ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

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ENVIRONMENTAL RISK MANAGEMENT AUTHORITY

DECISION

Application code

Application type

18 April 2020

HSC02005

To import a hazardous substance into containment under Section

31 of the Hazardous Substances and New Organisms (HSNO) Act

1996

Applicant

Purpose

Date received

DuPont New Zealand Limited

To conduct small plot field testing of Compound DP1902 10SC and DP2902 10SC to determine the efficacy of the product in controlling target pest species using various rates of product diluted in water.

21 October 2002

Consideration date 25 November 2002

Considered by Hazardous Substances Standing Committee of the Authority.

1 Summary of Decision

1.1

The application to import into containment the hazardous substances DP1902 10SC and DP2902 10SC is approved 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 substances have been given the following unique identifiers for the ERMA New

Zealand Hazardous Substances Register:

DP1902 10SC

DP2902 10SC

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 these substances:

Main category

Industry category

Function/use category

3 Non-dispersive use

1 Agricultural Industry

38 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 Application Process

3.1

The application was formally received on 21 October 2002 and verified on 25

October 2002.

3.2

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:

Ministry of Health.

Department of Labour (Occupational Safety and Health).

New Zealand Food Safety Authority (Agricultural Compounds and Veterinary

Medicines Group - ACVMG).

Department of Conservation.

3.3

A response was received from the Ministry of Health to the effect that they had no comment to make.

3.4

3.5

The information available to the Committee comprised:

The application including as attachments commercially sensitive information

The ERMA New Zealand Evaluation and Review Report

A facsimile to the Committee dated 21 November 2002 with amended proposed controls.

The application does not include a full identification of the substances. Instead the applicant has limited the disclosure of the active ingredients to a description of the class of compounds to which these belong, together with a generic description of the properties of the class, and a description of the properties of the substances.

3.6

The Authority has decided that limited disclosure of information is acceptable in a limited number of instances, provided that sufficient information is presented to reassure the Hazardous Substances Standing Committee that any uncertainty about potential or unknown hazards can be removed by the containment controls employed.

Environmental Risk Management Authority Decision: Application HSC02012 Page 2 of 9

3.7

The Committee accepts that this application can be validly considered because: a) the fullest possible information on the substances has been provided without compromising intellectual property, b) the substances are still under development so data are limited, c) the applicant is attempting to gather data on the hazardous properties of the analogues and formulated substances, d) the substances are still awaiting patent protection, and e) the applicant understands and accepts that more stringent controls than usual may apply or that the application may even be declined if residual uncertainty remains too great.

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), Dr Lindie Nelson, and Professor George Clark to consider the application. The application was considered on 25 November 2002.

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.

4.3

Purpose of the Application

The applicant has stated that the purpose of the application is to conduct field trials to assess the efficacy of the DP1902 10SC and DP2902 10 SC in certain crops. The aim of the trial work is to gather sufficient information to determine which formulations are the most suitable for registration.

4.4

As the purpose amounts to “research and development on any hazardous substance”, the Committee considers that the application qualifies for consideration under sections 30(b) and 30(ba).

4.5

Hazardous properties of the Substances

The Committee notes that a containment application does not require a rigorous assessment of the hazard classification but sufficient understanding of the hazardous properties and areas of data uncertainty to ensure that any risks can be managed by the containment controls.

4.6

The Committee notes that ERMA New Zealand has adopted a precautionary approach in reviewing the applicant’s assessment of the hazardous properties of the substances. The Committee agrees that the revised hazard profile of both of the substances is:

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6.3B (skin irritant)

6.4A (eye irritant)

9.1A (aquatic ecotoxicant)

4.7

The Committee has concluded that the limited disclosure of information regarding the identity of the analogues will not result in unidentified substances being used in the field trials, since the hazard profile for these are not permitted to be different from the hazard profile identified in this application.

