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This update includes FDA updates, USDA updates, FDA warning letters, and other items of interest, including the release of an online tool for suspected anticompetitive practices, guidance for the enforcement approach to human food with chlorpyrifos residues, the publishing of the origin of livestock final rule for organic dairy, and more.

FDA Updates

FDA Releases Guidance for Industry on Enforcement Approach to Human Food with Chlorpyrifos Residues Following EPA Tolerance Revocation
In early February, FDA released a new question-and-answer guidance to help producers handle foods potentially containing residues of the pesticide chlorpyrifos. Per the guidance, foods are not deemed unsafe solely based on the presence of chlorpyrifos if the chemical compound was applied prior to the expiration of EPA tolerance policy and if the residue does not contain a level exceeding the amount permitted by the agency at the time of application. This FDA guidance comes as the EPA recently revoked all tolerances for chlorpyrifos effective February 28, 2022. The FDA is responsible for enforcing all EPA pesticide tolerances in all food products except for certain meats, poultry, and fish regulated by USDA.

The full guidance issued by FDA can be read here.

Motif FoodWorks, Inc. Files Color Additive Petition
Motif FoodWorks, Inc. has submitted a petition to amend current color additive regulations by exempting myoglobin as a safe color additive in meat and poultry analogue products (e.g., plant-based meat and poultry substitutes). If the federal agency determines an exemption applies, neither an environmental assessment nor environmental impact statement will be required. The company argues myoglobin occurs naturally and does not significantly alter the concentration or distribution of the substance, its metabolites, or degradation in the environment. If the FDA determines the exemption does not apply, it will request an environmental assessment and make it available to the public.

Read the FDA’s Notice here.

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FDA Warning Letters

Bakery Project Inc. dba Delano Bakery
FDA recently notified Bakery Project, Inc. regarding the results of an inspection of their Kansas facilities from August 3, 2021 – August 27, 2021. The agency alleges numerous violations including nearly fifteen cockroach sightings in proofer and packaging areas. Rodent droppings and dead insects were also reported. In addition, baking appliances and personal hygiene practices did not meet acceptable cleanliness standards.

A comprehensive database of all FDA Warning Letters can be found here.

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USDA Updates

USDA Publishes Origin of Livestock Final Rule for Organic Dairy
The USDA recently published the Origin of Livestock (OOL) final rule for organic dairy. This rule intends to promote a fairer and more competitive market for organic dairy producers, making sure that all certified USDA organic dairy products are produced to the same standard. USDA’s National Organic Program will oversee the new rule. Additional information on the Origin of Livestock rule can be found here. The USDA’s full report can be found here.

USDA, DOJ Launch Online Tool Allowing Farmers, Ranchers to Report Suspected Anticompetitive Practices
The U.S. Departments of Agriculture and Justice announced earlier this month a combined effort to reduce unfair and anti-competitive practices in the meat and poultry sectors. Farmers and ranchers can now anonymously report potentially illegal and unfair practices to a database collected by the two agencies. USDA Packers and Stockyards Division staff and DOJ staff will review the tips and, if necessary, elevate concerns to appropriate agencies. This new tool is aimed to advance the Biden Administration’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, by creating more competitive agricultural markets.

The reporting tool can be accessed here.

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Other Items of Interest

USDA Sets Meal Standards to Help Ease School Supply Issues
In February, USDA announced new transitional standards for school meal programs set for the 2022-23 and 2023-24 school years. The changes allow child-care providers serving children ages 6 and older to offer flavored low-fat (1%) milk in addition to the current milk offerings. In addition, the weekly sodium limit will decrease 10% in 2023-24 to align with USDA’s guidance on voluntary sodium reduction targets for processed and packaged foods. The COVID-19 pandemic and subsequent supply chain issues have made healthy school lunches a major challenge. In a November 2021 School Nutrition Association supply chain survey, 96% of respondents highlighted challenges with suppliers not carrying sufficient menu items to meet whole grain, sodium and fat nutrition standards.

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This Regulatory Update covers information from February 1 – February 14, 2022. Please contact Paul Benson, Taylor 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 michaelbest.com.

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.

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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.

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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.

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Other Items of Interest

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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.

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The full language of the bill can be read here.

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This Regulatory Update covers information from December 15, 2021 – January 15, 2022. Please contact Paul Benson, Taylor 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 michaelbest.com.