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Minor Uses and Minor Species - Australian Perspective

Australian Pesticides & Veterinary Medicines Authority. Minor Uses and Minor Species - Australian Perspective. Dr Phil Reeves Principal Scientist, Residues and Veterinary Medicines. APVMA’s legislative responsibilities.

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Minor Uses and Minor Species - Australian Perspective

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  1. Australian Pesticides & Veterinary Medicines Authority Minor Uses and Minor Species- Australian Perspective Dr Phil Reeves Principal Scientist, Residues and Veterinary Medicines

  2. APVMA’s legislative responsibilities Under the Agricultural and Veterinary Chemicals Act 1994, the APVMA must ensure that veterinary drugs registered in Australia are: • safe to target species, users, consumers and the environment • efficacious • suitably formulated and properly labelled • not an undue prejudice to trade when used according to instructions

  3. Regulation of MUMS in Australia Approval options 1. Full Registration 2. Minor Use Permit

  4. Option 1 Full Registration Data required to register new products with new constituents are as follows: • Chemistry and manufacture • Environmental safety • Toxicology • Occupational health and safety • Metabolism and toxicokinetics • Efficacy and target animal safety • Residues • Other trade aspects e.g. residues in wool • Overseas trade aspects of residues in food • Special data requirements e.g. antimicrobial resistance, genetic manipulation

  5. Option 2 Minor Use Permit • Requires the Applicant to satisfy the same criteria for registration i.e. the chemical product is safe for people and the environment, will not affect Australia’s international trade through residue problems and is efficacious • As the extent of the chemical’s use may be quite small and therefore the related risks potentially lower, the supporting data requirements and evaluation processes may be simpler • Data gaps usually result in certain restrictions being placed on the supply and use of the product

  6. Control of Use • Off-label use in minor food-producing species permitted • Offence for anyone to use contrary to a “Restraint” statement • (except ‘single’ animal by vets only) 3. Offence for anyone to use contrary to a “DO NOT …. ” statement • Appropriate labels or advice notes required for products dispensed • by vets 5. Offence to cause violative residues in animal products

  7. Veterinarians’ Prescribing Rights • APVMA legislation and State / Territories laws make provision for prescribing rights • rights may not extend to food-producing animals in all States / Territories • the meaning of “Animals under their care ….. ” • if MRLs have not been established, residues must deplete to non-detectable levels at the slaughter withholding period advised by the prescribing veterinarian

  8. MUMS in Australia Minor Species • Alpacas • Gamebirds (pheasants, quail, partridges) • Ratites (emus) • Rabbits • Aquaculture species Minor Uses in Major Species • Goats • Deer • Turkeys • Dairy heifers • Marsupials (kangaroos, wallabies) • Replacement pullets • Honey bees

  9. Minor Uses in Major Species Dairy heifers and replacement pullets • Many veterinary chemical products currently registered for use in either cattle or poultry carry a label restraint prohibiting their use in cattle and poultry that are now producing, or may in future produce, milk or eggs for human consumption. • The restraints limit the availability of the veterinary chemical products, leaving few products available for use in dairy heifers or replacement pullets

  10. Minor Species In terms of minor species, efforts in Australia to date have focused predominantly on three industries. These are: 1. Aquaculture 2. Honey 3. Goats

  11. Australian Aquacultural Industry Pearls Barramundi Prawns Crocodiles Pearls Barramundi Prawns Pacific oysters Redclaw crabfish Pearls Sydney rock oysters Marron Yabbies Trout Silver perch Murray cod Yabbies Abalone Mussels Atlantic salmon Pacific oysters Abalone Seahorse Trout Southern bluefin tuna Pacific oysters Abalone Mussels Abalone

  12. Australian Honey Industry Honey • Total production estimated at AUS$50 million • Export trade estimated at AUS$20 million • Main diseases/pests are European Foulbrood Disease and Varroa mite European Foulbrood Disease Oxytetracycline ‘dry treatment’

  13. Australian Goat Industry albendazole deltamethrin oxfendazole amitraz diazinon pyrethrins thiabendazole cypermethrin fenbendazole chlorfenvinphos morantel triclabendazole abamectin doramectin levamisole closantel ivermectin moxidectin triflumuron Veterinary drugs prioritised by industry Registered uses exist for: No registered uses exist for:

  14. Additional information? Visit the APVMA website at www.apvma.gov.au

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