What is the Produce Rule?

This page does NOT include information on the final Produce Rule. For information on the final rules visit NSAC’s Understanding FDA’s FSMA Rule for Produce Farms. FDA released re-proposed sections of this rule on September 19, 2014. This text has been updated to reflect changes in the new version of the proposed rules, which are open for comment until December 15, 2014.

The Food Safety Modernization Act (FSMA) required the Food and Drug Administration (FDA) to write new regulations that establish standards for produce safety (Produce Rule). In its proposed Produce Rule, FDA detailed new standards for the growing, harvesting, packing, and holding of produce for human consumption. During the second comment period, FDA re-proposed certain sections of the Produce Rule and is requesting additional public comment. Before finalizing the produce standards, FDA was required to consider all of the public comments received on both the proposed Produce Rule and the re-proposed sections.

FSMA baby tomato

Proposed Produce Rule Basics

The proposed Produce Rule sets forth new standards for growing, harvesting, packing, and holding of produce. The standards apply to fruits and vegetables normally consumed raw, such as apples, carrots, lettuce, onions, and tomatoes. The proposed Produce Rule does not apply to produce rarely consumed raw (such as winter squash) or produce grown for personal consumption.

The proposed Produce Rule establishes standards for:

  • Agricultural Water: Farmers would have to ensure that water that is intended or likely to contact produce or food-contact surfaces is safe and of adequate sanitary quality, with inspection and periodic testing requirements.
  • Biological Soil Amendments of Animal Origin: The proposed rule specifies types of treatment, methods of application, and time intervals between application of certain soil amendments — including manure and composted manure — and crop harvest.
  • Health and Hygiene: Farm personnel would have to follow hygienic practices, including hand washing, not working when sick, and maintaining personal cleanliness.
  • Domesticated and Wild Animals: With respect to domesticated animals, the proposed rule would require certain measures, such as waiting periods between grazing and crop harvest, if there is a reasonable probability of contamination. With respect to wild animals, farmers must monitor for wildlife intrusion and not harvest produce visibly contaminated with animal feces.
  • Equipment, tools, and buildings: The proposed rule sets requirements for equipment and tools that come into contact with produce, as well as for buildings and other facilities.
  • Training: The proposed rule requires training for supervisors and farm personnel who handle produce covered by the rule.
  • Sprouts: The proposed rule establishes separate standards for sprout production, including treatment of seed before sprouting and testing of spent irrigation water for pathogens.

Accompanying these standards are certain recordkeeping requirements that document adherence to the standards, including for training, agricultural water, biological soil amendments of animal origin, and sprouts.

Revised or “Re-Proposed” Produce Rule

FDA has revised, or “re-proposed,” certain sections of the Produce Rule related to:

Do These Standards Apply to Me?

Check out our Who Is Affected? guidance to help you determine if you may be affected by these proposed rules.

Learn More about Other Issues with the Proposed Produce Rule

Other issues with the proposed rule that the re-proposed sections do not address center around:

Get more information on these issues and how they might impact farmers on the Learn About the Issues page. Further guidance that goes into greater detail on all of these issues will be available soon.

Read the Rules

They aren’t exactly beach vacation reading, but if you think you may be affected it is in your best interest to read and analyze them yourself! Farmers and processors who have a direct stake in these rules need to read them and start asking questions about what they might mean for their businesses.

See our Past Comments on the Re-Proposed Produce Rule here.

At this time, there are no open related rules for public comment.