Progress 09/01/10 to 08/31/13
Outputs
Target Audience: The project was desgined to address the shortage of minor use animal drugs by fundng and overseeing the efficacy, animal safety, and human food safety research and environmental assessment required for drug approval. The project primarily benefitted the agricultural community involved in the production of minor species such as sheep, goats, fish, game birds, rabbits, ratites, and deer. Minor use animals drugs are pharmaceutical firm necessary to gain a Food and Drug Administration (FDA) approval. 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? The Ovadine study results have been put into immediate practice by many fish and game agencies. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Major activities completed Efficacy studies were conducted of Ovadine (Provodine Iodine, Western Chemical) as an egg disinfection compound for fish eggs with a particular emphasis on the reduction of Viral Hemorrhagic Septicemia Genotype IVb from walleye eggs. Our trial will build on preliminary efforts using the consensus treatment protocol of the Great Lakes Fishery Commission (50 mg/L iodine for 30 minutes). A disinfection trial was conducted during the 2010 walleye spawning season with the collaboration of the New York State Department of Environmental Conservation. Treatments included iodine doses of 0, 50 and 100 mg/L for 30 minutes. One manuscript on this work has been published and a second publication is in press. We are investigating the potential of indexing Ovadine for the above indication. We have also achieved protocol concurrence with the Center for Veterinary Medicine/FDA on a project designed to gain a label for the use of SrCl for otolith marking in salmonids. This effort is being coordinated with the CVM/FDA and the product sponsor. Protocol concurrence will allow us to apply for supplementary funds from the MUMS Program of FDA. There is a critical need for such a product to replace the use of oxytetracycline for otolith marking because there is the potential that oxytetracycline will be prohibited for that use because such use is not therapeutic. Specific objectives met Within the reporting period of this project the following specific objectives were addressed: a. Determination and prioritization of minor-use needs and data requirements. b. Review, analysis and evaluation of minor-use research proposals. c. Development and assembly of data for minor-use registrations. More specifically Ovadine was identified and evaluated for effectiveness in reducing the transmission of Viral Hemorrhagic Septicemia (VHSV) via fish eggs. In addition SrCl was identified as a high priority compound for fish marking and a protocol to investigate the use of SrCl was developed in a collaborative effort with the Center for Veterinary Medicine/FDA. Significant results….. Ovadine was found to be an effective compound for the reduction of transmission of VHSV via the eggs. Key outcomes… Fisheries managers and fish culturists became aware of the effectiveness of Ovadine for the reduction of transmission of VHSV via the eggs. They are aware of the correct dose of Ovadine that should be used for an effective treatment.
Publications
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Progress 09/01/11 to 08/31/12
Outputs
OUTPUTS: The original objectives of the project were to conduct a national program to obtain minor and specialty animal-drug clearances (tolerances, exemptions and registrations) in cooperation with state, federal and industry personnel to include: a. Determination and prioritization of minor-use needs and data requirements. b. Review, analysis and evaluation of minor-use research proposals. c. Development and assembly of data for minor-use registrations. d. Preparation and submission of petitions for drug registrations. Under the framework of these objectives, progress has been made in the following area: Administrative support and scientific oversight was provided to the New York State Department of Environmental Conservation during their conduct of field trials under our INAD 10-320 for the use of Oxytetracycline in fish. Efficacy studies were conducted of Ovadine (Provodine Iodine, Western Chemical) as an egg disinfection compound for fish eggs with a particular emphasis on the reduction of Viral Hemorrhagic Septicemia Genotype IVb from walleye eggs. Our trial will build on preliminary efforts using the consensus treatment protocol of the Great Lakes Fishery Commission (50 mg/L iodine for 30 minutes). A disinfection trial was conducted during the 2010 walleye spawning season with the collaboration of the New York State Department of Environmental Conservation. Treatments included iodine doses of 0, 50 and 100 mg/L for 30 minutes. One manuscript on this work has been published and a second publication is in press. We are investigating the potential of indexing Ovadine for the above indication. We are also developing a project designed to gain a label for the use of SrCl for otolith marking in salmonids. This effort is being coordinated with the Center for Veterinary Medicine/FDA and the product sponsor. There is a critical need for such a product to replace the use of oxytetracycline for otolith marking because there is the potential that oxytetracycline will be prohibited for that use because such use is not therapeutic. PARTICIPANTS: The project is coordinated by four Regional Coordinators (Dr. P.R. Bowser, NE Region, Cornell University; Dr. L. Tell, Western Region, UC Davis; Dr. R.W. Griffith, North Central Region, Iowa State University; Dr. T. Vickroy, Southern Region, University of Florida), and a National Coordinator (Dr. J.G. Babish). The project also benefits from interactions with a FDA/CVM Liaison (Dr. M. Oeller). Administrative Advisors for the project are Dr. M.E. Smith (Cornell Ag Expt. Station), Dr. John Baker (Michigan Ag. Expt. Station), Dr. Frank Galey (Wyoming Ag. Expt. Station) and Dr. Zhanjiang "John" Liu (Alabama Ag. Expt. Station) as well a USDA/NIFA Representative (Dr. G. Sherman). TARGET AUDIENCES: The project is designed to address the shortage of minor use animal drugs by funding and overseeing the efficacy, animal safety, and human food safety research and environmental assessment required for drug approval. The project primarily benefits the agricultural community involved in the production of minor species such as sheep, goats, fish, game birds, rabbits, ratites, and deer. Minor use animal drugs are analogous to human orphan drugs, for which the market is insufficient to justify costly research expenditures by a pharmaceutical firm necessary to gain a Food and Drug Administration (FDA) approval. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
The Ovadine study results have been put into immediate practice by some fish and game agencies.
