Dissenting report – Australian Greens
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has
only just gained the legislative triggers it needs to systematically review and
quickly remove highly hazardous and unmanageable pesticides from the market if
they fail to meet today’s scientific and regulatory standards, making way for
safer, greener pesticides.
It is extremely disappointing that these important and long overdue
amendments due to come into effect in July are being unwound. The re-approval
and re-registration scheme would ensure Australia finally undertook a
systematic review of its ag-vet chemical inventory, many of which have never
been subject to contemporary risk assessment and are not considered safe by
any modern measure, yet persist in our community.
Legislated risk-based re-registration schemes operate in the USA, Canada
and the European Union. The key focus of re-registration in these jurisdictions
is to ensure older pesticides on the market are subjected to the same standards
applied to pesticides registered today.
Australia has a problem and the re-registration scheme is designed to
fix it. Australia has hundreds of pesticides that were ‘grandfathered’ into the
National Registration Scheme that have never been risk assessed. These products
are sold and used today and the risks they pose to the community, the
environment and trade have never been quantified and the risk management
strategies needed to control their negative impacts have not been specified.
Without re-registration, the APVMA will continue to operate in much the
same way it always has with respect to chemical reviews and the fundamental
problem of inadequately assessed pesticides remaining on the market will not be
The APVMA has a poor track record with its chemical review program with
many high risk pesticides under review for 10-15 years without adequate action
being taken to mitigate risks, or indeed remove pesticides from use that are
clearly just too dangerous.
Without a re-registration scheme, the APVMA has only an ad hoc approach
to chemical review. There is no rationale in what ends up on the chemical
review list and no guarantee that regulatory effort will be focused in on the
pesticides of greatest risk.
According to the submission to the Senate Rural and Regional Affairs and
Transport Legislation Committee Inquiry by the Queensland Government (the
control of use regulator):
The general concept of re-registration and re-approval has
merit and is utilised by many overseas regulators as a way of ensuring that
agvet chemicals have been approved by modern risk assessment principles. In
Australia, there are a large number of uses if agvet chemical products that
were approved by the registration system of the States and Territories, prior
to the formation of the APVMA that have not been reassessed by modern risk
One of the great promises of national registration was that
the ‘grandfathered’ products would be re-assessed. There has been limited
progress in re-assessing the uses of these products under the APVMA Chemical
The re-approval and re-registration scheme does not undermine a
risk-based regulatory scheme - it enhances it. The current situation saw
hundreds of products permitted to be on the market without ever having been
risk-assessed to contemporary standards, and they’re not likely to be under the
Governments proposed ad hoc approach, this isn’t a rigorous science-based risk
assessment scheme; it’s hit and miss regulation.
The re-registration scheme is based on scientific information and
designed to make sure full chemical risk assessment reviews are done on the
most high-risk products. In the first instance, the re-registration scheme
sorts chemicals based on high, medium or low risk with hazard criteria helping
to inform this sorting process. For instance, if a pesticide causes cancer and
bioaccumulates in our bodies and the environment, then it should go to the top
of the list as a high priority.
Once sorted, the regulator determines whether they are satisfied based
on the science before it for that the product can continue to be used safely,
or whether it needs to conduct a full risk-assessment to ensure the product can
continue or not. If there are no concerns and current risk management
statements are adequate, then the pesticide doesn’t undergo full
There’s been a lot of discussion about hazard versus risk during this
inquiry and these are terms that need to be understood in the context of
chemical regulation. A risk assessment is a ‘science-based tool’ while ‘a
hazard-based approach takes away the scientific rigour of risk assessments.’
The Australian Greens support the retention of the risk based framework,
however we do not agree with the assertions that last year’s reforms undermined
Re-regulation is still a risk-based process, even though it is initially
informed by hazard assessment. Nor are the initial hazard assessments
fundamentally different to risk assessments in this context. They are still
based on the same toxicological and epidemiological research as risk assessment
(obviously, since risk assessment is the next step after hazard assessment).
Risk assessment uses an extra set of data (exposure scenarios) but
whether or not that makes it ‘more science-based’ must surely depend on the
quality of the science behind the extra data. An extra volume of data does not
necessarily improve the management of risk from a chemical; risk can still be
underestimated because an absence of data or because the impact of an exposure
to that chemical is simply too complex to model.
