The U.S. FDA Food Safety Modernization Act (“FSMA”) imposes new requirements on companies that supply food, food ingredients, beverages, pet foods or dietary supplements for consumption in the United States.
The new Act, signed into law last year by the President, requires food facilities to renew their FDA Food Facility Registrations between October 1, 2012 and December 31, 2012, and biennially thereafter. Companies located outside the United States must also: (A) designate a U.S. Agent and (B) Consent to FDA Inspections. Failure to renew a food facility registration can result in shipments denied entry into the U.S.
The U.S. Agent for FDA purposes serves a different function than an importer of record, customs broker, freight forwarder or distributor. FSMA imposes potential new liabilities on the foreign food facilities’ designated US agent. FDA not only will send communications to the designated U.S. Agent, including information regarding inspections, often requiring an immediate response, but also FSMA Section 107 holds the U.S. Agent responsible for the fees assessed for each foreign facility subject to a re-inspection in an amount sufficient to cover 100% of FDA’s total re-inspection-related costs.
Although delayed three weeks beyond the scheduled October 1 start date, FDA’s updated food facility registration system is now available for biennial registration renewal. The system is now accepting food facility registration renewals. Registrants can submit registration renewals to FDA using the online food facility registration module or paper Form FDA 3537. To facilitate this process, the agency is offering technical assistance online and through a help desk.
Please check FDA’s food facility registration website for more information and to register online.
For additional information please contact your MIQ Logistics representative.