Regulatory Register - Summer 2021

REGULATORY REGISTER Volume 23, Issue 3 Summer 2021

In this issue CDC Recommends Food and Ag Workers Get Priority Vaccine Status, Page 2 Dairy Gears Up for UN Food Systems Summit, Page 3 Yogurt Standard Revamp a Win for Dairy Labeling, Page 4

Group Convened to Look at Intentional Adulteration and Dairy Farms A 14-member study group organized through the National Conference on Interstate Milk Shipments (NCIMS) to explore dairy-farm inclusion in the Intentional Adulteration Act met for the first time July 20. The group includes NMPF’s Senior Vice President for Regulatory and Environmental Affairs, Clay Detlefsen.

President Obama in 2011 signed the Food Safety Modernization Act (FSMA) into law, including seven major rules and other provisions that the Food and Drug Administration is still trying to resolve.

The Intentional Adulteration Rule is unique in that, unlike all the other rules and provisions in FSMA, it opens the door for FDA to regulate dairy farms, with FSMA specifically stating that this rule would not be applied to farms, “except for dairy farms.” At the time the rule was drafted, there was a concern at high levels in the government that the dairy industry could be a target for intentional adulteration. Much of that concern has vaporized and the specific mode of operation for such an attack was proven to be false. Still, FDA believes that at the very least they need to explore the inclusion of dairy farms within the scope of the rule.

WOTUS To Be Re-written, Again The Environmental Protection Agency (EPA) and the Department of the Army announced their intent to revise the definition of the Waters of the U.S (WOTUS) on June 9, the same day the Department of Justice filed a motion requesting remand of the 2020 Navigable Waters Protection Rule (NWPR). That motion was granted July 14. The ruling also leaves the Navigable Waters Protection Rule in place while the revisions are being written.

EPA states that after reviewing the Navigable Waters Protection Rule, it determined that the “rule is leading to significant environmental degradation.” In the weeks leading up to the announcement on a call with agriculture stakeholders, NMPF had clearly expressed that the NWPR provided certainty to dairy producers as to which waters are regulated, and that the 2015 rule was an overreach.

EPA will hold listening sessions and regional roundtables to gather input on what should be included in the new definition.

The study group includes four members from FDA, five from state agencies and five from industry, Detlefsen and the study group’s chair, Antone Mickelson from Darigold.

The group’s first meeting established the following objectives: • To identify potential mitigation strategies (MSs) that could be implemented in a dairy farm environment to reduce vulnerability to intentional adulteration; • To evaluate potential mitigation strategies to determine if they are viable to implement on a dairy farm, considering current dairy farming practices and the impact particular mitigation strategies may have on farm operations; regulatory compliance with existing state, local, or federal requirements; and perceived feasibility and estimated costs involved in implementation of those strategies; and • To identify food defense awareness training activities relevant to dairy farms and identify potential gaps in those trainings.

NMPF staff is working to ensure that dairy farms are not regulated under the Intentional Adulteration rule but is open to identifying voluntary procedures that could be beneficial in reducing risks on a farm.

NMPF Farmer Leadership Meets with USDA on Animal Health Issues Karen Jordan, DVM, Chair of the NMPF Animal Health and Wellbeing Committee, and Jamie Jonker, Ph.D. NMPF Chief Science Officer staff, met with USDA APHIS Administrator Kevin Shae and other USDA animal health leadership July 29 to discuss animal-health issues for U.S. dairy farmers.

Dr. Jonker spoke about the importance of continued industrygovernment collaboration on preparedness for foreign animal diseases such as Foot and Mouth Disease. An example of that collaboration is the recent NADPRP cooperative agreement between USDA and NMPF to advance and integrate Everyday and Enhanced/Secure Milk Supply biosecurity into the National Dairy FARM Program. USDA is also in the process of modernizing the FMD Vaccine Bank due to increased funding in the 2018 FARM Bill advocated by NMPF and others.

“The NADPRP cooperative agreement and FMD Vaccine Bank modernization are the result of long-term collaboration by USDA and the dairy industry on foreign animal disease preparedness,” said Dr. Jonker.

