Regulatory Register - Fall 2023

REGULATORY REGISTER Fall 2023

1

Nutrition

NMPF Submits Comments to FDA on Dietary Guidance, Pushing for More Clarity

acknowledged as an issue in their draft guidance for the labeling of plant-based milk alternatives.

NMPF strongly objected to the Food and Drug Administration’s (FDA) discussion of plant-based milk and yogurt alternatives in the agency’s draft guidance, “Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry” published Sept. 25.

“Despite the agency’s instructions to use consensus statements from authoritative bodies in developing guidance statements, FDA appears to violate its own principle by describing a means by which plant-based alternatives other than fortified soy could make dietary guidance statements based on consensus statements about the dairy group,” NMPF wrote in its comments.

Dietary guidance statements can be used on food labels to provide consumers with information about foods or food groups that can contribute to a nutritious dietary pattern to help consumers make healthier choices.

NMPF’s comments supported the use of consensus statements from authoritative bodies as the basis for dietary guidance statements but requested clarification on food group equivalents. NMPF also questioned FDA’s approach to plant-based milk and yogurt alternatives, saying it will encourage false and misleading advertising – which FDA has already

NMPF’s comments on the proposed guidance for dietary statements is one small part of the organization’s broader campaign against the mainstreaming of plant-based beverages as legitimate dairy alternatives, an issue FDA itself has acknowledged is a public health threat. Other efforts include our campaign for a stricter version of FDA’s draft guidance on plant-based beverage labeling, multiple letters to the agency, and a Freedom of Information Act request on agency communications regarding plantbased beverages.

OUR COMMENTS ON THE PROPOSED GUIDANCE FOR DIETARY STATEMENTS IS ONE SMALL PART OF OUR BROADER CAMPAIGN AGAINST THE MAINSTREAMING OF PLANT-BASED BEVERAGES AS LEGITIMATE DAIRY ALTERNATIVES, AN ISSUE FDA ITSELF HAS ACKNOWLEDGED IS A PUBLIC HEALTH THREAT.

2

Nutrition

Dairy foods, regardless of fat level, appear to have either neutral or beneficial effects on chronic disease risks including cardiovascular disease, type 2 diabetes, obesity, and stroke.

- MIQUELA HANSELMAN, NMPF DIRECTOR OF REGULATORY AFFAIRS

NMPF Provides Comments to Dietary Guidelines Advisory Committee The National Milk Producers Federation’s (NMPF) Regulatory Affairs Director, along with an Olympic athlete (and dairy farmer), told the government’s Dietary Guidelines Advisory Committee how dairy is a critical part of American diets that should be considered for its full range of benefits in comments made before the panel Sept. 12.

Miquela Hanselman from NMPF, and Elle St. Pierre, a farmer-member of the Dairy Farmers of America cooperative and a world medalist track athlete who represented the United States in the women’s 1,500-meter race in the 2021 Tokyo Olympics, both offered their perspectives on dairy’s role in the diet before the panel that will shape the scientific report informing the 20252030 Dietary Guidelines for Americans.

Hanselman’s comments focused heavily on how dairy at all fat levels have neutral or positive health benefits and how current guidelines work against including the varieties of milk that Americans consume the most.

“With the scientific question focused on sources of saturated fats, this committee has the opportunity to remedy a previous oversight and include the newer science on dairy fats and the dairy matrix,” she said. “Dairy foods, regardless of fat level, appear to have either neutral or beneficial

3

effects on chronic disease risks including cardiovascular disease, type 2 diabetes, obesity, and stroke. This committee shouldn’t default to the overly broad recommendation to avoid saturated fats regardless of food source.”

St. Pierre, a U.S. track and field champion and recent new mom, spoke out against the proliferation of plant-based imitation beverages that offer wildly inconsistent nutritional value, cautioning against any consideration of them as potential dairy replacements.

Plant-based beverages “are so nutritionally different from real milk that whether one views them positively or negatively, their impact on health cannot be assumed to be the same as, or even similar to, that of milk,” said St. Pierre, who lives near Berkshire, VT. “I strongly caution against and oppose any inference that health impacts associated with milk consumption would apply to plant-based milk alternatives.”

