Veterinary Regulations

UDSA to Hold Listening Sessions Addressing the Rural Veterinary Shortage

Tue, 23 Sep 2025 17:26:30 GMT

Last month, Secretary of Agriculture Brooke Rollins announced the Rural Veterinary Action Plan, which will enhance the support available for rural veterinarians across the US. The plan includes the following action items:

Improve Veterinary Grant Programs
Better Understand the Rural Veterinary Shortage
Recruit and Retain Veterinarians
Catalog Federal Resources Available to Veterinarians
Work with Stakeholders to Understand the Barriers to Entry and Increase Recruitment in Rural Areas

This plan aims to address the rural veterinary shortage due to the low percentage of veterinary school students that come from rural areas or express an interest in rural practice, along with the low number of recent grads entering production animal medicine.

As a part of the working with stakeholders action item, USDA will be hosting two virtual listening sessions for the veterinary workforce on Sept. 29 and 30. The following USDA agencies will be represented at these sessions:

National Institute of Food and Agriculture
Economic Research Service
Food Safety and Inspection Service
Animal and Plant Health Inspection Service
Rural Development

These sessions will begin with a short update on the current veterinary landscape followed by stakeholder comments for the remainder of the meeting. Interested parties are invited to participate and must register for these sessions in advance. Both sessions will cover the same topics.

Register for the September 29 Session

Register for the September 30 Session

Preventing a One Health Crisis: How Science is Informing New Policy

Mon, 03 Feb 2025 18:43:22 GMT

The current One Health crisis brought about by the challenge of viral diseases and the need to improve the level of biosecurity practiced across species has spurred the American Veterinary Medical Association (AVMA) to take a big step forward to protect animals.

On Jan. 10, the House of Delegates of the AVMA voted unanimously to approve a resolution entitled “Biosecurity.” This resolution, authored by Scott Dee, DVM, and sponsored by the Minnesota Veterinary Medical Association, is based on scientific research documenting the ability of an evidence-based biosecurity programs to control PRRSV infection across a large-scale pork production system for an extended period.

“Globally, herds, flocks, companion animals, and exotic wildlife populations are at risk of infection by multiple agents, including porcine reproductive and respiratory syndrome virus (PRRSV), and African swine fever virus (ASFV) in pigs, along with highly pathogenic avian influenza virus (HPAIV) infection in multiple avian and mammalian species, resulting in a documented spillover into humans,” explains Dee. “Therefore, to protect the health and welfare of all that are at risk, veterinarians must practice biosecurity that is science-based, as historically, the practice of animal biosecurity has been long on marketing and short on science, resulting in mixed messages to animal owners and the public.”

Dee says the research not only proved the efficacy of science-based biosecurity, but also raised the question of how this new information could be leveraged beyond pigs and PRRSV for the benefit of “ all people short and tall, and all creatures great and small.”

Approval of the resolution led to an AVMA policy on biosecurity, as follows:

• Diseases of animals can be transmitted in many ways, including direct and indirect oral, airborne, and vector borne routes of transmission.

• Because of these many risks, prevention of disease transmission through the practice of biosecurity is critical to protecting the health and welfare of all species.

• To be effective, biosecurity programs should be, based on scientific evidence and current best practice(s) as applicable.

• The AVMA supports the protection of the health and welfare of animals through the practice of science-based biosecurity and encourages its members to become familiar with this approach.

“Since an AVMA policy on biosecurity did not previously exist, this was a logical first step to take,” Dee says. “As mentioned in the policy, all veterinarians across all species should become familiar with the science of biosecurity, follow an evidence-based approach to practice it in the field, and strive to bring answers to existing questions.”

Using scientific information from pivotal publications to write policy for the benefit of the profession is a novel approach when dealing with critical matters that affect animal and human health, Dee explains. Read more from the AVMA meeting here.

Unapproved Use of Aspirin in Dairy Cattle Prompts Reminder for Pork Industry

Tue, 14 Jan 2025 18:00:52 GMT

The increased use of aspirin (acetylsalicylic acid) to treat pyrexia and pain in dairy cattle infected with highly pathogenic avian influenza (HPAI) H5N1 prompted FDA to issue a warning to producers and veterinarians in October. Previously, FDA had stated that aspirin use was of low regulatory concern. However, due to its increased use because of H5N1, FDA has shifted its stance.

