FDA In Brief: FDA takes steps to improve ice cream production facility safety following inspections and environmental sampling efforts

April 24, 2019

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“Inspecting food facilities and collecting and testing samples from the environment where foods are produced are two of the many ways the FDA works to better understand microbial hazards and to help prevent contaminated products from reaching consumers. These activities help the FDA gather data and information necessary to develop prevention-based systems and, when contamination does occur, to respond swiftly to these hazards. Following a string of safety issues related to a number of U.S. ice cream distributors, the FDA engaged a team to inspect and obtain environmental samples from 89 ice cream production facilities in 32 states to test for Listeria monocytogenes and Salmonella. Although many of these facilities were adhering to good manufacturing practices, we did find that some were in violation of the law,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “Findings from our inspections resulted in three voluntary recalls that were conducted in 2017 and 2018 to protect public health. We also collaborated with inspected companies to help them make needed corrections and implement food safety plans designed to keep harmful bacteria out of their products and protect American consumers. These results serve as an important reminder to all food facilities distributing products in the U.S. of the importance of complying with rules set forth to mitigate safety issues. Ultimately, we must work together to ensure all necessary protective steps are taken so that Americans can continue having confidence that the foods available for purchase in the U.S. are safe and wholesome.”

The U.S. Food and Drug Administration today released a report on its findings from inspections and environmental sampling for Listeria monocytogenes and Salmonella at 89 ice cream production facilities in 32 states from Sept. 12, 2016 to Aug. 30, 2017. The agency began the sampling assignment following 16 recalls of ice cream products that occurred from 2013 to 2015 due to the presence of pathogens, and an outbreak of listeriosis linked to an ice cream maker in 2015 that involved three deaths. The sampling was designed to gain insights into the extent to which Listeria monocytogenes and Salmonella may be in the manufacturing environment, and to evaluate each establishment’s ability to identify, prevent, reduce, and/or eliminate microbial hazards of public health concern. No objectionable conditions or practices were observed in nearly half of the ice cream production facilities inspected. The FDA did detect Listeria monocytogenes in 19 of the facilities; however, only one of them was found to have the pathogen on a food-contact surface. The FDA also detected Salmonella in one facility.

As a result of these findings, three voluntary recalls were conducted in 2017 and 2018. These include two voluntary recalls of Working Cow Homemade Inc. ice creams due to potential contamination with Listeria monocytogenes, and a Nelson's Creamery LLC recall due to undeclared soy lecithin in one of their products. The FDA also suspended Working Cow Homemade Inc.’s food facility registration in 2018. The FDA lifted the suspension earlier this year after the firm changed its business model to cease making ice cream and only distribute product made by other manufacturers.

The findings affirm the need for commercial ice cream makers to ensure that they are controlling hazards in accordance with the Preventive Controls for Human Food rule established by the FDA Food Safety Modernization Act. Companies that follow the rule and employ robust environmental monitoring programs will likely occasionally detect environmental pathogens, but how an establishment responds to a pathogen finding is critica.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.