Brief Summary of Minutes

Summary of Minutes of Annual Meeting

12:00 PM Meeting organization

Report from The Administrative Advisor - Dr. Margaret Smith

Report from The National Coordinator - Dr. John G. Babish

Report from FDA/CVM – Dr. Amy Omer

Regional Accomplishments

Northeast Region: Dr. Rodman G. Getchell

North Central Region – Drs. Ronald W. Griffith and Amanda Kreuder   

Other business

Report from The Administrative Advisor - Dr. Margaret Smith

Dr. Smith opened the meeting by thanking all members of the Program for their hard work and dedication over the past year. She then indicated that minutes of this teleconference will be submitted as the required annual report. and complete progress reports should be submitted to Dr. Babish.    

Report from The National Coordinator - Dr. John G. Babish

Tactical Science Network (TSN) Priorities and Minor Use Animal Drug Program (MUADP).

During teleconferences over the past year, the TSN emphasized the importance of examining how climate change and biosecurity could be incorporated into each program. The following summarizes the information I presented to the TSN for minor species.   

1. Climate change – While TSN teleconference participants had a good, general understanding of climate change, it was disappointing that a majority of the participants failed to understand the potential effects of climate change on food animal production The National Institute of Food and Agriculture (NIFA) has designated climate change as a priority issue in agriculture and has directed all programs to consider its impact within the scope of their missions. Climate change is expected to have significant impacts on food animal diseases.

Some of the its effects include:

Spread of vector-borne diseases: Warmer temperatures and changes in precipitation patterns can result in the expansion of the geographic range of disease vectors such as mosquitoes and ticks. This expansion can lead to increased transmission of vector-borne diseases, affecting both humans and animals. For example, warmer temperatures have been associated with the spread of diseases like West Nile virus and Lyme disease, which also affect livestock.

Altered disease patterns: Climate change can disrupt ecosystems and affect the distribution and behavior of wildlife and pests. This can result in changes in disease dynamics, such as the emergence of new diseases or shifts in the prevalence of existing ones. Livestock may encounter novel pathogens from wildlife due to changes in their habitats or migration patterns.

Decreased productivity: Climate change-related impacts on food animal production diseases can ultimately lead to reduced livestock productivity. Disease outbreaks can result in high mortality rates, reduced growth rates, and decreased reproductive efficiency, negatively impacting the overall productivity and profitability of animal agriculture.

• Biosecurity - Biosecurity is the combination of practices and measures implemented to prevent the introduction and spread of diseases in animals. In the context of food animal health, biosecurity threats refer to any factors or events that can compromise the health and well-being of animals raised for food production. These threats can have significant economic and public health impacts. Some common biosecurity threats to food animal health include:

Infectious Diseases: Outbreaks of infectious diseases such as avian influenza, foot-and-mouth disease, swine flu, and African swine fever pose a major threat to food animal health. These diseases can rapidly spread within and between herds or flocks, causing illness, death, and economic losses. While Americans may think a pandemic like COVID can't start here, researchers say lax regulation of livestock and wild animals make it a real risk.

Pathogen Transmission: Pathogens can be introduced to food animal populations through various means, including the movement of people, equipment, vehicles, or other animals. Contact with contaminated surfaces, feed, water, or air can facilitate the transmission of diseases.

Wildlife and Pest Interactions: Wild animals, such as birds and rodents, can act as reservoirs or carriers of diseases that can be transmitted to food animals. Pest infestations, including insects and parasites, can also introduce diseases or weaken the animals' immune systems.

Globalization and Travel: Increased global trade and travel facilitate the movement of animals, people, and products, increasing the potential for disease introduction. Importing animals or animal products without proper screening or quarantine procedures can introduce new diseases to food animal populations.

TSN Scheduling and Progress- There has been little progress regarding the consolidation of the TSN into a formal budget proposal. Therefore, during 1Q23, the MUADP began considering conducting its own congressional efforts for funding.

Dr. Babish reviewed some general guidelines for being funded in the U.S. Farm Bill. These included: determine how your organization aligns with the purpose of the farm bill, create well-researched and comprehensive proposals, partner with other organizations, such as trade associations, agricultural groups, and nonprofits, keep updated with the development and passage of the farm bill, establish connections with members of congress, particularly those on the house and senate agriculture committees, monitor the introduction of bills related to the farm bill, educate the policymakers on the importance of including your organization in the farm bill, and understand that inclusion in the farm bill may not happen immediately.

With respect to the Program’s alignment with the objectives of the Farm Bill, the MUADP addresses the Farm Bill objectives of (1) Research and extension services, (2) Investment in rural communities (e.g., jobs, housing, and infrastructure), and (3) Agricultural trade issues by::Stimulating small farm economy; Protecting human food safety and biosecurity; Increasing the diversity of our agricultural base to include important specialty species; Decreasing dependence on imported foodstuffs; and Ensuring the health and welfare of agriculturally important specialty animal species in the US.

