The majority of submitters to the inquiry supported the bill's main objective
of removing the re-registration requirement for agricultural chemicals and
The bill would remove end dates for approvals and last renewal dates for registrations
so that approvals no longer end after a particular period and registrations
could be renewed perpetually.
In the main, submitters also supported other reforms introduced by the bill including:
- addressing concerns with chemical product quality;
reducing red-tape by allowing for less frequent renewal of
reducing red-tape by allowing for simpler variations to approvals
facilitating access to information held by APVMA about chemicals;
other amendments consequential to existing reforms.
The bill's primary objective, along with each of these other reforms,
are discussed below.
Removing re-registration and re-approval
The Agricultural and Veterinary Chemicals Legislation Amendment Act
2013 (the Amendment Act), discussed in the previous chapter, introduced the
re-approval of active constituents and re-registration of chemical products by
amending the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet
code). Without changes to the Agvet Code, re-registration requirements will
come into force on 1 July 2014, requiring periodic examination (every seven to
15 years) of active constituents and products.
Schedule 1 of the bill would amend the Agvet Code to implement an
election commitment to remove re-registration by:
- preventing the expiry of active constituent approvals and
preventing the application of dates after which a registration cannot be
removing provision for applications to be made to re-approve
active constituents or re-register chemical products; and
make additional consequential amendments to the Agvet Code, Collection
Act and Amendment Act.
Schedule 1 of the bill would also remove redundant provisions for
applications to re-approve and re-register active constituents and chemical
products. Consequential amendments would also be made to the Agvet Code, the Agricultural and Veterinary Chemical
Products (Collection of Levy) Act 1994 and the Agricultural and Veterinary Chemicals
Legislation Amendment Act 2013.
The majority of submitters support the removal of re-approval and
The Queensland Department of Agriculture, Fisheries and Forestry submitted that
'at a practical level, it is considered that the re-registration and
re-approval scheme was unlikely to have achieved its aim so the amendment to
remove references to re-approval and re-registration in the legislation is
The Australian Forest Products Association submitted that: 'The bill
details some positive reforms that will improve the existing regulation and
regulatory bodies, and create more certainty for all stages of the agvet
assessment and registration process.'
Issues raised by submitters in relation to re-approval and
re-registration include: impacts on industry and the APVMA; risk-based versus
systematic assessment; protection of consumers and the environment; and avoiding
the loss of generic and other products.
Impact on industry and the APVMA
In its submission the Department of Agriculture noted that without
changes to the Agvet Code, the re-registration requirements due to come into
force on 1 July 2014 would lead to significant costs to both industry and the
Unless removed, the re-registration scheme is expected to
increase the APVMA’s costs by $2.2 million per year once the initial roll-out
of the scheme is complete.
The Australian Bureau of Agricultural and Research Economics
and Sciences (ABARES) estimates total business costs would be $324,000 per year
in preparing applications for re-approval or re-registration.
The potential costs of the re-approval and re-registration were also
estimated by Croplife Australia, including direct costs to industry as well as
the opportunity costs of supporting existing registrations, as opposed to innovating
and developing new products:
Based on analysis conducted by CropLife Australia in 2011,
direct costs to registrants are conservatively expected to be at least $6.75
million per annum, representing an approximate increase of 25 per cent in total
cost recovered fees imposed on registrants. A more likely outcome would be in
excess of $10 million per annum.
The opportunity costs from registrants supporting existing
registrations rather than innovating, developing and registering new, safer and
softer agricultural chemical products will be significant.
Other disadvantages of the retention of the re-approval and
re-registration process include the extra time taken to complete a
re-registration, and the uncertainty and burden to industry.
CropLife Australia submitted that re-registration and re-approval would add
additional bureaucracy and inefficiency which would likely result in reduced
capacity within the APVMA to deliver timely, high quality chemical reviews.
The Australian Forest Products Association (AFPA) indicated that:
The mandatory re-approval and re-registration provisions were
unnecessary and did not meet the often stated objective to ‘increase the scrutiny of
chemical constituents and products through a scheme that minimises impacts on
industry’. The additional regulatory processes were likely to
increase costs and uncertainty for industry, making it very difficult to
maintain the existing suite of chemicals and minor uses.
The committee considers that removing re-registration and re-approval is
likely to reduce costs and other negative impacts on industry and the APVMA.
Submitters supported a return to a risk-based approach to regulation
that would result from the removal of re-registration and re-approval.
The Plastics and Chemicals Industries Association (PACIA) noted that the re-approval
and re-registration scheme was intended to be risk-based, however 'by failing
to identify areas of risk being targeted has resulted in a scheme that is not
targeted at risk, in contrast to the rest of the regulatory scheme.'
