April 11, 2018 0 Comment Montana Stockgrowers Association
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NCBA Lays Out Principles for Regulating Fake Meat

Today the National Cattlemen’s Beef Association submitted official comments to the United States Department of Agriculture (USDA) outlining key principles for the regulation of fake meat products. The comments, filed in response to Food Safety Inspection Service (FSIS) Petition Number 18-01, encourage USDA to look beyond modifying “standards of identity” in order to provide adequate protection for beef producers and consumers.

“It is critical that the federal government step up to the plate and enforce fair and accurate labeling for fake meat,” said Kevin Kester, President of NCBA. “As long as we have a level playing field, our product will continue to be a leading protein choice for families in the United States and around the world.”

NCBA’s regulatory principles are designed to effectively address both plant-based and lab-grown imitation beef products. Specifically, NCBA:

1) Requests that USDA work with the Food and Drug Administration (FDA) to “take appropriate, immediate enforcement action against improperly-labeled imitation products.”

NCBA firmly believes the term beef should only be applicable to products derived from actual livestock raised by farmers and ranchers. For misbranded and mislabeled plant-based protein products, existing legislation gives FDA the authority to take enforcement actions. However, the agency has a history of failing to enforce labeling laws. Rather than expending time and resources to develop a standard of identity the FDA will blatantly ignore, NCBA requests USDA engage with FDA to facilitate immediate, appropriate enforcement actions against imitation meat product labels that clearly violate existing laws.

2) Urges USDA to “assert jurisdiction over foods consisting of, isolated from or produced from cell culture or tissue culture derived from livestock and poultry animals or their parts.” 

NCBA believes that USDA-FSIS is the agency best placed to regulate emerging lab-grown meat products. First, USDA-FSIS possesses the technical expertise and regulatory infrastructure to ensure perishable meat food products are safe for U.S. consumers. Lab-grown meat must comply with the same stringent food safety inspection standards as all other meat products.

Second, USDA-FSIS labeling standards provided greater protection against false and misleading marketing claims. Unlike the FDA, USDA-FSIS requires pre-approval of all labels before products hit the marketplace. This will ensure consistent labeling practices across all products, and prevent misleading marketing labels such as “clean meat.”

October 21, 2014 Comments are off Montana Stockgrowers Association
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Addressing Antibiotic Resistance and Livestock Use

Antibiotics Use Livestock ResistanceFor many Americans purchasing food products at local grocery stores and retailers, there has been a growing movement to learn more about where our food comes from. Many food consumers have been asking to know who produces their food and under what conditions it was raised. Many people are asking for more transparency from food companies in order to learn more about the farming and ranching practices in place. As members of the farming and ranching community, we have a vital role in providing that information.

One of the more frequently discussed topics among food customers today is about the role of antibiotics use in livestock systems. As livestock producers, we understand there are variety of tools used on farms, ranches and feedlots which include vaccines, good nutrition programs and proper housing to keep animals healthy. Antibiotics are only one tool in a plan of good production practices to raise healthy animals. We also understand the importance of judicious use of these tools to keep them effective for animal health, food safety, costs, and proper management.

Last week, PBS Frontline aired an episode focused on the use of antibiotics and questions surrounding the cause of increasing antibiotic resistance in the human population. Though there are several possible sources for this medical trend, livestock were focused on as a possible cause. As members of the livestock we understand the continual to improve the way we utilize tools such as antibiotics, but we may not always communicate that clearly. It is a cooperation between local producers, veterinarians and federal officials who collaborate to improve our methods with food safety in mind.

With that in mind, we have a few points to address on the issue of antibiotic use in food animals and it’s relation to food safety. To learn more about these topics, be sure to consult your local veterinarian and be sure to share examples of how you ensure judicious and responsible antibiotic use on your livestock operation.

Antibiotic Resistance

Antibiotic resistance is incredibly complex and it’s rare for a strain of bacteria from our food supply to be resistant to antibiotics. 

