FDA announces new strategy to prevent contamination of fresh and frozen berries

The FDA has developed a new strategy to prevent the contamination of fresh and frozen berries with viruses such as hepatitis A and norovirus.

“Collaboration between regulators, the global berry industry, and other interest holders has been critical for the development of this strategy. We look forward to ongoing collaboration to ensure the success of this strategy, and others, for the prevention of foodborne illness,” said Conrad Choiniere, director of the Office of Microbiological Food Safety at the FDA’s Human Food Program.

The strategy applies to domestic and imported berries and was developed with input from industry. While no multistate enteric virus outbreaks have been linked to domestic berries in 35 years, according to the Food and Drug Administration, there have been outbreaks from imported fresh and frozen berries.

The most recent hepatitis A outbreaks linked to strawberries occurred in 2022 and 2023 when imported berries from the same grower were identified as the vehicle. In 2023 a joint expert panel of Food and Agriculture Organizations of the United Nations and the World Health Organization identified frozen berries contaminated with hepatitis A and norovirus as one of the virus-commodity pairs of “highest global public health burden” in its updated review of foodborne viruses and relevant food commodities of highest public health concern.

“Outbreak investigations related to berries highlight the recurring issues that inform the preventive actions outlined in the new prevention strategy to reduce the risk of viruses in fresh and frozen berries,” according to the FDA’s announcement about its new strategy. 

“Hygienic practices and challenges for the control of enteric viruses in berries and other hand-harvested produce apply globally. An approach that identifies, leverages, and shares effective practices can benefit domestic and global operators that grow, process, and source berries and other produce with similar risk factors.”

The new prevention strategy is designed to address factors that have the potential to contribute to the contamination of berries with enteric viruses. It outlines actions for the FDA, industry and other interest holders to take to identify and ensure accurate and timely communication and consistent application of effective prevention measures across the global berry industry.

With the new prevention strategy the FDA hopes to:

  • Promote high rates of compliance with FDA food safety requirements.
  • Encourage the berry industry to identify and ensure consistent application of processes, or a combination of processes, which describe adequate berry pre- and post-harvest sanitary practices for domestic and global berry operations, including promoting the use of root cause analysis when failures are observed in food safety systems.
  • Broaden scientific knowledge about the viability, persistence, detection, and mitigation of viruses in fresh and frozen berries, pre- and post-harvest environments, and agricultural water sources.
  • Incentivize industry and governments to embrace the use of public health prevention measures through immunization programs to promote worker health.

According to the FDA, its new prevention strategy addresses significant knowledge gaps by fostering scientific research to enhance the ability to detect and characterize enteric viruses in different sample types, as well as linking the source of contamination using advanced laboratory methods. The strategy also identifies research to understand the ecology of enteric viruses in berry and other fresh produce operations.

“These actions were informed by assessments of outbreak findings, engagement with food safety experts in industry and other interest holders, and a review of historical data. A surveillance sampling assignment conducted between FY19 to 23 further supports the need for vigilant monitoring and consistent application of effective controls,” according to an FDA statement about the new program.

Two industry groups applauded the FDA’s new program.

The American Frozen Food Institute (AFFI) said the release of the new prevention strategy aligns closely with AFFI-published guidance and related training courses for food safety professionals through the International Food Protection Training Institute. However, the  AAFI raised two concerns about the new FDA strategy.

According to the AFFI, the strategy has significant flaws that need to be corrected to ensure the berry industry and consumers have faith in  the system and are adequately protected. For example:

  • AFFI strongly believes the testing generated “false” positive signals that led to unnecessary recalls, food waste and consumer confusion. 
  • The report did not undergo review by an independent panel of third party, external food safety experts, a step that would engender greater confidence in the FDA’s testing and food safety recommendations.

The International Fresh Produce Association’s (IFPA) reaction to the new strategy did not include any criticism. 

A statement from the international association said the prevention strategy provides an opportunity for greater global cooperation to manage enteric viruses on berries. 

“Preventing food safety issues is of the highest priority for the industry, and IFPA appreciated the FDA’s acknowledgment in their report that there have been no enteric virus outbreaks associated with domestic berries in the past 35 years,” the IFPA statement said.

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