ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION ON GROUNDS FOR
REASSESSMENT OF A SUBSTANCE
19 June 2007
Application Code
RES07005
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
Methyl-parathion: to establish whether there are sufficient
grounds to justify a reassessment of methyl-parathion 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 methyl-parathion and its formulations.
1.2
The substances have the following unique identifiers on the ERMA New Zealand
Hazardous Substances Register:
Methyl-parathion
Approval No: HSR002868
Emulsifiable concentrate containing
600g/litre parathion methyl
Approval No: HSR000218
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
Methyl-parathion was transferred in July 2006 via the Hazardous Substances
(Chemicals) Transfer Notice 2006 and a formulation containing methyl-parathion was
transferred in July 2004 via the Hazardous Substances (Pesticides) Transfer Notice
2004 and therefore both are approved under HSNO for manufacture or importation
in New Zealand.
3.2
These substances were selected from 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. Methyl-parathion and its
formulations were identified as being high priority for reassessment.
3.3
Methyl-parathion is a broad-spectrum organophosphate pesticide effective against
most insects and phytophagous mites. It was used on a variety of crops including
grain, vegetables, fruit and ornamentals. Formulations containing methyl-parathion
were first registered for use in New Zealand in 1961. One substance, Folidol M50, was
registered as late as 2004. No products containing methyl-parathion are currently
registered for agricultural use in New Zealand.
3.4
The Agency has classified methyl-parathion as:
6.1A acute oral and dermal toxicant
6.1B acute inhalation toxicant
6.3B skin irritant
6.4A eye irritant
6.8B suspected human reproductive or developmental toxicant
6.8C reproductive or developmental effects on or via lactation
6.9A target organ systemic toxicant
9.1A very ecotoxic in the aquatic environment
9.2A very ecotoxic in the soil environment
9.3A very ecotoxic to terrestrial vertebrates
9.4A very ecotoxic to terrestrial invertebrates
3.5
The Agency’s classification of methyl-parathion indicates that the substance has the
potential to cause adverse effects to humans at low concentrations. Methyl-parathion,
like other organophosphates, causes neurotoxic effects at low concentrations following
both acute and chronic exposure. Organophosphates affect the nervous system by
inhibiting acetylcholinesterase, an enzyme essential for normal nerve impulse
transmission. Acetylcholinesterase inhibition causes acute effects in humans and other
mammals. The symptoms in humans may include: headache, exhaustion and mental
confusion together with blurred vision, sweating, salivation, chest tightness, muscle
twitching and abdominal cramps. The more severe effects can include muscle paralysis
leading to severe difficulty in breathing, so requiring respiratory support. Convulsions
and unconsciousness can occur.
ERMA New Zealand Decision: Application RES07005
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3.6
Methyl-parathion is very ecotoxic to the aquatic environment with an EC50 of 0.0001
mg/L for crustacea and an LC50 of 0.059 mg/L for fish. It is very ecotoxic to
terrestrial vertebrates with an LD50 of 3.08 mg/kg bw for birds. Methyl-parathion is
very ecotoxic to terrestrial invertebrates with an LD50 of 0.111 µg/honeybee.
3.7
The European Union (EU) banned plant protection products containing methylparathion in 2003. This ban was supported by information released in a final review
report in October 2002. This report identified concerns with regard to the safety of
operators potentially exposed to methyl-parathion and the possible impact of the
substance on non-target insects, birds and mammals. The content of this report was
not considered during the transfer of methyl-parathion to the full framework of the
Act and therefore can be considered to be “new” information.
3.8
The United States Environmental Protection Agency (USEPA) issued an Interim
Reregistration Eligibility Decision (IRED) for methyl-parathion in July 2006. This
IRED evaluated information relating to dietary risk (especially to children),
occupational risk to applicators and ecological risks to both aquatic and terrestrial
species. This information was not considered by ERMA New Zealand at the time that
methyl-parathion was transferred.
