By David Lennarz.
In 2013, New Zealand sent $3.5 billion worth of goods to the United States, with wine, dairy, eggs, and honey being some of the top exports. All of these products, along with other foods and beverages intended for consumption in the U.S., are regulated by the U.S. Food and Drug Administration (FDA).
FDA has required facilities exporting food and beverages to the United States to register with FDA since 2003, but the Food Safety Modernization Act (FSMA) updated the registration requirement in 2011 to include biennial registration renewals. Beginning in 2012, food and beverage facilities are required to renew their FDA registrations between October 1 and December 31 of each even numbered year.
Because registration renewal is still fairly new, many facilities are unfamiliar with the requirements and consequences of not renewing an FDA registration. Failing to renew can lead to costly delays in your distribution process, for FDA will hold any food shipped to the U.S. by a facility with an expired registration at its port of entry. The food will not be released to its importer, owner, or consignee until the facility is properly registered.
FDA will also check a facility’s registration status during an inspection. FSMA requires FDA to double the number of foreign inspections it conducts each year through 2016. In 2015, FDA is required to conduct a minimum of 9,600 foreign inspections. It’s always a good idea to prepare in advance of an FDA inspection, especially with the new re-inspection fees granted by FSMA. If an initial FDA inspection exposes certain food safety issues, and FDA decides to return to the facility for a re-inspection, FDA will charge $305 per hour spent on the reinspection, including the time spent on preparation and travel.
Facilities located outside the U.S. are required to list a U.S. Agent when they register with FDA. Registrar Corp, an FDA compliance firm in the United States, can act as a U.S. Agent. As your U.S. Agent, Registrar Corp will properly renew your registration for you and will be available 24 hours a day for FDA to contact about shipments and inspections. Additionally, Registrar Corp will send a food safety expert trained in FDA inspections to conduct a mock inspection of a facility to help it prepare. This service is available to Registrar Corp’s U.S. Agent clients at no additional charge other than travel and lodging expenses if FDA gives notice of an inspection date.
David Lennarz is vice president of Registrar Corp. If you have any questions about registration renewal or would like more information, phone the Registrar Corp's Office for Australia, New Zealand and New Guinea on 0061-8-7221 1992 or email [email protected]
You can also chat with a Regulatory Specialist 24 hours a day at http://www.registrarcorp.com/livehelp