ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
9 June 2008
Application Code
HRC08001
Application Type
To reassess any hazardous substance under section 63A of the
Hazardous Substances and New Organisms Act 1996 (“the
Act”)
Applicant
The Chief Executive, ERMA New Zealand
Date Application Received
25 March 2008
Submission Period
31 March 2008 – 29 April 2008
Consideration Date
23 May 2008
Considered by
A Committee of the Authority (“the Committee”)
Purpose of the Application
Modified reassessment of all vertebrate toxic agents (VTAs),
except those containing 1080. The sole proposed change is
the addition of a new control requiring notification of
formulation or use changes.
1 Summary of decision
1.1
The controls on VTAs (excluding those containing 1080) have been varied in
accordance with the relevant provisions of the Act, the HSNO Regulations, and
the HSNO (Methodology) Order 1998 (“the Methodology”) to add an additional
control requiring manufacturers or importers to notify the Authority of any
changes in formulation or use of VTAs (excluding those containing 1080).
1.2
The VTAs concerned are those identified in the application form. They contain
the following active ingredients:












Alpha-chloralose
Cholecalciferol
Coumatetralyl
Sodium cyanide
Potassium cyanide
Bromadialone
Brodifacoum
Diphacinone
DRC 1339 [chloro-p-toluidine]
Flocoumafen
Pindone
Yellow phosphorus
2 Legislative criteria for the application
2.1
The application was lodged by the Chief Executive pursuant to section 63A
following grounds for reassessment having been established under section 62 by
the Authority in its decision dated 11 February 2008.
2.2
Under section 63A, the Authority may, following a finding that there are
grounds for the reassessment of a hazardous substance, conduct a modified
reassessment of the substance.
2.3
According to section 63A(1), such a modified reassessment may be carried out
where the Authority considers that the reassessment will involve only a specific
aspect of the approval and the proposed amendment is not a minor or technical
amendment to which section 67A applies.
2.4
According to section 63A(2), the Authority, as a result of a modified
reassessment under section 63A, may vary the controls that attach to a hazardous
substance, but may not revoke an approval given to the substance under the Act
to import or manufacture the substance.
2.5
Pursuant to section 63A(6), in deciding whether to approve or decline an
application for a modified reassessment, the Authority must take into account all
the effects associated with the reassessment proposal and the best international
practices and standards for the safe management of the substance.
2.6
This reassessment decision was determined in accordance with section 63A,
taking into account matters to be considered in that section and matters specified
under Part II of the Act. Unless otherwise stated, references to section numbers
in this decision refer to sections of the Act.
2.7
Consideration of the application also followed the relevant provisions of the
Methodology. Unless otherwise stated, references to clauses in this decision
refer to clauses of the Methodology.
3 Application process
3.1
The application was formally received on 25 March 2008.
3.2
Section 63A(4) allows the Authority to reassess substances under section 63A
without publicly notifying the reassessment in accordance with section 53,
providing the Authority does everything reasonably practicable on its part to
consult with all persons who, in its opinion, may be affected by the reassessment
(section 63A(5)).
3.3
In its decision on the ‘grounds’ application, the Authority was of the view that
‘affected parties’ consultation, as opposed to ‘public notification’ was
appropriate in this case.
ERMA New Zealand Decision: Application HRC08001
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3.4
In accordance with section 63A(5), manufacturers of VTAs, the Ministry of
Health, the ACVM Group of the New Zealand Food Safety Authority and the
Department of Labour were notified on 31 March 2008 and provided with an
opportunity to make submissions or comments.
3.5
Submissions closed on 29 April 2008.
3.6
No submissions were received. Comments were received from the Ministry of
Health indicating their support for the addition of the new control.
3.7
No external experts were used in the consideration of this application (clause
17).
3.8
The following members of the Authority’s Hearings Committee considered the
application (under delegation under section 19(2)(b)): Ms Helen Atkins (Chair)
Dr Max Suckling and Dr Deborah Read.
3.9
The information available to the Committee comprised:
 the application.
 a memorandum from the Agency advising them that there were no
submissions and one comment in support of the application.
4 Consideration
Purpose of the application
4.1
To add an additional control to VTAs (excluding those containing 1080)
requiring manufacturers and importers to notify the Authority of any changes in
formulation or use of those VTAs.
Sequence of the consideration
4.2
In accordance with clause 24, the approach to the consideration adopted by the
Committee was to:
 consider the proposed additional control.
 identify and assess the effects associated with the proposal to vary the
controls (the addition of the new control) that attach to VTAs (excluding
those containing 1080).
 identify and assess best international practices and standards for the safe
management of VTAs.
 undertake an overall evaluation of the risks, costs, and benefits.
 consider whether to approve the additional control.
The requirements of section 63A
4.3
According to section 63A(1), a modified reassessment may be carried out where
the Authority considers that the reassessment will involve only a specific aspect
of the approval and the proposed amendment is not a minor or technical
amendment to which section 67A applies.
ERMA New Zealand Decision: Application HRC08001
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4.4
As effects relating to the changes to the formulation of VTAs may be more than
minor, the Committee is satisfied that the amendment proposal could not be
considered as a minor or technical amendment to which section 67A applies.
