LOS ANGELES - Following a series of recalls in prior years, an inspection of ice cream maker facilities across the country in 2016 and 2017 found the presence of harmful bacteria and resulted in multiple other voluntary recalls, the U.S. Food and Drug Administration announced Wednesday.
The FDA began the inspection in August 2016 after 16 ice cream products were recalled in the three years prior due to the presence of pathogens, and an outbreak of listeriosis linked to an ice cream maker in 2015 that involved three deaths.
The FDA said it obtained samples from 89 ice cream production facilities in 32 states from September 2016 to August 2017, choosing “larger establishments whose product would be expected to reach greater numbers of consumers.”
The facilities inspected account for 16 percent of all ice cream manufacturers in the U.S.
The FDA detected listeria monocytogenes, which can cause the serious listeriosis infection, in 19 of the 89 facilities and found salmonella in one of the facilities.
The agency detected listeria monocytogenes on food contact surfaces at only one of the 19 facilities, whereas all the other findings of the pathogen were found on non-food contact surfaces.
The salmonella-positive sample came from a non-food contact surface, the wheel of a forklift that transported ingredients from a storage area to a production area, according to the FDA.
The agency said the goal of the investigation was to gain insights into the prevalence of certain types of harmful bacteria in the manufacturing environment — and to evaluate each facility’s ability to prevent contamination.
“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.
As a result of the inspections, the FDA suspended the food facility registration for Working Cow Homemade Inc. in 2018. The suspension was lifted, however, after the firm changed its business model to stop making ice cream and only distribute ice cream products made by other manufacturers.
The Florida-based Working Cow Homemade also issued two voluntary recalls of its ice creams due to potential listeria contamination.
Pennsylvania-based Nelson's Creamery recalled one of its products due to an undeclared amount of soy lecithin, a food additive, according to the FDA.
“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,” Yiannas said.
According to the Centers for Disease Control and Prevention, listeriosis primarily affects pregnant women, newborns, older adults and people with weakened immune systems. Most people with “invasive” listeriosis require hospital care, and an estimated one in five people with the infection die.
Those infected with salmonella typically develop diarrhea, fever and abdominal cramps between 12 and 72 hours after infection, the CDC says. Children are at the highest risk for developing the infection.
The International Dairy Foods Association, which represents the nation’s dairy manufacturing and marketing industry, shared the following statement in response to the FDA report:
“Ice cream makers strive to ensure their products are safely produced. The result is a product that can be safely enjoyed every day, all across the country by millions of consumers. The FDA report released today should help to further understanding about foodborne pathogens and the steps being taken to build better controls and knowledge to ensure food safety—but it must be read and reported carefully and accurately so as not to exaggerate the findings. The report demonstrates very low rates of positive findings of Listeria monocytogenes (“Lm”) and Salmonella in ice cream plants—1.25% and 0.01%, respectively. Most importantly, just a single positive result was found on a food contact surface, whereas the rest were found in other areas of the plants that do not come into contact with food. Moreover, none of the samples taken were taken from retail products in the food supply. Lm, in particular, can commonly be found in the outside environment and makes its way into food plants through the movement of people, equipment and other materials, so the goal is to prevent these bacteria from getting into the food itself. Since this sampling was conducted back in 2016-17, significant changes have occurred throughout the industry as companies have learned more about these pathogens and enhanced their programs in conjunction with the preventive control requirements of the FDA Food Safety Modernization Act (FSMA). Plants have strengthened their food safety programs to seek out and eliminate harmful bacteria like Lm and Salmonella wherever they are found in ice cream production environments. IDFA has worked closely with the industry to ensure awareness of food safety risks and provide all information and resources necessary for the ice cream industry to continue to enhance their food safety programs and keep ice cream a safe, delicious treat.”