Chemical reconsideration and innovation
4.1
The APVMA has a formalised process for chemical reconsideration and a
program for chemicals subject to review that is based on assessment of risk,
rather than a pre‑determined schedule. The risk principle establishes a
balance between protecting community safety and maintaining access to safe and
effective chemicals.
4.2
The APVMA's reconsideration of glyphosate, a chemical that is commonly
used and essential to current farming methods in Australia, has been subject to
intense scrutiny, particularly in response to a perceived disagreement with the
evaluation undertaken by the International Agency for Research on Cancer (IARC).
While the APVMA's chemical risk and weight-of-evidence approach contrasts with
the IARC's hazard-based assessment, perceptions of a disagreement between the
two demonstrate the challenges for the APVMA in educating and informing the
general public of its approach.
4.3
The case of glyphosate has also raised the issue of alternative chemical
use and the barriers to innovation and investment for the Australian market for
Australian‑specific pests. This chapter explores the chemical review
process and evidence provided to the committee in relation to it.
Reconsideration (chemical review)
4.4
The APVMA has a legislated process, through its Chemical Review Program,
to undertake a formal chemical review (or reconsideration) of active
constituents after they have been approved or registered in Australia. This
allows the authority to take into consideration new and/or emerging scientific
information that could change the approved chemical's risk to human health, the
environment, animal or crop safety, or trade. Typically, an APVMA review might
focus on one or more areas, including environmental safety, worker safety,
public health, residues, trade or efficacy.[1]
4.5
A formal reconsideration process, under the Chemical Review Program, is
initiated when new scientific information raises concerns relating to the
safety or effectiveness of a pesticide or veterinary medicine. It incorporates
legislative, administrative and scientific elements, which inform a final
decision to affirm, vary, suspend or cancel an approval or registration.[2]
4.6
The APVMA observed that the process could be complex, requiring
significant organisational resources and time. During the assessment phase of a
reconsideration, companies must submit a range of data, which might include
laboratory studies, the results of field trials, target animal or crop studies
and human studies. These are scientifically assessed. Under current
legislation, reconsiderations must be completed within a maximum timeframe of
57 months.[3]
4.7
The Committee received evidence that this timeframe was not always met. For
example, the National Toxics Network stated the chemical chlorpyrifos had been
under review by the APVMA for 22 years.[4]
4.8
The Australian Food Sovereignty Alliance also raised concerns with
reconsideration timeframes and processes, stating:
Despite there being hundreds of chemicals on the market, the
APVMA has only prioritised five chemicals for reconsideration in the next 5
years. And of the 11,700 toxic pesticides registered, only 13 are being reviewed.
In terms of timeliness...a review of Chlorpyrifos began in 2009, Diazinon in
2003, and Paraquat 1997, but all are incomplete. By contrast, APVMA has
completed assessment of 757 new chemical applications since September 2018.[5]
4.9
The APVMA acknowledged its chemical review program was behind schedule,
but told the Committee that the risks were being managed. Dr Parker, CEO of the
APVMA, explained:
It is routine for the APVMA to take interim regulatory action
in the early stages of a chemical review to suspend registration, remove uses
or adjust label directions as a precaution. It is also common for us to
reinstate uses once they've been assessed by additional data that is provided
throughout the review process and that is finalised in our regulatory decision.
