Committee view and recommendations
The APVMA has a crucial role in assessing, registering and regulating
agvet chemicals in Australia. An effective and efficient regulator is essential
to protect the health and safety of people, animals and the environment, and to
support trade and commerce in agricultural commodities. To carry out its
legislated functions, the APVMA must make efficient decisions to ensure
Australia's farmers have timely access to safe, environmentally sustainable and
productivity enhancing products, whilst at the same time maintaining the
confidence of both industry and the community.
A number of issues have combined to create a situation where the APVMA
will face significant challenges in maintaining its ability to effectively
regulate agvet chemicals. The decision to relocate the APVMA to Armidale has
hampered the regulator's ability to address a number of long-running issues
with regard to its performance and funding. Without any prior strategic
planning to address the inevitable upheaval that would come from relocating a specialist
scientific agency, the regulator has lost important institutional knowledge and
technical expertise and must now overcome numerous challenges to effectively
and efficiently carry out its functions.
Evidence to the Committee has suggested that it will take the APVMA a
number of years to regain its lost scientific, technical and management
strength. The concern was raised that this will not only affect the APVMA's
ability to effectively regulate agvet chemicals, but will also hinder the implementation
of urgent organisational reforms required for its effective operation.
Consequences of relocation
The Committee is concerned about the manner in which the APVMA was
relocated to Armidale and of its impact on the availability of staff expertise
and assessment timeframes. It notes the flow‑on effects for farmers
across Australia who require timely and certain access to pesticides and
veterinary medicines. Further, the relocation has the potential to undermine,
or at least set back, the benefits that were to have come from reforms within
The Committee was informed that the satellite office in Canberra was
retained in order for the APVMA to maintain its performance and fulfil its
statutory responsibilities. Despite the best efforts of the APVMA in exploring
a range of mechanisms to fulfil these functions from Armidale, including that
of drawing on the private sector, the APVMA had no other option than to retain
a satellite office in Canberra.
Whilst the Committee appreciates the rationale for retaining a Canberra
satellite office, the evidence is clear that the relocation of the APVMA to
Armidale has undermined the authority's ability to retain scientific and other
experienced staff that would allow it to undertake its regulatory functions in
a timely manner.
The Committee notes that staff shortages have resulted in
management-level staff undertaking non-registration-related activities, with
increasing amounts of time being spent on general application processing at the
expense of other activities. That the APVMA is currently reviewing several
aspects of its own operations, and is the subject of proposed legislative
change, adds to the non-regulation-related workload of the authority.
The Committee regrets that the relocation has also brought into question
the independence of the authority and has delayed the implementation of essential
reforms within the authority, which would have improved its performance as well
as public confidence in its operations.
The Committee believes the importance of having a regulator that is able
to conduct robust, scientifically based regulatory activities cannot be
underestimated and should not be jeopardised.
It is vital that the regulator maintains the necessary expertise to
assess all applications it receives, and is able to oversight and control the
assessment process. The Committee upholds the view that sufficient staff should
be retained so as to ensure the authority is able to fulfil its regulatory
responsibilities in a timely and efficient manner. The Committee also appreciates
the considerable efforts underway by the APVMA to attract and secure staff, and
in particular regulatory scientists.
Use of international data to
improve regulator efficiency
The Committee heard suggestions that within a risk-based framework, a
greater use of international data and assessments would improve the regulator's
The Committee welcomes the direction issued by APVMA CEO, Dr Parker, to
APVMA staff detailing expectations with regard to the use of international
data, standards and assessments. Whilst the Committee is of the view that the
APVMA must make decisions based on Australian legislative requirements, the
regulator should incorporate the findings of international assessments as
The Committee notes that whilst the authority has made significant
effort in the area, some industry stakeholders remain concerned about the
APVMA's processes for accepting international data in support of registering
products in Australia. The Committee therefore encourages the APVMA to continue
to liaise with industry to provide clarity to applicants.
Training regulatory scientists
The Committee recognises the particular specialist skills required by
regulatory scientists and the difficulties the APVMA faces in recruiting and
training new scientific staff, which itself can take three to five years. The
reported global shortage of regulatory scientists adds a complicating factor.
