Regulatory Update: December 15, 2021 – January 15, 2022

This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the announcement of an outbreak investigation of Listeria monocytogenes in packaged salad, the proposal of an exemption to the COVID-19 vaccine rule for Canadian drivers, and more.

FDA Updates

FDA Announces Outbreak Investigation of Listeria monocytogenes in Packaged Salad
At the conclusion of December 2021, FDA, in conjunction with the CDC and state governments, announced it is investigating an outbreak of Listeria monocytogenes which may be linked to Dole packaged salads. The company has voluntarily issued a recall on all salads produced at two of their facilities with the production lot codes beginning with either the letter “N” or “Y” in the upper right-hand corner. The outbreak has been noted in 13 states including Iowa, Michigan, and Wisconsin, and caused 16 illnesses, 12 hospitalizations, and two reported deaths. The U.S. Food & Drug Administration recommends that the public clean and sanitize any surfaces or containers that may come into contact with these products to reduce the risk of cross-contamination as Listeria can survive refrigerated temperatures and can spread to other surfaces and foods. 

For more information, see the FDA Press Announcement here.

Amended Standards for Growing, Harvesting, Packaging, and Holding of Produce of Human Consumption Released
In early December, FDA announced the agency is proposing to amend the produce safety regulations and agricultural water provisions that cover farms which are considered too complex and challenging to implement. The proposed changes are intended to replace the microbial criteria and pre-harvest agricultural water testing requirements with systems-based assessments designed to be more feasibly implemented for an array of agricultural water systems and practices. This alteration is also intended to be adaptable for future advancements in water quality science aimed at improving the protections of public health and safety.

For more information and the proposed rule, click here. Comments on the proposed rule are due on April 5, 2022.

Amended Regulations for Laboratory Accreditation for Analyses of Foods
Earlier this month, FDA issued a final rule under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish programming for the testing of foods in certain circumstances by accredited laboratories. The Agency states that establishment of this new programming helps improve the safety of food in the United States by ensuring that certain foods deemed important to public health are tested under appropriate oversight and in alignment with model standards, producing reliable and valid testing results.

For more information, see the final rule here.

FDA Warning Letters

Food Wester Herb Products, Inc.
FDA issued a warning letter to Ebenezer International Food, LLC following a May 5, 2021, inspection of their Vermont facility. The inspection, as established by the Food Supplier Verification Program found the company in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for ground cassava leaves, cut sweet potato leaves, and cut sorrel leaves. The investigation cites that Ebenezer International Food did not follow an FSVP, as required by law for these products. The federal agency is requesting the company address these issues and notes failure to do so may result in the foods being placed on detention without physical examination.  

For more information on FDA Warning Letters, see their database here.

FDA Warns Hummus Manufacturer of Violations in Production and Manufacturing Processes
At the beginning of December, FDA issued a letter to hummus manufacturer Sabra Dipping Company, LLC following multiple violations of federal statutes. Outlined in the letter, the agency reported the company was notified of Salmonella enterica serovar Havana Group G (Salmonella Havana) in their Sabra Classic Hummus product which caused the company to issue a voluntary recall. Following an inspection of Sabra’s manufacturing facilities, FDA and VDACS found violations of several food safety practices, noting food products in the facilities were contaminated and packed in unsanitary conditions, violating the Federal Food, Drug, and Cosmetic Act.

Earlier this year, Sabra issued responses to FDA outlining their corrective actions. However, this new letter from FDA highlights areas the company failed to properly address and correct including whether biological hazards in frozen vegetables and garlic ingredients require preventative controls, and the failure to establish and implement supply-chain programs to assure the prevention of hazards to raw foods.

For more information on FDA Warning letters, visit FDA’s database here.

USDA Updates

USDA’s Bioengineered Food Disclosure Standard Takes Effect
January 1, 2022 brought the compliance deadline for USDA’s National Bioengineered Food Disclosure Standard, a sometimes controversial rule defining when food manufacturers, importers, and other parties who label foods for retail sale to disclose the use of bioengineered (sometimes referred to as “genetically modified” or “GMO”) ingredients. The federal rule creates a consistent, national framework for mandatory disclosure of GMO or bioengineered ingredients, preempting certain state laws requiring such disclosure. Importantly, because the USDA’s Bioengineered Food Disclosure Standard is a standard requiring mandatory disclosure of bioengineered foods and food ingredients, it does not impact GMO-absence claims such as “GMO free.”

USDA to Provide $800 million to Biofuel Producers Hit by Pandemic
In early December, the United States Department of Agriculture announced it will provide $800 million to biofuel producers affected by the pandemic. $700 million will be granted by the Biofuel Producer Program, as authorized by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), to maintain more available markets for products such as soybeans and carrots. An additional $100 million will be granted for biofuel infrastructure for products such as blender pumps to insure their availability in retail markets.

