Since the passage of the Public Health Security and Bioterrorism Preparedness Response Act, facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States have been required to register with the Food and Drug Administration (FDA) in order to provide the agency with information on the origin and distribution of food and feed products, thereby aiding in the detection and quick response to actual or potential threats to the U.S. food supply.
Starting this year, all food facilities required to register with the FDA must begin biennial re-registration to comply with the provisions of the Food Safety Modernization Act (FSMA). Signed into law on January 4, 2011, FSMA now requires that food facilities re-register every 2 years with the FDA, during the period beginning on October 1 and ending on December 31, in even numbered years. The first registration renewal cycle under FSMA was supposed to begin on Monday, October 1 and continue until Monday, December 31, 2012. Even if a food facility is already registered with the FDA, the facility is still obligated to renew registrations this year.
On September 28, 2012, the FDA posted the following on its website:
“Biennial Registration Renewal for Food Facilities will not be available on October 1, 2012. We therefore will not be accepting food facility registration renewals at this time. Please check FDA’s website at http://www.access.fda.gov at a later date or sign up for FSMA updates to be informed when it becomes available.”
When registering, it is important for food facility representatives to remember that additional information is now required to accompany the registrations under FSMA. Specifically, registrations must contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the U.S. agent for the facility, and an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by the FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by the FDA, for foods manufactured, processed, packed, or held at registering facilities.
In addition, for the first time, the FDA can now suspend the registration of a food facility in certain circumstances involving food manufactured, processed, packed, received or held by a registered facility that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. The FDA did not previously have a process for suspending the registration of a food facility in such circumstances. If the FDA were to exercise this authority and suspend the registration of a food facility, that facility would be prohibited from introducing any food into the stream of commerce in the U.S., including importing or exporting food into the U.S.
At this time, the FDA is recommending that food companies check the agency’s website to know when the registration renewal will become available.