FDA Releases Draft Guidance on Changing OTC Antimicrobial Status

The FDA released on September 23 draft Guidance for Industry #263 (GFI #263) “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.”

FDA’s intent with GFI #263 is for animal drug pharmaceutical manufacturers to voluntarily change the marketing status of the remaining approved animal drugs containing antimicrobials of human medical importance from over-the-counter (OTC) to prescription (Rx) under the oversight of licensed veterinarians. This draft guidance comes as part of the FDA’s five-year plan for supporting antimicrobial stewardship in veterinary settings as part of a strategy to address antimicrobial resistance associated with the use of antimicrobial drugs in animal agriculture.

GFI #213 was the FDA’s first step to increase oversight of antimicrobial use through voluntary industry action to change marketing status of medically important antimicrobials used in feed or drinking water for food-producing animals from OTC to VFD/Rx. This also resulted in the elimination of the use of these antimicrobials for production practices. While GFI #263 will be voluntary, NMPF anticipates that pharmaceutical manufacturers will change the marketing status of the limited number of dosage forms of medically important antimicrobials that are still available from OTC to Rx for both food-producing and companion animals.

NMPF has recognized that OTC availability of antimicrobials was going away and has made the Veterinarian Client Patient Relationship, a cornerstone of the National Dairy FARM Animal Care Program. NMPF supports the prudent and responsible use of antibiotics and will be examining the potential impact on small or geographically isolated dairy farmers who may have a lack of large animal veterinary services where they are located.

NMPF will submit comments to the docket.

Joint Agriculture Effort Supports APHIS Plan for Animal Disease Prevention and Management

NMPF participated Oct. 1 in a joint press conference with the National Pork Producers Council, the National Corn Growers Association and Iowa State University to urge the USDA to quickly spend mandatory funding included in the 2018 Farm Bill to buy enough vaccine to effectively contain and eradicate an FMD outbreak.

USDA’s Animal and Plant Health Inspection Agency announced in August initial plans to carry out new animal health activities using resources provided by the 2018 Farm Bill. Section 12101 of the law established a three-part program to comprehensively support animal disease prevention and management. The bill included funding to create two new programs: The National Animal Vaccine and Veterinary Countermeasures Bank (vaccine bank) and the National Animal Disease Preparedness and Response Program (NADPRP). It also expanded funding opportunities for the existing National Animal Health Laboratory Network (NAHLN).

These 2018 FARM Bill programs were initially identified in 2014 as priorities for Food and Mouth Disease (FMD) preparedness by the NMPF Animal Health and Wellbeing Committee. NMPF worked with a coalition of other stakeholders to obtain new funding in the 2018 FARM Bill for FMD preparedness.

“The time to build a best-in-class FMD Vaccine Bank is now,” said Jamie Jonker, Ph.D., vice president for Sustainability & Scientific Affairs at NMPF, at the news conference. “NMPF has been active in informing our members and the dairy community of the importance of preparation, and a vaccine bank is a crucial element of protection for the entire livestock industry.”

NMPF Submits Comments on Dairy Trade Barriers to USTR

Every year, the USTR solicits comments from stakeholders on trade barriers to help shape their annual National Trade Estimate Report on Foreign Trade Barriers. NMPF, in conjunction with USDEC, prepared an extensive review of trade policies hindering dairy exports to key markets.

NMPF is urging the U.S. government to continue its pursuit of fair and reciprocal trade agreements, while also cautioning them against using valuable resources to negotiate trade deals that will not yield agricultural benefits for the U.S. NMPF’s comments cover many detailed issues, including the importance of passing USMCA, the need to fully resolve the trade dispute with China, the trade imbalance driven by the EU’s unfair trade policies and FTAs, new technical regulations in the Gulf, and much more.

NMPF’s goal for this document is that it will inform and guide the USTR during trade negotiations and encourage them to make dairy’s needs a priority in any future deals.

