The proposed “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” rule implements the provisions set forth in the FDA Food Safety Modernization Act (FSMA), which, per Section 307, amends the Food, Drug, and Cosmetic (FD&C) Act and requires the FDA “to establish a system, within 2 years of enactment, for the recognition of accreditation bodies that accredit third-party auditors to conduct food safety audits and to issue certifications for eligible foreign food entities and their products.”1 The stated goal of this rule is to reduce the number of US citizens who suffer from food-borne illnesses due to contamination of foods imported into the United States. Unfortunately, as is argued in this comment, the evidence presented in the FDA Regulatory Impact Analysis (RIA) is not sufficient to determine whether this goal can be reached through the establishment of the proposed rule. Ultimately, the analysis fails to address numerous concerns; in addition, it confounds the claimed benefits from this regulation with the benefits from related regulations.
First, while the agency at least provides an estimate—albeit flawed in several respects—of the costs of the proposed regulation, it fails altogether to quantify the benefits of the proposed regulation. Without such an attempt, a proper determination of the net benefits is impossible. Furthermore, the failure to determine the numerical decline in food-borne illnesses resulting from this regulation makes it impossible to compute the cost effectiveness—the cost per illness abated—of the proposed regulation.
Second, the Regulatory Impact Analysis fails to consider alternative solutions to the potentially systemic problem of food-borne illnesses stemming from imported foods. This failure to consider alternatives is in direct conflict with the expectations outlined in Executive Order 12866.2 The agency appears to interpret the legal authority created in Section 307 of the FSMA as justification enough to ignore all other possible solutions, despite the existence of a default alternative of direct accreditation by the FDA for all third-party auditors as described in Section 808(b)(1)(A)(ii) of the FD&C Act. As such, it is impossible for the general public and those in Congress to assess whether the proposed solution is better than no regulatory action, the FD&C Act status quo, or any other reasonable alternative.
The third-party accreditation proposal could prove to be an effective mechanism in reducing food-borne illnesses derived from imported foods; however, the information presented in the NPRM and RIA makes such a determination impossible. The Department of Health and Human Services and the Food and Drug Administration should improve the Regulatory Impact Analysis to more accurately estimate all of the benefits derived from the proposed rule, to consider reasonable alternatives to the proposed rule, and to estimate the net benefits of those alternatives. Only after addressing these concerns is it possible to make an educated decision regarding the appropriateness of the proposed rule.