Regulatory Register - Spring 2024

REGULATORY REGISTER

Spring 2024

A NOTE ON HIGHLY PATHOGENIC H5N1 IN DAIRY CATTLE

Highly Pathogenic H5N1 Avian Influenza (H5N1) has been confirmed by USDA on dairy farms in several U.S. states. NMPF continues to closely monitor the rapidly evolving animal health issue and is working with federal and state partners to share updates and guidance as it becomes available. NMPF is also working with USDA’s Foreign Agricultural Service to provide assurances to international customers about the safety and quality of U.S. dairy products, and to address barriers to U.S. dairy exports.

The National Dairy Farmers Assuring Responsible Management (FARM) Program established the FARM Biosecurity Program in 2021 with support from USDA’s National Animal Disease Preparedness and Response Cooperative Agreement Program (NADPRP). The resources developed as part of the FARM Biosecurity Program have proven to be invaluable tools for producers navigating the H5N1 outbreak in dairy cattle. For the latest information about H5N1 in cattle, visit www.nmpf.org/hpai.

H5N1 in Dairy Cattle

USDA Implements Nationwide Mandatory Testing for Interstate Dairy Cattle Movements, Provides Aid for Dairy Farmers

USDA on April 24 issued a federal order requiring pre-movement testing for the interstate movement of lactating dairy cattle. As of April 29, a negative test result for H5N1 is now required for all lactating dairy cattle moving interstate before a Certificate of Veterinary Inspection can be issued.

USDA also announced that all laboratories and state veterinarians will be required to report positive H5N1 cases to USDA, aiming to limit the risk of virus spread to protect dairy workers, dairy herds and poultry facilities. For affected farms, the federal order will require business owners with dairy cattle that test positive for interstate movement to complete a comprehensive epidemiological questionnaire and provide animal movement tracing.

USDA’s actions are intended to enable USDA to take necessary measures to contain the disease and provide essential data for surveillance and epidemiological research. Accurate and timely reporting is essential to understanding the prevalence, distribution and dynamics of the virus, and the information collected is crucial for developing effective prevention and control strategies.

USDA announced May 23 expanded assistance for dairy farmers to improve on-site biosecurity in order to reduce the spread among herds. In addition, USDA is taking steps to make available financial tools for lost milk production in herds affected by H5N1. Building on the federal order addressing pre-movement testing, these steps will further equip producers with tools they can

use to keep their affected herds and workers healthy and reduce risk of the virus spreading to additional herds.

NMPF thanked Secretary Vilsack and federal leadership in a statement for “effectively using their existing authorities to offer necessary assistance for dairy farmers as they meet the challenges of H5N1 in dairy cattle.” Adding that “care for farm workers and animals is critical for milk producers, as is protecting against potential human health risks and reassuring the public.”

FDA Reaffirms That Pasteurization Is Effective Against H5N1, Commercial Milk Supply Safe

FDA confirmed again April 23 that pasteurization of milk consistent with the federal Grade “A” Pasteurized Milk Ordinance (PMO) destroys harmful pathogenic bacteria and other microorganisms, including H5N1 and other viruses.

The data cited by FDA is consistent with many other studies demonstrating that the legally required temperature and time for milk pasteurization will readily inactivate HPAI. Viral fragments detected after pasteurization are nothing more than evidence that the virus is dead; they have zero impact on human health. Further, the federal PMO prohibits milk from sick cows from entering the food supply chain. Milk and milk products produced and processed in the United States are among the safest in the world.

Animal Health

NMPF Awarded USDA Grants to Advance Dairy Industry Disease Preparedness

NMPF was awarded funding May 16 from the USDA Animal and Plant Health Inspection Service National Animal Disease Preparedness and Response Program (NADPRP) supporting two projects advancing dairy cattle disease preparedness, timely support as the dairy industry evolves in response to H5N1 in dairy cattle.