We did this with dimethoate, diuron and [f]enthion. This is the system working
as intended. It balances the spectrum of community, user and industry
perspectives by applying the scientific evidence to what can only be at times
an emotive debate over the safety of agriculture and veterinary chemicals.[6]
Chemicals subject to review
4.10
Over 5,000 agvet chemical products currently available in Australia were
registered under prior legislative arrangements, often involving less rigorous
assessments, some of which date back to the 1950s. These chemicals, previously
approved by the states and territories, were grandfathered into the NRS in
1995. The development of the NRS came out of a 1991 agreement between the
Commonwealth, states and territories to place under one national umbrella the
assessment and registration of all agvet chemical products, which had hitherto been
undertaken independently by the Commonwealth and each of the states and
territories.[7]
4.11
Initially over 300 chemicals on the NRS were nominated by stakeholders
as potential candidates for review. Ultimately, a priority list of 80 was
established. In the years since the Chemical Review Program has been operating,
an additional 80 chemicals have been nominated and prioritised for inclusion on
the review list with the original 80 chemicals. Of the chemicals on the review
list, 75 had been completed by 2014.[8]
4.12
The APVMA's process to identify and nominate chemicals for review remains
ongoing. In 2015, the APVMA consulted the public, industry and federal and
state government agencies on the prioritisation of 19 chemicals (or types of
chemicals) it had identified for review. Five chemicals were prioritised for
detailed scoping with the remainder prioritised once the first five had been
commenced.[9]
4.13
The Committee heard evidence that between 20 and 30 chemicals currently
sold in Australia had been either banned by other jurisdictions or were under
serious review in other jurisdictions—some of which were grandfathered into the
NRS.[10]
4.14
Bayer Crop Science responded to these claims and suggested that for insecticides
and herbicides, 'there may be a difference between Europe and Australia',
though they were not aware of any differences in registrations between the
United States and Australia.[11]
4.15
Bayer Crop Science went on to suggest that the differences in
registration could depend on the types of data requirements of regulators:
In the EU right now, there's a guidance document that makes
it extremely difficult to conduct the study in a way that can satisfy the
requirements, so it's almost impossible to get through. That can raise an
issue, whereas, in the risk based system that you have here in Australia or in
the US or Canada, there are ways to tier those studies to make sure your
product is safe, can be used safely and won't harm the environment but also is
going through a reasonable scientific assessment.[12]
Differences between jurisdictions—risk
and scheduled review
4.16
International regulators may use periodic reviews to conduct a re‑evaluation
of chemicals from first principles against contemporary standards, or target re‑evaluations
based on new information that addresses regulatory standards introduced since
initial registration.[13]
4.17
For chemical review, other national regulators often operate under
either risk‑based principles or legislated timeframes. For instance, the
Canadian PMRA has a legislated 15‑year re‑evaluation cycle to
ensure products meet the latest health and environmental risk assessment
standards. The European Union combines a risk‑based approach with a
maximum review period of 15 years. The United States Environmental Protection
Agency (EPA) has a 15‑year review period. Brazil has a risk‑based
approach.[14]
4.18
The APVMA's review program is risk‑based. A review is considered
when new scientific information becomes available that suggests there may be a
change in the risk posed by a product. In 2013 and 2014, the authority was
briefly required to conduct automatic reviews of all registrations according to
certain specified timeframes. The 2013 Amendment Act inserted into the Agvet
Code Act a requirement that the existing approvals and registrations of
active constituents and chemical products operate for a finite period; and when
that period elapsed, a new application was to be lodged for re‑approval
or re‑registration.[15]
The Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re‑approval
and Re‑registration) Act 2014 repealed this provision.[16]
4.19
Many witnesses and submitters favoured a risk‑based approach to re‑evaluation.[17]
One consideration emphasised in submissions was the adverse consequences of the
cost to industry of providing the information required by the regulator during
the review process. These costs would be exacerbated if scheduled (rather than
risk-based) reviews were enforced. DAWR stated the cost to industry in
addressing a review had 'resulted in the withdrawal of some chemical products
from the market in the absence of identifiable concerns for human, animal or
environmental health'.[18]
4.20
This perspective, particularly in the case of chemicals with a small
(yet important) market in Australia, was supported by the Australian Glyphosate
Sustainability Working Group.[19]
Chemistry Australia also spoke in support of a risk‑based approach,
stating:
In the context of our economy and the size of our economy, a
reconsideration process akin to what they have in the United States would be
costly, cumbersome and probably not deliver a lot better outcome.[20]
4.21
Mr Bernard Lee, Director of Policy and Regulation at Chemistry Australia
further explained that in the United States, the fact that the chemistry is
under constant review creates its own obstacle to market entry and can result
in farmers potentially paying more for the chemical products. Mr Lee continued:
If you wanted to duplicate that in this country, the market
size is not large enough to be having all of the companies involved generating
data on an ad hoc basis for a chemical review program. It is far better that it
be targeted at the risks associated. That's the beauty of the system we have—the
regulator can respond. If it identifies concerns—if there are community
concerns or if there are international developments that it becomes aware of—it
can respond and place a chemical under review.[21]
4.22
The Australian Glyphosate Sustainability Working Group described the
consequence of undertaking compulsory reviews of all products, and the impact these
reviews would have on companies:
The APVMA is looking after hundreds of active ingredients
and, if we were to have a review time frame that was too short, they'd be doing
nothing but reviewing existing products, which would just waste everybody's
time...One of the issues we have with reviews of agricultural products is that,
once products are off‑patent, companies are much less likely to do any
work to protect those products in the marketplace because the return on the
investment is going to be very small because you have a large number of generic
players. So, part of the risk we would run in having a too tight or a too firm
review process is that products which have been perfectly safe and with which
we've had years and years of safe use would simply not be reregistered because
nobody would present the data. They couldn't make any money out of doing so
because of all the generic players in the marketplace. We have hundreds of
generic players in the marketplace in Australia.[22]
4.23
CropLife Australia also raised the workload associated with scheduled re‑evaluation
and drew upon the example of Canada, which has a 15‑year re‑evaluation
for registered pesticides. It was noted that the re‑evaluation workload was
not sustainable, with the agency lacking resources to manage upcoming scheduled
re‑evaluations. The PMRA had almost double the staff of the APVMA.