  • Antibiotic resistance occurs when antibiotics attack the majority of bacteria but a few may survive and “mutate” or adapt to the drugs in ways that help them resist treatment by the same drug in the future.
  • The vast majority of antibiotic resistant bacteria are non-foodborne, emerging decades ago in hospital settings or communities and are not linked to animals in our food system.
  • There are occasional cases of antibiotic resistant foodborne bacteria, such as antibiotic resistant salmonella, but those cases are rare.

The chance a person becomes ill from antibiotic resistant foodborne bacteria and not being able to be treated with alternative antibiotics is slim, with many safeguards built in to keep it from happening, such as responsible antibiotic use, research and surveillance.

  • In order for foodborne bacteria to become resistant and impact human health, the bacteria would have to develop a resistant animal strain, survive food processing and handling, proper cooking and find a human with an illness/weakened immune system as the host, survive the human’s body (which will naturally fight the bacteria) and result in a human seeking treatment with the same antibiotic that was used to treat the animal. If antibiotic resistant bacteria were to cause human illness, it means that the standard treatment doesn’t work and that other treatments may have to be considered. So, people becoming ill from antibiotic resistant foodborne bacteria and not being able to be treated in some manner, is extremely rare.  

Farmers, ranchers, veterinarians and animal health experts work together to make sure they’re using antibiotics responsibly, in order to reduce the chances of antibiotic resistance forming. 

In the animal agriculture industry, we work hard to stop the potential formation of antibiotic resistant bacteria by using antibiotics responsibly:

  • Identify the right illness that the animal has by consulting with animal health experts and veterinarians when necessary
  • Pinpoint the right treatment and dose needed to treat that specific illness, condition or concern
  • Administer the antibiotic for the right amount of time by following the law and clear label instructions (not stopping antibiotics early, which is a threat for antibiotic resistance in humans)
  • Conduct the right research to make sure that we continue to protect both animal and human health

Continued research on antibiotic resistance is needed to fully understand antibiotic resistance and address questions about multiple resistance, or co-resistance, which is when bacteria become resistant to several different types or classes of antibiotics and the agriculture community is committed to being part of this important research and dialogue.

  • The agricultural community is proactively working to minimize future risk and continuing to conduct research to look at this important topic.
  • Everyone – farmers, ranchers, veterinarians, doctors, the government, researchers and companies working in animal or human medicine – needs to work collaboratively to protect animal and human health.
  • The agricultural industry is committed to looking at any and all opportunities to mitigate antibiotic resistance in order to make sure we’re continuing to improve the way we use these very important tools.

Antibiotic Use in the Livestock Industry

We can all agree that healthy animals are the basis of a healthy, humane and safe food supply.

  • When antibiotics are used, they are used judiciously to keep the potential risk extremely low of developing antibiotic resistant bacteria that is harmful to people.
  • The beef community has invested in quality assurance programs, research and education designed to maintain high standards of animal care and health and to help us continuously improve how we use antibiotics.
  • Farmers and ranchers have no reason to overuse antibiotics but rather every reason to use them as selectively as possible. For one, it’s the law, but antibiotics also are a costly input for the small business men and women who raise cattle for beef.
  • If farmers did not treat sick animals, many would suffer and die.  This would be inhumane.

The livestock community, including farmers, ranchers, veterinarians, the federal government and the animal health companies that make antibiotics, proactively are working together to continuously improve the way we responsibly use antibiotics in livestock.

  • Changes in FDA Guidance 209 and 213 that will eliminate growth promotion uses of medically important antibiotics and extend veterinary oversight.
  • Within about four years, any medically important antibiotics used in animals will only be for therapeutic purposes and under the supervision of a veterinarian.

To learn more about the use of antibiotics in livestock production, visit with a local veterinarian or find a farmer or rancher in the area to ask their perspectives. You can also find more online tools and information at these links:

August 28, 2014 Comments are off Montana Stockgrowers Association
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Cattle Health and FDA rule changes for antibiotics labeling | Podcast

MSGA 2nd Vice President, Bryan Mussard, helped attendees learn more about the services MSGA offers Affiliate members across the state.