4.5
Further, as the reassessment only relates to a specific aspect of the approval of
VTAs, namely the addition of a control requiring notification of changes to
formulations or use of VTAs, the Committee is satisfied that it can properly be
considered under section 63A.
Proposed additional control
4.6
The wording of the proposed new control is as follows:
Notification of changes of composition
Any changes to the composition or proposed use of [insert name of
VTA] must be notified to the Authority in writing before the substance
is used. The notification should include the following information, as
applicable:
 the name of substance and HSNO approval number;
 details of the original formulation;
 details of the revised formulation clearly identifying the
changed ingredients, their function in the bait, and their
concentration and CAS number if appropriate;
 the physical form, if different from the original;
 bait colour;
 changes in bait size;
 the intended use(s) of the substance (to include target species,
method(s) of release); change in food bait where the substance
requires mixing with bait prior to use;
 the physical properties of the substance (for example,
flashpoint, pH) if different from the original;
 the impurity profile and source of the ‘active’ ingredient, if
different from the original;
 any information on the effect that the formulation change may
have on the risk profile of the substance, including the results
of any palatability or field trials undertaken on both target and
non-target species.
4.7
The effect of this proposal is that manufacturers or importers of VTAs
(excluding those containing 1080) will be required to notify the Authority of any
changes in formulation or use before the substances are used.
ERMA New Zealand Decision: Application HRC08001
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Identification of the effects associated with the proposal.
4.8
This control was added to formulated substances containing 1080 as a result of
the reassessment by the Authority of those substances in 2007.
4.9
The Committee identified the following effects associated with addition of the
proposed control:



it ensures consistency of regulatory approach for all VTAs;
changes in risk profile due to changes in formulation and other matters such
as bait size will be able to be addressed. Each of the current HSNO
substance descriptions can cover a variety of formulations. Changes to a
formulation may conform to the substance description, but still affect the
substance’s risk profile. For example, changes to non-hazardous
components can affect palatability of a bait and hence the potential exposure
of non-target organisms. Depending on the nature and extent of the
formulation/bait changes, it may be necessary for the approval to be
amended (or a new approval obtained) before the substance may lawfully be
used.
there are no new risks to the environment, human health and safety, Maori
cultural and spiritual values, society and community or the market economy.
Assessment of effects
Assessment of risks associated with the reassessment proposal
4.10
The Committee notes that there are no risks associated with the proposal.
Assessment of costs associated with the reassessment proposal
4.11
The Committee notes that any costs associated with the addition of this control
accrue to the manufacturers and users of the substances. They are financial in
nature, and can be considered as private costs. No quantitative analysis of the
costs of the proposed control was undertaken. However, during consultation on
the grounds for reassessment, two of the four manufacturers who responded
indicated that the proposal was “largely common sense” and already required by
the New Zealand Food Safety Authority to enable that agency to manage risks
under their legislation.
4.12
One manufacturer who commented on the grounds for reassessment considered
that the proposal was in effect a duplication of regulatory oversight as the
NZFSA already required this information.
4.13
The other manufacturer did not comment on the issue of potential costs of the
proposal.
ERMA New Zealand Decision: Application HRC08001
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Assessment of effects on Māori issues and concerns associated with the reassessment
proposal
4.14
From the information provided, the Committee considers that the reassessment
proposal is unlikely to have an impact on the relationship between Māori culture
and their traditions with their ancestral lands, water, sites, waahi tapu, valued
flora and fauna and other taonga. This is on the condition that the substances are
stored and used in accordance with all relevant regulations, conditions, and any
other relevant controls applying under other legislation.
Assessment of benefits associated with the reassessment proposal
4.15
The Committee notes that the proposed amendment will allow better regulatory
oversight of changes in formulation and use of VTAs. While it is not possible to
assess the benefits associated with reduction in risks to non-target species, the
Committee considers that such benefits will be potentially significant.
Identification and assessment of best international practices
4.16
As required, best international practices and standards were considered in
proposing the new control.
4.17
The Committee notes that in general, agencies involved in pesticide registration
and approval require notification of changes to formulations of any product to
ensure that any resultant change in risk is adequately managed. These include
the Australian Pesticide and Veterinary Medicines Authority, the United
Kingdom Pesticide Safety Directorate and the United States Environmental
Protection Agency Office of Pesticide Programs.
4.18
The New Zealand Food Safety Authority also requires such notification to
ensure that risks addressed by their legislation are managed.
4.19
The Committee also notes that the reassessment will have no impact with respect
to New Zealand’s international obligations.
5 Conclusion
5.1
The Committee considers that there are potential benefits associated with the
addition of the requirement to notify the Authority of any changes in formulation
or use of VTAs.
5.2
The Committee does not consider there to be significant risks to human health,
the environment, Maori cultural wellbeing, society and community, the market
economy, or to New Zealand’s international obligations from the addition of the
proposed control.
5.3
Accordingly, the Committee considers that the benefits of the proposal outweigh
the costs.
