Jay Sjerven

The U.S. Food and Drug Administration on Jan. 13 issued a draft guidance for industry for “Control of Listeria monocytogenes in ready-to-eat foods.” The draft guidance updates the guidance for industry titled “Control of Listeria monocytogenes in refrigerated or frozen ready-to-eat foods” that was issued in February 2008. The current document reflects consideration of public comments made on the earlier draft guidance. Additionally, with its emphasis on prevention, the revised draft guidance is consistent with the F.D.A. Food Safety Modernization Act.

The updated document was published in the Federal Register on Jan. 17. Its publication commenced a 180-day period during which the F.D.A. will accept public comments.

With its emphasis on prevention, the draft guidance is consistent with the F.D.A. Food Safety Modernization Act.

“Industry best practices and the ‘seek and destroy’ approach used by the Food Safety and Inspection Service (F.S.I.S.) of the U.S. Department of Agriculture have been incorporated into the draft guidance,” the F.D.A. said. “Integrating these approaches along with the food safety requirements under F.S.M.A. should lead to more effective efforts to control
Listeria monocytogenes in ready-to-eat products. Ready-to-eat facilities that produce foods that are regulated by both the F.S.I.S. and F.D.A. will also benefit from a uniform federal approach to reducing the risk of environmental contamination withListeria monocytogenes.”

The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as treatments that killListeria monocytogenesand formulations to prevent it from growing during storage of the food between production and consumption. The draft guidance does not change or alter what constitutes a ready-to-eat food.

The principal difference from the previous draft guidance is its incorporating what has been called “search and destroy” procedures as already allowed by F.S.I.S. for food facilities under its purview, said Jim Gorny, vice-president, food safety and technology, Produce Marketing Association, Sacramento, Calif. Mr. Gorny explained under the 2008 F.D.A. draft guidance , persons conducting environmental monitoring of their facility and who detect a Listeria species (there are several with onlyListeria monocytogenesas harmful to human health), they either must assume what was detected was, indeed,Listeria monocytogenesor conduct tests to determine the species. If the test is positive forListeria monocytogenes, and it was found on a food contact surface, “you are immediately put in a recall mode.”

Mr. Gorny said, “That approach was problematic because it was a disincentive for persons to actually seek and find niches and harborages ofListeria monocytogenesand destroy them.”

The approach outlined in the new draft guidance is aligned with that employed by the F.S.I.S., “which basically says if you look for Listeria species and find it once, you take corrective actions, clean, and then go back and verify that you now have negatives in that area, and you’re good to go,” Mr. Gorny said. “You don’t have to recall, as it may have been what we call transientListeria monocytogenes, which may have been brought into the facility on raw material and does not signify the pathogen has been established in your facility.”

The F.D.A. in the new guidance provides detailed instruction on what steps should be taken in the event of detection ofListeria monocytogeneson a food contact surface in a facility with requirements escalating at each step should positive detections continue to be recorded.

Mr. Gorny said the new draft guidance encourages environmental monitoring and the active search for Listeria species.

“We acknowledge there is great importance to preventing listeriosis, and this really unleashes the power of the industry to go and start doing that,” he said.

“Food and beverage manufacturers are committed to ensuring the safety of their products, and that includes protecting them from foodborne pathogens such as Listeria monocytogenes,” said the Grocery Manufacturers Association in a statement to Food Business News. “We appreciate F.D.A.’s new draft guidance for the control of Listeria monocytogenes in ready-to-eat foods and look forward to reviewing it to determine how it may further enhance our control strategies for guarding against the presence of this pathogen in products and manufacturing facilities.”