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FDA Issues Draft Guidances, Sets March Public Meeting, on Listeria monocytogenes

Constituent Update

February 7, 2008

The Food and Drug Administration (FDA) today issued draft compliance policy guidance on Listeria monocytogenes (L. monocytogenes) in ready-to-eat (RTE) foods, and draft guidance for the industry on controlling the food-borne pathogen in refrigerated or frozen RTE foods. The agency is inviting public comments on both.

In addition, FDA announced it will convene a March 28 public meeting to discuss and share information with stakeholders about the new guidance.

The draft Compliance Policy Guide (CPG) is intended to provide clear policy and regulatory guidance for FDA staff regarding L. monocytogenes in certain foods. In particular, the draft CPG sets forth an enforcement policy concerning L. monocytogenes in RTE foods that support the growth of L. monocytogenes and RTE foods that do not support the growth of L. monocytogenes. The draft CPG describes the characteristics of RTE foods that do and do not support the growth of L. monocytogenes and identifies examples of foods that fall into each category.

The new guidance is expected to provide a public-health benefit by enabling FDA to focus inspection resources on food products that pose the highest risk of Listeriosis to public health.

L. monocytogenes is a bacterial pathogen that is widespread in the environment. It can contaminate foods and, if consumed, cause a severe, life-threatening illness in the elderly, in individuals with decreased immune function, and in fetuses and neonates who are infected after the mother is exposed to the pathogen during pregnancy.

Most RTE foods do not contain detectable numbers of L. monocytogenes. For many RTE foods, contamination with L. monocytogenes can be avoided through the use of good manufacturing practices, including specific control measures. FDA's draft guidance to industry provides recommendations for specific controls for preventing contamination of refrigerated and frozen RTE foods with L. monocytogenes.

FDA considers an RTE food to be a food that is customarily consumed without cooking by the consumer, or that reasonably appears to be suitable for consumption without cooking by the consumer.

The two new draft guidances appear in today's Federal Register: Docket No. FDA-2008-D-0058, titled "Draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes," and Docket No. 2007D-0494, titled "Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods." To view the draft guidances and obtain information for submitting written or electronic comments, see Docket No. FDA-2008-D-0058 (73 FR 7293) and Docket No. 2007D-0493 (73 FR 7293).

The public meeting on the new guidance on L. monocytogenes will be held March 28, 9 a.m. to 4:30 p.m., at the FDA's Center for Food Safety and Applied Nutrition, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, Md. The building is located directly across from the College Park Metro Station. Stakeholders will have an opportunity to ask questions and provide oral comments on the draft CPG at the meeting. Additional information regarding the public meeting can be found in Docket No. FDA-2008-D-0058 (73 FR 7298).

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