NRSP-7 2003 Annual Report

Project Number: NRSP-7

Project Title: NRSP-7 A National Agricultural Program to Approve Animal Drugs for Minor Species and Uses

Duration: October 1, 2002 – September 30, 2003

Statement of the Problem

In 1976, the Food and Drug Administration (FDA initiated an extensive study of the minor use of animal drugs through the efforts of a minor use/minor species drug committee. This committee, comprised of representatives of the FDA’s then Bureau of Veterinary Medicine and Bureau of Foods, the U.S. Department of Agriculture (USDA), the pharmaceutical industry, and animal producer groups identified the scope of the problem a lack of approved drugs for (1) diseases of minor species an (2) the principle minor diseases of major species. The committee identified the principal diseases for which drugs were not available in the minor species. The committee also recognized that the livestock industry in the United States relies heavily on the judicious use of drugs for the prevention and treatment of diseases in food animals. Without these drugs, animal suffering and mortality would greatly increase, as would the cost of producing animal-derived food products. However, before a drug can be marketed for use in a food animal species, it must be shown to be safe to the human consumer of the animal-derived food, and safe and efficacious in the target animal.

The process of generating the safety and efficacy data necessary for FDA approval of a drug is costly and time-consuming. At present, the estimated cost to a pharmaceutical company for research necessary to obtain FDA approval for a new drug exceeds $20 million, and requires 8 to 10 years of concentrated research effort. The addition of a new label claim is also costly, averaging $2 to $8 million. Because of this substantial investment in time and resources, pharmaceutical companies must be assured that the drug will have a reasonable potential for profit. Therefore, most drug approvals are sought only for those animal species that are produced in sufficient numbers to support large volume sales, specifically cattle, swine, chickens and turkeys. There is little economic incentive for pharmaceutical firms to generate data necessary to seek FDA approval of drugs in minor species; hence, very few drugs are available for management of diseases in these species. Inequities in drug availability represent serious management and economic problems for producers for minor species.

The FDA was aware that veterinarians and livestock producers were using unapproved drugs without the safeguards that approved drugs carry. Such unapproved drug use could not only cause detrimental effects to the animals being treated, but could also lead to the persistence of drug residues in animal products intended for human consumption. A definite need was established for approval of minor use veterinary drugs and the scope of the problem was defined. This need was also affirmed by various grower organizations.

In 1982, the IR-4 Animal Drug Program was established as part of the overall IR-4 Minor Use Pesticide Management Program. Since that time the animal portion established itself as a national means of securing approved drugs and as a conduit between the animal industries and the FDA.

In December 1990, the USDA/CSRS requested a peer review of the IR-4 program, including both the pesticide portion and the minor use animal component. A reorganization of the minor use animal drug section was one of the recommendations of the Review Team. This Change was carried out with the development of a separate Minor Use Animal Drug Technical Committee that reported to the IR-4 Administrative Advisors.

In 1992, IR-4 Administrative Advisors recommended that with the change from interregional Projects (IR’s) to National Research Support Projects (NRSP’s), as well as the experience gained under the reorganized IR-4 Project, that the two programs (pesticide and animal) be separated into two projects. In 1993, NRSP-7 was thus created as the Minor Use Animal Drug Program.

Justification and Stakeholders

Gross annual income from production of minor animal species has been estimated by USDA at over $9 billion in the US. Production of aquatic species alone accounts for nearly $1 billion in revenue, much of this isolated in one or two states. Revenues from processing effectively triple the annual revenues produced by minor species in the US. While the cumulative contribution of minor species to agricultural income is great, the return to pharmaceutical companies for research on therapeutics is small and generally unprofitable. Since 1964, private sponsors have approved the use of drugs for this need as follows: none for rabbits, one for ducks and pheasants (none for other game birds), two for food fish, four for goats and twenty‑one for sheep. Minor and specialty use needs have continued to accumulate, leaving the producer of these species without the drugs necessary for disease prevention and control. More than 100 drugs are identified as urgently in need of approval for minor species. Research at State and Federal Laboratories to provide data necessary for such approval will be provided through the Minor Use Animal Drug Program.

