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Fresh Produce

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FSMA Produce Safety Rule 

The produce safety rule may apply to your farm if you grow, pack, process, or sell fresh produce that is a Raw Agricultural Commodity (RAC). 

For comprehensive information about this rule, refer to North Carolina Fresh Produce Safety

Do I have to comply with the Produce Safety Rule? 

See 21 CFR 112.1 to identify food covered in this rule and FDA’s Decision Tree & Fact Sheet on coverage and exemptions/exclusions. 

Your farm or operation may be exempt or excluded from the FSMA Produce Safety Rule (PSR) based on: 

  • The type of food you grow 
  • Total annual sales of the food you grow 
  • Where you sell your food 
  • Who you sell food to 

See a summary of how is produce classified and exemptions

Farms can also determine their status with the PSR by using this template provided by NC Fresh Produce Safety. 

The following major areas are covered in this rule: 

  • Worker training, health, and hygiene 
  • Agricultural water  for pre- and post-harvest (eg.quality and microbiological testing requirements)
  • Biological soil amendments (eg. raw manure and valid composting methods) 
  • Domesticated and wild animals (contamination of produce by grazing animals, working animals, and animal intrusion) 
  • Equipment, tools, buildings, and sanitation 
  • Sprouts (eg. spent irrigation water testing, environmental testing)
  • Required records 

At least ONE supervisor or responsible person for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration. FSMA training course developed by  the Produce Safety Alliance at Cornell University is recognized as one way to fulfill this training requirement. See the FDA Fact Sheet on Training Requirements for PSR for more information.

Additional links that may be helpful include:

North Carolina Fresh Produce Safety

Produce Safety Alliance


Small Entity Compliance Guide: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Produce Safety Rule Review 

Draft guidance for sprout operations

Sprout Safety Alliance