“The U.S. Food and Drug Administration understands that veterinarians and dairy farmers may be treating lactating dairy cattle for pyrexia and pain with aspirin and wants to clarify that there are no FDA-approved aspirin products for use in cattle,” FDA said in a letter to veterinarians . “There are FDA-approved products for controlling pyrexia and pain in lactating dairy cattle that are safe, effective, and have established milk and meat withdrawal periods.”

How Does This Affect the U.S. Swine Industry?
The same regulations that guide the use of aspirin in dairy cattle also guide its use in swine, reminded Locke Karriker, DVM, professor at Iowa State University College of Veterinary Medicine and American Association of Swine Veterinarians (AASV) president-elect, in a recent Swine Health Information Center/AASV webinar.

“Currently, those regulations mean that there is no legal pathway to use aspirin in swine and it should be avoided,” Karriker says.

Under the Animal Medicinal Drug Use Clarification Act (AMDUCA), veterinarians may use only FDA-approved human or animal drug in food-producing species under specific conditions in an extra-label manner. The extra-label use of unapproved drugs in food-producing species is prohibited.

All FDA-approved animal products are required to carry one of the following statements on the label:

“Approved by FDA under NADA # XXX-XXX” (for brand name animal drugs), or
“Approved by FDA under ANADA # XXX-XXX” (for generic animal drugs).

With no legal pathway to use true aspirin in swine, experts are looking into other potential treatments and other nonsteroidals and how they may be evaluated.

“The industry, veterinarians and university-based clinical scientists are working to develop alternatives to aspirin use while exploring the development of products that contain aspirin and conform to regulatory requirements,” Karriker says. “This includes cooperation among the professional veterinary organizations for bovine, poultry and swine medicine as well as dialog with the FDA directly.”

Dusty Oedekoven, DVM, chief veterinarian for the National Pork Board, says this situation is a good example why involvement of a licensed, accredited veterinarian is important in providing timely care for animals while ensuring regulatory compliance and food safety.

“My recommendation to producers is to consult with your herd veterinarian regarding the use of any animal health products, including aspirin products (acetylsalicylic acid),” Oedekoven says.

Karriker adds that depending on the case context and clinical signs, there may be several options that do have a legal status.

Learn more here from this list of resources compiled by AASV:

Extra-label Drug Use (AMDUCA)

FDA AMDUCA website — Resource information from the FDA regarding AMDUCA.

AMDUCA and Extra-label Drug Use in Swine — A brochure providing an algorithm for the use of drugs in an extra-label manner and describing additional restrictions for the extra-label use of cephalosporins and fluoroquinolones.

AVMA: Extralabel Drug Use (ELDU) Algorithm — An online algorithm.

AMDUCA Revisited — JSHAP article describing AMDUCA in swine medicine.

Your Next Read: I’m Going Into 2025 With Increased Concerns About HPAI H5N1

What The Trump Administration's Mass Deportation Plans Could Mean for Agriculture

Mon, 23 Dec 2024 17:39:39 GMT

Farmers and food industry leaders are warning that President-elect Donad Trump’s plans to deport millions of immigrants could devastate agriculture — an industry in which immigrants make up a good chunk of the workforce.

Nearly half of all farmworkers are undocumented, and industries such as dairy and meatpacking plants are especially vulnerable to labor shortages.

“Admittedly, there are some people who slip through,” says Scott VanderWal, vice president of the American Farm Bureau Federation. “Perspective employers are required to take documentation that appears to be legal and valid. There are times when that’s not the case and then ICE [U.S. Immigration and Customs Enforcement] comes in and cleans house, the workers disappear and go wherever they take them and the employers are left without help.”

While the H-2A visa program has grown, it only covers seasonal work and cannot replace year-round jobs at meat processing plants and on dairy and pork farms.

“Our packing plants need labor. Many of our farms use temporary visa labor — educated, skilled individuals work on our sow farms,” says Lori Stevemer, president of the National Pork Producers Council. “We have been experiencing an increased number of denials over the past year, which really makes it a challenge to find workers. The H-2A visa doesn’t work well when we have animals that need care 24/7, year-round.”

