A Meeting on Listeria With Potentially High Stakes

December 2, 2015

By Ricardo Carvajal

FDA’s Food Advisory Committee (FAC) will meet on December 7-8 to discuss a number of issues related to Listeria monocytogenes (L. mono) in ready-to-eat (RTE) foods.  As summarized in the supporting background document, the public health and regulatory challenges posed by L. mono have bedeviled FDA and industry since at least 1996, when the agency established a zero tolerance for the presence of L. mono in cooked, RTE foods.  Subsequently FDA issued draft guidance documents in which it signaled that it was considering softening that stance for RTE foods that do not support the growth of L. mono, based on a risk assessment and follow-on analysis suggesting that such foods presented a lower risk of listeriosis.  A move away from zero tolerance certainly would have been welcome by affected segments of industry.  However, recent developments – including a dose-response model developed by the agency, and an outbreak of listeriosis associated with ice cream – now have FDA rethinking whether a move away from zero tolerance would be adequately protective of “the most vulnerable individuals in at-risk subpopulations.”  

The FAC meeting would be noteworthy even if the above issue were the only one on the agenda.  However, FDA has teed up a number of other significant issues, including:

  • Whether frozen vegetables and foods that appears to be cooked should be considered RTE, even if they bear cooking instructions;
  • Whether FDA should soften its stance on steps manufacturers should take when they detect Listeriaspp. on a food-contact surface, so as not to discourage the implementation of “robust Listeria control programs”;
  • The need to generate data to help FDA distinguish between contamination of produce with L. monothat could occur in packinghouses versus contamination originating in a growing area – an issue of interest to produce packers regardless of whether they are subject to the new produce safety rule or the preventive controls rule issued under the authority of FSMA; and 
  • Whether FDA should change its sampling priorities, which are currently biased toward increased sampling of foods that support the growth of L. mono.

Additional information on the meeting – including access to all background materials – is available here.