Veterinary Regulations

FDA Reorganizes Animal Drug Evaluation Structure to Better Align Innovative Products, Generic Drugs

Mon, 07 Oct 2024 16:07:08 GMT

The U.S. Food and Drug Administration is announcing that it is reorganizing the Office of New Animal Drug Evaluation (ONADE) within the Center for Veterinary Medicine (CVM) into two separate offices that will handle pre-market evaluation of originator animal products and generic drugs. The reorganization implementation will take place October 20, 2024.

The realignment of ONADE into the Office of New Animal Product Evaluation (ONAPE) and the Office of Generic Animal Drugs (OGAD) comes at a critical time in the animal drug review program. This reorganization will enable ONAPE to continue to build capacity to support review of new and innovative technologies, which the center sees as the future of animal agriculture and animal health products.

At the same time, the agency has seen unprecedented growth in the generic animal drug review program over the past 8-10 years. Standing up OGAD as an independent office will provide for concentrated focus for the generic animal drug program and maximize the program’s effectiveness.

The reorganization also includes certain changes to CVM’s Office of Management (OM). The Records and Information Management Team, which resided in ONADE, will become part of OM’s Business Informatics Staff. Additionally, the new Financial Management Staff will be created by combining the Budget Planning and Evaluation Staff and Program and Resource Management Staff functions and resources under one Staff Director.

A full list of the changes can be found in the Federal Register notice .

For more information:

Colorado Ramps Up Bird Flu Response, Requires Milk Testing

Wed, 24 Jul 2024 15:37:45 GMT

Colorado began requiring dairies to test milk supplies for bird flu every week, the state’s veterinarian told Reuters on Tuesday, as a federal team arrived to help investigate an escalating outbreak in cows that has spread to chickens and people.

The state’s new mandate aims to identify additional farms that could be infected and spread the disease to other dairies or poultry flocks, after the largest cluster of human cases to date in the United States occurred on a Colorado farm this month.

Bird flu infections linked to dairy cows have wiped out 3.1 million egg-laying chickens in Colorado in recent weeks, and poultry workers also tested positive.

Colorado has confirmed infections in 47 dairy herds since the U.S. outbreak in cows began in late March, with about 60% of its cases detected in the past month, according to U.S. data. Nationally, 13 states have reported infections in about 168 herds since spring.

In Colorado, the loss of millions of chickens triggered the requirement for licensed dairies with lactating cows to test bulk milk supplies weekly, state veterinarian Maggie Baldwin said in an interview. About 70% of the state’s laying hens were eliminated, according to U.S. data.

“We really said what we’re doing right now is not effective and we need to change strategy,” Baldwin said.

The U.S. Department of Agriculture since late April has required testing for lactating cows that are being shipped over state lines. The agency later launched a voluntary program to test bulk milk supplies .

A USDA epidemiological “strike team” arrived in Colorado this week to assess how the virus may be spreading among dairies there, Baldwin said. Workers or vehicles can carry the virus from farms.

If mandated testing reveals additional infections, Colorado can take further steps to contain the virus, Baldwin said.
Six Colorado farm workers tested positive for bird flu in July after culling chickens at an infected egg farm, the U.S. Centers for Disease Control and Prevention said.

More than 150 workers were exposed to the infected poultry, and 69 developed symptoms and were tested, according to the Colorado Department of Public Health and the Environment.

Colorado’s public health department reported a presumptive positive human case on a different Colorado poultry farm on Friday. About 350 people were involved in culling chickens at that farm, where 23 workers developed symptoms and were tested, the department told Reuters. The CDC has not confirmed the presumptive positive case.

Testing remains in progress, Colorado’s health department said on Tuesday.

Reporting by Tom Polansek in Chicago and Leah Douglas in Washington; Editing by Bill Berkrot

USDA Issues Permit for Santa’s Reindeer to Enter the U.S.

Fri, 22 Dec 2023 20:58:37 GMT

USDA’s Animal and Plant Health Inspection Service (APHIS) today issued a transit permit to Mr. S. Nicholas Claus of the North Pole, a distributor with Gifts and Good Cheer, Inc. The permit will allow reindeer to enter and exit the United States between the hours of 6 p.m. on Dec. 24, 2023, and 6 a.m. on Dec. 25, 2023, local time, through or over any U.S. border port.

“USDA is delighted to grant Mr. Claus and his reindeer a special permit to enter the United States, ensuring a seamless journey for the joy they bring each holiday season,” said Jenny Lester Moffitt, Under Secretary for Marketing and Regulatory Programs. “We extend a warm welcome to Mr. Claus and recognize the vital role of U.S. milk and cookies in fueling his festive flight.”

Veterinary officials ensured the reindeer met all entry requirements before issuing the permit. Dr. Rosemary Sifford, USDA’s Chief Veterinary Officer, stated: “At a recent inspection, the reindeer were found to be healthy and able to prance and paw with each hoof.”

It was noted on the health certificate that one reindeer, Rudolph, has a minor physical anomaly. However, APHIS indicated that Rudolph’s red nose, while bright, was normal for him and not a concern.

APHIS regulates the movement of cervids, including reindeer, to protect the health of America’s livestock population. The permitting process provides assurance that only healthy animals enter the United States.

USDA has confirmed that the reindeer will arrive pulling a wooden sleigh with jingling bells attached, filled with brightly wrapped gifts. Port personnel will clean and disinfect the runners and underside of the sleigh at the time of entry. They will also conduct a short visual inspection of the reindeer. Mr. Claus has been asked to disinfect his boots and thoroughly wash his hands. These measures are intended to prevent the entry of any livestock diseases the team may encounter during deliveries to farms and houses around the world prior to entering the United States.

Mr. Claus also provided an advance list of what port personnel should expect upon their arrival. This includes a variety of food items, all of which come from approved locations and none of which pose a threat to U.S. animal or plant health.

“It’s important that Gifts and Good Cheer, Inc. take all the right steps and precautions to protect against the potential introduction of pests and diseases,” explained Mr. Claus. “I appreciate USDA’s assistance every year as we gear up for our big night.”

FDA Unveils Draft Guidance on Antibiotic Duration Of Use in the Feed of Food Animals

Thu, 28 Sep 2023 21:28:39 GMT

The U.S. Food and Drug Administration (FDA) announced earlier this week it has published draft guidance for defining appropriate duration of use for antibiotics used in the feed of food-producing animals.

The guidance aims to address an issue that critics say the FDA has neglected in its efforts to promote more judicious use of medically important antibiotics in livestock and poultry. Roughly one-third of medically important antibiotics approved for use in food-producing animals have no duration limit, meaning farmers can use those antibiotics in animal feed for extended periods of time to prevent disease—a practice critics say compensates for poor living conditions that promote disease in herds and flocks.

Advocates for more robust antibiotic stewardship in US meat production say the overuse of medically important antibiotics on US farms promotes antibiotic resistance and threatens the effectiveness of antibiotics that are critical for human and veterinary medicine. Some groups have called for the FDA to limit the duration of use for medically important antibiotics to 21 days.

In a 5-year action plan released in 2018, the FDA’s Center for Veterinary Medicine said that establishing appropriate duration limits would be one of its priorities.

Minimizing antibiotic exposure
The agency says the scope of the draft guidance is limited to drugs that are approved for use in animal feed, since antibiotics that have been approved in non-feed forms already have appropriately defined durations of use.

“FDA’s objective in issuing this guidance is to provide specific recommendations to animal drug sponsors on how to revise the product use conditions (e.g., dosage regimen, instructions for use) of affected products, as necessary, to better target when and for how long a drug may be used to effectively treat, control, or prevent the disease(s) for which the product is indicated,” the draft guidance states.

While compliance with the guidance is voluntary, the FDA says the revisions are, “intended to provide for the continued effective use of these products while minimizing the extent of antimicrobial drug exposure, thereby supporting efforts to mitigate the development of antimicrobial resistance.”

The public comment period on the draft guidance is open until December 26.

About The Author

This article was written by Chris Dall, a news reporter for CIDRAP News, focusing on antimicrobial resistance and stewardship. Chris has written about health and medicine for the online health news startup PresentNation and worked for several years as a news producer at Minnesota Public Radio. He has a master’s degree in journalism from Emerson College in Boston. He enjoys writing about public health, infectious disease, and the history of medicine.

Over-The-Counter Livestock Antibiotics Officially a Thing of the Past

Thu, 08 Jun 2023 17:39:23 GMT

Farmers have had months to prepare, but on June 11, the FDA’s new directive “Guidance for the Industry #263” will officially go into effect. This means over-the-counter (OTC) livestock antibiotics will no longer be available through traditional retail channels. Instead, these antibiotics will now require a prescription from a licensed veterinarian.

According to the FDA, this is part of a broader effort to combat antimicrobial resistance, a serious threat to both animals and the public health. While livestock producers are continuously working to practice judicious antibiotic usage, this guidance will provide consumers with an extra layer of assurance.

“It’s a confidence thing,” says Jim Lowe, DVM, director of the College of Veterinary Medicine I-Learning Center at the University of Illinois. “The regulators have said, ‘Listen, we want some more oversight here, so we have more confidence in the supply chain.’ My perception is we’re not changing what we’re doing. We’re just going to document and tell people what we’re doing better. It’s about transparency.”

While the guidance states that livestock producers will need to obtain a valid prescription from a licensed veterinarian with whom they have a veterinarian-client-patient-relationship, the prescription status does not require that these products be purchased directly from a veterinarian. Instead, the FDA notes that you may be able to buy prescription animal drug products from various suppliers or distributors pending certain state requirements. These suppliers would then act as a “pharmacy” and customers would have to show a prescription prior to purchasing them.