The Horticultural Industries Bodies also raised concerns that the Amendment Act
moved away from a risk-based approach:
Horticultural industries recognize that an important element
of the regulatory framework is the reassessment of older chemicals against
contemporary standards. Nevertheless, industries were extremely concerned that
the approach taken in the legislation signified a more prescriptive regulatory
approach which appeared to be moving away from current risk-based assessments
with the potential to adversely impact on agvet chemical access.
Croplife Australia also supported a risk-based approach, on the basis
that it would focus the APVMA's resources where they are needed, rather than
spreading the resources too thinly.
In addition, Grain Producers Australia supported the bill, noting the
difference between the European hazard-based approach and the risk-based
approach used in Australia.
The proposed removal of Schedule 2 – 47A relating to varying
duration—decisions of foreign regulators is supported by GPA. This section
would have potentially forced the APVMA to consider a large number of such
compounds upon the implementation of the EU hazard-based regulatory scheme,
i.e., where use of a compound with dual applications may be prohibited in the
EU on the basis of hazard-based policy rather than risk as considered in Australia.
The committee considers that the bill would return the assessment of
agvet chemicals to a risk-based approach, and notes that this is supported by
Protection of consumers and the
Some submitters raised concerns that the bill could see a reduction in
the level of protection for consumers and the environment from risks associated
with pesticides and products.
However, the Department of Agriculture advised that sufficient protections are
in place to ensure health and safety, noting the comprehensive powers of the
APVMA, strong systems to trigger chemical reviews and powers to recall or
suspend unsafe products:
...[the bill] will retain the existing comprehensive powers the
APVMA has that ensure any newly identified risks about the use of a chemical on
human, animal and environmental safety, to efficacy or to trade are examined.
...A reconsideration may be triggered if previously unknown
potential risks to safety, efficacy or trade have been reported or if the APVMA
discovers evidence that shows a product may be unsafe...
The APVMA also retains powers to recall unsafe chemical
products if the product may not meet the contemporary safety, efficacy or trade
criteria for registration, or to stop sale of the product.
The APVMA may also suspend or cancel the registration of a
chemical product or approval of an active constituent if it no longer meets the
stringent criteria for registration. After 1 July 2014 the APVMA will also be
able to suspend or cancel an approval or registration to prevent imminent risk
to persons of death, serious injury or serious illness.
Avoiding the loss of products to
Several submitters noted that one of the benefits of removing the
re-registration and re-approval is that it will avoid the loss to the market of
many established treatments and products that would have otherwise occurred
under the existing legislation.
The Horticultural Industries Bodies submitted that:
The allocation of resources would also have been the scenario
facing horticultural industries wishing to support continued access to any
agvet chemicals under reassessment, i.e., industry funding to support nominated
compounds could not be provided in the requisite timeframes. The unforseen
outcome of which would have been the loss of access to many needed agvet
chemicals, irrespective of any identified concerns, thereby, reducing available
pest, disease and weed management options.
Grain Producers Australia raised similar concerns about the loss of
generic products under the existing legislation and welcomed the changes in the
bill, including returning to a scientifically sound registration process:
It is important that APVMA reviews are based on science-based
evidence where adverse events or new international scientific evidence calls
for reconsideration of existing chemical actives. The Australian grains
industry is not resourced to meet the potential significant cost of an
unnecessary regulatory process where time bound compulsory re-registration is
likely to result in commercial market failure for regulatory support of generic
off patent chemical actives. The repeal of the Schedule 1 compulsory
re-registration process is a scientifically sound and appropriate decision for
The NSW Farmers' Association consider that the changes proposed in the
bill would provide better incentives for the research and development of safer
During consultation over the 2013 amending bill, the major
registrants of new and novel agricultural chemical technologies outlined that
the costs of compliance with the reregistration/re-approval scheme would
actually result in a perverse outcome in which less money within their R&D
budgets would be allocated to the bringing of newer, novel and potentially
safer chemical products to market. The repeal of the uncommenced scheme is an
important part of providing a stable and effective regulatory regime that will
provide the incentives for these newer technologies to be brought to Australia
sooner for the benefit of agricultural productivity and profitability, and to
provide tools to better manage environmental pests and disease.
The committee notes that the changes proposed in the bill are designed
to avoid the loss of products that could have occurred under the existing legislation.
Addressing concerns with chemical product quality
There are concerns that chemicals that have been imported for which the
contents of the product are not consistent with its label, or that it is a
danger to health because of impurities in the product.
