December 1, 2016

Patrick Kennedy, Mérieux NutriSciences USA

USA: FSMA guidance explains how food companies should disclose hazards to FDA

A draft guidance document to support industry compliance
Mérieux NutriSciences hazard

The U.S. Food and Drug Administration (FDA) recently published a draft guidance document to support industry compliance with an important issue mandated by the Food Safety Modernization Act (FSMA). The new draft guidance contains the agency’s recommendations for complying with the controversial FSMA requirement for disclosing hazards.

Written disclosure statements for identifying hazards are mandated by four of the seven foundational FSMA rules.  
The ‘customer assurance’ requirements apply to situations whereby food safety controls are applied downstream by a customer of a manufacturer/processor. 

According to the draft guidance, FDA will accept the disclosure statement on a wide variety of document types. The draft guidance provides additional information regarding acceptable terminology and document types specific to each of the four FSMA regulations.
Due to the expected burden of this requirement on industry, FDA issued a final rule in August 2016 granting a two-year extension for industry to comply with the requirements. 

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Source:  U.S. Food and Drug Administration

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