MSGA 2nd Vice President, Bryan Mussard, helped attendees learn more about the services MSGA offers Affiliate members across the state.

On today’s podcast, we’ll follow up on discussions held during the recent summer cattle industry conference held in Denver Colorado. In this section we’ll focus on several issues related to cattle health.

The Cattle Health and Well-Being committee passed policy regarding foreign animal diseases, which could cause a widespread quarantine and possible massive depopulation of the U.S. cattle herd. A resolution was passed to oppose the importation of live cattle, beef, and/or beef products into the U.S. from foreign countries with histories of significant chronic animal diseases and lack of strict animal disease control and eradication measures.

This committee also focused on discussion and explanation of changes in FDA rules regarding feed through antibiotics use in livestock production. This would include label changes on antibiotics, feed additives and veterinary feed directives, which would make access to these medications more difficult for ranchers. MSGA’s 2nd Vice President, Bryan Mussard from Dillon attended the meeting and has more comments in the podcast below.

Conference attendees also had the opportunity to receive an update from CattleFax senior market analyst, Kevin Good, which described the industry as transitioning from a liquidation to an expansion phase. Good said the industry is accelerating the rate of expansion, and “it’s a great opportunity to take advantage of the trend.” However, while the fundamentals are “friendly,” he said, “the market will have a correction.” And that correction could be soon. “Something needs to give,” he said. “You have to be prepared for that ceiling.”

Bryan also provides us with a great take-home message coming out of the meetings in Denver which should serve as an encouragement for Montana ranchers working with MSGA. Find out more about these topics in the podcast below, and be sure to listen to parts 1 and 2 shared in posts earlier in the week.

May 12, 2014 1 Comment Montana Stockgrowers Association
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Changes in the Use of Feed Grade Antibiotics | Montana Nutrition Conference and Livestock Forum

MSU Extension Montana Nutrition Conference and Livestock ForumMontana Stockgrowers was proud to sponsor the 2014 Montana Nutrition Conference and Livestock Forum. The following is a recap of the issues covered from the May Cow Sense Chronicle by Rachel Endecott, MSU Extension Beef Cattle Specialist. To view speaker slides from the conference, follow this link to MSU Extension’s website. To view the monthly Cow Sense Chronicle, click here.

Greetings from Bozeman! It’s hard to believe the month of May has already arrived. This year’s Montana Nutrition Conference and Livestock Forum was held April 22‐23. Among the many great presentations was a wonderful overview from Dr. Russ Daly about the changes coming down the line in regard to the use of feed‐grade antibiotics for livestock. Dr. Daly is the South Dakota State University Extension Veterinarian, and also serves as the State Public Health Veterinarian for the South Dakota Department of Health. For this month’s Cow Sense Chronicle, I will provide a highlight of his remarks. You can find his and other conference speaker’s slides at www.msuextension.org/beefcattle, then click “Resources”.

The FDA has published two “Guidance for Industry” proposals, #209 and #213 (click here for FDA info). The first deals with the use of medically important (to human medicine) antibiotics in food‐producing animals, and the second recommends that drug companies voluntarily align their product use with GFI #209.

Guidance #209 has two main proposals: 1. the use of medically important antibiotics in food‐ producing animals should be limited to those uses that are considered necessary for assuring animal health; and 2. the use of medically important antibiotics in food‐producing animals should be limited to those uses that include veterinary oversight or consultation. Guidance #213 asks drug companies to voluntarily revise their product labels to remove growth promotion and feed efficiency claims and provides for moving over‐the‐counter products to prescription or veterinary feed directive (VFD) status.

A VFD consists of paperwork for the drug in question which is filled out by a veterinarian (a veterinary‐client‐patient relationship should be in place) and gives a description of the livestock to be treated, some instructions to the feed mill, and an expiration date. The feed mill must have the VFD before feed can be distributed, and the feed mill must notify the FDA.

What will change for livestock producers and veterinarians as a result of these FDA Guidances? Growth promotion uses of antibiotics in feed will no longer be allowed (examples: CTC, Aureomycin, virginiamycin), and use of “medically important” feed antibiotics will need a VFD and can only be used for treatment, control, or prevention. Each state’s regulations or veterinary board will define what is a valid veterinary‐client‐patient relationship, and “medically important” water medications will move to prescription status.

