25 September 2003
Application Code
Application Type
Applicant
Purpose of the Application
HSC03009
To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Bayer New Zealand Limited
To field test the substances Galmano and Galmano Plus to assess the efficacy and phytotoxicity.
14 August 2003 Date Application Received
Consideration Date 25 September 2003
Considered by Bas Walker, Chief Executive of ERMA New Zealand
1.1
The application to import into containment the hazardous substances Galmano and
Galmano Plus is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act) and the
HSNO (Methodology) Order 1998.
1.2
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
Galmano
Galmano Plus
1.3
ERMA New Zealand 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 these substances:
Main category
Industry category
Function/use category
3 Non-dispersive use
1 Agricultural Industry
38 Pesticides
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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 additional matters to be considered in that section and 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 decision 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.
3.1
The application was formally received on 14 August 2003 and verified as having sufficient information on 15 August 2003.
3.2
The applicant supplied the following documents:
3.3

The application

Confidential appendices, containing compositional information, Safety Data Sheets, a Management Plan and a Project Plan.
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 (ACVM Group)).
3.4
A response was received from ACVM Group, stating that as the application will be considered under the ACVM Act, any issues which may arise under the Acts administered by MAF/NZFSA will be considered as part of that application.
3.5
The applicant was provided with a copy of the proposed controls for Galmano and
Galmano Plus and given the opportunity to comment on them. No comments were made by the applicant.
3.6
The ERMA New Zealand Senior Advisor (Māori Affairs) was advised of the application. Her comments form the basis of paragraphs 4.19 – 4.20 and the second sentence of control 25 of this Decision.
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Sequence of the Consideration
4.1
This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e) of the HSNO Act).
4.2
In accordance with section 32 of the Act, the approach adopted when considering this application 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 substances 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 purpose of the application is to import into containment the substances Galmano and Galmano Plus for field testing to assess their efficacy, crop selectivity and residue decay profile, in order to compare their performance to current industry standards.
4.4
As the purpose amounts to “research and development on any hazardous substance”, I consider that the application qualifies for consideration under section 30(ba) of the Act.
Hazard Classification
4.5
I note that a containment application only requires sufficient understanding of the hazardous properties to ensure that any risks can be managed by the containment controls.
4.6
The applicant has assessed the available information and has identified that the hazardous properties of Galmano Plus are limited to toxic (acute oral toxicity and possibly acute inhalation toxicity) and ecotoxic (aquatic ecotoxicity and terrestrial vertebrate toxicity) properties.
4.7
The applicant provided data for Galmano Plus and stated that the data for Galmano will be very similar.
4.8
I have reviewed the applicant’s hazard information and consider that it is sufficient to describe the hazards associated with the substances to ensure that any risks can be managed by the containment controls.
Life Cycle
4.9
Bayer New Zealand Ltd plans to import up to 5L of each formulation. The proposal is to import 1 L of each formulation initially and then import further quantities if the initial trial results look promising. The substances will arrive in securely packed containers, which will be stored by Bayer New Zealand Ltd in secure facilities in the company laboratory. The substances will be dispensed into trial sized quantities as required to treat the appropriate amount of seed, which will be treated in a batch process in an enclosed laboratory at Bayer New Zealand Ltd’s Christchurch premises. Treated seed will then be weighed out into plot sized amounts, bagged, labelled and transported to the
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trial site or green house. Appropriate disposal procedures for surplus samples, used containers and treated produce are detailed in the Management Plan supplied by the applicant.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.10
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential risks of escape from containment under the headings of environmental, human health and welfare and Māori issues and concerns.
4.11
In the application, the applicant identified and assessed potential risks, and detailed proposals for, and impacts of, risk management. I have taken this into account in my consideration of the risks.
Risks to the Environment
4.12
If released into waterways, the substances may have adverse effects on aquatic organisms. If the substances do not remain contained, they may have adverse effects on terrestrial vertebrates.
4.13
On the basis of the lifecycle of the substances outlined in paragraph 4.9, effects on aquatic organisms could arise from:

An accident during storage, use or transportation, resulting in release of the substances into waterways

Failure to follow correct use and disposal procedures as outlined in the Management
Plan.
4.14
Effects on terrestrial vertebrates could arise from:

An accident during storage, use or transportation, resulting in release of the substances such that they become accessible to terrestrial vertebrates

Ingestion of treated seed

Failure to follow correct disposal procedures as outlined in the Management Plan.
4.15
I consider that, taking into account the properties of the substances, the quantities involved, the proposed containment regime and controls in place under other legislation, there are no significant risks to the environment.
Risks to Human Health and Welfare
4.16
Ingestion of the substances has the potential to result in adverse effects on human health. It is possible that inhalation of the substances may result in adverse effects on human health.
4.17
On the basis of the lifecycle of the substances outlined in paragraph 4.9, adverse effects on human health and welfare could arise from:

An accident, resulting in exposure, during storage, use or transportation

Failure to follow safety precautions for seed preparation

Failure to adhere to the Management Plan, including the disposal procedures.
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4.18
I consider that, taking into account the properties of the substances, the quantities involved, the proposed containment regime and controls in place under other legislation, there are no significant risks to human health and welfare.
Māori issues and concerns
4.19
I have considered the potential Māori cultural effects of this application in accordance with sections 6(d) and 8 of the HSNO Act 1996, and the assessment framework contained in the ERMA New Zealand User Guide “Working with Māori under the
HSNO Act 1996”.
4.20
On the basis of the information provided by the ERMA New Zealand Senior Advisor
(Māori Affairs), I consider that the substances are unlikely to have an impact on the relationship of Māori and their culture and 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 used in accordance with the proposed containment regime.
5.1
I have evaluated the adequacy of the containment arrangements of the applicant and the controls listed in Appendix 1, and note that these cover the matters set out in Part III of the Third Schedule of the Act, being

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 substances by experimenters working with the substances.

