Current regulatory environment
Only registered agricultural chemicals and veterinary medicines (agvet
chemicals) may be used in Australia. Registration and other aspects of their
regulation are administered through a cooperative National Registration Scheme
for Agricultural and Veterinary Chemicals (NRS) which was agreed to by the
Australian Agriculture Council in 1991.
The NRS is a partnership between the Commonwealth and the states and
territories, with a shared division of responsibilities. The assessment and
registration of agvet chemicals and the control of supply activities up to the
point of retail sale are undertaken on behalf of the states by a Commonwealth
Government authority, the Australian Pesticides and Veterinary Medicines
Authority (APVMA). Control of use of agvet chemicals after sale is the
responsibility of the states and territories.
The APVMA's operations were described by the Department of Agriculture,
Fisheries and Forestry (DAFF) as follows:
With input from other government agencies, the APVMA approves
active constituents and agvet chemical products, undertakes reviews of existing
approvals and registrations and monitors the compliance of approvals and
registration up to and including the point of retail sale. The APVMA’s
processes provide assurance, through rigorous science based risk assessments,
that agvet chemical use is safe for human and animal health and the
environment. They also provide assurance that agvet chemicals will be effective
and will not adversely affect Australia’s ability to trade agricultural
produce. Australia currently has around 9900 separate agvet chemical products
registered, each of which contains one or more of around 1883 approved active
In addition to approving, reviewing, registering and monitoring
compliance of registrants of agvet chemicals, the APVMA may also issue permits
and license manufacture. The APVMA's procedures are determined in great detail
by the provisions of the Agvet Code, which is set out in a schedule to the Agricultural
and Veterinary Chemicals Code Act 1994.
In the Explanatory Memorandum to the bill the Government stated that
the proposed amendments would:
- Enhance the consistency, efficiency and transparency of agvet
chemical approvals, registrations and reconsiderations through development,
publication and implementation of a risk framework, which the APVMA must have
regard to and legislative amendments to align regulatory effort with chemical
- Ensure the ongoing safety of agvet chemicals and improving the
effectiveness and efficiency of current agvet chemical reconsideration
arrangements by implementing a mandatory re-approval and re-registration regime,
designed to identify any potentially problematic chemicals while minimising any
negative impacts on affected businesses;
- Improve the efficiency and effectiveness of assessment processes
for agvet chemicals applications for approval, registration and variation, and
improving the timeliness of agvet chemical approvals, registrations and
- Improve the ability of the APVMA to enforce compliance with its
regulatory decisions by providing the APVMA with a graduated range of
compliance enforcement powers and introducing a power to apply statutory
conditions to registrations and approvals;
- Improve consistency in data protection provisions and remove
disincentives for industry to provide data in support of ongoing registration
of agricultural and veterinary chemicals; and
- Address perceptions of a conflict of interest by providing for an
agency other than the APVMA to collect the chemical products levy, should it be
cost effective to do so.
The Bill also includes other amendments to remove redundant
provisions and amend out of date provisions.
In this regard, the Government has identified six areas for improvement,
- Approvals, registrations, permits and licences;
- Re-approval and re-registration;
- Data protection;
- Levy collection; and
- Other amendments.
Each of these areas is addressed in turn below.
Approvals, registrations, permits
The approvals process is to be reformed to ensure that applications for
approvals or registration are of the required standard to be assessed. The
amendments require the APVMA to refuse inferior or deficient applications.
Applicants would be assisted by the APVMA's principles and processes being
made transparent by the publication of a risk framework or compendium.
Applicants would also be offered assistance with their applications, for a fee,
before they are submitted. It is expected that the new processes will improve
the predictability of regulatory decisions.
The amendments also introduce timeframes for assessment and
reconsideration that include the total time elapsed, including the time taken
to provide additional information, so that assessments are not frustrated by
the late provision of sometimes inadequate information.
Re-approvals and Re-registrations
The Government has stated that there is now no mandatory requirement for
agvet chemicals, once approved or registered, to be reviewed. The amendments
will provide for such a scheme.
The Explanatory Memorandum states that:
The scheme provides a greater level of assurance that
existing chemicals and products do not pose an undue risk to human health or
the environment, and further promotes public confidence in agvet chemical
The provisions surrounding the re-approval and re-registration process
are canvassed in some detail in Chapter 3 of this report.
The intent of the amendments relating to enforcement is to provide the APVMA
with a range of penalties more appropriate to its regulatory role. New
provisions would allow the Authority to impose penalties other than a warning
letter or criminal prosecution as is the case at present. The amendments also
create new offences, for example, failing to comply with directions of
inspectors and failing to comply with a notice to produce documents or things or
attend an interview to answer questions.
The Government has stated that the new offences either align with
existing offences or are consistent with the Government's A Guide to Framing
Commonwealth Offence, Infringement Notices and Enforcement Powers.
The amendments relating to enforcement have been considered in some
detail by other Parliamentary committees – in Alert Digest No. 1 of the Senate
Standing Committee for the Scrutiny of Bills and in the First Report of 2013 of
the Parliamentary Joint Committee on Human Rights.
See Chapter 3 for further discussion.
Data protection is stated to be a common feature of agvet chemical
regulation in countries that have comparable registration systems to that of Australia.
According to the Explanatory Memorandum:
The current data protection provisions are overly complex and
do not provide meaningful access to data protection for information provided to
a reconsideration. By enhancing data protection provisions, the Bill removes
disincentives to invest in innovative product development and to improve the
productivity of Australia’s agri-food industries.
The APVMA is funded by the industry through fees, charges and levies on
the wholesale sale of agvet chemicals, which are collected by the Authority.
The bill would allow for another Australian Government agency to collect the
levies if that were cost effective. The amendments are intended to address any
perception of a conflict of interest given that the APVMA is both the regulator
and collector of fees.
Other amendments to the current legislation include those that preserve
Parliamentary oversight of legislative instruments made under the legislation.
Recent developments in regulation
In 2006, the Council for Australian Governments (COAG) identified
the need for regulatory reform in relation to chemicals and established a
Ministerial Taskforce, to 'develop
a streamlined and harmonised national system of chemicals and plastics
COAG also referred the matter to the Productivity Commission for advice. In
2008, the Commission published a report, Chemicals and Plastics Regulation,
...the current institutional and regulatory arrangements are broadly effective in
managing the risks to health and safety, but are less effective in managing
risks to the environment and national security. Efficiency could be
enhanced by: national uniformity in some regulatory areas; reducing costs and
delays in obtaining regulatory approvals; and attaining economies of scale in
In 2009, COAG announced that a Memorandum of Understanding for Chemicals
and Plastics Regulatory Reform had been agreed to, and established the Standing
Committee on Chemicals, whose role was to co-ordinate, monitor and advise governments
on the implementation of reforms identified by the Productivity Commission as
The Australian Government's response, a discussion paper entitled Better
Regulation of Agricultural and Veterinary Chemicals, was published in
That document identified the need for the development of a Regulatory Impact
Statement (RIS) to assess the effect of the proposed reforms. A RIS was
published in November 2011.
The Government published an exposure draft of the bill in November 2011
and a revised draft of the bill in September 2012.
DAFF invited public comment on the discussion paper and on the exposure
drafts and received many submissions from industry groups, environmental
groups, primary producer associations and Commonwealth, state and territory
governments. The submissions were considered and the drafts of the bill addressed
many of the issues raised in the consultation process.
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