Amended by section 67A on 11 April 2008
ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
September 2006
Application Code
HSC06016
Application Type
To import or manufacture hazardous substances in
containment under Section 31 of the Hazardous Substances
and New Organisms Act 1996
Novartis New Zealand Limited
Auckland
New Zealand 1034
AHC 2102225: To import and conduct field trials in
containment of an oral anthelmintic for sheep.
Applicant
Purpose of the Application
Date Application Received
27 July 2006
Consideration Date
31 August 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
SUMMARY OF DECISION
1.1
The application to manufacture in containment the hazardous substance, AHC 2102225,
has been approved with controls in accordance with the relevant provisions of the
Hazardous Substances and New Organisms Act 1996 (the Act) and the HSNO
(Methodology) Order 1998 (the Methodology).
1.2
The substance have been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
AHC 2102225
2
LEGISLATIVE CRITERIA FOR APPLICATION
2.1
The application was lodged pursuant to section 31 of the Act. The decision was
determined in accordance with section 32, taking into account additional matters to be
considered in that section and matters as specified under Part II of the Act and the
provisions of Part III of the Third Schedule of the Act. Unless otherwise stated,
references to section numbers in this decision refer to sections of the 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 27 July 2006.
3.2
Project Team:
Brendon Noonan
Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Zack Bishara
Advisor (Māori Unit)
Report review and sign-out by:
Noel McCardle
Senior Advisor (Hazardous Substances)
3.3
The applicant supplied the following documents:
 the application; and
 confidential appendices, including data such as formulation details, toxicological
and environmental fate data, the study protocol and safety data sheets.
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 (Workplace Group); and
 the Agricultural Compounds and Veterinary Medicines (ACVM) Group of the New
Zealand Food Safety Authority (NZFSA).
3.5
ACVM was the only notified party to respond and stated that any issues arising through
the approval process under the ACVM Act will be considered as a part of that
application.
3.6
The applicant was provided with a copy of the proposed controls for AHC 2102225 and
given the opportunity to comment on them. The comments received from the applicant
were taken into account when considering this application.
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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 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
substance 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 application has been submitted to cover the importation of a small quantity of the
substance, AHC 2102225, into containment for administration to sheep, under trial
conditions, to determine the substance’s effectiveness against internal parasites in New
Zealand.
4.4
The Project Team considers that the purpose of the application, as stated, amounts to
“research and development on any hazardous substance” and therefore qualifies for
consideration under section 30(ba) of the Act.
Life cycle
4.5
Novartis New Zealand limited intends to import 64 litres of the experimental
anthelmintic, AHC 2102225. The substance will be imported packaged in containers
proven capable of containing the substance. The containers will be clearly labelled and
will be accompanied with sufficient documentation to enable the safe handling, storage
and transport of the substance.
4.6
The applicant has stated that the substance will generally be kept in secure, locked,
facilities while in New Zealand. The exception to this will be when the substance is
being transported to trial sites for use. Transport will be carried out by licensed
operators, familiar with the requirements for safe handling and transport of hazardous
substances.
4.7
Small quantities of the substance, in sealed packages, will be sent to selected farms for
trialling on sheep. Documentation of farms and animals used in the trial will be kept.
During the trials, handling of the substance will be managed and supervised by trained
personnel knowledgeable about the safe handling of the substance and the trial protocol.
The substance will be administered to animals selected specifically for the trial and will
be identified with numbered ear tags. Farm owners will be trained and advised of their
responsibilities in regards to the management of treated animals.
4.8
After the trials are completed, any remaining substance will be returned to Novartis
New Zealand Limited where it will be kept in secure storage until it is rendered non-
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hazardous, exported from New Zealand or has been fully approved for release under the
HSNO and Agricultural Compounds and Veterinary Medicines (ACVM) Acts.
Hazardous properties
4.9
The Project Team notes that containment applications only require a sufficient
understanding of a substance’s hazardous properties to ensure that any risks posed can
be managed by controls set under the containment provisions.
4.10
The applicant has examined the hazardous nature of the substance, AHC 2102225, and
considers it to be of low toxicity based on study data for the formulation. Based on the
operator safety data provided by the applicant and other available data the Project Team
considers that the substance is likely to trigger a 6.9, target organ systemic toxicity,
classification. The applicant’s toxicity assessment indicates that personal protective
equipment should be used when handling the substance.
4.11
The applicant has also stated that the studies of the substance’s ecotoxicity and
environmental have found that AHC 2102225 has a low ecotoxicity and that little of the
substance will enter the environment through its proper use, administration to farm
animals. Further studies have indicated that the breakdown products and parent
compound excreted from treated animals will only pose a minimal risk to the
environment. The Agency has not been provided with these studies so is not in a
position to verify the validity of the applicant’s statements.
4.12
The Project Team has reviewed the summary data and other information supplied by
the applicant and considers that the information is sufficient to determine that any risks
posed within the defined lifecycle of the substance in New Zealand can be managed
through the application of controls as defined in Appendix 1.
