REGULATORY REGISTER
Summer 2024
Animal Health
NMPF Starts USDA Grant Projects for Dairy Industry Disease Preparedness
NMPF secured two grants in May from the USDA Animal and Plant Health Inspection Service National Animal Disease Preparedness and Response Program (NADPRP) to expand FARM Biosecurity resources, including an inperson enhanced biosecurity training and to develop a white paper on the implementation of the foot and mouth disease bulk tank milk assay. The FARM Biosecurity Program provides dairy farmers with the tools to protect the health of their herds and employees and prepare for a foreign animal disease outbreak.
Biosecurity resources developed from the initial 2021 USDA funding are currently being used to respond to the H5N1 dairy cattle outbreak. NMPF is now expanding educational resources and training opportunities for producers, cooperatives, state animal health officials and FARM Program evaluators, updating the Secure Milk Supply Plan guidance, and further developing the capabilities of the FARM Biosecurity database with the additional NADPRP funding.
The second grant is allowing NMPF to bring together stakeholders to conduct a gap analysis and create a report outlining current capabilities and guidance for industry and policymakers to implement a foot-and-mouth disease diagnostic assay using bulk tank milk samples to provide herd-level disease surveillance in the event of an outbreak. Stakeholders in the focus groups will include dairy cooperatives, milk haulers, milk testing labs, state and federal animal health officials and National Animal Health Laboratory Network lab directors.
World Organization of Animal Health Updates Standards at General Session
The World Organization of Animal Health (WOAH) approved updates to several international animal health standards in the Terrestrial Animal Health Code important to the U.S. dairy industry at its 91st General Session held May 26-30 in Paris.
The WOAH World Assembly of Delegates updated standards for foot-and-mouth disease to recognize the safe trade of dairy products through a variety of pasteurization processes. The delegates also updated standards for Prudent and Responsible Use of Antimicrobials to reflect a need for a One Health approach to antimicrobial resistance, including updated recommendations for the organization’s list of antimicrobial agents of veterinary importance. The WOAH delegates elected Dr. Emmanuelle Soubeyran (France) as the next the organization’s Director General and Dr. Susana Guedes Pombo (Portugal) as its next President. Dr. Rosemary Sifford (USDA Chief Veterinary Officer) was also elected as President of the animal health organization’s Americas Regional Commission.
WOAH is recognized by the World Trade Organization as the international intergovernmental animal health authority for the safe trade of animals and animal products. Supported in part by the U.S. Dairy Export Council, Dr. Jamie Jonker serves as a dairy expert to USDA for the standard revision process in advance of and during the organization’s General Sessions.
Global Leaders Prepare for High-Level Meeting on Antimicrobial Resistance
The Global Leaders Group on Antimicrobial Resistance on May 6-7 made its final recommendations for the United Nation General Assembly (UNGA) High Level Meeting on Antimicrobial Resistance in September.
The group, established in November 2020, collaborates globally with governments, agencies, civil society and the private sector through a One Health approach to advise on and advocate for prioritized actions for the mitigation of antimicrobial resistant infections through responsible and sustainable access to and use of antimicrobials.
The first UNGA high-level meeting on the topic was held in 2016. It included a political declaration in which nations pledged to strengthen regulation of antimicrobials, improve knowledge and awareness, and promote best practices to combat antimicrobial resistance. The September meeting will build on the 2016 pronouncement with a second political declaration to focus on tangible commitments for outcomes by 2030, including antimicrobial use in livestock. Final negotiations on the political declaration are occurring this summer.
NMPF has been advocating for the U.S. government partners to make political declaration commitments that reflect the important role of antimicrobials for animal health, welfare, and food safety outcomes. Dr. Jamie Jonker has served as a member of the Global Leaders Group since February 2023.
USDA Begins Accepting Applications for H5N1 Vaccines in Livestock
The USDA Center for Veterinary Biologics announced July 23 that it is accepting license applications for vaccines to protect livestock against H5N1.
USDA is supporting vaccine research and development to ensure animal and public health. In addition to research and development, USDA is conducting comprehensive epidemiological investigation and laboratory analysis to understand precisely how the H5N1 virus is transmitted so that farmers will understand how to prevent, detect, and control its spread.
USDA also has committed $33.65 million of Commodity Credit Corporation funds set aside to combat H5N1 in dairy cattle to support Agricultural Research Service’s vaccine research and development in cattle, turkeys, pigs, and goats. USDA is also making available, through Animal and Plant Health Inspection Services and that National Institute of Food and Agriculture, up to $10 million for HPAI research opportunities, including but not limited to vaccine research, development, and evaluation.
The USDA notice will open the doors for research into H5N1 vaccination for livestock but it is not a guarantee that a vaccine will be made available or approved for use.
Food Safety
FDA Study Results Reaffirm Pasteurized Milk’s Safety
The U.S. Food and Drug Administration (FDA) and USDA on June 28 announced results from a first-of-its-kind study using the process typically used by commercial milk processors. The study was done to further confirm that pasteurization is effective at inactivating H5N1 virus in fluid milk and other dairy products made from pasteurized milk.
