ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
17 November 2003
Application Code
HSC03016
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
Deer Industry New Zealand
Purpose of the Application
To import into containment the substance CFD, a local
anaesthetic, for use in efficacy, residue, safety and
stability trials.
Date Application Received
11 November 2003
Consideration Date
17 November 2003
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substance CFD 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:
CFD
1.3
ERMA New Zealand 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 this substance:
Main category
Industry category
Function/use category
3
1
41
Non-dispersive use
Agricultural Industry
Pharmaceuticals, Subcategory veterinary
medicines
ERMA New Zealand Decision: Application HSC03016
Page 1 of 8
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 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 November 2003 and confirmed as having
sufficient information on 12 November 2003.
3.2
Project Team:
Amanda McKenzie
Applications Advisor (Hazardous Substances)
Graeme Dick
Senior Scientific Advisor, Science & Analysis
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
 Confidential appendices, containing compositional information, a Material Safety
Data Sheet, a Trial Protocol and additional reference material.
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 New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)) stating that “the ACVM has considered this
substance for a provisional application covering trial work in deer. Trial animals are
restricted from sale or slaughter for human consumption for a period of 14 days
post-treatment. Velvet harvested within 14 days post-treatment is not to be taken for
human consumption. This application has been approved subject to the approval
ERMA New Zealand Decision: Application HSC03016
Page 2 of 8
under HSNO. As a consequence the ACVM Group has no objection to the approval
of a containment trial by ERMA”.
 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). We understand that ACVM will be managing the risks to human
health arising from velvet and venison consumption of the animals that will be
subject to the trial.”
3.6
The applicant was provided with a copy of the proposed controls for CFD and given the
opportunity to comment on them; their verbal comments were taken into account.
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 import into containment the substance CFD, a local
anaesthetic, for use in efficacy, residue and safety trials on deer. A small amount of
CFD will also be used in the stability testing of the substance in the laboratory.
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.
Hazard Classification
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 assessed the available information and has identified that the
hazardous properties of CFD are limited to toxic properties (skin irritancy, eye irritancy
and sensitisation).
4.7
I note that the applicant considered the mutagenic, carcinogenic and
reproductive/developmental effects of the substance CFD, but could find no
information currently available relating to these effects.
ERMA New Zealand Decision: Application HSC03016
Page 3 of 8
4.8
I have reviewed the applicant’s hazard information and consider that it is sufficient to
describe the hazards associated with the substance to ensure that any risks can be
managed by the containment controls.
Life Cycle
4.9
Deer Industry New Zealand plans to import up to 500 vials of CFD. Each vial contains
20 mL of CFD. It will be stored in a secure facility at the Animal Health Services
Centre, Massey University, Palmerston North. From there the sealed vials will be
dispensed, as necessary by the trial investigator.
4.10
In a laboratory, the substance will be transferred from the vials into 500 mL Flexi-Paks,
before being transported to the trial sites. The trial sites will either be commercial farm
sites or farms belonging to Massey University/AgResearch.
4.11
CFD will be administered to deer, as a subcutaneous injection, prior to velvet removal.
4.12
The administration will be carried out within closed deer handling yards by a
veterinarian or closely supervised by a veterinarian.
4.13
All deer involved in the trials will be securely pastured behind animal-proof fencing.
4.14
Appropriate disposal procedures for surplus samples, needles and used containers, are
detailed in the Trial Protocol supplied by the applicant.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.15
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.
4.16
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of risk management. I have taken this into account in my
consideration of the risks.
Risks to the Environment
4.17
The applicant has assessed CFD as not triggering any HSNO thresholds for class 9
(ecotoxicity). I agree with this assessment and consider that the risks to the
environment need not be considered further.
Risks to Human Health and Welfare
4.18
Dermal or ocular exposure or inhalation of the substance may result in adverse effects
on human health and welfare.
4.19
On the basis of the lifecycle of the substance outlined in paragraphs 4.9 to 4.13, adverse
effects on human health and welfare could arise from:
ERMA New Zealand Decision: Application HSC03016
Page 4 of 8
 An accident, resulting in dermal or ocular exposure of people during storage, use or
transportation;
 Failure to follow correct disposal procedures as outlined in the Trial Protocol.
