SAES-422 Multistate Research Activity Accomplishments Report
Sections
Status: Approved
Basic Information
- Project No. and Title: NRSP7 : A National Agricultural Program for Minor Use Animal Drugs
- Period Covered: 09/01/2014 to 04/30/2015
- Date of Report: 06/21/2019
- Annual Meeting Dates: 05/18/2015 to 05/19/2015
Participants
John Babish, Minor Use Animal Drug Program Rod Getchell, Cornell University Ronald Griffith, Iowa State University Meg Oeller, US FDA, Center for Veterinary Medicine Amy Omer, US FDA, Center for Veterinary Medicine Gary Sherman, USDA NIFA George Smith, Michigan State University Margaret Smith, Cornell University Lisa Tell (via phone link), University of California - Davis
NRSP7 Business Meeting MInutes
Update: Western Regional Experiment Station Directors Meeting
John Babish reported on this meeting, which he attended to represent NRSP7. Comments were that there is a need to document the value of NRSP drug approvals, not the value of minor species in general. The group discussed the possibility of getting data from pharmaceutical manufacturers or the Agricultural Marketing Service. Data that FDA receives, for example from the industry marketers of sheep/goat CIDR devices, might be helpful.
GLP Studies
Eric Nelson (Director of the Division fo Compliance) and Vernon Touelle (Team Leader of the BIMO Inspections Team) met with the NRSP7 group to share goals, approaches, and ideas regarding GLP inspections. Emphasis in FDA is shifting from a "regulatory public health agency" to a "public health regulatory agency." In other words, finding violations is now not the primary focus. Support in the form of trainng via webinars and a "GLP roadmap for academic institutions" were discussed. This area is a challenge since the regulations are written with drug company R&D labs in mind. The group also considered where an NRSP7 archival site for paper and electronic records could be situated.
Report from USDA NIFA
Gary Sherman shared information about the proposed $33 million for anti-microbial resistance studies (would need to be approved by Congress) and the Foundation for Food and Agriculture Research (FFAR). The latter is a public:primvate initiative requiring a 1:1 match in funding, with the goal of pursuing scientific work that is not readily funded through other USDA/NIFA avenues. It is modelled on a similar foundation associated with NIH.
Regional Reports
Regional coordinators reported on work underway in each region, and FDA CVM reported on status of animal drug approvals. The compiled reports are in an attached document.
Accomplishments
A study of the safety of strontium chloride for Chinook salmon fry was completed at Cornell University.
Goat CIDR effectiveness data was shipped to FDA/CVM for comment.
Target animal safety data for fenbendazole in pheasants was approved as complete by ONADE, and research results were published in Avian Disease.
Effiicacy studies for cattle fever tick control with ivermection were continued.
NRSP7 website was re-organized and updated with alisting of all on-going and completed studies.
Impacts
- Determined that strontium chloride margin of safety to Chinook salmon fry extends to at least 9,000 ppm strontium chloride when administered by immersion for three consecutive days.
- Showed that the proposed dose of 100 ppm fenbendazole in young pheasant feed for seven consecutive days is well within the margin of safety.
- Demonstrated that fendbendazole fed at 100 ppm for seven days did not adversely affect reproductive performance in hen pheasants
- Two cattle herds/pastures in Texas where cattle were fed ivermectin-containing tubs were totally cleared of cattle fever tick.
Publications
Griffith, R., M. Yaeger, S. Hostetter, L. Tell, S. Wetzlich, T. Vickroy, B. Lillie, W. MacFarlane, T. Laudenslager, E. Whitley, R. Dzikamunhenga, and W. Larson. 2014. Safety of fenbendazole in Chinese ring-necked pheasants (Phasianus colchicus). Avian Diseases 58:8-15.
Marmulak, T., L.A. Tell, R. Gehring, R.E. Baynes, T.W. Vickroy, and J.E. Riviere. 2015. Egg residue considerations during the treatment of backyard poultry. J. American Veterinary Medical Association 247(12):1388-1395.