The Committee acknowledges the work of the APVMA to train its newly
recruited regulatory scientists through the Accelerated Regulatory Science
Training Program. However, it believes a 10‑month training program,
however intensive, cannot compensate for the lost experience and expertise that
was caused by the decision to relocate the authority.
Having considered the evidence presented, the Committee believes that
over the next five years, there is a risk that the quality of the authority's
assessments will be affected by a lack of expertise and experience. The absence
of a robust quality control framework exacerbates this problem.
Having regard to evidence of a shortage of regulatory scientists, and
the need for regulatory scientists across a number of government agencies, the
Committee believes there is merit in investigating the education, training, and
future supply of regulatory scientists in Australia. The Committee is of the
view the sector would benefit from the establishment of more graduate courses
in regulatory science, and consideration of a dedicated school of regulatory
The Committee acknowledges the current work being undertaken by enHealth
in relation to the regulatory science workforce (both in the private and public
sector), and encourages the APVMA to continue its participation in this study.
The Committee considers, however, that the Australian Government should be
treating this issue as a matter of priority.
The Committee also believes there is much to be gained from the
regulator working with existing educational institutions to provide practical
experience for science students in a regulatory environment, with the long‑term
outcome of ensuring Australian agencies are able to attract suitably qualified
In light of these views, the Committee makes the following recommendations
for a scoping study on the Government's need for regulatory scientists, and the
expansion of integrated learning opportunities in regulatory environments for
The Committee recommends that the Australian Government undertakes a
comprehensive scoping study on the need for regulatory scientists across
Australian Government agencies. The scoping study should consider:
the current educational, training and work experience environment
for regulatory scientists;
the likely future demand for regulatory scientists and the skills
and competencies they will require; and
the findings of the Environmental Health Standing Committee
(enHealth) on the need for regulatory scientists.
6.22 In undertaking this study, relevant educational and training
bodies, and Australian Government agencies, should be consulted as required.
6.23 The Committee recommends that the Australian Pesticides and
Veterinary Medicines Authority works closely with the Australian education
sector to identify and expand integrated learning opportunities that would
provide science graduates with experience in regulatory environments.
Regulator performance and efficiency
The Committee acknowledges there is a longer history of performance and
efficiency concerns in relation to the APVMA, and that the regulator has been
subject to significant administrative, legislative and regulatory change.
The additional pressure created by the relocation to Armidale, not the
least of which has been caused by the loss of a significant proportion of the
regulator's experienced staff, has exacerbated a number of underlying problems.
The relocation has caused considerable disruption to staff and severely
weakened the authority's ability to operate effectively and efficiently. Based
on the evidence before it, the Committee recognises that the Government must
prioritise the authority's ability to perform its regulatory functions over
imposing an overarching policy of decentralisation.
The Committee expresses concern that reforms such as a robust quality
control framework and a fit‑for‑purpose workflow management system
remain unfulfilled at a time of significant disruption. Indications from the
regulator are that these reforms remain years from completion.
The absence of these measures has the potential to affect the quality
and efficiency of the regulator's work, endanger its ability to fulfil
legislative requirements, and undermine trust in the authority.
The Committee therefore recommends that the APVMA progresses, as a
matter of priority, a robust quality control framework and a fit-for-purpose
workflow management system.
6.29 The Committee recommends that the Australian Pesticides and
Veterinary Medicines Authority progresses, as a matter of priority, the
development and implementation of a robust quality control framework and a fit‑for‑purpose
workflow management system.
The Committee recommends that the Australian Government takes into
consideration the disruption caused by the forced relocation of the Australian
Pesticides and Veterinary Medicines Authority (including the ongoing impact on
staff capability and capacity), and prioritises a fit-for-purpose and stable
workforce over any decentralisation policy.
APVMA funding model and its implications
APVMA cost recovery funding model
The Committee shares the concern of a number of submitters that the
APVMA is not operating on a sound financial footing, particularly at a time of
organisational upheaval, and encourages the timely completion and
implementation of the current funding review.
