ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION ON GROUNDS FOR
REASSESSMENT OF A SUBSTANCE
19 June 2007
Application Code
RES07002
Application Type
Grounds for reassessment of a substance under section
62(1)(b) of the Hazardous Substances and New Organisms
Act 1996 (the Act)
Applicant
R Forlong
Chief Executive
ERMA New Zealand
Date Application Received
30 May 2007
Consideration Date
5 June 2007
Considered by
A Committee of the Authority
Purpose of the Application
Azinphos-Methyl: to establish whether there are sufficient
grounds to justify a reassessment of the broad-spectrum
insecticide azinphos-methyl and its formulations.
1 Summary of decision
1.1
The Committee has decided under section 62(2) that there are grounds for the
reassessment of azinphos-methyl and its formulations.
1.2
The substances have the following unique identifiers on the ERMA New Zealand
Hazardous Substances Register:




Azinphos-methyl (approval code HSR002815)
Suspension concentrate containing 350g/L azinphos-methyl (approval code
HSR000160; referred to in this decision document as “substance A”)
Wettable powder containing 350g/kg azinphos-methyl (approval code
HSR000161; referred to in this decision document as “substance B”)
Cotnion 200 insecticide containing 200g/L azinphos-methyl (approval code
HSR002486; referred to in this decision document as “substance C”)
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 62(1)(b). The decision was determined
in accordance with section 62(2). Unless otherwise stated, references to section
numbers in this decision refer to sections of the Act.
2.2
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology).
Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3 Background to the application
3.1
Azinphos-methyl was transferred to the HSNO framework via the Chemicals Transfer
Notice (01 July 2006). Substances A and B were transferred to the HSNO framework
via the Pesticides Transfer Notice (1 July 2004). While there are no products
registered under the Agricultural Compounds and Veterinary Medicines Act against
the HSNO approval for Substances A or B, two products registered against the
approval for Substance A are included on an ACVM Register of cancelled Trade
Name Products. On of the substances had its registration cancelled on 05 July 2006,
the other on 07 August 2006. Substance C is the only substance containing azinphosmethyl that has been approved under Part V of the Act and that has a current ACVM
registration.
3.2
Azinphos-methyl appears on the Chief Executive initiated reassessments priority list,
which was released in March 2007. The generation of this list involved consultation
with stakeholders and other interested parties. Azinphos-methyl was identified as
being high priority for reassessment.
3.3
Azinphos-methyl is a broad-spectrum insecticide. In New Zealand, azinphos-methyl is
registered for application to grapes, kiwifruit, pipfruit, stonefruit and potatoes for the
control of leaf-rollers, greedy scales, codling moths, bronze beetles, cherry sawflies,
grass grub beetles, oriental fruit moths and potato tuber moths. Formulations
containing azinphos-methyl are applied by conventional ground spray equipment.
3.4
The Agency has classified azinphos-methyl as:
6.1A acute oral and inhalation toxicant
6.1B dermal toxicant
6.4A eye irritant
6.5B contact (skin) sensitiser
6.9A toxic to human target organs or systems
9.1A very ecotoxic in the aquatic environment
9.2D slightly harmful in the soil environment
9.3A very ecotoxic to terrestrial invertebrates
9.4A very ecotoxic to terrestrial invertebrates
3.5
The Agency has insufficient data to classify azinphos-methyl with respect to
respiratory sensitisation. While the exact hazards of the formulations used in
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commercial applications differ, the formulations retain at least the following hazards as
triggered by the azinphos-methyl component: 6.1B, 6.4A, 6.5B, 6.9A, 9.1A, 9.3A, 9.4A.
.
3.6
Both the Canadian Pest Management Regulatory Authority (PMRA) and the US
Environmental Protection Agency (EPA) have recently completed re-evaluations of
azinphos-methyl. These re-evaluations were part of broader re-assessment
programmes underway in both jurisdictions, which aim to determine whether older
chemicals are acceptable according to current standards of safety and effectiveness.
The findings of the re-assessments have led to the phase-out of the substance by the
end of 2007 in Canada and 2012 in the US. The PMRA cites unacceptable risks to the
health of agricultural workers as the reason for the phase-out. The EPA drew similar
conclusions about the risks to workers and in addition found that the risks to aquatic
ecosystems were unacceptable.
3.7
Azinphos-methyl is currently under review by the Australian Pesticide and Veterinary
Medicine Authority (APVMA) who have recommended, in their preliminary findings,
that more stringent controls be applied to products containing the substance, in order
to mitigate the occupational, ecological and dietary risks associated with its use.
3.8
Azinphos-methyl is not listed under the Rotterdam Convention.