CropLife Australia also provided evidence of the regulatory burden of scheduled
re‑evaluations (and their delays) in the EU and the United States.[23]
4.24
The APVMA, given the nature of the formal process, stated that it 'seeks
to address regulatory issues pragmatically by exploring alternative regulatory
and non‑regulatory pathways before deciding to conduct a review'.[24]
4.25
DAWR noted that although there were different triggers for regulatory
reconsideration in other similar agencies located in international
jurisdictions, once started, APVMA reconsiderations were 'comparable in their
assessment rigour once evaluation has commenced'.[25]
APVMA chemical risk approach
4.26
As with regulators in other countries, the APVMA undertakes a risk‑based
weight‑of‑evidence assessment to determining chemical risk.[26]
A risk‑based assessment includes a hazard assessment and an exposure
assessment. It draws upon evidence reproduced independently by different
researchers.[27]
Risk assessment: hazard assessment
and exposure assessment
4.27
A hazard assessment examines the data related to the intrinsic toxicity
potential of an active ingredient and/or formulated product, and is the first
step in determining whether a chemical poses an undue risk.[28]
4.28
An exposure assessment involves an examination of the likely exposure of
humans and environmental organisms to a chemical, and considers how the
chemical product is intended to be used, the type and formulation of the
product, and the crops or animals to be treated.[29]
4.29
By combining these two elements, the APVMA assesses the likelihood and
extent to which an adverse outcome would occur if the product was used
according to the instructions on the approved product label.[30]
Weight‑of‑evidence
assessment
4.30
In a weight‑of‑evidence assessment, data is considered
validated when it is reproduced independently by different researchers. This
type of assessment considers the number of studies reporting a particular
conclusion and the quality of the study design and data evaluation.[31]
4.31
Although there was significant support for the APVMA's chemical
risk approach, several submitters were critical of it (for both initial
assessment and reconsideration), calling instead for the introduction of a
system based on the precautionary principle.[32]
Gene Ethics explained that in the European re‑approval and re‑registration
process, which is based on the precautionary
principle, 'if registrants do not come up with the evidence to show their
products are safe, they are deregistered'.[33]
This issue is discussed further in chapter 5.
Glyphosate
4.32
The case of the glyphosate re‑assessment is illustrative of the
broad range of factors that bear upon the work of chemical regulators.
