A NATIONAL AGRICULTURAL PROGRAM FOR MINOR USE ANIMAL DRUGS

• Sponsoring Institution: National Institute of Food and Agriculture
• Project Status: TERMINATED
• Funding Source: HATCH
• Reporting Frequency: Annual
• Accession No.: 1009143
• Project No.: FLA-VME-005493
• Multistate No.: NRSP-7
• Project Start Date: Jan 15, 2016
• Project End Date: Sep 30, 2016

Project Director
Vickroy, TH, W.

Recipient Organization
UNIVERSITY OF FLORIDA
G022 MCCARTY HALL
GAINESVILLE,FL 32611

Performing Department
College of Veterinary Medicine

Non Technical Summary
The activity of a National Research Support Project (NRSP) focuses on the development of enabling technologies, supportactivities (e.g., collect, assemble, store, and distribute materials, resources and information), or the sharing of facilities neededto accomplish high priority research, but which is not of itself primarily research. The overall objectives of NRSP-7 the USDAMinor Use Animal Drug Program are to provide for human food safety and animal health through the judicious use of antibioticsand therapeutics in food and fiber producing animals. To accomplish these goals, the Program has developed the followingmissions: 1. Identify animal drug needs for minor species and minor uses in major species, 2. Generate and disseminate datafor safe and effective therapeutic applications, 3. Facilitate FDA/CVM approvals for drugs identified as a priority for a minorspecies or minor use, and 4. Provide alternatives to antibiotic use in food animals through the identification and FDA/CVMapproval of naturally occurring biotherapeutics and feed additives. Minor uses include minor species (all species except dogs,cats, horses, cattle, swine, chickens, and turkeys), while minor uses in major species are those that occur infrequently or inlimited geographical locations. The primary emphasis of the Program is on food-and/or fiber- (hair, wool, fur, feathers or hide)producing minor species with a secondary interest in non-food animals such as bees and tropical fish.

Animal Health Component

100%

Research Effort Categories

Basic

25%

Applied

70%

Developmental

5%

Classification

Knowledge Area (KA)	Subject of Investigation (SOI)	Field of Science (FOS)	Percent
711	0810	1180	20%
711	3040	1180	20%
711	3310	1180	60%

Knowledge Area
711 - Ensure Food Products Free of Harmful Chemicals, Including Residues from Agricultural and Other Sources;

Subject Of Investigation
0810 - Finfish; 3040 - Honey, honey products, and apiary products; 3310 - Beef cattle, live animal;

Field Of Science
1180 - Pharmacology;

Keywords

food animals

minor species

drugs

drug residues

human food safety

Goals / Objectives
Identify the animal drug needs for minor species and minor uses in major species. Generate and disseminate data for the safe, effective, and legal use of drugs intended for use in minor animal species. Facilitate FDA/CVM approvals of drugs for minor species and minor uses. Provide alternatives to antibiotic use in food animals through the identification and FDA/CVM approval of naturally occurring biotherapeutics and feed additives.

Project Methods
1. Organizational structure - NRSP-7 is composed of a Technical Committee and fourAdministrative Advisors representing state experiment station directors. These AdministrativeAdvisors provide liaison among the directors of the state experiment stations, USDA/CSREES,FDA/CVM, various animal organizations, and others coordinating the efforts of this program.The organizational structure of the Minor Use Animal Drug program follows:Administrative Advisory CommitteeThe Administrative Advisory Committee is composed of one appointee by Experiment StationDirectors from each of the four regions (North Central, Northeast, Southern, and Western). Thechair of the committee is selected internally. The role of the Administrative Advisory Committeeis to provide liaison among the directors of the agricultural experiment stations in the fourregions, colleges of veterinary medicine, the USDA/CSREES, the FDA/CVM, various animalorganizations, and with those coordinating the efforts of this program. This committeeestablishes and sets policy consistent with the mission of the project. This committee alsoadvises on budget and administrative matters relating to the program.Technical CommitteeThe Technical Committee is composed of the following representatives:• National Animal Drug Coordinator (Chair)• Regional Animal Drug Coordinators representing each of the four regions(North Central, Northeast, Southern, and Western)• Administrative Advisory Committee Chair (non-voting)• USDA/CSREES Representative (non-voting)• FDA/CVM liaison to NRSP-7 (non-voting)In addition to the above committee, the FDA/CVM has a group of Minor Use Animal Drugreviewers that meets with the Technical Committee generally once a year at the semi-annualmeetings of the Technical Committee. This FDA/CVM group consists of representatives fromthe Division of Therapeutic Drugs for Food Animals, the Division of Human Food Safety, theDivision of Production Drugs, and the Environmental Sciences Staff. The National Animal DrugCoordinator is salaried on a part-time basis and maintains an office. The Regional Animal DrugCoordinators are not compensated by salary except for secretarial or technical services.

