3. APVMA ASSESSMENT &
REGISTRATION
Human health, Toxicology and Occupational Health and
Safety (Office of Chemical Safety)
Environmental (Department of Environment, Water,
Heritage and the Arts)
Efficacy and safety (State Primary Industries
Departments and expert external reviewers)
Chemistry (APVMA) & Residues (APVMA, FSANZ)
Trade (APVMA) & Others (AQIS, OGTR, EAGAR)
4. Qld legislation = Chemical Use Act
& Regulations
Chemical Usage (Agricultural and Veterinary)
Control Act (1988) and Regulations 1999
But now nationally harmonised legislation is being
developed
All states have similar legislation for use of
veterinary treatments for animals
5. Queensland legislation
Office of the Queensland Parliamentary
Counsel web-site
http://www.legislation.qld.gov.au/OQPChome.
htm
Chemical Usage (Agricultural and Veterinary)
Control Act 1988 & Regulation 1999
Health (Drugs and Poisons) Regulation 1996
Veterinary Surgeons Act 1936
6. What does this mean for goat
producers?
● You need to have a vet to prescribe “off label”
use for your goats i.e. use a sheep medicine
● This vet needs to visit your property and know
your goats and their husbandry
● You can’t share vet drugs between goat owners
● You can’t import vet medicines from overseas
without APVMA approval
● Only a vet can split packs & only if the vet then
labels with instructions
7. Maximum Residue Levels - What are
they? Why do we have them?
MRL= Limit for AgVet chem. breakdown products
– Set as part of approval /registration process
Regulation / Control
Indicators of Good Agricultural Practice (GAP)
Minimize Human Health Risk as set well below any
human heath issue levels
Facilitate trade as set after consideration of major
trading partners
8. MRL’S - Who sets them in
Australia?
Now only One, not Two, Federal Approval Systems
APVMA does the chemical assessment &
Registration / Permit approval & MRL for both FSANZ
& APVMA
APVMA must ensure the drug works and minimal
risk to consumers; persons handling, applying
or administering the chemical; the environment
& trade
9. MRL’S - How are they assessed
& approved?
APVMA assessment
1 The toxicological evaluation;
2. The maximum residue limit (MRL) evaluation; and
- chemistry, metabolism, residue data,
-residue data extrapolations for minor use,
emergencies
3. The dietary exposure evaluation
Now FSANZ accepts APVMA's MRLs
10. MRL’S - Who uses them ?
Control of Use Legislation
State Departments – DPI&F, EPA
Public Health and Food Safety
Health Departments Food Safety Agencies eg
Queensland Health – Safe Food Queensland
National Residue Survey
Trade BUT Codex MRL are a separate process
AQIS Imports and Exports
11. Withholding periods
=Minimum period that must elapse between last
use of a product and
(if crop or pasture): harvesting/cutting/grazing of
animals on it
(if animal, including feeding with treated feed):
shearing/slaughtering/collecting milk or eggs
12. Withholding periods in trade animals
● must be identified during treatment period and
withholding period e.g. tagging, physical
segregation, written records.
● person supplying an animal must advise if
WHP has not elapsed
● Vet must provide in writing if using off label e.g.
using a sheep drug in a goat
13. Export Slaughter Intervals (ESIs)
ESIs = advisory times that should be observed,
allowing exporters of food commodities to meet
the residues standards of a trading partner. They
relate to the time between the last administration
or feeding of a chemical product to livestock, or
last application to crops, and the slaughter or
harvesting of those livestock or crops for export.
Only currently available for sheep & cattle
May be different from WHPs
14. Historic market failures caused by residue incidents in Beef
Year Market
Issue
closure/reaction
1987 DDT and Dieldrin US
1990 Antibiotics US, Japan
1991 Penicillin, Tick Control US, Canada, North Asia
Chemicals
1992 HGPs Europe
1993 HGPs Europe
1994 Tick Control Chemicals US, Asia
1995 Cotton Trash US, Asia
(Chlorofluazuron)
1996 Endosulphan US, Asia
1997 BHC Domestic
1998 Endosulphan US, Asia
1999 HGPs Europe
2001 Bioresmethrin Korea
2002 Endosulphan US
2007/8 Tilmicosin Domestic/Japan
2011 Teracyclines group Russia
15. Other Commodities- no goat products - yet
2006 Pork – three Singapore
incidents
2006 Chickens Domestic
2007 Honey UK
2007 Barramundi Domestic
16. EU tests 764,736 samples /year
Report on veterinary drug bovines (0.34 %),
residues in animals and
animal products pigs (0.30 %)
01 JUN 2011 The sheep and goats (3.65 %),
European Feed Safety
Authority (EFSA) …issued horses (1.27 %)
a report on … veterinary
drugs residues in animals poultry (0.05 %),
and animal products in and aquaculture (0.46 %).
Europe. 0.34% were non-
compliant i.e. had residues
19. GLOBAL TRENDS AFFECTING
GOAT INDUSTRIES
● Increasing Age & Health consciousness in
Developed Countries
● Demands for food safety & traceability
● Demand for Food Traceability
● Global ICT – rapid info exchange
● Global regulatory convergence
20. Global trends cont.
● Increasing Complexity of International Trade
● – more FTAs
● Challenges to Scientists’ Credibility post
mad cow disease in UK
● Huge laboratory testing capacity overseas
● Bioterrorism Risks – hence more traceability
demands
23. Australia can not realistically
influence chemical regulation in
world trade
So goat producers must ensure trade in
goat products is not jeopardized by residues
of veterinary treatments or agricultural
residues or contaminants in fodder