For a complete list of antibiotics that will no longer be available over-the-counter, click here. Products unaffected by the change include ionophores, antiparaciticides, injectable and oral nutritional supplements, oral pro/prebiotics and topical non-antibiotic treatments. These products will continue to remain available through standard OTC marketing channels.

For more on Guidance for the Industry #263, read:

Over-the-Counter Antibiotics: What You Need to Know Before June 11

Thu, 23 Mar 2023 20:30:52 GMT

When kids are sick, parents want to do the best they can to help them feel better fast. It’s no different when animals are sick. Livestock producers want to do everything they can to help them feel better fast. It’s understandable why most people want to turn to antibiotics so quickly – it’s what they know to be an effective treatment for illness and disease.

But antibiotics aren’t effective on viruses, whether in kids or livestock.

“Just as physicians have started to try and educate people to not utilize antibiotics in those cases, we’re really trying to have the same conversation with the livestock industry,” says Mike Lormore, DVM, head of technical services over pork and cattle for Zoetis.

On June 11, FDA’s Guidance for Industry (GFI) #263 brings 91 over-the-counter (OTC) antimicrobial products from OTC to prescription oversight. This is part of a broader effort by FDA to combat antimicrobial resistance (AMR), a serious threat to animal and public health. Using antimicrobials judiciously, in all settings, can help slow the rate at which AMR develops.

“It’s a confidence thing,” says Jim Lowe, DVM, director of the College of Veterinary Medicine I-Learning Center at the University of Illinois. “The regulators have said, ‘Listen, we want some more oversight here, so we have more confidence in the supply chain.’ My perception is we’re not changing what we’re doing. We’re just going to document and tell people what we’re doing better. It’s about transparency.”

FDA’s guidance is a result of a long conversation around improving the quality of and control systems around antimicrobial use in food production, Lormore explains. Making this transition will ensure the remaining 4% of medically important antimicrobials currently available OTC are used under a licensed veterinarian’s supervision.

Although this guidance doesn’t go into effect until June 11, now is the time for producers to begin preparing if they haven’t done so already.

Why VCPRs Matter

Now is an important time to seek out a veterinarian-client-patient relationship (VCPR). The VCPR is a mutual agreement between the animal owner and the veterinarian where the veterinarian has an understanding of the animals on an operation, the type of care they’re given on a regular basis, their purpose, and the risk factors associated with management of those animals, Lormore explains.

“Pig farmers are working every day to protect the food supply and provide safe, nutritious food to customers. This protection includes having a VCPR to provide the most updated treatment and recommended technology to keep animals, and ultimately the public, healthy,” explains Heather Fowler, VMD, National Pork Board’s director of producer and public health.

She says a producer doesn’t need to know everything, but they should know to call their veterinarian when needed, not only to protect their herd, but to also reduce an economic strain or loss of production proactively.

“Our sense collectively is major producers in the U.S. pork industry have veterinarians on their staff, they have good relationships with all kinds of veterinarians, and this guidance is probably not going to impact them very much. It’s really directed towards very small operators, or backyard/hobby animal raisers that don’t have that same level of expertise,” Lormore says.

However, he notes there are some areas of the country that don’t have as many veterinarians in place. If that’s you, he recommends reaching out to state veterinary medical associations, state livestock producer organizations, friends or other colleagues to find out what veterinary resources they utilize.

Once a VCPR is in place, animal owners would simply contact the veterinarian to discuss the situation at hand and the veterinarian would then provide them a prescription if needed. Every state has a different set of pharmacy laws, so how those prescriptions will be filled will look different throughout the country, Lormore notes.

In general, Lowe doesn’t believe veterinarians are thrilled about the obligation to have to write more scripts and maintain more records. No one likes paperwork, Lowe points out.

“I think some producers have grumbled it’s just a way for the veterinarians to make more money, but I certainly don’t think veterinarians view it that way. We are all going to have to do more work, but how do we make it a positive? Let’s lower costs, create better production, get the right diagnosis, work a little harder and create value out of it. That’s our opportunity,” Lowe says.

Why is antibiotic stewardship so important?

Thanks to advances in hygiene, biosecurity and new technology, America’s pig farmers are making significant strides in protecting their herds from disease, Fowler says.

“This is done in part through relationships farmers maintain with their licensed herd veterinarians, who prescribe and oversee the use of antibiotics and other medications on farm,” she says. “Responsible antibiotic use means using only what’s necessary for pig health. This sensible approach means doing what’s best for animal wellbeing, food safety, and the environment.”

It’s no secret that healthy animals are more productive and more efficient. The goal is always to prevent disease, rather than wait for it to become clinical and have to treat it, Lormore says.

“That being said, the bugs are generally smarter than we are, and they can move faster than we can. So, sooner or later, you will see clinical disease in one shape or form,” he adds.

Lormore believes FDA’s guidance #263 is good for the health of animals because it allows veterinarians who have the appropriate training, experience and expertise to handle these drugs and help talk people through protocol development and treatment protocols when needed.

“We all have to do our part to improve and ensure the viability of antimicrobials going forward. And this is just one way that we will do this in the livestock industry, to show our support for those initiatives,” Lormore says.

Do What’s Best for Your Animals

The goal of all of this is to have better health and welfare for the animals under our care, Lowe explains.

“Nobody likes being told what to do – but the intent is to have a chat about this and make sure it’s right. We are bringing ourselves under the same standard as human medicine in the U.S.,” he says.

Although it’s hard to stand around and wait for your animal to get better, Lormore reminds producers, “Biology takes its own sweet time, and we don’t necessarily get a chance to change that timeline. The more producers intervene when it’s not necessary, the more likely they are to get an outcome that’s not in the best interest of the animals.”

Vaccines are one way livestock producers work to prevent disease rather than treat clinical disease, Lormore adds.

“Mitigating risks of diseases that we can control through vaccinations is both in the best interests of the animals, the best interest of the farms that own those animals and is the least stressful to the animals themselves overall,” Lormore says. “Prevention is always preferred over treatment.”

As foreign animal disease threats rise, Lowe says it’s a great time to foster more conversation between animal owners and veterinarians.

“This is one more excuse to have a conversation about what we are doing for FAD preparedness,” Lowe says. “There’s some other good that can come out of this to build relationships, so we don’t find ourselves at the point of, ‘What do we do now?’”

Read More:

Health Advocates and Online Activists Sue FDA Over Antibiotics in Livestock

DVM Reaches out to Livestock Owners About OTC Antimicrobials Move to Rx

FDA Publishes 2021 Report on Antimicrobial Use in Livestock

The Pig That Does More with Less (Antibiotics)

OTC Livestock Antibiotics Will Require Prescription June 11

Tue, 14 Feb 2023 17:32:16 GMT

Don’t wait. Get to know your local veterinarian now and establish a veterinarian-client-patient relationship if you expect to treat livestock in the future, as over-the-counter livestock antibiotics will soon require a prescription.

That is the advice of a team of Texas A&M AgriLife Extension Service experts trying to help livestock owners who are used to going to the local feed store to buy some of their antibiotics and administer treatment themselves.

All of that will change on June 11, when these medically important antimicrobial drugs will require veterinary oversight.

The following experts answer some frequently asked questions to let livestock owners know what to expect:

— Tom Hairgrove, DVM, Ph.D., AgriLife Extension cattle veterinary specialist in the Texas A&M College of Agriculture and Life Sciences Department of Animal Science, Bryan-College Station.

— Joe Paschal, Ph.D., former AgriLife Extension livestock specialist, now representing industry as the executive vice president of the American Brahman Breeders Association, Corpus Christi.

— Billy Zanolini, Ph.D., assistant professor and 4-H and youth development specialist, Bryan-College Station.

What is the new rule?

The Food and Drug Administration recommends manufacturers of medically important antimicrobial drugs that continue to be available over the counter and are approved for use in animals, both companion and food-producing, regardless of delivery mechanism, to voluntarily bring these products under veterinary oversight or prescription marketing status.

By June 11, labels of the remaining over-the-counter antibiotics for livestock use will be required to read: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian,” and the purchaser must have a prescription or drug order to buy it.

How does this differ from the Veterinary Feed Directive and why are the two confused?

Over-the-counter antibiotics used in animal feed were moved to Veterinary Feed Directive, VFD, in 2017, allowing closer veterinarian oversight of antimicrobial use in animal feeds. All over-the-counter antibiotics placed in the drinking water were moved to prescription status at the same time. This new rule concerns the few antibiotics that remained available over the counter in the form of injectables, intramammary tubes and boluses.

What does medically important mean?

Medically important drugs are essential to human medicine and also used to treat animals.

What antibiotics does this affect?

Prescription-only items will include injectable tylosin, injectable and intramammary penicillin, injectable and oral oxytetracycline, sulfadimethoxine and sulfamethazine, gentamicin, cephapirin and cephapirin benzathine intramammary tubes.

How and where can these items be purchased after the rule goes into effect?

Individuals with veterinary-client-patient relationships, VCPR, may purchase antibiotics directly from their veterinarian or from a distributor with the vet’s prescription.

What constitutes a VCPR?

Three requirements must be met:

(1) The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions.

(2) The veterinarian has sufficient knowledge of the animal to initiate at least a general or preliminary diagnosis of the animal’s medical condition. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal by examining the animal or by medically appropriate and timely visits to the premises where the animal is kept.

(3) The veterinarian is readily available or has arranged emergency coverage and follow-up evaluation in the event of adverse reactions or the failure of the treatment regimen.