4.20
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
4.21
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 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 substance by experimenters working with the
substance.
 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
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 into containment
hazardous substances, and pursuant to section 32, I am satisfied that this application is
for the purpose specified in section 30(ba).
ERMA New Zealand Decision: Application HSC03016
Page 5 of 8
6.2
Having considered the risks associated with the lifecycle of CFD, 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 CFD is thus
approved pursuant to section 32 of the Act, with controls as set out in Appendix 1.
Bas Walker
Date: 17 November 2003
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code: HSC000078
ERMA New Zealand Decision: Application HSC03016
Page 6 of 8
Appendix 1: List of controls that apply to the
hazardous substance CFD
1.
The trials shall be undertaken in accordance with the Trial Protocol, which accompanied
the application.
2.
Modifications of this Protocol may be approved in writing by ERMA New Zealand
providing that it continues to comply with the following controls.
3.
Notwithstanding the requirements of control 1 above, the trials shall also comply with the
following controls.
4.
Access to each trial site shall be by permission of the Trial Investigator1 or owner of the
property on which it is located. The trial site boundaries shall be clearly marked and
distinctly visible from outside the trial site throughout the life of the trials. The primary
access points shall be signed indicating that unauthorised access is not allowed, and that the
animals on the site are subject to a trial.
5.
The trial sites shall be secured by stock-proof fencing to contain the trial animals for the
duration of the trial, and to exclude other grazing animals.
6.
Treated animals shall be retained on the field trial sites for 14 days after being injected with
CFD.
7.
The substance shall be stored in a secure facility under lock and key, only accessible to the
trial investigator and one other person designated as the approved test substance controller.
8.
The substance shall be securely packed in suitable containers that 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 the shipment.
9.
The substance shall be transported in compliance with the Land Transport Rule: Dangerous
Goods 1999.
10.
The volume of CFD transported to the trial site, shall not exceed the volume sufficient for
administration for the day.
11.
The administration of the substance shall be carried out or supervised by a registered
veterinarian using best current practice.
12.
To minimise the effects of any accidental release of the substance, appropriate safety
precautions and relevant first aid measures for immediate action pending medical attention
shall accompany the substance.
1
The Trial Investigator is the individual appointed by the applicant to be responsible for the overall conduct
of the trial in accordance with the Trial Protocol and approval controls.
ERMA New Zealand Decision: Application HSC03016
Page 7 of 8
13.
Surplus substance remaining at the end of the trials shall be contained in an exempt
laboratory, exported or degraded to a non-hazardous substance. (Note that once the trials
are complete the substance does not have approval to be present in New Zealand except in
an exempt laboratory).
14.
Any accidental spillage of the substance shall be contained, and absorbed with an
appropriate absorbent material. This material shall be placed into sealed containers and
disposed of at an appropriate waste disposal facility (which may include a landfill), subject
to the facility’s waste acceptance policy.
15.
A record shall be kept of all use of the substance. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Class 6, 8 and 9 Controls)
Regulations.
16.
The care of the trial animals shall comply with the relevant Animal Welfare Act(s) and
Regulations of New Zealand.
17.
Trial animals shall be restricted from sale or slaughter for human consumption for a period
of 14 days after being injected with CFD.
18.
Velvet harvested within 14 days of treatment shall not be taken for human consumption.
19.
Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the location,
start, and completion of the trials. The OSH project manager shall be informed at least
three working days prior to the commencement of the trial.
20.
If for any reason a breach of containment occurs, the Trial Investigator shall notify OSH
and ERMA New Zealand within 24 hours of the breach being detected.
21.
The Authority, or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
22.
This approval remains in place for the term of any concurrent approval required under the
Agricultural Compounds and Veterinary Medicines Act 1997, to a maximum of 2 years.
23.
The maximum total quantity of CFD that shall be imported under this approval is 10 litres.
ERMA New Zealand Decision: Application HSC03016
Page 8 of 8