- Frozen Berries Surveillance Sampling
- Questions and Answers
- Results as of 10/1/2019
- Additional Information
Frozen berries are used as ingredients in many foods and, like other produce, can be an important part of a healthy eating pattern. While frozen berries are used in pies and other baked goods, they are also used raw in fruit salads or smoothies and have been associated with outbreaks of foodborne illness. The FDA reported three hepatitis A virus outbreaks and one norovirus outbreak linked to frozen berries in the United States from 1997 to 2016.
Strawberries, raspberries and blackberries are delicate and may become contaminated with bacteria or viruses if handled by an infected worker who does not use appropriate hand hygiene, or if exposed to contaminated agricultural water or a contaminated surface, like a harvesting tote. Freezing preserves berries but generally does not kill viruses, which can survive at low temperatures.
Questions and Answers
The FDA plans to collect samples throughout the year, across all seasons.
The FDA will collect domestic samples of frozen berries from processors, distribution centers, and warehouses. The FDA initially collected some samples at retail locations but has since removed retail collection from the sampling assignment to minimize the amount of product in commerce in the event of a positive sample, thereby further strengthening public health while minimizing market disruption. The agency will collect import samples of frozen berries from ports of entry, importer warehouses, or other storage facilities where foreign goods are cleared for entry into the country.
Samples may be collected from the same establishment or importer on more than one occasion. To minimize impact on any one firm, the FDA will not exceed three collections every six months from the same establishment, as a general rule, assuming no violations are found.
The FDA plans to collect a total of 2,000 samples of frozen berries (1,000 domestic, and 1,000 of international origin) under this assignment. The agency will only collect frozen strawberries, frozen raspberries, and frozen blackberries in retail packaging.
The FDA is testing all samples for hepatitis A virus and norovirus. From the beginning of the assignment the FDA used an RT-qPCR method that has undergone multi-laboratory validation by the FDA for the detection of hepatitis A virus and norovirus in soft fruit. While this remains the primary test for this assignment, starting in August 2019, we also initiated Sanger sequencing as a routine component of the assignment in order to further characterize viral sequences present in any RT-qPCR positive samples.
Per standard FDA practice, the agency will not provide pre-notification to firms prior to collecting samples, to preserve the study’s integrity. Sampling is a routine and critical activity that the agency is authorized to conduct to help ensure the safety of the food supply.
If the FDA detects hepatitis A virus or norovirus RNA in a sample, the agency will notify the firm of the findings and work with the firm to take appropriate action to protect the public health. Enforcement activities include actions to correct and prevent violations and to remove violative food from the market, as appropriate. Since July, the FDA began notifying firms of positive RT-qPCR positive samples and is awaiting the results of the Sanger sequencing to affirm the findings before asking the affected firms to conduct an immediate voluntary recall of the product.
See detailed information on what to expect when the FDA collects samples
The FDA plans to publish the test results on a quarterly basis. Check here as they will be posted at the bottom of this page.
The FDA is sensitive to the concerns of domestic firms and importers and strives to provide analytical results to industry as soon as they are available. The FDA will notify firms of all analytical results as soon as possible once sample analysis is complete.
Results as of 10/1/2019
The FDA began collecting and testing frozen berries (strawberries, raspberries, and blackberries) in November 2018. This assignment is anticipated to last about two years. The FDA may adjust the number of samples to be collected or the collection timeline based on factors that the agency may encounter during the assignments.
The information that follows presents the laboratory results through September 30, 2019, as interim figures subject to potential revision. The FDA will publish a summary report of its results (to include final figures and breakdowns of its findings) once the assignment is complete. People who wish to see an example report on the FDA’s food product surveillance sampling can view any of the agency’s summary reports listed at the bottom of its microbiological surveillance sampling page.
In the event that samples are found to be positive for microbial hazards, the FDA will consider regulatory and enforcement options. Enforcement activities include actions to correct and prevent violations, and to remove violative food from the market. The agency will detail any enforcement action it takes in its summary report(s).
The FDA plans to collect 2,000 samples of frozen berries (1,000 domestic, and 1,000 of international origin) under this assignment. As of September 30, 2019, the agency had collected and tested 339 domestic samples (34 percent) and 473 import samples (47 percent) of the totals. The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.