SAES-422 Multistate Research Activity Accomplishments Report

Status: Approved

Basic Information

Participants

Amy Omer FDA/CVM Amy.Omer@fda.hhs.gov John Babish MUADP jgb7@cornell.edu Lucy Lee FDA/CVM Lucy.Lee@fda.hhs.gov Margaret Smith Admin Advisor, CUAES mes25@cornell.edu Meg Oeller FDA/CVM Margaret.Oeller@fda.hhs.gov Peter Johnson NIFA PJOHNSON@nifa.usda.gov Rodman G. Getchell Cornell University rgg4@cornell.edu Ronald Griffith Iowa State University rgriffit@iastate.edu

Accomplishments

  • Fenbendazole for pheasants  
    • TAS: complete
    • HFS: complete (except for tox piece);
    • Effectiveness: outstanding—completed in 2000; must re-affirm data with white paper; goal is that by the end of this calendar year to be submitted;
    • Environmental impact: initially wanted to ask for categorical exclusion from the EA, that request rejected; Eric Rosenblum will put together an exposure assessment report, including relevant information on how pheasants are managed, where leftover feed goes, etc.
  • Fenbendazole for quail
    • Effectiveness: (a) farmed quail- completed back in 2000, would need to re-affirm; (b) free-ranging quail- recent study completed, submission being prepared
    • TAS: recent study completed, study designed to cover both farmed and free-ranging quail, submission being prepared
    • Environmental impact/free-ranging quail: Planning a categorical exclusion request (regs say that if the drug is already approved in a species that has similar animal management practices, the proposed new use can be excluded from having to provide an EA).
    • Human food safety: method/validation is currently under review; residue depletion study completed, final study report undergoing QA review
    • The indication for the free-ranging quail = Lots of stakeholders! Lots of resources towards combatting the decrease of quail – especially in Texas !
  • Erythromycin in salmon
    • New sponsor to work on CMC technical section; will require a new API (active pharmaceutical ingredient)
    • Still working with Chris Moffitt as conduit between manufacturer and end-users;
    • Effectiveness: TS complete in 2000, when asked for re-affirmations in 2012-13 claim for all salmonids came back as chinook only; ONADE recommended we do another study; hope to write justification
    • TAS:  TS complete in 2000, when asked for re-affirmations in 2012-13 claim for all salmonids came back as chinook only;
    • Have had conversations with ONADE about going back to all salmonids for both EFF and TAS TSs, but with new API, calling into question EVERYTHING;
    • Environmental impact: EA completed back when previous sponsor was involved;  will need to be revised based on removal of proprietary information
  • Strontium chloride in salmon
    • TAS:  Rod did TAS study (submitted in Jan 2016; incomplete); TAS will be submitted by the end of the year;
    • Effectiveness, environmental, HFS:  white paper arguments for the rest of the TS; lots of data from the public domain—i.e. public health organizations
  • Ivermectin block in cattle
    • Collaboration between= (Texas cattle fever tick, USDA/ARS/APHIS, state veterinary, Postive Feeds)
    • Project was deemed minor use bc it was geographically contained to a small area to eradicate cattle fever tick; this product is not intended to be used outside the quarantine zone
    • TAS, HFS, environmental, effectiveness:  No progress on any of the technical sections
    • Postive Feeds has made no progress on the CMC technical section.  Have recommended that they seek advice from a manufacturing consultant.
    • Is there an option for another legal status? Perhaps legal compounding?
    • Dr. Baca, our USDA contact down in Texas, recently retired; Amy needs to contact Dr. Hallie Hassel
    • Need to have an action plan for this project
    • APHIS will likely want to continue this if at all possible; Mexico has seen ivermectin resistance and tick is spreading along the edges of the quarantine zone
  • CIDR in goats
    • TAS, HFS, environmental: 3 TS COMPLETE
    • Effectiveness: did complete effectiveness studies but lots of data errors
    • Write up on the data from the farms that we do have; explain why other farms left out
    • Zoetis approved for use in sheep and goats in other countries
    • Not used in dairy goats

Impacts

  1. Progress towards completion of files has been made on six new minor use/minor species animal drug approvals.
  2. Plans were developed and ideas shared for how to meet the needs for minor use/minor species animal drug approvals going forward.
  3. A grant was prepared and submitted to USDA-NIFA by Rod Getchell for $500,000 over five years, "Increasing the number of safe and effective therapeutics for aquaculture."

Publications

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