Public oral comments are part of the committee’s information-gathering process for the next set of guidelines. The Dietary Guidelines Advisory Committee is convened every five years by the U.S. Department of Agriculture (USDA) and the Department of Health and Human Services to make recommendations for American diets, affecting many federal nutrition programs.

Animal Health

USDA Finalizes Organic Program Animal Welfare Standards USDA’s Agricultural Marketing Service (AMS) issued a final rule on Oct. 25 amending the organic livestock and poultry production requirements by adding new provisions for livestock handling and transport, slaughter, and avian poultry living conditions; and expanding and clarifying existing requirements covering livestock care and production practices and non-avian living conditions. Many of these changes date back to a Final Rule under the Obama administration that were rescinded during the Trump administration.

NMPF has commented several times on the various proposals, most recently making comments on Nov. 22, 2022. NMPF in those comments emphasized the role of the FARM Animal Care Program in ensuring the best animal care and well-being decisions program for all dairy farmers, conventional and organic, with critical input from their veterinarians and other animal care experts.

The USDA-AMS has determined the FARM Program animal welfare standards meet the requirements of the International Organization for Standardization (ISO) Animal Welfare Technical Specification.

NMPF noted that the standards proposed by USDA-AMS in the Proposed Rule generally align with the FARM Animal Care ISOaccredited standards. NMPF also gave specific comments on many of the proposed standards to improve clarity and alignment

4

with the FARM Animal Care standards, such as including training for personnel who perform euthanasia, clarity for the use of shade structures, and stronger standards on recordkeeping for animal treatment.

The Final Rule aligns well with the FARM Animal Care Program and USDA-AMS incorporated many of the concepts raised in our comments. In some areas, NMPF comments offered improvements which USDA-AMS did not accept, resulting in a standard which may not be as advanced as the National Dairy FARM Animal Care Program. In other areas, NMPF comments discussed real-world complexities which require flexibility which were not incorporated into the final rule. These few examples provide an illustration for all these conditions: The Final Rule definition for “Outdoors or outdoor space: Any area outside an enclosed building or enclosed housing structure.

Enclosed housing structures with open sides (e.g., open-sided freestall barns) are not to be considered outdoors or outdoor space” unfortunately omits consideration for lean-tos and other roofed areas attached to an enclosed building or enclosed housing structure that is otherwise not enclosed.

NMPF Comment: “The rule should be clearer about the allowance for shade structure whether attached to an indoor living space or not. NMPF proposed changing the definition to: “Any area outside an enclosed

Animal Health

building or enclosed housing structure, including roofed areas that are not enclosed and shade structures.”

The Final Rule standard for “Physical alterations may be performed for identification purposes or the safety of the animal. Physical alterations must be performed: at a young age for the species, in a manner that minimizes stress and pain, and by a person that can perform the physical alteration in a manner that minimizes stress and pain” largely aligns with the FARM Animal Care Program but omits the important role of veterinarian involvement.

NMPF Comment: “Physical alterations may be performed to benefit the welfare of the animals, for identification purposes, or for safety purposes. Physical alterations must be performed on livestock at a reasonably young age, with pain mitigation as approved by a veterinarian, and by a competent person.”

The Final Rule prohibition on “tail docking of cattle” now aligns with the FARM Animal

5

Care Program prohibition. However, it is unclear in the Final Rule if there is an exemption for traumatic injury where docking the tail would improve the animal welfare outcome.

NMPF Comment: “§ 205.238(a)(5)(iii) An exception to prohibited practices may be made in the event of traumatic injury where implementing the practice improves the animal welfare outcome.”

The Final Rule standards include “Monitoring of lameness; timely and appropriate treatment of lameness for the species; and mitigation of the causes of lameness,” which now aligns the National Dairy FARM Animal Care Program standards including taking action when lameness is observed.

NMPF Comment: “Monitoring and treatment of lameness” For dairy farmers, the requirements will be enforced one year after publication of the final rule in the Federal Register – approximately Nov. 1, 2024.

Animal Health

FARM Program Launches Enhanced Biosecurity Initiative The National Dairy Farmers Assuring Responsible Management (FARM) Program announced the launch of FARM Biosecurity – Enhanced on Oct. 4, a new aspect of the FARM Biosecurity Program that includes training and an online database.