ERMA New Zealand Decision: Application HRC08001
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6 Decision
6.1
The Committee determines that:
6.1.1
the application meets the criteria for consideration under section 63A.
6.1.2
having considered all the effects associated with the reassessment
proposal and best international practices and standards for the safe
management of VTAs, that the controls on VTAs (excluding those
containing 1080) should be varied to add the control set out in
paragraph 4.6 above, to require manufactures and importers of the listed
VTAs to notify the Authority of any changes in formulation or use of
the substances.
6.1.3
accordingly, the additional control set out in Appendix 1 shall apply to
the listed VTAs.
6.2
In accordance with clause 36(2)(b), the Committee records that, in reaching this
conclusion, it has taken into account the criteria of section 63(6).
6.3
It has also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 14 – costs and benefits accruing to New Zealand;
 clause 21 – the decision accords with the requirements and regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant
considerations;
 clause 24 – the use of recognised risk identification, assessment,
evaluation and management techniques;
 clause 25 – the evaluation of risks;
 clause 26 – negligible risks;
 clause 33 – risk characteristics;
 clause 34 – the aggregation and comparison of risks, costs and benefits;
and
 clause 35 – the costs and benefits of varying the default controls.
Ms Helen Atkins
Chair
ERMA New Zealand Decision: Application HRC08001
Date: 9 June 2008
Page 7 of 10
ERMA New Zealand Approval Codes:
Bait containing 0.02 g/kg brodifacoum (Reassessed HRC08001)
HRC000004
Bait containing 0.05 g/kg - 0.1 g/kg bromadiolone
(Reassessed - HRC08001)
HRC000005
Bait containing 0.05 g/kg brodifacoum (Reassessed HRC08001)
HRC000006
Bait containing 0.05 g/kg diphacinone (Reassessed HRC08001)
HRC000007
Bait containing 0.05 g/kg flocoumafen (Reassessment HRC08001)
HRC000008
Bait containing 0.25 - 0.5 g/kg pindone (Reassessment
- HRC08001)
HRC000009
Bait containing 0.375 - 0.5 g/kg coumatetralyl
(Reassessed - HRC08001)
HRC000010
Bait containing 0.55 - 1.84 % w/w encapsulated
potassium cyanide (Reassessed - HRC08001)
HRC000011
Bait containing 8 g/kg cholecalciferol (Substance A)
(Reassessed - HRC08001)
HRC000012
Bait containing 8 g/kg cholecalciferol (Substance B)
(Reassessed - HRC08001)
HRC000013
Encapsulated paste containing 500 g/kg potassium
cyanide (Reassessed - HRC08001)
HRC000014
Encapsulated pellet containing 800 g/kg potassium
cyanide (Reassessed - HRC08001)
HRC000015
Feratox 475 g/kg (Reassessed - HRC08001)
HRC000016
Paste containing 0.3 g/kg diphacinone (Reassessed HRC08001)
HRC000017
Paste containing 25 g/kg alpha-chloralose (Reassessed
- HRC08001)
HRC000018
Paste containing 4.5 - 5 g/kg yellow phosphorus
(Reassessed - HRC08001)
HRC000019
ERMA New Zealand Decision: Application HRC08001
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Paste containing 500 - 600 g/kg sodium cyanide
(Reassessed - HRC08001)
HRC000020
Paste containing 9.5 - 10 g/kg yellow phosphorus
(Reassessed - HRC08001)
HRC000021
Powder containing 7.4 g/kg coumatetralyl (Reassessed
-HRC08001)
HRC000022
Powder containing 970 - 980 g/kg 3-chloro-p-toluidine
hydrochloride (Reassessed - HRC08001)
HRC000023
Solid containing 900 - 1000 g/kg alpha-chloralose
(Reassessed - HRC08001)
HRC000024
Soluble concentrate containing 34 g/litre pindone as
the sodium salt (Reassessed - HRC08001)
HRC000025
Treated seed containing 22 - 25 g/kg alpha-chloralose
(Reassessed - HRC08001)
HRC000026
ERMA New Zealand Decision: Application HRC08001
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APPENDIX 1: ADDITIONAL CONTROL FOR VTAS
(EXCLUDING THOSE CONTAINING 1080)
Notification of changes of composition
Any changes to the composition or proposed use of [insert name of
VTA] must be notified to the Authority in writing before the substance
is used. The notification should include the following information, as
applicable:
 the name of substance and HSNO approval number;
 details of the original formulation;
 details of the revised formulation clearly identifying the
changed ingredients, their function in the bait, and their
concentration and CAS number if appropriate;
 the physical form, if different from the original;
 bait colour;
 changes in bait size;
 the intended use(s) of the substance (to include target species,
method(s) of release); change in food bait where the substance
requires mixing with bait prior to use;
 the physical properties of the substance (for example,
flashpoint, pH) if different from the original;
 the impurity profile and source of the ‘active’ ingredient, if
different from the original;
 any information on the effect that the formulation change may
have on the risk profile of the substance, including the results
of any palatability or field trials undertaken on both target and
non-target species.
ERMA New Zealand Decision: Application HRC08001
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