This is why in some circumstances a line needs to be drawn in the sand,
even within a risk-based system. There are some pesticides that simply cannot
be risk-managed and this must be acknowledged. The global direction is to move
away from highly hazardous pesticides towards safer ones and Australia
shouldn’t be left behind.
As new evidence emerges about the possibility of low-dose effects,
cumulative toxicity of mixtures, endocrine disruption and so forth – all new
developments unanticipated by risk assessment practices in the past, the
Regulator needs a process in place to respond to the information.
If re-registration were to be repealed, we would return to the status
quo whereby the Regulator would be reliant on an ad hoc chemical review program
to address the problem of the hundreds of pesticides ‘grandfathered’ onto the
National Registration Scheme that have not been adequately risk-assessed.
While comparable jurisdictions like the USA and Canada move ahead with
legislated re-registration programs to ensure the ongoing safety of their
pesticide inventories, Australia will continue to lag behind, putting its
farmers, consumers, environment and trade at risk.
The science of toxicology is undergoing a revolution with the
recognition of unintended impacts of pesticide exposure on our health and the
environment. The role that environmental pesticide exposures might play in the
development of certain cancers, Parkinson’s disease and metabolic disorders for
instance is currently subject to a great deal of scientific scrutiny.
Leaving the APVMA without a systematic mechanism to bring products back
before it for assessment is asking them to regulate with one hand tied behind
their backs. Science is always changing and throwing up new concerns, community
expectations are changing and farmers need the safest tools to use.
The Australian Greens support the retention of the re-registration
program. However, if re-registration is removed from the Act, then including
criteria that will ensure high priority pesticides are identified quickly and
–re-assessed is vital. The Greens recommend that the triggers outlined in the
letter from then Minister for Agriculture Senator Ludwig, tabled as part of the
debate on the APVMA Amendments last year and included as an appendix to these
comments, be incorporated into the APVMA Act itself rather than left in
On toxicity to humans and wildlife:
- chemicals in Schedule 7 of the Poisons Standard, that is,
dangerous poisons with a high potential for causing harm at low exposure and
which require special precautions during manufacture, handling or use;
On bioaccumulation, about chemicals that accumulate in fatty tissues:
- chemicals with a recognised bioconcentration factor of greater
than 500, or with an octanol/water partition coefficient of greater than 4;
On degradation and persistence, chemicals that remain intact for
exceptionally long periods of time:
- chemicals that do not rapidly degrade (assessed using OECD test
guidelines 301 or 306) or chemicals with a half-life in water greater than two
months or in soil or sediment greater than six months;
- the absence of rapid degradation in the environment can mean that
the substance in water can exert toxicity over a wide temporal and spatial
On long range transport, potential for wide distribution throughout the
- chemicals that don’t rapidly degrade and which may be used in
circumstances that can lead to transport beyond the target use site, chemicals
measured at levels of concern in locations distant from release.
These criteria can be satisfied by prescribing all substances that are
classified as chronic Category 1 under the United Nations’ Globally Harmonised
System of Classification and Labelling of Chemicals (GHS) and that are included
in Schedule 7 of the Poisons Standard maintained by the Department of Health
and Ageing. The letter notes that DAFF’s initial assessment was that there are
around 42 substances that would meet these criteria.
Furthermore, one or more comparable jurisdictions having banned or
severely restricted a pesticide should also be incorporated as triggering a
review by the APVMA, if re-registration is repealed.
In conclusion, The Australian Greens believe that unwinding the
re-registration scheme will re-introduce the assumption that a pesticide is
‘innocent’ of any negative impacts until it’s proven ‘guilty’, beyond a doubt
that damage is occurring from it. This benefits chemical corporations, not the people
or the environment. It is well overdue for Australia to develop a systematic
approach to removing previously untested chemicals from the market. The
re-registration scheme remains the most rigorous, cost-effective and efficient
approach to achieving that outcome.
For these reasons, the Australian Greens recommend that this Bill not be
Senator Rachel Siewert
Australian Greens Senator for Western Australia
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