Listeria Policy Announced by FDAFeb 20, 2008 | Parker Waichman LLP
Listeria, a sometimes deadly form of food poisoning, has made news in recent weeks, as Listeria outbreaks have been tied to tainted milk and other ready-to-eat foods. The US Food and Drug Administration (FDA) announced a new draft compliance policy to the control the growth Listeria monocytogenes – the bacteria that causes Listeria – in ready-to-eat foods. This is a groundbreaking policy in that this is the first time different policies have been created for foods that do and do not support growth of the toxic organism. The American Meat Institute (AMI) has long looked to the Food Safety and Inspection Service (FSIS) to adopt a similar science-based policy reflecting international standards adopted by Europe, Canada, and other nations.
For foods that do not support the growth of the listeria bacteria, the FDA will revise its tolerance level; the “zero tolerance” standard for ready-to-eat foods that do support the growth of the bacteria will not change. 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including a draft Compliance Policy Guide that provides guidance for FDA staff on the agency’s enforcement policy, a draft Guidance for Industry on Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods, and a Notice of a Public Meeting on March 28, 2008 to receive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 (Lm) in ready-to-eat foods under FDA jurisdiction.
Listeriosis is a type of food poisoning dangerous to the elderly, pregnant women, newborns, and those with chronic medical conditions. Most people experience only mild flu like symptoms—fever, muscle aches, nausea, or diarrhea. In serious cases, the disease spreads to the nervous system, causing headaches, stiff neck, and convulsions. Listeria lives in soil and water and can easily contaminate dairy and beef products; because listeria thrives in cold, milk is an ideal environment.
The draft defines ready-to-eat foods that do not support growth of the bacteria using criteria based on the food’s pH and other factors, including a listeristatic control measure. FDA policy does not change and the agency will consider the food to be contaminated when the bacteria is present in foods supporting the growth of Lm during shelf life. Foods that do not support listeria growth will be considered contaminated when bacteria is present or above the new criterion.
“We welcome the Food and Drug Administration’s new Listeria monocytogenes draft guidance on Listeria monocytogenes control in food,” said Randall Huffman, Ph.D., vice president of scientific affairs at the AMI. “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 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.” Codex Alimentarius is a commission created to protect consumer health, fair food trade practices, promote coordination of food standards work by international governmental and non-governmental organizations.