April 2021 Regulatory Update | 2 of 2

These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from April 16-30, 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 UPDATES

  • FDA Launches “New Era of Smarter Food Safety TechTalk” Podcast
  • “Real Water” Linked to Non-Viral Hepatitis Outbreak Still Being Sold Online Despite Recall

USDA UPDATES

  • USDA Seeks Comments on Food System Supply Chains MUST READ

FDA WARNING LETTERS (APRIL)

  • FDA Sends Warning Letter to IMAD International, LLC for Foreign Supplier Verification Program (FSVP) Violation
  • FDA Sends Warning Letter to Sky Global Food, Inc. for Foreign Supplier Verification Program (FSVP) Violation

OTHER DEVELOPMENTS

  • CDC’s Morbidity and Mortality Weekly Report (MMWR) Reveals Continued Pathogen Threat from Raw Flour MUST READ
  • Coalition Launches First-Ever Food Safety Certification Program for Leafy Greens Grown Indoors

FDA UPDATES

FDA Releases Updates on Salmonella Duisbur and E. coli O145:H28 Outbreaks
As of April 23, FDA’s investigation into a multistate, five-patient outbreak of Salmonella Duisbur, a rare Salmonella variant, was ongoing. The outbreak was linked to consumption of Jule’s Cashew Brie, a plant-based vegan cheese alternative made by Jule’s Foods of Carlsbad, California. Jule’s Foods voluntarily recalled all of its Cashew Brie products on April 21, as well as its plant-based dairy alternative Jule’s Spinach Artichoke Dip and Jule’s Vegan Ranch Dressing.

On April 28, FDA posted a new entry in its weekly report of ongoing foodborne illness outbreak investigations. According to the report, the agency is currently investigating an outbreak of E. coli O145:H28 that has sickened 15 people. FDA has initiated traceback on the unnamed product or products linked to the outbreak.

Read FDA’s Salmonella Duisbur Outbreak Investigation update here and FDA’s weekly outbreak investigation report here.

 

FDA Launches “New Era of Smarter Food Safety TechTalk” Podcast
April 29:FDA released the first episode of its new quarterly podcast series covering the four “Core Elements" of the New Era of Smarter Food Safety Blueprint: (1) Tech-enabled Traceability, (2) Smarter Tools and Approaches for Prevention and Outbreak Response, (3) New Business Models and Retail Modernization, and (4) Food Safety Culture. The podcast will feature experts in food safety and technology as they examine different aspects of these Core Elements.

In Episode 1, the co-leaders of the Core Element 1 team “lead a discussion with top technology and food industry experts on the role they envision new technologies playing in improving [food] traceability, and their perspectives on how FDA can help facilitate adoption of new technologies,” according to FDA’s Constituent Update.

Read FDA’s Constituent Update here and access Episode 1 of the podcast here. Read about the New Era of Smarter Food Safety Blueprint here.

 

“Real Water” Linked to Non-Viral Hepatitis Outbreak Still Being Sold Online Despite Recall
In early March 2021, an outbreak of acute non-viral hepatitis, inflammation of the liver that can result in acute liver failure, was linked to the consumption of “Real Water” brand alkaline water. During FDA’s investigation, brand owner Real Water Inc. did not fully cooperate with the agency, failing to provide certain requested records. On March 24, Real Water Inc. issued a recall of all sizes of its “Real Water” brand drinking water and concentrate. On March 31, however, FDA became aware that “Real Water” still was being sold online, and an audit revealed that multiple distributors had not been notified directly about the recall by Real Water Inc.

After March 31, the firm did provide some of the records FDA had requested, and FDA investigators completed inspections at Real Water Inc. facilities in Nevada and Arizona. Nevertheless, on April 26, the Southern Nevada Health District announced that it was investigating reports of six additional probable cases of acute non-viral hepatitis associated with “Real Water.” FDA also announced that it had become aware that “Real Water” was still being sold through online retailers.

The agency stated in its Outbreak Investigation update, “The agency is working to locate any remaining products to ensure they are no longer available to consumers. The FDA will continue to monitor this situation closely and follow up with retailers as we become aware of recalled products being offered for sale… The public is urged to report any product being offered for sale to the FDA Consumer Complaint Coordinator in their region.”

Read FDA’s Outbreak Investigation update here.


USDA UPDATES

USDA Seeks Comments on Food System Supply Chains
April 21:On February 24, 2021, President Biden issued Executive Order 14017 on “America's Supply Chains.” Among other directives, the Executive Order directed the Secretary of Agriculture to submit a report assessing the supply chains for agricultural commodity and food production within one year. In response to the Executive Order, USDA published a Federal Register Notice requesting public comments and information to assist the agency with its preparation of the report.

According to USDA’s Press Release, the agency is inviting comments on both the agricultural supply chain and ways “to target pandemic-related stimulus relief programs and spending authorized by Congress in the Consolidated Appropriations Act (CAA) and American Rescue Plan Act (ARPA) toward long term, systemic change that results in food supply chain resiliency.” Specifically, USDA is seeking input on “addressing local and regional food systems, creating new market opportunities…facilitating fair and competitive markets…advancing efforts to transform the food system, meeting the needs of the agricultural workforce, supporting and promoting consumers' nutrition security, particularly for low-income populations, and supporting the needs of socially disadvantaged and small to mid-sized producers and processors.”

