Source: CORNELL UNIVERSITY submitted to NRP
MINOR USE ANIMAL DRUG PROGRAM: NORTHEAST REGION
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
0187937
Grant No.
2001-34143-10301
Cumulative Award Amt.
(N/A)
Proposal No.
2001-03052
Multistate No.
(N/A)
Project Start Date
May 1, 2001
Project End Date
Apr 30, 2004
Grant Year
2001
Program Code
[(N/A)]- (N/A)
Recipient Organization
CORNELL UNIVERSITY
(N/A)
ITHACA,NY 14853
Performing Department
MICROBIOLOGY & IMMUNOLOGY
Non Technical Summary
The project is designed to facilitate the registration process for therapeutic compounts in minor food and fiber animal species. This cooperative effort of university researchers, USDA, FDA and drug manufacturers has led to registration of such minor use therapeutic compounds that are so desperately needed by the minor agricultural animal species.
Animal Health Component
50%
Research Effort Categories
Basic
50%
Applied
50%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
3113711110020%
3133712111020%
7113713118015%
3113714110015%
3133299111015%
7113699118015%
Goals / Objectives
To conduct a national program to obtain minor and specialty-drug clearances (tolerances, exemptions and registrations) in cooperation with state, federal and industry personnel to include: (1) Determination and prioritization of minor-use needs and data requirements. (2) Review, analysis and evaluation of minor-use research proposals. (3) Development and assembly of data for minor-use registrations.
Project Methods
A system has been devised, through the NRSP7 Program, to review, evaluate and recommend the feasibility of each animal drug proposal submitted. When a proposal is accepted, the necessary data will be obtained, compiled and submitted to the FDA for establishment of a Public Master File that will lead to registration of a drug.

Progress 05/01/01 to 04/30/04

Outputs
The focus of this project was to evaluate therapeutic compounds for use in minor food and fiber production animals. The therapeutic options for such species are extremely limited. Studies conducted under this project are designed to focus on the data needs in the areas of target animal safety, efficacy and human food safety of selected therapeutic compounds. During the term of this project the primary focus was the development of a species grouping (crop grouping) concept for antibiotics in fish. This was a continuation of our effort with oxytetracycline. During this period, our efforts involved evaluation of the therapeutic compound Romet-30. A series of human food safety, tissue elimination studies were conducted in tilapia (25C, 30C), walleyes (20C, 25C), and summer flounder (17C, 20C). We had proposed to also include hybrid striped bass (20C, 25C) but that species would not consume the medicated feed due to palatability problems. Since that time, the current sponsor, Alpharma Animal Health, has modified their produce to circumvent this issue. We anticipate the conduct of human food safety, tissue elimination trials using hybrid striped bass in the future. As a general conclusion of our studies with Romet-30, the elimination kinetics of the drug suggests that the current withdrawal time for food fish (trout, salmon) appears to be adequate for tilapia, walleye and summer founder. During this reporting period of a number of publications from our earlier efforts on hydrogen peroxide as a therapeutic compound in fish were published in the peer reviewed literature.

Impacts
The project has developed significant new data describing the safety tissue elimination kinetics of Romet-30 in three important cultured food fishes in the United States. The data also appears to be consistent with current withdrawal times specified on the current label for trout and salmon. The data is of value for its application to these three cultured species as well as being important in the growing body of information we have developed for oxytetracycline and now for Romet-30, in support of a species grouping concept for therapeutic compounds in cultured fish. Such a concept is needed to facilitate the approval process on an all fish basis rather than developing expensive data packages for each species of fish for which a label is desired.