The Animal and Plant Health Inspection Service (APHIS) recently reported that 9.4% of the lambs born alive died before weaning and that death losses in adult sheep during 1995 were 5.1% of inventory. With 7.8 million sheep and lambs in inventory in 1997, this loss is significant in dollar value. These are but two examples of agricultural losses due to disease and the impact on farm income. There is no total dollar value loss for all minor species as the result of diseases but has been estimated to be in the billions of dollars. Additionally it should be born in mind the goat industry is growing. Despite this, approval of drugs for use in these animals by the Food and Drug Administration (FDA) has been greatly hampered by increased regulatory requirements and increased costs of drug development. The full implementation of the Animal Medicinal Drug Uses Clarification Act [AMDUCA] and the Animal Drug Approval Act [ADAA] have produced new orders of priorities in drugs for minor species. Additionally in the past 12 months the Congress has considered bills to promote drug availability for minor uses in major species and for minor species. This “MUMS Bill” was introduced in both houses but, in the events following the September terrorist attacks, languished and will have to come up again in the new session. This bill will give significant incentives to Pharmaceutical Manufacturers to work for drug approvals in the MUMS arena as well provide grant funds that the NRSP-7 regions may well compete for.

The limitations imposed by AMDUCA on extra-label drug use in feeds proved to be a major problem to aquaculture and gamebird industries and a guidance document has outlined conditions where limited extralabel use of approved formulations will be permitted under conditions of a valid veterinarian-client-patient relationship. The Minor Use Animal Drug Program is the only organized State/Federal effort to address the inadequate number of FDA approved drugs available for minor-use species and has been responsible for nearly all of the progress made in the approval of minor-use/minor-species drugs. The history of the program is that prior to October 1, 1993, the Minor Use Animal Drug Program operated as a part of the IR-4 program. At that time it was separated from the plant orientated IR-4 and re-established as the National Research Support Project 7 (NRSP-7) for the Minor Use Animal Drug Program. It is now in it’s second cycle of Congressional approval.

Federal regulations require an extensive examination of experimental data on efficacy, safety, and residue depletion before any drug can be used in a food animal species. Data must also be obtained for each animal species for which drug use is intended. At present, most minor species of food animals do not have the benefit of safe and effective drugs such as are available for cattle, swine and poultry. This situation has the potential to cause adverse effects upon both the producers and consumers of animal products.

Objectives

1. Identify the animal drugs for minor species and minor uses in major species.

2. Generate and disseminate data for the safe, effective, and legal use of drugs intended for use in minor animal species.

3. Facilitate FDA/CVM approvals of drugs for minor species and minor uses.

Minor uses include minor species (all species except dogs, cats, horses, cattle, swine, chickens, turkeys) and minor uses in major species are those that occur infrequently or in limited geographical locations. The primary emphasis of The Program will be on food-and/or fiber- (hair, wool, fur, feathers or hide) producing minor species.

Organization

NRSP-7 is composed of a Technical Committee and four Administrative Advisors representing State Experiment Station Directors. These Administrative Advisors provide liaison between the Directors of the State Experiment Stations, USDA/CSREES, FDA/CVM, various animal organizations, and others coordinating the efforts of this program. The Administrative Advisors provide input on policy, budget and administrative matters.

The organizational structure of the Minor Use Drug program follows:

Administrative Advisory Committee

The Administrative Advisory Committee is composed of one Experiment Station Director from each of the four regions (North Central, Northeast, Southern, and Western). The chair of the committee is selected internally. The role of the Administrative Advisory Committee is to provide liaison between the Directors of the Agricultural Experiment Stations in the four regions, Colleges of Veterinary Medicine, the USDA/CSREES, the FDA/CVM, various animal organizations, and with those coordinating the efforts of this program. This committee will establish and set policy consistent with the mission of this project. This committee will also advise on budget and administrative matters relating to this program.

