ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
25 September 2006
Application Code
HSE06001
Application Type
To import, manufacture and use a hazardous substance in a
special emergency under Section 49D of the Hazardous
Substances and New Organisms Act 1996 (the Act)
Applicant
Ministry of Agriculture and Forestry, Biosecurity New
Zealand
Purpose of the Application
To import, manufacture and use substances containing the
active ingredient fipronil, to kill feral bees in an area of the
South Island of New Zealand known to be infested with the
Unwanted Organism, Varroa destructor.
Date Application Received
21 September 2006
Consideration Date
22 and 25 September 2006
Considered by
Hearings Committee of the Authority
1
SUMMARY OF DECISION
1.1
The application to import Technical Grade fipronil and manufacture and use
Acarimate in a special emergency declared under section 49B is approved with
controls in accordance with the relevant provisions of the Act and the HSNO
(Methodology) Order 1998 (the Methodology).
1.2
The substances have been given the following unique identifiers for the ERMA
New Zealand Hazardous Substances Register:
Technical Grade fipronil for
use in a special emergency
Acarimate (suspension
concentrate containing 0.1%
fipronil) for use in a special
emergency
2
HSNO Approval Number HSE000001
HSNO Approval Number HSE000002
LEGISLATIVE CRITERIA FOR APPLICATION
2.1
On 18 September 2006 and pursuant to Section 49B of the Act, the Minister for
Biosecurity declared an adverse event, the incursion of the varroa bee mite Varroa
destructor into the South Island, to be a special emergency until 30 June 2007.
2.2
On 21 September 2006, MAF lodged an application pursuant to section 49D to
manufacture and use Acarimate in the special emergency. The decision was
determined in accordance with section 49F taking into account additional matters to
be considered in that section, the matters specified in Part II of the Act (Purpose of
Act) and the relevant provisions of the Methodology. Unless otherwise stated,
references to section numbers in this decision refer to sections of the Act and
clauses to clauses of the Methodology.
2.3
In accordance with section 49F, the approach adopted when considering this
application was to consider all the information having regard to the particular
circumstances of the special emergency that the applicant provided under section
49E and determine whether:


3
technical grade fipronil and Acarimate are necessary for use in the special
emergency; and
the proposed plan adequately controls the adverse effects of technical grade
fipronil and Acarimate.
APPLICATION PROCESS
3.1
The application was formally received on 21 September 2006.
3.2
Project Team:
Andrea Eng
General Manager (Hazardous Substances)
Noel McCardle
Senior Advisor (Hazardous Substances)
Sue Scobie
Senior Science Advisor (Hazardous
Substances)
Michael Morris
Legal Advisor
3.3
The applicant supplied the following documents:
 the application;
 a proposed plan for dealing with the use of the substances in the special
emergency; and
 two research papers commissioned by the applicant on field tests conducted by
HortResearch:
Taylor, M.A. (2003). Field Testing Proposed Methods for Destroying
Feral Bee Colonies. HortResearch Client Report No: 10541.
Taylor, M.A. and Goodwin, Dr R.M. (2001). Destruction of managed and
feral honey bee (Apis mellifera) Colonies. HortResearch Client Report No:
2001/392.
The application and the management plan were amended (25/09/06) after further
discussion with the applicant to clarify points raised by the project team, relating
primarily to the concentration of the field strength bait solution.
3.4
Pursuant to sections 49F(2)(a) and 49F(2)(b), the Agency consulted with
Department of Conservation, the Ministry of Health, the Department of Labour and
the Agriculture Compounds and Veterinary Medicines Group of the New Zealand
Food Safety Authority on the proposal.
3.5
The Committee had particular regard to the views of the Department of
Conservation (DoC) (as set out in the document Submissions from Government
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Agencies when considering whether the applicant’s plan will adequately control the
adverse effects of the substances. The issues raised by DoC related mainly to the
impact of the toxic bait on non-target species.
