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FDA Delays Start of FSMA Re-Registration Period

Monday, October 01, 2012
STR Client Advisory


FDA Delays Start of FSMA Re-Registration Period 

New date is expected to be published in a week. 

The Food & Drug Administration (FDA) announced that the start of the food facilities re-registration period under the Food Safety Modernization Act (FSMA) has been delayed. 

Under FSMA §102, all domestic and foreign facilities that manufacture, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the Food & Drug Administration (FDA) before the end of 2012. FSMA §102 changes the registration requirement for food facilities originally established in 2002 under the Bioterrorism Act. In addition to requiring all food facilities to re-register in 2012, FSMA §102 requires re-registration every two years thereafter. 

The initial re-registration period was scheduled to begin today, October 1, 2012, and run through December 31, 2012. Over the weekend, the FDA announced a delay in opening the 2012 re-registration period, but did not give a new date for re-registration to begin. While the FDA gave no specific reason for the delay, it is believed that this is a temporary delay due to issues with the updated database. Potential registrants should check for updates on the FDA webpage in one week. 

All those affected by the new registration requirements are reminded that the FSMA also imposes new burdens and potential liabilities on entities designated as U.S. Agents to foreign food facilities. One of these liabilities stems from FSMA §107, re-inspection fees. It is believed that in 2013 the FDA will begin charging $289/hour for the time it devotes to re-inspecting a foreign food facility, resulting in the potential for invoices to reach several thousands of dollars per re-inspection. The party FDA will hold responsible for paying these invoices is the U.S. Agent. Accordingly, brokers, forwarders and importers of record will likely want to find alternatives to becoming U.S. Agents themselves and foreign food facilities will need to seek out entities to become U.S. Agents. 

A Sandler, Travis & Rosenberg FDA Practice Group member can help you in finding a new U.S. Agent and answer any questions you have regarding food facility registration requirements or FSMA in general. We will send information regarding the new opening date for re-registration as it becomes available from the FDA.

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