3.9
The Chief Executive considers that the outcomes of the reassessments undertaken by
North American regulatory authorities, and the preliminary findings of the Australian
review, constitute “new information” and as such are sufficient grounds upon which
to initiate a reassessment of the substance in accordance with section 62(2)(a) of the
Act. In addition, the Chief Executive notes that there are less hazardous alternatives
to azinphos-methyl available (such as spinosyns and pyrethrins) and that a
reassessment of the substance would align with the Agency’s risk reduction strategy,
which aims to reduce the risks that hazardous substances and new organisms may pose
to the New Zealand people and environment. Accordingly, the Chief Executive is
requesting that the Authority decide whether there are grounds to reassess the
approval of azinphos-methyl and its formulations.
4 Application process
4.1
The Chief Executive submitted the application, to establish whether there are
sufficient grounds to justify a reassessment of azinphos-methyl and its formulations,
on 30 May 2007.
4.2
Public notification of the application was not required under the Act. However, the
Chief Executive advises that an indication of the intention to submit the application,
along with a copy of the Evaluation Sheet (produced by the Agency in November
2006) was distributed to a number of government departments and other interested
parties.
4.2.1
Both the Ministry of Health and HortNZ responded to acknowledge that
there are sufficient grounds for the reassessment.
4.2.2
Agronica New Zealand Limited (the registrants of the only product
containing azinphos-methyl currently available in New Zealand) also
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responded, raising several questions regarding the quality and relevance of the
data cited by the Agency in the Evaluation Sheet.
4.3
The application was considered on 5 June 2007 by the following members of the
Authority, appointed in accordance with section 19(2)(b) of the Act: Professor George
Clark (Chair), Mr Neil Walter and Dr Kieran Elborough.
4.4
The information available to the Committee comprised:
 the application and supporting documents (including the submissions); and
 a consideration paper from the Agency.
5 Consideration
5.1
In considering the application, the Committee took into account the information
provided by the Chief Executive and the Agency (paragraph 4.4). The Committee
considers that the information constitutes an adequate and appropriate basis for
considering the application (clause 8).
5.2
Section 62(2) sets out grounds to be taken into account by the Authority in deciding
whether or not a reassessment is justified.
62(2) Where any request has been made under section (1) of this section, the Authority may decide
that grounds exist to reassess that substance or organism after taking into account that(a) Significant new information relating to the effects of the substance or the organism has become
available; or
(b) Another substance with similar or improved beneficial effects and reduced adverse effects has
become available; or
(c) Information showing a significant change of use, or a significant change in the quantity
manufactured, imported, or developed has become available.
5.3
The Authority may also take into account factors other than those listed in section
62(2) if it is appropriate to do so in the context of the overall purpose and spirit of the
Act. The purpose of the Act is to protect the environment, and the health and safety
of people and communities, by preventing or managing the adverse effect of
hazardous substances and new organisms (section 4). The principles relevant to the
purpose of the Act pertain to safeguarding the life-supporting capacity of the
environment; and the capacity of people and communities to provide for their own
economic, social, and cultural wellbeing (section 5). Consequently, ‘other factors’ are
considered where they are perceived as relevant to the purpose of the Act and the
principles pertaining to this purpose.
5.4
The Committee has considered the information provided by the Chief Executive and
the Agency and notes the following:
 Formulations containing azinphos-methyl have been registered for use in New
Zealand since 1965. Currently, one product is registered for agricultural use in
New Zealand (Cotnion 200 Insecticide);
 Regulatory authorities in the US and Canada have recently completed
reassessments of azinphos-methyl. The findings of these reassessments have led
to the phase-out of the substance, with all uses expected to be phased by 2007 in
Canada and 2012 in the US. A review is currently underway in Australia, with
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

5.5
preliminary findings indicating that more stringent controls will be applied to
products containing the substance although its use will not be phased out.
There are less hazardous alternatives to azinphos-methyl available;
The reassessment of azinphos-methyl and formulations containing it aligns with
the principles of the ERMA New Zealand Risk Reduction strategy.
The Committee unanimously agreed that there is new information from overseas
regulatory authorities relating to the effects of the azinphos-methyl and that, in light of
this new information, reassessment of the substance is warranted. The Committee
acknowledges that there are alternatives to azinphos-methyl, adding weight to the
justification for a reassessment of the substance. In addition, the Committee considers
that a reassessment of azinphos-methyl and its formulations aligns well with the
Agency’s risk reduction strategy, which seeks to reduce the risks New Zealanders may
be exposed to via new organisms or hazardous substances.
6 Conclusion
6.1
In accordance with section 62, and having regard to the information provided by all
relevant parties, as detailed above, the decision of the Committee is that:
6.1.1
grounds exist to reassess azinphos-methyl and its formulations.
George Clark
Date 19 June 2007
Chair
ERMA New Zealand Decision: Application RES07002
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