The first award will expand on USDA funding NMPF received in 2021 to build the FARM Biosecurity Program. FARM Biosecurity provides dairy farmers with the tools to protect the health of their herds and employees from everyday and foreign animal diseases.

Biosecurity resources developed from the initial 2021 USDA funding are currently being used to respond to the H5N1 animal health issue. This new funding will expand educational resources and training opportunities for producers, cooperatives, state animal health officials and FARM Program evaluators; update the Secure Milk Supply Plan guidance and further develop the capabilities of the FARM Biosecurity database.

The second award will bring together stakeholders including dairy cooperatives, milk haulers, milk testing labs, state and federal animal health officials and National Animal Health Laboratory Network (NAHLN) lab directors 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.

“USDA funding for continued enhancement of biosecurity on dairy farms for emerging and foreign animal diseases arrives at a time when the dairy industry is already using USDAfunded resources to address the challenges of H5N1,” Gregg Doud, president and CEO of NMPF, said. “This ongoing collaboration between USDA and NMPF is building resiliency for the U.S. dairy industry now and for the future.”

THIS ONGOING COLLABORATION IS BUILDING RESILIENCY FOR THE U.S. DAIRY INDUSTRY NOW AND FOR THE FUTURE

APHIS Announces Animal Disease Traceability Rule

USDA’s Animal and Plant Health Inspection Service (APHIS) announced April 26 that the agency is putting in place the technology, tools and processes to help quickly pinpoint and respond to costly foreign animal diseases for certain cattle and bison.

The final rule requires official eartags to be visually and electronically readable for official use for interstate movement of certain cattle and bison, and revises and clarifies certain record requirements related to cattle. NMPF provided comments emphasizing the dairy sector’s more than two-decade support of mandatory animal identification via electronic tags for animal disease traceability purposes. NMPF supported most of USDA’s proposed changes, as official ID has been required for dairy cattle in interstate commerce for more than a decade. NMPF did specifically oppose a change to the definition of dairy cattle, specifically in reference to cross bred beef on dairy cattle. USDA’s final rule did not change the definition, per NMPF’s request.

The new rule is intended to limit the impacts of animal disease outbreaks to certain regions. In the unlikely event of a disease outbreak, trade in disease-free regions can continue, limiting the significant economic to affected areas. Animal traceability is necessary to establish

disease-free zones and reestablish foreign and domestic market access with minimum delay in the wake of an animal disease event.

FDA, USDA Clarify Roles for Regulation of Intentional Genomic Alterations in Animals

USDA said May 1 that it’s taking important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals.

USDA and FDA released a joint MOU to clarify roles and responsibilities for regulation of IGAs in animals. FDA also released two updated guidance documents, final Guidance for Industry (GFI) #187A and draft revised GFI #187B to help industry understand the existing statutory and regulatory requirements as they apply to IGAs in animals and to inform the public about the FDA’s process for regulating them.

FDA first issued final guidance on the regulation of certain alterations in animals in 2009 when it clarified the scope of its guidance to include animals with intentionally altered genomic DNA developed through use of genome editing technologies. NMPF previously provided comments to FDA and USDA for their gene editing regulations and continues to monitor the issue.

Nutrition

USDA Makes Low-Fat, Skim Flavored Milk a Rule in Schools

In its final school nutrition standards rule on April 24, USDA solidified schools’ ability to offer 1% and fat-free flavored milk in school meals for children of all ages. The policy culminates more than a dozen years of efforts from NMPF on behalf of dairy farmers, and it will encourage consumption of the essential nutrients provided by dairy.

“This final rule helps ensure kids will be able to choose a nutritious milk they tend to prefer,” Gregg Doud, NMPF CEO and president, said. “Many children prefer low-fat flavored milk over fat-free, and flavored milk offers the same nutrients as regular milk with a minor amount of added sugar.”

NMPF praised its member cooperatives for their tireless work to decrease the level of added sugar in flavored school milk, which now generally falls below the added sugar maximum

established in this final rule. “Not only does flavored milk offer the same nutrients as regular milk, but its presence also correlates with decreased waste in school cafeterias. I am proud of our industry’s successful commitment to providing a healthy product that kids want,” Doud said.

