Application Code
Application Type
Applicant
27 October 2006
HSC06023
To import or manufacture a hazardous substance in containment under
Section 31 of the Hazardous Substances and New Organisms Act 1996
BASF New Zealand Limited
Purpose of the Application To import under containment experimental plant protection compounds for the purpose of testing for the control of weeds, plant damaging organisms or the management of crop plants in various agricultural, horticultural and forestry crops. (Generic, field)
Date Application Received 19 September 2006
Consideration Date
Considered by
27 October 2006
Rob Forlong, Chief Executive of ERMA New Zealand
1.1
The application to import into containment the hazardous substances, BNZ0106 -
Experimental Plant Protection Compounds [insert code], is approved with
controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the Act) and the HSNO (Methodology) Order 1998
(the Methodology).
1.2
The substances have been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
BNZ0106 - Experimental Plant Protection Compounds [insert code]
2.1
2.2
The application was lodged pursuant to section 31. The decision was determined in accordance with section 32, taking into account additional matters to be considered in that section and matters specified under Part II of the Act and the provisions of
Part III of the Third Schedule of the Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the Act.
Consideration of the application followed the relevant provisions of 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 19 September 2006.
3.2
Project Team:
3.3
3.4
3.5
3.6
Brendon Noonan
Sue Scobie
Linda Robinson
Application Advisor (Hazardous Substances)
Senior Advisor (Hazardous Substances)
Group Manager, Maori Unit
The applicant supplied the following documents:
 the application
 a confidential appendix containing the proposed study and management plan, information regarding containment and samples of trial protocol.
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 (Workplace Group);
 The New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
No responses were received.
The applicant was provided with a copy of the proposed controls for BNZ0106 -
Experimental Plant Protection Compounds [insert code] and given the opportunity to comment on them. The comments provided were taken into account in the setting of controls.
4.1
4.2
In accordance with section 32, 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.
This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e)).
4.3
4.4
This application has been submitted to cover the import into containment of experimental plant protection compounds for the purpose of testing for the control of weeds, plant damaging organisms or the management of crop plants in various agricultural, horticultural and forestry crops.
The project team considers that the purpose stated by the applicant amounts to
“research and development on any hazardous substance” and therefore qualifies for consideration under section 30(ba).
ERMA New Zealand Decision: Application HSC06023 Page 2 of 11

4.5
BASF New Zealand Limited intends to import and trial a range of experimental plant protection compounds that contain biologically active ingredients. The applicant expects that a maximum of 100 L or kg (20 L or kg per season) of each compound will be imported over the period of the approval. The applicant expects the compounds to trigger hazard thresholds under the Act; however, they are likely to be the minimum degrees of any hazard class, as defined in the Hazardous
Substances (Minimum Degrees of Hazard) Regulations 2001.
4.6
4.7
Each experimental plant protection compound will be imported in a ready to use form, fully packaged in polyethylene terephthalate (PET) bottles or other suitable
United Nations (UN) compliant containers.
Import is expected to be by sea; however, air freight has not been excluded.
Persons handling the substance during transport will only do so when the compounds are in a fully packaged state. That is, containers holding the compounds will be packaged in absorbent material within an outer package.
4.8
4.9
Storage and transport within New Zealand will be carried out in compliance with the controls prescribed in Appendix 1 of this decision and all other relevant legislative requirements.
Trialling of the substances will be carried out in small scale field plots in accordance with the management plan and proposed controls submitted to the Agency in support of this application. Trials will also be conducted in accordance with the individual project plans submitted each substance.
4.10
The applicant has stated that the experimental plant protection compounds will be mixed and applied by qualified personnel during the trials. Application of the substances will be by ground based techniques only. Aerial application or application into or onto water has been specifically excluded.
4.11
Management of each substance, its packaging, treated crops and the trial sites post application will be covered by the individual project plans as required by the controls prescribed in Appendix 1 and the management plan.
4.12
The project team notes that a containment application only requires sufficient understanding of the hazardous properties to ensure that any risks can be managed by the containment controls.
4.13
It is also noted that the scope of the hazard information will often be limited, as the substances will be experimental and may not be commercialised. Each substance imported under this approval will be notified to ERMA New Zealand prior to its trialling, and the notification will include compositional information, a Project Plan and a Safety Data Sheet and any available hazard information.
4.14
The applicant expects that the experimental plant protection compounds are likely to have hazardous properties and that trigger the minimum degrees of hazard for each allowable hazard category, as defined the Hazardous Substances (Minimum
Degrees of Hazard) Regulations 2001 and as limited in Appendix 1.
4.15
After taking into account the substances’ likely hazardous properties, the project team considers that the information provided is sufficient to determine that any risks can be managed by the containment controls proposed in Appendix 1.
ERMA New Zealand Decision: Application HSC06023 Page 3 of 11

