What is the Produce Rule?
The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to write new regulations that establish standards for produce safety (Produce Rule). In its proposed Produce Rule, FDA has detailed new standards for the growing, harvesting, packing, and holding of produce for human consumption. These standards are not final and FDA is requesting comments from the public before finalizing the produce standards.
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.
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 the Issues with the Proposed Produce Rule
Some key issues with the proposed rule center around:
- Manure and Compost
- Natural Resource Conservation Practices
- Domesticated and Wild Animals
- Agricultural Water
- Exemptions and Modified Requirements
- Costs to Producers and Consumers
- Integrated Approach vs. Commodity-Specific Approach
- “All Food” vs. Covered Product
- Farm Registration
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.
Comment on the Proposed Produce Rule!
We need your help! Everyone – farmers, processors, and consumers – can and should comment on this rule! Learn more about how to comment and speak out today!