ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
5 March 2003
Application code
Application type
HSC02014
To import a hazardous substance into containment under Section
31 of the Hazardous Substances and New Organisms (HSNO) Act
1996
Applicant
Bayer New Zealand Limited
Purpose
Date received
To import into containment the substance Larvin SC to conduct
field trials to assess the efficacy on Springtails in forage brassicas
and Argentine Stem Weevil and Black Beetle in grasses
6 January 2003
Consideration date
28 February 2003
Considered by
Hazardous Substances Standing Committee of the Authority.
1
Summary of Decision
1.1
The application to import into containment the hazardous substance Larvin SC is
approved with controls in accordance with the relevant provisions of the Hazardous
Substances and New Organisms Act 1996 (the HSNO Act), the HSNO Regulations,
and the HSNO (Methodology) Order 1998.
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
Larvin SC
1.3
The Committee has adopted the European Union use classification system as the
basis for recording the nature and uses of substances approved. The following use
categories are recorded for this substance:
Main category
Industry category
Function/use category
3
1
38
Non-dispersive use
Agricultural Industry
Pesticides
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2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31 of the HSNO Act. The decision
was determined in accordance with section 32, taking into account matters relevant
to the purpose of the Act, as specified under Part II of the HSNO Act and the
provisions of Part III of the Third Schedule of the HSNO Act. Unless otherwise
stated, references to section numbers in this report refer to sections of the HSNO
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
3.1
3.2
3.3
3.4
Application Process
The application was formally received on 6 January 2003 and verified on 7 January
2003.
The following Government Departments were advised of the receipt of the
application (in accordance with clause 2(2)(e)) and given the opportunity to
comment.
 The Ministry of Health.
 The Department of Labour (Occupational Safety and Health).
 The New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group - ACVMG).
 The Department of Conservation.
The Ministry of Health stated that, from the public health perspective, it had no
concerns to raise at this time relating to the acceptance of this application. As the
Ministry of Health did not know the identity of the active ingredient, it had no other
comments to make at this time.
The information available to the Committee comprised:
 The application, including as confidential attachments:
 Appendix 1
Substance information
 Appendix 2
Material Safety Data Sheet
 Appendix 3
Management Plan
 Appendix 4
Project Plan
 Appendix 5
Draft Label
 The ERMA New Zealand Evaluation and Review Report
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4
Consideration
Sequence of the Consideration
4.1
In accordance with section 19(2)(b) of the HSNO Act, the Authority appointed Mr
Tony Haggerty (Chairperson) and Prof George Clark to consider the application.
The application was considered on 28 February 2003.
4.2
In accordance with section 32 of the Act, the approach adopted by the Committee
was to confirm whether the application was for one of the purposes specified in
section 30, to identify and assess the risks and to determine whether the substance
could be adequately contained by controls to provide for each of the matters
specified in Part III of the Third Schedule of the Act.
Purpose of the Application
4.3
The applicant states that the purpose of the application is to field test the substance
Larvin SC to assess the efficacy on Springtails in forage brassicas and Argentine
Stem Weevil and Black Beetle in grasses. The aim of the trial work is to gather
sufficient information to determine if the substance is suitable for use in New
Zealand and to provide data for future application for approval for release.
4.4
As the purpose amounts to “research on any hazardous substance to acquire
information for use in assessing that substance for a HSNO approval”, the
Committee considers that the application qualifies for consideration under sections
30(b).
Hazardous properties of the Substance
4.5
The Committee notes that a containment application does not require a rigorous
assessment of the hazard classification but only sufficient understanding of the
hazardous properties to ensure that any risks can be managed by the containment
controls. The applicant has assessed the hazardous properties and described the
hazard profile in sufficient detail and based on verifiable evidence to satisfy the
requirements of a containment application.
4.6
Despite different conclusions being reached by ERMA New Zealand and the
applicant in relation to inhalation toxicity and aquatic ecotoxicity, the Committee is
satisfied that the management plan provided by the applicant is sufficient to contain
the substance and address the hazards presented.