4.16
The applicant has identified and assessed potential risks and detailed proposals for, and impacts of, risk management. The Agency has reviewed the applicant’s assessment of the risks to the environment, human health and welfare and Maori issues and concerns as set out below:
4.17
If released off target, the substances have the potential to result in adverse effects on the environment.
4.18
On the basis of the lifecycle of the substances outlined in paragraphs 4.5-4.11, adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the substances;
 failure to follow correct disposal procedures as outlined in the management plan; or
 failure to follow the correct operational procedures as set out in the controls, management plan and project plans, resulting in release of the substances.
4.19
The project team considers that, taking into account the likely properties of the substance, the quantities involved, the containment regime proposed by the applicant, the controls set in Appendix 1 and in place under other legislation, there are no significant risks to the environment.
4.20
If the substances are ingested or inhaled, or come in contact with skin or eyes they have the potential to cause adverse effects on human health.
4.21
On the basis of the lifecycle of the substances outlined in paragraph 4.5-4.11, adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the substances;
 failure to follow correct disposal procedures as outlined in the management plan; or
 failure to follow the correct operational procedures as set out in the controls, management plan and project plans, resulting in release of the substances.
4.22
The project team considers that, taking into account the properties of the substances, the quantities involved, the containment regime proposed by the applicant, the containment controls in Appendix 1 and controls in place under other legislation, there are no significant risks to human health and welfare.
ERMA New Zealand Decision: Application HSC06023 Page 4 of 11

4.23
The project team has considered the potential Māori cultural effects in accordance with clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8. In addition, the project team has applied the assessment framework contained in the ERMA New Zealand
User Guide “Working with Māori under the HSNO Act 1996” in consideration of this application.
4.24
The project team expects that the BASF New Zealand Limited experimental plant protection compounds covered under this approval will have hazardous properties that trigger HSNO thresholds for toxicity, ecotoxicity and/or physical hazards.
Given that the substances will have hazardous properties, there is a potential for cultural risk, including deterioration of the mauri of taonga flora and fauna, the environment and the general health and well-being of individuals and the community. In addition the potential exists for these substances to inhibit the ability of iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of waterways.
4.25
After careful consideration of the risks associated with these experimental plant protection compounds and the containment regime proposed, the project team does not consider that any significant adverse effects are likely to occur to Māori culture or traditional relationships with their ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. This assessment is made on the condition that the compounds are handled, stored, transported, used, and disposed of, in accordance with the explicitly stated HSNO 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 suggested that BASF New
Zealand Limited notify the appropriate authorities 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.
4.26
In its assessment the project team has not found any evidence to suggest that the controlled and contained use of these compounds will breach the principles of the
Treaty of Waitangi and does not see any requirement for the applicant to consult with Māori regarding this application.
5.1
The project team has evaluated the adequacy of the containment arrangements proposed by the applicant and the controls listed in Appendix 1, and notes 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 (for example, control 9);
 to exclude organisms from a facility (for example, control 19);
 to exclude unauthorized people from the facility (for example, control 18);
 to prevent unintended release of the substances by experimenters working with the substance (for example, control 22);
 to control the effects of any accidental release of the substance (for example, control 30);
 inspection and monitoring requirements (for example, control 35); and
 qualifications required of the person responsible for implementing the controls (for example, control 21).
ERMA New Zealand Decision: Application HSC06023 Page 5 of 11