Progress 01/15/16 to 09/30/16

Outputs
Target Audience:Veterianarians, producers of minor food animal products, drug/pharmaceutical companies, regulatory agencies Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? 1). Nothing specific to report. 2). Generate and disseminate data for the safe, effective, and legal use of drugs used primarily in therapy or reproductive management of minor animal species. Facilitate FDA/CVM approvals of drugs for minor species and minor uses. NRSP-7 has published 211 articles in peer-reviewed journals, averaging 6.6 per year over the term of the program. For the last five years, however, publications have increased to nearly 10per year. Thus, although FDA/CVM drug approvals have waned due to increasing costs, the Program has increased its efforts to supply critical data needs to minor species producers. The data generated by the Program is also shared with the Food Animal Residue Avoidance Database (FARAD program to further increase visibility. 3) Nothing specifc to report for the Southern region. 4). Provide alternatives to antibiotic use in food animals through the identification and FDA/CVM approval of naturally occurring biotherapeutics and feed additives. Modeling after the IR-4 Program's work with HopGuard for varroa mites in honey bees, NRSP-7 has initiated discussion with BetaTech for inclusion of their hops beta acids into the Program. NRSP-7 would assess the potential of these beta acids to serve as a substitute for antibiotics as growth promoters in animal feeds. BetaTech currently holds four patents on a number of hops acids as growth promoters and bioterapeutics for a range of bacterial infections in ruminant and avian species. Discussions with FDA/CVM have been positive and the Program looks forward to beginning to work with game bird stakeholders in assessing the potential of these natural compounds. As feed additives and growth promoters, the hops beta acids will fall under different FDA/CVM regulations than therapeutics, but the Agency has already assured NRSP-7 it will work to accommodate these changes.

Publications

• Type: Journal Articles Status: Published Year Published: 2016 Citation: Marmulak, T, Tell, LA, Gehring, R, Baynes, RE, Vickroy, TW and Riviere, JE, Egg residue considerations during the treatment of backyard poultry. J. Am. Vet. Med. Assoc. 247(12): 1388?1395 (2016). PMID:26642132
• Type: Journal Articles Status: Published Year Published: 2016 Citation: DeDonder KD, Gehring R, Riviere JE, Baynes RE, Tell LA and Vickroy TW. Residue concerns following exposure of livestock to oil and petroleum products. J. Am. Vet. Med. Assoc. 248(2):145-146 (2016). PMID:27108460
• Type: Journal Articles Status: Published Year Published: 2016 Citation: Rairat T, Ou SC, Chang SK, Li KP, Vickroy TW and Chou CC. Plasma pharmacokinetics and tissue depletion of cyromazine and its metabolite melamine following oral administration in laying chickens. J. Vet. Pharmacol. Ther. Nov 29. doi: 10.1111/jvp.12379. [Epub ahead of print] (2016). PMID:27900792
• Type: Journal Articles Status: Published Year Published: 2017 Citation: Sidhu PK, Gehring R, Mzyk DA, Marmulak T, Tell LA, Baynes RE, Vickroy TW and Riviere JE. Avoiding violative flunixin meglumine residues in cattle and swine. J. Am. Vet. Med. Assoc. 250(2): 182-189 (2017). PMID:28058945

Progress 01/15/16 to 09/30/16

Outputs
Target Audience:Veterianarians, producers of minor food animal products, drug companies Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? 1). Identify the animal drug needs for minor species and minor uses in major species. To date 354 drug requests have been submitted by stakeholders to the Minor Use Animal Drug Program for the development of data in support of the submission of a New Animal Drug Allowance (NADA). Through a prioritization process that has included (i) constraints imposed by concerns of antimicrobial resistance, (ii) limitations of availability of certain expensive or rare animal species, (iii) appropriate efficacy models, and (iv) high risk/benefit liabilities and lack of economic incentive for certain pharmaceutical manufacturers, the number of highest priority projects has been estimated at 40. Added to our current active projects, the backlog of projects represents a research commitment stretching over several decades. The Southern Region has taken responsibility for the NRSP-7 Home-Page [www.nrsp-7.org]. This resulted in reworking the public sector and, the IP limited access site ["Ringer Site"] that continues to allow members of the committee access to archival data, relevant media material, and information on on-going projects. The latter includes an ASP interactive database ["MUMS Rx"] that will complete development in the current year and be available for public access. Over the last six years, drug coordinators and the FDA/CVM liaison group attend regular monthly teleconferences. These have been coordinated by the PI of the Southern Region and have proved very successful in facilitating communication and coordination among the parties participating. These teleconferences usually take place at noon EST on the first Tuesday of each month. Additionally, twice each year, the Program conducts an annual teleconference meeting as travel costs have prohibited meetings in Washington, D.C. 2) Generate and disseminate data for the safe, effective, and legal use of drugs intended for use in minor animal species. At the conclusion of the funding period, there werenine active research projects involving five animal species and seven different drugs. Ruminant species remain the predominant group with a majority of Public Master Files (53%) as well. 3) Facilitate FDA/CVM approvals of drugs for minor species and minor uses. In the 31 years of the Program, data supplied by the Program provided for the modification of 52 label claims to include minor species, an overall average of 1.6 per year. Included in these approvals were one fr rabbits, nine for game birds, 16 for fish, lobster and shrimp, 15 for meat and dairy goats, eight for bison and reindeer, one for foxes and two for honey bees. 4) Provide alternatives to antibiotic use in food animals through the identification and FDA/CVM approval of naturally occurring biotherapeutics and feed additives. No new results to report,

Publications