Was It Something I Ate? Implementation of the FDA Seafood HACCP Program

We use FDA’s seafood inspection records to examine: (i) how FDA has targeted its inspections under HACCP regulation; (ii) the effects of FDA inspections on compliance with both HACCP and plant sanitation standards; and (iii) the relationship between HACCP regulations and pre-existing sanitation standards. We use a theoretical model of enforcement to derive hypotheses about FDA’s targeting of inspections and firms’ patterns of compliance. We test those hypotheses using econometric models of inspection and compliance. Contrary to the predictions of the theoretical model and to FDA’s own stated policies, FDA does not seem to have targeted inspections based on product risk or past compliance performance. Firms’ compliance strategies seemed to be broadly in accord with the predictions of the theoretical model. The threat of inspection increased the likelihood of compliance, although the deterrent effect was statistically significant for sanitation standards but not for HACCP. Firms tend to persist in compliance status, especially with respect to sanitation standards. Contrary to FDA’s presupposition, however, HACCP compliance does not improve compliance with sanitation standards, suggesting that the two are not complementary.