Experts say mass deportations would disrupt food production, raise prices and jeopardize the stability of U.S. agriculture.

Deportation falls under the Department of Homeland Security. President-elect Trump has selected South Dakota Republican Gov. Kristi Noem to lead that agency.

“With Governor Noem at the helm, she’s going to bring common sense to that discussion and make sure we don’t close businesses, make sure we get everyone in line, get the workforce in line and then make sure we’re following our country’s rules,” says Hunter Roberts, secretary of South Dakota’s Department of Agriculture and Natural Resources.

Meanwhile, farm groups continue to urge for reforms to immigration policies or a guest worker program to secure a stable workforce.

“At the same time as controlling the border, we need to overhaul our labor system,” VanderWal says. “We need to make H-2A apply to your own workers or come up with a decent program that will help.”

We need some type of H-2A visa reform to allow those workers to stay year-round, Stevemer adds.

Even then immigration is likely to continue to be a political hot potato in 2025, and labor shortages will continue to top the list of challenges for agriculture.

USDA Reports First H5N1 Detection in Swine

Wed, 30 Oct 2024 19:05:00 GMT

USDA announced on Oct. 30 the first reported case of H5N1 in a pig in an Oregon backyard farm. It’s important to note there is no concern about the safety of the nation’s pork supply as a result of this finding, USDA said. This farm is a non-commercial operation, and the animals were not intended for the commercial food supply.

“The confirmed case in Oregon poses no threat to consumer health or food safety; properly handled and cooked pork products remain safe for consumption,” Bryan Humphreys, National Pork Producers Council (NPPC) CEO said in a statement. “The entire pork industry remains committed to safeguarding food safety and human and animal health.”

The case was discovered on a backyard farm that includes a mix of poultry and livestock, including swine. The Oregon Department of Agriculture announced on Friday, Oct. 25, that poultry on this farm represented the first H5N1 detection in Crook County, Oregon. On Tuesday, Oct. 29, the USDA National Veterinary Services Laboratories also confirmed one of the farm’s five pigs to be infected with H5N1, marking the first detection of H5N1 in swine in the U.S., USDA reports.  

“The livestock and poultry on this farm shared water sources, housing, and equipment; in other states, this combination has enabled transmission between species. Although the swine did not display signs of illness, the Oregon Department of Health and USDA tested the five swine for H5N1 out of an abundance of caution and because of the presence of H5N1 in other animals on the premises,” USDA wrote.

The swine were euthanized to facilitate additional diagnostic analysis. Although test results were negative for two of the pigs, and test results are still pending for two others.  
The farm has been quarantined to prevent further spread of the virus. Other animals on the farm include sheep and goats that remain under surveillance.  

“USDA’s National Veterinary Services Laboratories (NVSL) has conducted genomic sequencing of virus from the poultry infected on this farm, and that sequencing has not identified any changes to the H5N1 virus that would suggest to USDA and CDC that it is more transmissible to humans, indicating that the current risk to the public remains low,” USDA wrote.

H5N1 detections include viral genome sequencing to provide additional information of interest to medical professionals and the research community to improve understanding of the virus. Genetic sequencing for these samples is underway, but results may be inconclusive due to low viral levels in the samples, USDA said.   

Pork Producers Practice Biosecurity to Protect Pigs
Biosecurity is critical to eradicating H5N1 and other viruses. Not only does biosecurity protect the health of livestock, but it also protects the health of farmworkers and their families. For more information on protecting farmworkers, visit the CDC’s website .
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10 Powerful Take Homes to Enhance Biosecurity on Your Pig Farm
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The pork industry has worked alongside USDA’s Animal and Plant Health Inspection Service (APHIS) since 2009 to carry out the swine influenza surveillance program to identify influenza viruses circulating in swine, proactively detect reassortment viruses that could impact public health, and gain knowledge to contribute to improved animal health diagnostics and vaccines, NPPC pointed out in a statement.

“Pork producers have always been proactive and diligent about implementing biosecurity plans as part of their daily production practices to assure animals wellbeing and food safety,” Lori Stevermer, NPPC president and Minnesota pork producer said. “This detection serves as a reminder for producers of all sizes to understand and address influenza virus risks.”

