"Generic HAACP Plans for Regulatory Analysis"
Do federal HACCP regulations meet HACCP standards?

INTRODUCTION

"The rapid expansion of food inspection based on the Hazard Analysis and Critical Control Points (HACCP) system has created a wealth of new research opportunities for applied economists. HACCP systems are so different from prior approaches to food technology that new analytical tools and methods must be developed to enable manufacturers to gain a better grasp of the cost-effectiveness of both production innovations and new products. Similarly, as government regulators proceed to extend HACCP to additional product lines and stages in the food production and distribution system, the benefits and costs of these new regulations must be reliably assessed.

"This paper draws an analogy between HACCP as applied to food technology and long-established standards for analysis of the consequences of regulatory action. To get these analyses right, a foundation for quality analysis among regulatory agencies must be established that is as obedient to fundamental analytic principles as HACCP rules require industry to behave toward the food they make. Regulatory agencies imposing HACCP principles and rules to more sectors of the food business should apply these same principles to the way they analyze the consequences of alternative regulatory approaches and design regulations. Unless regulators set such an example, their credibility among those they regulate will wither, thereby undermining the moral legitimacy of their role.

"To make these points clear I use as examples the seafood HACCP rule promulgated by the Food and Drug Administration in 1995 And the meat and poultry HACCP rule promulgated by the United States Department of Agriculture's Food Safety and Inspection Service. Both regulations were accompanied by regulatory analyses as required under Executive Order 12866 for "economically significant" rules. This Executive order (as well as its predecessor, Executive Order 12291 could be thought of as a "Generic HACCP Plan for Regulatory Analysis." Both Plans were supplemented with what may be called "Generic HACCP Implementation Guides for Regulatory Analysis." However, neither analysis conformed to elementary principles in these Plans and Guides, despite the fact that the Guides have been in place for almost a decade and the Plans since 1981. Had these analyses been subjected to enforcement provisions analogous to those which FDA and FSIS use to ensure compliance by food producers with HACCP regulations, both agencies would have been subject to significant sanctions. One can only speculate as to whether the regulators' analyses as 'products' would have been embargoed until made compliant, recalled as defective or adulterated, or destroyed as unwholesome and unfit for consumption.

"Federal food safety agencies continue to expand mandatory HACCP requirements to additional food products, such as juice, and new sectors, such as retail. To an impartial regulatory analyst, it is troubling that these decisions are proceeding based on both extremely high expectations for their effectiveness at reducing foodborne illness and a surprisingly weak analytical foundation for claims that they actually do. Analysis suggests that successes will be limited, unsatisfying, and achieved at enormous expense and frustration, thus imperiling public confidence in both HACCP as a risk-reducing tool and the agencies as effective guardians of public health. Better compliance with established HACCP Principles for Regulatory Analysis would reduce the likelihood of these undesirable outcomes and increase the odds that regulatory action cost-effectively reduces the social costs of foodborne illness" (footnotes omitted).

The full paper is here.