By Ching-Fu Lin
Earlier this year, the Food and Drug Administration (FDA) published for public comment the proposed rule to implement §307 of the FDA Food Safety Modernization Act (FSMA). The proposed rule is to establish a program for accreditation of third-party auditors to provide the FDA with a more efficient tool to regulate food products. Particularly, it assists the FDA in regulating food entering the United States via international trade, as it is recognized by the FSMA that the FDA is administratively and financially unable to ensure the safety of imported foods solely on its current system of border inspection. Under the new program, the FDA would recognize accreditation bodies, which would in turn accredit third-party auditors. These third-party auditors would then conduct onsite food safety audits in foreign jurisdictions and issue certifications for foreign food producers. According to the FSMA and the proposed rule, an accreditation body can be a foreign government/agency or a private third party, and a third-party auditor can be a foreign government, foreign cooperative, or a private third party. Both are required by the proposed rule to meet standards for legal authority, competency and capacity, impartiality/objectivity, quality assurance, and records procedures.
Will such a multilayer delegation structure result in dilution of accountability and effectiveness?
Congress -> FDA -> Accreditation Body -> Third-Party Auditor -> Producer
The FSMA seems to have created a regulatory dilemma for the FDA in terms of addressing imported food safety. The dilemma results from a structural mismatch between the broad scope of power granted to the FDA and the long chain of delegation to foreign/private actors as primary “regulators.” The FSMA instructs the FDA to delegate its regulatory authority to foreign governments and/or private third parties, aiming to largely increase the effectiveness of regulation along the global supply chain. However, the FSMA does not give the FDA adequate capacity to closely oversee such foreign/private regulatory agents along the delegation chain. Thus, the FSMA cannot hold foreign/private regulatory agents fully accountable for their failures in ensuring food safety.