Notice of FDA Facility Registration Test

Issue 520, July 7, 2006

Beginning July 10th 2006, the United States Food and Drug Administration (FDA) will be conducting an initial test to verify the accuracy of the emergency contact information contained in their food facility registration database. Any company that is registered as a food facility with the FDA needs to be alert for the potential of contact by the FDA during this test. You should be prepared to respond to the communications as required.

FDA established the registration database in response to Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), as implemented by the Registration of Food Facilities Final Rule at 21 CFR Part 1, Subpart H. The Bioterrorism Act and the aforementioned final rule require owners, operators, or agents in charge of domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA. The registration for domestic facilities must include the name of an emergency contact person who is accessible at all times. The registration for foreign facilities must contain the name of the U.S. agent who also serves as the emergency contact, unless the facility chooses to designate an alternate person as the emergency contact. The FDA is testing their emergency contact system to ensure that they can quickly notify facilities that may be affected by an actual or potential threat to the U.S. food supply.

A statistically representative sample consisting of 800 facilities has been chosen at random from the total registration data base to be the subject of this test. The FDA will be contacting 400 domestic facilities by email and/or telephone and the U.S. agents or emergency contacts for 400 foreign facilities by email, fax and/or telephone during this test. When contact is made by email or fax, the message will request that the recipient check a box indicating that he or she is or is not the emergency contact or U.S. agent of the named domestic or foreign facility. An emergency contact or U.S. agent may receive multiple test messages during this test if they are listed in FDA's registration database as the emergency contact or U.S. agent for multiple facilities.

If the FDA determines, as a result of this test, that a required registration element for a facility is inaccurate, a letter will be sent to the respective owner, operator, or agent-in-charge of the facility notifying them of the rule's requirement to update all mandatory registration data elements within 60 calendar days of the change. The results of this test will be used to assess the accuracy of the emergency contact information in the registration database. This, in turn, will enable the FDA to determine next steps in ensuring that the data within the registration database can provide needed information in the event of an actual or threatened public health emergency involving food under FDA's jurisdiction.

For additional information, you may contact the FDA at 1-800-216-7331 or 1-301-575-6156 or check their website at http://www.cfsan.fda.gov/~furls/helpf.html