Every food facility that registered with the U.S. FDA before this Oct. 1 is required to renew its FDA registration by Dec. 31, 2014. FDA will consider registrations that are not renewed by this date to be expired, making it a prohibited act for that facility to distribute food in the United States. FDA will hold any food shipped from a foreign facility with an expired registration at its U.S. port of entry until the facility is properly renewed.
All facilities, domestic and foreign, that manufacture, process, pack or hold food for human or animal consumption in the U.S. must renew their FDA registration each even-numbered year between Oct. 1 and Dec. 31. The fairly new requirement, established in 2011 by the Food Safety Modernization Act (FSMA), ensures that FDA always has access to updated information about the facilities it regulates. Registration renewals may be submitted by mail, fax or online. Facilities may also use third-party consultants to help ensure the renewal is properly filed.
Facilities should be aware of two recent updates to FDA’s Food Facility Registration Module (FFRM) that will affect the renewal process for some registrants. Foreign facilities have long been required to list an email address for a “U.S. Agent for FDA communications” when registering with FDA. However, some facilities chose to list the same email address for both the U.S. agent and the facility contact. The FFRM will no longer allow registrants to submit a registration or renewal if these emails are the same.
The FFRM also no longer allows registrants to enter a post office box as their physical address. Any facility with a registration that currently lists the same email for both the U.S. agent and facility contact or lists a post office box as its address will be required to update these elements before the renewal can be submitted.
Another amendment FSMA made to registration requirements was that by registering or renewing with FDA, registrants are now agreeing that FDA will be permitted to inspect their facility. FSMA has placed inspection mandates upon FDA. In 2011, FSMA required that FDA inspect 600 foreign facilities and double that number every year through 2016. For facilities in the U.S., FDA is required to inspect all high-risk facilities by 2016 and then again every three years thereafter. FDA must inspect all non-high-risk facilities in the U.S. by 2018 and then again every five years after that. FDA will notify foreign facilities of inspections in advance. Domestic facilities will get no notification at all.
Facilities should prepare for FDA facility inspections in advance, since FSMA now allows FDA to collect fees for reinspections. Original inspections are free of charge, but if an inspection reveals certain food safety issues, FDA may feel the need to return for a reinspection. FDA will charge hourly for everything involved in the reinspection, from preparation for the inspection to travel to and from the facility. From now until Sept. 30, 2015, FDA will charge $217 per hour for reinspections of domestic facilities and $305 per hour for reinspections of foreign facilities.
Food facilities should renew their FDA registrations as soon as possible to allow time for FDA to process the renewal and contact the facility with any additional information it may need. Facilities should also take time to educate themselves on FDA requirements and prepare for inspections in order to avoid any costly fees, delays from detentions, or other setbacks due to a violative inspection.