The focus of media attention is currently on FDA’s proposed rules for a Foreign Supplier Verification Program and for Accreditation of Third-Party Auditors. But I would draw your attention to a FSMA provision that is already in force, which, from the agency’s viewpoint, is the most significant new authority under the new law — biennial registration of facilities.
The true significance of the registration mandate is, I believe, being overlooked in the media because of the focus on proposed rules and delays. Under FSMA, facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the agency every two years. There are some exemptions, namely farms, retail food establishments, restaurants, non-profit food establishments, and fishing vessels. But the mandatory registration requirement means that a large number of companies that were not previously very visible to the agency will now be on the radar screen.
Prior to the Bioterrorism Act of 2002, food manufacturers were not required to register with FDA so the agency had to do the best job it could to compile an inventory of food manufacturers so they could be inspected on a regular basis. This was supposed to occur at least once every five years. FDA relied on the states to identify food firms in their state based on tax records and other state requirements for licensing and registration. But this information was often inaccurate or incomplete. Compiling a list of foreign food firms that imported to the U.S. was even more problematic.
On several occasions, outbreaks of foodborne illness were traced to firms that had never been inspected by FDA either because they were considered low on FDA’s priority list or because they were not in FDA’s inventory.
The Bioterrorism Act required all food manufacturers foreign and domestic to register with the FDA thus solving the inventory problem. But the amount of information required by the law was very limited so that FDA often could not tell whether the firm was producing low-risk or high-risk foods. The greatest limitation to the Bioterrorism Act was that companies were only required to register one time. Companies were required to update their registration information if they made changes in the foods they produced and other changes, but many neglected to inform FDA. A 2009 Inspector General’s report indicated that 48 percent of registered facilities gave inaccurate information or failed to update information. Over time the inventory became less and less accurate, which contributed to the disaster that was the Peanut Corporation of America.
PCA’s Blakely, GA plant was registered with FDA as a roaster and blancher of peanuts which was considered fairly low-risk by FDA. By the time of the massive Salmonella outbreak beginning in late 2008, the plant was producing a variety of peanut products including peanut paste. These peanut products were sold to other food companies throughout the U.S. including large companies like Kellogg. When FDA traced the source of the outbreak to the PCA Blakely plant in early 2009, I believe all of the prior inspections were conducted by Georgia state officials under FDA contract. At $500 per inspection under the FDA contract, Georgia inspectors could not do a thorough job and missed many GMP violations that contributed to the establishment and spread of Salmonella throughout the plant. Had PCA bothered to update its registration to reflect its expanded product line, the FDA may have targeted the Blakely plant for an inspection ($10,000 is the cost of an FDA inspection) and prevented the outbreak.
Under FSMA, food facilities are required to reregister every other year and list any changes to the food categories they produce. Furthermore FSMA gives FDA authority to suspend registration if facilities do not comply with the registration requirements. Overall this gives FDA much greater control of its food facility inventory, increases its ability to target high-risk firms, and provides regulatory teeth to encourage compliance.
Posted in Foods, FSMA Perspective and tagged Stephen Sundlof.