Industry expresses support for new FDA guidance on Listeria monocytogenes

Saying its new guidance will emphasize prevention of food safety problems, the Food and Drug Administration has issued revised draft guidance on the control of Listeria monocytogenes in fresh produce and other ready-to-eat foods.

"The emphasis on prevention in this draft guidance is consistent with the FDA Food Safety Modernization Act and reflects the FDA's current good manufacturing practice requirements, as well as new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls," FDA said in a news release.

The draft guidance will have a six-month comment period that begins Jan. 17, according to the FDA. Interested parties can submit comments by visiting www.regulations.gov and typing FDA-2008-D-0096 in the search box.

Industry best practices and the "seek and destroy" approach used by the Food Safety and Inspection Service of the U.S. Department of Agriculture have been incorporated into the draft guidance, according to the release.

The FDA said integrating these approaches should lead to more effective efforts to control listeria in ready-to-eat products.

The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, sanitation and other topics.

Industry food safety experts said the revised guidance will find strong support in the fresh produce industry.

"This is a really important guidance to the produce industry and the food industry in general because it relates to how people implement procedures, policies and practices to reduce the risk of Listeria monocytogenes in ready-to-eat foods, including produce," said Jim Gorny, vice president of food safety and technology for the Produce Marketing Association, Newark, Del.

Gorny said the revised guidance doesn't appear to place a firm in regulatory jeopardy for testing for listeria species and taking corrective action. In 2008, Gorny said, the FDA issued a draft guidance on Listeria monocytogenes that precluded people from using a "seek and destroy" monitoring program.

The 2008 guidance put firms at risk because if they sought out Listeria monocytogenes on a food contact surface they were compelled to issue product recalls.

"We have been advocating with United Fresh Produce Association and other folks in the food industry for FDA to take the approach of USDA's Food Safety Inspection Service on ready-to-eat foods, and quite frankly that is what they have done," he said. "This is a victory for the industry in that FDA did listen."

The revised guidance will allow operators to test food contact surfaces using routine environmental monitoring, he said. Those tests can determine if listeria species - a genus of bacteria that contains six species, of which only Listeria monocytogenes is harmful to human health - are detected.

If anything is found, the guidance permits food manufacturers to clean and sanitize food contact surfaces, conduct an investigation and test again, Gorny said. If everything is negative after a second test, the food manufacturer can continue production.

Under the old guidance, Gorny said food suppliers who found positive tests on food contact surfaces for listeria species were advised to identify the type of listeria found or assume that it was Listeria monocytogenes and enter recall mode.

"This is a great leap forward as far as I'm concerned in terms of FDA's thinking on listeria," he said.

Gorny predicted produce and food industry support for the revised guidance.

Jennifer McEntire, vice president of food safety and technology for United Fresh Produce Association, said in an e-mail that the FDA document will allow the United Fresh/PMA joint work group on listeria to move ahead more confidently with plans for a listeria workshop and to develop other publications to help the fresh produce industry further enhance their food safety systems.
 
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