Technical Committee

The Technical Committee is composed of the following representatives:

· National Animal Drug Coordinator (Chair)

· Regional Animal Drug Coordinators representing each of the four regions (North Central, Northeast, Southern, and Western)

· Administrative Advisory Committee Chair (non-voting)

· USDA/CSREES Representative (non-voting)

· FDA/CVM liaison to NRSP-7 (non-voting)

In addition to the above committee, the FDA/CVM has a Minor Use Animal Drug Committee that meets with the Technical Committee generally once a year at the semi-annual meetings of the Technical Committee. This FDA committee consists of representatives from the Division of Therapeutic Drugs for Food Animals, Antimicrobial Drugs Branch, Methods Validation and Analytical Branch, Companion and Wildlife Drugs Branch, and the Environmental Sciences Staff. The National Animal Drug Coordinator is salaried on a part-time basis and maintains an office. The Regional Animal Drug Coordinators are not compensated by salary except for secretarial or technical services.

Cooperating Agencies and Principal Leaders:

US Department of Agriculture/CRESS

Dr. Larry R. Miller USDA/CRESS Representative

US Food and Drug Administration/Center for Veterinary Medicine

Dr. Meg R. Oeller FDA/CVM Liaison

Administrative Advisors

Dr. Donald. C. Robertson (Chair) Kansas AES

Dr. Kirklyn M. Kerr Connecticut AES

Dr. David Thawley Nevada AES

Dr. Gary Adams Texas AES

National Coordinator

Dr. John G. Babish New York AES

Regional Coordinators

Dr. Arthur L. Craigmill California AES

Dr. Paul R. Bowser New York AES

Dr. Alistair I. Webb Florida AES

Dr. Ronald W. Griffith Iowa AES

Funding

The Minor Use Animal Drug Program is funded through USDA Special Research Grant, administered by CSREES in cooperation with the NRSP-7 Technical Committee. Currently, there are no “off-the-top” Regional Research funds allocated to the Minor Use Program. The program receives significant “in-kind support from several sources including the institutions conducting the research (State Agriculture Experiment Stations, Colleges of Veterinary Medicine, Federal laboratories), animal producer groups through contributions of animals for research, and pharmaceutical companies. Perhaps the most significant of this “in-kind” support comes through the cooperation of the pharmaceutical companies, which provide access to their proprietary data package prepared for the drug approval in a major species. In addition, the pharmaceutical sponsors complete the approval package by adding the new use of the drug to their current label, and often contribute to the program in the form for drug research, as well as direct financial aid. Without the generous support of the pharmaceutical manufactures, this program would not be possible.

The Regional Animal Coordinators are not compensated by salary for time contributed to the Minor Use Program. In some cases, secretarial and/or technical support services are budgeted from the Program. Funding is provided for the National Drug Coordinator’s part-time salary and the maintenance of an office.

The breakdown of funding by source for NRSP-7 is presented in Table 2. Since 1982, grants have been awarded from appropriated USDA funds in the amount of $240,000 per year for fiscal years 1982-85; $229,000 per year for fiscal years 1986-1989; $226,000 for fiscal year 1990; $450,000 for fiscal year 1991; $464,000 per year for fiscal years 1992 and 1993; $611,000 for fiscal year 1994; $550,000 per year for fiscal years 1995-2000; $548,970 in fiscal year 2001; and $588,000 in fiscal years 2002 and 2003.

The non-federal funds and sources provided for NRSP-7 since 1991 included $156,099 state appropriations, $29,409 industry contributions and $11,365 miscellaneous in 1991; $265,523 state appropriations, $1,182 product sales, $10,805 industry contributions and $59 miscellaneous in 1992; $212,004 state appropriations, $315 industry contributions and $103 miscellaneous in 1993; $157,690 state appropriations and $7,103 miscellaneous in 1994; $84,359 state appropriations in 1995; $191,835 non-federal support in 1996; $357,099 non-federal support in 1997; $104,596 state appropriations and $97,375 industry contributions in 1998; $317,225 state appropriations and $9,678 industry contributions, and $7,000 miscellaneous in 1999; $349,250 state appropriations and $9,500 industry contributions in 2000; $87,000 state appropriations and $38,850 industry contributions in 2001; and $137,720 state appropriations and $30,480 industry contributions in 2002. Figures for federal funding were similar to 2002 for 2003, however there were no industry funds in 2003.

In the 22 years of the minor species drug program, a total of $9,116,000 has been granted through federal funding and an additional 41 percent, on average, has been obtained through nonfederal funds. The average total expenditure per completed research for a drug approval or publication of a Public Master File was $398,000. This figure includes submissions currently under review at FDA/CVM as well as the 30 projects listed in Table 3. Average federal expenditures per completed research for a drug approval or publication of a Public Master File was $304,000.