4.33
In 2015, the World Health Organization's IARC evaluated glyphosate as 'probably
carcinogenic to humans'.[34]
In the same year, the APVMA proactively self‑nominated glyphosate for
reconsideration.[35]
4.34
The Committee was told there had been considerable community concern raised
by the IARC report. The Australian Glyphosate Sustainability Working Group
spoke of reactions within the agricultural community:
They [were] concerned about how this has happened, because
they'd been told for years and years that glyphosate was safe, and suddenly
here it was as a probable carcinogen and did they have to worry about it and
those sorts of things.[36]
4.35
More broadly, the Committee was informed that some local councils
were reviewing their use or had stopped using Roundup (glyphosate) for weed
management.[37]
Some submissions to the inquiry drew on the IARC
report to call for further examination of glyphosate while others called for it
to be restricted or phased out on the basis that there remained too many
questions as to the chemical's safety.[38]
Gene Ethics was of the view that:
Overall it is fair to say that IARC conclusions call into
question the safety of GBHs [glyphosate‑based herbicides] beyond 'reasonable
certainty of no harm'...To improve GBH safety standards...the following [should] be
urgently undertaken...:
-
human biomonitoring for glyphosate and its metabolites;
-
prioritisation of glyphosate and GBHs for hazard assessments,
including toxicological studies that use state‑of‑the‑art
approaches;
-
epidemiological studies, especially of occupationally exposed
agricultural workers, pregnant women and their children; and evaluations of
GBHs in commercially used formulations, recognising that herbicide mixtures
likely have effects that are not predicted by studying glyphosate alone.[39]
APVMA assessment of glyphosate
4.36
The APVMA commissioned the Office of Chemical Safety (OCS) within the
Department of Health to undertake a two‑phase review of the IARC report:
-
phase 1: a preliminary scoping review of the IARC report to
determine the relevance of the glyphosate classification as 'probably
carcinogenic to humans' and the implications for glyphosate approvals and
registrations in Australia; and
-
phase 2: detailed assessment of studies identified during the phase
1 assessment which required further evaluation.[40]
4.37
The APVMA also evaluated the studies referenced in the IARC report, as
well as other studies and data, including recent international assessments of
glyphosate undertaken by other regulators.[41]
4.38
The APVMA received 197 submissions during a consultation period on the
proposed regulatory position report and the OCS reports between 30 September
2016 and 30 December 2016. Submissions were received from:
-
representatives of growers who use glyphosate (2);
-
representatives of non‑government organisations (8);
-
private business (1); and
-
members of the public (186).[42]
4.39
The APVMA noted that the majority of submissions received were beyond
the scientific scope of the APVMA's assessment; and no new scientific evidence
relating to the possible carcinogenicity of glyphosate not already considered
by the APVMA was received during the consultation period.[43]
4.40
In March 2017, the APVMA released its final regulatory position on
glyphosate, which stated:
Based on this nomination assessment, the APVMA concludes that
the scientific weight‑of‑evidence indicates that:
-
exposure to glyphosate does not pose a carcinogenic or genotoxic
risk to humans
-
there is no scientific basis for revising the APVMA's
satisfaction that glyphosate or products containing glyphosate:
-
would not be an undue hazard to the safety of people exposed to
it during its handling or people using anything containing its residues
-
would not be likely to have an effect that is harmful to human
beings
-
would not be likely to have an unintended effect that is harmful
to animals, plants or things or to the environment
-
would be effective according to criteria determined by the APVMA
by legislative instrument, and
-
would not unduly prejudice trade or commerce between Australia
and places outside Australia.
-
there are no scientific grounds for placing glyphosate and
products containing glyphosate under formal reconsideration
-
the APVMA will continue to maintain a close focus on any new
assessment reports or studies that indicate that this position should be
revised.[44]
4.41
The APVMA responded to questions about the comprehensiveness of its re‑evaluation
of glyphosate during a public hearing. Dr Parker stated:
When the APVMA looked at the International Agency for
Research on Cancer's report on glyphosate, we evaluated all 264 studies
referenced in that report, plus further studies and data. We took the time to
get the science right. We found that, on balance of scientific information, we
did not have a need to change our stance on glyphosate.[45]
4.42
Many submissions to the Committee supported the APVMA's assessment.[46]
However, some interpreted it as contradicting the IARC findings (and other
international evidence). A significant number of submitters argued there was
sufficient publicly available evidence that demonstrated the dangers of