The study found that the most commonly used pasteurization time and temperature requirements were effective at inactivating H5N1 in milk. These results complement FDA’s initial retail sampling study in May, in which all 297 samples of retail dairy products were found negative for viable H5N1 virus.
FDA and USDA will expand on this study by testing for pasteurization effectiveness in cream and other dairy products.
The results from this and previous studies reinforce that milk and milk products produced and processed in the United States are among the safest in the world.
FDA Reorganization Establishes Human Foods Program
FDA on May 30 created a unified Human Foods Program (HFP) and other significant modernization efforts as part of an agency reorganization.
The restructuring establishes the HFP by combining food-related activities of several offices—the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs—under one program, led by Deputy Commissioner Jim Jones.
By creating centralized structure within FDA for regulation, the agency hopes to create efficiencies that will result in more inspections and quicker responses to outbreaks and other food emergencies such as the infant formula crisis of 2022. The transparency and efficiency that FDA aims to create through this new organizational structure should be a positive step in the right direction and may affect the dairy industry especially, given that dairy foods are the most highly regulated foods next to infant formula.
The reorganization is set to begin Oct. 1. A full list of expected changes can be found in the Federal Register
THE TRANSPARENCY AND EFFICIENCY THAT FDA AIMS TO CREATE THROUGH ITS NEW ORGANIZATIONAL STRUCTURE SHOULD BE A POSITIVE STEP IN THE RIGHT DIRECTION
Nutrition
NMPF Submits Comments to 20252030 Dietary Guidelines Advisory Committee
NMPF underscored the important role dairy plays American diets in comments submitted July 26 to the Dietary Guidelines Advisory Committee (DGAC).
NMPF’s comments note that dairy should remain a distinct food group, with at least three servings recommended for older children and adults, and corresponding amounts for younger children in the next Dietary Guidelines for Americans. NMPF also states that including plant-based alternatives as substitutes for dairy beyond fortified soy would be a disservice to the American people because there is little to no science supporting the nutritional equivalence of plant-based alternatives.
The comments urge extreme caution in recommending plant-based dairy alternatives beyond fortified soy as substitutes for dairy products in the dairy group.
“Dairy foods have been well-studied over decades, and the evidence for the benefits of the dairy food matrix, including nutrient bioavailability and impacts on health outcomes, is well-established. By contrast, we are aware of few, if any, studies that have similarly tracked and identified health outcomes for highly processed plant-based dairy alternatives. These products vary tremendously in their nutrient content, and in contrast to dairy foods, FDA has not established Standards of Identity for any of the alternatives, so there is no requirement that they meet any particular nutrient content.”
NMPF also encourages the DGAC to review the growing body of science that shows dairy foods have beneficial or neutral effects on chronic
disease risk at all fat levels.
“The scientific evidence supports removing lowfat and fat-free limitations on dairy recommendations, although consumers should certainly be able to choose these varieties if they enjoy them or they need to limit caloric intake,” NMPF said in its comments.
The guidelines have significant effects on nutrition in the United States becausethey form the basis of federal nutrition policy and programs; they also helps guide health promotion and disease prevention initiatives at the federal, state and local levels. The DGAC is expected to release its scientific report with recommendations to USDA and HHS for updating the guidelines in the fall.
IN CONTRAST TO DAIRY FOODS, FDA HAS NOT ESTABLISHED STANDARDS OF IDENTITY FOR ANY OF THE PLANT-BASED ALTERNATIVES, SO THERE IS NO REQUIREMENT THAT THEY MEET ANY PARTICULAR NUTRIENT CONTENT
Labeling & Standards
Chevron Decision May Aid NMPF in Plant-Based Labeling Fight
The U.S. Supreme Court’s June 28 ruling overruling the landmark 1984 decision in Chevron v. Natural Resources Defense Council by a vote of 6-3 holds important implications for dairy in areas such as plantbased product use of dairy terms.
The 1984 ruling gave rise to what came to be known as “Chevron deference,” a doctrine that basically states that if Congress has not directly addressed the question at the center of a dispute, a court was required to uphold the federal agency’s interpretation of the statute, as long as it was reasonable.
Overturning the decision will have widespread effects on the way that federal agencies operate and enact the laws passed by Congress. While the future of regulation in a post-Chevron world is difficult to predict, NMPF analysis indicates the ruling will be beneficial in many instances.
For one example, NMPF has long held that FDA is not properly applying the law or its own food and dairy regulations when it comes to labeling plant-based foods using dairy terminology. Congress clearly defined the law in these three provisions:
• “Butter” shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.
• A food is considered misbranded if it imitates another food without proper labeling. Specifically, the label of an imitation food must include the word “imitation” followed immediately by the name of the food being imitated. This requirement ensures transparency for consumers and helps them distinguish between genuine products and their imitations. If a food is a substitute for another but is nutritionally inferior, it falls under this category of imitation foods. In these cases, “imitation,” is a signal that the product resembles another food but may not be nutritionally equivalent.
• A food shall be deemed to be misbranded…
• If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated, or
• If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 341 of this title, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.