What won’t change? Use of non‐medically important drugs such as ionophores and coccidiosis treatments will remain unchanged. The ability to use feed‐grade antibiotics that are currently labeled for treatment, control, and prevention won’t change, but will need a VFD. Injectable medication uses will remain the same, and extra‐label uses of feed‐grade medications is currently and will continue to be illegal. Feed mill operators will continue to supply feed medications and veterinarians should still be involved in medication decisions.

As Dr. Daly discussed, antibiotic resistance is a complex topic involving both animal and human health professionals. Hopefully this overview gives you some additional understanding of how these changes will impact the feed and livestock industry and your operation.

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Part 2: Beta-agonists, the Environment and Cattle Feed Intake
February 17, 2014 Comments are off Montana Stockgrowers Association
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Part 2: Beta-agonists, the Environment and Cattle Feed Intake

Part 2: Beta-agonists, the Environment and Cattle Feed Intake

Part 2: Beta-agonists, the Environment and Cattle Feed Intake. After analyzing feed intake data from three feedlots that used Zilmax in their rations, Chris Reinhardt, K-State feedlot specialist, found that cattle fell off on feed intake more in the summer months compared to any other time of year, and the cattle that were consuming more feed prior to the initiation of Zilmax not only had a much higher likelihood of losing intake but the size of the intake drop-off was larger. Click image for original story.

In this part 2 of a two-part series, a K-State feedlot specialist provides a look into how environmental factors, including heat stress, coupled with the use of beta-agonists potentially affects cattle feed intake. See Part 1 here.

MANHATTAN, Kan. – Growing cattle that are more efficient in converting feed to muscle is a main goal in the beef industry. Many cattle producers, feedlot operators and researchers strive to use genetics and modern feedlot technologies to continuously improve that efficiency.

Chris Reinhardt, feedlot specialist for Kansas State University, is one of those researchers seeking to find solutions to improve efficiency in cattle production. Reinhardt has looked specifically at how beta-agonists, a cattle feed supplement approved by the U.S. Food and Drug Administration and considered safe from a food safety perspective, improve the cattle’s natural ability to convert feed into more lean muscle.

“Beta-agonists increase the deposition of lean muscle on the carcass,” Reinhardt said. “They make cattle more efficient at converting grain to muscle. They also improve the efficiency of converting an animal carcass into sellable meat.”

Zilmax, formally known as zilpaterol hydrochloride, is one of only two beta-agonists approved for cattle feeding on the market. However, Merck Animal Health, manufacturer of Zilmax, voluntarily suspended sales of the product last September when major U.S. meat packer Tyson announced it would stop buying cattle fed Zilmax due to an animal welfare concern, which questioned if the product affected the ambulatory ability, or movement, of cattle.

There has been no direct link established between the use Zilmax and impaired cattle mobility, Reinhardt said. Cattle fatigue syndrome may be caused by many factors, such as summer heat, and exertion prior to harvest. But, studying the reasons behind stiff-muscled and tired cattle, and if beta-agonists play a role, isn’t the only angle of research being examined. Reinhardt has been looking more closely to see if beta-agonists, particularly Zilmax, affect cattle feed intake.

“Over the past few years, on certain occasions, feedlots have seen where Zilmax was started in the feed, and cattle would fall off on intake,” Reinhardt said. “Sometimes the intake would come back to normal, and sometimes it wouldn’t. Because Zilmax is a growth promotant, if we’re losing some of the dry matter intake and some of the energy intake, are we getting full value for that growth promotant?”

Reinhardt has looked at data from three separate commercial feedlots over the past three years and studied some of the differences in feed intake in 1,100 pens of cattle. He looked at the dry matter intake prior to and through the end of the cattle-feeding period. He compared this to the time when Zilmax was brought into the feed rations, the sex and weight of the cattle, and the location of the feedlot, to try to filter out any common factors when the cattle did or did not lose feed intake.

