This paper provides a critical review of the regulatory analyses prepared by the Food and Drug Administration and the Food Safety and Inspection Service in support of their major HACCP rulemakings in 1995 and 1996, respectively. These rulemakings set the stage for a dramatic expansion in federal control over the processes by which food is produced in the United States. They also set in motion a considerable amount of new research into the economics of HACCP.

The review proceeds by taking HACCP principles, as applied to food products, and applying them to these regulatory analyses as products. The analytic principles set forth in Executive Order 12866 are described metaphorically as comprising a "generic HACCP plan." This Plan includes the following areas in which "critical control points" may be located:

(a) the clear identification of the market failure or other basis for government intervention;

(b) an examination of the extent to which existing laws or regulations have caused or contributed to the problem that regulatory action is intended to correct;

(c) a comparative risk analysis used for both priority setting and as a real-world reality check on whether regulatory action is warranted;

(d) non-efficiency concerns, including incentives for innovation, consistency, predictability, flexibility, distributive impacts and equity;

(e) the fair analysis of a reasonable number of alternatives, including innovative approaches; and

(f) competent assessment of social benefits and costs.

Reviewing these analyses using the lens of HACCP demonstrates that neither of them provided a credible ex ante prediction of the likely effects of the Seafood HACCP and Meat and Poultry HACCP rules. Both analyses exhibited extensive, material errors across multiple dimensions. Had they been food products regulated under a system of HACCP controls, both analyses would have been seized, recalled and ordered destroyed.

Based on the problems noted, several hazards to quality regulatory analysis are identified. These hazards begin with the dubious competence of some of the analysts charged with producing regulatory analysis, for quality products cannot be produced by persons unskilled in the relevant analytic methods. Hazards extend to limitations and gaps in the relevant science, for the absence of scientific information invites the use of convenient but specious assumptions, defaults and models. Finally, a host of conflicting objectives acts as a gauntlet of hazards, whether from program management, the agency's general counsel staff or political appointees.

Like in the application of HACCP to food, overcoming these hazards requires careful attention to identifying critical control points and the levels beyond which corrective action is necessary. Even then, quality is enhanced but not guaranteed. In the case of regulatory analysis, the HACCP system also lacks a set of credible enforcement tools. The depth of noncompliance with HACCP principles in regulatory analysis may be attributed to this fact.

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