Identification and Evaluation of the Significant Risks of the Substance
4.7
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the Committee
considered the potential risks of escape from containment under the headings of
environmental, human health and welfare and Māori issues and concerns.
4.8
The applicant has identified a number of risks to the environment and to human
health and welfare. The Committee accepts the applicant’s risk assessment and
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considers that, taking into account the proposed containment regime and controls in
place under other legislation, there are no significant risks to the environment or to
human health and welfare.
4.9
5
On the basis of information in the Evaluation and Review report the Committee
considers there are no issues or concerns to Māori.
Containment and Controls
5.1
The Committee evaluated the adequacy of the containment arrangements of the
applicant and the proposed controls in the Evaluation and Review Report. The
Committee notes that these cover the following requirements, thereby addressing
the matters set out in Part III of the Third Schedule of the Act.
 To limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances.
 To exclude organisms from a facility.
 To exclude unauthorized people from the facility.
 To prevent unintended release of the substance by experimenters working with
the substances.
 To control the effects of any accidental release of the substance.
 Inspection and monitoring requirements.
 Qualifications required of the person responsible for implementing the controls.
5.2
Therefore, the Committee is satisfied that, with adherence to the controls listed in
Appendix 1, that the substance Larvin SC can be adequately contained.
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Decision
6.1
The Committee has considered this application under section 31 to import into
containment a hazardous substance and pursuant to section 32, the Committee is
satisfied that this application is for one of the purposes specified in section 30,
being section 30(b).
6.2
The Committee is satisfied that, given the controls imposed, the substance can be
adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology the Committee records that,
in reaching this conclusion, it has applied the criteria specified in section 32 of the
Act.
6.4
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 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.
6.5
The application to import into containment the hazardous substance Larvin SC is
thus approved, with controls, as set out in Appendix 1.
Mr Tony Haggerty
Date
5 March 2003
Chair, Hazardous Substances Committee
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Appendix 1: Controls
1. TO LIMIT THE LIKELIHOOD OF ESCAPE OF ANY CONTAINED HAZARDOUS
SUBSTANCE OR CONTAMINATION BY HAZARDOUS SUBSTANCE
1.1.
The trials shall be undertaken in accordance with the Project Plan and Management
Plan which accompanied the application except where the following controls direct
otherwise. Modifications of the Project Plan or Management Plan may be approved
in writing by ERMA New Zealand providing that they comply with the following
controls.
1.2.
The substance shall be applied to the seeds in a batch treater in an enclosed building
at Wrightson’s Research Farm at Lincoln, and all substance shall only be taken to the
field in the form of treated seed. Access to the treatment facility shall be limited to
personnel authorised by the Trial Director. (Wrightson’s Research Farm is an
approved seed quarantine facility with adequate security being part of that approval).
1.3.
The GROWSAFE Code of Practice for the Management of Agrichemicals,
NZS8409: 1999 shall be followed.
1.4.
The trial plots1 shall be chosen so as to minimise the risk of any of the substance
entering any surface water system or groundwater system.
1.5.
The trial plot boundaries shall be clearly marked and distinctly visible from outside
the trial plot throughout the life of the trial. The existence of the trial shall be clearly
marked to avoid accidental/incidental access or grazing.
1.6.
All trial plots shall be at least 50 metres from buildings where people live or work
(commercial and research glasshouses, and buildings on research stations where the
trial is being conducted being exceptions).
1.7.
Field trial plots shall be sprayed with a dessicant herbicide at the completion of the
trial. Pot trials shall be allowed to dry off and shall be disposed of in a compost
system or spread over ground that will be cultivated within the containment facility.
(Refer also 6.6).
1.8.
Access to the trial site(s)2 shall be by permission of the Trial Director or owner of the
property on which it is located. The trial site(s) shall be secured by stock-proof
fencing and all potential access points shall be signed indicating that unauthorised
access is not allowed, that the site is subject to a trial, and that the crops should not
be removed or disturbed.
1.9.
The substance shall be securely packed in containers being identified in accordance
with the draft label, submitted as Appendix 5 of the application.
1
Trial plot – a defined area within the trial facility where the seed will be sown.