The final rule will include sodium limits on school meals that will not be more restrictive than the Target 2 limits from the 2012 school meals rule, a compromise NMPF supports. Added sugar maximums will also be placed on flavored yogurt (12 grams per 6 ounces) and flavored milk (10 grams per 8 ounces) beginning with the 2025-26 school year, followed by a weekly menu-wide limit of an average of less than 10 percent of calories per meal from added sugars beginning with the 2027-28 school year.

Despite noteworthy progress, the work to ensure adequate milk access in schools isn’t finished yet. NMPF supports the Whole Milk for Healthy Kids Act, which would restore whole and 2 percent varieties to school lunch menus. Led by Reps. Glenn ‘GT’ Thompson, R-PA, and Kim Schrier, D-WA, the legislation overwhelmingly passed the House of Representatives in December and awaits Senate approval.

THIS FINAL RULE HELPS ENSURE KIDS WILL BE ABLE TO CHOOSE A NUTRITIOUS MILK THEY PREFER

WIC Reduces Access to Dairy; Adds Container Flexibility

USDA issued its final rule April 9 updating the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) program, maintaining proposed cuts to dairy across the food packages. WIC is a vital program ensuring that pregnant women, new mothers, infants, and children have access to key nutrients that may be lacking in their diets. The final rule decreases the amount of dairy by 12.5-25 percent, depending on the package.

Other provisions that affect dairy include:

• Establish added sugar limits for yogurt;

• Allow plant-based beverages as substitutes for milk if they meet nutrient specifications;

• Require all states to authorize lactosefree milk;

• Increase container size flexibility; and

• Remove the existing limitation of 4 quarts on total yogurt and cheese substitutions for milk.

Milk, cheese, and yogurt are three of the top five redeemed items through WIC. They also provide three of the four nutrients of public health concern identified in the 2020 Dietary Guidelines for Americans.

“At a time of rising food costs, it‘s important to focus on increasing access to a wide variety of healthful, nutrient-dense, and affordable foods, including dairy products,” NMPF President and CEO Gregg Doud said. “It’s disappointing that the final rule limits WIC family purchasing power for nutritious dairy foods.”

While disappointed in the cuts to the dairy allotments in the WIC packages, NMPF appreciates the rule’s requirement that states offer lactose-free milk and includes a wider selection of product package sizes. These changes will help make dairy products more accessible for all WIC participants.

Sustainability & the Environment

EPA Adds PFAS to Superfund, Invokes Enforcement Discretion Policy to Protect Farmers

In a disappointing move, EPA on April 19 released a final rule designating Perfluorooctanoic Acid (PFOA) and Perfluorooctane sulfonic Acid (PFOS) as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).

Commonly known as the Superfund, CERCLA is intended to hold “known polluters” accountable. After making this designation, EPA can force responsible parties to either clean up contaminated sites themselves or fully reimburse EPA for remediation.

According to the Enforcement Discretion policy issued in tandem with the CERCLA rule, EPA will focus on holding significant contributors accountable, such as those who have manufactured Per- and polyfluoroalkyl substances (PFAS) or used PFAS in the manufacturing process, other industrial parties and federal agencies or facilities responsible for spread. EPA does not intend to pursue entities where equitable factors do not support seeking response actions or costs under CERCLA, which includes farmers, municipal landfills, water utilities, municipal airports and local fire departments.

NMPF has on numerous occasions cautioned EPA about the consequences of adding PFAS to Superfund out of concern that farms will become Superfund sites and that farmers will be designated as responsible parties and be

made to pay for the cleanup costs. While EPA’s intentions are good, the agency does not control all the potential litigation avenues that are commonly associated with messy Superfund liabilities.

To assuage NMPF’s concerns, EPA told NMPF that if another party brings a farmer into a Superfund claim, EPA would intervene in that litigation, settle the matter and use the settlement to shield the farmer. NMPF supports EPA’s desire to protect and help farmers but remains skeptical that EPA’s rule won’t result in many unintended consequences.

