1. AGRICULTURAL & VETERINARY CHEMICALS REGULATION IN AUSTRALIA
Dr Chris Parker
Chief Executive Officer
Australian Pesticides and Veterinary Medicines Authority August 2018

2. A brief history
In Australia, agricultural and veterinary (agvet) chemicals are regulated under a cooperative statutory scheme
APVMA established centralised (Federal) chemical registration previously done by all states and territories
We are the independent statutory responsible for assessing and registering pesticides and veterinary medicines proposed for supply in Australia
Our regulatory responsibility extends from registration and manufacturing through to the point of sale
Beyond this point the state and territory governments are responsible, including controlling the use of these chemicals
public.

3. APVMA & States - a national system of regulation
Point of Sale
APVMA
Product registration
Active constituent approval
Permits
Chemical review
Manufacturing licensing
Compliance (product supply)
Adverse experience reporting
STATES & TERRITORIES
Control of use
Compliance (product use)
Training and licensing
Australian Government Legislation
State Government Legislation plus mirror legislation
Intergovernmental Agreement

4. Our Purpose
We provide a regulatory service for the supply of safe and effective agvet chemicals in Australia
OUR VISION
To be a world leader in agvet chemical regulation, that uses the best science and attracts strong investment to register safe products that advance Australia’s agricultural productivity and animal health
OUR MISSION
We place clients at the centre of our business, invest in our people and embrace technology to define how we regulate — ensuring our decisions are risk-based and transparent

5. Our organisational strategies
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6. APVMA at a glance Over 11 480 registered products
Finalised an average of applications annually between – 17 – 2017 – 18
≈ 53% products, actives and permits
≈ 47% minor changes, industry advice, support import/export
≈ 200 APVMA staff
Cost-recovered
Registrants pay application fees
Sales levies

7. Agricultural Chemicals
Total agricultural chemicals: 9 252
(as at 15 March 2018)

8. Our assessment Legislated Criteria Assessments Chemistry Toxicology
Worker safety
Residues
Efficacy
Environment
Legislated Criteria
Safety
Trade
Labelling

9. Registration and approval process
APPLICATION LODGED ONLINE
PRELIMINARY ASSESSMENT
Administrative completeness
APPLICATION ENTERS Evaluation
EVALUATION PLANNING
Registration Managers work with Assessment Areas to determine what assessments are needed
SCIENTIFIC ASSESSMENT
Assessments done by internal or external experts
FINAL RISK ASSESSMENT
Risk Managers bring together all assessments and determine whether application meets statutory criteria
DECISION
Delegates sign off on final decision (to approve or refuse)
FINALISATION
Places product on register and sends appropriate notices

10. Criteria for assessing applications
SAFETY
Is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues
Is not, or would not be likely to have an effect that is harmful to human beings
Is not, or would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment
TRADE
The use of the product does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia
EFFICACY
The product would be effective according to the criteria determined by the APVMA in a Legislative Instrument

11. Policy settings and inputs
Department of Agriculture & Water Resources
Set domestic policy and legislation for agvet chemical regulation
Undertake National Residues Survey
OECD
Risk Assessment Framework informs APVMA approach
FSANZ
Safety of MRLs is confirmed
APVMA

12. Labelling criteria Label must contain adequate instructions as to;
How product is used
Times when it should be used
Frequency
Withholding periods
Re-entry periods
Disposal
Safe handling

13. Outcomes of risk assessment
Active constituent approvals
Product registrations
Label approvals
Establishment of standards (where necessary):
ADI and ARfD
Maximum Residue Limits (MRLs)
Import tolerances are considered and established by the Food Standards Australia New Zealand (FSANZ)

14. International involvement
11/23/2018
International involvement
Involved in international fora - OECD, CODEX including JMPR/CCPR
We publish guidance on the use of international data and assessments in Australia
Participate in global joint reviews

15. More about APVMA
apvma.gov.au
Twitter @APVMA
Regulatory Update