Food Safety

FSMA Compliance Even More Important As Frozen Berries Come Under Scrutiny For Norovirus & Hepatitis A


Norovirus is a contagious virus causing vomiting and diarrhea nausea and stomach pains and outbreaks are quite common. It spreads easily and quickly through contaminated food products as well as from other people and contaminated surfaces.  Since one in six Americans gets sick from eating contaminated food each year, it is in everyone’s best interest to take a proactive and preventative approach to the problem.

Hepatitis A is a highly contagious liver infection caused by the Hepatitis A virus spread from contaminated food, water or contact with someone else who is infected.  Symptoms include fatigue, abdominal pain, jaundice, fever and dark urine.  Fortunately, the occurrence is quite rare with fewer than 20,000 cases in the United States reported annually.  It is preventable by vaccine and resolves itself within a few days to weeks with proper medical treatment.

Since November 2018, the FDA (U.S. Food & Drug Administration) has been sampling frozen berries for Hepatitis A virus and Norovirus from both domestically produced and imported product. Samples of frozen berries have been and are now being collected from retail stores, warehouses, processors and distribution centers, as well as from ports of entry, and cold storage facilities for imported goods.

Recently there have been numerous recalls of frozen berries due to the potential of Hepatitis A (HAV) and Norovirus. Now that the summer is here with warmer temperatures, people are eating even more raw berries in products like frozen smoothies, ice cream and fruit salads.  The potential for concern arises because berries are consumed without having undergone a “kill step” such as cooking that reduces or eliminates pathogens. Freezing the fruit generally doesn’t kill the pathogen, since pathogens can survive at low temperatures.  Eating berry fruits that have been cooked in baked goods and pies should not present any risk.

Fruits like strawberries, blackberries and raspberries may become tainted with the virus or bacteria quite easily.  “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.”

The recent increased sampling by FDA is part of the FDA’s new sampling approach under FSMA (the Food Safety Modernization Act) in an effort to keep contaminated products from reaching consumers.  The FDA’s current approach is to collect a large number of samples of targeted foods (such as frozen berries) over a relatively short period of about 18 months, to ensure enough data has been collected to make informed decisions.  This helps the FDA determine if there are any commonalities with regard to origin, variety or season, while previously the FDA only collected a relatively small number of samples of many different commodities over many years. When the hepatitis A virus (HAV) or Norovirus is found, the firm is notified of the findings and FDA will work with that company or in some cases may take action such as placing a company or importer on alert, oversee a recall or issue a public warning.

AFFI, the American Frozen Food Institute, is the national trade association working on behalf of all members to advance frozen foods and food safety.  Recently AFFI has been working tirelessly to assist its members through this tedious process of frozen berry recalls and is particularly concerned with the methodology of collection by FDA. Alison Bodor, President and CEO of AFFI wrote to the members in May 2019 that:

“AFFI has also had multiple conversations and correspondence with FDA to discuss our primary concern, which is that frozen berries will be regarded by the consumer as a risky food that should be cooked to reduce the risk of foodborne illness when, as we know, frozen berries are a low-risk, ready-to-eat food. We have requested that FDA revise the Constituent Update to better represent the purpose of the sampling assignment and the low risk that frozen berries represent when consumed as intended (as a ready-to-eat food).”

On Friday, June 21, AFFI provided an update indicating frozen berry sampling may be modified as follows:

“The American Frozen Food Institute (AFFI) was contacted by FDA Deputy Commissioner Frank Yannas Friday afternoon. While FDA is not yet prepared to confirm their next steps on the sampling program, the deputy commissioner conveyed that the program will likely be modified to address the concerns that AFFI has raised. We believe this means that moving forward presumptive positive PCR results will not be considered violative and therefore, should not trigger a class II recall or market withdrawal and associated public statement. We expect FDA will confirm modifications to the berry sampling program next week.

In the meantime, should your company experience pressure from FDA to issue a public announcement, please contact AFFI. We will continue to keep you apprised of the latest developments and our progress with FDA.”

This is excellent news, but despite the potential changes in methodology of sampling, all of the recent recalls underscore the importance of compliance with FSMA regulations and the advancement of food safety practices in our industry.

















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