Both PFOA and PFOS are known as “forever chemicals.” These types of chemicals are commonly found in materials such as nonstick cookware and waterproof clothing. Farmers and their property have exposure from contaminated groundwater where the farms are proximate to military activity, industrial activity or from the land application of contaminated biosolids. In the past few years, several studies have noted and collected data on health risks from PFAS and PFOA. Ailments such as various cancers, reproductive and developmental issues, thyroid disease, reduced immune response, increased cholesterol levels, respiratory illness and numerous other health-related concerns may be associated with PFAS exposure, though the science is far from conclusive.

EPA Finalizes PFAS Drinking Limits

NMPF Considers Unsound

EPA finalized its National Primary Drinking Water Regulation (NPDWR) establishing Maximum Contaminant Levels (MCLs) for drinking water at 4 parts per trillion (ppt) for PFOS and PFOA, with a goal of zero.

The new limits are inconsistent with international limits, which NMPF repeatedly cautioned EPA against. The World Health Organization (WHO) issued preliminary drinking water limits of 100ppt for PFOS and PFOA individually, or 500ppt in combination with other PFAS, but allows four times as much in low- and middle-income communities. Canada limits to 200ppt for PFOA and 600ppt for PFOS.

NMPF has long been concerned that such low limits based on incomplete science will drastically raise consumers’ water bills in small and rural communities where the high cost of technologies to reduce or eliminate PFAS chemicals cannot be spread over a large base of customers. The American Water Works Association has estimated the cost to be minimal in urban areas with large population resulting in an annual cost of $80 to $105, but in the smallest rural communities the annual cost per household could be as much as $11,150.

NMPF has also raised the concern to EPA that setting a non-science-based limit for water will likely be translated to food, given that there are no federal limits on the allowable amount of PFAS in food products. While EPA cautions stakeholders to limit the application of MCLs to drinking water only, it is not uncommon for people, including consumers, reporters and activists, to use drinking water limits as a baseline when looking at food products. Setting low limits that are inconsistent with science and international standards has the potential to create serious confusion for the public.

Consumer

Reports

Releases

Study on PFAS in Milk

Consumer Reports shared results from its exploration of PFAS in milk in an article published May 2. The lengthy article does not provide information beyond what was already known about PFAS on farms for the past five years.

Consumer Reports took 50 retail whole milk samples from California, Michigan, New Jersey, Texas and Virginia for five brands: 365 Whole Foods, Great Value, Horizon, Kirkland and Organic Valley. Consumer Reports claims to have detected positives in six retail milk samples-- three from plastic bottles and three from paperboard cartons. In California, there were two positives, Kirkland Signature milk at 84ppt and 365 Whole Foods milk at 60ppt. The remaining four positives could not be quantified but are estimated to be in the range of 20 to 50ppt.

PFAS are extremely difficult to test for, and NMPF is highly skeptical of the test results from the article. Consumer Reports itself has a history of questionable research practices on this issue; in a story two years ago, the magazine attempted to look at PFAS in food contact packaging but opted instead to test for fluorine as a surrogate indicator for PFAS.

Consumer Reports is not the first to discover how exceedingly difficult it is to test for PFAS chemicals. Federal agencies with decades of experience testing for PFAS have learned that mistakes are easy to make and have had to recall positive test results. FDA had to recall tests results for chocolate cake and chocolate milk after learning chocolate can trigger a false positive test result, and EPA recently had to recall positive test results for pesticides in HDPE containers when, for unknown reasons, they learned those results were erroneous.

Consumer Reports acknowledged that FDA

disagrees with at least one finding in their study, the finding of PFOA in milk. The methods Consumer Reports used may have also been altered from FDA’s validated testing methods, further compromising the validity of the study.

