Regulatory Update: February 1 – February 14, 2022

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.


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.


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.


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.


This Regulatory Update covers information from February 1 – February 14, 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 michaelbest.com.

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