ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
14 December 2005
Application Code
HSC05036
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Dow AgroSciences (NZ) Ltd
89 Paritutu Road
New Plymouth
Purpose of the Application
EF-1440, GF-1571: To import a limited quantity of EF1440 under containment to use on a trial basis to
manufacture a pilot batch of GF-1571 to export to
Australia for use in product evaluation trials as a
herbicide
Date Application Received
10 November 2005
Consideration Date
14 December 2005
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import and manufacture in containment the hazardous substances
EF-1440 and GF-1571 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, (the Methodology).
1.2
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
EF-1440
GF-1571
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 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 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 10 November 2005 and assessed as having
sufficient information on 14 November 2005.
3.2
Project Team:
Beth Dye
Applications Manager (Hazardous Substances)
Sue Scobie
Senior Science Advisor (Hazardous Substances)
Report review and sign-out by:
Noel McCardle
Applications Team Leader (Hazardous Substances)
3.3
The applicant supplied the following documents:
 The application, including confidential appendices containing commercially
sensitive information.
3.4
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)).
3.5
A response was received from the Ministry of Health, stating that “with appropriate
HSNO controls, the Ministry has no issues to raise at this time relating to the
acceptance of this application based on non-confidential information provided from a
public health perspective (non-occupational)”.
3.6
The applicant was provided with a copy of the proposed controls for EF-1440 and GF1571 and given the opportunity to comment on them. Issues raised by the applicant
were taken into consideration in setting the controls.
4
Consideration
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).
ERMA New Zealand Decision: Application HSC05036
Page 2 of 8
4.2
In accordance with section 32 of the HSNO 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 HSNO Act.
Purpose of the Application
4.3
The purpose of the application is to import a limited quantity of EF-1440 under
containment to use on a trial basis to manufacture a pilot batch of GF-1571 to export to
Australia for use in product evaluation trials as a herbicide.
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
HSNO Act.
Description and Use of the Substances
4.5
EF-1440 is a florasulam manufacturing concentrate which will be imported and then
used in the manufacture of GF-1571. GF-1571 will be manufactured at the Dow
AgroSciences manufacturing facility in New Plymouth and exported to Australia for
use in field trials under an APVMA permit.
Hazardous Properties
4.6
I note that a containment application only requires sufficient understanding of the
hazardous properties of the substance to ensure that any risks can be managed by the
containment controls.
4.7
The applicant notes that limited information is available about the toxicity of the
substances to humans and considers that both substances may cause eye irritation.
Likewise limited information is available regarding ecotoxicity but the substances are
expected to be very ecotoxic to terrestrial and aquatic plants as would be expected of
herbicides.
4.8
I have reviewed the applicant’s hazard information. This is insufficient to fully
describe the hazards of the substances but provides a workable basis for setting the
containment controls to ensure that any risks can be adequately managed.
Life Cycle
4.9
A total of 1000 litres of EF-1440 will be imported into New Zealand in 200 litre
containers, and transported by road or rail to the manufacturing site of Dow
AgroSciences in New Plymouth. It will be used to manufacture a 10,000 litre pilot
batch of GF-1571. This process will be a “test run” to determine the optimal
formulating processes, as GF-1571 has never been formulated on a pilot scale
previously.
ERMA New Zealand Decision: Application HSC05036
Page 3 of 8
4.10
GF-1571 will be exported in 5 and/or 10 litre containers to Australia for use in field
trials under an APVMA permit.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.11
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.
4.12
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of risk management. I have reviewed the applicant’s
assessment of risks and agree that it is suitable for the consideration below.
Risks to the Environment
4.13
Limited information is available regarding ecotoxicity but the substances are expected
to be very ecotoxic to terrestrial and aquatic plants as would be expected of herbicides
and EF-1440 will be toxic to birds.
4.14
On the basis of the lifecycle of the substances outlined in paragraph 4.9-4.10, adverse
effects could arise from:
 An accident during manufacture or transportation, resulting in release of the
substances.
4.15
I note that limited quantities of the substances will be imported and manufactured. I
note that the manufacturing site is fenced and secure and contains appropriate bunding
and other physical measures designed to prevent accidental discharge of substances into
the environment. I note that the substances will be packaged in appropriate containers,
and their size (200L for EF-1440 and 10 L maximum for GF-1571) will limit the
amount able to be released should an accident occur during transport.
4.16
I consider that, taking into account the likely properties of the substances, the quantities
involved, the containment controls in Appendix 1 and controls in place under other
legislation, there are no significant risks to the environment.
Risks to Human Health and Welfare
4.17
Limited toxicological data are available on the substance, but the applicant considers
that the significant risk with respect to human health may be eye irritation for both
substances. I note that the substances also have possible target organ effects.
4.18
On the basis of the lifecycle of the substance outlined in paragraph 4.9-4.10, adverse
effects on human health and welfare could arise from:
 An accident, resulting in exposure during manufacture or transportation.
