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October 12, 2006
Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) requires facilities that manufacture, process, pack, or hold food for consumption in the U.S. to register with FDA, and FDA to compile and maintain an up-to-date list of facilities that are registered. FDA established a Food Facilities Registration Database in response to Section 305, as implemented by the Registration of Food Facilities Final Rule (21 CFR Part 1, Subpart H). 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 a U.S. Agent who also serves as the emergency contact, unless the facility chooses to designate an alternate person as the emergency contact (21 CFR 1.232(d) and (e)). To date, 300,840 facilities have registered with FDA (127,046 domestic and 173,794 foreign).
From July 10, through August 2, 2006, FDA conducted an initial test to verify the accuracy of the Emergency Contact and U.S. Agent information contained in our Food Facility Registration Database to ensure that FDA can quickly notify facilities that may be affected by an actual or potential threat to the U.S. food supply. FDA chose a statistically representative sample consisting of 400 domestic facilities and 400 foreign facilities ("800 test facilities") at random from the total registration data base to be the subject of this test. FDA selected e-mail as the primary mode of transmission for this test, as this mode of communication is the most efficient way for FDA to notify facilities quickly in the event of a true emergency and more than 80% of the 800 test facilities provided an e-mail address to FDA in the facility's registration. If a test facility did not provide an e-mail address, but provided a phone number or fax number, FDA used those modes of transmission as the primary mode of transmission. FDA's test message requested that the recipient verify, verbally or by checking a box, that he or she is or is not the Emergency Contact or U.S. Agent of the named domestic or foreign facility. Despite multiple attempts, FDA did not receive a response from all test facilities, and thus, was not able to determine whether the intended recipient of our test message was indeed the facility's Emergency Contact or U.S. Agent.
The results for domestic test facilities and foreign test facilities are similar. Based on the results from the domestic test facilities, FDA estimates with 95% confidence that both the primary mode of transmission and the identity of the Emergency Contact are accurate for 52.0% to 61.9% of all registered domestic facilities in the Food Facilities Registration Database. We further estimate with 95% confidence that either the primary mode of transmission or the identity of the Emergency Contact is inaccurate for 20.6% to 30.5% of all registered domestic facilities in the Food Facilities Registration Database. FDA also estimates with 95% confidence that the primary mode of transmission is accurate but the accuracy of the identity of the Emergency Contact is unknown for 12.6% to 22.4% of all registered domestic facilities in the Food Facilities Registration Database.
Similarly, based on the results for the foreign test facilities, FDA estimates with 95% confidence that both the primary mode of transmission and the identity of the Emergency Contact/U.S. Agent are accurate for 38.5 to 48.5% of all registered foreign facilities in the Food Facilities Registration Database. We further estimate with 95% confidence that either the primary mode of transmission or the identity of the Emergency Contact/U.S. Agent is inaccurate for 21.8% to 31.8% of all registered foreign facilities in the Food Facilities Registration Database. FDA also estimates with 95% confidence that the primary mode of transmission is accurate but the accuracy of the identity of the Emergency Contact/U.S. Agent is unknown for 24.8% to 34.8% of all registered foreign facilities in the Food Facilities Registration Database.
FDA intends to take follow-up action with those test facilities that were determined to have inaccurate information in the registration database as a result of this test and will also communicate the test results to trade associations and foreign Embassy officials with a request that all registered facilities ensure that all the information for their registered facilities is current. FDA also intends to repeat the test in FY07 to determine whether the accuracy of the data in the registration database improves. FDA's report summarizing the test protocol and results is available at Summary Report of the U.S. Food and Drug Administration's Initial Test of the Accuracy of the Emergency Contact/U.S. Agent Data in the Food Facilities Registration Database; a summary of the number of facilities registered by country and by U.S. state is also available online.