Activities, Accomplishments, Interactions with Stakeholders and Communications

Prior to the Minor Animal Drug Approval Program, the FDA had approved the use of drugs for minor species as follows: none for rabbits, one for ducks and pheasants (none for other game birds), two for food fish, four for goats and twenty‑one for sheep. Minor and specialty use needs have continued to accumulate, leaving the producer of these species without the drugs necessary for disease prevention and control. More than 100 drugs have been identified as urgently in need of approval for minor species. The Minor Use Animal Drug Program has received 333 Animal Drug Requests submitted by researcher investigators at federal, state, and university laboratories, veterinarians, and animal industry personnel for approval of a specific drug for the control of a certain disease in an animal industry.

Since the first drug approval in 1984 a total of 30 Public Master Files [PMF] have been published in the Federal Register (Table 3), an average of 1.4 per year during its twenty-two years of funding (Table 2). These PMF involve 13 animal species including 4 aquatic species. Three additional PMFs are currently under review by FDA/CVM. Twenty-six PMFs have supported New Animal Drug Application (NADA) approvals, to date. These NADA's mean that 13 minor species animal industries have new drugs at their disposal not previously available to treat disease and relieve animal suffering. The NRSP-7 Program anticipates that several NADA's will be forthcoming in the next year as one pharmaceutical manufacturer has reconsidered label changes. Thus, 29 drugs will have gained approval through this program, nearly trebling the number approved for all minor species and minor uses when this program was initiated.

Currently there are 18 active research projects involving 17 unique animal species and 15 different drugs (Table 4). Approximately 39% of the active projects involve ruminant species, 11% avian, 33% aquatic and 17% other. While a majority of Public Master Files (53%) involved ruminant species, current active projects are more evenly divided between ruminants and aquatic species. Drug approvals and current research on avian species remains relatively consistent.

Objective 1

Identify the critical needs of the various producers of minor livestock species

The Staff of the Southern Region represented NRSP-7 at the AVMA's annual meeting in Boston last July and at the North American Veterinary Conference in Orlando early this year. The Southern Region has taken responsibility for the NRSP-7 Home-Page [www.nrsp-7.org]. This resulted in reworking the public sector and, the IP limited access site [“Ringer Site”] which continues to allow members of the committee access to archival data, relevant media material, and information on on-going projects. The latter includes an ASP interactive database [“MUMS Rx”], which will complete development in the current year and be available for public access.

During the last year, drug coordinators and the FDA liaison commenced regular teleconferences. These have been coordinated by the PI of the Southern Region and have proved very successful in facilitating communication and coordination between the parties participating. This usually takes place at 1100 hours EST on the first Monday of the month.

Objectives 2 and 3

Generate and disseminate data for the safe, effective, and legal use of drugs used primarily in therapy or reproductive management of minor animal species.

Facilitate FDA/CVM approvals of drugs for minor species and minor uses.

NRSP-7 has been responsible for 30 Public Master File (PMF) publications in the Federal Register, an average of 1.4 per year during its twenty-two years of funding (Tables 2/3). These Public Master Files have supported FDA approval for 27 products. These PMF involve 13 animal species including 4 aquatic species. Three additional PMFs are currently under review by FDA/CVM. Twenty-six PMFs have supported New Animal Drug Application (NADA) approvals, to date. These NADA's mean that 13 minor species animal industries have new drugs at their disposal not previously available to treat disease and relieve animal suffering. The NRSP-7 Program anticipates that several NADA's will be forthcoming in the next year as one pharmaceutical manufacturer has reconsidered label changes. Thus, 29 drugs will have gained approval through this program, nearly trebling the number approved for all minor species and minor uses when this program was initiated. Additionally, NRSP-7 has completed the target animal safety and antimicrobial resistance components for honeybee studies with lincomycin and tylosin for Varroa mite infection. Effectiveness studies for Carp Pituitary extract as a spawning aid for various fish have been concluded.

Regional coordinators and members of NRSP-7 were active in presentations and publications. A total of 11 presentations, seven peer-reviewed publications, and one dissertation were produced during the past year.

