Presentation on theme: "Reform of Agvet Chemical Regulations. Reform History 1999 - Chemicals and Plastics Action Agenda established 2006 - Reducing the Regulatory Burden on."— Presentation transcript:
Reform of Agvet Chemical Regulations
Reform History Chemicals and Plastics Action Agenda established Reducing the Regulatory Burden on Business taskforce report 2008 – PC report into Chemicals and Plastics Regulation Primary Industries Ministerial Council endorsement of a national policy framework, followed by COAG agreement.
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.
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.
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.
Reforms Delivered to Date Passage of the Agricultural and Veterinary Chemicals Code Amendment Bill 2010 passed on 24 June 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.
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 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.
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.
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: o National versus state control of control - of- use functions o Access to chemicals (eg minor use) o Training and licensing of chemical users o Use control systems (eg monitoring, auditing, record keeping) o Management of risk o Efficiency and effectiveness of chemical registration and review.
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.
‘ Better Regulation of Chemicals’ reform Policy discussion paper released on 19 November 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.
‘ 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.
‘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.
‘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 – 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.
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.