What’s your advice to livestock owners without a VCPR?

Producers who already have a VCPR in place and purchase their animal health products through their veterinary office or through other distributors under an existing prescription system will likely notice little change. However, this may have significant impacts on how the livestock owners can access antibiotic therapy for their animals, so contact your local veterinarian as soon as possible.

Why shouldn’t I go ahead and stock up on antibiotics now?

Do not stock up on these products to avoid needing a prescription once this change takes effect. Animal health products are expensive, have expiration dates and are sensitive to storage time and conditions.

Are there any specific instructions that should be given to livestock show exhibitors?

Livestock exhibitors, like all producers in animal agriculture, are responsible for understanding animal treatment regulations. For junior shows, students complete the “Quality Counts” quality-assurance curriculum that stresses the importance of VCPR.

What health/medical items can livestock owners continue to purchase over the counter?

Most vaccines, dewormers, injectable and oral nutritional supplements, ionophores, pro/prebiotics and topical nonantibiotic treatments will not require a veterinary prescription. However, there are some exceptions. Always read the label.

FDA to Resume Enforcement of all Federal VCPR Requirements for Veterinary Telemedicine

Fri, 06 Jan 2023 17:37:15 GMT

The Food and Drug Administration announced on Dec. 21, 2022, its withdrawal of Guidance for Industry #269, “Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak.”

The effective date of the decision is Feb. 21, which means that the FDA will again hold veterinarians to the federal requirements for the veterinarian-client-patient relationship beginning on that date. As stated by the FDA, the federal VCPR definition “requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept” and “cannot be met solely through telemedicine.”

With the withdrawal of GFI 269, veterinarians using telemedicine to deliver patient care must be sure to establish a veterinarian-client-patient relationship that complies with federal requirements so they may, for example, issue a veterinary feed directive for a client.
GFI 269 was issued in March 2020 during the early days of the pandemic, when human illness and efforts to mitigate the spread of COVID-19 created challenges for in-person examinations of veterinary patients and the conduct of premise visits.

To help address these challenges and support the use of telemedicine to deliver patient care, GFI #269 indicated that the FDA would temporarily not enforce federal requirements for an in-person animal examination or premise visit to establish a VCPR for activities covered by the federal VCPR definition, including extralabel drug use and issuing veterinary feed directives.

Now, nearly three years later, the FDA says the conditions that created the need for the enforcement policy have evolved such that the policy is no longer needed. That means, as of Feb. 21, veterinarians will need to meet all the requirements of the federally defined VCPR, including an in-person examination or premise visit, to establish the relationship prior to engaging in covered activities. A VCPR that meets the federal definition cannot be established through telemedicine. Once established, the VCPR may be maintained via telemedicine between medically appropriate examinations and premise visits.

Over-the-Counter Antibiotics Are Going Away: 5 Tips to Prepare Your Farm

Fri, 28 Oct 2022 20:14:52 GMT

On June 11, 2023, the FDA’s new directive, “Guidance for the Industry #263,” is slated for implementation, meaning that over-the-counter (OTC) antibiotics will no longer be available through traditional retail channels. Instead, these antibiotics will now require a prescription from a licensed veterinarian.

While livestock producers are continuously working to practice judicious antibiotic usage, no longer having the ability to purchase commonly used antibiotics, such as penicillin, can throw farmers a curveball.

Linda Tikofsky, DVM and Senior Associate Director of dairy professional services at Boehringer Ingelheim, says there are several steps producers should be taking now to prepare for the change.

Take Inventory

“I think the number one thing to do is just take inventory of what you’re using and what you won’t be able to purchase after June 2023,” Tikofsky says. “Go through your drug cabinet, take note of what you’re using and how often you’re using it.”

Know What You’re Treating

It’s hard to know what you need if you don’t know what you’re treating. According to Tikofsky, part of judicious antibiotic use is understanding the diseases on your farm and knowing how to treat them.

“Understanding what you’re up against and how to treat a disease is an important part of animal husbandry,” Tikofsky says. “Very often, antibiotics are not the only avenue when treating an illness or condition. Talk with your veterinarian to better understand when and how to treat when using an antibiotic, and work with them to see if there are other treatment options available.”

Prioritize Preventative Management

The best way to avoid using antibiotics is to prioritize preventative management. Take time to review herd health protocols and work proactively with your veterinarian and other consultants to address health issues within the herd.

Talk With Your Vet

Now is the time to work with your veterinarian to develop a plan to adjust the way your farm will access animal health products.

“Going forward, all prescriptions will need to be provided by a licensed veterinarian with whom the producer has a valid veterinary-client-patient relationship,” Tikofsky says. “This really shouldn’t affect farmers too much, it will just require them to have a good working relationship with their vet, which is always the goal. When it comes to obtaining antibiotics, producers will either need to purchase antibiotics from the veterinarians themselves or use a distributor that has a pharmacy license. Your vet should be able to help you find one of these distributers.”

Assemble Your Team

Surrounding your farm with the best team members should always be top of mind. According to Tifkofsky, now is the time to make sure your entire team is on board with your farm’s animal health objectives.

“It’s important to not only talk to your veterinarian about this, but also your nutritionist, herd managers and employees,” she says. “Make sure you’re assembling the right team to set your operation up for success.”

For more on herd health, read:

Cattle Veterinarians Have New Vaccination Guidelines

Thu, 20 Jan 2022 19:40:46 GMT

Veterinarians who serve U.S. dairy and beef producers have a new, comprehensive information tool to assist them in developing vaccination protocols for their clients, thanks to the efforts of the American Association of Bovine Practitioners (AABP).

The AABP Committee on Pharmaceutical and Biological Issues (CPBI) recently released a first-of-its-kind Cattle Vaccination Guidelines document to its members. The vaccine guidelines are the result of a thorough, two-year effort to consolidate cattle vaccine recommendations and information into one comprehensive document.

Dr. Justin Kieffer of Ohio State University chaired the seven-person committee of veterinary practitioners and researchers who developed the document, which also was reviewed and edited by other industry experts before its publication. The final document was approved by the AABP board of directors in September 2021.

On a recent edition of AABP’s monthly podcast, “Have You Herd?” , Kieffer said the committee prioritized a format that would be easy for veterinary practitioners to utilize, while thorough in nature and supported by research-based evidence.

The contents are organized by disease pathogen, with a listing of all vaccines available to address each one. Vaccine categories are explained, and adverse reactions – and how to best manage them – also are addressed.

Kieffer said the committee felt it was important to define a set of core diseases for which virtually all cattle should be vaccinated. Their list included IBR, BVD, PI3, BRSV, and most clostridiums except for Clostridium haemolyticum and Clostridium tetani. For lactating dairy cattle, they also included vaccination against E. coli mastitis with a rough mutant (J5) vaccine.

Additionally, the committee defined a list of “risk-based” disease pathogens that should be considered for vaccination, depending on a herd’s geography, management, and disease pressures. Kieffer said examples include Brucella, Salmonella, K99 E. coli, and Clostridium tetani.

“There are a wide variety of beef and dairy operations that are served by AABP members, with an even wider range of environmental, genetic, nutritional, and management differences, which makes outlining a standard vaccine protocol impossible” said Kieffer. “We hope these guidelines can provide practitioners with the base knowledge to construct protocols customized to bovine client needs across the production spectrum.”

AABP Executive Director Fred Gingrich called the document “a one-stop shop for everything you need to know about vaccinating cattle,” and said AABP members can access the guidelines by logging onto the AABP website and clicking through: “Committees – Committee Resource Files – Pharmaceuticals and Biologics – Vaccination Guidelines.”

Gingrich noted the Vaccination Guidelines publication is a living document that will be reviewed and updated periodically, as new disease information and vaccine technology becomes available.

Antibiotic Rules Continue to Evolve

Fri, 20 Nov 2020 05:54:33 GMT

Beef and dairy producers have adapted to significant changes in antibiotic regulations over the past three years, and that trend will continue. Continued public pressure and regulatory actions will drive ongoing change, with more emphasis on preventive care and veterinarian oversight of antibiotic use.

In September 2019, FDA released draft guidance for industry (GFI) 263, outlining a process for bringing remaining animal drugs containing antimicrobials of medical importance under the oversight of licensed veterinarians. This includes injectable antibiotic products now available over the counter.

The action builds on the GFI 213 and the veterinary feed directive (VFD) rule, which, in January 2017, eliminated performance claims from labels for medically important antibiotics and brought purchase of most medicated feeds under veterinarian oversight.

Also, by September 2020, FDA plans to issue a draft strategy to ensure all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have a targeted duration of use.

While the industry has made progress in antibiotic stewardship, research shows opportunity for further improvement. The CDC’s 2019 Antibiotic Resistance Threats Report for example, shows an 18% reduction in annual antibiotic-resistance (AR) associated deaths since 2013. Even so, the report notes AR bacteria and fungi cause more than 2.8 million infections and 35,000 deaths in the United States each year.

In December, the FDA’s 2018 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals showed domestic sales and distribution increased 9% between 2017 and 2018. Without proper context, the year-over-year increase could generate disproportionate reactions. A year earlier, FDA’s summary report showed sales and distribution of those same products declined 33% between 2016 and 2017, and 41% since 2015, which was the peak year for sales and distribution of those products.

While the report does not evaluate reasons behind the year-to-year increase, it seems plausible that 2018 brought a readjustment following a major disruption. Implementation of the VFD rule could have reduced sales below the natural demand level, because of unfamiliarity with the rule and VFD process. Also, sales during 2016 likely reflected effects of some stockpiling ahead of the new rules, making the 2017 decline more dramatic.