The data analysis uncovered two main findings. First, season played a role in the drop-off in feed intake. Second, cattle that were consuming more feed prior to the initiation of Zilmax had a much higher likelihood of losing intake, and the size of the intake drop-off was larger.

“The drop-off was quite a bit larger in the summertime than in the other seasons,” Reinhardt said. “In spring and fall, there was very little change in intake. What pens did fall off on intake for the most part actually recovered back to normal.”

Reinhardt said this could mean weather and season, particularly heat, plays a factor in cattle’s response to beta-agonists. Surprisingly, the winter months showed more of a drop-off on intake overall compared to spring and fall, and Reinhardt said this issue, perhaps due to cold stress, must be looked at more closely as well.

On the issue surrounding big-eating cattle falling off more on intake once Zilmax was initiated, Reinhardt said it could be because the cattle that are eating more feed are also eating more of the drug.

“Really we don’t know the economic impact from these intake losses,” Reinhardt said. “We do know that some pens of cattle were more subject to loss of intake than other groups. The question is, is it economical to continue to use the beta-agonist even though you’re seeing a decrease in intake, or should the decision be made in extremely warm weather to not use the drug for a period of weeks until the weather abates?”

Advice for feedlot operators

Reinhardt said it will take more research to make specific recommendations on using beta-agonists to cattle feeders, but this initial research is one step closer to understanding how environmental factors, combined with the use of beta-agonists, might affect cattle feeding.

While Merck recently announced that it is too early to determine when Zilmax will return to the market (Merck Animal Health Shares Progress on Zilmax and the Five-Step Plan for Responsible Beef), many feedlots might have switched to using a competing beta-agonist called Optaflexx, or ractopamine. The transition from one product to another, Reinhardt said, hasn’t been a huge challenge for many feedlot operators, but he said the products do work differently. More research needs to be done to further understand how all beta-agonists on the market work in cattle feeding.

“Knowledge is power, and I hope we continue to have the opportunity to utilize technologies in our feedlot community,” Reinhardt said. “But, I hope we use them with the best information available to help feedlots be more profitable and sustainable.”

This story is part 2 of a two-part series on how beta-agonists and environmental factors potentially play a role in cattle fatigue and feed efficiency. For more information about beta-agonists, see Part 1 on environment and cattle fatigue.

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Part 1: Beta-agonists, the Environment and Cattle Fatigue
February 13, 2014 Comments are off Montana Stockgrowers Association
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Part 1: Beta-agonists, the Environment and Cattle Fatigue

Part 1: Beta-agonists, the Environment and Cattle Fatigue

Cattle fatigue syndrome is not a new phenomenon, said Dan Thomson, K-State veterinarian. The swine industry discovered pig fatigue syndrome in the past, where stress played a role in animal mobility at packing facilities. Click image for original.

MANHATTAN, Kan. – In agricultural production, maintaining a level of excellence that includes environmental sustainability, animal welfare and food safety, while keeping food affordable for consumers is top-of-mind for many farmers and ranchers, as well as the researchers looking to help them find solutions to ensure this level of excellence.

As consumers shop at their local grocery stores and markets, they might notice that beef products are double or triple the price of other protein sources, and rightfully so, might hold beef to an even higher standard of excellence, said Dan Thomson, Kansas State University veterinarian, professor and director of the Beef Cattle Institute.

“Beef is one of the purest, most wholesome and most humanely raised forms of protein that we produce worldwide,” Thomson said. “As a beef industry, we are being asked day in and day out to take a holistic view of technology.”

The use of beta-agonists in cattle feeding is among the modern feedlot technologies making waves in the beef industry. K-State researchers, including Thomson, are among the many researchers who are examining how beta-agonists affect cattle performance and how the feed supplement might cause cattle, particularly in the summer months, to be slow-moving and stiff-muscled once they arrive at packing facilities.

