June 2021 Regulatory Update | 1 of 2
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This Regulatory Update includes information from June 1-17, 2021. Please contact Paul BensonTaylor Fritsch, or Leah Ziemba for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best & Friedrich, to help navigate this challenging time, please follow these hyperlinks to Michael Best’s COVID-19 Resource Center and CARES Act Relief Resource Center.


  • FDA Issues Compliance Policy Guide on Aflatoxins in Human Food MUST READ
  • FDA Releases Fact Sheets on FY 2022 Budget Request
  • FDA Releases Investigation Report on Summer 2020 Salmonella Outbreak in Peaches
  • FDA Issues Final Rule to Revoke Standards for Lowfat and Nonfat Yogurt and Amend Standard for Yogurt MUST READ
  • FDA Issues Threshold of Regulation Exemption for Metal Carbides in Food Processing Equipment MUST READ


  • USDA-FSIS Issues Public Health Alert for Possible Salmonella Contamination of Frozen Raw Breaded Chicken Products MUST READ
  • USDA Announces Over $4 Billion Investments in Critical Supply Chain through Build Back Better Initiative
  • USDA Announces Plan to Issue Three Proposed Rules Supporting Enforcement of Packers and Stockyards Act MUST READ
  • USDA Announces Additional Aid Via Pandemic Assistance for Producers Initiative


  • National Cattlemen’s Beef Association (NCBA) Petitions USDA-FSIS for Updated Beef Product Labeling Standards MUST READ


FDA Issues Compliance Policy Guide on Aflatoxins in Human Food
FDA released a Compliance Policy Guide on the presence of aflatoxins, known carcinogens that are associated with liver cancer when consumed or ingested at high levels, in human food. According to the guide, “Aflatoxins may occur in food as a result of mold growth in susceptible raw agricultural commodities. The growth of molds that produce aflatoxins is influenced by environmental factors such as temperature, humidity, and extent of rainfall during the pre-harvesting, harvesting, or post-harvesting periods.” The foods most susceptible to molds that produce aflatoxins are peanuts; corn; some tree nuts, including Brazil nuts and pistachios; and some small grains, such as rice.

The guide describes FDA’s policy regarding aflatoxins in human food: a food product containing total aflatoxins greater than 20 micrograms per kilogram (mcg/kg) or parts per billion (ppb) is considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guide also outlines the criteria for submitting a recommendation for seizure of certain human foods adulterated with aflatoxins. Brazil nuts, peanuts and peanut products, and pistachio nuts, each have their own aflatoxin Compliance Policy Guides.

Read the Compliance Policy Guide here.  Read the Aflatoxins in Brazil Nuts guide here, Aflatoxins in Peanuts and Peanut Products guide here, and Aflatoxins in Pistachio Nuts guide here 


FDA Releases Fact Sheets on FY 2022 Budget Request 
June 7:FDA released four fact sheets outlining major food safety and nutrition investments in President Biden’s Fiscal Year (FY) 2022 Budget Request, which allocated $1.6 billion in budget authority to FDA for food safety – an increase of $134 million from FY 2021. Of that additional $134 million, approximately $45 million will support initiatives to advance the New Era of Smarter Food Safety initiative, $20 million will support an updated approach to dangerous chemicals and toxins in foods, and $ 18 million will support programs to improve maternal and infant health and nutrition.

The fact sheets cover FDA’s recent food safety-related accomplishments; FDA’s goals for investing in the New Era of Smarter Food Safety, including broadening the use of rapid deployment tools in response to foodborne illness outbreaks; FDA’s goals for addressing chemical and toxicology issues, including recruiting more experts to detect and reduce exposure to dangerous chemicals; and FDA’s goals for improving maternal and infant health and nutrition, including establishing action levels for toxic elements in baby foods.

Access and read the fact sheets here.


FDA Releases Investigation Report on Summer 2020 Salmonella Outbreak in Peaches
June 11:  FDA released its report on CDC and FDA’s investigation of the Salmonella Enteritidis outbreak linked to peaches during Summer 2020. The outbreak, which appears to be the first known Salmonella outbreak linked to peaches, caused 101 reported illnesses, including 28 hospitalizations, across 17 states. According to FDA’s Executive Summary of the report, “this multistate outbreak appears to represent a novel commodity/pathogen pair.”

