Australian Greens' Minority Report
The Australian Greens welcome improvements in the regulation of
agricultural and veterinary chemicals however the inquiry identified some areas
that requirement amendments in order to improve the effectiveness of this regulation.
We therefore cannot agree that the bill should proceed without amendments.
There is no doubt that some agricultural and veterinary chemicals have
damaged human and environmental health and continue to pose risks to both. Risk
management should be at the core of any registration program and those
chemicals that pose unacceptable and unmanageable risks should not be permitted
We want the approach to risk taken by the Australian Pesticides and
Veterinary Medicines Authority (APVMA) to reflect contemporary science in
toxicology and regulatory approaches in other countries and we are concerned
this is currently not the case.
There is still too much discretion being given to the APVMA to determine
“undue hazard” to the safety of people and the environment without a suitable
framework under which to determine that risk. These additional comments outline
our concerns and provide recommendations to improve how the APVMA carries out
Conflict of interest
As a fully cost recovered agency, the APVMA can be placed in a position
that gives rise to conflict of interest and is sometimes perceived to be unduly
influenced by the agrochemical industry in its decisions.
The APVMA should come under the responsibilities of either the health or
environment ministers, or a combination of the two so that any potential for
industry’s influence over the APVMA is minimized.
Manageable and Unmanageable risks
The majority report recognises that many chemistries were
‘grandfathered’ into the present national scheme and that it is time to conduct
a full health and environmental risk assessment. Re-registration is a crucial
part of that assessment and the Australian Greens strongly support this work.
However the Australian Greens are concerned that this assessment will be
compromised by a lack of definition around risk.
While the objectives recognise that the use of chemical products that
pose unmanageable risks to the health and safety of human beings, animals and
the environment is not appropriate in Australia, there is no definition of
‘unmanageable risks’ in the Bill or regulations.
Other organisations focused on manageable risk, essentially approaching
the definition problem from the opposite perspective, and the weight of
evidence raising concerns about the lack of definition around risk is
The Australian Greens share WWF’s concerns that as the Bill is currently
drafted, unmanageable chemicals could still potentially get a 7-year
re-approval/re-registration after a 4.5-year review, which effectively means
they could be on the market for another 11.5 years, or possibly longer. In
particular the Australian Greens agree with WWF's assessment that:
In its current form, Schedule 2 is unlikely to quickly remove
the backlog of unmanageable chemistries from the market that no longer meet the
health and safety standards of today because the Bill fails to define
‘unmanageable risks’ and it doesn’t provide clauses for the implementation of
this objective, and the proposed timeframes for review and removal of
unmanageable products from the market are far too long.
This is absolutely unacceptable. It should be a matter of urgency to
identify the chemicals that pose unmanageable risk and fast track this work
within the first 12 months.
Definition of unmanageable risk
WWF provide an example of an internationally accepted definition for a
highly hazardous pesticide that could be adopted in Australia, while still
taking account of unique use and exposure scenarios in Australia:
Highly hazardous [or unmanageable] pesticides are pesticides
that are acknowledged to present particularly high levels of acute or chronic
hazards to health or environment according to internationally accepted
classification systems such as WHO or GHS or their listing in the annexes of relevant
binding international agreements or conventions. In addition, pesticides that
cause severe or irreversible harm to health or the environment under conditions
of use in a country.
Definition of 'meets the safety criteria'
The Bill should also give greater clarity as to how a definition of
unmanageable risk might trigger action by the APVMA.
As well as providing a definition for unmanageable risk, WWF suggested
including an addition clause at 5A(1)(d) which explicitly references
unmanageable risk to ensure that the APVMA can act to address unmanageable risk
and would improve the efficiency of the system by ensuring time and resources
are not wasted assessing unmanageable risks.
That the Bill includes a definition of unmanageable risk in the objects
and the assessment triggers of the Bill.
Toxicity of degradation products and metabolites
In some instances the degradation products and metabolites of an active
constituent, may be more toxic or persistent than the parent compound. If the
APVMA are genuinely conducting a risk assessment to determine “undue hazard” to
people, animals and the environment, this must be taken into consideration. For
the purposes of being satisfied as to whether an active constituent meets the
safety criteria, the APVMA must also assess the toxicity of the degradation
products and metabolites, of the active constituents. WWF suggested the Bill
could be strengthened by including a reference to the toxicity of a chemical’s
degradation products and metabolites in the safety criteria at 5A(2)(a)(i).