What’s Next?
USDA recently approved two vaccine field safety trials for vaccine candidates designed to protect dairy cows from H5N1, and continues to explore vaccine options for other species.   As USDA takes additional steps to protect the health of livestock, it will continue to work closely with CDC to protect the health of people and FDA to protect the safety of the food supply.

“These collective, collaborative efforts have helped protect farmworkers and farmers, the health and welfare of livestock animals, and reaffirmed the safety of the nation’s food supply. The U.S. government remains committed to addressing this situation with urgency,” USDA said.

Learn more about USDA’s response to HPAI in dairy cattle.

The situation is being monitored by local public health officials, Oregon Health Authority, Oregon State Veterinarian, Oregon Department of Agriculture, as well as USDA and U.S. Department of Health and Human Services.   

Read More:
Get the Facts Straight on Highly Pathogenic Avian Influenza
Animal Health Experts Open Up About Future Disease Preparedness
How the Swine Industry Responded to H5N1 Outbreak in Dairy Cattle
A Message to the Ag Industry about H5N1

FDA Plans Five-Year Blueprint for Antimicrobial Stewardship

Thu, 13 Jun 2024 00:12:08 GMT

FDA Commissioner Scott Gottlieb, M.D., issued the following statement on efforts to advance antimicrobial stewardship in veterinary settings.

Antimicrobial resistance is a global public health challenge. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years. When used judiciously, antimicrobials can effectively fight bacterial infections. However, we know that overuse or misuse of these drugs promotes the development of antimicrobial-resistant bacteria.

For all of these reasons, it’s critical that we implement good antimicrobial stewardship practices in human healthcare and veterinary settings. We must continue to take new steps to slow the development of resistance and extend the usefulness of these lifesaving drugs.

Combating antimicrobial resistance continues to be a top priority for the U.S. Food and Drug Administration (FDA).

To further these efforts, the FDA will soon implement a new, five-year blueprint for how the FDA plans to build on its current programs to advance antimicrobial stewardship in veterinary settings. We’ll expand on the FDA’s existing actions, and launch some new programs. Our aim is to reduce overuse of antimicrobial drugs and combat the rising threat of resistance.

As part of the FDA’s regulatory mission, our Center for Veterinary Medicine (CVM) is responsible for ensuring the safety and effectiveness of animal drugs, including antimicrobials. CVM has already taken important steps to update the approved conditions of use for medically important antimicrobials (i.e., antimicrobials important for treating human disease) to support judicious use in food-producing animals. While important progress has been made, we know that additional work is needed to address the complex challenge of antimicrobial resistance.

At FDA, we believe that the concept of antimicrobial stewardship encompasses several important principles of judicious use. These are critical to slowing the rate at which bacteria develop resistance to antimicrobial drugs. In simple terms, we believe medically important antimicrobial drugs should only be used when necessary to treat, control or prevent disease. In addition, when such use is necessary, these antimicrobials should be used in an optimal manner. They should only be used under the oversight of a licensed veterinarian.

Among the steps that CVM has already taken, perhaps the most significant action was implementation of Guidance for Industry #213 . On Jan. 3, 2017, the FDA announced that it had completed implementation of GFI #213. This was the culmination of a process launched in 2013. The goal was to transition medically important antimicrobials that are used in the feed or drinking water of food-producing animals to veterinary oversight, and to eliminate the use of these products in animals for production purposes, such as for growth promotion.

Of the 292 new animal drug applications initially affected by GFI #213, 84 were completely withdrawn. Of the remaining 208 applications, 93 applications for oral dosage form products intended for use in water were converted from over-the-counter to prescription status; while another 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status. Moreover, production indications (e.g., growth promotion) were withdrawn from all 31 applications that included such indications for use.

Last year, we also published a paper proposing the use of a biomass denominator to adjust annual data on the amount of antimicrobials sold or distributed for use in food-producing animals in the U.S. This adjusted estimate is intended to provide more insight into broad shifts in the amount of antimicrobials sold for use in food-producing animals and give the FDA a more nuanced view of why sales increase or decrease over time in a manner that is specific to U.S. animal production. The agency also recently launched the Resistome Tracker. This is an interactive research and data visualization tool for antibiotic resistance genes.

