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FDA Unveils New Policy to Address Listeria Control in Food

Thursday, February 7, 2008

(American Meat Institute)

The Food and Drug Administration (FDA) has announced a new draft compliance policy for control of  Listeria monocytogenes (Lm) in ready-to-eat (RTE) foods that for the first time creates different policies for foods that support growth of the organism and foods that do not. AMI has long sought the Food Safety and Inspection Service (FSIS) to adopt a similar science-based policy which reflects international standards adopted by Europe, Canada and other nations.

For foods that do not support growth of  (Lm), FDA will revise its tolerance level from zero to 100 colony forming units per gram of food (cfu/g). The “zero tolerance” standard for those RTE foods that support the growth of the pathogen will remain the same.

Three draft documents are published in today's Federal Register, including a draft Compliance Policy Guide that provides guidance for FDA staff on the agency’s enforcement policy, draft Guidance for Industry on Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods, and a Notice of a Public Meeting on March 28, 2008 to receive public comments on the proposed changes to the agency’s policy for Listeria monocytogenes in ready-to-eat (RTE) foods that are under the jurisdiction of FDA.

FDA’s proposed new policy recommends the creation of two categories for RTE foods: those that support growth of the pathogen and those that do not.

The draft CPG defines RTE foods that do not support growth of Lm using the following criteria:

 The pH of the food is less than or equal to 4.4; or
 Is customarily held and consumed in a frozen state; or
 The water activity of the food is less than or equal to 0.92; or
 Is processed using an effective listeristatic control measure (e.g., an antimicrobial substance or a combination of factors such as pH, water activity, and antimicrobial substances).

For the category of foods that support the growth of Lm during the shelf life, FDA policy does not change and the agency will consider the food to be adulterated when Lm is present in the food based upon the analytical method that can detect 1.0 cfu per 25 grams (g) of food (i.e. 0.04 cfu/g).  For the category of foods which have been determined to not support the growth of Lm FDA may regard the food as adulterated when Lm is present at or above 100 cfu/g of food. 

“We welcome the Food and Drug Administration’s new Listeria monocytogenes draft guidance on Lm control in food,” said Randall Huffman, Ph.D., vice president of scientific affairs at the American Meat Institute Foundation (AMIF). “AMI will review and provide comments to the agency on this important initiative.  Our initial review indicates that FDA’s action appears scientifically sound, will ensure public health and reflects Listeria control policies in Europe, Canada and other nations as well as the current thinking within the Codex Alimentarius. Given global food trade, it is important food safety policies be harmonized in this way.  We hope that FDA and USDA’s Food Safety and Inspection Service (FSIS) will work toward harmonizing food safety policies in a similar way within the United States.  We urge FSIS to follow FDA’s lead on this policy.”

To view these documents, go to http://www.access.gpo.gov/su_docs/fedreg/frcont08.html or the FDA’s Web site at http://www.fda.gov/.

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