The Registry creates a serious, urgent burden for food companies who discover food in commerce that has a reasonable probability of causing serious adverse health consequences or death (for example, because it’s contaminated with dangerous microbes, or incorrectly labeled so as not to reveal a major allergen): these companies, defined as “responsible parties” under the law, have 24 hours in which to report the food to FDA through a specially created Internet portal.
The law says that a “responsible party” has to make the report. If your company submitted a food facility registration to FDA under the Bioterror Act provision requiring food facilities to be registered, whether you are located in the U.S. or anywhere else, you are a “responsible party.” It is a violation of the Federal Food, Drug and Cosmetic Act for a responsible party to fail to make a required report about a reportable food.
The responsibility to make these Reportable Food Registry reports applies to FDA-regulated foods, including animal feed and pet food, but not including dietary supplements or infant formula, which have separate reporting obligations. The Registry does not apply to meat and poultry products regulated by the U.S. Department of Agriculture.
The online portal for making Registry reports was changed in May, so that it is now part of the Safety Reporting Portal that FDA operates with the National Institutes of Health.
Packaging problems as such are not immune from coverage by the program, so if a food’s packaging issues cause a potential health hazard, that food would be reportable. If recent events, including Kellogg’s off-taste and odor in cereals attributable to excessive hydrocarbons in a coating on package liners and McNeil’s drug product off-odors in polymer bottles picking up odor from pallets, are any indication, packaging as the cause of food adulteration may in fact be on the rise. Sometimes packaging may only lead to quality problems like off-odors, not reportable potential health hazards. Only foods likely to result in serious health consequences need to be reported. (At presstime, it was unclear whether any company reported the Kellogg issue to the registry though it doesn’t appear they’d have to do so.) But it’s not difficult to imagine that an undeclared major allergen or toxic contaminant in a packaging material, or a failure of packaging to keep food free of microbial contaminants, could make the food reportable under the program.
Because the legal obligation to make the reports falls upon any packer, manufacturer processor, or distributor who becomes aware of the food, the Registry has resulted in many instances in which multiple companies report about the same suspect food. It’s not unlike all the neighbors calling in to 911 about the same fire. FDA has been clear that the program is intentionally set up that way, because one of its chief goals is to define the scope and extent of a problem as quickly as possible after it is identified, so remedial actions can be more effective. In fact, FDA considers the Registry an important new tool allowing it to more quickly identify the scope of potential contaminations and confirm corrective actions.
FDA says that during the program’s first seven months, from September 2009 through March 2010, there were 125 primary reports and 1,638 subsequent reports about the same food identified in the initial 125. What isn’t clear and perhaps can never be known is how many of these potentially dangerous foods would have been efficiently discovered and remedied anyway, if the Registry had never existed. Among the incidents that were first identified under the Registry was the problematic hydrolyzed vegetable protein that had been used as an ingredient in many products. That problem was reported by more than 1,000 entities.
Of those 125 primary reports, FDA says about a third related to Salmonella contaminations, about a third were for undeclared allergens or similar issues, and 13 per cent related to Listeria monocytogenes.
Looking forward, if the pending food safety law called the Food Safety Modernization Act is passed by the U.S. Senate (a similar bill passed the House already), it very likely will contain a provision that expands the scope of ‘responsible parties’ who must report to the Registry about potentially hazardous foods, so that farms, restaurants, food retailers, and importers would also have the obligation. This would represent a dramatic expansion of the population of potential reporters, expanding it in some instances to entities that don’t otherwise have any FDA-related responsibilities.
Implementation of such an expanded program could present some sticky practical problems. It would be interesting to see, if this expansion is made law, the extent to which FDA gets reports of suspect food it wouldn’t otherwise hear about, or merely more reporters sending it more reports about the same suspect foods.