3.6
4
The Committee also considered the comments made by the Ministry of Health, the
Department of Labour and the Agriculture Compounds and Veterinary Medicines
Group of the New Zealand Food Safety Authority.
CONSIDERATION
Sequence of the Consideration
4.1
This application was considered by the following members of the Authority’s
Hearings Committee (acting under a delegation under section 19(2)(b)): Mr Tony
Haggerty (Chair), Professor George Clark, Dr Manuka Henare and Mr Neil Walter
on 22 and 25 September 2006.
4.2
In accordance with section 49F and clause 24, the approach adopted when
determining the application was to:




consider whether the applicant had provided sufficient information to
determine whether the substances should be used in a special emergency;
consider the purpose of the application and determine whether the substances
are necessary for use in the special emergency;
consider the lifecycle of the substances and determine the hazardous properties
and adverse effects of the substances; and
consider whether the management plan provided by the applicant adequately
controls the adverse effects of the substances.
Information review
4.3
The Committee has reviewed the applicant’s information and additional
information available to it and considers that there is sufficient information to
determine whether technical grade fipronil may be approved for importation and
whether Acarimate can be manufactured and released for use in the special
emergency.
Purpose of the application
4.4
The purpose of this application is to obtain approval under the Act to import,
manufacture and use a substance containing the active ingredient fipronil, to kill
feral bees in an area of the South Island of New Zealand known to be infested with
the Unwanted Organism, Varroa destructor. A poison to kill feral bees is needed in
defined geographical areas of the South Island to eliminate bees carrying the
Varroa destructor mite from the infested areas. The active ingredient fipronil has
been demonstrated in field trials conducted by HortResearch to be the most
effective poison for this purpose.
4.5
As the purpose amounts to “the import of a hazardous substance for release”; the
manufacture of hazardous substance in containment” and the “use of an agricultural
compound in a manner that would contravene the Act”, the Committee considers
ERMA New Zealand Decision: Application HSE06001
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that the application qualifies for consideration under sections 49L (in relation to the
importation of the technical grade fipronil) and 49D(2)(b) and 49D(2)(d) (in respect
of the manufacture and use of the Acarimate suspension concentrate).
Criteria for declining the application
4.6
Under section 49F(3) the Authority may decline the application only if it is satisfied
that –
(a) the hazardous substances are not necessary for use in the special
emergency; or
(b) the proposed plan does not adequately control the adverse effects of the
hazardous substances.
The necessity to use the hazardous substances to deal with the special
emergency.
4.7
Removal of all bees (Apis mellifera) is a key step in the elimination of the obligate
parasite Varroa destructor. Removal of managed bee hives in the infested region is
complete. Elimination of the remaining feral bees in the infested region is now
necessary if the Varroa elimination attempt is to succeed.
4.8
A substance that is effective in killing bees through slow action following contact is
necessary to poison bees in feral hives. Use of compounds such as insecticide
permethrins that are immediately effective, killing bees at a bait station, preclude
carriage of the toxin back to the feral bee colony and therefore do not kill the entire
bee colony. There are no agricultural compounds registered to kill bees in New
Zealand. However, tests have shown that substances containing fipronil are the
most effective in eliminating feral bees.
4.9
The Committee has reviewed the information provided by the applicant and is
satisfied that the application should not be declined on the basis that the importation
of technical grade fipronil and manufacture and use of Acarimate are not necessary
for use in the special emergency.
Controlling the adverse effects of the substances.
Lifecycle
4.10
In assessing the adverse effects of the substances, the project team reviewed the
lifecycle of the substances as described in the applicant’s management plan.