U.S., Mexican Dairy Industries Hold Fourth Annual Summit, Commit to Shared Goals

Strengthening their commitment to promoting dairy trade between their nations, the U.S. and Mexican dairy industries held their fourth annual meeting in Torreón, Mexico in October, discussing the importance of finalizing USMCA, addressing concerns regarding a proposal mandating front-of-packaging nutrition labeling in Mexico and reaffirming their commitment to advancing shared priorities.

NMPF, USDEC and organizations representing dairy producers and processors in Mexico attended the meeting. The U.S. and Mexican industries released a joint statement following the summit, including a multi-point pledge to protect and promote dairy.

“The dairy industries of Mexico and the United States are proud to be among the world’s leading providers of wholesome and nutritious dairy products. We help feed communities around the globe while driving economic growth and bringing myriad positive benefits to each of our respective nations. We salute the hard work of the dairy farmers and processors in both Mexico and the United States who produce superior dairy products in an increasingly competitive marketplace,” they wrote.

The annual country-to-country meeting came as the U.S. awaits congressional passage of the U.S.-Mexico-Canada Agreement. Mexico has already passed the trade pact, which will help further secure the partnership shared by the U.S. and Mexico and support the important role dairy farmers play in rural economies and providing high-quality food products to consumers. NMPF will continue working with partners in Mexico to achieve these common goals for the benefit of dairy producers.

NMPF Files Comments Emphasizing the Unintended Consequences of Horizontal Standards of Identity

NMPF filed comments Nov. 12 to the Food and Drug Administration’s modernizing standards docket, emphasizing that in many cases so called “horizontal” changes to standards are unnecessary, and has potential for unintended consequences. NMPF cautioned FDA to not move forward with this proposal.

Horizontal standards, which would be guidelines applied to all current standards of identity as a way to modernize them all at once, were proposed at a meeting in September in which NMPF spoke of how some companies may use it to cheapen their food products, not make them healthier. “When dealing with hundreds of very different standards, and the intention is to improve one, such changes may not be transparent when applied to different foods, and stakeholders could be deprived of a proper opportunity to weigh in,” Clay Detlefsen, NMPF regulatory expert, said.

NMPF’s comments focused on why maintaining the standards of identity are necessary to meet consumers’ expectations of products, noting that innovation in food groups is already happening without horizontal standards. “Creating these horizontal standards could just allow companies to cheapen their products under the guise of innovation legally,” NMPF wrote. The full comments can be found here.

Dairy Industry Helping Lead USMCA Push

NMPF has been outspoken in its advocacy for USMCA and its benefits for dairy farmers. As this year’s congressional session draws to a close, NMPF is increasing efforts to encourage congressional leaders and USTR to come to an agreement that moves this trade pact forward.

NMPF president and CEO Jim Mulhern on Oct. 31 joined House Agriculture Committee Livestock Chairman Jim Costa and other agricultural leaders at an event on Capitol Hill to stress the importance of passing USMCA American agricultural prosperity. Together, they called on Congress to act swiftly to pass USMCA to improve our trade relationships and secure increased export opportunities.

Mulhern also penned an op-ed for Agri-Pulse that was published in conjunction with the event, writing, “The trade relationships the U.S. shares with our North American neighbors are among our most important, but they are long overdue for an upgrade. Congress has the opportunity to make that happen by passing the United States-Mexico-Canada Agreement (USMCA). With just a handful of legislative days left on the congressional calendar in 2019, there’s no time to waste and congressional action is urgently needed.”

NMPF has also been a driving force behind an effort to amplify the voice of the dairy farmer in USMCA outreach. Working closely with members and with USDEC, NMPF spearheaded and secured placement for farmer-led guest columns in the Cedar Rapids Gazette in Iowa, the Daily Star in New York, the Reading Eagle in Pennsylvania, and the Star Tribune in Minnesota.

Dairy Margins Widen to Highest Since 2017 in Positive Economic Sign

In welcome news for the dairy economy, the September margin under the Dairy Margin Coverage program rose by $0.56 per cwt. over the August margin to reach $10.41 per cwt, the second consecutive month margins have fallen outside the threshold necessary to trigger a federal payment. The is the highest seen since the beginning of 2017, allowing for the change in the alfalfa hay price in the margin formula’s feed cost calculation. The September all-milk price was $0.40 per cwt. higher than August’s and the DMC calculated feed cost for September was $0.16 per cwt. lower than August’s, mostly due to a drop in the price of corn.