Include a reference to the degradation products and metabolites as part
of any reference to toxicity within the safety assessment criteria.
Banned in comparable overseas markets
Submitters expressed concern about the use of chemicals that have been
banned elsewhere but are still used in Australia. Comparable jurisdictions have
since banned some of the chemistries still widely used in Australia, because
they did not meet contemporary health and environmental standards.
Paragraph 47A(1)(a) of the Bill Varying duration-decisions of foreign
regulators, read in association with the Draft Regulations, provide a
process to vary approval periods based on the actions of other jurisdictions,
but conditions which require more than one foreign country to prohibit the use
of a chemical based on a health or an environmental concern are too
Given that the list of ‘regulators that are prescribed by the
regulations’ in the draft regulations does not include all European Union
member states, this section is very limited in its scope. The reason for the
exclusion of EU members is unclear because as WWF note:
Given that the decisions and supporting documents such as
risk assessments from the EU are always provided in English, language should
not be an issue when considering all EU member countries.
WWF recommended that when action is taken in any of the jurisdictions
prescribed under the regulations to prohibit the use of a chemical, based on
health or environmental concerns, 'then that chemical will go to the top of the
list in Australia and the registrant will be given notice, following the
process in the Bill, that the registration will not be re-approved.'
The 7 year time frame in Schedule 2, section 47A is also too
restrictive. Given that Australia still has pesticides registered that have
long been banned in other countries because, after risk assessment, they failed
to meet contemporary health and safety standards and the public’s expectations,
there is no justification why these same pesticides should be considered safe
to use in Australia because those bans have been in place for more than 7
Strengthen the relationship between actions taken by foreign jurisdictions
and Australian decision making.
Onus on chemical companies to prove their products remain safe at regular
The onus is still on the APVMA to prove safety because no minimum data
requirements have been established within Schedule 2, Re-approvals and
Re-registrations for industry to comply with.
As a result, the APVMA is reliant on data and testing from the
manufacturer and the APVMA does not have explicit powers to quickly remove a
chemical or product if there are data gaps in relation to its toxicology or
uses in Australia.
Reverse the onus of proof so that chemical companies have to address
data gaps in order to maintain registration.
Addressing regulatory burdens
Some submitters such as the Animal Health Alliance outlined concerns
that some chemicals also have to go through a Therapeutical Goods Authority
(TGA) registration process. This can result in an extra level of regulatory
red-tape that they felt was unnecessary.
In future reforms the Government should consider excluding chemicals that have
been subject to a TGA assessment from this registration process or introducing
some other method of data sharing and decision making that helps streamline
Other submitters raised concerns about the minor use permits and
While we would not seek to undermine the risk-assessment process, and
have some concerns about anything other than the most targeted and clearly
specified off-label use, we appreciate some of the concerns of growers such as
those raised in the Australian Mushroom Growers Associations and the National
Farmers Federations’ submissions that touch on regulatory burden.
In the review process the Australian Greens would like to see included
an examination of the minor use and off-label use that looks at ways to ensure
that while the registration and assessment processes are rigorous, that the
regulatory burdens associated with minor and off-label use on growers is not
In conclusion, this reform is essential, but it is important that the
re-registration process and subsequent reviews of chemical use achieve the
ultimate goal of managing risk to human life and the environment, and are based
on scientific analysis, take account of decision made in other countries and
the actions of the APVMA are not hampered in its risk assessments by a lack of
data or a lack of definitional clarity. A definition of unmanageable risk will
also help focus the review on efficiently and effectively excluding chemicals
that present an unacceptable level of harm. The Bill should be amended to
address the issues raised above.
Include a definition of unmanageable risk in the objects
and the assessment triggers of the Bill.
Include a reference to the degradation products and
metabolites as part of any reference to toxicity within the safety assessment
criteria of the Bill.
Strengthen the relationship between actions taken by
foreign jurisdictions and Australian decision making in the Bill and the
Reverse the onus of proof in the Bill so that chemical
companies have to address data gaps in order to maintain registration.
Greens Senator for Western Australia
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