BPA Fish and Wildlife FY 1997 Proposal

Section 1. Administrative
Section 2. Narrative
Section 3. Budget

see CBFWA and BPA funding recommendations

Section 1. Administrative

Title of project
Fish Medicine Field Studies

BPA project number   5504900

Business name of agency, institution or organization requesting funding
Western Regional INAD Project

Sponsor type   OR-Consultant

Proposal contact person or principal investigator

BPA technical contact   , EWN

Biological opinion ID   Redfish Lake Sockeye/Fall Chinook/Snake R. Chinook

NWPPC Program number   10.2B.3, 7.2, 7.2D, 7.2D.1, 7.2D.4

Short description
Project will ensure availability of fish medicines essential to the protection and survival of threatened and endangered species under NMFS recovery plans and to fulfill Tribal, State and Federal obligations under US v Oregon andthe CRBFWP.

Project start year   1997    End year   1999

Start of operation and/or maintenance   1997

Project development phase   Maintenance

Section 2. Narrative

Related projects
Redfish Lake Sockeye Recovery- Would ensure ability to use drugs and chemicals required for survival of endangered species.

Integrated Hatcheries Operation Team (IHOT)- Meets CRBFWP for improving hatchery standards and practices. Improves survival and fish health of fish at hatcheries thus helps accomplish the goals of the Northwest Power Planning Council (NPPC) to double the runs of anadromous fish in the Columbia River Basin.

Lower Snake River Compensation Plan (LSRCP)- Would ensure the continued use of drugs and chemicals required for survival of anadromous and resident fish, some of which are threatened and endangered.

Project history

Biological results achieved

Annual reports and technical papers

Management implications

Specific measureable objectives
The analysis of data collected and the reporting of the results obtained from clinical field trials of new aquatic animal drugs is essential for improved fish health, survival and production of fish in the Columbia River Basin. This project will improve the chances of achieving the NPPC goal of doubling fish runs as called for in the CRBFWP. This project will also increase survival of threatened and endangered species required under the Endangered Species Act (ESA). Increased survival will translate into increased production necessary to carry out existing BPA funded programs ie: Redfish Lake Sockeye, Missing Coded Wire Tag Groups, and all Migration Studies. The project will also achieve the NPPC measures called for in IHOT�s Policies and Guidelines for improving and standardizing fish cultural practices in the Columbia Basin�s Anadromous fish hatcheries. It will also protect resident fish reared in the Basin as called for in the CRBFWP.

Testable hypothesis
The objective of this project is to prove that the health, survival and performance of cultured anadromous or resident fish is enhanced through appropriate legal use of new aquatic animal drugs that clinical field trials show to effectively and safely prevent or control certain infectious diseases or parasites of fish. Data resulting from trials demonstrating the efficacy of new compounds will be provided to advance efforts toward drug registration and use labeling.

Underlying assumptions or critical constraints
Compounds to be tested in this project will be only those drugs and chemicals currently being used at Columbia River Basin hatcheries assigned a high research priority by the Quality Assurance Working Group of the Joint Subcommittee on Aquaculture (JSA) and already meeting the requirements of the FDA�s workload management plan of October 15, 1995.

Methods
Practical, production-scale clinical field trials, some of which will include untreated controls where feasible, will be conducted under FDA-approved study protocols. Tests will be conducted on Chloramine-T for the control of bacterial gill disease and external flexibacteriosis in salmonids; on Formalin to control external fungus on pre-spawning adult salmon, steelhead or trout; and on Oxytetracycline feed additive for the control of bacterial diseases not now listed on the current label and at water temperatures below 9 degrees C for which Oxytet use is not now permitted. Statistical analyses will be those required by the FDA and carried out by affiliated researchers at the National Biological Service lab at La Crosse, Wisconsin. As many as 190 MILLION fish may be involved in Columbia River basin clinical field trials for this project.

Brief schedule of activities
Data and observations collected from clinical field trials must be reviewed for completeness and summarized for analysis. At the end of year one a preliminary summary report is prepared for the FDA and to inform participating Tribes and Agencies. Detailed analysis of the data then follows and a final report to the FDA is submitted by the end of year two. Also, at the end of year two a summary report on year two results must be submitted to the FDA and distributed to participating Tribes and Agencies. This data collection, analysis and reporting cycle proceeds fro all three compounds for the duration of the project.

Biological need
This project will increase survival of anadromous and resident fish essential to meeting the CRBFWP goals as established by the NPPC. It will also help to meet the restoration and conservation goals of the State, Tribal and Governmental agencies involved in managing fish within the Columbia River Basin.

Critical uncertainties
There are no critical uncertainties regarding the need for effective aquatic animal medicines. What is a CRITICAL UNCERTAINTY is when FDA will complete the registration and labeling process for these compounds and no longer require the collection, analysis and submission of data on the results of clinical field trials. Until that time, however, full compliance with FDA requirement is necessary if Columbia Basin hatcheries use these compounds for the protection and survival of anadromous and resident fish necessary to carry-out the NPPC CRBFWP.

Summary of expected outcome
The expected outcome from this project would be to increase survival of anadromous and resident fish within the Columbia River Basin thus ensuring that the goals of the NPPC are met. Tribal, State and Federal agencies would be able to comply with federal regulations ie: EPA, ESA, FDA.

Dependencies/opportunities for cooperation
Currently, as a condition for drug or chemical use under this project, all participating Tribal and Agency fish hatcheries have obtained clearance from applicable environmental agencies to use and discharge compounds involved in clinical field trials. This project has the support of all of the Agencies involved as well as Tribal Fishery Staff support. It complies with IHOT policies and guidelines with regard to standardization of hatchery practices and improved fish health in Columbia Basin fish hatcheries.

Risks
The primary risks associated with this project derive from the lack of approved drugs and chemicals for effective fish health management. All studies funded by BPA, to be reliable, must utilize healthy fish. Fish compromised by disease cannot be expected to behave normally, manage environmental problems adequately, migrate normally nor feed or adapt to saltwater normally. This project is an essential step toward improved fish health and improved results in all anadromous and resident fish hatcheries withing the Columbia River Basin.

Monitoring activity
The Western Regional Inad Project (WRIP) is currently monitoring most of the existing INAD�s within the Basin and would be responsible for analysis and reporting the results obtained from clinical field trials on authorized drugs and chemicals. Yearly monitoring reports are prepared for FDA and all participating Tribal, State and Federal agencies.

Section 3. Budget

* For most projects, Authorized is the amount recommended by CBFWA and the Council. Planned is amount currently allocated. Contracted is the amount obligated to date of printout.

Funding recommendations

CBFWA funding review group   System Policy

Recommendation    Tier 1 - fund

Recommended funding level   $60,000

BPA 1997 authorized budget (approved start-of-year budget)   $12,000