“We’re going to learn more about the last 30 days on feed,” Thomson said of research on beta-agonists. “Do we have heat stress mitigation plans in place at the feeding facilities? Are we pushing that boundary of having too heavy weight carcasses? Are we using low-stress cattle handling techniques? How far away from the load out facility are the fat cattle being moved? Are we shipping them during the afternoon in the heat of the day, or are we shipping them at 2 a.m.? Are the truckers trained to properly transport these animals? How long do they wait at the slaughter facility? All of these different risk factors are going to have to be bundled in.”

History of beta-agonist use

Feedlots have used beta-agonists, a cattle feed supplement approved by the U.S. Food and Drug Administration (FDA) and considered safe from a food safety perspective, to improve the cattle’s natural ability to convert feed into more lean muscle.

Zilmax, formally known as zilpaterol hydrocholoride, is one of only two beta-agonists approved for cattle feeding on the market. However, Merck Animal Health, manufacturer of Zilmax, voluntarily suspended sales of the product last September when major U.S. meat packer Tyson announced it would stop buying cattle fed Zilmax due to an animal welfare concern, which questioned if the product affected the ambulatory ability, or movement, of cattle.

Thomson said that because the slow-moving cattle reports were more consistent during the summer months, he has questioned how heat stress and feeding beta-agonists might together create what he calls “cattle fatigue syndrome.”

“This isn’t a new phenomenon,” Thomson said. “We’ve seen this in other species. The swine industry 15 to 20 years ago discovered pig fatigue syndrome. It occurred about the time they started feeding beta-agonists at a very high level to pigs. Market hogs would arrive at the plant, and they were stiff, open-mouth breathing, had blotchy skin, muscle tremors and were going through stress.”

Thomson said many in the swine industry started calling these pigs “NANI” pigs, meaning non-ambulatory, non-injured.

“So these pigs show up (at the packing facility), and they don’t have any clinical signs of injury besides that they don’t move,” Thomson said. “(Researchers) did diagnostic tests to look at the difference between non-ambulatory pigs and pigs within the same truckload that were able to move. They found elevated serum lactate and creatine phosphokinase (CPK) levels, which are both indicative of depletion of muscle glucose or muscle damage in these big, heavily muscled animals.”

Regardless of beta-agonist use in feeding pigs, Thomson said, the swine industry went from having about a 250-lb. average out weight to a 300-lb. average out weight on market hogs. So the hogs had more weight to carry around at the packing facility.

To see if beta-agonists played a role in the movement concerns, researchers did a series of tests on market hogs that were not fed beta-agonists. They put some through a stressful situation prior to shipping them to slaughter, while the others did not experience any stress.

“They were able to recreate the same syndrome that we’re now seeing in some cattle,” Thomson said. “Generally, physical stress, whether they were on a beta-agonist or not, showed clinical signs of fatigue in these market hogs.”

Still, the swine industry has since cut the dose of beta-agonists in feeding by about 75 percent, Thomson said.

For additional information on how ractopamine is used in feeding swine today, please see this page from PorkCares.

A closer look at cattle fatigue syndrome

The beef industry has a really good start on understanding what cattle fatigue syndrome is, Thomson said, but the reason more research must be done is that, like the NANI pigs, the syndrome has shown up in cattle that were fed a beta-agonist and cattle that were not fed a beta-agonist.

“In our research, when we’ve looked at cattle that are not stressed and they’re on one of the beta-agonists on the market, we’ve not seen anything but an increase in heart rate by about 10 beats per minute and no difference in lactate or CPK levels,” Thomson said. “However, we have to understand that when we have seen the issues with this fatigue cattle syndrome at packing facilities, it’s during the summer months when we have heat stress.”

Moving forward, Thomson said the industry needs to better-understand the clinical and physiological responses of beta-agonists in cattle, if dosages in cattle feeding rations might need to be altered and if there is a potential genetic component to it as well.

Advice for feedlot operators

Thomson said that he is very pro-technology. While Merck recently announced that it is too early to determine when Zilmax will return to the market (Merck Animal Health Shares Progress on Zilmax and the Five-Step Plan for Responsible Beef), many feedlots might have switched to using a competing beta-agonist called Optaflexx, or ractopamine.