Between August and October 2020, outbreak investigators conducted over 700 tests on environmental, peach, and peach tree leaf samples.  They did not find the outbreak strain responsible for the reported illnesses, but whole genome sequencing analysis and geospatial analyses of the orchards that supplied fresh peaches during the time period in question “suggested several plausible opportunities for contamination[,] including from airborne transmission of fugitive dust possibly originating from adjacent animal operations (e.g., poultry or cattle).” These findings strengthened FDA’s concerns about potential contamination associated with planting produce on lands adjacent to animal operations. 

Read FDA’s Constituent Update here and access the report here. 


FDA Issues Final Rule to Revoke Standards for Lowfat and Nonfat Yogurt and Amend Standard for Yogurt
June 11: Partly in response to a citizen petition submitted by the National Yogurt Association (NYA) in February 2000 and as a follow-up to the agency’s January 2009 proposed rule, FDA issued a final rule removing standards of identity for lowfat and nonfat yogurt and modernizing the standard of identity for yogurt.

The final rule moves lowfat and nonfat yogurt under the general definition and standard identity for foods that deviate from other standardized foods due to compliance with a nutrient content claim. Furthermore, it amends the standard of identity for yogurt in multiple respects. Specifically, it permits reconstituted forms of basic dairy ingredients; permits the use  of optional safe and suitable milk-derived ingredients; establishes functional classes of such ingredients as cultures, flavoring, color additives, stabilizers, emulsifiers, and preservatives; permits the optional labeling statement “contains live and active cultures”; and requires the statement “does not contain live and active cultures” on labels for yogurts treated to inactive viable microorganisms.

The final rule will be effective July 12, 2021, with a compliance date of January 1, 2024.

Read the final rule here and FDA’s Constituent Update here


FDA Issues Threshold of Regulation Exemption for Metal Carbides in Food Processing Equipment
June 17: FDA issued a Threshold of Regulation (TOR) exemption for “the use of metal carbides and metal carbide alloys as a component or ceramic coating in repeat-use applications such as parts in food processing equipment,” according to FDA’s Constituent Update. This TOR exemption allows for the use of such substances in repeat-use applications without requiring manufacturers or suppliers to submit a Food Contact Substance Notification (FCN) to FDA.FDA based its TOR exemption on evidence that “the dietary exposure level from the intended use of the food contact substance (FCS), is below 0.5 parts per billion (ppb) and the FCS itself is not a known carcinogen.” The agency also reviewed the use of metal carbides in food processing equipment in response to numerous FCNs and concluded that “[t]here is little or no likelihood that components of metal carbides would migrate to food at other than insignificant amounts, nor would the metal carbides otherwise affect food.”   

Read FDA’s Constituent Update here and see FDA’s database of TOR exemptions here.


USDA-FSIS Issues Public Health Alert for Possible Salmonella Contamination of Frozen Raw Breaded Chicken Products
June 2: USDA-FSIS issued a Public Health Alert, ongoing as of June 18, 2021, in response to a Salmonella Enteritidis illness cluster suspected to be linked to frozen, raw, breaded, and pre-browned stuffed chicken products labeled “chicken cordon bleu,” chicken with “broccoli and cheese,” or “chicken Kiev.” Cases within the illness cluster had onset dates ranging from February to May 2021.

According to USDA-FSIS’s Public Health Alert, “[t]he products of concern may appear to be ready-to-eat but are in fact raw and need to be fully cooked before consumption.” Some of the case patients reported not having followed the cooking instructions, which could have contributed to their illness. The agency cautioned consumers that “particular attention needs to be taken to safely prepare and cook these frozen, raw poultry products to a temperature of 165 F” and offered recommendations for preventing salmonellosis, one of the most common bacterial foodborne illnesses.

USDA-FSIS still does not have the necessary information to request a recall of the products that tested positive for the outbreak strain of Salmonella Enteritidis, since the production lots that tested positive were not known to have been purchased by any of the case patients.

