SAES-422 Multistate Research Activity Accomplishments Report
Sections
Status: Approved
Basic Information
- Project No. and Title: NECC1702 : Establishment of a Formal Structure for the Minor Use Animal Drug Program
- Period Covered: 10/01/2017 to 09/30/2018
- Date of Report: 11/19/2018
- Annual Meeting Dates: 09/17/2018 to 09/18/2018
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
- Progress towards completion of files has been made on six new minor use/minor species animal drug approvals.
- Plans were developed and ideas shared for how to meet the needs for minor use/minor species animal drug approvals going forward.
- 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."