Reform of Agvet
Chemical Regulations
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.
Reform Issues
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Overly complex and prescriptive regulation
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Duplication and inconsistent regulation
–
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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
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characterised by often unclear systems and processes.
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
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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
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Passage of the Agricultural and Veterinary Chemicals Code Amendment Bill 2010
passed on 24 June 2010. Provides for:
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An exemption from the general prohibition on using confidential commercial
information when registering a permit for minor use or emergency use.
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Trade issues considered when addressing the adequacy of product labels by
extending the definition of “adequate”.
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Access to a simplified application process to notify the APVMA of a limited
range of defined, low risk, minor variations to approvals or registrations.
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Removal of the requirement to notify the APVMA in writing of the
authorising of an approved person.
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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
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•
•
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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.
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
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Consultation RIS to be released for public comment
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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
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Primary Industries Ministerial Council (PIMC)
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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
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Policy discussion paper released on 19 November 2010.
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Stakeholder views sought on key areas of reform to the
assessment and registration of agvet chemicals.
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Reforms to improve the assessment and registration
processes, including in relation to review of chemicals.
‘Better Regulation of Chemicals’
Who will it benefit?
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Chemical manufacturers through faster and more
predictable assessment and registration processes.
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Chemical users through faster access to a wider range of
new and innovative chemicals, including in relation to
minor crops
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The community through more transparent and systematic
processes and standards for registration and review.
‘Better Regulation of Chemicals’
State of Play
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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.
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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
2012.
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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
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Public consultation to occur with these changes.
Concluding Remarks
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Large and complex reform agenda – both technically and
politically
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Need to get it right but reform is overdue and stakeholders
keen to see results.
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Government has provided resources to get the right reform
outcome in a short timeframe.
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Reform will be significant and deliver real benefits to industry
and the community.
•
COAG reform will strengthen and further lock in these reform
outcomes.