Publications

  • Tort, M.J., D. Pasnik, C. Fernandez-Cobas, G.A. Wooster and P.R. Bowser. 2002. Quantitative scoring of gill pathology of walleyes (Stizostedion vitreum) exposed to hydrogen peroxide. Journal of Aquatic Animal Health. 14:154-159.
  • Tort, M.J., C. Fletcher, G.A. Wooster, and P.R. Bowser. 2003. Stability of hydrogen peroxide in aquaria as a fish disease treatment. Journal of Applied Aquaculture 14:(3/4) 37-45.
  • Chen, C.-Y., G.A. Wooster, R.G. Getchell, P.R. Bowser, and M.B. Timmons. 2003. Blood Chemistry of Healthy, Nephrocalcinosis-affected, and Ozone-treated Tilapia in a Recirculation System, with Application of Discriminant Analysis. Aquaculture 218:89-102.
  • Tort, M.J., G.A. Wooster and P.R. Bowser. 2003. Effects of Hydrogen Peroxide on Hematology and Blood Chemistry Parameters of Walleye (Stizostedion vitreum). Journal of the World Aquaculture Society 34:236-242.
  • Bowser, P.R., G.A. Wooster, C.-Y. Chen, and R.S. Mo. 2004. Polymicrobic infection of hybrid striped bass (Morone chrysops X M. axatilis) with three bacterial pathogens: A case study. Journal of Fish Diseases. 27(2):123-127.
  • Chen, C.-Y., G.A.Wooster, and P.R.Bowser. 2004. Comparative blood chemistry and histopathology of tilapia infected with Vibrio vulnificus or Streptococcus iniae or exposed to carbon tetrachloride, gentamicin, or copper sulfate. Aquaculture 239:421-443.
  • Chen, C.-Y., R.G.Getchell, G.A.Wooster, A.L. Craigmill and P.R. Bowser. 2004. Comparative depletion of oxytetracycline in four species of fish. Journal of Aquatic Animal Health (in press).
  • Chen, C.-Y., G.A.Wooster, R.G.Getchell and P.R.Bowser. 2001. Nephrocalcinosis in tilapia (Oreochromis niloticus) from a recirculation aquaculture system: a case report. Journal of Aquatic Animal Health. 13:368-372.
  • Tripi, C.M. and P.R. Bowser. 2001. Toxicity of hydrogen peroxide to pre-exposed young-of-the-year walleye (Stizostedion vitreum): effects of water quality and age of fish. Journal of the World Aquaculture Society. 32:416-421.
  • Tort, M.J., C. Jennings-Bayshore, D. Wilson, G.A. Wooster and P.R. Bowser. 2001. Assessing the effects of increasing hydrogen peroxide dosage on rainbow trout (Onchorhynchus mykiss) gills utilizing a digitized scoring methodology. Journal of Aquatic Animal Health. 14:95-103.


Progress 01/01/02 to 12/31/02

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, significant progress has been made in the following area: An effort has been initiated to validate a species grouping concept for a number of finfish species was undertaken. The focus of this study involved the comparison of pharmacokinetics of Romet-30 in several different species of fish. The fish species were selected to serve as model species that represented fish cultured under different environmental conditions: summer flounder (cool water marine), hybrid striped bass (warm water marine), walleye (cool water, fresh water) and tilapia (warm water, freshwater). To date one tissue depletion/pharmacokinetic trial has been conducted in which tilapia were fed a ration medicated with Romet-30. Samples collected during the trial are currently being analyzed for concentration of the candidate compound.

Impacts
Efforts to demonstrate a species grouping concept for aquatic species will greatly facilitate future efforts to approve therapeutic compounds for finfish as a group, rather that approvals for individual species.

Publications

  • Chen, C.-Y., G.A.Wooster, R.G.Getchell and P.R.Bowser. 2001. Nephrocalcinosis in tilapia (Oreochromis niloticus) from a recirculation aquaculture system: a case report. Journal of Aquatic Animal Health. 13:368-372.
  • Chen, C.-Y., G.A. Wooster, R.G. Getchell, P.R. Bowser, and M.B. Timmons. 2003. Blood Chemistry of Healthy, Nephrocalcinosis-affected, and Ozone-treated Tilapia in a Recirculation System, with Application of Discriminant Analysis. Aquaculture 218:89-102.