Reform of Agvet Chemical Regulations

1. Reform of Agvet Chemical Regulations

2. Reform History • 1999 - Chemicals and Plastics Action Agenda established • 2006 - Reducing the Regulatory Burden on Business taskforce report • 2008 – PC report into Chemicals and Plastics Regulation • 2010 - Primary Industries Ministerial Council endorsement of a national policy framework, followed by COAG agreement.

3. Reform Issues • Overly complex and prescriptive regulation • characterised by often unclear systems and processes. • Duplication and inconsistent regulation • differences in licensing and training requirements imposed on • pesticide applicators. • prescriptive interpretation of APVMA conditions, as compared to • a performance-based approach. • Gaps in the regulatory framework • risk framework, minor use crops, monitoring and feedback loops. • Optimisation of regulatory intervention across risk continuum • compensating rather than whole of system actions due to separate • control of use and assessment and registration responsibilities.

4. Why are these problems? • Higher costs to business leading to • Changed production systems (less minor use crops) • Reduced innovation (pest resistance, less new chemistry) • Higher barriers to competitive entry (less generics). • Higher costs/reduced choice for consumers • Access to chemicals for minor crops • Higher farm costs feeding into food costs. • Potential for reduced community confidence • Demands for tighter controls in the absence of clearer, • more transparent systems.

5. Reform Processes • Development of a single national regulatory framework • for agvet chemicals. • Better Regulation Partnership commitment to reform the • APVMA. • Follow up to COAG ‘early harvest’ reforms.

6. Reforms Delivered to Date • Passage of the Agricultural and Veterinary Chemicals Code Amendment Bill 2010 • passed on 24 June 2010. Provides for: • An exemption from the general prohibition on using confidential commercial • information when registering a permit for minor use or emergency use. • Trade issues considered when addressing the adequacy of product labels by • extending the definition of “adequate”. • Access to a simplified application process to notify the APVMA of a limited • range of defined, low risk, minor variations to approvals or registrations. • Removal of the requirement to notify the APVMA in writing of the • authorising of an approved person. • Enabling applicants to make changes to labels that do not affect the safe and • effective use of a product without the APVMA’s approval.

7. Reforms Delivered to Date • Passage of the Food Standards Australia New Zealand Amendment Act 2010 • on 28 October 2010 providing for FZANZ recognition of APVMA’s residue • risk assessment and promulgation of maximum residue limits to the Food • Standards Code • Regulatory gap reduced from 18 to 4 months in promulgating • MRLs?? • Agreement by the Primary Industries Ministerial Council in April 2010 to a • reduced regulatory approach for on‑farm dairy cleansers • Dairy industry working with APVMA to develop suitable registration • models. • Development of a labelling reform package to enable non-technical changes • to labels without APVMA approval • In place and supported by Amendment Bill 2010 passed on 24 June • 2010. • Regulations in place providing for exclusion of certain products from the • National Registration Scheme. • Certain water sanitisers for industrial use to be also excluded. • Development of a regulatory process for low-risk agvet chemicals. • Registration model for low-risk oral equine electrolytes for horses in • exercise has been published on the APVMA website 8 December 2010.

8. Where to From Here? • Development of a single national regulatory • framework for agvet chemicals as per the COAG • reform. • Progress Federal Government’s ‘Better Regulation of • Chemicals’ reform. • Both reform agendas closely linked and • complementary.

9. COAG Single National Regulatory Framework • Consultation RIS to be released for public comment • Builds on policy framework document endorsed by • COAG on 16 August 2010 • Canvases options in relation to: • National versus state control of control - of- use functions • Access to chemicals (eg minor use) • Training and licensing of chemical users • Use control systems (eg monitoring, auditing, record keeping) • Management of risk • Efficiency and effectiveness of chemical registration and review.

10. COAG Single National Framework • Primary Industries Ministerial Council (PIMC) • Will consider responses to the COAG consultation • Regulation Impact Statement • Set policy direction of key issues related to the reform. • PIMC to provide COAG a regulatory model, an • inter-governmental agreement, and funding model • for consideration. • Timing uncertain - reforms potentially in place • from mid 2013.

11. ‘Better Regulation of Chemicals’ reform • Policy discussion paper released on 19 November 2010. • Stakeholder views sought on key areas of reform to the • assessment and registration of agvet chemicals. • Reforms to improve the assessment and registration • processes, including in relation to review of chemicals.

12. ‘Better Regulation of Chemicals’ Who will it benefit? • Chemical manufacturers through faster and more • predictable assessment and registration processes. • Chemical users through faster access to a wider range of • new and innovative chemicals, including in relation to • minor crops • The community through more transparent and systematic • processes and standards for registration and review.

13. ‘Better Regulation of Chemicals’ State of Play • In total, 88 submissions received during the consultation • period (ended 4 February). • Very broad support (industry, community groups) for • significant reform. • General agreement across stakeholders on improving • transparency, aligning risk with regulatory effort, and • promoting innovation. • Differences around chemical re-registration, advisory • structures, accelerated assessment.

14. ‘Better Regulation of Chemicals’ Timing • Legislation to be developed by mid 2011, after • which draft legislation released for comment. • Passage of legislation anticipated in early 2012, • with changes proposed to commence from mid • 2012. • Complex, resource intensive changes to be phased in to • allow orderly implementation. • Operational changes, not requiring legislation, will • be implemented earlier eg IT upgrade and risk • framework • Public consultation to occur with these changes.

15. Concluding Remarks • Large and complex reform agenda – both technically and • politically • Need to get it right but reform is overdue and stakeholders • keen to see results. • Government has provided resources to get the right reform • outcome in a short timeframe. • Reform will be significant and deliver real benefits to industry • and the community. • COAG reform will strengthen and further lock in these reform • outcomes.