NMPF Continues to Push Back on Reduced Opportunities for Dairy Under California’s CFS Program

NMPF has continued to collaborate with and support coalition efforts in California opposing California’s AB 2870, a bill introduced by state Assembly Member Muratsuchi to alter existing state Low Carbon Fuel Standard (LCFS) regulations for livestock and dairy manure management operations.

As of April 24, the bill is no longer being considered due to lack of committee support. This is the second time this year that the California legislature has rejected attempts to curb or eliminate the avoided methane crediting in the Low Carbon Fuel Standard, a positive signal to the California Air Resources Board (CARB) as it finalizes the LCFS update. The 65 stakeholders who signed on to coalition letters – 19 associations and 46 companies, including NMPF – helped make a difference in the outcome of this bill.

CARB is expected to vote on the LCFS within the next few months, and it is critical that dairy and dairy biogas be promoted. CARB Board members are aware of the conversations around this issue and NMPF will continue to advocate on behalf of dairy farmers in California and beyond.

FARM Program, NMPF Celebrate Dairy Conservation Efforts

The FARM Program released findings from its Conservation Practice Questionnaire highlighting the leading stewardship of dairy farmers in time to celebrate Earth Day.

The questionnaire, a voluntary addition to the FARM Environmental Stewardship (ES) Program, highlights some of U.S. dairy farmers’ conservation efforts, including practices and technologies that show effective water, energy and other resource stewardship.

FARM ES launched the questionnaire in August 2022 after significant stakeholder feedback and on-farm piloting. More than 450 of them have been completed on dairy farms across 20 states since its launch, with respondents ranging in milking herd size from 17 cows to more than 15,000. The completed questionnaires offer a lens into the natural resource stewardship of the dairy farmers who participate.

As of March 2024, questionnaires indicate that:

• 79% of participating dairy farmers reuse or recycle water on their farm: 76% reuse plate cooler water to flush the barn, as drinking water, or for other uses; 14% capture rainwater for cleaning or other use; and 29% reuse water for irrigation;

• 90% of participating farms report implementing field conservation practices;

• 68% of participating farmers use recycled manure, recycled sand or byproducts as bedding for their cows; and

• More than 97% of participating dairy farmers use energy saving technologies and practices.

A two-page document outlining additional

findings from the questionnaire is available here.

“Dairy farmers have long been early adopters of sustainable practices and good stewards of the land,” Nicole Ayache, NMPF’s chief sustainability officer, said. “The findings from our Conservation Practice Questionnaire underscore the U.S. dairy industry’s commitment to continuous improvement and finding new ways to be even more sustainable.”

To further support dairy farmer efforts to implement conservation practice and technologies, the FARM Program launched a searchable database of technical and financial resources. Farmers and their technical advisers may use the new resource to identify support suitable to the farm’s conservation goals.

The database contains information from government, non-profit, extension, state planning tools, and many other relevant financial or technical assistance providers and resources. Financial resources include grants, cost-share, loan programs and other incentives available. The database’s first areas of focus are on resources for cover cropping, conservation tillage, energy efficiency, nutrient management, and pollinator habitat.

To learn more about the Conservation Practice Questionnaire, the searchable resource database, or general information about FARM ES, visit nationaldairyfarm.com

THE FINDINGS FROM OUR CONSERVATION PRACTICE

QUESTIONNAIRE UNDERSCORE

THE U.S. DAIRY INDUSTRY’S COMMITMENT TO CONTINUOUS IMPROVEMENT AND FINDING NEW WAYS TO BE EVEN MORE SUSTAINABLE

International

NMPF Works Toward Clarifying and Streamlining FDA’s Trade Role

NMPF and the U.S. Dairy Export Council (USDEC) met with FDA Deputy Commissioner for Human Foods Jim Jones Feb. 9 to underscore the importance of FDA’s role in facilitating dairy exports, advocate for a more streamlined exporting facility listing process and urge careful due diligence in the agency’s Grade A equivalence evaluations of the New Zealand and European dairy industries.