4.8

The Committee has noted that the applicant has indicated that these substances will be handled as ‘hazardous chemicals’

Identification and Evaluation of the Significant Risks of the Substance

4.9

In accordance with sections 5, 6, and 8 and clauses 9 and 11, the Committee has considered at all stages of the lifecycle, the potential risks of escape from containment under the headings of environmental, human health and welfare and

Māori issues and concerns.

4.10

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 as reviewed in the ERR, and considers that, taking into account the controls imposed in this decision, and controls in place under other legislation, there are no significant risks to the environment or to human health and welfare.

4.11

On the basis of information in the Evaluation and Review report the Committee considers there are no issues or concerns to Māori.

5 Containment and Controls

5.1

The Committee has evaluated the adequacy of the containment arrangements proposed by the applicant and the controls proposed by ERMA New Zealand.

5.2

The Committee has considered that some of the controls that had been proposed in the Evaluation and Review report, and in the facsimile of 21 November 2002 should be amended. The final set of controls are listed in Appendix 1 of this Decision.

6 Decision

6.1

The Committee has considered this application under section 31 to import into containment hazardous substances, and pursuant to section 32, the Committee is satisfied that this application is for one of the purposes specified in section 30, being sections 30(b) and 30(ba).

6.2

The Committee is satisfied that given the controls imposed, the substances can be adequately contained.

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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

6.5

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;

The application to import into containment the hazardous substances DP1902 10SC and DP2902 10SC is thus approved , with controls as set out in Appendix 1.

Mr Tony Haggerty

Chair, Hazardous Substances Committee

Date 16 th

December 2002

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Appendix 1: Controls

For the purpose of these Controls, the following terms are defined:

Trial site – the commercial or private property where the trial is to be conducted.

Trial plot – a defined area within the trial site where the crops to be tested are located.

Trial period – the period of time when the trial will proceed from spraying to when the plot can be reused (about 8 months).

Approval period – the period in which trials can be conducted (up to 3 years).

Trial director – the person nominated to be in charge of the conduct of the trial.

Spray drift – the occurrence of spray moving off the target area/trial plot due to wind, or poor application technique.

1. TO LIMIT THE LIKELIHOOD OF ESCAPE OF ANY CONTAINED HAZARDOUS

SUBSTANCES OR CONTAMINATION BY HAZARDOUS SUBSTANCES

1.1.

The trials shall be undertaken in accordance with the Management Plan, which accompanied the application except where the following controls direct otherwise.

Modifications of the Management Plan may be approved in writing by ERMA New

Zealand providing that they comply with the following controls.

1.2.

Trial plot area will be a maximum of 20 m

2

for each substance.

1.3.

The substances will be diluted prior to use and applied by way of hand-held spray- application equipment, using low pressure compressed air, on plots specifically designated and marked for each treatment.

1.4.

The substances will be applied in the volumes and concentrations according to the test protocols described in Appendix 1 Addendum C of the application.

1.5.

The trial plot locations shall be chosen so as to prevent any of the substances entering any surface water or groundwater system.

1.6.

All trial plots must be at least 50 metres from buildings where people live or work

(commercial and research glasshouses being an exception), and at least 100m from public roads.

1.7.

The maximum amount of substance for the trials is limited to 40 gai (grams active ingredient) at each trial site.

1.8.

The maximum amount of active ingredient to be imported for all the trials is limited to 120 gai.

1.9.

The substances will be securely packed in containers that are identified in accordance with the Hazardous Substances (Identification) Regulations 2001 and a Material

Safety Data Sheet (MSDS) will accompany each shipment.

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1.10.

Transport of the substances will be undertaken by local chemical transport and customs experts employed for the purpose, with a MSDS accompanying transport.

1.11.

Storage will be in accordance with the Code of Practice for the Management of

Agrichemicals NZS8409:1999 .

1.12.

Any portion of the substances surplus to requirements will be returned to DuPont

New Zealand Ltd for disposal.

1.13.

Spraying and mixing must be in accord with Section 5 of Code of Practice for the

Management of Agrichemicals NZS8409:1999 .

1.14.

Solid waste, namely treated produce, will be disposed of by ploughing in.