As of November 6, USDA’s DMC Decision Tool, which can be accessed online, projected the margins shown in the chart below. The DMC margin is currently projected to remain above $9.50 per cwt. for the remainder of 2019 and during all of 2020. Milk prices are expected to generate most of the monthly changes in the margin forecast, while feed costs are anticipated to remain relatively stable during that time.

The DMC information page on NMPF’s website offers a variety of educational resources to help farmers make better use of the program. NMPF also posted a new video explaining how farmers can benefit from the DMC.

NMPF Highlights Dairy’s Resilience, Honors Farmer Leaders at Annual Meeting

National Milk Producers Federation President and CEO Jim Mulhern highlighted the resilience of U.S. dairy farmers in a challenging economic and policy environment at NMPF’s joint annual meeting in New Orleans on Nov. 6, pledging that dairy would speak with one voice on crucial issues.

“Resilience against hardship has always been a fact of life in dairy,” Mulhern said. “We know that if we embrace change while holding true to our values, we will win.”

NMPF’s portion of the Nov. 4-6 conference was highlighted by bylaws changes that bolster its position as the premier organization for U.S. dairy farmers. The biggest U.S. dairy-farmer group also honored longtime leaders who have helped build today’s industry.

The organization added the chairman of its Small Cooperative Caucus, Jimmy Kerr of Cooperative Milk Producers Association based in Blackstone, Virginia, to its now 15-member Executive Committee, ensuring that cooperatives of all sizes have a voice in the organization’s thought-leadership body. The Executive Committee, that was formed earlier this year, enhances the geographic and size diversity the organization needs in its governance structure.

“NMPF represents a broader range of dairy farmers and interests than any other industry organization,” Mulhern said. “Committing to diverse leadership makes our united voice is the strongest it can be. Brighter times lie ahead for dairy, and we are ready to advance in a wide range of areas that serve all of our members.”

The meeting, NMPF’s main policy conference of the year, attracted more than 850 attendees, about 50 more than the previous year. It featured discussions of the state of the dairy industry and economy, with remarks from the organization’s chairman, Missouri dairy farmer Randy Mooney.

“Dairy farmers play an important role in society. We help preserve communities,” he said. “Like all of you, I’m proud to be a dairy farmer, producing the most nutritious product in the world.”

NMPF staff also presented on issues ranging from immigration to the fight against inappropriate labeling of plant-based products.

Awards presented at the meeting included the winner of the Communicator of the Year award, this year given to Michigan Milk Producers Association, and the winners of the annual cheese contest, with this year’s overall honor going to Associated Milk Producers Inc.

The Young Cooperators portion of the program, which began on Sunday, Nov. 3, included seminars on communications, the FARM program, and other topics of interest to younger producers.

NMPF also named new members to its Board of Directors, including:

  • James Jacquier, Agri-Mark Inc.
  • Harold Howrigan, Dairy Farmers of America, Inc.
  • David Kyle, Foremost Farms USA
  • Joey Fernandes, Land O’Lakes
  • Sonia Fabian, Lone Star Milk Producers.

NMPF also recognized four dairy leaders with “Honorary Director for Life” designations for their service to NMPF and the broader dairy community:

  • Adrian Boer, Northwest Dairy Association
  • Cornell Kasbergen, Land O’Lakes
  • Neal Rea, Agri-Mark
  • George Rohrer, Dairy Farmers of America.

Remarks from the 2019 Joint Annual Meeting in New Orleans

This month’s CEO’s Corner comes from NMPF President and CEO Jim Mulhern’s remarks at the National Milk Producers Federation annual meeting in New Orleans, delivered Nov. 6. Remarks condensed from full address.