The Committee does appreciate the challenge, as highlighted by Dr Parker,
of ensuring sufficient staff expertise remains within the APVMA to carry out
the authority's regulatory functions upon which the cost recovery funding model
is dependent. The departure of staff has impacted on productivity and will
continue to do so.
Notwithstanding this point, the Committee believes the cost recovery funding
model is comparable to the funding models of other national and international
Access to chemicals and veterinary
medicines in Australia
The Committee acknowledges that the combination of small market size and
regulatory cost has an impact on access to agvet chemicals for minor uses in
Australia. That applications for registration contain fewer label usages has
negative consequences for farmers in general, and for those who farm specialty
crops or animals in particular.
The APVMA's new cost recovery implementation statement, scheduled
for release in 2019–20, may result in increases in some costs. In light of
this, some submitters suggested that a reduction in fees for the registration
of minor use chemicals would provide a way to compensate for the low commercial
return on investment.
The Committee recognises the Government's efforts to address the problem
of access to minor‑use chemicals through the Improved Access to
Agricultural and Veterinary Chemicals Initiative, which provided some funding
for the registration of agricultural chemical products for minor uses and
specialty crops. However, the Committee also recognises that the allocated $8
million of funding was committed for 2014–2018. The Committee takes the view
that funding for this initiative should be continued.
The Committee recognises that a thorough assessment of the actual impact
of regulatory costs on the registration of chemicals for minor uses is
necessary to inform policymaking into the future. Understanding the impact will
allow for effective and targeted policymaking to address chemical availability
Accordingly, the Committee makes recommendations with regard to funding
the Improved Access to Agricultural and Veterinary Chemicals Initiative, and to
assessing the impact of regulatory costs on the registration of minor use
chemicals in Australia.
6.39 The Committee recommends that the Australian Government confirms
its ongoing support for the Improved Access to Agricultural and Veterinary
Chemicals Initiative and provides sufficient funding for the initiative over
the forward estimates to ensure its continued operation.
6.40 The Committee recommends that the Australian Government
commissions an independent assessment of the impact of regulatory costs on the
registration of minor use chemicals, with a view to obtaining evidence that
would inform policy and consider the availability of minor use chemicals in
Perceptions of independence
The Committee received significant evidence with regard to the cost
recovery funding model and its relationship to the perceived independence of
Regardless of whether the authority does recover the full cost of its
activities, because the regulator is funded by those whose products it regulates,
its cost recovery funding arrangement is perceived by some as a conflict of
interest. This funding model, however, is not a unique arrangement for
regulatory agencies in Australia or internationally; and it complies with the
Australian Government Charging Framework.
The Committee is confident that the authority's clearly legislated
regulatory responsibilities do not allow for industry to unduly influence the
decisions of the regulator, by the fact that it is industry funded. Furthermore,
the Committee does not share the view, held by some submitters, that the APVMA
has an incentive to approve chemicals to gain funding through levies or that
companies might be encouraged by the APVMA to create products for their
registration so the APVMA can meet funding targets and increase capital.
The Committee agrees with those who argue that the current funding model
provides adequate checks and balances to prevent preferential treatment, such
as the acceleration of any particular chemical application from any particular
The Committee considers the current funding arrangement to be adequate
and appropriate. Further, it believes application fees provide an incentive for
the submission of quality applications.
The Committee acknowledges the industry is united in the view that the
funding model does not allow for undue influence over the decisions of the
regulator, which are robust and based on sound scientific principles. The
Committee does see value, though, in looking to formalise some of the contact between
the regulator and industry so as to discuss, in a transparent manner, a range
of issues with regard to agvet chemical regulation in Australia.
Liaison between industry and the
The Committee accepts that it is important the APVMA has direct contact
with industry groups and applicants, and responds to broad industry concerns. While
the Committee acknowledges the efforts of the APVMA to make assessment
requirements clear to applicants, there is considerable scope for a more
formalised and ongoing engagement.
