Draft Compliance Policy Guide Sec.555.320 Listeria monocytogenes: Availability

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April 18, 2008 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Docket No. FDA-2008-D-0058: FDA Draft Compliance Policy Guide, Guidance for FDA Staff, Sec. 555.320 Listeria monocytogenes The Grocery Manufacturers Association (GMA) submits the following comments on FDA's Draft Compliance Policy Guide on Listeria monocytogenes. We will be submitting comments separately on FDA's guidance for industry on control of L. monocytogenes in refrigerated and frozen ready-to-eat foods. GMA represents the world's leading food, beverage and consumer products companies. The association promotes sound public policy, champions initiatives that increase productivity and growth and helps to protect the safety and security of the food supply through scientific excellence. The GMA board of directors is comprised of chief executive officers from the association's member companies. The $2.1 trillion food, beverage and consumer packaged goods industry employs 14 million workers, and contributes over $1 trillion in added value to the nation's economy. For more information, visit the GMA Web site at www.gmaonline.org GMA commends FDA in its thoughtful approach and thorough consideration of the science to develop this Compliance Policy Guide (CPG) on Listeria monocytogenes. Listeriosis is a serious foodborne illness and industry must continue to take steps to minimize the potential for contamination of ready-to-eat (RTE) foods and reduce the risk to consumers. We strongly support FDA's use of microbial risk assessment to develop risk management strategies for control of L. monocytogenes. We have worked with industry, academia and regulatory agency scientists for almost two decades to develop the data and other scientific information needed for assessing which products pose the greatest risk to the consumer. This information clearly demonstrates that the greatest risk comes from RTE foods that support growth of L. monocytogenes to high numbers, and that the greatest benefit to public health comes from reducing RTE food servings that contain high numbers of L. monocytogenes. This CPG clearly recognizes that the most effective approach to reducing listeriosis is to remove from commerce foods contaminated with high numbers of L. monocytogenes, and that ready-to-eat (RTE) foods in which the organism can grow are the ones most likely to contain high numbers of L. monocytogenes. We offer the following comments in support of the CPG and the scientific basis for the approach. In addition, we are providing recommendations for revision to the CPG that will further focus FDA's resources on the products most likely to present a public health problem. Low levels of L. monocytogenes in foods that do not support growth do not present a greater risk to public health than the current policy It is entirely appropriate for FDA to focus its resources where the greatest benefit to public health can be made in addressing the risk of L. monocytogenes in foods. The CPG allows FDA to do this by applying more resources to foods that support the growth of L. monocytogenes to levels that could cause listeriosis. GMA believes that a policy that allows 100 L. monocytogenes/g in foods that do not support growth does not present an increased risk to public health compared to current policy. In fact, it will encourage industry to develop product formulations that will be inhibitory to growth of L. monocytogenes, which will serve to enhance public health. GMA believes the science supports that foods containing 100 L. monocytogenes /g present a minimal risk even to highly susceptible consumers. We have outlined the evidence for this in Appendix I. In brief, all risk assessments conducted to date have concluded that nearly all cases of listeriosis result from the consumption of high numbers of L. monocytogenes and that the consumption of low numbers has a low prob…