ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
12 February 2004
Application Code
HSC03019
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
Institute of Veterinary, Animal and Biomedical
Sciences, Massey University
Purpose of the Application
To manufacture small amounts of 11-ketotestosterone, a
fish-specific androgenic steroid, for use by scientific
researchers in contained laboratories only
Date Application Received
15 December 2003
Consideration Date
12 February 2004
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to manufacture in containment the hazardous substance 11ketotestosterone 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 substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
11-ketotestosterone
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.
ERMA New Zealand Decision: Application HSC03019
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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 15 December 2003 and assessed as having
sufficient information on 16 December 2003.
3.2
Project Team:
Beth Dye
Applications Advisor (Hazardous Substances)
Linda Robinson
Senior Advisor (Māori Affairs)
Report review and sign-out by:
Ted Taylor
Programme Manager (Applications)
3.3
The applicant supplied the following documents:
 The application, including non-confidential appendices comprising a reference list,
proposed label and proposed MSDS
 A confidential appendix, 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 (nonoccupational) given that the substance will be limited for research purposes only.
3.6
The applicant was provided with a copy of the proposed controls for 11ketotestosterone and given the opportunity to comment on them. Several questions
were raised and answered, and the applicant had no further issues with the proposed
controls.
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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).
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 manufacture small amounts of 11-ketotestosterone,
a fish specific androgenic steroid, for sale to scientific researchers who will use it for
research purposes in contained laboratories only.
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.
Hazardous Properties
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 searched the available literature and has found no specific
information on the substance. The applicant has therefore considered possible
hazardous properties by comparison with other steroids and has identified that the
hazardous properties of 11-ketotestosterone are likely to be limited to toxic
(carcinogenic, reproductive/developmental and target organ/systemic) and ecotoxic
(aquatic) properties.
4.7
I have reviewed the applicant’s hazard information. This is insufficient to fully
describe the hazards of the substance but provides a workable basis for setting the
containment controls to ensure that any risks can be adequately managed.
Life Cycle
4.8
11-ketotestosterone will be synthesised in quantities totalling 10-20 grams per year in
the Nanomaterials Enterprises Laboratory, Institute of Fundamental Sciences, Massey
University. In each batch, 1 gram of the substance will be manufactured and it will be
stored in a secure locked facility prior to sale to research laboratories mainly in North
America, Japan and Europe. The scientific researchers in these laboratories will be
primarily investigating fish reproductive physiology. Relevant information for the enduser will be contained in the Safety Data Sheet supplied with each batch.
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Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.9
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.
4.10
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
4.11
No ecotoxicological data are available on the substance. The applicant has indicated
that the substance may be classified as 9.1C, as some steroids disrupt the development
of aquatic invertebrates.
4.12
On the basis of the lifecycle of the substance outlined in paragraph 4.8, adverse effects
could arise from:
 An accident during manufacture, use or transportation, resulting in release of the
substance
 Failure to follow correct disposal procedures as outlined in the Safety Data Sheet.
4.13
I note that the quantities involved are very small (a total of 10-20g per year with
individual batches of 1g).
4.14
I consider that, taking into account the properties of the substance, the quantity
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
4.15
No toxicological data are available on the substance. The applicant has indicated that
the substance may be classified in the 6.7, 6.8 and 6.9 classes, as some steroids may
cause carcinogenic or teratogenic effects, be toxic to the cardiovascular system or the
liver, or may affect the reproductive and musculoskeletal systems by inducing growth
and development.
4.16
The applicant has noted the possibility of steroid abuse, as the substance is an
androgenic hormone. However, the quantities being manufactured are very small, it
will be sold to research laboratories and the price is hundreds of times higher than other
more readily available androgens.
4.17
On the basis of the lifecycle of the substance outlined in paragraph 4.8, adverse effects
on human health and welfare could arise from:
 An accident, resulting in exposure during manufacture, use or transportation
 Failure to follow correct disposal procedures as outlined in the Safety Data Sheet.
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4.18
I consider that, taking into account the properties of the substance, the quantity
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
4.19
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 substance is 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 substance is used 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.
 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 substance can be adequately contained.
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6
Decision
6.1
I have considered this application under section 31 to manufacture in containment a
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 11-ketotestosterone, I am
satisfied that the controls imposed, including those in place under other legislation, will
result in the substance 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 substance 11-ketotestosterone
is thus approved pursuant to section 32 of the Act, with controls as set out in Appendix
1.
Bas Walker
Date 12 February 2004
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
11-ketotestosterone:
HSC000081
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Appendix 1: List of controls that apply to the
hazardous substance 11-ketotestosterone
1. The laboratory where the substance will be synthesised must comply with the Hazardous
Substances (Exempt Laboratories) Regulations 2001. Compliance with these regulations
will cover the matters to be addressed by the containment controls for hazardous
substances contained in Schedule 3, Part III, of the HSNO Act.
2. The substance may only be sold to a research laboratory in New Zealand whose use of
the substance will qualify the laboratory for exemption under section 33 of the HSNO
Act, or to a research laboratory overseas.
3. A maximum of 50g of the substance shall be manufactured each year.
4. Each package for shipment shall not be greater than 25g.
5. The primary containment is the laboratory glassware or vessels used for processing of the
various reagents to synthesise the substance. Secondary containment is the fume-hood in
which the substance shall be manufactured. All work surfaces and other surfaces that
could be exposed to the substance shall be resistant to the substance and shall not absorb
it.
6. All personnel carrying out the synthesis and handling the substance in the laboratory shall
wear appropriate personal protective equipment.
7. Handling of the substance shall be in accord with good laboratory practice. Any spillage
of the substance shall be cleaned up with water and paper towels which shall be placed in
a designated rubbish bin for disposal at an appropriate waste disposal facility (which may
include a landfill), subject to the facility’s waste acceptance policy. No substance shall
be disposed of through the waste water system.
8. The substance shall be stored in a secure locked facility in the laboratory. Only
authorised personnel shall be allowed into the laboratory, and the laboratory shall be
locked when no-one is present.
9. The substance shall be packaged for transportation in a container within a container
(secondary containment) and that secondary container shall be sufficient to control any
release if the primary container should leak. The containers shall 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.
10. The substance shall be transported in accordance with good practice. This may require
compliance with the Land Transport Rule: Dangerous Goods 1999.
11. If for any reason a breach of containment occurs, the Study Director shall notify OSH and
ERMA New Zealand within 24 hours of the breach being detected. It is suggested that if
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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.
12. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facility at any reasonable time.
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