← REGULATORY CHANGES
FEDERAL REGISTER · PROPOSED RULEJanuary 7, 2025PROPOSED — NOT IN FORCE

Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSPROPOSED — NOT IN FORCE
PROPOSED EFFECTIVE—
COMMENTS CLOSEMay 7, 2025 · closed
APPLIES TO · SPEQ TAGDeviceFood
Document type
Proposed Rule
Agency
Health and Human Services Department
Published
January 7, 2025
Comments close
May 7, 2025
Document number
2024-31528
CFR references
21 CFR 106, 21 CFR 117
Docket
FDA-2024-D-2604
ABSTRACT

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event." The draft guidance, when finalized, will explain FDA's current thinking on establishing a routine sanitation program for low-moisture ready-to-eat human foods (LMRTE foods) that can help prevent contamination of food or a food-contact surface with a pathogen and will explain our current thinking for corrective actions, including corrective actions to remediate contamination of food-contact surfaces, if prevention fails.

Abstract as published in the Federal Register.

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