FDA guide addresses produce safety rules for farms and related facilities

The U.S. Food and Drug Administration released a compliance guide to help small entities such as farms and farm mixed-type facilities comply with changes to the Produce Safety Rule’s preharvest agricultural water requirements for most produce covered under the rule.

The FDA issued the update in May 2024, and compliance dates will be phased in beginning on April 7, 2025. The dates are staggered based on farm size, with larger entities going first. This rule applies to domestic, as well as foreign, companies that grow, harvest, pack and hold produce.

In many instances, smaller companies have a difficult time complying with complex regulatory requirements. As such, the FDA issued this guidance document to help small entities understand and meet their obligations under the Produce Safety Rule. The guidance addresses topics such as qualified exemptions, inspecting and maintaining agricultural water systems, biological soil amendments, domesticated and wild animals, water testing methods, hygiene and training.

Farms or farm mixed-type facilities with an average annual monetary value of produce sold during the previous three-year period of more than $25,000 (on a rolling basis) are considered “covered farms.” They are subject to the applicable preharvest agricultural water requirements for covered produce.

Essentially, all produce, including mixes of intact fruits and vegetables (e.g., fruit baskets), is covered under this rule. The only exceptions are agricultural products that are rarely consumed raw, including but not limited to:

• Asparagus
• Beans
• Beets
• Cashews, hazelnuts and pecans
• Eggplant
• Food grains
• Peanuts
• Cocoa beans and coffee beans
• Corn
• Dates and figs
• Potatoes
• Squash

Key takeaways

Companies should review the Produce Safety Rule and consult the FDA’s compliance guide to assess the applicability of the changes and make any necessary improvements. Some key considerations for companies include the following:

• Evaluate all areas of the farm where produce is grown, harvested, packed and held to identify potential hazards that can affect produce safety.
• Regularly test preharvest and postharvest water to ensure it meets safety standards.
• Train all employees on food safety, including proper hygiene and sanitation practices.
• Maintain detailed records of all safety practices, including water testing results.