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FDA FSMA Final Rule: COUNTDOWN for Companies exporting to the US

FSMA Final Rule for Preventive Controls for Human and Animal Food starts beginning September 2016.

The FDA Food Safety Modernization Act (FSMA) finalized the Preventive Controls for Human and Animal Food.

Compliance dates begin in September 2016.

Under the final rule, human and animal food facilities are required to develop food safety plans that evaluate food safety hazards, and identify the preventive measures to protect against those hazards.

The plans must also describe how manufacturers will monitor their preventive measures to ensure they are working, and keep records of that monitoring.

Covered facilities must establish and implement a food safety system that includes an analysis of hazards which must consider known or reasonably foreseeable biological, chemical, and physical hazards.

The rule sets requirements for a written food safety plan that includes:

- hazard analysis through first step of the hazards identification;

- preventive controls which include process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan;

- oversight and management of preventive controls through:

a) omonitoring designed to provide assurance that preventive controls are consistently performed;

b) corrective actions to be documented with records and corrections;

c) verification for ensuring that preventive controls are consistently implemented and effective; they include validation with scientific evidence, calibration of process monitoring and verification instruments, in addition to reviewing records.

Primary Production and Secondary Activities Farms conducting activities on produce covered by the Produce Safety Rule will be required to comply with that rule.

Covered food facilities are responsible for ensuring that these foods are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use.

Current Good Manufacturing Practices (CGMPs) are updated and clarified. The FDA’s longstanding position that cGMPs address allergen cross-contact is now explicit in the regulatory text.

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