To date 333 drug requests have been submitted to the Minor Use Animal Drug Program for the development of data in support of the submission of a New Animal Drug Approval (NADA). Through a prioritization process that has included (i) constraints imposed by concerns of antimicrobial resistance, (ii) limitations of availability of certain expensive or rare animal species, (iii) appropriate efficacy models, and (iv) high risk/benefit liabilities and lack of economic incentive for certain pharmaceutical manufacturers, the number of highest priority projects has been estimated at approximately 47. Added to our 18 current active projects, the backlog of projects represents a research commitment stretching over several decades.

By region

Northeast Region

ADR#259 - Hydrogen Peroxide as a Therapeutic Compound for Bacterial Gill Disease in Fish. (INAD 9493).

It is anticipated that at least two efficacy studies will be completed during the upcoming year.

ADR#285 - Oxytetracycline for the treatment of bacterial infections in fish. (INAD 10-319)

This project constitutes one of the efforts with a long-term goal of supporting a species grouping concept for therapeutic compounds in fish. Research within this effort will shift toward efficacy and target animal safety. It is expected that target animal safety studies will be completed in at least two fish species. In addition, it is anticipated that at least one efficacy trial will be completed, most likely for a systemic bacterial infection in walleye.

ADR#313 – Sulfadimethoxine/ormetoprim (Romet-30) for the treatment of bacterial infections in fish (INAD 10-823).

Initial work within this project have focused on human food safety studies for tilapia and summer flounder. Due to problems with palatability of Romet-30-medicated feed by hybrid striped bass, a decision was made to eliminate hybrid striped bass from the test system. Efforts will now shift toward Human Food Safety in walleyes. Two groups of walleyes are currently being reared in our Aquatic Animal Health Program facilities to grow them to a size appropriate for the conduct of human food safety studies. It is anticipated that the human food safety studies will be completed for walleyes at two different water temperatures (20^°C, 25^°C) during the upcoming year.

A.DR#272 - Sulfadimethoxine/ormetoprin for the treatment of bacterial infections in pheasants. (INAD 10-804)

It is anticipated that one Target Animal Safety Study and one efficacy trial of Rofenaid (Sulfadimethoxine/ormetoprin) for control of Pasteurella multocida infection in pheasants will be completed in the coming year.

Projects under Consideration.

Consideration is being given to initiation of a project to investigate the potential of analgesics in goats. Consideration is also being given to evaluation of florfenicol in fish within the context of the species grouping study.

North Central Region

In September 2002, Dr. Robert Holland then Coordinator for the North Central Region relinquished his duties as project director and Dr. Ron Griffith (Iowa State University) was approved to replace him.

ADR#258 - Subcontract No. 61-4127 with Dr. Keith Inskeep, West Virginia University was active at that time and a final report was subsequently received for this project in December 2002. The research evaluated: (a) the effectiveness of intravaginal progesterone (P₄) inserts to advance (induce) and synchronize fertile estrus in anestrous ewes, (b) the effectiveness of concomitant treatment with a single injection of FSH in propylene glycol to increase ovulation rate in anestrous ewes, and (c) the effectiveness of P₄ inserts to synchronize fertile estrus in cycling ewes. The investigators found that the use of the CIDR-G for 5 days provided optimum pregnancy rates and was superior to natural exposure to the ram and use of the CIDR-G for 12 days. Because the thoroughly tested CIDR-G exists now, the proposed work can result in a viable product for out-of-season breeding of sheep in the United States.

A project was initiated with Dr. Dennis Hallford at New Mexico State University to perform tissue residue studies with the CIDR-G. The protocols for this study have been submitted to the FDA for review.

ADR#330 - A project to evaluate the use of Apitol (cymiazole) was terminated in the planning stages because the manufacturer could not guarantee adequate GMP supplies of the drug.

ADR#252 - Subcontract No. 61-4127B with Dr. Alistair Webb at the University of Florida, was initiated to perform analytical assays for the pharmacokinetic studies of tilmicosin in veal age calves. The protocols have been submitted to the FDA for review.

ADR#329 - Projects were initiated with Dr. Art Craigmill, University of California, Davis to perform analytical assays for pharmacokinetic studies of Nuflor (florfenicol) in veal age calves

ADR#333 - Dr. Hank Harris, Iowa State University to determine efficacy of florfenicol for treatment of necrotizing hepatopancreatitis and vibriosis in shrimp.