To control the effects of any accidental release of the substances.

Inspection and monitoring requirements.

Qualifications required of the person responsible for implementing the controls.
5.2
I am satisfied that with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, the substances can be adequately contained.
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6.1
I have considered this application under section 31 to import into containment hazardous substances, and pursuant to section 32, I am satisfied that this application is for the purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of the substances Galmano and
Galmano Plus, I am satisfied that the controls imposed, including those in place under other legislation, will result in the substances being adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology I record that, in reaching this conclusion, I have applied the criteria specified in section 32 of the Act.
6.4
I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substances;
 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 substances Galmano and
Galmano Plus is thus approved pursuant to section 31 of the Act, with controls as set out in Appendix 1.
Bas Walker Date 25 September 2003
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
Galmano
Galmano Plus
HSC000052
HSC000053
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1.
The trials shall be undertaken in accordance with the information contained in the application. 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.
2.
Notwithstanding the requirements of control 1 above, the trials shall comply with the following controls.
3.
The substances shall be transported and stored in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001, and shall be labelled in accordance with the Hazardous Substances (Identification) Regulations 2001. A Safety Data Sheet shall accompany each shipment.
4.
The substances shall be transported in accordance with good practice. This may require compliance with the Land Transport Rule: Dangerous Goods 1999.
5.
The substances shall be stored in secure facilities in the enclosed laboratory at Bayer New
Zealand’s Christchurch premises, in accordance with good practice. This would generally be achieved by compliance with the Code of Practice for the Management of
Agrichemicals NZS8409. Access to the treatment facility shall be limited to personnel authorised by the Trial Director
1
.
6.
The substances shall be prepared and applied to the seed in accordance with good practice. This would generally be achieved by compliance with the Code of Practice for the Management of Agrichemicals NZS8409. The substances shall be applied to the seeds by suitably qualified personnel (for example, GROWSAFE accredited) in an enclosed laboratory at Bayer New Zealand’s Christchurch premises. The substances shall only be taken to the trial sites in the form of treated seed.
7.
Only sufficient material to treat the appropriate amount of seed shall be removed from the container.
8.
Treated seed shall be weighed out into plot sized amounts, bagged and labelled before being transported to the trial site.
9.
Only sufficient seed for each trial shall be taken to the trial site.
10.
All seed shall be sown and covered with soil.
11.
Personnel applying the substance to the seeds shall wear appropriate protective clothing, as specified by the Safety Data Sheet.
12.
Personnel handling the treated seed shall wear rubber gloves.
1 The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the trial in accordance with the Management Plan and approved controls.
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13.
Equipment used for treating the seed shall be triple rinsed after use and the rinsate disposed of over a non-cropping, non-grazed area. Any surplus treatment mixture shall be further diluted and disposed of as above.
14.
Surplus substances remaining at the end of the trials shall be returned to Bayer New
Zealand Ltd for secure storage in an exempt laboratory, exported or degraded to a nonhazardous substance. (Note that once the trials are complete the substances do not have an approval to be present in New Zealand except in an exempt laboratory).
15.
All substance containers, once empty, shall be triple rinsed. The rinsate will then be disposed of over a non-cropping, non-grazed area, and the container shall be disposed of in an appropriate waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance policy.
16.
Any spillage of the substances 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 containers and disposed of at an appropriate waste disposal facility
(which may include a landfill), subject to the facility’s waste acceptance policy. Any spillage of the treated seed shall be contained, collected and disposed of similarly.
17.
To minimise the effects of any accidental release of the substances, the container labels shall carry appropriate safety precautions and relevant first aid measures for immediate action pending medical attention. A copy of the Safety Data Sheet shall accompany the substances to the seed treatment facility.
18.
Should accidental release and exposure occur, normal precautions shall be followed, as detailed in the Safety Data Sheet.
19.
The trial sites shall be chosen so as to prevent any of the substances entering any surface water or groundwater system.
20.
Access to the trial sites shall be by permission of the Trial Director or owner of the property on which it is located. The trial site boundaries shall be clearly marked and distinctly visible from outside the trial site throughout the life of the trials. The primary access points shall be signed indicating that unauthorized access is not allowed, that the site is subject to a trial, and that the crops should not be removed or disturbed.
21.
The trial sites shall be secured by stock proof fencing to exclude grazing animals for the duration of the trial.
22.
At the completion of the trial, field trial plots shall be cultivated, and pot trials shall be allowed to dry off, and disposed of in a compost system or spread over ground that will be cultivated. No seed produce shall enter the human or animal food chain, and treated seed shall not be sold.
23.
A record shall be kept of all use of the substances by the Trial Director. This record shall cover all matters referred to in Regulation 6 of the Hazardous Substances (Class 6, 8 and
9 Controls) Regulations.
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24.
Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or equivalent position] and ERMA New Zealand shall be informed in writing of the location, start, and completion of the trials. The OSH project manager shall be informed at least three working days prior to application at specific sites.
25.
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. It is suggested that if a breach in containment results in contamination of a waterway, the relevant iwi authorities be advised.
26.
The Authority, or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time.
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