FDA notes that although sales data do not necessarily reflect actual antimicrobial use, sales volume observed over time is a valuable indicator of market changes. However, when evaluating progress, we need to consider actual use data, animal demographics, animal health data, and data on resistance.

Several recent reports have shown the livestock industry has made progress toward continuous improvement in antimicrobial stewardship. Nevertheless, activists and consumers will continue to apply pressure for more regulations, and for retail-driven standards beyond those imposed by government. Looking ahead, we’ll need to practice and publicize efforts to improve antibiotic stewardship while protecting animal health, welfare, food safety and producer profitability.

Farm Journal editors have covered this issue extensively, and compiled a comprehensive list of articles to keep you up to date on the latest trends, successes and challenges in antimicrobial stewardship. For links to those articles, visit https://www.bovinevetonline.com/article/antibiotic-resistance-2020-fight-fiction-facts .

Sidebar

Regulatory Timeline

Key FDA Steps toward Greater Antibiotic Stewardship

1996: Together with the USDA and CDC, FDA/CVM established the National Antimicrobial Resistance Monitoring System (NARMS) program.

1997: Prohibited extralabel use of fluoroquinolones and glycopeptides.

2003: Published GFI #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.”

2005: Withdrew the approval of fluoroquinolones for use in poultry.

2010: Published first annual summary report on antimicrobials sold or distributed for use in food-producing animals.

2012: Published GFI #209, “The Judicious Use of Medically Important Antimicrobial Drugs in FoodProducing Animals,” establishing a framework for ending production uses of medically important antimicrobials.

2013: Published GFI #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals.”

2015: Updated the veterinary feed directive (VFD) regulation, governing how veterinarians authorize the use of VFD designated animal drugs in feed and establishing a framework for VFD inspections.

2016: Sought public input on establishing appropriately targeted durations of therapeutic use of medically important antimicrobial drugs in food-producing animals.

2017: Completed implementation of GFI #213, transitioning medically important antimicrobial drugs used in the feed or drinking water from over-thecounter status to VFD or prescription status and eliminating production uses .

2019 FDA releases draft guidance for industry (GFI) #263, outlining a process for voluntarily bringing remaining approved animal drugs containing antimicrobials of human medical importance under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter (OTC) to prescription (Rx).

2020 (By September) FDA will a draft strategy to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use.

Prepare for More Antibiotic Rules

Fri, 20 Nov 2020 05:53:54 GMT

Washington Streamlines Cattle Transaction Reporting

Fri, 20 Nov 2020 05:53:26 GMT

The Washington State Department of Agriculture (WSDA) is now offering Washington ranchers a quicker, more cost-effective way to report cattle sales and out-of-state movement of their cattle through WSDA’s Electronic Cattle Transaction Reporting (ECTR) system.

Previously, beef producers had to pay fees and travel expenses for state inspectors to make in-person visits when cattle were sold or moved out of state. The on-line ECTR system was previously available only to dairy producers.

This year, as part of an industry-led push to modernize the state’s cattle identification system , WSDA expanded the ECTR system allowing cattle owners to electronically report ownership changes and out-of-state movement.

“Expanding the ECTR system is a major step toward simplifying and streamlining reporting requirements that increases efficiency and reduces costs for our producers as well as our agency,” WSDA Director Derek Sandison said. “It demonstrates important progress toward synchronizing the industry and government with today’s technology.”

Cost Savings
Cattle producers using ECTR to report ownership changes and out-of-state movement could save up to 39 percent compared to using traditional livestock inspections. For example, if a rancher records the sale of 10 branded cattle with a traditional livestock inspection, the sum of the required fees would total nearly $50. The fees associated with a comparable sale for a rancher using the ECTR system total about $30.

The updated system came online earlier this month in a soft launch that provided time to make sure the custom software, that includes the ability to upload proof of ownership documents, was working smoothly. Now, with several successful registrations in the system, WSDA’s Animal Services Division is promoting ECTR to increase usage.

ECTR Promotion
In addition to cost savings associated with change-of-ownership and out-of-state-movement transactions, the first producers who enroll in the system are eligible to receive free 840 RFID tags, which are required to use ECTR.

Producers with herds of 50 head or fewer will be eligible to receive 40 tags and one applicator. Those with herds of more than 50 qualify to receive 100 tags and one applicator.

Requirements
All cattle that are reported in ECTR must have an official electronic individual identification (840 RFID) tag. A premises identification number is required to obtain 840 RFID Tags.

WSDA adopted ECTR application, licensing and reporting fees though a rule that went into effect October 24 authorizing the new ECTR system for use by cattle owners. The ECTR fee is currently set at $1.30 per head, and the system operates on a cost-recovery basis. By rule, WSDA will set the fee to match, as closely as possible, the costs associated with operating the program.

For more information about ECTR, contact WSDA’s Animal Services program at ectr@agr.wa.gov or (360) 902-1855.

FDA Cracks Down on Unapproved CBD Products

Fri, 20 Nov 2020 05:53:23 GMT

Over the past few years, cannabidiol (CBD) has become wildly popular as a dietary supplement and “natural” treatment for a laundry list of health conditions in humans and animals. Products containing CBD – a non-psychoactive component of cannabis plants – are widely available online and at retail stores, with claims for treating conditions ranging from arthritis and insomnia to seizures and depression. Formulations include various oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams.

This week, the FDA moved to enforce regulations against marketing un-licensed, un-tested drugs, waring 15 companies for illegally selling various products containing CBD. Violations include marketing unapproved new human and animal drugs, se and adding CBD products as dietary supplements, and adding CBD to human, animal foods.

To date, FDA has approved only one CBD-based prescription drug, for treatment of two uncommon pediatric epilepsy disorders.

In a news release, FDA notes safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, changes in mood, interference with development and function of testes and sperm, reduced testosterone levels and impaired sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.

FDA also notes that one product outlined in a warning letter to Apex Hemp Oil LLC is intended for food-producing animals. This raises food-safety concerns, due to a lack of data establishing safe CBD residue levels in food products such as meat, milk, and eggs.

“In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D in the FDA release. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD can’t hurt.”

Read the full release, including a list of companies receiving the warning letter from FDA .

Read more about cannabis issues related to livestock production in these articles from BovineVetOnline:

Cannabis in Veterinary Medicine

Facts and Fiction About Hemp in Animal Feed

Perdue Answers Buzz on Hemp in Animal Feed

GMO for CBD?

FDA Revises Draft GFI on Compounding Animal Drugs

Fri, 20 Nov 2020 05:53:14 GMT

Animal drug compounding can provide tailored treatments for patients or conditions not easily addressed with FDA-approved drugs, but the practice also entails some risks and can violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Drug compounding in veterinary medicine typically involves a state-licensed pharmacist or state-licensed veterinarian combining, mixing or altering drug ingredients to create a medication tailored to the needs of an individual patient.

In an effort to clarify circumstances in which compounding can serve legitimate and legal purposes, the FDA this week issued draft guidance for industry (GFI) #256, entitled “ Compounding Animal Drugs from Bulk Drug Substances .” The FDA is accepting public comments on the new draft GFI beginning on November 20, 2019. Stakeholders should submit comments by February 18, 2020 to ensure consideration before FDA finalizes the GFI. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2018-D-4533 in the search box.

FDA previously published a draft guidance (Draft GFI #230) on this issue in 2015, but withdrew the draft based on stakeholder comments, intending release a revised draft at a later date.

According to FDA, GFI #256 addresses particular situations, such as when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances to:

Fill patient-specific prescriptions for nonfood-producing animals;
Compound “office stock” from bulk drug substances for nonfood-producing animals; and
Compound antidotes for food-producing animals.

The agency is also developing the “ List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals .” Under the circumstances of Draft GFI #256, only bulk drug substances on this list can be compounded into drugs for office stock or for antidotes for food-producing animals.

View the Draft GFI #256 from the FDA.

For more on compounding animal drugs, see these articles from BovineVetOnline.com:

FDA Issues Warning About Compounded Equine Medication

GAO calls on FDA to better monitor, regulate compounded veterinary drugs

FDA Plans New Guidance on Animal Drug Compounding

Five Animal Health Topics to Think About

Fri, 20 Nov 2020 05:52:38 GMT

Behind the scenes, animal health officials are working on behalf of producers and the livestock industry. Some issues are top-of-mind, like African swine fever, but others might not be on your radar. Participants of the National Assembly of State Animal Health Officials met on Friday, Oct. 25, in conjunction with the 2019 U.S. Animal Health Association (USAHA) annual meeting in Providence, R.I. Here are six topics of interest discussed during the meeting.

1. Flurry of activity on antibiotic use: Ron Phillips, vice-president of legislative and public affairs for the Animal Health Institute provided an update on antibiotics legislation and regulation. Several states have drafted or passed legislation in the last three to five years with similar themes. “Many of these issues also are being addressed on the federal level,” Phillips said. Recent data shows a significant decline in the sale of medically important antibiotics in 2017 (a 33% decline from 2016 and 43% lower than the peak year of 2015). FDA is in the process of getting use information, which will be a better indicator than sales data. All remaining medically important products will be moved from over-the-counter sale to Rx by 2022. Duration-of-use information on labels also will be addressed, Phillips said. “Some labels don’t have specified duration of use and FDA is working to collect more information for science-based duration-of-use guidelines,” he said.