4.19
I note that limited quantities of the substances will be imported and manufactured. I
note that manufacture and packing will be done in a manufacturing facility designed
and operated for the purposes of handling hazardous substances. All personnel are
required to wear appropriate personal protective equipment. Transport of the
ERMA New Zealand Decision: Application HSC05036
Page 4 of 8
substances will be done by contract carriers who specialise in the transport of hazardous
substances.
4.20
I consider that, taking into account the likely properties of the substances, the quantities
involved, the containment controls in Appendix 1 and controls in place under other
legislation, there are no significant risks to human health and welfare.
Māori issues and concerns
4.21
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”.
4.22
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 managed in accordance with the controls in Appendix 1, and in
accordance with any other relevant controls applied under other legislation.
5
Containment and Controls
5.1
I have evaluated the adequacy of the containment arrangements proposed by 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.
5.2
I am satisfied that with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, the substance can be adequately contained.
6
Decision
6.1
I have considered this application under section 31 to import and manufacture in
containment any hazardous substance, 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 EF-1440 and GF-1571, 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 HSNO Act.
ERMA New Zealand Decision: Application HSC05036
Page 5 of 8
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 HSNO 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 EF-1440 and to
manufacture in containment the hazardous substance GF-1571 is thus approved
pursuant to section 32 of the HSNO Act, with controls as set out in Appendix 1.
Rob Forlong
Date 14 December 2005
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
EF-1440:
GF-1571:
HSC000226
HSC000227
ERMA New Zealand Decision: Application HSC05036
Page 6 of 8
Appendix 1: List of controls that apply to the
hazardous substances EF-1440 and GF-1571
1. A maximum of 1000 litres of EF-1440 shall be imported under this approval. A
maximum of 10,000 litres of GF-1571 shall be manufactured under this approval.
2. Manufacture of GF-1571 shall take place at the Dow AgroSciences pesticide
manufacturing plant at New Plymouth.
3. All GF-1571 which is manufactured shall be exported to Australia for use in field trials
under an APVMA permit.
4. All personnel carrying out the manufacture and packaging of the substances shall wear
appropriate personal protective equipment.
5. The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
6. The outer packaging of a multiple package or the packaging of a single container which
is not contained within a multiple package must comply with:
a) the priority identifier information required by regulations 9, 11 and 14 of the
Hazardous Substances (Identification) Regulations 2001; or
o the labelling or marking required by
 Land Transport Rule 45001: Dangerous Goods 2005; or
 Civil Aviation Rule 92: Carriage of Dangerous Goods; or
 Maritime Rule 24A: Carriage of Cargoes - Dangerous Goods; or
o The pictogram for “Dangerous in the Environment” as described in directive
92/32/EEC (instead of identifier requirements of regulations 9 and 20); or
o The relevant class or subclass label assigned by the 14th revised edition of
the Recommendation on the Transport of Dangerous Goods Model
Regulations, published by the United Nations
b) EF-1440 and GF-1571 must be identified by enough information to enable their New
Zealand supplier or manufacturer to be contacted, either in person or by telephone
c) EF-1440 and GF-1571 shall not have on their packaging, or with them, any
information suggesting that either belongs to a class or subclass it does not in fact belong
to.
d) If the outer packaging of a multiple package or the packaging of a single container
which is not contained within a multiple package complies with these requirements, it
does not need to comply with the secondary identifier requirements of regulations 18, 19,
20, 22 and 25 of the Hazardous Substances (Identification) Regulations 2001.
e) Any requirement to label the outer packaging of a multiple package of EF-1440 or GF1571 or the packaging of a single container which is not contained within a multiple
package of EF-1440 or GF-1571 as containing a substance that is hazardous to the
environment/ecotoxic, specified in the rules and regulations stated above, is omitted
when the substance is stored in New Zealand in a secure warehouse or other secure
ERMA New Zealand Decision: Application HSC05036
Page 7 of 8
storage facility owned, operated or otherwise under the control of the manufacturer or the
shipping agency prior to exportation from New Zealand.
7. A Safety Data Sheet for each substance shall accompany each shipment.
8. The substances shall be transported in accordance with good practice. This may require
compliance with the Land Transport Rule: Dangerous Goods 2005.
9. Any surplus EF-1440 remaining at the end of the manufacturing process shall be held in
secure storage in an exempt laboratory, exported or degraded to non-hazardous
substances (note that once the manufacturing process is complete the substance does not
have approval to be present in New Zealand except in an exempt laboratory).
10. If for any reason a breach of containment occurs, Dow AgroSciences shall notify OSH
(HSNO Project Manager) and ERMA New Zealand (Beth Dye) 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 of the contamination
and the measures taken in response.
11. The Authority, or its authorised agent or properly authorised enforcement officers, may
inspect the facility at any reasonable time.
12. This approval remains in place for one year from the date of signature of the decision.
ERMA New Zealand Decision: Application HSC05036
Page 8 of 8