To build on the progress already made, we’re announcing that the FDA will shortly publish a blueprint on how we’ll press forward and implement additional steps to address antimicrobial resistance in veterinary settings. This blueprint will serve as the FDA’s new, five-year plan. We’ll include key goals, objectives and actions that CVM will focus on during fiscal years 2019 – 2023.

Our new activities will be aimed at addressing three key goals:

Aligning antimicrobial drug product use with the principles of antimicrobial stewardship; supporting efforts to foster better stewardship of antimicrobials in veterinary settings; and enhancing the monitoring of antimicrobial resistance and antimicrobial drug use in animals.

The specific objectives and actions will be outlined in our forthcoming plan.

Some of the important issues to be addressed in this new plan include establishing appropriate durations of use of medically important antimicrobials, and bringing all dosage forms of medically important antimicrobials under veterinary oversight. We are also developing and advancing new strategies for promoting antimicrobial stewardship in companion animals.

We’ll advance these goals in new guidance that the FDA will develop with broad stakeholder input. And we’ll enhance transparency and keep the public apprised of progress being made.

For example, we’ll shortly publish a list of all medically important antimicrobials labeled for use in animals that lack a defined duration of use on their labels. We’ll keep this list updated as we work to implement a science-based approach for addressing this important issue.

We’re also advancing new strategies to improve the collection and sharing of data on antimicrobial drug use and resistance. To advance evidence-based practices, we need to make sure that the entire community has access to good information. And we need to develop a long-term strategy for implementing a practical, efficient antimicrobial use monitoring and reporting system for veterinary settings. Our plan will address new ways to advance these goals.

Many stakeholders helped make our previous efforts a success. These include the animal pharmaceutical and feed industry; veterinary organizations; animal producer organizations; consumer organizations; various local, state and federal agencies; legislators; and other key stakeholders.

I look forward to releasing this plan shortly, and continuing to work collaboratively to promote stewardship and preserve the effectiveness of antimicrobials for human and animal health.

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.”

House Passes Bill to Preserve Veterinary Use of Xylazine

Wed, 13 Dec 2023 20:45:55 GMT

The House of Representatives passed the Support for Patients and Communities Reauthorization Act on Tuesday. The Act, in part, fights the illicit use of xylazine in humans while preserving access to the drug for use in animals.

“For beef packers, xylazine is used to quickly and humanely sedate sick or injured cattle in a manner that can safely and effectively be administered by workers. Xylazine has both animal welfare and worker safety benefits at beef plants, and there are no equally safe and effective alternatives,” said Meat Institute President and CEO Julie Anna Potts.

Xylazine is used to a lesser degree in pigs than in beef. “But it is an issue for vets in general as DEA schedule drugs are a huge hassle and really limit access. It is one more limit on what we can do,” Jim Lowe, DVM, associate dean of Online Programs and Extension at the University of Illinois College of Veterinary Medicine told Farm Journal’s Pork earlier this month.

At issue is the concern that xylazine, a drug approved by the U.S. Food and Drug Administration for use in animals, is being imported illegally in powder form and added to fentanyl. Xylazine is not approved for human use.

The Combating Illicit Xylazine Act was included in the Support for Patients and Communities Reauthorization Act, H.R. 4531, approved by the House with a vote of 386-37.

“We appreciate the hard work of Congressmen Jimmy Panetta (D-CA) and August Pfluger (R-TX) and the Energy and Commerce Committee for including the xylazine measures in the bill passed by the House with strong bipartisan support,” said Potts. “We now call for swift Senate consideration.”

The bill will ensure the Drug Enforcement Agency (DEA) has the power to stop the illegal flow of xylazine to humans, while allowing its continued access for veterinary purposes.

Xylazine Bill Protects Veterinary Access to the Sedative

Xylazine Bill Protects Veterinary Access to the Popular Sedative

Wed, 08 Nov 2023 19:50:50 GMT

Xylazine is an important animal sedative that’s used in almost every sector of veterinary medicine. However, illicit or illegal xylazine is increasingly showing up in street drugs.

Legislation proposed earlier this year and supported by the American Veterinary Medical Association (AVMA) and American Association of Bovine Practitioners (AABP) would help combat the emerging threat posed by illicit xylazine while protecting veterinarians’ ability to legitimately use the product.