2. Addressing gaps in regulation and oversight: Greater regulatory clarity is needed around animal movement between the exclusive economic zones (EEZ) and state shores, said Dr. Warren Hess with the American Veterinary Medical Association. An EEZ is a sea zone prescribed by the 1982 United Nations Convention on the Law of the Sea, over which a state has special rights regarding the exploration and use of marine resources, including energy production from water and wind. Participants want to see more guidance and regulation on aquatic animal health matters including disease reporting and management. More research and expanded education and training is needed, Dr. Hess said. On non-EEZ aquatic issues, the AVMA believes aquatic animal movement should be regulated like terrestrial animals, in which case they would be regulated by state departments of agriculture, and rules for aquatic animal movement would be risk-based like most terrestrial animals. He also discussed animal air travel issues and the AVMA is helping educate private veterinarians as well as the airlines on these issues. Algal bloom is another hot topic. “You’re going to hear more about harmful algal blooms from AVMA,” he said. “We want veterinarians to know more about it, where to go for more information and how to report it.”

3. The Centers for Disease Control and Prevention (CDC) continues to build coordination, collaboration and communication at the animal-human-environment interface: Dr. Julie Sinclair, with CDC’s One Health office, shared a multitude of activities in which the CDC is involved. The CDC One Health Office has been in existence for 10 years and Dr. Sinclair serves as the CDC One Health Liaison to the World Organization for Animal Health (OIE). Dr. Sinclair highlighted the CDC’s Healthy Pets, Healthy People website and several opportunities for continuing education credits such as the monthly Zoonoses One Health Update call.

Dr. Sinclair mentioned that the CDC along with USDA regulates the importation of dogs and cats into the U.S. A ban was recently placed on the importation of dogs coming from Egypt (the third rabid dog from Egypt was recently identified). State officers had further questions about whether state offices could again receive dog importation notifications from the CDC. Dr. Sinclair clarified that these notifications had been solely for dogs not fully immunized against rabies and referred state officers to the CDC Quarantine and Border Health Services website and the CDC Zoonoses Team for further information. The CDC also works on foodborne, waterborne and environmental diseases, bacterial pathogens, vector-borne diseases, and much more.

4. Funding for diagnostic laboratories is critical: Veterinary diagnostic labs handle millions of tests each year, said Dr. Deep Tewari, president-elect of AAVLD, and director of the Pennsylvania Veterinary Diagnostic Laboratory. In fact, the Iowa State VDL alone handles more than 1.4 million tests each year. The U.S. Veterinary Diagnostic Laboratory System has many goals on which it has made progress: Improve animal and human health, enhance disease detection through laboratory networks, identify novel and emerging microbial strains, ensure food safety and security, and improve quality of U.S. animals and animal products. “The main mission is still supporting animal health,” Dr. Tewari said. This mission takes money, and AAVLD is asking for additional funds to meet its goals. AAVLD accreditation is a voluntary, third party-reviewed process. The organization has been revamping its standards, particularly related to risk assessment.

5. Markets are private businesses: Pierce Bennett, government and industry affairs associate for the Livestock Marketing Association, reminded the animal health officials that livestock markets are private businesses. “We’ve been very good at skipping right over the markets,” when there’s talk about how to handle a foreign animal disease outbreak, Bennett said. Market owners want to work with industry and officials, and they want to know what they are – and are not – supposed to do if they get a call. “These are private businesses – unless they say you can place livestock there, you don’t get to just place them there,” he said. “We need a better outline of protocols, of who’s going to handle an event. We’re always open to changes, and we’d like to get some support behind it.”

The 2019 USAHA meeting covers topics ranging from zoonotic diseases, to regulations, to specific diseases in cattle, horses, sheep, cervids, poultry and pigs, and much more. Leaders from government, industry and academia gather alongside producers to find solutions to health issues that can help animal agriculture thrive.

FDA Issues Draft GFI on Conditional Drug Approvals

Fri, 20 Nov 2020 05:51:55 GMT

The U.S. Food and Drug Administration today released draft Guidance for Industry, entitled “ Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs ,” to assist animal drug sponsors and potential sponsors who may be interested in pursuing conditional approval to market animal drugs to address serious or life-threatening diseases or conditions, or an unmet animal or human health need, and for which demonstrating effectiveness would require complex or particularly difficult study or studies.

Until recently, only new animal drugs intended for minor use in major species or for use in a minor species (MUMS) were eligible for conditional approval. In 2018, as part of the reauthorization of FDA’s Animal Drug User Fee Act (ADUFA) program, Congress amended section 571 of the Federal Food, Drug and Cosmetic Act (FD&C Act) to expand FDA’s authority to grant conditional approval to include certain animal drugs for use in major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for diseases or conditions that would not be eligible for conditional approval under the MUMS provisions of the FD&C Act.

Expanded conditional approval has the potential to incentivize drug development and provide veterinarians with legally marketed new animal drugs to treat serious or life-threatening diseases or conditions and to fill treatment gaps where currently no therapies are available.

The draft guidance issued today includes proposed definitions for the key terms, “serious or life-threatening disease or condition,” “unmet animal or human health need,” and “complex or particularly difficult study or studies,” that appear in section 571 of the FD&C Act. With the release of the draft guidance, the agency is fulfilling a statutory requirement to provide information to the animal drug industry to further clarify the criteria for determining a drug’s eligibility for the new expanded conditional approval pathway.

The FDA currently reviews applications for conditional approval of MUMS drugs, i.e., new animal drugs intended for minor uses (animal diseases and conditions that occur infrequently or in limited geographic areas and in small numbers of animals) in major species, or for use in minor species (those other than horses, dogs, cats, cattle, pigs, turkeys, and chickens). Expanded conditional approval extends the availability of the conditional approval pathway beyond MUMS drugs to also include new animal drugs not intended for MUMS uses that address a serious or life-threatening disease or condition, or an unmet animal or human health need, and for which demonstrating effectiveness would require a complex or particularly difficult study or studies. FDA intends to use the term “expanded” conditional approval only when referring to applications for conditional approval under the new expanded pathway for non-MUMS drugs. Applications for conditional approval involving MUMS drugs would not be covered by that term.

Conditional approval, including under the new expanded pathway, allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured in accordance with full approval standards, and that there is a reasonable expectation of effectiveness for use. The initial conditional approval is valid for one year with the potential for four annual renewals. During this time, the animal drug sponsor must demonstrate that it is actively working toward collecting the remaining effectiveness data needed to achieve full approval. The animal drug sponsor must attain full approval within five years after receiving conditional approval or the conditional approval will be terminated.

The FDA is accepting public comments beginning on September 30, 2019. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2019-D-3361 in the search box. For assistance in submitting electronic comments, please see regulations.gov help .

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2019-D-3361 on each page of your written comments.

Comments will be accepted at any time but should be submitted no later than January 28, 2020 to ensure that the FDA takes the information into consideration before it begins work to finalize the guidance.

Dockets Management Staff
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:

Notice of Availability of Draft Guidance for Industry; Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

Regulations.gov : please note that the public comment period opens on September 30, 2019

FDA Reports on VFD Compliance

Fri, 20 Nov 2020 05:51:10 GMT

Before and after the current Veterinary Feed Directive (VFD) rules took full effect in January, 2017, the FDA focused primarily on education and outreach to help feed mills, veterinarians and producers understand and comply with the requirements. Since then, FDA has gradually increased the number of VFD inspections and initiated enforcement actions when necessary.

On August 29, FDA released its first report on inspection and compliance activities. The report, titled “ Summary Assessment of Veterinary Feed Directive Compliance Activities Conducted in Fiscal Years 2016 – 2018 ,” is available online.

Overall, the FDA reports a high level of compliance across the affected livestock-industry sectors.

In fiscal year 2016, FDA began a small, three-part pilot inspection program that began with inspectors visiting feed distributors to review randomly selected VFD documents. The inspectors then selected one VFD at the distributor and conducted further inspections of the veterinarian and producer (client) named on that VFD.

In fiscal years 2017 and 2018, FDA continued those three-part inspections and expanded the program to include state feed regulatory partners. In fiscal year 2017, state personnel inspected VFD distributors and reviewed selected VFDs for compliance with the requirements. In 2018, those state inspectors began conducting three-part inspections, similar to those conducted by the FDA investigators. With state inspectors contributing, the number of VFD inspections increased from 57 in 2016 to 130 in 2017 and 269 during 2018.

Of the 269 inspections during 2018, 230 required no action, 38 indicated voluntary action and just one indicated official enforcement action.

Key findings in the report include:

Distributors (2018)

Distributor had notified FDA of their intent to distribute VFD feeds -- 94.8%
Distributors who distributed a VFD feed that complied with the terms of the VFD -- 91.5%
Distributors who manufacture VFD feed: Drug inventory or production records showed the correct amount of drug was added to the feed for the VFD reviewed -- 96.7%
Distributors who manufacture VFD feed: Labels and formulas matched the VFD reviewed -- 91.0%
Distributor’s VFD feed labels contained the VFD caution statement -- 77.2%

Veterinarians

Veterinarians had an active license in the state where the VFD feed authorized on the VFD order(s) is being fed -- 100%
VFDs included veterinarians’ electronic or written signature -- 98.6%
VFDs included the withdrawal time, special instructions, and/or cautionary statements -- 95.3%

Producers

Client did not feed VFD feed beyond the expiration date on the VFD -- 100%
Client fed VFD feed to the animals authorized on the VFD (number, species, and/or production class) -- 100%
Client fed VFD feed for the duration identified on the VFD -- 100%
Client complied with the special instructions on the VFD -- 100%

FDA issued just one warning letter following inspections during fiscal year 2018, for a feed mill that “adulterated and misbranded VFD feed by distributing VFD feed to other distributors without first receiving an acknowledgment letter, in addition to adulterating and misbranding medicated and non-medicated feed for other reasons.”