FARM Biosecurity – Enhanced, includes an online database to develop and securely store dairy producers’ enhanced biosecurity plans (EBP) and an online training that helps users write those plans. FARM has also developed a FARM Biosecurity – Enhanced Biosecurity Prep Guide and Database User Guide to complement these tools.

Stronger, or enhanced, levels of biosecurity will be needed to protect cattle against the highly contagious foot-and-mouth disease (FMD) found in two-thirds of the world.

One FMD case in the United States could shut down movement across the nation of livestock and their products for at least 72 hours.

FARM Biosecurity – Enhanced incorporates the on-farm elements of the Secure Milk Supply Plan for Continuity of Business. The Secure Milk Supply Plan for Continuity of Business was designed to help the dairy industry prepare for an FMD outbreak by providing producers with the tools to develop an enhanced biosecurity plan. The FARM Biosecurity – Enhanced database not only securely stores the EBP plans, but with producer permission will share the plans with state animal health officials for their approval to speed up issuing a movement permit in the event of an FMD outbreak.

FARM Biosecurity has two parts: Everyday Biosecurity for common disease threats and

6

Enhanced Biosecurity for highly contagious foreign animal diseases. The FARM Biosecurity resources aim to protect dairy cattle, build resiliency and future business continuity opportunities for the dairy industry.

NMPF and the FARM Program thank the USDA National Animal Disease Preparedness and Response Program for funding the FARM Biosecurity initiative through a cooperative agreement and Dr. Danelle Bickett-Weddle with Preventalytics who was instrumental in the development of the FARM Biosecurity resources.

To learn more about the FARM Program or access protocol templates and training aids, visit the FARM website.

To learn more about the Secure Milk Supply Plan, access templates, standard operating procedures, movement logs, and more, visit securemilk.org.

FARM BIOSECURITY RESOURCES AIM TO PROTECT DAIRY CATTLE, BUILD RESILIENCY AND FUTURE BUSINESS CONTINUITY OPPORTUNITIES FOR THE DAIRY INDUSTRY.

Food Safety

NMPF Hosts NCIMS Executive Board Meeting in September

how FDA handles equivalency and food safety here.

NMPF hosted the National Conference on Interstate Milk Shipments (NCIMS) Executive Board for a post-conference meeting to review the recent NCIMS conference program, activities, proposed actions and a non-concur letter.

The next NCIMS Conference will be held in April 2025 in Minneapolis.

Prior to the meeting, FDA had sent the chair of NCIMS its concur/non-concur letter for all proposals voted on at the conference.

In that letter, FDA concurred with all the passed proposals, except for Proposal 301.

Proposal 301, which defined equivalency in the Pasteurized Milk Ordinance (PMO), had procedural issues because it was not voted on twice, which is required. Following months of discussion about how to handle this proposal and recognizing FDA’s improved transparency on the issue of equivalency, NMPF withdrew the proposal, thus solving the issue.

The proposal’s withdrawal had nothing to do with its content; the procedural flaw warranted a withdrawal. With Proposal 301 no longer a problem, FDA concurred with the other passed proposals. The conference is reformatting the conference voting process on proposals amended at the conference to become a “Procedures Change” to assist in addressing the two-vote issue at the committee, council and delegate floor levels. People can learn more about

7

NMPF Joins Innovation Center’s Food Safety Operating Committee Clay Detlefsen, NMPF Senior Vice President for Regulatory and Environmental Affairs, was voted onto the Innovation Center for U.S. Dairy’s Food Safety Operating Committee to represent member needs and gain insights into current industry issues.

The committee focuses on numerous food-safety issues, including training and food safety outreach to others in the dairy processing community. The Innovation Center for U.S. Dairy is a voluntary organization that works across the dairy value chain to foster collaboration and progress to build a healthy and sustainable future for the dairy community. NMPF is pleased to become part of this industrious group of professionals.

THE COMMITTEE FOCUSES ON NUMEROUS FOOD-SAFETY ISSUES, INCLUDING TRAINING AND FOOD SAFETY OUTREACH.