Identification and evaluation of the significant risks of the substance
in containment
4.13
The applicant has identified and assessed the potential risks and impacts that may arise
from the substance’s contained presence and use in New Zealand. The applicant has
also detailed measures to manage those identified risks and impacts. The Project Team
has reviewed the applicant’s assessment of potential risks and impacts with regard to
the environment, human health and welfare, and Maori issues and concerns. The Project
Team’s review of potentially significant risks is summarised below.
Risks to the environment
4.14
If released into the environment the substance has the potential to result in adverse
effects within the environment, for example to aquatic organisms or non-target
terrestrial invertebrates.
4.15
On the basis of the lifecycle of the substance outlined in paragraphs 4.5 to 4.8, adverse
environmental effects could arise from:
 an accident during importation, transportation or storage, resulting in release of the
substance into the environment;
 failure to maintain or properly use application equipment;
 failure to follow correct disposal procedures as outlined in the containment plan;
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

4.16
failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance; or
elimination of the substance and metabolites from treated animals entering the
environment.
The Project Team considers that the contained import and trialling of AHC 2102225
will not pose any significant risks to the environment. In its consideration, the Project
Team took several factors into account, including the containment regime proposed by
the applicant, the overall quantity of the substance involved, the controls set out in
Appendix 1 and the requirements of other legislation.
Risks to human health and welfare
4.17
Given the level of detail and related uncertainty involved in studies conducted for the
experimental substances such as AHC 2102225 the Project Team considers that adverse
effects to human health and welfare may result from exposure(s) to the substance.
4.18
On the basis of the substance’s lifecycle, outlined in paragraphs 4.5 to 4.8, exposure
resulting in adverse effects could arise from:
 an accident during importation, transportation, storage or use, that results in release
of the substance;
 failure to follow correct disposal procedures as outlined in the containment plan; or
 failure to follow the correct operational procedures as set out in the controls,
resulting in release the substance.
4.19
Taking into consideration factors, such as, the substance’s limited availability, its
handling by trained staff and use of personal protective equipment (PPE) the Project
Team considers it unlikely that the contained import and trialling of AHC 2102225
would result in adverse effects to human health and welfare. If any effects were to
occur it is envisioned that they would be relatively minimal in nature and would be
limited to persons directly involved in the trials, for example persons handling the
substance or managing treated animals.
Māori issues and concerns
4.20
The Project Team has considered the potential effects that the contained import and
trialling of AHC 2102225 may have on Māori culture in accordance with the
Methodology, clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the Act. In
addition the Project Team has use the assessment framework contained in the ERMA
New Zealand User Guide “Working with Māori under the HSNO Act 1996” in
assessing this application.
4.21
On the basis of the information provided by the applicant and the associated risks the
Project Team considers that the substance is unlikely to have an impact on the
relationship of Māori and their culture and traditions with ancestral lands, water, sites,
wahi tapu, valued flora and fauna and other taonga. Further the Project Team has no
evidence to suggest that the contained use and trialling of AHC 2102225 will breach the
principles of the Treaty of Waitangi and see no requirement for the applicant to consult
with Māori regarding this application.
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4.22
This assessment is made on the condition that the substance is imported, handled,
stored, transported, used and disposed of, in accordance with the explicitly stated
controls, and any controls stipulated in other applicable Acts. However, should
inappropriate use, or an accident, result in the contamination of waterways or the
environment, it is recommended that the Trial Director notify the appropriate
authorities including the relevant iwi authorities in that region. This action should
include advising them of the contamination and the measures taken to contain and
remedy it.
5
CONTAINMENT AND CONTROLS
5.1
The Project Team has evaluated the adequacy of the containment arrangements
proposed by the applicant and the controls listed in Appendix 1, and notes 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 (for example, control 4);
 to exclude organisms from a facility (for example, control 17);
 to exclude unauthorized people from the facility (for example, control 11);
 to prevent unintended release of the substances by experimenters working with the
substance (for example, control 13);
 to control the effects of any accidental release of the substance (for example, control
20);
 inspection and monitoring requirements (for example, control 25); and
 qualifications required of the person responsible for implementing the controls (for
example, control 12).
5.2
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, AHC 2102225, can be adequately
contained.
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6
DECISION
6.1
I have considered this application made under section 31, pursuant to section 32, and
am satisfied that this application is for the purpose specified in section 30(ba) i.e. for
purposes of the “research and development” on AHC 2102225.
6.2
Having considered the risks associated with the lifecycle of the substance, I am satisfied
that the controls imposed in Appendix 1 and those in place under other legislation, will
result in the substance being adequately contained. Further, I consider that the controls
applied are not too onerous to be complied with.
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 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, AHC 2102225, is
thus approved pursuant to section 32 of the Act, with the controls set out in Appendix 1.
