May 2021 Regulatory Update | 1 of 2

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This Regulatory Update includes information from May 1-15, 2021. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business.

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  • FDA to Conduct Consumer Research on Symbols for Conveying “Healthy” Nutrient Content Claim MUST READ
  • FDA Opens Industry Portal for FSVP Records Submission MUST READ
  • FDA to Test Leafy Greens from Salinas Valley, CA for Shiga Toxin-Producing Escherichia coli (STEC)


  • FDA Releases Report on Foodborne Illness Risk Factors in Retail Delis
  • FDA Releases Report on June – October 2020 Red Onion Salmonella Outbreak MUST READ


  • USDA to Purchase $159.4M in Domestically Produced Seafood and Other Food Products for Distribution to Food Assistance Programs   MUST READ


FDA to Conduct Consumer Research on Symbols for Conveying “Healthy” Nutrient Content Claim
May 6: FDA published a Federal Register procedural notice about its upcoming research on food package symbols that could be used to convey the “healthy” nutrient content claim. According to the agency’s Constituent Update, it is conducting the research “in conjunction with the development of a [forthcoming] proposed rule…that would update when manufacturers may use the ‘healthy’ nutrient content claim on food packages.”

FDA’s proposed update to the definition of the “healthy” claim and creation of a symbol for the claim are part of its Nutrition Innovation Strategy (NIS), which it launched in March 2018 to innovate tactics for reducing nutrition-related chronic diseases. One of the NIS’s goals is modernizing nutrient claims, “which serve as quick signals for consumers about what benefits a food or beverage they choose might have” and “can encourage companies to reformulate products to improve their nutritional value.”

Submit comments about FDA’s proposed information collection to its Federal Register notice by July 6, 2021.

Read FDA’s Constituent Update here, Press Announcement here, and Federal Register notice here. Read about the NIS here.


FDA Opens Industry Portal for FSVP Records Submission
May 10: FDA officially opened its Foreign Suppliers Verification Programs (FSVP) “Importer Portal for FSVP Records Submission.” The Portal allows importers of human and animal food into the U.S. to submit requested FSVP records electronically to FDA.

Under the FSVP regulation of the Food Safety Modernization Act (FSMA), importers are required to participate in “certain risk-based activities to verify that their foreign suppliers are producing food in accordance with U.S. food safety standards,” according to FDA’s Constituent Update. Although FDA typically inspects FSVP records at importers’ places of business, the agency may request those records in writing and require importers to provide them to FDA electronically, “or through another means that delivers the records promptly.”

Read FDA’s Constituent Update here. Read the User Guide for the Portal here (PDF).


FDA to Test Leafy Greens from Salinas Valley, CA for Shiga Toxin-Producing Escherichia coli (STEC)
May 11: In response to recurring foodborne illness outbreaks linked to California’s Salinas Valley, FDA will be collecting and testing the region’s leafy greens for Shiga toxin-producing Escherichia coli (STEC), including E. coli O157:H7, and Salmonella spp., from May through November 2021.

FDA plans to sample and test approximately 500 post-harvest samples of iceberg, leaf, and romaine lettuce collected from commercial cooling and cold storage facilities “where field heat is removed from harvested lettuce and where product is cold-stored before processing,” according to the agency’s Constituent Update. If FDA detects a pathogen like E. coli O157:H7 during its sampling, it “will conduct a follow-up investigation to identify potential sources and routes of contamination.”

This new assignment builds on FDA’s ongoing collaboration with stakeholders in the California Central Coast growing region to identify the likely routes of leafy greens contamination with STECs. As part of its March 2020 Leafy Greens Action Plan, in November 2020 the agency launched a multi-year longitudinal study on improving food safety in the region in partnership with the California Department of Food and Agriculture (CDFA), the University of California, Davis, and the Western Center for Food Safety (WCFS).

