Manufactured food establishments that are solely engaged in the storage of unexposed packaged foods are exempt from preventive controls requirements in Title 21, Part 117, Subpart C, Code of Federal Regulations (CFR) and supply-chain program requirements in 21 CFR 117 Subpart G. However, if the unexposed packaged food requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens, you are subject to the modified requirements found in 21 CFR 117.206.

The requirements are as follows:

• Establish and implement adequate temperature controls.
• Monitor the temperature controls with adequate frequency.
• Take appropriate corrective action if there is a loss of temperature control to:
  • Correct the problem and reduce the likelihood that the problem will recur;
  • Evaluate all affected food for safety; and
  • Prevent the food from entering into commerce, if you cannot ensure the affected food is not adulterated.
• Verify the temperature controls are consistently implemented by:
  • Calibrating temperature monitoring and recording devices;
  • Checking temperature monitoring devices for accuracy;
  • Reviewing records of calibration within a reasonable time; and
  • Reviewing records of monitoring and corrective actions within seven working days.
• Establish and maintain records that:
  • Document the monitoring (affirmative records demonstrating temperature control or exception records demonstrating loss of temperature control) for any refrigerated packaged food;
  • Document corrective actions taken when loss of temperature control impacts the safety of the refrigerated packaged food; and
  • Document verification activities.

All records that a manufactured food establishment must establish and maintain are subject to the requirements of 21 CFR 117 Subpart F. Learn more about records requirements.