Publications
- Emily R. Cornwell, Geoffrey H. Groocock, Rodman G. Getchell, and Paul R. Bowser. 2010. Residual tannic acid destroys virucidal properties of iodine. North American Journal of Aquaculture. 73(1):8-12.
- Groocock, G.H., R.G. Getchell, E.R.Cornwell, S.A. Frattini, G.A.Wooster and P.R.Bowser. 2012. Iodophor Disinfection of Walleye Eggs Exposed to Viral Hemorrhagic Septicemia Virus type IVb. North American Journal of Aquaculture. In Press.
- Abstracts at Scientific Meetings: Groocock, Geoffrey H., Emily R. Cornwell, Rodman G. Getchell, Gregory A. Wooster, Paul R. Bowser. 2010. Efficacy of iodophore disinfection of viral hemorrhagic septicemia virus (VHSV) on walleye (Sander vitreus) eggs. Annual Meeting of the New York Chapter of the American Fisheries Society. Lake George, New York. 10-12 February 2010.
- Groocock, G.H., E.R. Cornwell, R.G. Getchell, G.A. Wooster, and P.R. Bowser. 2010. Iodophor Disinfection of Walleye (Sander vitreus) Eggs. 35th Eastern Fish Health Workshop. Shepherdstown, WV. 24-28 May 2010.
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Progress 09/01/10 to 08/31/11
Outputs
OUTPUTS: The original objectives of the project were to conduct a national program to obtain minor and specialty animal-drug clearances (tolerances, exemptions and registrations) in cooperation with state, federal and industry personnel to include: a. Determination and prioritization of minor-use needs and data requirements. b. Review, analysis and evaluation of minor-use research proposals. c. Development and assembly of data for minor-use registrations. d. Preparation and submission of petitions for drug registrations. Under the framework of these objectives, progress has been made in the following area: Administrative support and scientific oversight was provided to the New York State Department of Environmental Conservation during their conduct of field trials under our INAD 10-320 for the use of Oxytetracycline in fish. Efficacy studies were conducted of Ovadine (Provodine Iodine, Western Chemical) as an egg disinfection compound for fish eggs with a particular emphasis on the reduction of Viral Hemorrhagic Septicemia Genotype IVb from walleye eggs. Our trial will build on preliminary efforts using the consensus treatment protocol of the Great Lakes Fishery Commission (50 mg/L iodine for 30 minutes). A disinfection trial was conducted during the 2010 walleye spawning season with the collaboration of the New York State Department of Environmental Conservation. Treatments included iodine doses of 0, 50 and 100 mg/L for 30 minutes. One manuscript on this work has been published and a second publication is in press. We are investigating the potential of indexing Ovadine for the above indication. PARTICIPANTS: The project is coordinated by four Regional Coordinators (Dr. P.R. Bowser, NE Region, Cornell University; Dr. L. Tell, Western Region, UC Davis; Dr. R.W. Griffith, North Central Region, Iowa State University; Dr. T. Vickroy, Southern Region, University of Florida), and a National Coordinator (Dr. J.G. Babish). The project also benefits from interactions with a FDA/CVM Liaison (Dr. M. Oeller). Administrative Advisors for the project are Dr. M.E. Smith (Cornell Ag Expt. Station), Dr. John Baker (Michigan Ag. Expt. Station), Dr. Frank Galey (Wyoming Ag. Expt. Station) and Dr. Zhanjiang "John" Liu (Alabama Ag. Expt. Station) as well a USDA/NIFA Representative (Dr. G. Sherman). TARGET AUDIENCES: The project is designed to address the shortage of minor use animal drugs by funding and overseeing the efficacy, animal safety, and human food safety research and environmental assessment required for drug approval. The project primarily benefits the agricultural community involved in the production of minor species such as sheep, goats, fish, game birds, rabbits, ratites, and deer. Minor use animal drugs are analogous to human orphan drugs, for which the market is insufficient to justify costly research expenditures by a pharmaceutical firm necessary to gain a Food and Drug Administration (FDA) approval. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
The Ovadine study results have been put into immediate practice by some fish and game agencies.
Publications
- Emily R. Cornwell, Geoffrey H. Groocock, Rodman G. Getchell, and Paul R. Bowser. 2010. Residual tannic acid destroys virucidal properties of iodine. North American Journal of Aquaculture. 73(1):8-12.
- Groocock, G.H., R.G. Getchell, E.R.Cornwell, S.A. Frattini, G.A.Wooster and P.R.Bowser. 2012. Iodophor Disinfection of Walleye Eggs Exposed to Viral Hemorrhagic Septicemia Virus type IVb. North American Journal of Aquaculture. In Press.
- Abstracts at Scientific Meetings: Groocock, Geoffrey H., Emily R. Cornwell, Rodman G. Getchell, Gregory A. Wooster, Paul R. Bowser. 2010. Efficacy of iodophore disinfection of viral hemorrhagic septicemia virus (VHSV) on walleye (Sander vitreus) eggs. Annual Meeting of the New York Chapter of the American Fisheries Society. Lake George, New York. 10-12 February 2010.
- Groocock, G.H., E.R. Cornwell, R.G. Getchell, G.A. Wooster, and P.R. Bowser. 2010. Iodophor Disinfection of Walleye (Sander vitreus) Eggs. 35th Eastern Fish Health Workshop. Shepherdstown, WV. 24-28 May 2010.
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