Read FDA’s Constituent Update here. Read about FDA’s partnership with the CDFA, et al., in our November 2020 (Part 2) Regulatory Update here.


FDA Releases Report on Foodborne Illness Risk Factors in Retail Delis
May 7: FDA released a report on its study of foodborne illness risk factors in retail food store deli departments. The data, which was collected during 2015-2016, showed that “delis with well-developed Food Safety Management Systems (FSMS) were more likely to properly control foodborne illness risk factors than delis with less developed FSMS,” according to FDA’s Constituent Update. The agency also found that delis with Certified Food Protection Managers (CFPM) “ha[d] significantly better developed FSMS than delis that d[id] not have a CFPM present or employed.”

FDA’s data analysis further revealed that deli departments had the best control over “ensuring no bare-hand contact with ready-to-eat foods” and “cooking raw animal foods to required temperatures,” whereas the most common food safety areas in need of improvement included “ensuring employees practiced proper handwashing,” “holding foods requiring refrigeration at the proper temperature,” and “cooling foods properly.”

The results of FDA’s data analysis will inform future activities to modernize traditional retail food safety approaches as part of its New Era of Smarter Food Safety initiative.

Read FDA’s Constituent Update here and the report here (PDF).


FDA Releases Report on June – October 2020 Red Onion Salmonella Outbreak
May 13: FDA released its report on the Salmonella Newport outbreak that caused over 1,600 reported illnesses in the U.S. and Canada between June and October 2020 – the largest Salmonella foodborne illness outbreak in more than a decade. FDA, CDC, state partners, and Canadian officials traced the outbreak to whole red onions supplied by California-based Thomson International Inc. According to the agency’s Constituent Update, the report “includes an overview of the traceback investigation, subsequent on-site interviews, visual observations of the growing fields, and environmental sampling, and various factors that potentially contributed to the contamination of red onions with Salmonella.”

Although the agencies were unable to pinpoint a single conclusive root cause of the outbreak, they did identify multiple potential contributing factors. The leading hypothesis was that contaminated irrigation water used in a growing field in Holtville, California had contaminated the onions. Other hypothesized factors included “sheep grazing on adjacent land; signs of animal intrusion, including scat (fecal droppings), and large flocks of birds that may spread contamination; and food contact surfaces that had not been inspected, maintained, or cleaned as frequently as necessary to protect against the contamination of produce.”

In light of the report, FDA offered several food safety recommendations for farms, encouraging them to use risk-based preventive measures; to consider the risks posed by adjacent and nearby land uses; to consider pre-harvest and/or post-harvest sampling and testing of products; and to improve product traceability by increasing digitization and standardization of traceability records. 

Read FDA’s Constituent Update here, Press Announcement here, and Executive Summary here. Access the report here.


USDA to Purchase $159.4M in Domestically Produced Seafood and Other Food Products for Distribution to Food Assistance Programs 
May 13: USA announced that it will purchase up to $159.4 million in domestically produced seafood, fruits, legumes, and nuts for distribution to food assistance programs and charitable institutions. This purchase, intended to support U.S. seafood producers hit heavily by the pandemic and to combat food system disruptions and worsening food insecurity, will be the single largest purchase of American-raised seafood in USDA’s history.

USDA plans to purchase, among other commodities, Alaska pollock, apricots (canned, dried, and frozen), chickpeas, dry peas, Gulf of Mexico and South Atlantic wild-caught shrimp, lentils, navy beans, Pacific pink shrimp, Pacific rockfish fillets, Pacific whiting fillets, pistachios, prepared peaches, and sockeye (red) salmon. According to USDA’s Press Release, “[t]he inventories of these commodities are in high oversupply due to a decrease in demand because of the COVID-19 pandemic and disruption in the supply chain, as restaurants and other outlets closed during the pandemic.”

Solicitations will be available through the Web-Based Supply Chain Management (WBSCM) system and on the Agricultural Marketing Service's website.

Read USDA’s Press Release here.