Dr. Jordan stressed the importance of USDA cattle health programs for dairy farmers, including revising and updating the National Tuberculosis Eradication Program standards to meet contemporary challenges of disease eradication, including

disease transmission, lower disease incidence, and changing production systems. This year, NMPF formed a multi-stakeholder task force with dairy farmers, veterinarians, and state and federal animal and public health officials to address the transmission of Bovine TB from cattle to humans and humans to cattle. Dr. Jordan also discussed emerging animal health and safety issues including the Asian longhorn tick and black vultures which are a threat to dairy cattle on pasture.

“Long-term USDA cattle health programs like the National Tuberculosis Eradication Program are important for the health and welfare of dairy cattle and economic viability of dairy farmers,” Dr. Jordan said. “USDA work on emerging pests like the Asian longhorn tick and black vultures is important as well.”

Both speakers also stressed the importance of USDA in trade for U.S. dairy farmers.

With more than 15 percent of U.S. milk exported around the world, USDA APHIS leadership is necessary to maintain and enhance market access for U.S. dairy farmers, according to Jonker and Jordan. This work includes important APHIS efforts with Codex Alimentarius, the World Organization for Animal Health, and animal health certification for export certificates, which are vital to maintain and expand trade.

NMPF Comments on FDA Antimicrobial Use Duration NMPF joined NCBA, AABP, and AVC on June 6 in joint comments to the U.S. Food and Drug Administration on the concept paper titled, “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use in or On Feed: A Concept Paper.”

Consistent with National Dairy FARM Program standards, the comments included support for the use of antimicrobial drugs in cattle for disease treatment, prevention, and control, under the oversight of the Veterinarian of Record and working within a valid Veterinarian-Client-Patient Relationship (VCPR). The comments further indicated support for efforts to improve and implement the judicious use of medically important antimicrobial drugs.

At the same time, these efforts must not compromise animal health and welfare. Defining durations of antimicrobial use on a label should not restrict the veterinarian’s ability to adapt treatment protocols to changing management practices and changes in the epidemiology of infectious cattle diseases.

Replacing the current clear pathway of veterinary oversight with overly restrictive duration of use labels for the medically important antimicrobial drugs used in and on feed will affect the ability of the veterinarian to protect cattle health and welfare.

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NMPF Comments on Executive Order on Tackling the Climate Crisis at Home and Abroad NMPF submitted April 29 a series of comments to USDA on the Executive Order on Tackling the Climate Crisis at Home and Abroad. President Biden issued the Executive Order on Jan. 27 “to pursue action at home and abroad to avoid the most catastrophic impacts of that crisis and to seize the opportunity that tackling climate change presents. Domestic action must go hand in hand with United States international leadership, aimed at significantly enhancing global action.”

Broadly, these comments spoke to the ability of US dairy and US agriculture in general to be environmental solutions to climate change. The three sets of comments are: • NMPF highlighted the U.S. dairy 2050 sustainability goals and the Net Zero Initiative in joint comments with Newtrient. Dairy farmers can provide real solutions to many of today’s biggest environmental challenges like carbon emissions, soil health, water quality and water quantity. Embracing new practices and technologies is key to making America’s dairy farmers an environmental solution while providing wholesome and nutritious dairy products to the U.S. and the world.

• NMPF and a broad coalition of agriculture and environmental organizations submitted comments under the umbrella of the Food and Agriculture Climate Alliance that support voluntary, market- and incentive-based policies; advance and accelerate science-based outcomes; and promote resilience and help rural economies better adapt to climate change.

• Finally, as part of a broad-based biotechnology coalition comments, NMPF stressed support for a science- and risk-based regulatory system which fosters innovation, values the environmental benefits that using biotechnology enables agriculture to achieve, recognizes the long and safe track record of plant and animal breeding, and the overwhelming evidence of the safe use of genetic engineered plants and animals.

Dairy Gears Up for UN Food Systems Summit The United Nations held a Food Systems Pre-Summit Ministerial in Rome from July 26-28 to summarize progress to date in discussions leading up to the September UN Food Systems Summit to be held in New York. Although dairy and modern agriculture opponents were vocal at this international meeting, U.S. officials pushed back on the notion that a one-size fits all, anti-trade and anti-innovation approach would yield the progress needed to advance global food systems.

UNFSS Pre-Summit Ministerial, the Global Dairy Platform (GDP) hosted a side event July 26 to announce the Pathways to Dairy Net Zero Initiative. A multi-stakeholder group of organizations including the International Dairy Federation, SAI Platform and other representatives from the global dairy sector, scientific, and research communities, are working together to develop methodologies, tools and pathways that work for every dairy system.