In its report, FDA reminds stakeholders that VFD medicated feeds must be used in according to the approved conditions of use and must be under the oversight of a licensed veterinarian and consistent with a lawful VFD order. The agency intends to continue monitoring compliance, and to provide education, but FDA will also use enforcement strategies when voluntary compliance with the VFD final rule requirements is not achieved.

See the full summary report from FDA.

For more on the VFD rules and compliance, see these articles from BovineVetOnline.com.

VFD Audits: What to Expect

VFD Audits: Start with the Feed Distributor

FDA Draft Guidance Updates VFD Q&A

TAHC Proposes New Rules for Trich, BVD

Fri, 20 Nov 2020 05:48:07 GMT

The Texas Animal Health Commission (TAHC) has proposed a Bovine Viral Diarrhea Virus (BVDV) control program, including designating BVDV as a reportable disease. Also during its recent meeting the TAHC proposed changes to trichomoniasis testing requirements and removed some requirements for brucellosis testing in exotic cervids.

Noting the ongoing adverse effects of BVDV on animal health and productivity, the Commission proposes creating a new chapter to the Texas Administrative Code outlining a BVDV control program. The proposal would designate BVDV as a reportable disease, and specifies primary elements and standards of a BVDV Control Program, including movement restrictions on animals determined to be persistently infected (PI), reporting requirements, official BVDV tests and testing requirements, official identification requirements, biosecurity standards, and recordkeeping requirements. Transient BVDV infections, the Commission notes, cause diarrhea, decreased milk production, reproductive disorders, increased occurrence of other diseases and death. The losses from fetal infection include abortions, congenital defects, weak and abnormally small calves, unthrifty, and death among PI animals.

Due to the adverse effects the disease has on both the health and productivity of cattle, TAHC proposes to designate BVDV as a reportable disease in order to control the significant animal disease threat. The proposed rule contains the primary elements and standards of a BVDV Control Program which include: movement restrictions on animals determined to be persistently infected (PI), reporting requirements, official BVDV tests and testing requirements, official identification requirements, biosecurity standards, and recordkeeping requirements. Bovine viral diarrhea is a viral disease of cattle and other ruminants that is caused by the bovine viral diarrhea virus. BVDV is a member of the pestivirus genus. The transient BVDV infections cause diarrhea, decreased milk production, reproductive disorders, increased occurrence of other diseases and death. The losses from fetal infection include abortions, congenital defects, weak and abnormally small calves, unthrifty, and death among PI animals.

The Commission also proposed three changes trichomoniasis rules:

The proposed amendment no longer allows samples to be pooled by approved laboratories as an official trichomoniasis test for positive herds, herds identified as adjacent premises, and change of ownership testing. These samples must be submitted individually.
The Commission proposes that use of virgin certificates be restricted to sexually intact male cattle under 18 months of age belonging to a breed registry, which maintains an official list of animals within a specific breed and associated with a unique identification. Thus, the amendment requires all male cattle under 18 months of age not belonging to a breed registry to be tested for trich before being sold.
The proposed amendment requires sellers to provide a written disclosure for female cattle that have been exposed or potentially exposed to a trich-positive bull within the six months prior to sale. The provision allows a buyer of female cattle to take this information into account for herd management when purchasing female cattle for breeding purposes.

In related action, the TAHC removed some brucellosis testing requirements for captive exotic cervids entering Texas. The state will continue to require brucellosis testing for captive exotic cervids if they were once free ranging or if they resided within the Designated Surveillance Area or the Greater Yellowstone Area.

Complete details of the rule proposals are available on the TAHC website at www.tahc.texas.gov/regs/proposals.html

For more on trichomoniasis and BVD, See these articles from BovineVetOnline:

Part 2: Webinar Addresses VFD Questions

Fri, 20 Nov 2020 05:25:18 GMT

In late March, FDA released its draft Guidance for Industry 120 , which aims to address questions that emerged since implementation of the current Veterinary Feed Directive rules in 2017. This week, Global VetLink (GVL) hosted a webinar for veterinarians featuring members of its Expert Council, reviewing some key updates from the draft guidance.

Presenters included:

Tyler Holck, DVM, an independent swine veterinary consultant and owner of Feed His People, LLC, who also serves as leader for the GVL Expert Council.
Michael Apley, DVM, PhD, Professor of Production Medicine / Clinical Pharmacology in the Department of Veterinary Clinical Sciences at Kansas State University.
Matt Frederking, Vice President of Regulatory Affairs and Quality at Mid America Pet Food.
Christopher Rademacher, DVM, Senior Clinician and the ISU Swine Extension Veterinarian in the Veterinary Diagnostic and Production Animal Medicine (VDPAM) department at the Iowa State University College of Veterinary Medicine.

Part 1 of this series summarized several of the questions and answers the panel discussed. This follow-up article addresses questions not covered in Part 1.

Q: Can I assign an extended withdrawal to a VFD medication even though the producer will be using the VFD feed as labeled?

A: Yes, but the withdrawal time listed on the label must be included on the VFD. If the client’s protocols indicate a longer withdrawal time, such as for export or specialty markets, the veterinarian can include that information in the special instructions.

Q: Our veterinary clinic has multiple veterinarians. Can any of our veterinarians write a VFD for any of our clients?

A: Yes, as long as the federal requirement for a valid veterinarian-client-patient relationship (VCPR) is met. In states with their own VCPR specifications, veterinarians should verify the state VCPR requirements before issuing a VFD.

Q: Can I work with a feed distributor, nutritionist, or other animal health professionals in order to write a VFD?

A: Yes, the system works best when stakeholders work together for compliance, to achieve antibiotic stewardship goals and protect animal health. The veterinarian, however, is ultimately responsible for compliance with VFD regulations.

Q: Do I need to have a laboratory confirmation of disease prior to writing a VFD?

A: No, the VFD regulations do not require laboratory diagnoses. The FDA has given veterinarians discretion to make decisions regarding VFD drugs based on their clinical and diagnostic evidence, along with a valid VCPR.

Q: My client has requested a new VFD to replace the former VFD that will soon expire. Can I fill out the new VFD ahead of time and date it to begin when the previous VFD expires?

A: The veterinarian can issue a new VFD to continue treatments after an existing VFD expires. However, the date the veterinarian signs the VFD is the effective date, and any extended treatment must comply with specifications on the product label.

Q: If a veterinarian makes a mistake on a VFD and wants to go back and make corrections to the VFD rather than fill out a new VFD, can the veterinarian do that?

A: If the VFD has been signed and issued, either in paper or electronic form, the veterinarian needs to cancel that VFD and issue a new version, and notify the client and feed distributor. The FeedLINK system simplifies this process with a “void” option that automatically notifies all parties while enabling the veterinarian to issue the new VFD.

Q: If ownership of a group of animals changes during the course of a VFD treatment, does the veterinarian need to issue a new VFD?

A: If the animals remain under the care of the same caretakers, such as feeder cattle changing ownership while in the feedlot, the existing VFD remains valid. If the cattle move to a new caretaker, the veterinarian must file a new VFD and meet the requirements for a valid VCPR.

Q: If the rations for a group of cattle will change during the course of the VFD treatment, and the client will obtain those rations from different feed distributors, is a separate VFD required for each treatment period?

A: A single VFD can cover those changes in rations and in distributors. The veterinarian should note those changes in the special instructions on the VFD form.

For more about the VFD rules and compliance, see these articles on BovineVetOnline:

Part 1: Webinar Addresses VFD Questions

VFD Audits: What to Expect

Allow VFD Rules to Work

VFD: One Year Later

Part 1: Webinar Addresses VFD Questions

Fri, 20 Nov 2020 05:25:15 GMT

When the Food and Drug Administration (FDA) issued its final veterinary feed directive (VFD) rules back in 2015, they also released a draft guidance for industry (GFI) offering answers to anticipated questions regarding application of the rules in common and unusual circumstances.

The VFD rules, along with GFI 213, which removed performance or production claims for medically important antibiotics used in food animals, began full implementation on Jan. 1, 2017. Not surprisingly, producers, veterinarians and feed distributors have, over the past two years, encountered questions and situations that required more clarity for VFD compliance. In late March, FDA released its draft GFI 120 , which aims to address those questions. FDA will accept comments on the draft GFI until May 28.

This week, Global VetLink (GVL) hosted a webinar for veterinarians featuring members of its Expert Council, reviewing some key updates from the draft guidance.

Presenters included:

Tyler Holck, DVM, an independent swine veterinary consultant and owner of Feed His People, LLC, who also serves as leader for the GVL Expert Council.
Michael Apley, DVM, PhD, Professor of Production Medicine / Clinical Pharmacology in the Department of Veterinary Clinical Sciences at Kansas State University.
Matt Frederking, Vice President of Regulatory Affairs and Quality at Mid America Pet Food.
Christopher Rademacher, DVM, Senior Clinician and the ISU Swine Extension Veterinarian in the Veterinary Diagnostic and Production Animal Medicine (VDPAM) department at the Iowa State University College of Veterinary Medicine.

Since VFD implementation in January 2017, Holck says, GVL has processed about 230,000 VFD documents for more than 3,000 veterinarians through its FeedLINK electronic records system. About 68% of those VFD orders were for cattle.

Key questions and answers the group addressed include:

Q: My client will have multiple groups of animals moving through their farm during the time period the VFD covers. Can I write the VFD to include the successive groups of animals that will be on the farm during the time period?