Submit comments to the Federal Register Notice by May 21, 2021

Read USDA’s Press Release here and Federal Register Notice here. Read Executive Order 14017 here.


FDA WARNING LETTERS (APRIL)

FDA Sends Warning Letter to IMAD International, LLC for Foreign Supplier Verification Program (FSVP) Violation
FDA sent a warning letter to New York-based food importer IMAD International, LLC for its “significant” violation of the Foreign Supplier Verification Program (FSVP) regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the importer failed to develop, maintain, and follow FSVPs for its imported plantain chips, and it did not meet hazard analysis requirements for its melon seeds and honey beans. Furthermore, IMAD International, LLC did not establish and follow written procedures to ensure that FSVPs were conducted for its foreign suppliers.

FDA gave IMAD International, LLC 15 working days from its receipt of the letter to address its violations.

Read FDA’s warning letter here. Read the FSVP final rule here and learn more about it here.

 

FDA Sends Warning Letter to Sky Global Food, Inc. for Foreign Supplier Verification Program (FSVP) Violation
FDA sent a warning letter to California-based food importer Sky Global Food, Inc. for its “significant” violation of the Foreign Supplier Verification Program (FSVP) regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the importer failed to develop, maintain, and follow FSVPs for any of its imported foods, including its imported Dried Red Chili Pepper Powder, Wheat Noodles, and Dried Eggplant.

FDA gave Sky Global Food, Inc. 15 working days from its receipt of the letter to address its violations.

Read FDA’s warning letter here. Read the FSVP final rule here and learn more about it here.


 

OTHER DEVELOPMENTS

CDC’s Morbidity and Mortality Weekly Report (MMWR) Reveals Continued Pathogen Threat from Raw Flour
April 23:CDC’s Morbidity and Mortality Weekly Report (MMWR) highlighted a study on outbreaks of Shiga toxin-producing E. coli (STEC) O26:H11 infections linked to the consumption of raw flour (“Multistate Outbreak of Escherichia coli O26 Infections Linked to Raw Flour — the United States, 2019”).

According to the report, investigators of a 2018 multistate outbreak initially hypothesized that the E. coli infections had been caused by ground beef due to early interviews with affected patients. Gene sequence comparisons suggested that something other than ground beef was to blame, however, and investigators pivoted after CDC “noted that one patient consumed raw cookie dough and that most patients were young adult females, similar to demographic distributions of past flour-associated STEC outbreaks.” A new questionnaire focusing on exposure to ground beef, leafy greens, and raw flour found that six of the 13 patients asked about flour exposures had eaten, licked, or tasted raw homemade dough or batter during the week before illness onset. The questionnaire ultimately helped CDC and FDA trace the outbreak to a single milling facility in Buffalo, New York and led to a recall of all lots of raw flour by the milling company and the store chain that had sold contaminated flour.

The report concluded, “Flour is increasingly recognized as a cause of STEC outbreaks. Raw flour is not a ready-to-eat product, and this outbreak highlights the continuing risk for illness associated with consumption of flour and raw dough or batter. The investigation was aided by considering demographic information early in the investigation because these characteristics were similar to those in past flour-associated outbreaks.”

Read the raw flour report in CDC’s April 23 MMWR here.

 

Coalition Launches First-Ever Food Safety Certification Program for Leafy Greens Grown Indoors
April 29: The CEA (controlled environment agriculture) Food Safety Coalition launched the first food safety certification program specifically for CEA-grown leafy greens. Members of the CEA Food Safety Coalition, which was founded in 2019 to distinguish between CEA- and field-grown greens and has helped educate CDC and FDA on the limited risk of contamination for CEA-produced leafy greens, can choose to be assessed for the CEA Leafy Greens Module. Upon successful completion of the module, members may use the CEA food-safe seal on certified product packaging. According to Food Safety News, the module “is measured against science-based criteria and is an add-on to existing compliance with an underlying Global Food Safety Initiative (GFSI) recognized food safety standards.”

The certification program, which must be  completed annually,  will assess CEA growers based on four key areas: hazard analysis (including the use of water, nutrients, and site control); water (including the use of recirculating water and zone-based environmental monitoring); site control, infrastructure, and system design (including food contact surface hazard control); and pesticide and herbicide use and testing.

Food Safety News quoted the Coalition’s executive director Marni Karlin as stating: “Current food safety standards were written for the field, and many do not address the unique attributes of controlled, indoor environments…This new certification process and the accompanying on-pack seal helps to unify CEA growers while also differentiating them from traditional field agriculture. It also better informs consumers and provides a quick-glance image to know when produce has been grown safely indoors, with a high standard of quality and without some of the hazards of the field, such as potential contamination from animal byproducts.”

 

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