The committee heard that removing re-registration would also remove an
opportunity for the APVMA to confirm that chemical products supplied to the
market are the same as the product evaluated and registered by the APVMA.
Schedule 2 of the bill addresses this issue by amending section 99 of
the Agvet Code to improve the ability of the APVMA to require a person who
supplies an agvet chemical product in Australia to provide information about
the product they are supplying. The
information that may be required includes:
- the constituents of the substance or mixture;
the concentration of the constituents of the substance or
the formulation type of the substance or mixture;
the composition or purity of a constituent of the substance or
the name of each manufacturer of the substance or mixture;
the address of each site at which the substance or mixture is
the packaging or labelling of the substance or mixture;
advertising material related to the substance or mixture;
whether substances mixtures conform to standards; and
any other prescribed information or documents.
Submitters largely supported the chemical product quality changes
proposed in the bill.
CropLife Australia considered that improving the capacity for the APVMA to
secure information about the safety of chemicals supplied in the market would
provide a meaningful improvement in human health, safety or environmental
protection. CropLife supported the APVMA having all necessary powers to
properly manage the agricultural chemical portfolio.
Choice submitted that it would prefer chemical product quality
information to be gathered systematically.
Other submitters considered limits on APVMA's information gathering powers to
be important. For example, the Australian Forest Products Association advocated
that safeguards should be put in place to prevent the APVMA from requiring
information unless it believes it is reasonably necessary to do so:
AFPA understands the Government’s policy objective for the
APVMA to improve its ability to secure information about the safety of
chemicals supplied in the market. AFPA urges that any reform in this area be
scientifically based, targeted at areas of concern, and aligned with the
principles of assessment for ‘risk’ rather than ‘hazard’. AFPA supports the
implementation of an effective and practical safeguard system to be applied to
the APVMA in relation to this issue. The safeguard system would prevent the
APVMA from requiring information unless it believes it is reasonably necessary
to protect human, animal, plant or environmental health or safety, or
implications on trade.
The NSW Farmers' Association supported the changes on chemical product
quality and noted in its submission that reasonable restraints would be
retained upon APVMA's power, including that the APVMA 'must hold a reasonable
suspicion prior to exercising the power.'
Reducing red-tape by allowing for less frequent renewal of registration
The APVMA currently keeps product and company details up to date through
an annual renewal of registration. The associated fees recover some of the
ongoing costs of regulating agvet chemical products available on the market.
The bill would reduce red tape by providing for less frequent renewal of
registration. The renewal period would be set in regulations, and would be
aimed at balancing flexibility for industry against the cost of administration.
Measures to allow less frequent renewal of registrations, including
flexible renewal options, were popular.
The NSW Farmers' Association suggested that the development of options for
renewal periods should be undertaken in consultation with peak bodies.
Croplife Australia emphasised the importance of a flexible approach for
chemicals that have short and long commercial uses:
Due to different chemical products having differing
commercial drivers, there is a need to have both annual and multiple year
renewal of registration options. There will always be the case where products
are intended to be superseded in the short to medium term. By only having
multiple year renewal periods available, refunds of renewal fees or
unacceptable renewal fees for products with a limited future would be required.
Therefore, to encourage innovation by allowing for the flexible management of
chemical product renewals, both annual and multiple year renewal of
registration options are required.
It was also noted that consideration of any changes arising from the
review of APVMA's costs recovery arrangements will be important.
The committee notes that less frequent renewal of registration is
likely to reduce red-tape and improve efficiency for industry and the APVMA.
Reducing red-tape by allowing for simpler variations to approvals and
The bill would amend Division 2A of Part 2 of the Agvet Code Act and
insert a new Division 2AA designed to improve the effectiveness of the Agvet
Code and increase efficiency in dealing with variations of approvals and
The explanatory memorandum argues that:
These simplified application processes will greatly reduce
the supporting information required and industry time taken to make a variation
to a registration or approval. Without these amendments to the Agvet Code, the
APVMA would have to complete a more onerous technical assessment of these
variations with no real benefit to improving chemical safety.
The Department of Agriculture submitted that the new provisions would
allow for a streamlined application process for simple variations which would
be set out in regulations. The new process would avoid more onerous technical
assessments. A variation would only be able to be made under these simplified
provisions if the chemical product still meets safety, trade and efficacy
The following variations were identified through consultation with industry as
being candidates for the simplified process :
changes to a product’s name, perhaps because the supplier company
changes hands, or to respond to market demand;
introducing smaller pack sizes where larger versions already
specialising products by focussing on particular use patterns for
a product with a specialised name;
changing sites of manufacture to respond to changes in the
company’s supply chain;
minor variations to chemical composition resulting from improved
ingredient quality, to respond to changes in the company’s supply chain or to
respond to market demand – for example, to change the scent of a personal
insect repellent or change the colour of a flea collar.