As long as beta-agonists are available, approved by the FDA, accepted by the consumer and work in a particular management system to improve efficiency of animals and profitability, then it is fine to use them, he said. But, the industry must always look at ways to improve and make sure technologies are continuously helping.

“We’re given a job, task and responsibility, and we don’t take it lightly,” Thomson said.

This story is part 1 of a two-part series on how beta-agonists and environmental factors potentially play a role in cattle fatigue and feed efficiency. For more information about beta-agonists, see Part 2, will be posted on Monday, on environment and feed efficiency.

To watch an interview with Thomson on this subject, log on to the K-State Research and Extension YouTube channel at Beta Agonist Research Update.

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Zilmax cattle feed beta agonist animal welfare
January 8, 2014 Comments are off Montana Stockgrowers Association
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Merck Animal Health Shares Progress on Zilmax and the Five-Step Plan for Responsible Beef

During the 2013 MSGA Annual Convention, during the Beef Production and Marketing Committee, Dr. Marshall Streeter, Merck Animal Health, presented attendees with some great information and an update on the recent events developing around Zilmax, a beta agonist used in cattle finish feeding for more efficient lean beef production, being pulled from the market after claims of animal lameness by Tyson Foods. The following is an update on the Zilmax follow-up from Merck Animal Health shared to provide you more insight on the steps that go into evaluating safety of animal feed products.Zilmax cattle feed beta agonist animal welfare

During the last 90 days, Merck Animal Health, with the input and oversight of its Advisory Board, has worked to implement its Five-Step Plan to Ensuring Responsible Beef and has made considerable progress. The findings that come as a result of the plan will add to the significant amount of data that already exists for Zilmax® (zilpaterol hydrochloride), including numerous animal safety and well-being trials. Zilmax is a feed supplement approved by the FDA and other regulatory authorities. While we have made considerable progress, it is too early to determine when Merck Animal Health will return Zilmax back to the market in the United States and Canada.

“At Merck Animal Health, we continually evaluate our processes and procedures across the entire company to ensure that we maintain the best science-based practices and procedures for the health and well-being of animals,” says KJ Varma, BVSc, Ph.D., Senior Vice President Global R&D, Merck Animal Health. “Our five-step plan is a direct reflection of that commitment to science. It also reflects our commitment to working with our industry partners to maintain the highest standards of care for the health and well-being of cattle. We are pleased to be able to tap into the vast knowledge and expertise of professionals from throughout the industry to help us carry out this significant undertaking.”

The implementation of the five-step plan has included the following key components.

Merck Animal Health Advisory Board
Formed in August, the Merck Animal Health Advisory Board is comprised of representatives from packers, large, medium and small cattle feeder operations, cow-calf producers, veterinarians, academia and industry consultants. In addition to helping the company maintain an open dialogue on animal well-being, beta agonist use and related matters, the objectives of the Board include:

  • Review all available animal safety and well-being research data on Zilmax
  • Review the existing Zilmax Quality Assurance program (ZQA) and make recommendations, as needed
  • Provide input on the certification and scientific audit processes; and
  • Review and provide guidance on best management practices for using Zilmax

The Advisory Board has provided input on, reviewed and approved all initiatives in support of the plan.

Certification Process
To help further ensure safe and effective product use by customers, a formal certification process has been developed. As part of the certification, every feedyard team member, nutritionist and veterinarian who uses Zilmax or provides consultative services on feeding Zilmax to cattle must be trained annually on the proper use of the product.

The training will focus on safety practices, product handling, mixing protocols, cattle management, product inventory, record keeping and clean-out procedures. Every certified operation will also be required to pass an initial homogeneity test to ensure proper mixing practices, as well as four additional feed mix tests throughout the year. Before a feedyard can participate in the Zilmax Field Evaluations, the operation will need to be certified.

Zilmax Field Evaluations
In addition to implementing the certification process, the company has also worked with its Advisory Board to develop and finalize the protocol for the field evaluations for Zilmax-fed and control cattle (previously noted as “scientific audit”), which are expected to begin in Q1 2014.

