So What Does “Reasonable Probability of Serious Adverse Health Consequences or Death” Really Mean?

By Ricardo Carvajal –      

On July 23, FDA held the first of three public workshops to explain the Reportable Food Registry requirements that will take effect on September 8, 2009.  One thing was made clear: the agency has no plans to offer a definition of the standard that triggers the reporting obligation. Rather, it will be left to individual firms to determine, on a case-by-case basis, what constitutes a “reasonable probability that the use of, or exposure to, [the] article of food will cause serious adverse health consequences or death to humans or animals.”  In response to questions, agency officials acknowledged that firms can look to past Class I recall situations to get some indication of how the agency has interpreted and applied what is essentially the same standard in that context. 

The electronic reporting form that firms must use to submit instances of reportable food is a work in progress.  The agency presented the latest version of the form, but will continue to work on the form and present updated versions at the remaining workshops.  In addition, the agency plans to release a step-by-step guide to preparation of the form prior to September 8.  A brief reminder: to ensure that FDA considers comments on its draft guidance on the Reportable Food Registry before the date on which the Registry takes effect, the Agency asks that comments be submitted by July 27, 2009.  For more on the Registry, see our prior post here.