NMPF, working closely with USDEC, has been active in touting the U.S. dairy industry’s sustainability story – both present and planned – and in working closely with the U.S. government to support the development of positions that would advance our sector’s goals for continued science and innovation-based sustainability gains.

Pathways to Dairy Net Zero will officially launch during the UN Food Systems Summit in September and aims to generate commitments at the UN Climate Change Conference, COP26, in November. The U.S. Dairy Net Zero Initiative, begun last year, is well underway and is demonstrating U.S. leadership in this space; the initiative was submitted earlier this year as a gamechanger to the UNFSS. The initiative is a strong example of the type of progress GDP is working to spur in other parts of the world as well.

The U.S. delegation was led by U.S. Deputy Secretary of Agriculture Jewel Bronaugh, illustrating the high level of importance the administration has placed on helping drive a more pragmatic and positive narrative on the food systems and sustainability topics.

NMPF and others in the U.S. food and agriculture sector are reinforcing the value of that approach and encouraging the U.S. to deepen its commitment to building a strong base of allies to work with in that pursuit. In conjunction with the

The U.S. Dairy Net Zero Initiative was also highlighted on the global stage this week as a case study in the 2021 IDF Dairy Sustainability Outlook, a special edition dedicated to the United Nations Food Systems Summit demonstrating our commitment to nourishing the global population with safe and nutritious foods through sustainable U.S. dairy production.

U.S. Dairy Initiatives Highlighted as UNFSS Gamechangers United Nations Secretary-General António Guterres in September is convening a Food Systems Summit (UNFSS) as part of the Decade of Action to achieve the 17 Sustainable Development Goals by 2030. The U.S. dairy industry has been active in events leading up to the Summit, highlighting U.S. dairy’s sustainable food system with engagement and dialogue through multi-stakeholder activities to address the five UNFSS Action Tracks.

In May, the U.S. Dairy industry hosted three UNFSS Virtual Gamechanger Events highlighting our industry’s initiatives and actions.

• The Net Zero Initiative UNFSS Virtual Gamechanger Event was held May 25. Led and moderated by Karen Scanlon (Dairy Management incorporate), this discussion explored U.S. dairy as an environmental solution across three key focus areas: what makes the Net Zero Initiative a game-changing solution; economic viability and incentives; and the critical importance of partnerships and collaboration. (white paper; video) • The National Dairy FARM Program UNFSS Virtual Gamechanger Event was held May 24. Emily Yeiser Stepp (Vice President of the FARM Program at NMPF), moderated a virtual experience highlighting the FARM Program as

an important contribution dairy is making in the U.S. and globally to improve and enhance food systems and contribute meaningfully to a sustainable future.

The discussion underscored the dairy industry’s strong track record of social responsibility in the areas of animal welfare, antibiotic stewardship, biosecurity, environmental stewardship, and workforce development, and dissected how the FARM Program works to help the industry improve and meet verifiable stewardship targets through scientifically based standards and best practices. (white paper; video) • The Food Security, Hunger Effort UNFSS Virtual Gamechanger Event was held May 18. The National Dairy Council hosted a game changing interactive experience titled “Food System Disruptions and Solutions: Partnerships that Provide Game Changing Solutions in the Face of Unprecedented Challenges.”

This experience allowed U.S. dairy to highlight its leadership in improving food security for those in need, to build and strengthen relationships with influential food systems stakeholders, and to position the U.S. dairy industry as a crucial resource and partner on a global food systems scale for the UNFSS and beyond. (white paper; video)

Yogurt Standard Revamp a Win for Dairy Labeling A new Food and Drug Administration (FDA) final rule on yogurt that took effect July 12 strongly defends standards of identify, a key pillar of NMPF’s effort to ensure transparency in dairy-product versus plant-based food labeling.

The final rule published June 9 amends the standard of identity for yogurt and revokes the standards of identity for low-fat and nonfat yogurt, modernizing the yogurt standard to allow for technological advances while preserving the basic nature and essential characteristics of yogurt and promoting honesty and fair dealing in the consumer interest. FDA strongly defends the importance of standards of identity, stating “any food that purports to be or is represented as yogurt, must conform to the definition standard of identity for yogurt” further proving that plant-based products need to be held accountable for illegally using dairy names.

