FDA’s Draft Guidance on Listeria monocytogenes (In Case You Missed It)

Just a few days before the presidential inauguration, FDA published a revised draft guidance on control of Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods.  The significance of the guidance to the food sector is difficult to overstate.  Since FDA published the original draft guidance in February 2008, the modernized CGMP and preventive controls regulation issued under the authority of FSMA has come into effect (see 21 CFR Part 117).  The revised draft guidance is intended to help manufacturers of RTE foods comply with the requirements of that regulation, and takes into account recommendations made by FDA’s Food Advisory Committee in December 2015 (see here and here).

Lm contamination accounts for a significant percentage of Reportable Food Registry incidents (@17% in the most recent year for which data are available), and has been at the heart of a number of notable Class I recalls, not to mention a few criminal investigations and prosecutions.  That, together with the advent of FDA “swabathons” during inspections and the agency’s increasing use of whole genome sequencing, has aroused consternation about the appropriate implementation of sanitation and environmental monitoring programs to control environmental pathogens such as Lm.  The revised draft guidance addresses that topic (among many others) in considerable detail, and should be read in its entirety by any producer of RTE foods.  Although the guidance is in draft form, it would be prudent to assume that it reflects FDA’s current thinking – something to bear in mind as FDA begins carrying out inspections for compliance with Part 117.  Comments on the guidance are due by July 26, 2017.