3.9
In addition to the actions taken by the EU and the USEPA, the Australian Pesticides
and Veterinary Medicines Authority (APVMA) is also reviewing approvals for methylparathion. Whilst further data is generated for the review of methyl-parathion, the
APVMA has proposed certain interim regulatory measures to mitigate occupational
and environmental risks. These include labelling and other restrictions - that methylparathion be available to persons appropriately trained in using chemicals - that
product labels are strengthened to include environmental and occupational exposure
warnings and that spray drift minimisation strategies are applied.
3.10
There are a number of alternative insecticides on the New Zealand market that do not
contain organophosphates. The adverse human health effects of the available
alternative substances are much less than those associated with methyl-parathion.
3.11
Methyl-parathion and its formulations are listed under the Rotterdam Convention as
chemicals that have been banned or severely restricted for health or environmental
reasons and are subject to the ‘Prior Informed Consent’ provisions of the convention.
The Rotterdam Convention has been ratified by New Zealand.
3.12
The Chief Executive claims that grounds for reassessment of methyl-parathion and its
formulations exist under section 62(2) on the basis that significant new information
about the adverse effects of the substances has become available, that alternative
substances exist that have reduced adverse effects, and that other factor exist which
should be considered as additional grounds. Accordingly, the Chief Executive is
requesting that the Authority decide whether there are grounds to reassess the
approval of methyl-parathion and its formulations.
ERMA New Zealand Decision: Application RES07005
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4 Application process
4.1
The Chief Executive submitted the application to establish whether there were
sufficient grounds to justify a reassessment of methyl-parathion 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 a draft application was distributed to a number of
government departments and other interested parties. The Agency received two
submissions on the proposal that there are grounds for a reassessment and the
comments made were supportive of the application.
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
 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.
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5.4
The Committee considered the information provided by the Chief Executive and the
Agency and noted the following:
•
Methyl-parathion was transferred in July 2006 via the Hazardous Substances
(Chemicals) Transfer Notice 2006 and a formulation containing methylparathion was transferred in July 2004 via the Hazardous Substances (Pesticides)
Transfer Notice 2004 and therefore both are approved under HSNO for
manufacture or importation in New Zealand;
•
One formulation containing methyl-parathion was registered under the ACVM
Act for use in New Zealand as late as 2004;
•
There are no products containing methyl-parathion currently registered for
agricultural use in New Zealand;
•
The European Union banned the use of methyl-parathion in plant protection
products in 2003 based on information that was not reviewed at the time of
transfer;
•
Other overseas jurisdictions have reviewed, or are in the process of reviewing,
approvals for the use of methyl-parathion.
•
Concerns exist about the safety of operators potentially exposed to methylparathion and the possible impact of the substance on non-target insects, birds
and mammals;
•
Methyl-parathion is listed under the Rotterdam Convention as a chemical that
has been banned or severely restricted for health or environmental reasons and is
subject to the ‘Prior Informed Consent’ provisions of the convention;
•
The Rotterdam Convention has been ratified by New Zealand; and
•
The reassessment of methyl-parathion and its formulations aligns with the
principles of the ERMA New Zealand Risk Reduction strategy; and
•
No objections to this application have been raised by key stakeholders.
In summary, the Agency considers that there is significant new information about the
adverse effects of the substance, that there is sufficient information that a number of
alternative substances exist which have reduced adverse effects, that New Zealand has
an international commitment relating to the restriction of the substance and that
ERMA New Zealand has a commitment to risk reduction via its Risk Reduction
Strategy.
5.5
The Committee unanimously agreed that there is significant new information about
the adverse effects of the substance, that there is sufficient information that a number
of alternative substances exist and that, in addition, there are other reasons relating to
the overall purpose and spirit of the Act that warrant the reassessment of methylparathion and its formulations.
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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 methyl-parathion and its formulations.
George Clark
Date: 19 June 2007
Chair
ERMA New Zealand Decision: Application RES07005
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