Guiding principles of the field evaluations include:

  • Observing cattle throughout the system – before and after receiving Zilmax – at the feedyard and at the packing plant
  • Evaluating the mobility of cattle by trained third-party experts utilizing an established mobility scoring system
  • Reviewing potential compounding factors, such as nutrition, transportation, receiving facilities, flooring surfaces, and cattle management and handling practices

The field evaluations will take place with the oversight of a well-known independent epidemiologist and veterinarian, who will serve as principal investigator and collect all data, analyze results and publicly communicate findings in support of the company’s commitment to transparency and communication.

“We at Merck Animal Health remain highly confident in the safety of Zilmax, which is supported by the results of more than 30 studies, totaling 65,000 cattle that were conducted by well-respected universities and third-party experts,” says Dr. Varma. “We believe the field evaluations we are conducting as part of the five-step plan will support the results of previous studies and the safety of the product, and we are confident that they will help create a greater understanding of the best management practices that are so vital to helping ensure the well-being of cattle.”

For additional information about the Five-Step Approach to Ensuring Responsible Beef, please visit: http://www.merck-animal-health-usa.com/news/2013-8-13.aspx.

ZILMAX has a withdrawal period 3 days prior to harvest. Not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves. For complete safety information, refer to product label and ZILMAX website.

About Merck Animal Health
Today’s Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.

Merck Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

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December 20, 2013 Comments are off Montana Stockgrowers Association
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An Overview of the FDA Final Guidance 213 and Proposed Veterinary Feed Directive (VFD)

National Cattlemens Beef USA logoBy Dr. Kathy Simmons, DVM, NCBA Chief Veterinarian

On Dec. 12, the Food and Drug Administration (FDA) published their final Guidance #213 and a proposal for revisions to the current Veterinary Feed Directive (VFD). These revisions proposed for the VFD are in response to complaints from stakeholders that the current VFD process can be burdensome. This current guidance is part of FDA’s larger strategy for judicious use of the antibiotics that are most important for use in human medicine and are currently used in feed and water for food-producing animals. Guidance #213 is directed toward the use of these products in feed and water and pertains to the medically important antibiotic classes listed in Appendix A of Guidance 152. The specific drugs or product applications affected by Guidance #213 can be found in a list on the FDA website here.

Guidance #213 does not pertain to the ionophores, such as monensin, unless used in a combination product with a medically important antibiotic.

Guidance #213 is a follow up to final Guidance #209, which states that the antibiotics important to human health should only be used in animal agriculture in ways that are necessary to maintain animal health and with veterinary oversight. Guidance #213 establishes the roadmap for the animal drug manufacturers to phase out the growth promotion use of these products in feed and water over the next three years and revise product labels as needed for use indications of control, prevention and therapy. All medically important antibiotics used in feed and water will require a veterinary prescription or a VFD in order to obtain these products for control, prevention and treatment use.

What is the objective of this FDA guidance? Doubtless, most everyone is aware of the global concern for increasing antibiotic resistance and the problems that antibiotic resistance creates for effectively treating infections in humans and animals. FDA has responsibly chosen to address the concern of antibiotic resistance and its threat to public health. FDA guidance seeks to eliminate the subtherapeutic use of medically important antibiotics in feed and water for growth promotion. The cattle industry, through the Beef Quality Assurance program, also supports this stance by stating in the Judicious Antibiotic Use Guidelines that, “Subtherapeutic Antibiotic Use is Discouraged: Antibiotic use should be limited to prevent or control disease and should not be used if the principle intent is to improve performance.”

So, what does this guidance really mean for cattlemen and women? The loss of the medically important antibiotics for growth promotion has only a minimal impact as there are really very few of these products used for growth promotion in the cattle industry. Our current use of antibiotics in feed is primarily for the prevention and control of conditions/diseases such as liver abscesses, coccidiosis and anaplasmosis. The use of these products will still be available in feed and water for control, treatment and prevention through the oversight of the veterinarian by Rx or VFD. It is extremely important to cattlemen and women to have an efficient and dtreamlined VFD process in order to facilitate the timely and uninterrupted access to these