As I was putting my thoughts together for this year’s meeting, I was walking through the office a couple weeks ago and I saw a sign in one of my staff members’ offices. I’ve seen this sign hundreds of times, but as I was thinking of this meeting it struck me anew. The sign has a word on it, and the word is resilience. I think that one word really captures what this industry is all about, what you are all about and it’s what I want to briefly focus on this morning.

It’s an understatement to say we’ve been in tough times these last five years, and your resilience in the face of the economic challenges that we’ve been dealing with has been remarkable. And it’s driven all of us who work for you to work that much harder to support you and advance your agenda, whether it’s in Washington on the policy front or on the promotion front across this country — and really around the world.

It has been a tough time. A year ago we were in our fourth straight year of low prices, and Congress hadn’t passed the farm bill. Today it’s a different situation. Prices are improving. We’ve got the Dairy Margin Coverage program in place, providing more than $300 million in assistance this year, assistance that wouldn’t have happened without that program, without the hard work of all of you and the folks you represent around the country.

And it isn’t just that safety net. It’s also provisions in the program for better risk management for larger producers– getting a revenue protection program in place, getting LGM (Livestock Gross Margin program) caps lifted. We’ve got better tools to deal with the vagaries of the market and as we go into the future, that’s really going to help us.  We all know that dairy farming can be challenging, even in the best of times, and these certainly haven’t been the best of times, but they’re getting better. Improved prices that we’re seeing, and a better safety net and improved risk management, will encourage a more resilient dairy industry in the months and years ahead.

It’d like to talk about just a couple issues. Trade has been an area where we’ve had to be especially resilient, given the challenges we’ve faced these last few years.  We know our future is heavily dependent on our ability to access the international market and gain access to that market. We produce 30 billion pounds more milk today than we consume in the United States. Domestic demand is strong, but you guys are stronger in your ability to produce milk, so we’ve got to look to those export markets to grow this industry and grow opportunity for the future.   We’ve got an incredible leader, as you just saw this morning and as I get to see on a daily basis, an incredible leader in Secretary Tom Vilsack, working on your behalf at the U.S. Dairy Export Council, providing tremendous guidance not only on exports, but even broader issues, such as sustainability, and giving greater visibility to the work of this industry, all to help advance our interests.

The picture a year ago was not a pretty one.

We had cheese exports to Mexico hit by tariffs. Virtually all our products going to China, hit by tariffs. The European Union, busily negotiating bilateral agreements with important markets to us like Mexico and Japan. Big challenges on many fronts. USMCA was approved, but still not done through the Congress yet.

These challenges have threatened to derail our efforts to grow exports, but we’ve been at the fight every step of the way pursuing our global strategy, and we have made great progress in the last year.

The USMCA agreement does protect our access to our number-one market, Mexico. The agreement has hard-fought disciplines on Canada. We’ve got a down payment agreement with Japan. We didn’t get everything we wanted, but secured important access, to U.S. cheese in particular. There is more work to be done, we’re going to keep at it, but it was an important gain.

Another issue: Airbus. It has nothing to do with the dairy industry directly — but it’s part of the continual effort of the European Union to deploy trade policy to protect their domestic industries, blocking our products out. We fought hard to make sure that given the EU practices on the Airbus issues, and the WTO approval of the United States’ ability to put retaliatory tariffs in place, we wanted to make sure dairy was high on that retaliation list — not because cheese has much to do with airplanes, but because we wanted to send a message to the Europeans that the way you play the game is not acceptable. If you’re not going to give us access to your market, you don’t deserve unfettered access that lets you sell about $1.5 billion worth of cheese to the United States while we are blocked from selling much more than about $150 million total dairy product into the EU because of these barriers.

It also sends a message on common food names. The Italian president was in the White House about two weeks ago, complaining to the president about how those retaliatory tariffs the United States put on the EU were going to increase the price of Italian cheeses and that wasn’t fair. We reminded the president the next day that what wasn’t really fair was what I just talked about — the Europeans blocking access for us to that market and their efforts to take away common food names that are important for our future growth in the cheese market around the world.

