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The Policy Bureau
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
View on Regulations.gov

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  • The guidance supersedes the 2008 guidance on microbial food safety hazards in fresh-cut produce and finalizes a draft guidance from 2018.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

Pulled live from Regulations.gov. Stage/status are inferred from document type and comment-period fields and may lag the official record by a few hours.