Periods of transitions in Washington are always filled with unreliable speculation. When considering food-safety or agricultural policy, this is particularly the case at the onset of an administration headed by an individual who appears to have little background or track record involving such issues. In such a circumstance, about the only certainty is that the U.S. Dept. of Agriculture will be extraordinarily efficient at making sure that pictures of both the new president and the new secretary are prominently placed throughout the USDA complex within a week of inauguration day.
While it is difficult to therefore talk about how other more-pressing matters will turn out, it is more reasonable to identify issues that are likely to resurface. One important one is the long-dormant question of the status of microbiological performance standards for meat and poultry products.
It is worth reviewing some of the basics and history. With the notable exception of E. coli O157:H7 in certain beef products, raw meat and poultry containing pathogenic organisms is not considered to be adulterated, and therefore, can be marked as inspected and passed and may enter into commerce. When FSIS adopted its Hazard Analysis and Critical Control Point (HACCP) regimen in the mid-90s, it did not directly alter this basic concept, but it did introduce a new wrinkle into the equation through the establishment of performance standards. The official title of the so-called "megareg", which brought HACCP into being was "Hazard Analysis Critical Control Point Systems and Pathogen Reduction." As this title indicates, at the time the regulation was issued, USDA fully subscribed to the notion of pathogen reduction in raw products as an independent regulatory goal.
The agency started down this road with its initial establishment of Salmonella performance standards. Before doing so, it ran some tests and made a series of statistical assumptions. What it ruled was that establishments making serious efforts at pathogen control and reduction should be allowed to fall below the target incidence rates.
Those not able to demonstrate these efforts were to be considered outliers who would lose their eligibility to maintain inspection service and thus be driven out of business. As originally envisioned, this pathogen-reduction approach was to go forward as a dynamic process. As such, the Salmonella performance standards were to be expanded into other product categories. It was also suggested that other performance standards for pathogens other than Salmonella would eventually be established. The Food Safety and Inspection Service also implied these standards could and should be tightened over time. As the industry imposed its pathogen-reduction efforts, it was argued the statistical analysis would change along with it, and this would dictate a higher level of performance in order to avoid becoming an outlier.
All of this has some underlying policy logic behind it. To the extent that pathogens are the source of food-safety problems, it is in the public interest to promote their reduction. But in reality, this idea of a dynamic system never got off the ground. Instead, the initial performance standards as enacted over a decade ago remain as written, and they have neither been ratcheted down nor have they been expanded into other product categories. Meanwhile, no other pathogens of concern received similar regulatory treatment.
There appear to be three basic reasons why things have unfolded in this fashion. The first was the litigation in Texas involving Supreme Beef. Without revisiting many details, it is fair to say the Supreme case successfully advanced the position that regardless of its merits, the idea of pursuing pathogen reduction as an independent goal is not consistent with the fundamental grant of authority extended to FSIS under the Meat and Poultry Inspection Acts. For enforcement purposes, at least, unless FSIS can more directly tie an establishment’s failure to adhere to these standards to an adulteration or misbranding problem, such establishments must be continued to be allowed to operate.
The second development was the presidential transition of 2001. The Supreme Beef issue unfolded as the Clinton era was drawing to a close and Republicans assumed control of the executive branch. It is a fair to suggest that independent of any litigation related developments, the new overseers of food safety within USDA had somewhat less of an investment in this concept of a dynamic performance standard system than did their predecessors.
The third critical variable involves the evolution or perhaps devolution of the regulatory process itself. To the extent that FSIS committed itself to future changes in performance standards through traditional notice and comment rulemaking, it was tying such future developments to a process which has largely ceased to function within the agency in any timely or meaningful fashion. To the contrary, we see FSIS’ increasing willingness to take a position that, subsequent to the establishment of HACCP regulations, it essentially has freed itself from the time, trouble and need for receptiveness to other people’s opinions that are all inherent to the regulatory process. In so doing, its representatives have found that it is much easier, and perhaps much more fun, to treat every new problem that comes along as an opportunity to exercise their own unreviewable discretion and position it as an interpretation of what merely establishments must do to comply with the established overarching HACCP requirement.
Performance standards question
Given this history and given these underlying constraints, will performance standards re-insert themselves in a significant way? It is difficult to say. It is fair to assume that some of the staunchest advocates of this approach remain on the scene and will now probably have a better chance of bending the ears of new decision-makers. It is also fair to assume that, as it is exactly this issue like many others could well be crisis driven. Any food safety incident, which might be associated in the near future with the presence of Salmonella or any other pathogen in raw product, could well provide a stimulus reaction at the regulatory, perhaps even the congressional level.
Against this possibility, it may be prudent for the meat and poultry industries to take a fresh look at the performance standard issue and perhaps reach a coherent position. This has never really happened. When the idea was introduced within the HACCP regulatory process, rather than pointing to its underlying conceptual flaws, most industry interests chose to nibble at the edges of the issue. This led in time to a perception within some corners of the consumer-interest community that there had been an effective buy-in to the concept, and that the legal challenge to the system which ultimately emerged were somehow a betrayal of a mutual understanding. Such arguments, of course, overlooked the rather inconvenient truth that someone seeking to assert his legal rights in a situation where his entire livelihood is being threatened is hardly going to consider himself bound by what some stranger, attempting to represent a broader coalition of interests, may or may not have said two years previously in a conference room at the back of the USDA cafeteria.
Subsequent to the Supreme litigation and ever since, industry has continued a rather artful straddle of the issue, perhaps fearful that if it gave too much emphasis to the underlying point – that such performance standards are fundamentally unenforceable under current law – would fuel an effort to obtain such authority through new legislation.
And on the government side, the regulators have chosen to exercise some creative avoidance as well, by continuing to maintain the cast, trouble and structure of the performance standard system without having any real access to a direct enforcement mechanism.
Exactly how these circumstances might change within the new administration is presently unknown and unknowable. But there is certainly an excellent chance that some revival of this issue will take place and that those individuals behind the pictures which are beginning to show up at hallways along Independence Ave. may find themselves presiding over a sequel to the performance-standards drama.
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.
This article can also be found in the digital edition of MEAT&POULTRY, January 2008, starting on Page 44. Click