The Committee recognises merit in re-establishing an industry advisory
committee or establishing a similar liaison forum. The purpose of the
communication mechanism would be to discuss the needs of those who use and rely
upon the APVMA's services. While it is not the role of the Committee to
prescribe the nature and form of any such forum, as this is a matter for the
APVMA and involved industry stakeholders to develop, consideration should be
given to ensure that there are adequate opportunities to discuss specific
issues, for instance plant, pests or veterinary medicines. Furthermore, any
such forum should provide for broad, representative membership and develop
clear terms of reference which set out the working arrangements. To provide for
greater transparency, the minutes of meetings of the liaison forum or
committees should be recorded and published in a timely manner.
The Committee therefore recommends that the APVMA, in cooperation with
industry, develop a liaison committee or forum to facilitate open and
transparent communication between industry and the APVMA.
6.50 The Committee recommends that the Australian Pesticides and
Veterinary Medicines Authority consults with key stakeholders to establish a formal
mechanism for ongoing liaison and discussion. The forum should develop clear
terms of reference which set out its working arrangements, and the minutes of
each meeting should be recorded and made public in a timely manner.
APVMA's process for chemical
The Committee acknowledges the significant concern expressed by some
submitters as to the APVMA's process and schedule for the review of agvet
chemicals, some of which were grandfathered into the NRS, having been assessed
under previous standards.
The Committee received evidence of the APVMA's Chemical Review Program
and examined its chemical risk process, which combines hazard and exposure
assessments through a weight-of-evidence approach.
As to the timing of reviews, the Committee acknowledges the diverse
views with regard to risk-based versus scheduled review of agvet chemicals. The
Committee supports the APVMA's current risk-based approach to chemical
reconsideration, believing it strikes an appropriate balance between community
safety and access to chemicals. This approach allows the regulator to
reconsider a chemical whenever it identifies evidence that would support
The Committee is concerned, however, about the delay in the current
schedule of reconsiderations and encourages the APVMA to ensure sufficient
resourcing is dedicated to this task.
Reconsideration of glyphosate, and its
use in Australia
The Committee considered the approach taken by the APVMA in its
reconsideration of glyphosate following the IARC classification of the chemical
as 'probably carcinogenic to humans'.
The Committee acknowledges the range of strongly-held views about the
APVMA's decision on glyphosate. However, it considers the APVMA's scientific
processes to be robust, noting that all 264 of the studies referenced in the
IARC report were independently evaluated by the OCS, in addition to other
studies and data.
Further, the Committee was informed that the regulator did not receive
any new scientific evidence during the consultation period relating to the
possible carcinogenicity of glyphosate that it had not already considered.
The Committee points out that many of the concerns raised about the
APVMA assessment are addressed in the APVMA's Final Regulatory Position
report on glyphosate and in other APVMA material about the decision.
The Committee recognises the centrality of glyphosate to the
sustainability and productivity of Australian farming. It is concerned,
however, that neither the government nor industry has contemplated a loss of
access to glyphosate or the impact in Australia of a ban on glyphosate overseas.
While the Committee does not hold a view on alternative methods of pest
control to glyphosate, it recognises the need to consider alternative
techniques and methods that can be used to manage pests when glyphosate is not
accessible. However, the Committee also appreciates that concerns regarding
viable alternatives to glyphosate stem from a broader problem of limited
investment in innovation and research.
The Committee was very concerned by evidence that international chemical
companies are reluctant to contribute resources towards research, development
and innovation to address Australian‑specific pests and circumstances,
particularly at a time of growing pest resistance. The Committee appreciates
that Australia's small market has placed it at a competitive disadvantage
globally and that research and development to discover new products is an
Nevertheless, the Committee is of the view the lack of research and
development for Australian‑specific conditions—whether for chemicals or
other weed control strategies—has the potential to endanger the productivity
and sustainability of Australia's agricultural industries.
The Committee supports the innovative programs run by the GRDC and other
research organisations, to develop pest solutions for Australian‑specific
conditions. However, it believes these programs are not sufficient to address
the current situation.