“We don’t use much xylazine in pigs as we don’t do much anesthesia,” says Jim Lowe, DVM, associate dean of Online Programs and Extension at the University of Illinois College of Veterinary Medicine . “But it is an issue for vets in general as DEA schedule drugs are a huge hassle and really limit access. It is one more limit on what we can do.”

Combating Illicit Use of Xylazine

Xylazine, also known as “tranq,” is being used as a low-cost drug cutting agent. The Drug Enforcement Agency (DEA) reported 23% of fentanyl powder contained it in 2022. In humans, the product can cause depressed breathing and heart rate, unconsciousness, necrosis, and even death. Naloxone does not reverse the effects of xylazine because it is not an opioid.

The Combating Illicit Xylazine Act (S. 993/H.R. 1839) – a bipartisan bill that the AVMA helped develop, introduce, and build bipartisan support for – was introduced to Congress in March. The Biden administration designated fentanyl combined with xylazine as an “emerging threat” to the U.S. in April.

The designation allows the federal government to put together resources to counteract the illegal supply of the drug combination found nationwide, according to a press release from the Biden administration.

It’s the first time the United States has declared a drug an emerging threat, a category enabled by a 2018 federal bill, said Rahul Gupta, M.D., director of the Office of National Drug Control Policy (ONDCP), in the release.

Illicit xylazine’s growing role in being sold illegally and overdose deaths nationwide prompted the White House to make this designation.

Schedule III Designation Would Help

If the proposed legislation becomes law, it will make the manufacturing, distribution, dispensing, or possession of illicit xylazine for trafficking subject to Schedule III penalties under the federal Controlled Substances Act, the AVMA reports.

Illicit use of xylazine includes any use, or intended use, in people and would address any diversion of xylazine from veterinary sources. At the same time, the legitimate uses mean xylazine would remain an FDA-regulated, prescription veterinary drug.

A call to action urging veterinary advocates to reach out to their members of Congress in support of the legislation was recently featured by the AVMA’s Congressional Advocacy Network.

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:

Preparing for Prescription-Only Antibiotics in Livestock Industry: Important Changes Ahead

Wed, 31 May 2023 18:24:03 GMT

While another month has come and gone for the 2023 production year, if you haven’t already heard, June will hold some significant changes for the livestock industry.

When it comes to livestock antibiotics, many products that have typically been used over-the-counter will now need a veterinary prescription.

“ 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, the FDA’s Guidance for Industry (GFI) #263 will take effect, bringing 91 over-the-counter antimicrobial products under prescription oversight.

While the sales of antimicrobial injectables in 2021 declined by 11% from 2016 , Lormore says the FDA’s guidance is a result of a long conversation around improving the quality of and control systems around antimicrobial use in food production.

The guidance applies to all food animals , including cattle, hogs, ruminants (goats/sheep) and poultry. In addition, it also applies to animals not intended for food, such as horses, pet rabbits and backyard chickens.

“ W hile this change does not require the purchase of products from a veterinarian, going forward, producers will be legally required to obtain a prescription from a licensed veterinarian with whom the producer has a valid veterinary-client-patient relationship ,” says Becky Funk, DVM, and Jesse Fulton in a University of Nebraska-Lincoln article.

Specifically, the veterinary-client-patient relationship (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.

Preparing for OTC Antibiotics to Go Prescription-Only

If you do not have a relationship with a veterinarian, start visiting with a local practitioner so they can become familiar with you and your animals on your operation.

Additionally, Linda Tikofsky, DVM and senior associate director of dairy professional services at Boehringer Ingelheim says, “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. Go through your drug cabinet, take note of what you’re using and how often you’re using it.”

This will help you prepare for conversations with the veterinarian, discussing standard operating procedures and routine drug orders.

A full list of products to soon require a prescription can be found here .

For more information regarding these changes:

Over-The-Counter Access to Antibiotics is Going Away

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

If You ‘Doctor’ Livestock, a New Rule will Determine How or If You can Buy Antibiotics

Beef Implant Changes

For beef producers using growth-promoting implants, additional changes will be taking place in June.

While implants are labeled for sex, age or stage of production, until recently, implant labels did not include directions for reimplantation within the production stage for which they are intended, Sandy Stuttgen, DVM, senior outreach specialist and Taylor County Extension agriculture educator with the University of Wisconsin Extension.

