The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), section 305, added section 415 to the Federal Food, Drug, and Cosmetic Act, which required domestic and foreign facilities to register with the U.S. Food and Drug Administration (FDA) (for the first time ever) by December 12, 2003, if they manufacture, process, pack or hold food for human or animal consumption in the U.S. The purpose of this registration is to provide FDA with sufficient and reliable information about food and feed facilities. When used with the administrative detention, recordkeeping and prior-notice provisions in sections 303, 306 and 307, respectively, of the Bioterrorism Act, such registration helps provide FDA with information on the origin and distribution of food and feed products, and thereby aid in the detection and timely response to actual or potential threats to the U.S. food supply. Registration information also helps FDA to notify facilities that may be affected by the actual or potential threat.
In the preamble to the Registration Final Rule [68 FR 58894 (Oct. 10, 2003), as affirmed by 70 FR 57505 (Oct. 3, 2005)], FDA estimated that the total number of food facilities that must register with FDA would be approximately 420,000. When FDA launched its Food Facility Registration module on October 16, 2003, FDA provided periodic reports indicating that the number of food facilities registered as expected:
• By 2006: 275,000 food facilities registered with FDA
• By 2009: 360,000 food facilities registered with FDA
• By 2012: 440,000 food facilities registered with FDA
Food Safety Modernization Act
Although 21 CFR 1.234(a) required facilities to update registration information within 60 calendar days of change, many failed to make required updates. Further, the Bioterrorism Act did not require food facilities to periodically renew their registrations. As such, FDA’s older data were less reliable. FDA addressed this issue with the Food Safety Modernization Act (FSMA) that was signed into law January 4, 2011. FSMA required any company that manufactures, processes, packs or holds food, beverages and dietary supplements to renew its facility’s registration between October 1–December 31, 2012, and biennially thereafter. In October 2012, more than 440,000 registered food facilities from around the world had to renew their registrations. Many of the food facilities did not renew their registration numbers for various reasons, such as discontinuing shipments to the U.S. or going out of business. Additionally, many facilities may have had duplicate registration numbers created over the years and now would only renew one registration number per facility as required. As a result, the reported number of valid food facility registrations in FDA’s electronic database decreased by more than 50 percent. The data received in response to a recent Freedom of Information Act request indicates that, as recently as January 22, 2014, the number of valid FDA food facility registrations on file is approximately 195,500 (still less than 55 percent of the 2012 estimates).
The Consequences of Registration Renewal
Was FDA’s estimate that approximately 420,000 food facilities would require registration inaccurate, or do the current numbers indicate that many food facilities failed to comply with FDA’s obligatory registration renewal requirement? The answer is likely both. Certainly, there has been a lot of consolidation of food facilities since 2003, and the global recession has caused many to close or reduce shipments to the U.S.; however, that alone would not account for the reported decrease in registered facilities. Food facilities that failed to renew their food facility registrations prior to FDA’s deadline have “committed a prohibited act under section 301 (dd) of the FD&C Act.”
Unfortunately, most companies discover that their registrations are not valid during a moment of crisis. Foreign facilities typically become aware of invalidated registrations when their products are detained at the port of entry; domestic facilities find out when they are cited during FDA inspections. Considering that FDA’s reported registration numbers are currently so far below the estimates, it is prudent for food facilities to confirm that their food facility registration’s status remains valid.
Additionally, all registered food facilities outside the United States must appoint a U.S. Agent for FDA communications, which serves a different function than an importer, customs broker or commercial distributor. FDA sends communications including facility inspection notices to the designated U.S. Agent, often requiring an immediate response. Due to FSMA’s new inspection schedule, it is now critical to have a professional U.S. Agent handling FDA communications.
David Lennarz is vice president of Registrar Corp. He has conducted seminars on FDA regulations for food and beverages for foreign governments and trade associations in more than 30 countries around the world. He served as a technical expert for FDA’s Foreign Facility Registration Verification Program.