Sustainability & the Environment

USDA Releases Growing Climate Solutions Act Report on Carbon Markets USDA released the report “A General Assessment of the Role of Agriculture and Forestry in the U.S. Carbon Markets” on Oct. 23, which provides a comprehensive look at current market activity, barriers to participation and opportunities to improve access to carbon markets for farmers and forest landowners. The report is the first of USDA’s deliverables under the Growing Climate Solutions Act, which was signed into law on Dec. 29, 2022, as part of the Consolidated Appropriations Act of 2023.

As part of a broader effort to combat climate change, carbon markets offer a promising tool to achieve net-zero emissions. Farmers, ranchers and forest landowners can generate carbon credits by adopting practices to reduce emissions or sequester carbon on their land, and carbon markets may provide them with new income opportunities through carbon credit sales. Purchasing these carbon credits may also help companies achieve voluntary greenhouse gas reduction goals.

The USDA report identifies a variety of barriers that have hindered the participation of agriculture in these markets. Among other things, farmers face limited returns on investment due to high transaction costs in carbon markets, including the costs of greenhouse gas quantification, verification,

8

and reporting. However, a clear assessment of these barriers gives federal agencies, scientists, farmers and other partners valuable insight into what kinds of solutions can facilitate increased and more beneficial participation by farmers.

The U.S. dairy sector is a leader in climate smart ag solutions thanks in part to NMPF advocacy. Accessing carbon markets is critical for dairy farmers to be able to implement the next generation of climate smart ag solutions.

THE U.S. DAIRY SECTOR IS A LEADER IN CLIMATE SMART AG SOLUTIONS THANKS IN PART TO NMPF ADVOCACY. ACCESSING CARBON MARKETS IS CRITICAL FOR DAIRY FARMERS TO BE ABLE TO IMPLEMENT THE NEXT GENERATION OF CLIMATE SMART AG SOLUTIONS.

Labeling & Standards

American Butter Institute Sends a Strong Message on Grading Proposal to USDA The American Butter Institute (ABI) filed comments Oct. 16 supporting a USDA-AMS proposal making minor changes to the butter testing system in processing plants, while advocating that the agency should also consider allowing butter manufacturers to use their own personnel to perform grading services.

The testing proposal would allow for in-plant or third-party butterfat testing to be the basis for satisfying USDA shield minimum butterfat requirements. ABI in its comments requested clarification on a few issues, such as what specific tests would USDA want to review (finished product, in-process, etc.), how many tests would need to be reviewed, what existed and emerging testing

9

methodologies are approved for butterfat analysis among other issues.

On the larger subject of the USDA butter grade, ABI informed USDA that consumers do not understand the value of the USDA Grade AA shield, with USDA doing little to improve recognition of the shield’s value, part of ABI’s strong message about the overall grading program. The institute also pointed out that it is difficult to arrange for USDA inspectors to be on site in a timely manner, which can cause numerous problems in meeting customer needs. ABI’s Board of Directors, at its October meeting, agreed that butter manufacturers would prefer to take complete charge of preforming all the parameters and procedures required to earn the Grade AA shield and then have USDA review records that attest to ensuring that the butter manufacturers have properly fulfilled the requirements.

International NMPF Tells FDA to Streamline Dairy Export Facility Listings FDA should not impose a charge on facilities seeking to be included in the agency’s lists of approved export facilities, NMPF said in an Aug. 10 letter to FDA Commissioner Robert Califf.

FDA’s export facility registration program helps ensure that U.S. dairy facilities in good regulatory standing are authorized to export to foreign markets that require facility registration lists. Several countries currently require such lists and others are considering introducing them. NMPF’s joint letter with USDEC was sent as FDA is contemplating a new fee per facility, per export list – a significant new financial burden, especially for companies that have many facilities and ship to multiple markets.

“Should FDA decide to instead proceed with

imposing new fees for dairy export facility listing, it is essential that this be done in a transparent manner that ensures those fees will not place undue expenses on U.S. dairy companies that require such listings in order to access export markets,” said Jim Mulhern, NMPF president and CEO. Additionally, NMPF urged FDA to create a unified, standard exporter list to allow facilities to be approved for all countries that require authorization, through a single registration step. This new streamlined process would allow facilities to register a single time to be approved to export to all markets that require FDA authorization.

NMPF’s trade policy team, in collaboration with the USDEC Market Access and Regulatory Affairs team, met with FDA several times earlier this year to provide feedback on how to best structure approvals.

