Project number: 2013-027
Project Status:
Current
Budget expenditure: $199,597.50
Principal Investigator: Marty R. Deveney
Organisation: SARDI Food Safety and Innovation
Project start/end date: 14 Mar 2013 - 14 Mar 2016
Contact:
FRDC

Need

The Australian Southern Bluefin Tuna Industry Association (ASBTIA) aims to obtain a Minor Use Permit (MUP) for praziquantel (PZQ) to treat blood fluke (Cardicola forsteri) infections in Southern bluefin tuna (SBT). Treatments to date have been undertaken under ministerial approvals pursuant to Regulation 11 of the Aquaculture Regulations 2005 (SA). The Department of Primary Industries and Regions (PIRSA) Fisheries and Aquaculture Division has indicated however, that Regulation 11 and off-label prescription is not appropriate for use of veterinary medicines used in large volumes and discharged to the marine environment. Approvals will not be continued indefinitely unless ASBTIA works towards obtaining a permit or product registration issued by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Without a ministerial approval, permit or product registration, it would be illegal to use PZQ to treat SBT for blood fluke infections.

Objectives

1. Develop methods to quantify Cardicola forsteri and Cardicola orientalis infections (year 1)
2. In vitro study to show equivalent efficacy of praziquantel as a treatment for Cardicola forsteri and Cardicola orientalis infections (year 1)
3. Determine minimum optimum dose to treat Cardicola spp. (year 2)
4. Determine safety margin / display target animal safety (year 2)
5. Determine ANZECC-compliant environmental trigger value and model environmental release (year 2)
6. Dose optimisation field study (year 2)
7. Develop toxicology database (year 3)
8. Determine withholding period from residue studies (year 3)
9. Collate occupational health and safety data (year 3)

Final report

Author: Principal Investigator: Marty Deveney
Final Report • 2021-01-01 • 460.66 KB
2013-027-DLD.pdf

Summary

This report provides a summary of work performed to develop methods to quantify Cardicola forsteri and Cardicola orientalis infections in Southern Bluefin Tuna (SBT) and an in vitro study to determine the efficacy of praziquantel as a treatment for C. forsteri infections. The project was also intended to: determine the efficacy of praziquantel as a treatment for C. orientalis infections; determine minimum optimum dose to treat Cardicola spp.;  determine safety margin / display target animal safety; determine ANZECC-compliant environmental trigger value and model environmental release; perform a dose optimisation field study; develop toxicology database; determine withholding period from residue studies; and collate occupational health and safety data. However, due to changing industry practices and subsequent changes in research priorities, this project was ceased and did not address these additional outcomes. Despite this, the project delivered on its overarching aim of optimising the use of praziquantel to manage blood fluke infections, while developing data to underpin the requirements for an Australian Pesticides and Veterinary medicines Authority (APVMA) Minor Use Permit (MUP) application.  Given the outcomes of this project, the APVMA has indicated that they would accept a Minor Use Permit (MUP) application to be submitted for praziquantel. This application would make label claims against C. forsteri alone, with APVMA indicating that adequate supporting data for this application would comprise data on mortality and cardio-vascular health. This fulfils the primary reasons for undertaking this research project.  

Related research

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PROJECT NUMBER • 2022-135
PROJECT STATUS:
CURRENT

Minor use permit for Chloramine-T in marine and freshwater finfish

1. Obtain data to satisfy identified gaps, and collate available data, to satisfy specified requirements of a minor use permit application for the use of Chloramine-T (N-chloro-4-methylbenzenesulfonamide sodium salt) to treat bacterial or parasite infections in marine and freshwater finfish.
ORGANISATION:
University of Adelaide