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

A brief history In Australia, agricultural and veterinary (agvet) chemicals are regulated under a cooperative statutory scheme APVMA established 1993 - 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.

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

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

Our organisational strategies Replace

APVMA at a glance Over 11 480 registered products Finalised an average of 5 600 applications annually between 2016 – 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

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

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

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

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

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

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

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)

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

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