glyphosate, and that this evidence had been ignored by the regulator.[47]
4.43
Academic and research scientist, Dr Ian Musgrave, indicated that he had examined
the process used by the APVMA in its review and advised the Committee:
I checked the APVMA review against the similar reviews produced
by the EFSA, the ECHA and the US EPA and compared what they reviewed, how they
reviewed it and the depth of the review. My conclusion was that the APVMA had
done a comparable job to other regulators in coming to their conclusion.[48]
4.44
Bayer Crop Science gave evidence to the Committee that there was no
engagement by Monsanto Australia with the APVMA as part of APVMA's review 'on
any matters of substance'. However, there had been limited communication at
relevant times about the APVMA's intentions for the review with regard to
process and timing, and to clarify the scope of the review. Bayer Crop Science
stated 'the review undertaken by APVMA was independent of any input from
Monsanto Australia'.[49]
IARC assessment
4.45
The IARC report (referred to as a monograph) on glyphosate was an
evaluation of cancer hazard—defined as 'an agent capable of causing cancer
under some circumstances'. This differed to an evaluation of cancer
risk—defined as 'an estimate of the carcinogenic effects expected from exposure
to a cancer hazard'.[50]
4.46
The IARC emphasised the distinction between hazard and risk, stating that
its Monograph publications 'identify cancer hazards even when risks are
very low at current exposure levels'.[51]
4.47
The classification given by the IARC to a chemical is based on the
strength of the evidence that an agent causes cancer. It is a measure of how
confident the scientists who undertook the evaluation are that an agent causes
cancer in humans. As a consequence, elements with different potencies can be
placed in the same classification. The IARC cites the case of tobacco,
plutonium, diesel engine emissions, hepatitis viruses and processed meat as having
sufficiently strong evidence to classify them in the same group of cancer‑causing
agencies—group 1.[52]
4.48
Given its stated purpose, the IARC report examined the intrinsic
toxicity potential of glyphosate as a cancer‑causing agent only. The IARC's
evaluation consulted epidemiological studies that examined the circumstances
under which human exposure occurs and at what levels. However, according to the
APVMA, the assessment did not specifically consider risk management in actual
use situations, nor did it examine the risk of cancer when glyphosate was used
according to label instructions in a registered chemical product.[53]
4.49
The IARC stated that identifying a carcinogenic hazard, based upon
observable data, was a first step in risk assessment and management. It deferred
risk assessment and risk management to national and international bodies;
judging that risk assessment involved extrapolation beyond observed data, and
risk management included social, economic and political considerations.[54]
4.50
Dr Musgrave summarised the findings of the IARC report, observing:
The IARC concluded that glyphosate was a probable human
carcinogen. They made that ruling independent of whether humans will be exposed
to the levels of glyphosate that could potentially cause any form of cancer...it
picks up hazards. Then it is up to the regulators...to make regulations based on
their understanding of the data that the IARC brings forward.[55]
Use of glyphosate in Australia
4.51
Bayer Crop Science estimated that around $400 million of glyphosate‑based
products were sold in the Australian market each year—the largest selling agricultural
chemical product on the Australian market.[56]
The Committee was also told glyphosate had been crucial to growth in farming
productivity in Australia's dry conditions.[57]
4.52
The Committee was advised that herbicides, including glyphosate,
contribute to the preservation of soil health and stored carbon through their
ability to facilitate no‑till (or minimum till) farming practices; and
through reducing chemical use in genetically modified canola systems.[58]
4.53
Bayer Crop Science elaborated on what it saw as the benefits of
glyphosate:
It really has enabled the uptake of zero‑till farming,
and, without those sort of practices, we wouldn't be able to store moisture
over summer and we wouldn't be able to have more reliable cropping systems, and
I think we've also seen higher yields. But we've also seen some environmental
benefits around the reduction in tillage, and the reduction in wind and water
erosion.[59]
4.54
Around 85 per cent of growers in Australia were estimated by Grain
Producers Australia to have adopted no‑till production systems, one of
the highest rates in the world.[60]
Chemistry Australia gave evidence that glyphosate:
...has led to more sustainable agriculture, particularly the
practices of minimum till. Minimum till reduces agricultural CO2
emissions and it aids in the retention of soil moisture. Without advances like
this from chemistry, we might well be sitting here today discussing the loss of
Australia's prime agricultural land due to soil erosion.[61]
4.55
Grain Producers Australia also observed that 'farmers today are growing
a lot more on a lot less moisture with the technology that's available to us.