To bring clarity, the FDA has defined specific production stages, which will be used to determine if and when a growth-promoting implant can be administered.

Beef cattle will still be allowed to receive multiple implants across different stages of production, including each of the following phases defined by FDA GFI 191:
• Beef Calves:
1) Pre-ruminant or ruminant beef calves nursing their dams from birth until 2 months of age
2) Ruminating and nursing their dams from 2 months of age to weaning
• Growing beef steers or heifers on pasture (stocker, feeder or slaughter): weaned and maintained on pasture and receiving most of their diet from grazing
• Growing beef steers or heifers in a drylot: weaned and maintained in a dry lot and fed harvested forage (possibly with supplement)
• Growing beef steers or heifers fed in confinement for slaughter: weaned growing and finishing animals confined in group pens or grow yards and fed progressively high-energy diet ad libitum as their sole ration until slaughter

For more on beef implant changes: Beef Cattle Implant Changes: What You Need to Know

Overall, as a good practice in administering any vaccine or implant, Stuttgen encourages producers read the product label and lean on your veterinarian to determine how the products should be best used in the operation.

Iowa Governor Announces Funding for ISU Veterinary Diagnostic Lab

Sat, 21 Jan 2023 14:30:11 GMT

Iowa Gov. Kim Reynolds announced $40 million in funding from American Rescue Plan Act dollars to help complete Phase 2 of Iowa State University’s Veterinary Diagnostic Laboratory (VDL). She has also proposed an additional $20M in her budget from the Rebuild Iowa Infrastructure Fund (RIIF)—$10M in FY24 and $10M in FY25—to total $60M in state support for the VDL project in a release from her office .

Construction of the front end of a new VDL in Ames is scheduled to be finished this year. The $75-million Phase 1 of the project does not cover the majority of the lab’s operations, Iowa Pork Producers Association noted in a statement. Phase 2, which is expected to cost $62.5 million, would provide an additional 70,000 square feet for laboratory testing, research and support functions.

“Pig farmers and cattle producers across Iowa are extremely grateful Governor Kim Reynolds is providing significant financial support to upgrade Iowa State University’s Veterinary Diagnostic Lab and we hope the Iowa legislature will join her in providing additional funding, as she has proposed,” said Iowa Pork Producers Association President Kevin Rasmussen, a farmer from Goldfield, in a joint statement with Iowa Cattlemen’s Association President Bob Noble of Riceville.

Gov. Reynolds explained that the VDL is critical to support and protect not only the Iowa agriculture industry and food supply, but the U.S. as well.

“The new state-of-the-art facility will keep Iowa State at the forefront in helping recognize foreign animal diseases that threaten the nation’s food supply well into the future. We sincerely appreciate her efforts and willingness to keep animal and human health as top priorities,” Rasmussen and Noble said in a release.

This investment will significantly expand the VDL’s capacity to support Iowa’s $32.5 billion animal agriculture industry and will keep this nationally-recognized lab on the forefront of cutting-edge technology, Reynolds said in the release.

“We are deeply grateful to Governor Reynolds for allocating these critical resources to construct Phase 2 of the Veterinary Diagnostic Laboratory,” Iowa State University President Wendy Wintersteen said in a release. “This funding will help ensure the VDL can continue to provide cutting-edge services and support to Iowa’s livestock and poultry producers.”

The state’s close relationship with the VDL has been essential in implementing the state’s response to the highly pathogenic avian influenza outbreak and Iowa Secretary of Agriculture Mike Naig said they rely on the VDL’s recommendations as Iowa continues to enhance foreign animal disease preparedness.

Editor’s Note: Fully accredited by the American Association of Veterinary Laboratory Diagnosticians, the VDL provides quality diagnostic services for animal species, including necropsy, bacteriology, serology, histopathology, virology, parasitology, molecular diagnostics, and toxicology as well as offering analytical services. The full-service laboratories at the VDL process upwards of 100,000 cases each year and conducts more than a million tests annually.