A: Yes, but the veterinarian should include information such as the estimated number of animals in each treatment group and ensure that the treatments fall within the time frame specified in the VFD.

Q: Does the VFD feed authorized by a VFD need to be shipped in one load, or can it be delivered in multiple loads?

A: The VFD can cover multiple loads. The veterinarian should specify the approximate number of animals treated and ensure treatments comply with the VFD expiration date.

Q: Does it matter whether the veterinarian uses a drug’s trade name (generic) or proprietary (pioneer) name in the VFD?

A: If the veterinarian specifies the brand-name pioneer drug on the VFD, the client should use that product. If the veterinarian uses the generic name, the client and feed distributor can choose between proprietary or generic formulations.

Q: What if the label for the VFD drug uses the dosage, such as mg/head/day, instead of the level of the drug, such as g/ton, in the feed? Can I just include the dosage on the VFD?

A: The VFD should specify the level of drug in the feed, such as g/ton, along with the number of animals treated. When the drug label just lists dosage, the veterinarian calculates the level for the VFD order. Also, if the drug level in the feed needs to change over the course of the VFD’s duration, due to changes in the animals’ body weight and feed intake, the veterinarian calculates those levels to ensure the proper dosage.

Q: If a single entity or company manufactures VFD feeds, owns the animals covered by a VFD and employs the veterinarian writing the VFD, do they need to retain three copies of VFD orders?

A: No, the company would need to retain just one copy of each VFD.

Q: If clients manage animals at multiple premises, do they need to keep VFD records at each location?

A: No, the client can keep VFD records at one location, as long each VFD specifies the premises for covered animals and the records are readily accessible for inspection.

Q: If the client decides to switch feed suppliers for a medicated feed under an existing VFD, is a new VFD required?

A: Yes, unless the new supplier is part of the same business as the original supplier, the veterinarian needs to cancel the existing VFD and issue a new one. All parties should document the reason for cancelling the original VFD.

Q: If a veterinarian is licensed in one state, can they write a VFD for animals located in another State?

A: The veterinarian issuing the VFD must be licensed in the state in which the covered animals are located.

Q: If a VFD label has a duration range in which a VFD can be fed, such as 21 to 42 days, and the veterinarian authorizes the use of the VFD for the full 42 days, can the client decide when to stop feeding the VFD feed after the minimum provided in the range?

A: The veterinarian specifies the duration of treatment on the VFD. If the veterinarian specifies 42 days, the producer needs to comply with that duration, If the veterinarian enters a range, such as 21 to 42 days, in compliance with the drug label, the producer and veterinarian have flexibility in deciding duration of treatment.

The comment period for this draft revised guidance is 60 days and will end May 28, 2019. For instructions on submitting comments to the FDA, please see the Federal Register notice .

See the full draft guidance for industry 120 .

For more about the VFD rules and compliance, see these articles on BovineVetOnline:

USDA APHIS Launches Interactive Map for Premises ID

Fri, 20 Nov 2020 05:24:47 GMT

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) launched an interactive website that provides livestock producers with important information. The site contains web links for obtaining premises identification numbers (PIN) and location identifiers (LID) within livestock producers’ respective States. Federal PINs or state specific LIDs are unique codes permanently assigned to a physical location. PIN and LID registrations, administered by the States, allow animal health officials to quickly identify and locate animals in the event of an animal health or food safety emergency. A PIN or LID is required to purchase official animal identification tags.

This interactive map is part of APHIS’ efforts to advance the Animal Disease Traceability (ADT) program. ADT is a key component of our domestic livestock disease programs. ADT is also critical to sustaining domestic and international trade. On September 25, 2018, Under Secretary Greg Ibach announced USDA’s four overarching goals for advancing ADT to protect the long-term health and economic viability of the U.S. livestock industry. These goals include efforts to:

Advance the electronic sharing of data among federal and state animal health officials, veterinarians and industry; including sharing basic animal disease traceability data with the federal animal health events repository.
Deploy electronic identification tags for animals requiring individual identification to make the transmission of data more efficient.
Enhance the ability to track animals from birth to slaughter through a system that allows tracking data points connection.
Elevate the discussion with States and industry to work toward an electronic transmitting system for animal health certificates from private veterinarians to state animal health officials.

This interactive map compliments the infrastructure investments already made by livestock industry sectors and States in developing their traceability programs. The USDA is committed to continued collaboration to ensure we coordinate traceability efforts throughout the country.

The interactive map may be accessed here: ADT Map (PINs and LIDs) .

For more on premises ID and the Animal Disease Traceability program, see these articles from BovineVetOnline:

APHIS Revises Standards for ADT Tags

APHIS Offers Funds for ID, Traceability Projects

USAHA Resolution Supports Limited Expansion of ADT Program

Webinar to Outline FDA’s Update to VFD Policies

Fri, 20 Nov 2020 05:24:43 GMT

Earlier this year, the FDA provided updates to its Draft Guidance for Industry (GFI) 120 , based on stakeholder questions regarding details around the veterinary feed directive (VFD) rules. The revised document, called “Veterinary Feed Directive Regulation Questions and Answers,” adds 53 new VFD questions and responses and revises 14, covering a variety of topics.

This month, GlobalVetLink plans two webinars to outline the updates and discuss what they mean to industry stakeholders. The first webinar , scheduled for Tuesday, May 14, 2019, at 12:00 pm Central Time, will focus on questions and answers as they apply to veterinarians. The second, on Thursday, May 16, targets feedmills and feed distributors affected by the VFD rules.

Presenters include:

Michael Apley, DVM, PhD, Professor of Production Medicine / Clinical Pharmacology in the Department of Veterinary Clinical Sciences at Kansas State University.
Tyler Holck, DVM, an independent swine veterinary consultant and owner of Feed His People, LLC.
Christopher Rademacher, DVM, Senior Clinician and the ISU Swine Extension Veterinarian in the Veterinary Diagnostic and Production Animal Medicine (VDPAM) department at the Iowa State University College of Veterinary Medicine.
Matt Frederking, Vice President of Regulatory Affairs and Quality at Mid America Pet Food.

Attendees may earn one hour of continuing education (CE) credit for this webinar, pending RACE approval. Anyone who is unable to attend the live webinar will be able to watch it online later and earn one hour of CE, after completing the post-test. CE certificates will be sent to everyone who qualifies within two weeks after watching the live or recorded webinar.

Register here for the veterinarian webinar , and here for the feedmill webinar .

Read more about the VFD rules and recent FDA guidance in these articles from BovineVetOnline:

FDA Draft Guidance Updates VFD Q&A

Antibiotic Stewardship: FDA Cites Progress

VFD Audits: What to Expect

USDA Withdraws Proposed Change to TB, Brucellosis Programs

Fri, 20 Nov 2020 05:23:21 GMT

Based on comments received regarding a proposed rule, USDA’s Animal and Plant Health Inspection Service (APHIS) announced this week it will partially withdraw the proposal. Among other changes, the proposed rule would have consolidated regulations governing bovine tuberculosis and those governing brucellosis. Specifically, APHIS has announced withdrawal of portions of the proposed rule that would have affected provisions governing domestic brucellosis and tuberculosis programs.

Those provisions were included in the proposed rule published December 16, 2015 (18 FR 78462). APHIS solicited comments for 90 days ending on March 15, 2016, and extended the deadline for comments until May 16, 2016. The agency received a total of 164 comments by that date, from captive cervid producers, cervid breeders’ associations, cattle industry groups, State agriculture departments, State game and fish departments, veterinarians, representatives of foreign governments, and private citizens. The commenters raised a number and concerns about the proposed rule, including:

Commenters were concerned about the proposal to combine the bovine tuberculosis and brucellosis domestic programs into a single program for cattle, bison, and captive cervids, noting differing disease epidemiology, source populations, modes of transmission, surveillance streams, movement controls, testing, and management practices.
Commenters expressed concern that states may lack personnel, resources, and funding to implement and maintain required animal-health plans including cattle, bison, and captive cervid demographics, sources of bovine tuberculosis or brucellosis and surveillance and mitigations in the state.
The proposal would have based each state’s status on whether it had implemented and maintained its animal-health plan instead of prevalence rates, which commenters said would divert the program from disease eradication and international standards and require foreign trading partners to re-evaluate their requirements for importing U.S. cattle.
Many captive cervid producers expressed concern over proposed requirements to test entire herds and individual cervids as a condition of interstate movement, unless they come from accredited herds for brucellosis. Commenters also expressed concerns that, if an area had a known source of tuberculosis and brucellosis that presents a risk, that area could not be accredited or reaccredited.
Some commenters objected to a proposal requiring exhibited, rodeo, and event cattle and bison to be tested 60 days prior to initial interstate movement and again at 180 day intervals after initial interstate movement, with limited exceptions. Many State animal health officials and several industry groups objected to considering exhibited cattle and bison equivalent to rodeo and event animals in terms of disease risk, saying exhibited cattle and bison are at low risk for bovine tuberculosis and brucellosis.
Wildlife and animal health authorities expressed concern over a proposal that, if a state has known wildlife sources of bovine tuberculosis or brucellosis that pose a risk of transmission, the state would have to conduct surveillance of these source populations. In some states, wildlife authorities lack authority to conduct such testing, while other states lack funds for wildlife testing.

View the proposed rule, supporting documents, and comments AHIS received on this federal regulations website .

For more on bovine tuberculosis and brucellosis, see these articles on BovineVetOnline:

Gene Editing for TB Resistance

Brucellosis Vaccination: Still a Good Idea?