One of those key parameters for us is the use of glyphosate in terms of that minimum
tillage and stored water'.[62]
4.56
Given its centrality to contemporary farming methods, the Committee received
evidence regarding the impact that the loss of glyphosate would have. The
Grains Research and Development Corporation stated that, 'if glyphosate, for
some reason, were no longer available and herbicide resistance continues to
spread, it will cause pain to our grain growers'.[63]
This was confirmed by GrainGrowers, which pointed out:
When we consider Australian grain farmers, we're talking
about a group of a bit over 20,000 farm businesses who sustainably manage over
20 million hectares of Australian agricultural land, so there is a very large
area that they look after and manage. And, if we think about those growers, if
there were an immediate ban on, or removal of, glyphosate from the system, that
would have absolutely catastrophic short‑term impacts on Australian
production systems.[64]
4.57
AgForce Queensland agreed with other stakeholders about the significant
consequences should glyphosate become unavailable, stating:
If, from public pressure and lack of trust, social licence
caused the loss of glyphosate, the farming sector—our grain areas, our cane
areas and all those areas—would no longer be able to do minimal till and no
till. They would have to go back to tilling the land, which is digging up the
soil, because minimum till and no till require herbicides to suppress the
weeds, and that organic layer is keeping those soils protected until you plant
your crop.[65]
4.58
The NSW Farmers' Association described the potential impacts of removing
glyphosate from agricultural activities and estimated that without glyphosate:
There would be an annual environmental loss associated with a
net increase in the use of herbicides of 8.2 million kg of herbicide active
ingredient (+1.7%), and a larger net negative environmental impact, as measured
by the environmental impact quotient indicator of a 12.4%. Also, there would be
additional carbon emissions arising from increased fuel usage and decreased
soil carbon sequestration, equal to the equivalent of adding 11.77 million cars
to the roads.[66]
4.59
Many submitters and witnesses identified the lack of viable alternatives
to glyphosate and the consequences for farming and food production should it
become unavailable or banned in other jurisdictions.[67]
4.60
The National Farmers' Federation contended that this was a particular
concern for an industry that was export exposed.[68]
AUSVEG noted the lack of alternative products, saying it would be 'catastrophic'
to the industry if glyphosate were taken off the market.[69]
Grain Producers Australia agreed, pointing out:
There are no other alternatives at the moment, which is a concern
for industry. We don't have any other alternatives...The ability for us to
produce as we do today will be reduced, because we won't have that
alternative—we'll have to go back to tillage. Burning will become more of a
consequence of that—that's one of the natural weed control methods that we
still have today, but you will see a lot more concentration of that. You will
also see us having to resort to using other products that we don't necessarily
want to use, such as gramoxone and spray seed—those two particular products are
S7 poisons. For farmers, they're products that we don't necessarily like to use...you
would be going back to probably half of the current production area of
cropping. So you take all those things into account, in a growing global climate
of farmers right across the world having to do the same thing, and then we're
in no‑man's‑land.[70]
4.61
The trade impacts of glyphosate's removal were illustrated by Grain
Producers Australia:
If consumers around the world banned glyphosate, particularly
the European Union, that would have a big impact on our marketing of our grain
into those particular markets...they're going to be asking us to do something
that we cannot do in terms of our production system here in Australia. We will
have no other alternative...[71]
4.62
The difficulty of finding viable alternatives to glyphosate was also
made clear to the Committee. CropLife Australia remarked that 'even with US$10
billion of research and development money each year, none of our members have
come up with an alternative yet'.[72]
4.63
However, some submitters contended that there were alternatives to
glyphosate and other chemicals, and these could include: blade cultivation, rod
and saturated steam weeding, swathing (for wet harvest), mechanical slashing,
hand weeding, strategic plantings, and solarizing.[73]
Innovation for Australian conditions
4.64
The glyphosate case raises concerns about the next generation of
pesticides and veterinary medicines, particularly for a country like Australia
that experiences specific conditions and represents a small market when
compared globally.[74]
4.65
The growth of resistance to pesticides in some areas adds urgency to the
situation. Apple & Pear Australia, for example, noted that resistance was
becoming a more serious issue for its industry.[75]
AgForce Queensland stated:
An increasing concern for AgForce is resistance of parasitic
ticks to most acaricides and limited products for goat parasites. There is no
interest from agvet chemical registrants to develop new products for use in
Australia and no catalyst from Australian Government innovation programs to
overcome pesticide resistance.[76]
4.66
Associate Professor Christopher Preston also put forward his views on
the role of pesticides, pointing out:
This reliance on pesticides has come at some cost. Pests are
evolving resistance to pesticides requiring the adoption of new strategies for
pest management and the need for new pesticides. On the other side, Australia
is a relatively small market for pesticides. Internationally, there has been
tremendous consolidation in the agricultural chemical space as companies merge.