Finally, we’ve been busy with Cooperatives Working Together, working to expand export sales. That program is so important — when you have a situation which we face most of the time, where world prices are below our domestic market prices for key products, cheese in particular, but also butter and whole milk powder. We use CWT to provide needed assistance, to get that product into the world market. So far this year, the CWT exports that we’ve sent into the world market have covered more than twice the increase in milk production that’s occurred in the United States. That’s helping to improve the supply/demand balance and giving lift to milk prices.

All this has been important. But it’s important to recognize that in this trade environment turbulence likely will be the new normal. We need to be prepared for that. That’s the future we’re going to face, but gains are possible for this industry when we work together, and it’s a tribute to the collaborative effort of these organizations, of USDEC and DMI, on program after program, whether it’s the direct work of USDEC in terms of improving market access, or the market promotion all over the world formed in partnership with companies like Domino’s and many others trying to move our production to the world market. It is the effort of CWT to provide some assistance to get those exports out. It’s the effort of National Milk Producers Federation, working hand in glove with USDEC on trade policy.  Together we’re able to get a great deal done on your behalf.

I’m going to spend a couple minutes talking about a topic important to me and very important to you and that’s fake milk — and it gets a little into fake news as well.

When you feel under attack and facing tough time as we’ve certainly been experiencing, it’s easy for your opponents and those who don’t have your best interest at heart, it’s easier for them to try to take control of the narrative. Tom Gallagher did a great job yesterday, talking about the attack on our industry, the attacks on the checkoff program.

As an industry, we see these attacks virtually every single day.  Fewer farms since we’ve had tough times economically, the decline in fluid milk sales, growth in alternative dairy products — all of that is spun into a narrative that’s called the “death of dairy.”

We’ve also seen the stories about animal agriculture, not just dairy, means that cows are killing the planet. That’s what our well-funded critics want the public to believe. The reality, as you know, is just the opposite. Rather than an industry in decline, this is a growing sector with very bright days ahead. And that’s what we’ve got to keep in mind. We’ve been through tough times. It’s getting better now. This is an industry with an incredibly powerful future because we produce a food with unparalleled nutrition and great taste.

Central to our story of resilience is getting out the facts. The science and the true narrative about milk. You know those facts. For all the talk about the death of dairy and the decline in fluid milk consumption, the real story is that dairy consumption is at a 56-year high — the highest per capita consumption for dairy since 1962. That’s not the story that the vegan activist, the animal rights activists, want people to hear, but that’s why we need to be talking about it.

Milk is the number one source of nine nutrients in children, and it would be the number one source in the diets of everybody if adults consumed as much milk as would be good for them. That’s a part of our challenge, but those are important facts. There are a lot more on our side. We are winning in facts and we’re beginning to win on opinion on the fake milk issue, and we’re going to keep using these facts, that science, your support, to keep the pressure on the FDA to get action on this issue in 2020.

And finally, you’re going to hear a very positive story from Dr. Frank Mitloehner later this morning on dairy and agriculture — the sustainability story. We are able to tell this story because there is so much going on in this industry on sustainability. We’ve been the leaders. I’ve been privileged to have been engaged in our sustainability efforts for many years. We have more to do on the farm and in telling our story, but we all know that we can do it.

As we look ahead to 2020, we know that dairy has always been a cyclical industry. Our industry prices have been rising this fall, and we have reason to believe that 2020 will be a good year. But that doesn’t mean that there won’t be problems. There will be. But whatever they are, we’ve survived the worst. We know that, and we’re stronger today than we were a year ago.

Resilience against hardship has always been a fact of life in dairy. I’ve seen that resilience over the years, and it has always impressed me so much, and made me proud to work on your behalf.

It’s how we react to hardship that determines the outcome. The onus is on us. We see the signs of change all around us. Yes, this pace of change pushes us out of our comfort zone, and it can be scary. But we know that if we embrace change and hold true to our values, we will win out.

It’s the unity we forge on issues confronting us that will get us through. Whether it’s the longstanding bread-and-butter issues that impact our milk checks, or the new and emerging issues in the consumer marketplace, whether it’s animal care or climate change, or others, our resilience will inform all that we do in the next year, a year that will undoubtedly bring new challenges, but also undoubtedly will bring progress for all of us. I’m ready for it. I hope you are too. Let’s get after it. Thanks very much.

