The growing trend of retroactive recalls for already distributed food products calls into question commonly held beliefs about food safety. Americans expect that the foods they eat are safe, and, when a company becomes aware of a potential health hazard related to its food products, consumers expect that it will recall the products before people eat them. Consumers also expect that the USDA official mark of inspection on a meat or poultry product means the product is safe to eat because it has been certified by USDA’s Food Safety and Inspection Service (FSIS). In other words, the USDA seal is interpreted as a guarantee that the product is safe to eat because an FSIS inspector, who is continuously present in the facility, has verified the company’s compliance with regulations designed to protect the public health. What undermines this assumption, however, is a growing trend of retroactively recalling product after FSIS has inspected it and after the product has entered into commerce. This trend may confuse industry and consumers alike and creates uncertainty regarding the value for consumers of the USDA inspection seal.
Most meat, poultry, and egg processing facilities regulated by FSIS are familiar with the basic elements of the agency’s recall system. Among other things, FSIS often exercises its authority to request a voluntary recall of product—an offer that is, under most circumstances, difficult, if not impossible, to refuse. Many processors are also aware of the current regulatory requirement to have a recall plan in place (9 C.F.R. § 418.3) as well as the related requirement to self-report any knowledge of potentially adulterated or misbranded products in commerce (9 C.F.R. § 481.2).
Processors likely also have some familiarity with the major categories into which recalls can be placed. The first, and most visible, encompasses situations involving potential human health risk posed by the presence of a pathogenic organism in a product. The second category involves inaccurate labeling or some other type of error associated with the presence of a known human allergen. The third category is much less well understood, but it appears to be growing in its impact. It encompasses an increasingly broad range of situations where FSIS suspects or believes that a retroactive inspection failure necessitates resorting to a public recall.
Retroactive recalls vary considerably, but, based on our own direct experience and other incidents of public record, these situations can generally be demarcated by the following stages:
- The agency obtains information or evidence suggesting some type of inspection irregularity. This could involve potential misconduct by the regulated establishment, misunderstandings or disagreements about the scope of inspection jurisdiction, differences of opinion surrounding laboratory results, or a host of other contingencies.
- Based upon this information, USDA arrives at the working conclusion that the product—which, in most cases, has already been marketed as inspected, passed, and prepared under continuing inspection—should no longer remain in commercial channels.
- Under its guidelines, the agency then almost invariably concludes that there is a legitimate basis for a Class I recall, indicative of a significant public health concern.
In a number of situations, the underlying basis for such a recall request may be well founded, and, as noted above, companies resist accommodating such requests at their peril. However, the broad and open-ended nature of this assertion of federal authority, which attaches both to willful misconduct and innocent misunderstandings, should give significant pause. While it is understandable for the agency to request a recall when it uncovers evidence of a significant, tangible risk to consumers, problems arise when FSIS suggests that a company’s conduct—which has been fully acceptable to on-site inspection personnel for some period of time—should result in a recall.
This problem is compounded by the closed nature of the recall process itself. On many occasions, a company is only informed of the problem when the recall request is made, and it may be given little or no time in which to formulate a response or gather relevant data or evidence. In addition, and perhaps more significantly, the Agency’s position is that the recommendations of its Recall Committee are not reviewable or appealable.
FSIS, like all other government agencies charged with protecting the public health, must have procedures in place that allow it to act quickly and decisively when the public health is in jeopardy. The increasing use of retroactive recalls may cause further problems, however, in cases where the agency may reach a conclusion that is not justified by the facts currently available. In such situations—where the risks at issue are theoretical and where facts and information need to be more carefully shared by all interested parties—a different, more flexible, and open-ended procedural model should be considered and implemented for the benefit of both the industry and the consuming public.