FSMA and Third-Party Audits: What is a “Serious Risk to the Public Health?”

By Ricardo Carvajal –

In poring over FDA’s recently issued proposed rule on Accreditation of Third Party Auditors (see our prior post here), one thing that caught our eye is FDA’s discussion of FSMA’s notification requirement for auditors.  That requirement is embedded in new § 808(c)(4) of the FDC Act.  Consistent with that statutory provision, proposed 21 CFR 1.652(c) states in relevant part:

An accredited auditor/certification body must immediately notify FDA electronically, in English, when any of its audit agents or the accredited auditor/certification body itself, discovers any condition, found during a regulatory or consultative audit of an eligible entity, which could cause or contribute to a serious risk to the public health. 

When we first saw the language of the notification requirement in the statute, it seemed to us likely to lead to over-reporting of potential food safety problems because, under the terms of the statute, failure to notify could result in the withdrawal of an auditor’s accreditation.  Now the proposed rule has published and it appears that FDA is leaning toward a broad interpretation of the notification standard.  Such an interpretation could make it even more likely that auditors may err on the side of over-reporting.  In the preamble to the proposed rule, FDA states:

We note that section 808 of the FD&C Act does not define “serious risk to the public health,” nor does it give examples of “condition[s] that could cause or contribute to a serious risk to the public health.” The statutory description of notifiable conditions–as ones that “could” cause or contribute to a serious risk to public health–suggests to us that the scope of this provision is broad.

FDA goes on to request comment on whether the notification standard should encompass risks that would result in a Class I recall classification (i.e., reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death) and risks that would result in a Class II recall classification (i.e., use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote). 

Query whether FDA’s tentative view of the notification standard could act as a disincentive to participation in the third-party auditing program.  Under current law, industry is required to notify FDA of a potential food safety issue (through the Reportable Food Registry) only under circumstances that dovetail with the Class I recall standard; notification under lesser circumstances, such as those associated with Class II recalls, is voluntary.  If auditors are required to notify FDA of potential food safety issues associated with Class II recalls, manufacturers may well want to factor that loss of discretion into deciding whether to participate in the third-party auditing program.