Application Code
Application Type
24 June 2008
HSC08007
To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant
Purpose of the
Application
Date Application
Received
Consideration Date
Considered by
Novartis New Zealand Limited
To import into or manufacture in containment various Ecto and
Endo Parasitic formulations for local efficacy studies.
5 May 2008
24 June 2008
Rob Forlong, Chief Executive of ERMA New Zealand
1
1.1
The application to import into containment the hazardous substances, Novartis
Experimental Ecto and Endo Parasitic Formulations is approved with controls in accordance with the relevant provisions of the Act and the HSNO
(Methodology) Order 1998 (“the Methodology”).
1.2
The substances have been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
Novartis Experimental Ecto and Endo Parasitic Formulations
2
2.1
The application was lodged pursuant to section 31. The decision was determined in accordance with section 32, taking into account additional matters to be considered in that section and matters 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
3.1
The application was formally received on 5 May 2008.
3.2
Project Team:
3.3
3.4
3.5
3.6
3.7
Haydn Murdoch
Sekove Tinalevu
Zack Bishara
Noel McCardle
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Advisor (Māori Unit)
Acting Applications Manager (Hazardous
Substances).
The applicant supplied the following documents:
 the application;
 a confidential appendix including information on the lifecycle of the test substances and the containment system and proposed controls.
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 Department of Labour (Workplace Group);

The New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
No responses were received.
Further information was requested from the applicant during the evaluation and review of this application in accordance with section 58 and consequently the consideration was postponed for 9 working days.
The applicant was provided with a copy of the proposed controls for Novartis
Experimental Ecto and Endo Parasitic Formulations and given the opportunity to comment on them. The comments provided were taken into account in the setting of controls.
4
4.1
In accordance with section 32, 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.
4.2
This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e)).
4.3
According to the applicant, the purpose of this application is to allow the manufacture and/or importation of novel products for local efficacy and safety testing. The efficacy studies will involve testing against local endo and ecto parasites in farm animals.
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4.4
The Project Team considers that the purpose stated by the applicant amounts to
“research and development on any hazardous substance” and therefore qualifies for consideration under section 30(ba).
4.5
The applicant advises that the substances will be dealt with throughout their lifecycle in New Zealand in the following manner:
4.5.1
A maximum of 250 L of each test substance will be imported into or manufactured in New Zealand and transported to secure sites under the control of Novartis New Zealand Limited.
4.5.2
Manufacturing sites will be GMP accredited and meet the requirements of HSNO and the Resource Management Act 1991.
4.5.3
Packaging and labelling of imported test substances will meet international requirements for air/sea transportation with regards to packaging etc., and with New Zealand domestic transportation requirements.
4.5.4
Packaging will suitably and securely contain the test substances during transport and storage. Documentation will accompany the test substances outlining the safe handling, transport and storage of the substances.
4.5.5
Transport to the trial sites will be undertaken by persons experienced in the transport of hazardous substances and in compliance with New
Zealand’s transport legislation.
4.5.6
The test substances will be held under lock and key, in facilities that are appropriate for their safe and secure storage, at the trial sites at all times, except for short periods when they are being administered to animals.
4.5.7
The test substances will be administered to trial animals by suitably trained and qualified persons. The test products will be dosed using an essentially closed administration system and only relatively small volumes will be administered to each animal. It is expected that up to
400 animals may be treated with each new test substance. In each case the volume of test substance used will be fully documented and accounted for.
4.5.8
Treated animals will be located at designated secure trial sites and will be clearly and definitely identified using ear tags. Treated animals will not be allowed to enter the food chain until after the approved withholding period.
4.5.9
The excreta from treated animals will be collected for disposal if the substance contains an active ingredient which is not already present in
New Zealand. The collected excreta will be treated as hazardous and disposed of in a manner compliant with the disposal controls of this approval.
4.5.10
Surplus test substance will be returned to secure storage facilities contracted by Novartis New Zealand Limited. The product will then either be sent overseas, destroyed using a method know to render the substance non hazardous or it will be stored until approvals for its full
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release under the provisions of the HSNO Act and ACVM Act have been granted. Container and packaging disposal will meet the requirements of the Hazardous Substances (Disposal) Regulations 2001.
4.6
The Project Team notes that the understanding of the hazardous properties of the substance only needs to sufficient enough to ensure that any risks can be managed by the containment controls.
4.7
It is also noted that the scope of the hazard information will often be limited, as the substances will be experimental and may not be commercialised. Each substance imported or manufactured under this approval will be notified to
ERMA New Zealand prior to its trialling, and the notification will include compositional information, a Project Plan, a Safety Data Sheet and any available hazard information.
4.8
The applicant expects that some of the substances involved are likely to have hazardous properties and that trigger the minimum degrees of hazard for each allowable hazard category, as defined the Hazardous Substances (Minimum
Degrees of Hazard) Regulations 2001 and as limited in Appendix 1.
