I have read with some interest recent discussions in this space of the FSIS performance standards system and its relationship with the Supreme Beef litigation of a decade ago. Such interest is based first, upon the continuing importance of the issue, second, my belief that it continues to be widely misunderstood and, third, as an outgrowth of my personal involvement with the litigation itself, particularly at the District Court level.
There is little point at this late date in re-litigating the case itself. But I would note for the record that the case never should have been, or needed to have been litigated in the first place. This flows from the experience, of a very long weekend immediately prior to the initial preliminary injunction hearing, when, along with other representatives of the company, we worked successfully in conjunction with a team of hardworking career professionals at FSIS to hammer out a settlement. Unfortunately, despite the fact that on the front end of the discussions that group’s political overseers insisted that these individuals were authorized to make commitments on behalf of the USDA, the settlement was promptly repudiated by those same overseers. I will resist the temptation to speculate unkindly in writing at this late date as to why.
But back to performance standards themselves. It may contribute to an understanding of what they are and are not separating the discussion into (1) what they were before the litigation; (2) what they’ve been over the past several years; and (3) where they seem to be headed today.
Performance standards were a creation of the so-called Mega-Reg, whose official title was “Pathogen Reduction: Hazard Analysis in Critical Control Point (HACCP Systems).” As this formal title suggests, the goal of achieving pathogen reduction was very much the driver of the entire HACCP exercise. In pursuit of this goal, FSIS took highly unconventional measures. Established food safety law, as enforced in this country by both FSIS and FDA, and in large measure around the world as well, can be boiled down to a single sentence: Products that are considered adulterated cannot move in commerce; products that are not can. The performance standard concept breaks significant new ground by asserting that a product that is not adulterated in any definable way should still not be allowed to move in commerce if a given processor has failed to establish an acceptable record of pathogen reduction.
As the initiative made clear, this was not to be a static concept, limited to the specific Salmonella standards originally proposed for the limited categories of product first identified. Instead it was suggested that the standards would not only be expanded into other product categories and capture other pathogens of concern, but also that the standards would be ratcheted down over time. The concept can fairly be compared to a teacher establishing a test that (s)he believes 90 percent of the class should be able to pass. Once the bottom 10 percent are flunked out, a new, somewhat tougher, benchmark is to be established for those who remain in school. Thus, a virtuous cycle of continuous improvement is created.
From a general policy perspective this merits consideration as, at a minimum, an interesting idea. But from a legal perspective, the more immediate question is whether such an approach has been sanctioned by the inspection statutes. Having participated at the time in the drafting of a few comments that politely raised this question, I recall examining the Department’s attempt at an answer, in the publication of its final rule, with considerable interest. The response (you can look it up at 61 FR 38851 and form your own opinion) was, at least from this perspective, broad, evasive and unsatisfactory. It simply asserted that “the meat and poultry inspection statutes mandate regulatory oversight of unusual intensity and comprehensiveness, and they provide the Secretary broad rulemaking authorities to implement them.”
When Supreme Beef allegedly failed to meet these standards and when USDA forced litigation by refusing to settle, this issue was rejoined, but now in a concrete, as opposed to a theoretical, setting. Supreme’s defense boiled down to the argument that since the product it was prepared to ship was not adulterated, the Department had no authority to refuse to apply the marks of inspection which would have allowed it to enter into commerce.
At this point by way of defense, the government had two options. One would have been to recast and expand upon the argument cited above. In a manner similar to the way that the Supreme Court managed to tease out a right of privacy from the so-called “penumbras” of the Constitution, the Department might have argued that performance standards somehow exist within the penumbras of the inspection statutes. While I do not believe this argument would have been successful, it would have had the virtue of more honestly reflecting the Department’s true perspective at the time. But instead, for perhaps tactical reasons, it took a more traditional approach and attempted to link Supreme’s alleged failure directly to the sanitation provisions of the statute. When the District Court and subsequently the Fifth Circuit of the Court of Appeals both correctly concluded that, since the alleged problems of Supreme’s product had nothing to do with sanitation – the company was exclusively a grinder and the record established that any salmonella problems were entirely the function of the incoming raw materials — the government’s case was, quite appropriately, lost.
Over the ensuing decade, we have experienced a process of avoidance, finesse and muddling through with the issue. The avoidance flows from a continuation of FSIS’s unfortunate historical tendency to never go to the trouble of cleaning up its regulatory architecture whenever a piece of it has been rejected by the courts. As a result, we still have the original Mega-Reg performance standard language on the books, which flatly states a cause and effect relationship between any alleged failure to comply and FSIS’ ability to suspend operations, despite the fact that such authority demonstrably does not exist. Meanwhile in the real world, the Department continues to test and subject those establishments whose performance flirts with non-compliance to special scrutiny. Here is where finesse comes into play in two ways. First, if enforcement action is threatened or undertaken, it is never tied directly to any alleged performance standard failure. Somehow and miraculously, independent reasons involving sanitation or other alleged failings somehow manage to enter the enforcement mix. Second, and more importantly, FSIS also displays more flexibility in terms of withholding the application of sanctions if adequate compliance enhancements are put on the table. In essence, it is now willing to accept the type of settlement offer from other companies it was unwilling to accept from Supreme Beef.
After this long hiatus, performance standards re-emerged energetically in May of this year when FSIS published a notice establishing new performance standards for Salmonella and Campylobacter in young chicken and turkey slaughter establishments. In the case of Salmonella and consistent with the vision articulated in the Mega-Reg, it ratcheted the data downward based upon what the agency considers to be recent, relevant data. And, again consistent with this original vision, it expands into new territory with Campylobacter. It emphasizes that the notice will, among other things, further the objectives of the President’s Food Safety Working Group.
Unfortunately, the notice does litt
le to untangle the legal and procedural mess discussed in this article; if anything, it further complicates it. To be sure, at the end of its notice, it does tuck away a reference to the Supreme precedent, including an accurate summary of the relevant opinions. But it fails to take any action to remove an unenforceable of its books, nor does it provide any clear indication of what this does or doesn’t mean going forward. Instead, it reverts to some of the same circular discussion contained in the original rule, stating that it expects establishments to reduce pathogen exposure and that performance standards are an effective tool in this effort.
But FSIS has chosen to be even more adventurous this time around, as a procedural matter, through its attempt to create new standards through mere publication of a notice, as opposed to a proposal. By doing so, it is essentially saying that exposure of performance standards, both now and in the future, can be effected through a unilateral government edict, as opposed to the more structured open-ended and open-minded vehicle afforded by the notice and comment process.
In the end no one is well served by this attempt to jam an even larger square peg through the round hole of the inspection statutes. And it is worth noting that this does not simply reflect error on the government’s part. Those who are most enthusiastic about the performance standard concept recognize the desirability of, and the need for, its codification in the statutes. But they undercut this very argument by going along with the idea that it is unnecessary. And those who have a different view tend to downplay the legal problem, since they are reluctant to say anything that might encourage Congress to crack open the statute. This unfortunately suggests a future for performance standards much like its past, filled with controversy, confusion and obfuscation. We all can and should do much better.© Food Safety News