Read USDA-FSIS’s Public Health Alert here.


USDA Announces Over $4 Billion Investments in Critical Supply Chain through Build Back Better Initiative
June 8: As part of its new Build Back Better initiative, USDA announced plans to invest over $4 billion to support key its priorities of (1) increasing and streamlining food production; (2) expanding food processing capacity; (3) strengthening food system infrastructure to improve food aggregation and distribution; and  (4) increasing consumer access to healthy foods and expanding market opportunities for diverse growers.

Investments will include a mix of loans, grants, and innovative financing to address food supply chain challenges. According to USDA’s Press Release, this announcement supports the Biden Administration’s goal of improving critical supply chain resilience pursuant to President Biden’s February 24, 2021 Executive Order 14017 on America’s Supply Chains.

Read USDA’s Press Release here and Executive Order 14017 here. Learn about Build Back Better here.


USDA Announces Plan to Issue Three Proposed Rules Supporting Enforcement of Packers and Stockyards Act
June 11:USDA will begin work on three proposed rules to strengthen enforcement of the Packers and Stockyards (P&S) Act, which the agency described in its Press Release as a “100-year old law that was originally designed to protect poultry and hog farmers and cattle ranchers from unfair, deceptive, and anti-competitive practices in the meat markets.”

In the coming months, the agency plans to propose a new rule to strengthen enforcement of unfair and deceptive practices, undue preferences, and unjust prejudices. USDA also intends to propose a new rule on the poultry grower tournament system and to re-propose a rule clarifying the context under which parties may bring an action under the P&S Act.  

USDA emphasized that its updates to enforcement of the P&S Act will support the Biden Administration’s efforts to make the food system fair, resilient, equitable, sustainable, and more representative of the diverse U.S. workforce.

Read USDA’s Press Release here.


USDA Announces Additional Aid Via Pandemic Assistance for Producers Initiative
June 15: As a follow-up to its March 2021 pledge of at least $6 billion to ranchers and producers through the USDA Pandemic Assistance for Producers initiative, USDA announced an additional round of assistance to be implemented within 60 days. According to the agency’s Press Release, the follow-up programming “will continue to be focused on filling gaps in previous rounds of assistance and helping beginning, socially disadvantaged[,] and small and medium sized producers that need support most.”

Among other funding targets, this round of Pandemic Assistance for Producers will invest $700 million in biofuels producers; $400 million in the new Dairy Donation Program; $580 million in Supplemental Dairy Margin Coverage; and $700 million in Pandemic Response and Safety Grants to reimburse producers, processors, distributors, and farmers markets for Personal Protective Equipment (PPE).

Read USDA’s Press Release here and read about USDA’s launch of the Pandemic Assistance for Producers Initiative in our March 2021 (Part 2) Regulatory Update here.


National Cattlemen’s Beef Association (NCBA) Petitions USDA-FSIS for Updated Beef Product Labeling Standards
June 10:The National Cattlemen’s Beef Association (NCBA), the oldest and largest national trade association representing U.S. cattle producers, petitioned USDA-FSIS to issue a federal rule updating current labeling standards and eliminating broadly applicable “Product of the USA” (POTUSA) labeling claims about beef product origins. The NCBA argued that the POTUSA label, which can be used on meat products produced abroad and later imported to the U.S., is likely to mislead consumers.

Under the NCBA’s proposed labeling rule, beef producers could voluntarily use the claim “Processed in the USA” on any federally inspected product, while “[m]ore specific voluntary claims, such as ‘Raised and Harvested in the USA’ would continue to require appropriate review, verification, and oversight within the [USDA-]FSIS label approval system.” Additionally, interested parties could continue to develop related Process Verified Programs (PVPs) through USDA-AMS or alternative third-party certification mechanisms.

The NCBA argued that their proposed regulation would “eliminate misleading labeling practices and provide more accurate information to the American consumer while generating new marketing opportunities for the beef industry.”

Read the NCBA’s petition to USDA-FSIS here (PDF).