5.2
The project team is satisfied that, with adherence to the controls listed in Appendix
1 and those controls in place under other legislation BNZ0106 - Experimental
Plant Protection Compounds [insert code] can be adequately contained.
6.1
6.2
6.3
I have considered this application made under section 31 and, pursuant to section
32, I am satisfied that this application is for the purpose specified in section 30(ba), that is for “research and development on any hazardous substance”.
Having considered the risks associated with the lifecycle of BNZ0106 -
Experimental Plant Protection Compounds [insert code], I am satisfied that the controls imposed, including those in place under other legislation, will result in the substances being adequately contained. I also consider that the controls imposed are not too onerous to be complied with.
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have applied the criteria specified in section 32.
6.4
6.5
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.
The application to manufacture or import into containment the hazardous substances BNZ0106 - Experimental Plant Protection Compounds [insert code} is thus approved pursuant to section 32, with controls as set out in Appendix 1.
Rob Forlong
Chief Executive of ERMA New Zealand
Date
BNZ0106 - Experimental Plant Protection Compounds [insert code]
ERMA New Zealand Approval Code: HSC000251
ERMA New Zealand Decision: Application HSC06023 Page 6 of 11

1.
This approval covers the contained importation, manufacture and field trialling of experimental plant protection compounds, as notified to ERMA New Zealand pursuant to Control 5.
2.
3.
4.
5.
The maximum total quantity of each experimental plant protection compound that may be manufactured or imported under this approval is 100 litres or 100 kg.
This approval applies only to the ground-based application of the substances to agricultural and horticultural crops, forestry, pasture, and seeds.
This approval remains in place for five years from the date of this Decision.
Each substance imported or manufactured under this approval shall be notified in writing to ERMA New Zealand and The Department of Labour [Attn. HSNO
Project Manager (Workplace Group) or equivalent position] prior to its use in a field trial. The notification shall include:
composition details;
a Project Plan for the trial, containing information as specified in Appendix 2;
a Safety Data Sheet and/or any known hazard information; and
the following identifying details:
ERMA Application number HSC06023
Substance name/code BNZ0106 - Experimental Plant Protection Compounds
[insert code]
ERMA Approval number HSC000
ERMA Applications Advisor Brendon Noonan
6.
7.
8.
This approval does not apply to substances that trigger any hazardous property thresholds in classes 1, 2, 3.2, 4 or 5.
This approval excludes application of substances directly into or onto water.
This approval excludes the aerial application of any substance.
9.
The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
10.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001. The label must also set out instructions that any remaining substance must be returned in its original container to BASF New
Zealand Limited for storage and ultimately disposal.
ERMA New Zealand Decision: Application HSC06023 Page 7 of 11

11.
A Safety Data Sheet, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each shipment and be held at the each trial site during the period of the trial.
12.
The substance shall be securely stored in accordance with good practice. This may be demonstrated by compliance with the Code of Practice for the Management of
Agrichemicals NZS 8409: 2004.
13.
The substance shall be transported in accordance with good practice and where appropriate in compliance with any relevant requirements of the Land Transport
Act 1998, the Civil Aviation Act 1990 or the Maritime Transport Act 1994.
14.
Appropriate Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective clothing shall be worn by persons handling the substance during manufacture, use and disposal.
15.
The trials may be carried out at a location that is not defined until an infestation of the target pest has been found, provided the applicant:
16.
17.
18.
19.
a.
has written permission from the owner of the land to carry out the trial; and b.
notifies ERMA New Zealand in writing of the location in accordance with
Control 5.
The trial sites shall be chosen so as to prevent the substances entering any surface water or groundwater system.
The trial sites shall be located to prevent any residential building or workplace which is not related to the research from being exposed to the substances.
Access to the trial sites shall be by permission of the Trial Director 1 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 trial sites shall be signed indicating that unauthorized access is not permitted, that the site is subject to a trial, and that crops or plant matter should not be removed.
Trial sites that are at risk of entry by grazing animals shall be secured by stock proof fencing to exclude animals for the duration of the trial and any stock withholding periods set by the ACVM Group of the New Zealand Food Safety Authority.
20.
The trials shall be undertaken in accordance with the information provided in the application and the Project Plan which accompanies the notification of each substance. Modifications to the Project Plan or information provided in the application may only be made with the prior written approval of ERMA New
Zealand and must be in compliance with the controls specified in this document.
1 The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the trial in accordance with that proposed in the application and the approval controls.
ERMA New Zealand Decision: Application HSC06023 Page 8 of 11