VFD Audits: What to Expect

Fri, 20 Nov 2020 05:12:10 GMT

Comply with the rules, keep good records and organize those records for accessibility, and you shouldn’t worry about FDA inspectors scheduling an audit. That general message surfaced repeatedly during a recent webinar on the VFD audit process hosted by GlobalVetLink. The webinar featured several presenters representing different industry segments affected by the expanded VFD rules, implemented in January 2017. They included:

Tyler Holck, DVM, with Feed His People, LLC.
Peter Schneider, DVM, with Innovative Agriculture Solutions, LLC, and a swine producer.
Mike Apley, DVM, PhD, Kansas State University.
Matt Frederking, VP for Regulatory Affairs, Mid America Pet Food, LLC.

This article summarizes Dr. Schneider’s presentation which focused on his experience with a VFD “educational audit” FDA conducted at his family’s swine operation in 2017. Over the first year since the rules launched, FDA has focused its audits on education rather than penalties for non-compliance, but enforcement will become stricter over time.

Schneider says the typical pathway for an FDA investigation will begin at the feed distributor that sells medicated feeds subject to VFD regulations. These audits are unannounced, and the inspectors likely will review VFD orders from multiple customers.

The audit might end there, or the inspectors might select some VFD orders to follow back to the veterinarians who issued them and to the producers who purchased the medicated feeds. The inspectors will notify veterinarians and producers prior to the audit, but the time will be short, with most follow-up audits conducted within 24 hours of the initial feed-distributor audit.

Schneider notes that FDA relies on state departments of agriculture to assist with the audits. In his case, the inspection team included one representative from the FDA and one from the Iowa Department of Agriculture. The inspection, he says, was relatively painless and took less than one hour to complete.

The process, he says, was relatively simple. The inspectors asked to review the operation’s VFD records and used a standardized VFD inspection tool , essentially a checklist of questions for distributors, veterinarians and producers, to complete the audit. Key points included verification that the veterinarian is licensed to practice in that state and has a valid veterinarian-client-patient relationship (VCPR) with the operation, and that the producer has maintained records for the required two years and has followed the VFD and the product label specifications in administering the medicated feeds.

Schneider lists these take-home points:

Details are important. Ensure that your VFD forms include pertinent information on animals, rations, dosage and duration of use for VFD products
Justification is important. Be sure to document the reasons for using a VFD product, based on the veterinarian’s familiarity with the operation and animals, diagnostics and best professional judgement.
Beware of “double dipping.” Pulse treatments, or repeated treatments with a medicated feed, must be justified and a new VFD is needed for the second or subsequent courses of treatment.
If a producer and veterinarian determine a treatment is not working during the period covered by a VFD, they can and should switch to a different treatment, with a new VFD.
Keep good records. The biggest weakness the FDA has noted in VFD compliance has been a lack of documentation, particularly at the producer level. More records and greater detail probably will serve you better than less.

The recorded webinar is available for on-demand viewing from GlobalVetLink .

USDA Proposes New Regulations for Animal Diagnostic Labs

Thu, 19 Nov 2020 03:22:46 GMT

USDA’s Animal and Plant Health Inspection Service (APHIS) is trying to make it easier for animal diagnostic laboratories to carry out vital livestock disease testing on behalf of the agency.

A proposed rule is now available for public comment through July 29. USDA wants to update its regulations that outline how the agency approves laboratories to conduct official testing for animal diseases, as well as how they can remain approved.

The specifics for approval processes are currently listed in disease-specific sections throughout the animal health regulations and they vary by disease, a statement from APHIS said. APHIS is proposing to create a single, user-friendly process for laboratory approval and consolidate the existing regulations into one location.

“Approved laboratories play a vital role in our animal health efforts, by providing us with proven, accurate results in a specific timeframe. We rely on these laboratories every day to provide clear information about the health status of the nation’s many herds and flocks,” APHIS said.

The proposed changes will not only make it easier for laboratories to understand what they need to do to become approved, but also what they need to do to remain approved to conduct a wide variety of official tests.

The consolidated regulations would provide consistent inspection protocols, proficiency testing methods, quality system guidelines and definitions. This would also facilitate the approval of additional laboratories in emergency situations. The consolidated regulations would serve to simplify regulatory oversight and compliance.

Existing approved laboratories would begin using the new process when it is time for their next renewal. USDA said they would implement the new process for newly requested approvals immediately.

More from Farm Journal’s PORK:

McDonald’s CEO Says African Swine Fever’s Pushing Up Pork Prices

Telemedicine: Videochats with Veterinarians