NMPF Highlights Dairy’s Resilience, Honors Farmer Leaders at Annual Meeting

NEW ORLEANS – National Milk Producers Federation President and CEO Jim Mulhern highlighted the resilience of U.S. dairy farmers in a challenging economic and policy environment, pledging that dairy would speak with one voice on crucial issues in remarks at NMPF’s joint annual meeting with the United Dairy Industry Association and the National Dairy Promotion and Research Board.

“Resilience against hardship has always been a fact of life in dairy,” Mulhern said. “We know that if we embrace change while holding true to our values, we will win.”

NMPF’s portion of the conference was highlighted by bylaws changes that bolster its position as the premier organization for U.S. dairy farmers. The biggest U.S. dairy-farmer group also honored longtime leaders who have helped build today’s industry.

At its annual meeting in New Orleans, the organization added the chairman of its Small Cooperative Caucus, Jimmy Kerr of Cooperative Milk Producers Association based in Blackstone, Virginia, to its now 15-member Executive Committee, ensuring that cooperatives of all sizes have a voice in the organization’s thought-leadership body. The Executive Committee, that was formed earlier this year, enhances the geographic and size diversity the organization needs in its governance structure.

“NMPF represents a broader range of dairy farmers and interests than any other industry organization,” Mulhern said. “Committing to diverse leadership makes our united voice is the strongest it can be. Brighter times lie ahead for dairy, and we are ready to advance in a wide range of areas that serve all of our members.”

The meeting, NMPF’s main policy conference of the year, featured discussions of the state of the dairy industry and economy, with remarks from the organization’s chairman, Missouri dairy farmer Randy Mooney, and presentations from NMPF staff on issues ranging from immigration to the fight against inappropriate labeling of plant-based products. It also named new members to its Board of Directors, including:

  • James Jacquier, Agri-Mark Inc.
  • Harold Howrigan, Dairy Farmers of America, Inc.
  • David Kyle, Foremost Farms USA
  • Joey Fernandes, Land O’Lakes
  • Sonia Fabian, Lone Star Milk Producers.

 

NMPF also recognized four dairy leaders with “Honorary Director for Life” designations for their service to NMPF and the broader dairy community:

  • Adrian Boer, Northwest Dairy Association
  • Cornell Kasbergen, Land O’Lakes
  • Neal Rea, Agri-Mark
  • George Rohrer, Dairy Farmers of America.

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The National Milk Producers Federation (NMPF), based in Arlington, VA, develops and carries out policies that advance dairy producers and the cooperatives they own. NMPF’s member cooperatives produce more than two-thirds of U.S. milk, making NMPF dairy’s voice on Capitol Hill and with government agencies. For more, visit www.nmpf.org.

Dairy Defined Podcast: Mooney Speaks at Annual Meeting

 

(Note: NMPF’s Dairy Defined podcast explores today’s dairy farms and industry using high-quality data and podcast-style interviews to explain current dairy issues and dispel myths.)

ARLINGTON, Va. – U.S. dairy farmers have been through challenging times, but they’re ready to face the challenges of trade, the environment, climate and changing consumer tastes, said Randy Mooney, a Missouri dairy farmer and chairman of the National Milk Producers Federation. Mooney spoke this morning at the organization’s annual meeting, this in New Orleans.

“Dairy farmers play an important role in society. We help preserve communities,” he said. “Like all of you, I’m proud to be a dairy farmer, producing the most nutritious product in the world.”

To listen to the full podcast, click here. You can also find the Dairy Defined podcast on Spotify and SoundCloud. Broadcast outlets may use the MP3 file. Please attribute information to NMPF.

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 The National Milk Producers Federation (NMPF), based in Arlington, VA, develops and carries out policies that advance dairy producers and the cooperatives they own. NMPF’s member cooperatives produce more than two-thirds of U.S. milk, making NMPF dairy’s voice on Capitol Hill and with government agencies. For more, visit www.nmpf.org.