Over the last three years, the MUAP had developed and justified an annual budget of $5.5 million per year as necessary for a Program that would adequately meet the needs of our stakeholders. Moreover, we have identified sheep and goat stakeholders to lobby in behalf of the Program. Dr. Erica Sanko of the American Sheep Institute (see Dr. Omer’s report) and Dr. Paul Plummer of Iowa State University, indicated a willingness to meet with government agencies to promote the MUADP. This March, Dr. Plummer meet with representatives from the Animal and Plant Health Inspection Service (APHIS) describing our Program and budgetary needs. Continued or initiation of Farm Bill support from the following stakeholders was recommended by Drs. Omer and Van Schoick: gamebirds (pheasants, quail, partridges). sheep, goats, aquaculture, farmed deer, and honeybees.     

Congressional Progress on Farm Bill

US Senate draft-The Senate has completed a draft of the Farm Bill. Thus. it is too late to effectively lobby any of our Senators. Although there may be an opportunity to do so during the congressional reconciliation phase when House and Senate bills are merged.    

US House schedule for drafting of the Farm Bill remains in flux. Therefore, Dr. Babish, in concert with Cornell lobbyist Ms. Dianne Miller, contacted the office of Congressman Marc Molinaro of NY 19th district (Ithaca, NY) for Program support in the Agricultural Committee. Dr. Babish has initiated correspondence with Tyler Gutchess, congressional aide to Rep. Molinaro. Included in this correspondence were descriptions of the Program’s mission; how the MUADP addresses the Farm Bill objectives of (1) Research and extension services, (2) Investment in rural communities (e.g., jobs, housing, and infrastructure), and (3) Agricultural trade issues; engaged stakeholders, universities, and government agencies; and the commercial minor use species prominent in the NY19 congressional district. As of this date, the Farm Bill remains in the Agricultural Committee.      

Report from Center for Veterinary Medicine – Dr. Amy Omer

Drug Approval Work:

1. Fenbendazole in quail:

Overview: MUADP continued the collaboration with their research partners, Merck Animal Health and Dr. Ron Kendall of Texas Tech University, to generate the data necessary to obtain FDA approval of fenbendazole-medicated feed for the treatment of nematodes in quail.  This project has impact for both wild quail and farmed quail. With no anthelmintics currently approved for use in quail, successful completion of this project will provide access to a class of therapeutic drugs previously unavailable for quail. 

Human Food Safety: In collaboration with MUADP, Dr. Cassie Henry of Texas Tech conducted a GLP study to determine the tissue residue depletion profile of fenbendazole in liver of quail fed fenbendazole-medicated feed. In response to the submitted data, FDA-CVM concluded that the residue depletion study was acceptable for determining the withdrawal period for the use of fenbendazole in quail and determined that the residue data in liver support a zero-day withdrawal period.

Target Animal Safety: Dr. Cassie Henry of Texas Tech conducted a GLP margin of safety study evaluating the safety of fenbendazole when fed to quail at levels up to 300 ppm in feed. Based on the submitted data, FDA-CVM determined that the Target Animal Safety technical section is complete for the use of fenbendazole in quail for the proposed indication.

2. Tulathromycin for respiratory disease in goats:

Overview: Bacterial pneumonia is a major cause of morbidity and mortality in goats and represents a significant welfare challenge for operations in the US. In contrast to major food producing species such as cattle and swine, there is currently only a single antibiotic (ceftiofur) labeled for treatment of respiratory disease in goats. Therefore, there is a substantial need for additional FDA-approved labelled products for treatment of respiratory disease in goats. This project will address this unmet need and generate data necessary for the approval of tulathromycin in goats for treatment of respiratory disease.

Effectiveness: Dr. Amanda Kreuder of Iowa State University College of Veterinary Medicine received concurrence from FDA-CVM on a field study protocol to demonstrate effectiveness of tulathromycin injectable solution, indicated for the treatment of respiratory disease in goats associated with Mannheimia haemolytica, Bibersteinia trehalosi, and Pasteurella multocida. Based on this concurred protocol, two independent effectiveness studies of tulathromycin in goats were conducted in the Summers of 2022 and 2023. These data sets are currently being prepared for submission to FDA-CVM.

Human Food Safety: To address the Human Food Safety technical section, a residue depletion study must be conducted in order to establish an appropriate withdrawal period for tulathromycin in goats, but prior to conducting the required residue depletion study, the analytical method for the determination of the marker residue in samples generated from the residue depletion study must be validated.

Dr. Pat Gorden of Iowa State University College of Veterinary Medicine received concurrence from FDA-CVM on a method validation study protocol to validate an analytical method for the detection and quantification of tulathromycin in caprine liver.

Dr. Gorden has currently applied for a Minor Use Minor Species (MUMS) grant to fund the method validation study. The MUADP is awaiting response on the application.  

Outreach: Members of the MUADP Coordinating Committee met with members of the American Sheep Industry Association (ASI) to discuss future plans and the direction of the Minor Use Animal Drug Program, specifically how the program can work to meet the needs of the sheep industry.

Other Business

There being no further business brought forward, the meeting was adjourned at 1:25 pm.

Accomplishments

Publications

Impact Statements

1. Completed a study of safety of 50% florfenicol in medicated feed for marine fish species