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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

Australian Pesticides &

Veterinary Medicines Authority

Minor Uses and Minor Species- Australian Perspective

Dr Phil Reeves

Principal Scientist, Residues and Veterinary Medicines

slide2

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

regulation of mums in australia
Regulation of MUMS in Australia

Approval options

1. Full Registration

2. Minor Use Permit

option 1
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

option 2
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

control of use
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

veterinarians prescribing rights
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

mums in australia
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
minor uses in major species
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

minor species
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

australian aquacultural industry
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

australian honey industry
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’

australian goat industry
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:

additional information
Additional information?

Visit the APVMA website at www.apvma.gov.au