The U.S. Food and Drug Administration (FDA) has announced two new food safety prevention strategies intended to help prevent outbreaks of foodborne salmonellosis and listeriosis associated with imported enoki and wood ear mushrooms, and salmonellosis associated with bulb onions. The strategies are part of FDA’s Foodborne Outbreak Response Improvement Plan under its New Era of Smarter Food Safety. FDA is also working with industry, state, international, and other partners on the development of several other food safety prevention strategies that will be released as they become available.

The prevention strategies are based on findings learned from investigations that are carried out when a foodborne illness outbreak occurs. FDA states that the prevention strategies are an affirmative, deliberate approach undertaken by the agency and relevant stakeholders to help limit or prevent future outbreaks, similar to the approach taken as part of the Leafy Green STEC Action Plan (LGAP). The strategies examine commodity-hazard pairings, potential sources and routes of contamination, and what can be done to reduce future incidences of foodborne illness. The strategies also identify existing knowledge gaps and areas that require focus to inform, as well as promote research and engagement with, external stakeholders for collaborations to protect public health and prevent future outbreaks.

For a deep dive on FDA's commodity-specific prevention strategies for produce—including those that have already been released, and future strategies that are in development—listen to the Food Safety Matters podcast episode with Stephen Hughes, Prevention Coordinator within FDA's Center for Food Safety and Applied Nutrition (CFSAN), and Jennifer McEntire, Ph.D., Chief Food Safety and Regulatory Officer at the International Fresh Produce Association (IAFP).

Prevention Strategy for Salmonellosis and Listeriosis Associated with Imported Enoki and Wood Ear Mushrooms

In 2020, FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network, in collaboration with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated a multistate outbreak of Listeria monocytogenes infections linked to the consumption of enoki mushrooms imported from the Republic of Korea (ROK). The outbreak resulted in four deaths and 31 hospitalizations.

Also in 2020, CORE, CDC, and state and local partners investigated a multistate outbreak of Salmonella Stanley linked to the consumption of wood ear mushrooms imported from China. A total of 55 salmonellosis illnesses were reported in 12 states, and six patients were hospitalized. Based on a review of the outbreak findings, historical data, and engagements with industry and other stakeholders, FDA has identified measures that can be taken to reduce future incidences of foodborne illness related to imported enoki and wood ear mushrooms, including:

• Ensuring that exporting firms and competent authorities are aware of the applicable Produce Safety Rule requirements for specialty mushrooms and the potential cultural differences associated with consumption of raw specialty mushrooms   
• Engaging food safety authorities in ROK, China, Canada, and Japan to better understand the potential sources of contamination in enoki and wood ear mushrooms and what producers are doing to prevent contamination of these mushrooms    
• Conducting research to better understand how L. monocytogenes contaminates enoki mushrooms
• Conducting research to better understand the survival of L. monocytogenes and Salmonella on enoki mushrooms and wood ear mushrooms
• Increasing strategic and targeted FDA sampling of imported specialty mushrooms at U.S. ports of entry
• Increasing state sampling of specialty mushrooms at retail operations in the U.S.
• Working with industry to ensure that international specialty mushroom producers have access to training intended to help them meet requirements for ensuring the safe production of mushrooms for import into the U.S.

Prevention Strategy for Salmonellosis Associated with Bulb Onions

According to FDA, in 2020 and 2021, Salmonella outbreaks associated with the consumption of bulb onions produced in the U.S. and Mexico caused more than 2,100 confirmed cases of foodborne illness in the U.S. Based on findings from outbreak investigations led by CORE, CDC, and state and local partners; historical data; and engagements with industry and other stakeholders, FDA has identified measures that can be taken to reduce future incidences of foodborne illness related to bulb onions, including:

• Engaging domestic and foreign industry and government partners to promote a broad understanding of the outbreak investigation findings, applicable Produce Safety Rule requirements, and the importance of root-cause analysis after outbreaks
• Prioritizing inspections of bulb onion farms in the U.S. and Mexico that are covered by the FDA’s Produce Safety Rule
• Identifying and assessing practices and conditions associated with onion curing    
• Supporting research efforts to better understand bulb onion production practices, including the impact of different soil conditions and curing practices on the safety of bulb onions
• Supporting industry-led efforts to develop and implement best practices for bulb onion production  
• Prioritizing Foreign Supplier Verification Program inspections of bulb onion importers
• Increasing strategic, targeted sample collection and testing of imported bulb onions from the State of Chihuahua, Mexico
• Continuing to collaborate with Mexican competent authorities through the established Food Safety Partnership to help ensure the safe production of bulb onions in the State of Chihuahua, Mexico.

All FDA prevention strategies can be viewed on the agency’s Food Safety Prevention Strategy web page.