As part of its increasingly significant trade role, FDA maintains various lists of U.S. dairy facilities registered to export to certain foreign markets that require facility registration lists. In its meeting with Commissioner Jones, NMPF and USDEC promoted the idea of a standard, consolidated exporter list that would require just one registration step to ship to multiple markets and cautioned the agency against imposing excessive new costs that would make exporting products more difficult and costly for dairy exporters.

NMPF and USDEC also stressed the need for more transparency around the criteria that FDA is using as the agency evaluates the New Zealand dairy system to determine whether its products are “Grade A” equivalent. Were FDA to recognize a trading partner’s system as equivalent to U.S. “Grade A” requirements, it would significantly expand a country’s ability to ship “Grade A” products such as milk, cream, yogurt and other items to the United States.

NMPF also emphasized the importance of ensuring that any subsequent equivalence evaluation of the EU dairy system be conducted on a mutual basis to simultaneously address the myriad burdensome regulatory requirements

U.S. dairy exporters face in shipping into the EU market. Before making a final decision, NMPF urged FDA to consult with USTR and USDA, and to consider the disproportionate barriers to market access that U.S. exporters face when accessing several international markets.

NMPF Helps Secure UK Tariff Cut

The United Kingdom announced March 16 it was suspending tariffs on fat filled milk powder imports following a petition from NMPF and USDEC for reduced tariffs submitted in August 2023. The World Trade Organization Most Favored Nation (MFN) tariff of 6 percent for HTS 1901.90.95 will be reduced to zero until June 2026, with the possibility of extending beyond that date.

The United Kingdom’s departure from the European Union did little to help level the competitive playing field for U.S. dairy. Since Brexit, EU suppliers have continued to receive zero-tariff access into the United Kingdom while U.S. exporters face prohibitively high tariff rates. The United Kingdom has also recently inked new free trade agreements with Australia and New Zealand that both provide preferential access to its dairy market – putting the United States at a further disadvantage.

In response, NMPF and USDEC have worked to close this access gap by requesting that the United Kingdom reduce MFN tariff rates for a range of dairy imports to give American exporters a fair opportunity to compete. March’s announcement represents an important early step in that process.

NMPF Secures Progress for U.S. Facility Listings in Indonesia

On May 2-3, five American dairy facilities moved on to desk review in their processes to become approved dairy facilities that can export to Indonesia. The progress follows significant efforts from the NMPF and USDEC, including a March 6 meeting that NMPF Executive Vice President Shawna Morris and USDEC staff arranged with a delegation of Indonesian senators as part of a dedicated effort to continue to build a collaborative relationship and facilitate streamlined import processes.

As part of that undertaking, NMPF and USDEC have partnered with the New Mexico and Wisconsin Departments of Agriculture on developing programs designed to educate

Indonesia’s small-scale farmers on dairy best practices and position U.S. dairy as a key part of the solution for Indonesia’s school milk initiative.

USTR References Key Dairy Priorities in National Trade Estimate

In its annual National Trade Estimate (NTE) report released March 29, the U.S. Trade Representative highlighted several trade barrier and market access priorities that NMPF and USDEC underlined in their comments submitted to the agency in October.

In the comments, NMPF and USDEC detailed how the United States’ ongoing lack of new trade agreements has put the U.S. dairy industry at a competitive disadvantage. The comments also summarized priority trade agreement enforcement issues and various country-specific barriers that governments around the world are using to impede U.S. dairy exports. Dairy issues cited in the NTE as priorities for USTR included:

• Finding a solution for Indonesia’s problematic facility registration and Halal certification issues;

• Countering the European Union’s attempts to monopolize common food names in numerous markets;

• Ensuring the full implementation and compliance of Canada’s U.S.-MexicoCanada Agreement dairy market access and protein export threshold obligations;

• Addressing India’s tariff and nontariff barriers to dairy exports, including a mandated use of a health certificate that includes prescriptive animal feed standards despite the lack of scientific basis for the requirements; and

• Resolving Egypt’s protectionist and inconsistent Halal requirements.