This action was in part responding to a citizen petition submitted by the National Yogurt Association in February of 2000, and it is the first time in recent history FDA has modernized a standard of identity. NMPF was pleased with the outcome this rule and FDA’s clear and precise response to the 32 issues it covers. The full preamble and rule can be found here.

ABI Sends Complaint Letter to FDA Calling out Crisco “Butter” Spray The American Butter Institute (ABI) sent a letter to FDA on June 30 calling FDA’s attention to the mislabeling of Crisco’s No-Stick “Butter” Spray, which contains no butter at all. The no-stick spray both calls itself butter and features a pancake with a pat of butter on the label, even though canola oil is its top listed ingredient, with no dairy listed. This is in direct violation of the butter standard of identity — the only standard of identity to be defined by an act of Congress.

In addition to using the term butter on the package in violation of federal law, the product also doesn’t follow the basic rules for nomenclature on the label. As stated in the letter, “the product somewhat confusingly offers two possible alternatives as its

‘statement of identity,’ but neither, no matter the interpretation, provides proper labeling to prospective purchasers. One possible interpretation of the name of the food is that the name of the food is meant to be “Butter,” but in a spray form. Alternatively, the name of the food could also be ‘No-Stick Spray,’ but one that tastes and performs like butter. It is unclear which noun (butter or spray) represents the actual name of the food.”

ABI is urging FDA to take swift enforcement action against this product, which is clearly attempting to fool consumers into believing it’s a butter product. FDA acknowledged receipt of the letter.

FARM Publishes Biosecurity Webpage, New Excellence Awards The FARM Biosecurity webpage is now live and offers resources, information for farmers and a timeline of deliverables for the newest FARM program area.

Funded through a cooperative agreement with the USDA National Animal Disease Preparedness and Response program, FARM Biosecurity will integrate select on-farm elements (like the enhanced biosecurity plan) of the Secure Milk Supply program into the FARM Program and will develop an everyday biosecurity plan and resources for dairy farmers.

FARM also launched a new awards program to recognize farms and FARM evaluators who demonstrate excellence in their FARM Program. Award categories include Animal Care & Antibiotic Stewardship, Environmental Stewardship, Workforce Development, and FARM Evaluators. Nominations are open from July 1-Sept. 1. Farms or evaluators can be nominated by fellow dairy farmers, members of their communities, extension, cooperative or processor staff, veterinarians, themselves, or others. Winners in each category will receive tickets for two individuals to attend the Dairy Joint Annual Meeting in Las Vegas, Nov. 15-17.

Visit the FARM Excellence Awards page for more details.

FARM Receives PAACO Certification The Professional Animal Auditor Certification Organization (PAACO) has certified the National Dairy Farmers Assuring Responsible Management (FARM) Animal Care Program as an approved animal welfare evaluation. PAACO provides training and certification credentials for animal welfare auditors and audits for all sectors of food animal production.

all the key components required for evaluation of livestock animal welfare and is committed to continuous improvement.

“The FARM program has met requirements for audit structure, auditor expectations, and oversight and measurement of animal outcomes, facilities, and documentation” said PAACO Executive Director Collette Kaster.

“PAACO’s certification of FARM Animal Care affirms our commitment to the highest standards of animal welfare,” says Emily Yeiser Stepp, Vice President of the FARM Program. “This provides another layer of assurance to the supply chain that FARM is a comprehensive and rigorous tool that ensures dairy products are produced responsibly.”

FARM staff will also participate as members of the instruction team for PAACO dairy welfare auditor trainings. PAACO auditor certifications provide professional development opportunities for those looking to grow their animal welfare evaluating skillset.

To receive PACCO certification, the FARM Program went through a thorough review process of its Animal Care Version 4 standards, resources and evaluator training materials as compared to standards set by the PAACO Board of Directors.

The review ensured that the FARM Program evaluation includes

PAACO was developed in 2004 in response to the growing use of animal welfare audits by the retail and food service sectors.

This created the need for training, certification, and continuing education. Since its creation, PAACO’s vision is to be the trusted authority on animal welfare auditing, providing consistency and science-based training of auditors as well as rigorous, sciencebased audit standards.

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