ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
30 June 2016
Application code
Application type
HSC02012
To import a hazardous substance into containment under Section
31 of the Hazardous Substances and New Organisms (HSNO) Act
1996
Applicant
BASF New Zealand Limited
Purpose
Date received
To import into containment BNZ001/02 and BNZ002/02 to
conduct field trials to assess the efficacy of the substances in
certain crops.
24 October 2002
Consideration date
20 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 BNZ001/02
and BNZ002/02 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 substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
BNZ001/02
BNZ002/02
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
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
Application Process
3.1
The application was formally received on 24 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.
 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.
3.3
A response was received from the Ministry of Health who had no comment to make.
3.4
The information available to the Committee comprised:
 The application including as attachments commercially sensitive information
 The ERMA New Zealand Evaluation and Review Report
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 Dr Lindie Nelson to consider the application. The
application was considered on 20 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.
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Purpose of the Application
4.3
The applicant states that the purpose of the application is to conduct field trials to
assess the efficacy of the BNZ001/02 and BNZ002/02 in certain crops. The aim of
the trial work is to gather sufficient information to determine whether or not the
product has bio-equivalence to existing commercially available products.
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)
Hazardous properties of the Substances
4.5
The Committee notes that a containment application does not require a rigorous
assessment of the hazard classification but only to understand 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
The Committee agrees that the hazard profile will be no more hazardous than that
provided by the applicant which is:
BNZ001/02





6.1D (acute oral, acute dermal and inhalation toxicity)
6.3B (skin irritant)
6.4A (eye irritant)
9.1A (aquatic ecotoxicant)
9.3B (terrestrial vertebrate toxicant)
BNZ002/02




6.1D (acute oral, acute dermal and inhalation toxicity)
6.4A (eye irritant)
9.1A (aquatic ecotoxicant)
9.3B (terrestrial vertebrate toxicant)
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
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.
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4.9
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 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 substances can be adequately contained.
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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.
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 substances BNZ001/02
and BNZ002/02 is thus approved, with controls, as set out in Appendix 1.
Mr Tony Haggerty
Date
22nd September 2002
Chair, Hazardous Substances Committee
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Appendix 1: Controls
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 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 substances shall be applied by way of hand-held/operator-worn equipment, using
hydraulic pressure or compressed CO2 or air on plots specifically designated and
marked for each treatment.
1.3.
The trial sites shall be chosen so as to prevent any of the substances entering any
surface water or groundwater system.
1.4.
All trial sites shall be at least 50 metres from buildings where people live or work
(commercial and research glasshouses being an exception).
1.5.
Spraying shall be in accord with Section 5 of NZS8409: 1999 Code of Practice for
the Management of Agrichemicals.
1.6.
Sprayed produce shall be disposed of by either ploughing in, mulching or at an
appropriate local authority operated landfill.
1.7.
No sprayed produce shall be consumed by people or animals or offered for sale.
1.8.
The substances shall be securely packed in containers being identified in accordance
with the Hazardous Substances (Identification) Regulations 2001.
1.9.
The transportation of the substances shall comply with The Land Transport Rule:
Dangerous Goods 1999.
1.10.
Storage shall be in accordance with the Code of Practice for the Management of
Agrichemicals NZS8409: 1999.
1.11.
Any portion of the substances (undiluted) surplus to requirements shall be disposed
of by the following method:
 Returned to BASF.
1.12.
The trial site boundaries shall be clearly marked and distinctly visible from outside
the trial site throughout the life of the trial(s). The existence of the trial shall be
clearly marked to avoid accidental/incidental access and harvesting of treated crop.
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. The trial period means the period from the date of initial application of the
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substances to the date of site close-off in accordance with Control 6.6. (See also
Controls 1.1 and 3.1.)
3. TO EXCLUDE UNAUTHORISED PEOPLE
3.1.
Access to the trial site(s) shall be by permission of the Trial Director1 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 unauthorized
access is not allowed, that the site is subject to a trial, and that the crops should not
be removed or disturbed. 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 approval controls.
3.2.
The number of entrances shall be determined by the nature of the secure boundaries
and location of the site therein.
4. TO PREVENT UNINTENDED RELEASE OF THE SUBSTANCES BY
EXPERIMENTERS WORKING WITH THE SUBSTANCES
4.1.
The amount of the substances taken into each trial site shall be pre-measured in a
controlled environment (for example, a laboratory) so as to be sufficient for the
application to the designated plots.
4.2.
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 and non-grazed area at
the site.
4.3.
The equipment used shall be rinsed after use with the appropriate detergent or
decontaminant, and rinsate disposed of within the trial site by being sprayed over a
marked and designated non-crop and non-grazed area at the site.
4.4.
The mixing of the substances shall comply with section 5.5 of the Code of Practice
for the Management of Agrichemicals NZS8409: 1999.
5. TO CONTROL THE EFFECTS OF ANY ACCIDENTAL RELEASE OF THE
SUBSTANCES
5.1.
Any accidental spillage of the unmixed substances or spray mix shall be either
diluted with water, sand or earth, and then spread over a marked and designated noncrop and non-grazed area within the trial site, or taken to an approved landfill.
5.2.
To minimise the effects of any accidental release of the substances, the container
label or a readily available (within 10 seconds) information sheet, such as an MSDS,
shall carry appropriate safety precautions and relevant first aid measures for
immediate action pending medical attention.
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 approval controls.
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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 substances as per section 5.9.1 of
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 of the
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 at which approval is given.
6.6.
Site Close off – The Trial Director shall ensure that there are no detectable residues
of the test substances in the whole of the trial site, including the area used for
disposal of any surplus spray mix and rinsate.
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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