30 May 2004
Application Code
Application Type
Applicant
Purpose of the Application
HSC04002
To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Industrial Research Ltd
PO Box 31310
Gracefield
Lower Hutt
To manufacture in containment one monosaccharide derivative, for which no toxicology or ecotoxicology data is available, to be sold to a research laboratory overseas for research and development
Date Application Received
Consideration Date
29 April 2004
30 May 2004
Considered by Bas Walker, Chief Executive of ERMA New Zealand
1.1
The application to manufacture in containment the hazardous substance IRL
Glycotherapeutic 0004c 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:
IRL Glycotherapeutic 0004c
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
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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.
3.1
The application was formally received and assessed as having sufficient information on
29 April 2004.
3.2
Project Team:
Beth Dye Applications Advisor (Hazardous Substances)
Tania van Maanen
Linda Robinson
Report review and sign-out by:
Science Advisor (Hazardous Substances)
Manager (Māori Affairs)
Ted Taylor Programme Manager, Applications (Hazardous
Substances)
3.3
3.4
The applicant supplied the following documents:

The application, including confidential appendices containing commercially sensitive information.
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
3.6
No responses were received.
The applicant was provided with a copy of the proposed controls for IRL
Glycotherapeutic 0004c and given the opportunity to comment on them. The applicant raised no issues with the proposed controls.
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).
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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 one monosaccharide derivative, 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 0004c. 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 substance, it is not considered to be flammable, oxidising or corrosive; and based on testing of related substances, it is not considered to be explosive. The toxicity and ecotoxicity of the substance 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 0004c will be synthesised within IRL Glycosyn, a purpose-built, current Good Manufacturing Practice compliant, contained synthesis facility. Primary containment is provided by 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.
The total quantity synthesised will be no more than seven kilograms. It will then be exported to a contained research facility where it will be used as an intermediate in pharmaceutical research.
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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, 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 substance 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 seven kilograms of the substance will be manufactured. I note that the synthesis facility has primary, secondary and tertiary containment, and that export of the 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 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, 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 substance 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 seven kilograms of the 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 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.
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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 Manager (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.
5.1
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.
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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
0004c, 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 manufacture in containment the hazardous substance IRL
Glycotherapeutic 0004c is thus approved pursuant to section 32 of the Act, with controls as set out in Appendix 1.
Bas Walker Date 30 May 2004
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
IRL Glycotherapeutic 0004c: HSC000085
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1.
The facility (IRL Glycosyn) where the substance 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 substance shall be exported to the contained research facility overseas which has been identified in the confidential appendices to the application.
3.
A maximum of seven kilograms of the substance shall be manufactured.
4.
Entrances to IRL Glycosyn shall be by way of airlocks. Windows shall be non-opening.
HEPA-filtered air shall be provided for IRL Glycosyn.
5.
All personnel carrying out the synthesis and packaging of the substance shall wear appropriate personal protective equipment.
6.
Handling of the substance shall be in accordance with good laboratory practice. Any spillage of the substance 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.
7.
The substance shall be stored in IRL Glycosyn until it is 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.
8.
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.
9.
The substance shall be transported in accordance with good practice. This may require compliance with the Land Transport Rule: Dangerous Goods 1999.
10.
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.
11.
The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facility at any reasonable time.
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