Donald Hannah
Date 01 September 2006
Acting Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
AHC 2102225
HSR000242
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Amendment April 2008-04-11
Increase in the amount of the substance being imported from 24 litres to 64 litres on pages 3 and
8 of the decision.
Rob Forlong
Chief Executive
ERMA New Zealand
ERMA New Zealand Decision: Application HSC06016
Date
Page 8 of 11
APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
THE HAZARDOUS SUBSTANCE,
AHC 2102225
General
1. All lifecycle stages from import to disposal shall be undertaken in accordance with the
information provided by the applicant with their application in Appendices 4-6 and the
study protocol provided with the application (section 3 – confidential). Modification of
this information may be approved in writing by ERMA New Zealand provided that those
modifications comply with the following controls.
2. Notwithstanding the requirements of control 1 above, the importation and trials shall also
comply with the following controls:
Import
3. Novartis New Zealand Limited may import 64 litres the substance, AHC 2102225, into
containment in New Zealand.
Packaging and Information
4. The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
5. Packages shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001. The label must also set out instructions that any of the substance
remaining after each trial must be returned in its original container to Novartis New
Zealand Limited.
6. A Safety Data Sheet, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each shipment of the substance and be held at each
trial site for the duration of the trial.
Storage
7. The substance shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004.
Transport
8. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 or the
Maritime Transport Act 1994.
General handling of the substances
9. Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective
clothing shall be worn when handling the substances, for example during handling,
application and disposal.
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Trial Conditions
10. This approval applies to the oral administration of the substance, AHC 2102225, using
specialised equipment to sheep that have been allocated to the trial.
11. Access to the trial sites shall be by permission of the Trial Director1, nominated
researcher 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 trial sites shall be signed indicating that unauthorized access is not
permitted, that the site is subject to a trial, and that the sheep should not be removed.
12. During use the substance shall be under the control of experimental staff, who are trained
and experienced in the handling and administration of oral anthelmintic drenches under
test conditions using the specified equipment. Experimental staff should also be aware of
the study protocol and the controls in place in order to adequately manage the substance.
13. The substance shall be mixed, diluted, prepared or otherwise handled in accordance with
the relevant sections of the Code of Practice for the Management of Agrichemicals NZS
8409: 2004.
14. The substance shall be applied by direct oral injection to test sheep using calibrated
drenching equipment or by syringe. After use, the equipment used for application shall
be disposed of in an appropriate manner or be cleaned with the residue and/or rinsate
being treated in manner so that it is no longer hazardous.
15. The substance shall be applied in appropriate yard areas. The trial shall be conducted in
such a way as to prevent the substance entering any surface water or groundwater system.
16. The population of the trial flocks shall be marked in a manner that treated animals may be
clearly identified and be distinguished from untreated animals.
17. Treated animals shall be confined in the trial area as defined in the provisional
registration to be issued by the Agricultural Compounds and Veterinary Medicines
Group.
18. Any treated animal intended for human or animal consumption, or offered for sale shall
comply with any withholding period and maximum residue levels (MRLs) set by the New
Zealand Food Safety Authority (NZFSA). If no withholding period or MRLs are set by
the NZFSA then animals shall be destroyed and disposed of on site.
19. A record shall be kept of all use of the substance. This record shall cover all matters
referred to in Regulation 6(1) of the Hazardous Substances (Class 6, 8, and 9 Controls)
Regulations 2001 and must be kept for not less than 3 years after the date on which the
substance that the record relates to is applied or discharged.
1
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of
the trial in accordance with the Management Plan and approval controls.
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Emergency Management
20. Any accidental spillage of the substance shall be contained, prevented from entering
waterways, and absorbed with an appropriate absorbent material. This material shall be
placed in sealed containers and disposed of at an appropriate waste disposal facility
(which may include a landfill), subject to the facility’s waste acceptance policy.
Disposal
21. Any surplus substance remaining at the end of the trials shall be returned to Novartis New
Zealand Limited where it will be securely stored in an exempt laboratory, until needed for
further analysis, or be disposed of in a manner compliant with the Hazardous Substances
(Disposal) Regulations 2001. Please note that once the trials are completed the substance
does not have approval to be present in New Zealand except in an exempt laboratory.
22. Containers no longer used to contain the substance or residue or rinsate from equipment
used to handle the substance shall be disposed of in a manner compliant with the
Hazardous Substances (Disposal) Regulations 2001.
Notification and Inspection
23. The Department of Labour [Attn. HSNO Project Manager (Workplace Group) or
equivalent position] and ERMA New Zealand shall be informed in writing (by letter, fax
or email) of the location, start, and completion of the trials. Notifications shall include
the following details:
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
AHC 2102225
HSC06016
HSC000
Brendon Noonan
24. If for any reason a breach of containment occurs, the Trial Director shall notify the
Department of Labour 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.
25. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time. Trial documentation, as
described in Control 1, notwithstanding its confidential nature, shall be available for
inspection by any enforcement officer, upon request.
26. 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 five
years.
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