2
Trial site – the commercial or private property where the trial is to be conducted.
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1.10.
The transportation of the substance shall comply with The Land Transport Rule:
Dangerous Goods 1999.
1.11.
All surplus substance shall be held in the original container and stored in Bayer New
Zealand Ltd’s laboratory until the substance is approved for release by ERMA New
Zealand and registered for use by the New Zealand Food Safety Authority, or, if the
substance is not so approved and registered, it shall be disposed of via a commercial
incinerator designed for this purpose, and contracted outside the company.
2. TO EXCLUDE ORGANISMS OR CONTROL ORGANISMS
2.1.
Grazing animals shall be excluded from all trial sites for the duration of the trial
period. (See also control 1.8)
3. TO EXCLUDE UNAUTHORISED PEOPLE
3.1.
The seed treatment facility is on Wrightson’s Research Farm and public access is
limited. Visitors shall report to reception and they shall be escorted by staff while on
the property.
3.2.
Access to each trial site in the first instance shall be by access to the property through
the main entrance. The final entrance allowing access to the trial site shall be clearly
marked by a sign indicating such, and allowing no access without permission of the
Trial Director or property owner/manager. (See also control 1.8)
4. TO PREVENT UNINTENDED RELEASE OF THE SUBSTANCE BY
EXPERIMENTERS WORKING WITH THE SUBSTANCE
4.1.
All seed shall be treated at Wrightson’s Research Farm and application of the
substance to the seed shall be by suitably qualified staff. Equipment used for treating
the seed shall be triple-rinsed after use and the rinsate disposed of by spreading over
a designated non-cropping, non-grazed area (excluding areas where bees may be
foraging) on Wrightson’s Research Farm. Any empty substance containers shall be
triple-rinsed and then disposed of in an approved landfill.
4.2.
Treated seed will be weighed out into plot size amounts, bagged and labelled as
treated seed before being transported to the trial site.
4.3.
Personnel applying the substance to the seed shall wear appropriate protective
clothing.
4.4.
Personnel handling the dry treated seed shall wear rubber gloves.
5. TO CONTROL THE EFFECTS OF ANY ACCIDENTAL RELEASE OF THE
SUBSTANCE
5.1.
Any spillage of the substance shall be contained, prevented from entering waterways,
and absorbed with earth, sand, clay or other absorbent material. The material shall
then be placed into sealed, labelled drums ready for safe disposal. Any spillage of
the treated seed shall be contained and collected.
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5.2.
To minimise the effects of any accidental release of the substance, the container label
shall carry appropriate safety precautions and relevant first aid measures for
immediate action pending medical attention.
5.3.
Should an accidental release and exposure occur, normal precautions (such as the
careful washing of hands, face, clothing, and equipment) shall be observed.
6. INSPECTION AND MONITORING REQUIREMENTS
6.1.
The Trial Director shall keep track of all use of the substance as per section 5.9.1 of
Code of Practice for the Management of Agrichemicals NZS8409: 1999.
6.2.
Occupational Safety & Health, Head Office [Attn HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the
locations, start, and completion of the field trials.
6.3.
If for any reason a breach of containment occurs, the Trial Director shall notify OSH
and ERMA New Zealand within 24 hours of the breach being detected.
6.4.
The Authority or its authorised agent or properly authorised enforcement officers,
may inspect the facilities and trial sites at any reasonable time in accordance with the
Management Plan.
6.5.
This approval is for one year from the date on which approval is given. The approval
will extend for a further season provided ERMA New Zealand is notified in writing
of that request within one year from the date on which the approval is given.
6.6.
At the end of the trial, the plant material shall be destroyed by a dessicant herbicide
followed by cultivation of the soil. The trial plot shall not be used for grazing for at
least three months after the treated seed has been sown.
7. QUALIFICATIONS REQUIRED OF THE PERSON RESPONSIBLE FOR
IMPLEMENTING THE CONTROLS
7.1.
Technically qualified personnel shall carry out the studies using appropriate
management procedures.
7.2.
Trial personnel shall have GROWSAFE accreditation.
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