In the three examples above, Congress was not ambiguous and did directly address what butter is, what imitations foods are, and what misbranded foods are. FDA has not interpreted or reinterpreted the provisions above, but rather ignored them.
Post-Chevron, the Supreme Court has sent a message to federal agencies: Courts no longer need to defer to the judgment of the agencies where there is ambiguity in a statute. They also may — and arguably should — take a fresh look at an agency’s actions to determine whether they are right or wrong. In other words, agency decisions are no longer automatically the correct course of action.
Several of the class action litigation cases involving the labeling of plant-based foods using dairy terminology have featured judges who deferred to the agencies because of the Chevron doctrine. Chevron’s overturning makes it possible that the courts will give additional consideration to these types of cases moving forward.
NMPF will meet with FDA’s Office of Chief Counsel in August to discuss FDA’s unlawful non-enforcement of its rules and FDA’s negligence in ignoring the will of Congress.
WHILE
THE FUTURE OF REGULATION IN A POSTCHEVRON WORLD IS DIFFICULT TO PREDICT, NMPF
ANALYSIS INDICATES THE RULING WILL BE BENEFICIAL IN MANY INSTANCES
International
NMPF Helps Resolve Impractical EU Antimicrobial Proposal
NMPF and the U.S. Dairy Export Council (USDEC) worked closely with the U.S. government to address a new European Union regulation that threatened to significantly upend U.S. dairy exports to the EU market.
The European Commission’s Directorate General of Health announced in March that it would be retroactively enforcing EU Article 118 antimicrobial restrictions to cover the entire life of the source animal. The move, which contradicted earlier communications, amounted to an impractical policy designed to unfairly protect EU products.
Following that sudden reversal, NMPF and USDEC collaborated with the Foreign Agricultural Service and other U.S. government officials to create a viable solution in which the United States can attest that dairy exports are not using prohibited treatments. NMPF anticipates that AMS will announce the new steps required to document this approach later this year and that the new program will not impose any undue burden on U.S. dairy farmers or exporters.
NMPF Strengthens Trade Relationship with Indonesia
NMPF’s Shawna Morris and USDEC regulatory staff traveled to Indonesia April 18-21 to advance the U.S.-Indonesia Technical Collaboration Project on Dairy and discuss how Indonesia could streamline regulatory requirements to facilitate U.S.-Indonesia dairy trade.
The project is an educational curriculum designed to empower small-scale local producers to overcome challenges and achieve high-quality and higher-yield dairy production. NMPF and USDEC also discussed how U.S. dairy exports can best complement local production. The NMPF and USDEC trip comes as Indonesia prepares to fulfill a new pledge from incoming president Prabowo Subianto to provide free nutritious school meals, including milk, to all Indonesian schoolchildren.
NMPF AND USDEC
COLLABORATED
A focal point of the meetings with Indonesian officials was the importance of addressing Indonesia’s milk powder tariffs and non-tariff barriers – specifically its long, burdensome facility registration process. The unpredictable, multistep process currently takes as long as four years from start to end, hurting U.S. dairy producers and Indonesian consumers alike. With demand expected to increase significantly, NMPF relayed the importance of resolving and streamlining the approval process while simultaneously lifting tariffs for products imported to meet the needs of the school milk program.
Sustainability & the Environment
EPA Seeks Nominations for Farm, Ranch, and Rural Communities Advisory Committee
EPA is seeking members for its Farm, Ranch, and Rural Communities Advisory Committee (FRRCC), which provides advice and recommendations to the EPA administrator on a range of agricultural issues. The agency is soliciting nominations for people involved in some way in agriculture; participants would serve two- to three-year terms. The Federal Register notice says individuals are “generally appointed to serve on the FRRCC as ‘representative’ members” for a particular group or industry sector.
Other
Global Agencies Share Fact Sheet to Protect from Hacktivism
NMPF has worked with federal agencies on cyber issues for more than two decades. While the priorities and likely types of threats have shifted as technology has advanced, food and agriculture entities must take cybersecurity in all its forms seriously.
Seven U.S. government agencies plus Canadian and British agencies on May 1 shared a collaboratively created fact sheet to address pro-Russian “hacktivist” activity among four of the nation’s 16 critical infrastructure sectors — water and wastewater, dams, energy, and food and agriculture.
A targeted attack that could disrupt or destroy enough infrastructure to cause chaos remains a real risk. For dairy, that risk is largely borne by processors, which have many more internetconnected systems than an average dairy farm. Still, the risk to farms rises as more dairies integrate high-tech and internet-connected devices into their operations. Processors and farms should be particularly diligent with any internet-connected devices that could cause serious harm if compromised,
such as refrigeration equipment or rotary and robotic milking equipment. The fact sheet identifies resources that help improve an entity’s cybersecurity, along with several recommendations that will help ward off ransomware attacks and attacks on internetconnected operational technology.
NMPF has amplified this message in articles for Hoard’s Dairyman and a recent webinar cohosted with Dairy Management Inc. NMPF will continue to communicate with federal partners and keep the dairy industry informed. In the meantime, everyone is encouraged to share the government fact sheet with anyone who might find it useful.
