IDFA Supports FDA Policy Guide on Listeria, But Requests Clarification

At a public hearing held by the Food and Drug Administration (FDA) last week, IDFA Vice President Cary Frye presented oral comments in support of the agency's draft Compliance Policy Guide regarding the presence of Listeria monocytogenes in ready-to-eat foods. Frye commended FDA for recognizing that many dairy products do not support Listeria growth, but asked for clarification on its approach for regulating certain cheeses, cultured dairy products and yogurt.

"The dairy foods industry has worked closely with FDA over the past two decades to help improve the safety of dairy products by enhancing efforts to control potential post-pasteurization contamination of Listeria monocytogenes," Frye said. "We applaud the agency's risk-based approach to this issue."

Released in February, the draft guide sets an allowable limit of 100 Listeria monocytogenes organisms per gram for certain ready-to-eat foods, such as ice cream, cultured dairy products and hard cheeses, that do not pose a risk for foodborne listeriosis. Previously, under FDA's zero-tolerance policy, if even one Listeria organism was detected in a food, the manufacturer was required by FDA to conduct a Class I recall, a disruptive and costly procedure. The new guidance will exempt from recalls foods that do not support the growth of Listeria.

In her comments, Frye called attention to cultured dairy products and yogurt, which have intrinsic and processing factors that do not support the growth of Listeria monocytogenes but are not expressly covered in the guidance. Frye asked FDA to broaden the guidance to include these factors and other examples of scientific evidence that can be used in policy enforcement.

Although FDA released two guidance documents on Listeria in February, the hearing was restricted to comments on the Compliance Policy Guide, which is designed to provide FDA staff and the food industry with guidance on the agency's enforcement policy. In her conclusion, Frye expressed the dairy industry's concerns with the prescriptive nature of the second document, "Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods."

"We understand that there will be an additional opportunity to work with FDA on refining the guidance to the industry for controlling Listeria monocytogenes. IDFA will be urging the Agency to consider a more performance-based outcome approach," Frye said.

FDA announced an informal extension of the comment period until after last week's meeting transcript is released. IDFA plans to work with members to review the "Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods" and submit more detailed written comments on both guidance documents within the next 60 days. To read the text of the oral comments, click here.

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Posted April 7, 2008