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HHS Publishes OMB's Edits to FSMA Preventative Controls Proposal

April 18, 2013

The Department of Health and Human Services (HHS) has released documents showing the White House Office of Management and Budget's (OMB) edits to the original draft of the Food and Drug Administration's (FDA) proposal on standards for preventive controls. FDA was required to establish standards for preventive controls under Section 103 of the Food Safety Modernization Act (FSMA). FDA's proposals were sent to OMB in December 2011, and published on January 16, 2013.

 

A significant change to the FDA's original drafts is the removal of the requirement for companies to maintain a supplier approval and verification program. FDA's original document favored requiring companies to review complaints from consumers to determine whether a complaint relates to the effectiveness of its FSMA food safety plans, whereas, the published proposal asks stakeholders to comment on whether to include it in the final rule. A copy of OMB's edits (in red) to FDA's proposal on standards for preventive controls can be accessed at: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0014.