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FDA Issues New Draft Guidance on Listeria that Follows Science, Research

Feb 11, 2008

Responding to a petition filed four years ago by the International Ice Cream Association (IICA), the National Cheese Institute (NCI) and 15 other food organizations, the Food and Drug Administration (FDA) last week issued draft guidance for Listeria that closely aligns FDA recommendations with current scientific evidence and research results. Also last week, FDA issued draft guidance for industry that identifies more specific steps food companies can take to help prevent Listeria contamination.

The draft Compliance Policy Guide sets an allowable limit for certain ready-to-eat foods, such as ice cream and hard cheeses, that do not pose a risk for foodborne listeriosis. Although the recommendations are non-binding, they are designed to provide FDA staff and the food industry with guidance on the agency's enforcement policy for Listeria monocytogenes in all ready-to-eat foods.

"It's certainly good news that FDA has changed its guidance policy to align with the current scientific research on and understanding of Listeria. We commend the agency's decision to take action and adopt these recommendations, which are entirely safe and thoroughly tested," said Connie Tipton, IDFA president and CEO.

Specifically, the group petition asked FDA to establish a regulatory limit of 100 colony forming units per gram (cfu/g) for Listeria monocytogenes in foods that do not support its growth. The foods in this category are prepared foods that are held at or below -1 degree Celsius (such as ice cream and frozen foods); have pH values less than 4.4; have water activity less than 0.92 (this includes parmesan and other hard cheeses); or are foods demonstrating through scientific evidence that they do not support the growth of Listeria monocytogenes (such as foods with added microbial inhibitors).

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 would exempt from recalls all foods that do not support the growth of Listeria.

"It's always important for our food safety policies to actually promote food safety. In this case, it's clear that certain dairy foods are not a threat for the growth and transmission of Listeria," Tipton said.

In addition to NCI and IICA, the co-signers of the petition that spurred FDA to take action were the American Bakers Association, American Frozen Foods Institute, American Meat Institute, Grocery Manufacturers of America, Midwest Food Processors Association, National Chicken Council, National Fisheries Institute, National Food Processors Association, National Milk Producers Federation, National Turkey Federation, Northwest Food Processors Association, Snack Food Association, and United Fresh Fruit and Vegetable Association.

The draft compliance guide has been issued for review during a 60-day comment period that ends April 7. IDFA plans to submit comments supporting the guide. To read the document, click here. In addition, FDA plans to hold a public meeting to discuss the draft guide on March 28 in College Park, Md.

IDFA encourages members to review their current Listeria control measures and environmental testing plans in accordance with the second guidance document, titled "Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods."

"It appears that the new guidance recommendations are very comprehensive and prescriptive regarding environmental testing as well as finished-product testing plans," said Cary Frye, IDFA vice president of regulatory and scientific affairs. "IDFA can help individual companies to understand how these best practices can be applied in their plants."

The draft guidance for industry also is open to a 60-day comment period ending April 7. To read the document, click here.

Members with questions may contact Frye at or 202-220-3543.



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Posted February 11, 2008


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