Southern Region

Last year the FDA/CVM published the Public Master File of the pharmacokinetic studies comparing tilmicosin in sheep and cattle conducted by the Southern Region [Public Master File # 5673, INAD 9693]. This file supplies the kinetic data required to support a claim of efficacy and the manufacturer [Elanco] has adopted these data to facilitate their submission to FDA/CVM for a label extension for a sheep claim to their label. The FDA liaison to NRSP-7 requested a waiver of antimicrobial resistance monitoring requirements and this was granted and was a significant factor in Elanco applying for the label extension.

ADR#252 - The Southern Region will be working with Elanco towards an approval for tilmicosin in pre-ruminating calves. This work will be done in collaboration with the Central Region where Dr. Holland has expertise in infectious diseases.

ADR#280 - All work has been completed for the tissue depletion [HFS] and target animal safety [TAS] work for the fenbendazole in gamebirds [INAD 10-062] and the remaining analyses in quail tissue is currently in progress at the Western Region. The in vivo part of the target animal studies has been completed but a written report has yet to be received.

ADR#107/141 - The human food residues studies [HFS] for ivermectin in rabbits will have to be repeated at the Southern Region as the UCD laboratory has been unable to process the samples in a timely manner. The delay that would be caused by having to evaluate freezer stability would place this project too late in the FDA approval cycle. The Southern Region will be able to use this duplication in the training of the biological scientist to be hired. We have completed the target animal safety packet [TAS] and are in the process of submitting it to FDA/CVM without waiting further for the tissue depletion work to be completed.

ADR#274 Efficacy trials for zoalene [a coccidiostat-Zoamix^®] and ADR#273 nitarsone [an anti-histomoniasis drug] in gamebirds continue to be on hold until an investigator to do laboratory infection studies has been identified. To avoid these coordination problems in the future, the Southern Region has hired a biological scientist to coordinate these on-site trials and to personally supervise critical stages. That person is also undergoing training in GLP study management and quality control. It is anticipated by the manufacturer that zoalene will have a zero withdrawal should this product be labeled for game birds. For this, target tissue has to have zoalene concentrations below the FDA tolerance set for turkey [the major species the approval is being based on]. Those studies have been conducted at the Southern Region in the Clinical Pharmacology laboratory of the PI. The analyses were complicated in that the zoalene is degraded in freezing to ANOT [a zoalene derivative] and no standard was obtainable for that. The laboratory had to make the ANOT, have it's identity confirmed by GC and then validate the analysis. This has been recently amended and re-submitted to CVM/FDA.

ADR#271 – Carp pituitary as a spawing aid in various fish. The administrative work for crude carp pituitary extract is being handled by the Southern Region. The literature review to support the efficacy claims of crude carp pituitary extract has been submitted to FDA/CVM where it was augmented by the FDA Liaison. The initial target animal safety study [TAS] was completed by Dr. Anita Kelly at Mississippi State University and her report submitted. Further work is planned this spawning season to expand the TAS study to cover finned fish.

ADR#298/ADR#299 - Work has continued on developing protocols and recruiting collaborators for studies of lasalocid [a coccidiostat] in non-lactating goats and farmed deer. The manufacturer has been very active in assisting in this project development and will be conducting the tissue and feed analyses. The Efficacy Protocol has been reviewed by FDA/CVM and is under revision at this time.

Western Region

ADR#325 - Florfenicol in sheep

The Pharmacokinetic studies [Efficacy] were completed. More than 400 serum samples were collected for analysis after IM and IV dosing. Sample analysis is complete and the data analysis is in process. The Human Food Safety [HFS] protocols were submitted to FDA/CVM for review. The study is scheduled for early 2003.

ADR#258 - Progesterone CIDRs for sheep. A protocol for Target Animal Safety [TAS] has been submitted to FDA/CVM for review.

ADR#280 - Fenbendazole in game birds (collaborative project with the Southern Region). The method validation is being completed.

Romet-30 in fish (ADR#313) (collaborative project with the Northeast Region).

The western region laboratory continues the analysis of samples.