Should FDA decide to instead proceed with imposing new fees for dairy export facility listing, it is essential that this be done in a transparent manner that ensures those fees will not place undue expenses on U.S. dairy companies that require such listings in order to access export markets.

- J IM MULHERN, NMPF PRESIDENT AND CEO

10

International

NMPF Powers World Dairy Summit Success; Vilsack Honors Mulhern NMPF turned out in full force as a dairy industry leader at the International Dairy Federation’s (IDF) World Dairy Summit in Chicago, with numerous speakers and a special recognition for President and CEO Jim Mulhern at the event Oct. 15-19.

Agriculture Secretary Tom Vilsack honored NMPF President and CEO Jim Mulhern for his “exemplary leadership and decades of service to the U.S. dairy community” in remarks during the summit’s first day, commending Mulhern for his four decades of professional service for agriculture and dairy.

This year’s summit, the first hosted in the United States in 30 years, was brought to Chicago in large part in large part due to NMPF and U.S. Dairy Export Council (USDEC) leadership. Shawna Morris, NMPF and USDEC Executive Vice President for Trade Policy and Global Affairs and Nick Gardner, USDEC Senior Vice President for Sustainability and Multilateral Affairs, co-chaired the event. Together they oversaw the development of a conference that highlighted the U.S. dairy industry’s leadership on a variety of issues, including quality, sustainability, innovation, and more.

11

Jamie Jonker, Chief Science Officer and Vice President for Sustainability & Scientific Affairs, serves as IDF’s Chair of the Science and Program Coordination Committee and was prominently involved in multiple areas of the Summit. In that role, Jonker presented on the accomplishments in the IDF program of work during the last year.

Jonker also joined panelists from Codex, the International Standards organization, and IDF on the important role of international standards for safe trade of dairy products globally.

The conference’s regulatory focus included a panel on emerging contaminants that included NMPF’s Clay Detlefsen, who joined panelists from Switzerland and the Netherlands to discuss how regulatory actions affect dairy products now and in the near term. All three panelists seemed to be aligned in their concerns over existing and emerging contaminants such as chlorates, perchlorates, micro and nano-plastics, mycotoxins and Per and polyfluoroalkyl substances (PFAS).

Surprisingly, the panelists all seemed to feel that global PFAS contamination has been overblown. The panelists also seemed to concur that we need to be better acquainted plastic contamination which is garnering more global attention.

International

NMPF Highlights Significant Foreign Regulatory Trade Barriers to USTR NMPF and USDEC submitted comments to the U.S. Trade Representative (USTR) on Oct. 23 that outlined several of the most important regulatory barriers to dairy trade for the agency’s annual National Trade Estimate Report.

• Egypt’s refusal to recognize the longestablished U.S. halal certifying bodies as eligible to provide the new mandatory halal certification required for dairy products’ entry into that market. NMPF pointed out this opaque procedure is not WTO-compliant and should be replaced with halal certification procedures that permit multiple certification bodies, like those used for dairy in other markets.

NMPF emphasized the importance of exports to the health of the U.S. dairy industry and reiterated its concern that the administration has chosen to deprioritize pursuing free trade agreements that open new markets for U.S. dairy products. NMPF also listed the specific major non-tariff trade barriers confronting the U.S. dairy industry on a country-by-country basis in key markets. Examples of issues include:

• Emerging European Union (EU) Farm to Fork regulations that could upend trade due to attempts to impose domestic regulatory preferences unrelated to food safety on imported products. NMPF urged USTR to engage early and broadly with the EU on these measures to ensure they do not deepen the already stark U.S.-EU dairy trade deficit.

• Canada’s Tariff-Rate Quote allocation system, which represents an ongoing U.S.-Mexico-Canada Agreement (USMCA) violation. NMPF commended USTR’s pursuit of a second dispute settlement panel to address these shortfalls and pledged its support in working with the agency to ensure that Canada’s TRQ administration procedures are made fully USMCA compliant.

• Indonesia’s inability and/or unwillingness to register U.S. dairy plants. NMPF urged USTR and USDA to establish a streamlined and more predictable facility registration process.