Hazardous properties
4.11
The applicant and the project team have determined that the substances have the
following hazard profiles:
Classifications of Technical Grade fipronil and Acarimate
Technical Grade fipronil
6.1C
6.1C
6.1B
ERMA New Zealand Decision: Application HSE06001
Acarimate
Page 4 of 9
Technical Grade fipronil
Acarimate
6.4A
6.9A
9.1A very toxic in the aquatic
9.1B toxic in the aquatic environment
environment
9.3A very toxic to terrestrial vertebrates
9.4A very toxic to terrestrial invertebrates 9.4B toxic to terrestrial invertebrates
Note: the above classifications do not take into account the toxicity of photo-degradation
products
Identification and evaluation of the adverse effects of the substances in use in
the special emergency
4.12
In the application, the applicant identified and assessed potential adverse effects,
and detailed proposals for, and impacts of risk management. The Agency has
reviewed the applicant’s assessment of adverse effects and agrees that that it is
suitable for the consideration below.
Adverse effects to the environment
4.13
The applicant has identified that adverse effects to the environment may arise from
from:







spillage of the technical grade fipronil, in transit or during manufacture;
spillage of Acarimate in transit;
leakage of Acarimate during storage;
spillage of diluted Acarimate at the manufacturing site or at the Field Operations
Response Centre;
exposure to non-target species;
containers used;
residual risk of diluted Acarimate remaining in feral bee hives.
4.14
The application and the accompanying plan contain measures that must be taken to
avoid, remedy or mitigate the adverse effects arising from the importation of
technical grade fipronil and the manufacture and use of Acarimate.
4.15
The project team has reviewed these proposals and is satisfied that they are
adequate to control the adverse effects of the substances in the environment.
Adverse effects on human health and welfare
4.16
The applicant has identified that adverse effects to the human health and welfare
may arise from:








spillage of the technical grade fipronil, in transit or during manufacture;
spillage of Acarimate in transit or at the Field Operations Response Centre;
leakage of Acarimate during storage;
spillage of diluted Acarimate at the manufacturing site or at the Field Operations
Response Centre;
contact with the bait stations;
consuming honey from feral colonies inside eradication zone;
consuming honey from feral colonies outside eradication zone; and
consuming honey from managed hives re-introduced to eradication zone after
completion of baiting.
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4.17
The application and the accompanying plan contain measures that must be taken to
avoid, remedy or mitigate the adverse effects arising from the importation of
technical grade fipronil and the manufacture and use of Acarimate.
4.18
The project team has reviewed these proposals and is satisfied that they are
adequate to control the adverse effects of the substances to human health and
welfare.
Māori issues and concerns
4.19
The applicant advised that consultation with the Māori strategy group within MAF
did not identify any significant issues of concern to Māori. A representative of local
iwi was strongly supportive of the eradication of varroa from the South Island.
4.20
The project team is also unaware of any impacts that the substances could have on
Māori culture, or, on traditional relationships with ancestral lands, water, sites, wāhi
tapu, valued flora and fauna or other taonga. There is no evidence to suggest that
the use of the substances will breach the principles of the Treaty of Waitangi and
the Agency sees no requirement for the applicant to consult with Māori regarding
this application.
4.21
This assessment is made on the condition that the substances are manufactured,
handled, stored, transported, used and disposed of, in accordance with the explicitly
stated controls, and any controls stipulated in other applicable Acts. However,
should inappropriate use, or an accident, result in the contamination of waterways
or the environment, it is recommended that the appropriate authorities be notified
including the relevant iwi authorities in that region. This action should include
advising them of the contamination and the measures taken to contain and remedy
it.
Economic and related effects of the use of Acarimate
4.22
The applicant indicates that removal of Varroa destructor from the South Island is
expected to save an estimated $41-$54 Million over 20 years, increasing to between
$564 and $660 million over 35 years because of delayed pastoral impacts. The
principal impacts of the parasite relate to the increased cost of pollination and
honey production.
4.23
The cost of purchasing and importing sufficient fipronil for the emergency is less
than $4500. The cost of bait stations and application to the grid is estimated to be
$83,500; however, this cost is largely the labour cost, which is being provided by
volunteers from the bee keeping industry. The cost of medical waste disposal for
any unused compound is approximately $2500.