The Committee is of the view that the Australian Government cannot wait
for clear market failure or the development of uncontrollable pests before
taking stronger action. Accordingly, the Committee recommends the development
of a coordinated national approach to agvet innovation, by way of a national
strategic plan. The plan should be underpinned by an audit of areas where
alternative chemicals or practices are not available to the Australian market
and an evaluation of existing and developing pesticide and herbicide resistance.
The Committee further suggests that sufficient funding be made available to
implement the strategic plan.
6.65 The Committee recommends that the Australian Government develops
and implements a national strategic plan for agricultural and veterinary pest-control
innovation, which addresses Australian‑specific environmental conditions
Transparency and community confidence
Whilst stakeholders with active and regular engagement with the APVMA
spoke of their confidence in the regulator's scientific rigour, others
questioned its impartiality, processes and evaluations. The Committee
recognises there are concerns in some areas about the quality of decisions made
by the regulator, particularly from organisations and individuals who do not
have direct or regular contact with the authority.
The Committee heard concerns about a potential conflict in the role of
the APVMA to protect the community, promote ecologically sound development, and
further trade. It considered evidence that a product-specific focus to
assessments failed to take into consideration cumulative exposure to agvet
chemicals and that regulatory science was not sufficiently precautionary. The Committee
also considered concerns raised during the inquiry that the evidence upon which
the APVMA relies to make assessments is not publicly available for peer review;
and that the APVMA did not consult the community.
The Committee recognises the concerns expressed by a number of stakeholders
about the APVMA's processes. The Committee did not receive evidence that would
lead it at this time to question the scientific basis of the regulator's
assessments. The Committee believes the APVMA, through its regulatory approach
to the evaluation of data, balances the need to ensure community safety whilst
also supporting the viability of Australian agriculture. The Committee received
several examples of the APVMA's independence in the face of strong industry
resistance and of the APVMA's efforts to promote transparency by regularly
publishing material, including its decisions.
Nevertheless, the Committee believes that the industry and the regulator
both need to consider the industry's social licence to operate—not in terms of
compromising the scientific basis of the decisions made by the regulator, but
in communicating more effectively with the community about decisions, processes
The Committee acknowledges the reservations some stakeholders have
expressed about the responsiveness of the APVMA to community concerns and the absence
of general community consultation processes. It is concerning to hear of the
lack of confidence some in the community have in the scientific basis of the
The Committee notes the authority has no proactive means to engage with
consumers and others concerned about its procedures and assessments. This
absence of engagement can lead to a perception that the regulator's assessments
are flawed, despite the regulator's international reputation for robust,
As detailed in this report, there are other regulators that have
established robust, community-focused communication mechanisms. The Committee
encourages the APVMA to draw on the experience of these regulators, in
particular the UK Pesticides Forum and the United States EPA Pesticide
Program Dialogue Committee (PPDC) and develop its own communication mechanism
Drawing upon the cases of other regulators, the Committee believes there
would be much benefit in the establishment of a pesticides forum, based on the
UK or PPDC model that would bring stakeholders from all sectors together to
discuss issues of mutual concern and to express these concerns to the
appropriate government agencies.
The Committee believes an appropriately constituted forum could go some
way to allowing the APVMA to communicate its complex processes and procedures more
effectively. It would also enable the regulator to detail the extent of its
scientific assessment of applications, including supporting data. Furthermore,
through such a forum, the APVMA and industry could more directly address
community concerns. Conversely, such a forum would permit the public to
question the APVMA, to raise concerns and develop a more informed understanding
of the APVMA's regulation.
The Committee therefore recommends that a study of the UK Pesticides
Forum and the EPA's PPDC be undertaken with a view to establishing a similar
forum in Australia. The forum should have established aims, terms of reference,
and objectives; include diverse and representative membership; make publically
available its discussions and deliberations; and have its operating costs
funded by government.
6.76 The Committee recommends that the Department of Agriculture and
Water Resources and the Australian Pesticides and Veterinary Medicines
Authority undertake a formal study of the United Kingdom Pesticides Forum and
the United States Environmental Protection Agency Pesticide Program Dialogue
Committee with the aim of establishing a similar forum for the Australian
Senator Glenn Sterle
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