21.
22.
23.
24.
25.
26.
27.
28.
29.
The personnel applying the substances shall be able to demonstrate that they have the qualifications necessary to carry out the trial, for example, by holding appropriate Growsafe certification or an Approved Handler qualification.
Experimental staff shall be made aware of the study protocol and the controls in place in order to adequately manage the substances.
The substances shall be mixed, diluted or be prepared in any other way prior to application in accordance with good practice. This may be demonstrated by compliance with the Code of Practice for the Management of Agrichemicals
NZS8409:2004 or a Standard Operating Procedure retained as part of the applicant’s trial records.
The amount of spray prepared shall be the minimum necessary for the trial, but if there is any surplus spray mix it shall be disposed of within the trial site by spraying over a marked and designated non-crop and non-grazed area at the site, or alternatively within the trial plot.
The substances shall be applied using equipment calibrated to apply accurate doses to the nominated trial plots in accordance with good practice. This would generally be achieved through compliance with the Code of Practice for the Management of
Agrichemicals NZS8409:2004 or a Standard Operating Procedure retained as part of the applicant’s trial records. Special attention shall be paid to the minimisation of spray drift, and in particular to the avoidance of drift beyond boundaries agreed with the owner or occupier of the trial site and delineated in accordance with
Control 18.
The trials shall be conducted and managed so as to prevent vertebrates and non- target invertebrates from coming into contact with the substance throughout the trials.
Seed treatment applications shall be made using suitable seed treatment apparatus.
Treated seed shall be sown in a manner likely to minimise exposure to birds.
Where this is not possible, birds shall be actively deterred from foraging on the trial site.
No sprayed produce shall be consumed by people or (so far as is reasonably practicable) animals or be sold, offered for sale, given away, bartered or otherwise distributed unless the ACVM Group has approved this process as part of a provisional registration or research permit.
A record shall be kept of the use of the substance. This record shall cover all matters referred to in Regulation 6(1) of the Hazardous Substances (Class 6, 8 and
9 Controls) Regulations 2001 and must be kept for not less than 3 years after the date on which the substance that the record relates to is applied or discharged.
Any equipment used during application shall be triple rinsed after use with water and if required with an appropriate detergent or decontaminant, and the rinsate disposed of within the trial site by being sprayed over a marked and designated non-crop and non-grazed area at the site, or alternatively within the trial plot.
30.
Any spillage of the substance (diluted or not) shall be contained, prevented from entering water bodies, and be absorbed with an appropriate absorbent material.
The absorbent material shall be collected and placed in sealed containers for disposal at an appropriate waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance policy.
ERMA New Zealand Decision: Application HSC06023 Page 9 of 11

31.
32.
33.
34.
Any surplus substance remaining at the ‘end of the trials’ shall be returned to BASF
New Zealand Limited where it will be securely stored in a laboratory complying with the requirements set out in the Hazardous Substances (Exempt Laboratories)
Regulations 2001 for the purpose of further analysis or until disposed of. ‘End of trials’ is defined as the end of the trial programme as defined in the project plan for each substance. (Note that once the trials are completed the substance will not have approval to be present in New Zealand except within an exempt laboratory).
Any surplus substance shall ultimately be treated in a manner to render the substance, as a whole, non-hazardous or be exported from New Zealand. Disposal shall be carried out in a manner compliant with the Hazardous Substances
(Disposal) Regulations 2001.
Containers no longer used to contain the substance and residue or rinsate from equipment used to handle the substances shall be disposed of in a manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
Sprayed produce that may be at risk of being removed from the trial after its completion shall be disposed of by ploughing in, by mulching, by burial on the trial site or by deposition at an approved landfill. The Trial Director shall decide the method of disposal after assessing the relevant risks. Sprayed plant matter shall not be added into any composting operation.
35.
36.
If for any reason a breach of containment occurs, the Trial Director shall notify the
Department of Labour 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 waterbody, the relevant iwi authorities be advised.
The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time. Trial documentation, as described in Control 5, notwithstanding its confidential nature, shall be available for inspection by any enforcement officer, upon request.
ERMA New Zealand Decision: Application HSC06023 Page 10 of 11

8)
9)
10)
11)
12)
13)
14)
The Project Plan to be supplied for each substance shall contain information on the following points:
1) Direction, including identification of the Trial Director
2)
3)
4)
5)
6)
7)
Substance
Project title
Objectives
Locations
Dates (start and completion)
Plot size
Total treated area
Application method
Application period
Application rate
Protection of bees
For treated seeds, how risks to birds will be addressed
Disposal of treated produce
ERMA New Zealand Decision: Application HSC06023 Page 11 of 11