For additional information on how to apply for the Biofuel Producer Program, see the eligibility requirements here.

USDA Opens 2022 Signup for Dairy Margin Coverage Program
On December 13, the U.S. Department of Agriculture opened the enrollment period for the Dairy Margin Coverage (DMC) program which allows dairy producers better protection of their operations. In totality, the program will grant $580 million to support small- and mid-sized operations. Additionally, the program expands the initial benefits to those who increased production over the years but were not able to enroll the additional production. Under the new protocols, they will retroactively receive payments for this supplemental production. The agency has also updated the calculations for feed costs to further reflect the actual production expenses of dairy.

For more information on how to participate in the DMC program, contact your local USDA Service Center.

USDA Launches Loan Guarantee Program for Food Supply Chain
USDA announced in December the deployment of nearly $1 billion under the Food Supply Chain Guaranteed Loan Program to strengthen the national food supply chain by supporting private investments in processing and food supply infrastructure. As part of the American Rescue Plan Act, the loans will be administered to start up or expand supply chain activities for food products, address bottlenecks in supply chains, and increase the capacity of the U.S. food supply chain. The USDA will guarantee loans of up to $40 million to cooperatives, corporations, for profits, nonprofits, Tribal communities, public bodies, and people in rural and urban areas.

Learn how to apply for the Food Supply Chain Guaranteed Loan Program here.

Other Items of Interest

Groups Urge Exemption to COVID-19 Vaccine Rule for Canadian Drivers
On December 9, 2021, a coalition of groups including the North American Miller’s Association, the American Bakers Association, and the National Grain and Feed Association issued a letter to Transportation Secretary Pete Buttigieg and Homeland Security Secretary Alejandro Mayorkas urging an exemption to US COVID-19 vaccine mandates for truckers hauling agricultural goods from Canada. The letter argues vaccine mandates will impede trade flows and damage the intertwined supply-chains between the Canada and the United States. Furthermore, the coalition states their exemption should be in line with the Occupational Safety and Health Administration (OSHA) fact sheet stating that those who work alone and do not come into contact with fellow employees or customers pose little risk to others. A similar letter was issued to the Canadian minister of transport urging the Canadian government to work with U.S. officials in finding a solution to this growing issue.

California Legislator Introduces Bill Warning Parents about the Alleged Link Between Food Dyes and Child Behavior Problems
California State Senator Bob Wieckowski recently authored a bill that requires warning labels to be placed on foods containing artificial food colorings Red 40, Yellow 5, and Blue 1, among others. These dyes are common ingredients in candies, cereals, and other foods in the United States. This comes as the state senator argues new research indicates there exists a causal relationship between artificial food dyes and hyperactivity in children, a theory rejected by the FDA in 2011 and 2019. The California politician points to a peer-reviewed report, released in April 2021 which compiles findings from food and animal studies dating back to the 1970s. The data indicate that 64 percent of clinical studies analyzed show an association between food colorings and childhood behavioral problems. More recent studies were more likely to present such findings. State Senator Wieckowski is confident the bill will pass in 2022 and be implemented in California by 2023.

For more information, the bill can be found here.

PFAS Found in Maine Chicken Eggs, Raising Concerns Over Contamination in Area
In Fairfield, Maine, state officials identified PFAS chemicals in chicken eggs, spurring concerns associated with food products grown and raised in the area. PFAS compounds (sometimes referred to as “forever chemicals” due to their persistence in the environment) have been used for decades in a variety of products including nonstick cookware, carpeting and fabrics, and grease-resistant food packaging. FDA sampling activities have generally confirmed the safety of the national food supply (with the vast majority of samples showing no detection of PFAS), but there are localized concerns in areas such as Fairfield. High levels of PFAS have been found in 33 communities across the State of Maine causing Governor Janet Mills and the state legislature to appropriate $30 million to address the issue.

Read more at the The Portland Press Herald.

New Bipartisan Bill Aims to Clarify Food Date Labels
On December 7, U.S. Reps. Chellie Pingree (D-Maine) and Dan Newhouse (R-Washington), alongside U.S. Sen. Richard Blumenthal (D-Connecticut) introduced the bipartisan Food Date Labeling Act in both chambers of Congress. This bill is designed to clarify and standardize date labeling on food products in the United States. The federal government estimates that American consumers waste nearly 40 percent of all food supply on an annual basis, much of it caused by confusion around the food date labels. As no federal law regulates the language of food date labels, many change upon state lines with 41 states developing their own language. The Food Date Labeling Act establishes the universal language of “best if used by” to communicate food quality parameters and “use by” to communicate the estimated completion of a product’s shelf life. The bills were referred to the House Energy and Commerce Committee, House Agriculture Committee and the Senate Health, Education, Labor, and Pensions Committee.

The full language of the bill can be read here.

This Regulatory Update covers information from December 15, 2021 – January 15, 2022. 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, visit

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