This has dramatically reduced the number of companies doing research and
development on new pesticide molecules and frequently these molecules are being
developed for large markets in Europe and North and South America and the main
commodity crops grown in those locations.[77]
4.67
Bayer Crop Science, which completed its acquisition of Monsanto in 2018,
indicated that it spent approximately $2.6 billion each year on research and
development, yet:
The ability to find products has become harder and harder.
Success in finding new compounds takes a lot more investigation and a lot more
time, and there is a much greater cost to bring them to market than ever
before.[78]
4.68
Bayer Crop Science also noted:
Bringing new chemical compounds to market is now much more
difficult than ever. Thirty years ago, an average of one in every ten thousand
compounds that was tested could be developed for commercial release. Now the
rate is only one in every fifty thousand.[79]
4.69
Evidence provided to the inquiry indicated that Australia remains a low
priority for chemical producers. For example, Grain Producers Australia commented:
Australia is no longer on the global priority list for
pesticide and veterinary medicine investment in commercialisation as it was 20
years ago. Australia is also missing out from productivity improvement through
commercial investment in a large number of potential emerging biological,
biochemical and biotechnology based AgVet technologies.[80]
4.70
This point was echoed by AgForce Queensland:
Australia is only a very small part of the marketplace for
most pesticides—I think just over 1.25 per cent of agvet chemicals
internationally are used here—and most of our ticks are more an Australian
pest; they're not in every other country. So, for a lot of the large pesticide
companies, there is insufficient return on investment for them to work on a new
active constituent or a new pesticide that would overcome these issues we get
of pesticide resistance. Because there are millions of dollars that go into
finding a product and doing all the necessary testing to be able to get it
registered, unless a company knows it can forecast sales in that area, it's not
willing to do that work.[81]
Australian conditions
4.71
The Committee heard there have been some programs that aim to address
Australian‑specific pest‑management issues. One program run by the
Grains Research and Development Corporation (GRDC) in conjunction with Bayer
Crop Science has funded 33 postdoctoral positions to explore molecules
effective in Australian conditions on Australian weeds. Under the partnership,
postdoctoral students studied in Germany with Bayer Crop Science. The intent of
the program was to put extra capacity into discovery for herbicides.[82]
4.72
The GRDC reported that it had been working more broadly with the Bayer
herbicide innovation platform so Australian weeds were included in initial
screenings in herbicide discovery, including some resistant species. The early
molecules were then brought to Australia and tested under Australian conditions
against Australian weeds. According to the GRDC, part of the intention of the
work with Bayer was to try to discover new chemistries that had the potential
to replace chemicals like glyphosate.[83]
4.73
Further, the GRDC has worked with the University of Western Australia
under the Australian Herbicide Resistance Initiative to implement harvest wheat
seed control. It was also investigating the use of microwaves and lasers, and
the strategic use of tillage to control weeds.[84]
4.74
Bayer Crop Science's Commercial Operations Lead, Mr Anthony May, argued that
programs like the GRDC postdoctoral program had 'certainly elevated Australia
and Australian weeds in that targeted area—where we might have been left
behind—to larger markets, so I think it's been very effective in that way'.[85]
4.75
The importance of understanding the operation of chemicals in specific
conditions was highlighted by Associate Professor Susan Wilson. Noting that weed
incursions into Antarctica and the sub‑Antarctic are a considerable
threat, she explained that there was a concern about the application of
glysophate in soils in that region when the research on it has been conducted
with different soils and climatic conditions. Associate Professor Wilson
continued:
There's been a little bit on cold climate in the Arctic, in
the Northern Hemisphere. We've done a literature review in the first instance.
As to how we test glyphosate in Macquarie Island soil, we bring back the actual
soil and we specifically look at what would happen in the soil we're applying
it to. We're subjecting it to the lower temperatures and where you might have
higher persistence, a lot of rainfall and greater mobility. We're seeing
whether that is the case or isn't the case for glyphosate in those systems so
that, if a decision does need to be made regarding glyphosate use in weed
management, the regulators have the science to make sound decisions.[86]
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