ADR#275 - Ceftiofur in llamas and alpacas. Publication Pharmacokinetics of Ceftiofur in Red Deer has been completed and submitted to the Journal of Veterinary Pharmacology and Toxicology.

Species Grouping project. Comparative metabolism studies have begun for chickens, turkeys, bobwhite quail, and pheasants. To determine how much intra-specific variability exists within each species, birds will be obtained from multiple suppliers and standard assays of activity performed. The assay system is currently being optimized and converted to a 96 well plate assay.

Presentations and Abstracts:

1. Bowser, P.R., G.A. Wooster, C.-Y. Chen, and R.S. Mo. 2003. Concurrent Infection of Hybrid Striped Bass (Morone chrysops X Morone saxatilis) with Three Bacterial Pathogens. 28th Eastern Fish Health Workshop. Gettysburg, PA. 21-24 April 2003.

2. Chen, C.-Y., G.A. Wooster, R.G. Getchell, P.R. Bowser and M.B. Timmons. 2002. Blood chemistries of healthy, nephrocalcinosis-affected, and ozone-treated tilapia in recirculation systems. Eastern Fish Health Workshop. Charleston, S.C. 18-22 March 2002.

3. Chen, C.-Y. and P.R. Bowser. 2002. Discriminant Analysis of the Blood Chemistry of Streptococcus iniae and Vibrio vulnificus-infected Tialpia, with Reference to Histopathology. International Symposium on Aquatic Animal Health. New Orleans, LA, 31 August - 6 September 2002.

4. Chen, C.-Y., C.-B. Chao, A. Alcaraz and P.R. Bowser. 2002. Comparative Histopathology of Streptococcus iniae and S. difficile-infected Tilapia. International Symposium on Aquatic Animal Health. New Orleans, LA, 31 August - 6 September 2002.

5. Miller, L. January 2002, American Sheep Industry Association Annual meeting, San Antonio, TX

6. Miller, L. January 2002, North Central Region, Animal Health Advisory Committee, Washington, DC

7. Miller, L. February 2002, National Sheep Industry Improvement Center Board of Directors, Washington, DC

8. Miller. L. and Oeller, M. October 2002, American Dairy Goat Association annual meeting, Hagerstown, MD (joint presentation with Meg)

9. Miller, L. and Oeller, M. February 2003, American Sheep Industry Association Annual meeting, Washington DC

10. Miller, L. March 2003, North Central Region, Animal Health Advisory Committee, Washington, DC

11. Wooster, G.A., C.M. Martinez, D.S. Ohara, and P.R. Bowser. 2003. Human Health Risk Associated with Formaldehyde Treatments Used in Aquaculture. 28th Eastern Fish Health Workshop. Gettysburg, PA. 21-24 April 2003.

Publications Issued or Manuscripts Approved

1. 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.

2. Craigmill, Arthur L. A physiologically-based pharmacokinetic model for oxytetracycline residues in sheep. Journal of Veterinary Pharmacology and Therapeutics, 26(1):55-63, 2003.

3. Payne, M.A., Babish, J.G., Bulgin, M., Lane, M., Wetzlich, S. and Craigmill, A.L. Serum pharamcokinetics and tissue and milk residues of oxytetracycline in goats following a single intramuscular injection of a long-acting preparation and milk residues following a single subcutaneous injection. Journal of Veterinary Pharmacology and Therapeutics, 25(1)25-32, 2002.

4. Tort, M.J., C. Jennings-Bayshore, D. Wilson, G.A. Wooster and P.R. Bowser. 2002. 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.

5. 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.

6. 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) (in press).

7. Tort, M.J., G.A. Wooster and P.R. Bowser. 2002. Effects of Hydrogen Peroxide on Hematology and Blood Chemistry Parameters of Walleye (Stizostedion vitreum). Journal of the World Aquaculture Society (in press).

Dissertations:

Chun-Yao Chen, Ph.D. January, 2003

Graduate Field of Comparative Biomedical Sciences, Cornell University.

Ph.D. Dissertation: General Fish Health Management: The Tilapia Model.

Submitted:

John G. Babish, Ph.D. Date

National Coordinator

Chair, Technical Committee

Donald C. Robertson, Ph.D. Date

Chair, Administrative Advisors