FDA Reader
Simplifying Food Regulation


FDA Reader: Simplifying Food Regulation

FSMA for Food Distributors

If you warehouse and distribute only enclosed, packaged foods...

Then you are exempt from two major components of FSMA :

  • 117 Subpart C which requires you to have a hazard analysis and a food safety plan, and

  • 117 Subpart G, which requires you to have a Supply Chain Program.

This means you don't need a food safety plan, a recall plan, or a supplier verification plan.

What You Need To To:

Control Food Temperature

If you warehouse/distribute food that is kept refrigerated or frozen, then you must have systems to ensure that proper temperature is being kept at all times. Specifically, you must:

  • Establish temperature controls. This means outlining what are safe temperatures for refrigerated and frozen foods in your space and having this information written.

  • Regularly monitor temperatures of all of your refrigerated spaces (including vehicles) either manually with a log or through an automatic temperature monitoring system.

  • Take corrective action. If there is a temperature deviation that impacts the product, then you must take a corrective action. This means producing a written record showing that you corrected the problem, evaluated the product, and reduced the likelihood that it will recur.

  • Verify your temperature controls. You must calibrate your thermometers or check them for accuracy to make sure you're recording information accurately.

  • Verify your records. This means a supervisor must review the temperature logs (from your trucks or walk-ins) to make sure there was no deviation from the acceptable temperature ranges. You must also review corrective action records within 7 working days and calibration records within reasonable time.

  • Keep Records. You must be able to show that you have records of temperatures records, any corrective actions, and that they have been verified.

If you Import Foods From other Countries…

You are most likely required to implement a Foreign Supplier Verification Program (FSVP). Check out our guide to FSVP.

If you transport food yourself or hire a carrier to transport it for you…

If you are in any way involved in the transportation of food, then you are subject to the Sanitary Transportation of Human & Animal Food. We let you know exactly what you need to do to comply with that in our guide to Sanitary Transport