administration (FDA).
For an overview of how food safety plans fit in with FDA regulations related to animal food, see our diagram below.
Food safety plan help from NC State Extension
NC State Extension’s Marissa Herchler Cohen and Adam Fahrenholz were part of a national team that collaborated on a guide to help facilities write their food safety plan.
The guide was developed by members of the FSPCA Animal Subcommittee to outline and illustrate steps that a livestock food facility could follow to develop its FSP as required by PCAF regulations.
NC State Extension wants you to know: you aren’t alone in food safety planning for your facility. Contact Feed Milling’s Marissa Herchler Cohen for information about mock facility CGMP audits, helpful resources, including scientific information for hazard analyses, and food safety plan reviews.
We can’t write your food safety plans for you, but we can work with you every step of the way.
Who’s responsible for the food safety plan?
The food safety plan (FSP) must be written or developed by a Preventive Controls Qualified Individual (PCQI), who must be qualified by either job experience or training.
The only training recognized by the FDA for a PCQI is the Food Safety Preventive Controls Alliance (FSPCA) course Preventive Controls for Animal Food.
The FSP must also be signed by the owner, operator or agent in charge. The owner, operator or agent in charge may vary by facility. This person may or may not be the PCQI for the facility. The owner, operator or agent in charge should sign the food safety plan when it’s complete and any time it’s modified.
What goes in a food safety plan?
The requirements of the FSP are:
- Background Information (optional)
- Hazard Analysis
- Preventive Controls (as required, depending on the outcome of the hazard analysis)
- Supply-Chain Applied Controls (as required, depending on the outcome of the hazard analysis)
- Recall Plan (as required, if a preventive control has been identified in the hazard analysis)
- Monitoring & Implementation Procedures (as required, depending on any preventive controls identified in the hazard analysis)
- Corrective Action Procedures (as required, depending on any preventive controls identified in the hazard analysis)
- Verification Procedures (as required, depending on any preventive controls identified in the hazard analysis)
Food safety plan examples
Example food safety plans for animal food are available in the FSPCA Preventive Controls for Animal Food course manual.
The example in the FSPCA manual is for pet food. The concepts can be applied to a poultry or livestock animal food facility, too.
There’s an example in our food safety plan guide based on a hypothetical swine and poultry feed (medicated and non-medicated) facility.
FDA guidance for food safety plans
It’s important to remember that there’s no one “right way” to do a hazard analysis or write a food safety plan.
This is not a one-size-fits-all program — one feed mill’s plan won’t work for all feed mills. There will be differences in the severity and probabilities of the hazards identified, based on who does the hazard analysis and how the facility operates.
The FDA has published a guidance document for CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. This guidance document goes through the important definitions in the rule, exemptions and what to consider for CGMP compliance and the Hazard Analysis.
Compliance policy guides
The compliance policy guides linked below may be helpful when developing food safety plans.
- Advisory Levels for DON in Finished Wheat Products for Human Consumption and Grains and Grain By-Products Used for Animal Feed
- Determining the Number of Employees for Purposes of the “Small Business” Definition
- Fumonisin Levels in Human Foods and Animal Feeds
- Guidance for Industry: Determination of Status as a Qualified Facility
- Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
- Human Food By-Products for Use as Animal Food
- Salmonella in Food for Animals
- Small Entity Compliance Guide What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507)
For additional information contact
Marissa Herchler Cohen
NC State University
Cooperative Extension Service
Prestage Department of Poultry Science
234 D Scott Hall
Raleigh, NC 27695-7608
E-mail: marissa_cohen@ncsu.edu
Phone: +1 919.515.5396