But things start to get complicated in a hurry as one begins to parse out the various statutory meanings of the word "adulterated," the operative legal term tied to wholesomeness. These definitions have also remained stable over the past century and are essentially uniform across the entire food supply. What makes USDA-regulated products distinct is the government’s role, through the inspection program, as gatekeeper, something that is documented thousands of times every day through the issuance of the mark of inspection.
For this system to work properly, both the regulators and the regulated need to be on the same page with regard to the question of what does and does not get captured by this critical concept. To trot out a sports metaphor, the baseball game moves along a lot more efficiently from the perspective of pitcher, batter and umpire if they all work from a common understanding of the dimensions of the strike zone. Unfortunately as I write this column, any artist’s rendition of today’s adulteration strike zone could decidedly not be a neat rectangle. Instead, we would find ourselves gazing at a number of wavy lines or a growing series of question marks.
In the HACCP era, this problem has been gathering momentum for some time. Some of the FSIS theory that underlies it is captured by language in a recent notice on E. coli, which specified that an establishment that receives an intact beef item cannot conclude that it is wholesome simply because it bears the mark of inspection. To return to the earlier metaphor, the umpire is letting the manager know that simply because he called ball four and let one of his players reach first base, he fully reserves the right to change his mind if he sees some future evidence of a problem.
More critically, we have moved in recent months well beyond the impact of mere theory. Three things come to mind: First, we have seen some recalls of so-called intact beef products due to the alleged presence of E. coli O157:H7. Second, we have seen recalls of other beef items due to the alleged presence of certain strains of Salmonella. Third, we have seen recalls of certain ready-to-eat poultry products containing Salmonella in situations where evidence suggested that they may not have been properly cooked or handled by the consumer. Note that all of the products left the federally inspected facility bearing the mark of inspection. Also and quite remarkably, note that even if any of the products in question had been tested by either the government or the relevant establishment, and had been found to contain the particular pathogen at issue, the product still would have been considered wholesome, not adulterated and eligible to receive the mark. Subsequent developments turned balls into strikes.
Six legal theories
There are perhaps six different legal theories that start to bear upon such issues. In some cases, they appear to collide into, and perhaps even contradict, each other as they become applied to particular situations.
1. Direct product adulteration – Under the Acts, a product is considered to be directly adulterated if it contains any "poisonous or deleterious" substance, which may render it injurious to health. If Congress had stopped there, the entire issue would be simple since raw food would need to be sterile and the presence of any pathogen would render it adulterated. But to deal with this problem, the law also includes a proviso stating that if the substance in question occurs naturally, the product is acceptable if the substance is not present in a quantity that ordinarily renders it injurious to health. A confusing mouthful, but what it comes down to is that, with notable exception of E. coli in certain beef products, raw products containing pathogens are not considered to be adulterated because proper cooking and handling is assumed.
2. Sanitation theory – Even if a product is not perfectly wholesome, it cannot be prepared or held under unsanitary conditions, which might lead to contamination. In other words, if an inspector walks into a food warehouse with a serious rodent contamination problem, the inspector may condemn the goods because of the contamination itself, without having to necessarily prove there is anything wrong with a given container of product.
3. Pathogen reduction theory – As previously discussed, pathogen reduction was originally touted as an important policy goal, and quite distinct from HACCP itself, within the so-called mega reg. But it has limped along for virtually a decade since its underlying legality was effectively challenged in the Supreme Beef litigation.
4. HACCP/Process control theory – While not anchored in any particular legislative language, this has obviously become a critical component of the inspection system. The mark of inspection is to be withheld by the government even when it does not necessarily have the ability to prove the existence of any specific product or sanitation defect, if it believes that certain control measures were not followed or were not properly documented.
5. Public health theory – Such a theory seems to have been at work or an emphasis upon the work seems in some of the recent recalls referenced above. In simple terms, if someone has gotten sick, all bets appear to be off.
6. Product liability theory – This generally works outside the scope of government action, but its relevance to this particular discussion cannot be overlooked. Independent of these regulatory nuances, there is a concept, referred to as strict liability in tort, which can and does direct accountability to the manufacturer whenever someone is injured by a product.
Any effort to disentangle this would tax both the boundaries of this publication and the limits of any reader’s patience. It is also not the point to suggest that in any given situation that the government or the other parties involved may have made the right or wrong decision. It is not even to identify any particular disagreement about policy. The point is that anyone out there who is not very confused by all of this is not paying attention. It is also to suggest that given such confusion, there is a need for a coherent process through which all these issues can, in fact, be discussed and resolved with as much precision as possible. Continued freelancing, particularly within the compressed timeframes and tense atmospheres of potential recalls, is simply no longer good enough, as a matter of law, policy or common sense.
Alternatively, resorting to conventional, informal rulemaking has now become essential. In simple terms, this would provide a mechanism whereby the government would be expected and required to explain what it is doing and why, and anyone from the industry, the public interest community or anywhere else would be free to comment, publicly and on the record, in response. The government would then be required to take all such information into account, reach a final decision and explain it in sufficient detail.
Because of the time, effort and level of accountability required, the government is not particularly anxious to do any such thing. However, under the current, increasingly chaotic circumstances, resorting to such a process has become essential. The next batter up could be you.
Robert Hibbert is a Washington, D.C.-based attorney with K&L Gates L.L.P. which comprises 28 offices in three continents. His practice focuses on federal regulation of the food and agricultural industries, specializing on issues related to the U.S. Dept. of Agriculture. He formerly served as a senior attorney with the USDA and also served as general counsel to the American Meat Institute.