RegulationFDA-2018-D-3583Live
Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability
A final rule from FDA. Official abstract not available for this document.
Newly finalizedLast verified Aug 13, 2026, 8:16 AM UTC
What it does
- The FDA announces availability of a final guidance document titled 'Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce' to help manufacturers and processors comply with federal food safety regulations.
- The guidance supersedes the 2008 guidance on microbial food safety hazards in fresh-cut produce and finalizes a draft guidance from 2018.
- The guidance applies to ready-to-eat fresh-cut produce with water activity above 0.85 and provides recommendations on antimicrobial substances, supply chain controls, and time/temperature controls.
Why it matters
- The guidance helps industry comply with FDA regulations on current good manufacturing practices and hazard analysis and risk-based preventive controls for human food.
- Updated guidance incorporates FDA's current thinking on biological hazard minimization in fresh-cut produce and reflects comments received during the 2018-2019 draft comment period.
Who is affected
- Manufacturers and processors of ready-to-eat fresh-cut produce that is not a low-moisture food.
- Entities subject to FDA food safety regulations under 21 CFR Part 117.
What happens next
The guidance is now final and available for use; interested parties may submit comments on the guidance at any time through the Federal eRulemaking Portal or in writing to the Dockets Management Staff.
Important dates
- PostedAug 12, 2026
- Comment period openedAug 12, 2026
- EffectiveAug 12, 2026
Official links & sources
View on Regulations.gov ↗
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