ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
26 February 2004
Application Code
HSC04001
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
Industrial Research Ltd
PO Box 31310
Gracefield
Lower Hutt
Purpose of the Application
To manufacture in containment two monosaccharide
derivatives, for which no toxicology or ecotoxicology
data is available, to be sold to a research laboratory
overseas for research and development
Date Application Received
11 February 2004
Consideration Date
26 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 substances IRL
Glycotherapeutic 0004a and IRL Glycotherapeutic 0004b 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 substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
IRL Glycotherapeutic 0004a
IRL Glycotherapeutic 0004b
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
ERMA New Zealand Decision: Application HSC04001
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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 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 11 February 2004 and assessed as having
sufficient information on 12 February 2004.
3.2
Project Team:
Beth Dye
Applications Advisor (Hazardous Substances)
Tania van Maanen
Science 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 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
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for IRL
Glycotherapeutic 0004a and IRL Glycotherapeutic 0004b and given the opportunity to
comment on them. The applicant raised no 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 in containment two monosaccharide
derivatives, for which no toxicology or ecotoxicology data is available, to be sold to a
research laboratory overseas for research and development.
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 carried out an extensive literature search to determine the hazardous
properties of IRL Glycotherapeutic 0004a and IRL Glycotherapeutic 0004b. A large
number of databases (listed in the application) were searched using the CAS registry
numbers, and no relevant information was found. The applicant states that based on the
structure of the substances, they are not considered to be flammable, oxidising or
corrosive; and based on testing of related substances, they are not considered to be
explosive. The toxicity and ecotoxicity of the substances are unknown, but the
applicant considers that by comparison with similar substances, any toxicity or
ecotoxicity is expected to be low.
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
IRL Glycotherapeutic 0004a and IRL Glycotherapeutic 0004b will be synthesised
within IRL Glycosyn, a purpose-built, current Good Manufacturing Practice compliant,
contained synthesis facility. The total quantity synthesised will be no more than 5
kilograms of each substance. They will then be exported to a contained research facility
where they will be transformed by chemical synthesis into a developmental
pharmaceutical.
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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 substances, but the applicant considers
that by comparison with similar substances, any ecotoxicity is expected to be low.
4.12
On the basis of the lifecycle of the substances outlined in paragraph 4.8, adverse effects
could arise from:
 An accident during manufacture or transportation, resulting in release of the
substance.
4.13
I note that a maximum of 5 kilograms of each substance will be manufactured. I note
that the synthesis facility has primary, secondary and tertiary containment, and that
export of each substance will be in a container within a container, with the secondary
container sufficient to control any release should the primary container be damaged and
leak.
4.14
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
4.15
No toxicological data are available on the substances, but the applicant considers that
by comparison with similar substances, any toxicity is expected to be low.
4.16
On the basis of the lifecycle of the substances outlined in paragraph 4.8, adverse effects
on human health and welfare could arise from:
 An accident, resulting in exposure during manufacture or transportation.
4.17
I note that a maximum of 5 kilograms of each substance will be manufactured. I note
that the synthesis facility has been designed with a focus on operator safety, and that
export of each substance will be in a container within a container, with the secondary
container sufficient to control any release should the primary container be damaged and
leak.
4.18
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.
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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 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 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.
5.2
I am satisfied that with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, the substances 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 IRL Glycotherapeutic
0004a and IRL Glycotherapeutic 0004b, 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 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 manufacture in containment the hazardous substances IRL
Glycotherapeutic 0004a and IRL Glycotherapeutic 0004b is thus approved pursuant to
section 32 of the Act, with controls as set out in Appendix 1.
Bas Walker
Date 26 February 2004
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
IRL Glycotherapeutic 0004a:
HSC000082
IRL Glycotherapeutic 0004b:
HSC000083
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Appendix 1: List of controls that apply to the
hazardous substances IRL Glycotherapeutic 0004a
and IRL Glycotherapeutic 0004b
1. The facility (IRL Glycosyn) where the substances will be synthesised shall 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 substances may only be exported to the contained research facility overseas which
has been identified in the confidential appendices to the application.
3. A maximum of 5 kilograms of each substance shall be manufactured.
4. The primary containment is the closed vessels and lines used in the manufacturing
process. Secondary containment is the enclosed, bunded cells within which each vessel
is contained. Further containment is provided by the enclosed and bunded building.
5. Entrances to IRL Glycosyn shall be by way of airlocks. Windows shall be non-opening.
HEPA-filtered air shall be provided for IRL Glycosyn.
6. All personnel carrying out the synthesis and packaging of the substances shall wear
appropriate personal protective equipment.
7. Handling of the substances shall be in accordance with good laboratory practice. Any
spillage of the substances shall be cleaned up with appropriate absorbent material. The
used absorbent material shall be securely packaged and retained in IRL Glycosyn until it
has been rendered non-hazardous prior to disposal.
8. The substances shall be stored in IRL Glycosyn until they are exported. Only authorised
personnel shall be allowed into IRL Glycosyn, which has access controlled by electronic
security systems and is itself located within a controlled access site.
9. The substances shall each 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 substances 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 Manager: GSF Facility shall notify
OSH 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 waterway, the
relevant iwi authorities be advised of the contamination and the measures taken in
response.
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12. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facility at any reasonable time.
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