12

NMPF EMPHASIZED THE IMPORTANCE OF EXPORTS TO THE HEALTH OF THE U.S. DAIRY INDUSTRY AND REITERATED ITS CONCERN THAT THE ADMINISTRATION HAS CHOSEN TO DEPRIORITIZE PURSUING FREE TRADE AGREEMENTS THAT OPEN NEW MARKETS FOR U.S. DAIRY PRODUCTS.

International

U.S. Dairy Navigates New EU Veterinary Regulations As the European Union (EU) negotiates a new amendment to the EU’s Veterinary Medicines regulation, NMPF staff and USDEC’s Market Access and Regulatory Affairs teams have been meeting with the EU’s food safety authority and U.S. government officials to ensure that this new regulation does not upend trade to the bloc.

EU Article 118 would forbid imports from any third country supplier of animals and animal products which allows animals to be treated with antimicrobial products that are on a newly proposed EU list of unauthorized antibiotics. The EU’s reciprocity principle on antimicrobials violates the WTO’s Sanitary and Phytosanitary (SPS) agreement by outlawing the import from third countries of livestock products which have been produced from animals treated with any antimicrobial on the EU’s list of controlled

substances.

This new regulation is incompatible with a risk-analysis approach to controlling the spread of antimicrobials, and the European Union is therefore at risk of contravening the principles of the SPS agreement.

While the initial list appears to contain only substances not broadly used by U.S. dairy farmers, future iterations of the list may expand and could include other more important medicines. In a broader context, the EU’s move is consistent with a regulatory approach that attempts to dictate global farming practices through trade, a topic NMPF explored in detail in an article written for Hoard’s Dairyman magazine.

NMPF and USDEC continue to work with the U.S. government and allied organizations to ensure that Article 118 is implemented in a manner that does not become a burdensome obstacle to U.S. farmers and exporters.

NMPF AND USDEC, TOGETHER WITH THE OTHER U.S. AGRICULTURAL ORGANIZATIONS, STRONGLY OBJECT TO THE EU IMPOSING ITS DOMESTIC FARM PROCESS STEPS ON AMERICAN FARMERS.

13

Other NMPF News

NMPF Reorganizes Staff as Doud Begins Service NMPF announced a significant staff reorganization Sept. 7 as it transitions to new leadership, with incoming President and CEO Gregg Doud beginning work with the organization as the organization’s Chief Operating Officer, a position he will hold until current President and CEO Jim Mulhern retires in January.

“I am excited to announce these changes, which will enhance the efficiency and effectiveness of our organizational structure,” said Mulhern. “They also recognize the significant contributions of the affected individuals to our overall success in recent years and position the organization well for even greater success in the future.”

As part of the reorganization, NMPF named three Executive Vice Presidents – Paul Bleiberg, Shawna Morris and Alan Bjerga –

14

as part of the reorganization, recognizing responsibilities that are expanding across NMPF teams. Bleiberg will serve as Executive Vice President, Government Relations; Morris as Executive Vice President, Trade Policy & Global Affairs; and Bjerga as Executive Vice President, Communications and Industry Relations.

Other promotions include David West to Chief Administrative Officer; Stephen Cain to Senior Director, Economic Research & Analysis; Beverly Hampton Pfifer to Senior Director, FARM Animal Care; Theresa Sweeney-Murphy as Senior Director, Communications and Outreach; Miquela Hanselman to Director, Regulatory Affairs; and Tony Rice to Director, Trade Policy.

Staffers receiving title changes in line with new responsibilities are Chris Galen, who will serve as Senior Vice President of Member Services and Governance, and Claudia Larson, Senior Director, Government Relations & Head of Nutrition Policy.

Upcoming Webinars of Interest

Front-of-Package Nutrition Labeling Virtual Public Meeting Nov. 16, 2:30 - 5 PM ET Register here.

Virtual Public Meeting and Listening Sessions on Strategies to Reduce Added Sugars Consumption Virtual Public Meeting • Monday, Nov. 6, 11:00 AM - 4:00 PM ET Virtual Listening Sessions • Nov. 7, 10:00 - 11:30 AM and 2:00 - 3:30 PM ET • Nov. 8, 10:00 - 11:30 AM and 2:00 - 3:30 PM ET Click here for more information and to register.

15

National Milk Producers Federation 2107 Wilson Blvd., Suite 600 Arlington, VA 22201 703-243-6111 info@nmpf.org nmpf.org

16