1.15.

No treated produce shall be consumed by people or animals or offered for sale.

2. TO EXCLUDE ORGANISMS OR CONTROL ORGANISMS

2.1

Grazing animals shall be excluded from all trial plots, including buffer zones, by a stock proof fence for the duration of the trial period. The trial period means the period of the date of initial application of the substances to the date of site close-off

in accordance with Control 6.3.

2.2

Bird scaring devices shall be located on or near the trial plots.

3.

3.1

TO EXCLUDE UNAUTHORISED PEOPLE

Access to the trial site(s) shall be by permission of the Trial Director or owner of the property on which it is located. The trial site(s) or plot(s) shall be secured by stock proof fencing and all potential access points shall be sign-posted indicating that unauthorised access is not allowed, that the plot is subject to a trial, and that crops and produce should not be removed or disturbed.

4. TO PREVENT UNINTENDED RELEASE OF THE SUBSTANCE BY

EXPERIMENTERS WORKING WITH THE SUBSTANCE

4.1

The amount of material taken into each trial site will be pre-measured so as to be sufficient for the application to the designated plots.

4.2

The dispensing of the substance from the original imported container will be in a controlled environment (for example, storage area) to minimise inadvertent release, spillage, and unnecessary exposure. Dispensing will take place prior to transportation to each trial site for application.

4.3

The mixing of the substances will occur in a controlled environment (for example, a building or storage area) and comply with section 5.5 of the Code of Practice for the

Management of Agrichemicals NZS8409: 1999.

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4.4

Any surplus spray mix shall be disposed of within the trial site(s) by being further diluted and sprayed over a marked and designated non-crop area and non-grazed area at the site.

4.5

The equipment used shall be rinsed after use with water and/or the 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.

4.6

The disposal areas referred to in controls 4.4 and 4.5 shall be chosen so as to prevent

any of the substances entering any surface water or groundwater system.

4.7

Empty containers used to transport the substances may be disposed of according to the Code of Practice for the Management of Agrichemicals NZS8409: 1999.

5. TO CONTROL THE EFFECTS OF ANY ACCIDENTAL RELEASE OF THE

SUBSTANCE

5.1

Any accidental spillage of the unmixed substances or spray mix shall be contained with absorbent material and the spillage area decontaminated by washing with a bleach solution, mopping up and disposing the spill material (including mops). The spill material shall be disposed of by certified hazardous waste disposal contractors.

5.2

To minimise the effects of any accidental release of the substances, the container labels or MSDS will carry appropriate safety precautions and relevant first aid measures for immediate action pending medical attention.

5.3

All personnel involved with preparing and spraying the substances must wear appropriate protective clothing.

6. INSPECTION AND MONITORING REQUIREMENTS

6.1

The Trial Director or nominated researcher will keep track of all use of the substances as per section 5.9.1 of the Code of Practice for the Management of Agrichemicals

NZS8409: 1999.

6.2

Prior to the initial application of the substances, the Trial Director shall inform

Occupational Safety & Health, Head Office [Attn: HSNO Project Manager (OSH) or equivalent position) and ERMA New Zealand in writing of the locations of the trial sites. The Trial Director shall inform OSH and ERMA New Zealand in writing on completion of the field trials.

6.3

Site close off – The Trial Director shall ensure that the test substances in the whole of the trial site, including the areas used for disposal of any surplus mix and rinse, shall be below international cut-off levels for toxicological or ecotoxicological concern, or show that the environmental fate of these components is such that they are not readily available and will not move off the site.

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6.4

If for any reason a breach of containment occurs, the Trial Director will notify OSH and ERMA New Zealand within 24 hours of the event.

6.5

The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time.

6.6

This approval is for up to 3 years from the date on which this approval is given.

7. QUALIFICATIONS REQUIRED OF THE PERSON RESPONSIBLE FOR

IMPLEMENTING THE CONTROLS

7.1

The personnel applying the substances to the crops shall be GROWSAFE certified.

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