PACIA promoted the need to facilitate minor variations arising from
minor specification changes, such as might result from changes to manufacturing
processes, where there is no impact on product quality or safety.
Nonetheless, it was also noted that formulation changes can significantly
impact the toxicity of the products and that this area may need further
attention by the APVMA.
Some submitters suggested additional consultation (including with peak
bodies) will be needed on the legislative instrument to implement the changes:
While the content of the legislative instrument to be made
under section 26A would need to be subject to additional consultation to ensure
that it encompasses the greatest range of potential variations possible without
undermining product safety, PACIA supports this initiative as an important
component that, coupled with appropriately targeted compliance activities, can
successfully and efficiently address concerns about products supplied to the
Australian market. 
Animal Medicines Australia strongly supported the changes for simpler
variations, and emphasised the importance of future regulations containing a
defined set of circumstances for minor variations to be determined through
What is required to achieve greater simplicity in this area of
regulation is a clearly defined set of circumstances in which minor variations
may be rendered more or less self-executing by way of notification to APVMA.
Animal Medicines Australia is encouraged by initial consultation on this matter
with the Department of Agriculture, and is eager to continue to work with the
Department and APVMA to make improvements in this area.
The committee notes that the changes effected by the bill are likely to
make it easier for industry and the APVMA to keep product information up to
Facilitating access to information held by APVMA about chemicals
The APVMA is often asked by companies to provide information relating to
registered chemical products, such as the formulation and manufacturing details
provided in a registration application. The companies may not have retained the
information, or may not have received it when they acquired an interest in the
product. While the APVMA provides information under the Freedom of
Information Act 1982 (FOI Act), the fees charged do not cover the costs of
providing the information.
The Department of Agriculture submission indicates that:
The Bill will ‘turn off’ access under the FOI Act but will
provide for persons to apply to the APVMA for copies of documents it holds
about a chemical (of that company) for a fee.
PACIA acknowledged the challenges facing both the APVMA and industry in
maintaining information on chemical products:
As some products have very long product lifespans, they may
exist through a number of commercial restructures, divestments and mergers.
From time to time this may mean that a company is not fully aware of the
information that the APVMA holds in relation to its registered products. This
places particular challenges on the APVMA’s compliance activities and on
registrants’ responsibility to manage their product portfolio.
Submitters were comfortable moving to a more efficient mechanism than
FOI for accessing product information, as long as the mechanism was of low cost
PACIA welcomed further consultation on the fees that would be set.
While some concerns were raised about the impact of the proposed changes, the
Department of Agriculture concluded that 'These amendments do not reduce or
limit access to information to persons eligible to receive it. Access remains
subject to commercial-in-confidence considerations, protecting the commercial
property of companies.'
On balance, the committee considers that the proposed changes are likely
to be advantageous to the APVMA and industry, and adequate safeguards remain in
place to facilitate appropriate access to relevant information.
Other amendments consequential to
The explanatory memorandum notes that the bill seeks to correct some
technical issues with the Amendment Act to the Agvet Code and the Food
Standards Australia New Zealand Act 1991 (FSANZ Act):
the Amendment Act inadvertently undid 2010 amendments to the
FSANZ Act. The 2010 amendments were an efficiency measure to allow the APVMA to
amend the Maximum Residue Limit Standard of the Australia New Zealand Food
Standards Code. The FSANZ Act will be amended to correct an incorrect reference
to part of the Agvet Code in the FSANZ Act. Schedule 2 of the Bill addresses
...several minor technical amendments are required to the Agvet
Code to improve the readability of the legislation and reduce the possibility
of difficulties in implementing it. Schedules 1 and 2 of the Bill address these
miscellaneous amendments as appropriate.
Choice suggested that more explanation of the consequences of the
amendments could be provided.
WWF-Australia and the National Toxics Network had no problem with the
consequential amendments if they are genuinely minor in nature and do not
diminish human health and environmental protections.
PACIA supported the consequential amendments, including the reinstatement of
the FSANZ Maximum Residue Limit standard.
The committee has considered the bill and notes that the majority of
submitters support its passage. In particular, the committee considers that the
bill would improve the administration of the agvet regime by returning to a
risk-based approach to chemical assessment, approval and registration, and that
that is likely to provide efficiencies to both industry and the APVMA.
The committee recommends the bill be passed.
Senator the Hon Bill Heffernan
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