National Academies of Sciences to Outline Brucellosis Research

Managing Brucellosis Risk

FDA Draft Guidance Updates VFD Q&A

Fri, 20 Nov 2020 05:23:17 GMT

When the Food and Drug Administration (FDA) issued its final veterinary feed directive (VFD) rules back in 2015, they also released a draft guidance for industry (GFI) offering answers to anticipated questions regarding application of the rules in common and unusual circumstances.

The VFD rules, along with GFI 213, which removed performance or production claims for medically important antibiotics used in food animals, began full implementation on Jan. 1, 2017. Not surprisingly, producers, veterinarians and feed distributors have, over the past two years, encountered questions and situations that required more clarity for VFD compliance. This week, FDA released its draft GFI 120 , which aims to address those questions.

The revised draft guidance adds 53 new Q&As and revises 14 on a wide range of topics related to the VFD final rule. The document is organized to help address the needs of all parties involved with a VFD order, including veterinarians, feed distributors and clients. FDA has made these changes in response to stakeholder feedback and comments submitted to FDA’s Center for Veterinary Medicine since implementation of the VFD final rule and GFI 213.

New or revised questions the document addresses for veterinarians include:

Can I write a VFD for an OTC drug?
How do I authorize or limit the use of a VFD drug that is approved to be used in combination with OTC drugs?
Can I authorize a feed through pesticide to be used in a VFD feed? If so, how do I do that?
How do I cancel my VFD?
Can I make my own VFD form to authorize the use of a VFD drug
If the VFD has expired for a batch of feed, can I reissue a VFD to use the remaining feed?
Can I make my own VFD form to authorize the use of a VFD drug?
If the VFD has expired for a batch of feed, can I reissue a VFD to use the remaining feed?
I’m a veterinarian and I also want to sell VFD feed. What do I have to do?
If I’m licensed in one State, can I write a VFD for animals located in another State? What if I have a temporary license in the State where the animals are located?
If a VFD label has a duration range in which a VFD can be fed (e.g., 21-42 days), and I authorize the use of the VFD for the full 42 days, can the client decide when to stop feeding the VFD feed after the minimum provided in the range?
What if the label for the VFD drug uses the dosage (e.g., mg/head/day) instead of the level of the drug (e.g., g/ton) in the feed? Can I just include the dosage on the VFD?
Can I assign an extended withdrawal to a VFD medication even though the producer will be using the VFD feed as labeled (i.e., no extralabel use)?
Can I work with a feed distributor, nutritionist, or other animal health professionals in order to write a VFD?
My client will have multiple groups of animals moving through their farm during the time period the VFD covers. Can I write the VFD to include the successive groups of animals that will be on the farm during the time period?
Some drug labels have different wording for the duration of use. For example, some say feed for X days and some say feed up to X days. How should I fill out the duration of use on the VFD?
Our veterinary clinic has multiple veterinarians. Can any of our veterinarians write a VFD for any of our clients?
My client wants to use the VFD to receive a Type B medicated feed. Do I fill out the VFD with the Type B information?
My client has minor species. I would like to write a VFD for a therapeutic use of a medicated feed, but there is not an approval for this species. What should I do?
Do I need to have a laboratory confirmation of disease prior to writing a VFD?
If a veterinarian makes a mistake on a VFD and wants to go back and make corrections to the VFD rather than fill out a new VFD, can the veterinarian do that?
My client has requested a new VFD to replace the former VFD that will soon expire. Can I fill out the new VFD ahead of time and date it to begin when the previous VFD expires?

New or revised questions the document addresses for producers include:

Can I have my veterinarian write a VFD to authorize the use of a medicated feed that is not approved for the use I’m intending (i.e., extralabel use)?
What do I do if I need to treat animals for a specific duration (e.g., 30 days) but need to receive the VFD feed from two separate mills? For example, because of the animals’ growth stage and needs, one mill will provide the ration for animals during the first 20 days of the VFD’s duration and another mill will provide the ration for animals during the last 10 days of the VFD’s duration.
I feed my animals several different rations based on their nutritional needs during each growth stage. I have a VFD with a duration of use that will encompass several of these growth stages. Can my feed mill provide me VFD feed with different formulations over the duration of the VFD?
I have a VFD that authorizes me to feed my animals for 5 days as indicated on the drug approval. What happens if the animals get sick again? Can I use the same VFD to get additional VFD feed and feed the animals again for 5 days? Can the veterinarian write the VFD to allow me to use the VFD feed for more than one 5-day period prior to the 6-month expiration date?
I am currently feeding my animals a VFD feed under a valid VFD. I would like to transfer ownership of my animals. May I do that?
Does the VFD feed authorized by a VFD need to be shipped in one load, or can it be delivered in multiple loads?
My animals are in the United States, but I receive my feed from Canada. Can I get a VFD feed from Canada and if so what are the requirements?
The veterinarian used an affirmation statement to indicate that I can feed the VFD feed in combination with an over-the-counter (OTC) drug. Is it okay for me to feed the VFD drug alone?
I want to get a Type A medicated article and manufacture my own feed. What are the requirements?
When I purchase a Type A medicated article to create an authorized Type C VFD feed, where does the copy of the VFD intended for the distributor go?
I have 4 months remaining on my VFD and I would like to get my VFD feed from a different distributor. Can I ask my veterinarian to cancel the first VFD and issue a new VFD to the second distributor?
I am a client. Do I need to keep any records describing my use of the VFD feed in addition to keeping the VFD?

The comment period for this draft revised guidance is 60 days and will end May 28, 2019. For instructions on submitting comments to the FDA, please see the Federal Register notice .

See the full draft guidance for industry 120 .

For more about the VFD rules and compliance, see these articles on BovineVetOnline:

OIE Report Shows Global Progress on Use of Antibiotics in Animals

Fri, 20 Nov 2020 05:21:48 GMT

Efforts toward improving stewardship of antibiotics in livestock production have gained momentum worldwide, with more countries regulating antibiotic use and collecting data to document trends.

A new report from the World Organisation for Animal Health (OIE) show positive global progress in two key goals: more countries reporting data and fewer participants allowing use of antibiotics for growth promotion. The report also documents a continued need for enhanced surveillance and more consistent international surveillance of antibiotic use and resistance trends.

This third OIE annual report on the use of antimicrobial agents intended for use in animals provides a global and regional analysis from 2015 to 2017. In 2017, the third round of data collection, 155 countries, including 153 OIE Member Countries (85% of 181 Member Countries) and two non-OIE Member Countries completed reports. This alone shows progress since the first phase of data collection, when 130 Member Countries submitted completed reports.

According to the report, reported use of antimicrobials for growth promotion has declined from 60 to 45 countries since the last round of data collection. The authors note though, that key antimicrobials classified by the WHO as ‘Highest Priority Critically Important Antimicrobials’, including colistin, continue to be used routinely in several regions for growth promotion, creating risk for development of resistance among animal and human pathogens.

Earlier this year, a report from the FDA showed significant improvement in antibiotic stewardship here in the United States. According to the 2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, sales and distribution of all medically important antimicrobials decreased 33 percent decline between 2016 and 2017, 41 percent since 2015 (peak year of sales/distribution) and decreased 28 percent since the first year of reported sales in 2009.

The OIE report stresses the importance of countries becoming engaged in the process, with data collection and establishment of a regulatory framework serving as critical early steps. The new report shows 72 responding countries do not have a regulatory framework on the use of growth promotors. That number is down significantly from 110 countries that lacked such a framework in the first survey.

The OIE authors also note a steady increase in countries able to report quantitative data, such as quantities of antimicrobial agents used, in addition to qualitative data. The third report indicates an increase of quantitative data by 32% since the data collection started

“Many countries have already taken key actions, such as setting up surveillance systems and regulating the use of antimicrobials in human and animal health, but we still have a long way to go,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “Working together is the only way to avoid the huge human, social, economic and environmental costs of antimicrobial resistance.”

View the full report from the OIE .

For more on antibiotic stewardship and regulations in livestock production, see these articles on BovineVetOnline:

Antibiotic Stewardship: FDA Cites Progress.

Make Antibiotic Stewardship work

Antimicrobial Stewardship: A Need for International Standards

USDA Modifies Branding Requirements for Mexican Cattle

Fri, 20 Nov 2020 05:19:17 GMT

The USDA’s Animal and Plant Health Inspection Service (APHIS) has published a final rule updating requirements for identifying cattle imported to the United States from Mexico.

APHIS has required permanent identification for imported Mexican cattle to improve traceability and help prevent spread of tuberculosis and brucellosis, which remain endemic in parts of Mexico.

Currently, cattle imported from Mexico carry at least two forms of identification, generally a brand and an approved eartag. For feeder cattle, the requirements have specified that steers are branded with an “M,” while “Mx” designates spayed heifers. An “MX” brand or tattoo identifies breeding bovines imported from Mexico.

The new rule will simplify the brands to a simple “M,” while increasing the size of the brand and moving the brands for sexually intact bovines to the right shoulder of the animal. Under the new rule, the brands must be between 3 inches and 5 inches high and wide. For feeder cattle, the “M” mark must be applied to each animal’s right hip, with the top of the brand within 4 inches of the midline of the tailhead above the hook and pin bones. The brand should also be within 18 inches of the anus.

An “MX” ear tattoo remains an option for breeder cattle instead of a brand since they have not caused a readability problem and are considered a permanent form of identification.

According to APHIS, the changes will simplify the branding process while helping reduce or eliminate branding errors, rebranding and cattle rejections at port-of-entry inspection.

USDA published this final rule on December 14, and it becomes effective 30 days later, on January 13.