4.24
The project team is satisfied that the proposed use of the substances will not have
adverse effects on New Zealand’s market economy.
Effects related to New Zealand’s international obligations
4.25
The applicant states that New Zealand has international obligations pertaining to
any bee products, honey and wax exported. The applicant notes that the expected
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residue of this poisoning program is very low with less than 0.022g of fipronil
applied per square kilometre. In the short term all products from infested bee hives,
and bee equipment may not be moved from the Controlled Area, and feral bee
products found will be removed and destroyed where practical within the infested
zone. The issue of residues within managed hives moved into the infested zone,
post elimination, is being discussed with the Agriculture Compounds and
Veterinary Medicines Group of the New Zealand Food Safety Authority. It is
anticipated that no honey or wax from beehives reintroduced to the infested zone
will be sold until January 2008.
4.26
The project team is satisfied that the proposed use of the substances will not have
adverse effects on New Zealand’s international obligations.
The plan for dealing with the use of the substances in the special emergency
4.27
The applicant’s management plan is attached as Appendix 1 to this decision.
4.28
HortResearch has developed and field tested a method of destroying feral colonies
through baiting. This involves placing bait stations on a 1km x 1km grid in the
eradication zone. Each bait station is an open-topped container, secured against
access by stock and other vertebrates. Bait stations are filled with 50% sucrose
solution, and a diluted honey mixture sprayed in a one metre radius around the bait
station to attract bees. Individual bees detect the bait station while foraging, and
recruit other bees from their hive to switch to this food source.
4.29
When the number of bees feeding is sufficient (approximately 300+
simultaneously), the pre-bait is removed and approximately 2 litres of sugar
solution containing 0.011g/litre fipronil per litre is substituted. This is equivalent to
0.022 grams per bait station, and is produced by diluting Acarimate with sucrose
and water. In a HortResearch trial, most foraging bees were killed within one hour,
and all foraging ceased within five hours. When feeding ceases, any remaining
fipronil solution is removed and stored for disposal as hazardous waste. Bait
stations are closely monitored while containing fipronil, and all bait stations
containing toxic bait in areas accessible to the public will be continuously
supervised.
5
CONTROLS
5.1
6
The Committee has evaluated the adequacy of the arrangements proposed by the
applicant in the management plan and consider that these are adequate to control
the adverse effects of technical grade fipronil and Acarimate.
DECISION
6.1
The Committee has considered this application made under section 49D, and
pursuant to section 49F, the Committee is satisfied that the substances are necessary
for use with the special emergency.
6.2
Having considered the risks associated with the lifecycle of technical grade fipronil
and Acarimate, the Committee is satisfied that the specified management plan and
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the controls imposed, including those in place under other legislation, will result in
the substance being adequately managed in accordance with the Act.
6.3
The Committee has also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 21 – the decision accords with the requirements of the Act and
regulations;
 clause 22 – the evaluation of risks – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
6.4
The application to import technical grade fipronil and to manufacture and use
Acarimate is thus approved pursuant to section 49F, with the following controls:
6.4.1
The substances may only be used if the special emergency is managed in
accordance with the plan specified by the applicant as set out in Appendix
1.
6.4.2
The approval takes effect on the date of this decision and expires on 30
June 2007.
6.4.3
On expiry of this approval the technical grade fipronil and Acarimate must
be disposed of unless, before the expiry of the approval, the applicant has,
under any other provision of the Act, been granted an approval.
Tony Haggerty
Date
Chair
25 September 2006
ERMA New Zealand Decision: Application HSE06001
Approval Codes:
Technical grade fipronil
HSE000001
Acarimate:
HSE000002
Page 8 of 9
Appendix 1: Risk Management Plan for dealing with the Import, Manufacture and
Use of Substances containing fipronil in a Special Emergency
ERMA New Zealand Decision: Application HSE06001
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