4.9
After taking into account the substances’ potential hazardous properties, the
Project Team considers that the information provided is sufficient to determine that any risks can be managed by the containment controls proposed in
Appendix 1.
4.10
The applicant has identified and assessed potential risks and detailed proposals for, and impacts of, risk management. The Project Team has reviewed the applicant’s assessment of the risks to the environment, human health and welfare and Māori issues and concerns as set out below:
4.11
The Project Team consider that if released, excreted or discharged into the environment the substances have the potential to result in adverse effects within the environment. As the ecotoxic hazards are not identified at this stage, the
Project Team assumes that the substances could cause adverse effects within the aquatic, soil, or above-ground terrestrial environments.
4.12
The applicant has identified risks that could occur within the environment throughout the trials. Risks include spillage at any stage of the substance lifecycle; discharge to the environment through disposal; and ecotoxic residues present in the excreta of treated animals. The applicant has specified containment provisions intended to manage these risks.
4.13
The Project Team considers that, taking into account the likely properties of the substance, the quantities involved, the containment regime proposed by the applicant, the controls set in Appendix 1 and in place under other legislation, there are no significant risks to the environment.
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4.14
If the substances are ingested or inhaled, or come in contact with skin or eyes they have the potential to cause adverse effects on human health.
4.15
On the basis of the lifecycle of the substances outlined in paragraph 4.5.1 -
4.5.10, adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the substances;
 failure to follow correct disposal procedures as outlined in the controls and project plan; or
 failure to follow the correct operational procedures as set out in the controls and project plans, resulting in release of the substances.
4.16
The Project Team considers that, taking into account the properties of the substances, the quantities involved, the containment regime proposed by the applicant, the containment controls in Appendix 1 and controls in place under other legislation, there are no significant risks to human health and welfare.
4.17
The Project Team considered the potential Māori cultural effects of this application in accordance with sections 6(d) and 8, and the assessment framework contained in the ERMA New Zealand User Guide “Working with
Māori under the HSNO Act 1996”.
4.18
From the information provided, and considering that the application is for containment, the Project team considers that it is unlikely to have an impact on the relationship between Māori culture and their 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 HSNO controls established for this application, and in accordance with any other relevant controls applying under other legislation.
4.19
The Project Team has no evidence to suggest that the use of Novartis
Experimental Ecto and Endo Parasitic Formulations in containment will breach the principles of the Treaty of Waitangi.
4.20
The Project Team therefore considers that there is no requirement for the applicant to consult with Māori regarding this application. However, should inappropriate or accidental use, transport or disposal of the substance result in the contamination of waterways, it is suggested that the applicant notify the appropriate authorities including the relevant iwi authorities in the region. This action should include advising them of the contamination and the measures taken in response.
5
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 8);
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5.2
 to exclude organisms from a facility (for example, control 24);
 to exclude unauthorized people from the facility (for example, control 16);
 to prevent unintended release of the substances by experimenters working with the substance (for example, control 19);
 to control the effects of any accidental release of the substance (for example, control 29);
 inspection and monitoring requirements (for example, control 34); and
 qualifications required of the person responsible for implementing the controls (for example, control 18).
The Project Team is satisfied that, with adherence to the controls listed in
Appendix 1 and those controls in place under other legislation the substances identified as Novartis Experimental Ecto and Endo Parasitic Formulations can be adequately contained.
6
6.1
I have considered this application made under section 31 and, pursuant to section
32, I am satisfied that this application is for the purpose specified in section
30(ba), that is for “research and development on any hazardous substance”.
6.2
6.3
Having considered the risks associated with the lifecycle of Novartis
Experimental Ecto and Endo Parasitic Formulations, I am satisfied that the controls imposed, including those in place under other legislation, will result in the substances being adequately contained. I also consider that the controls imposed are not too onerous to be complied with.
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have applied the criteria specified in section 32.
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 or manufacture in containment the hazardous substances Novartis Experimental Ecto and Endo Parasitic Formulations is thus approved pursuant to section 32, with controls as set out in Appendix 1.
Rob Forlong
Chief Executive of ERMA New Zealand
Date: 24 June 2008
Novartis Experimental Ecto and Endo Parasitic Formulations
ERMA New Zealand Approval Code: HSC000334
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1.
This approval covers the contained importation, manufacture and field trialling of experimental veterinary medicines, as notified to ERMA New Zealand pursuant to Control 6.
2.
3.
This approval applies exclusively and is limited to products being studied by or on behalf of Novartis New Zealand Limited.
The maximum total quantity of each veterinary medicine that may be imported or manufactured under this approval is 250 litres.
4.
This approval applies only to direct administration of veterinary medicines to trial animals, and therefore excludes the application of any substance directly into the environment.
5.
6.
This approval remains in place for five years from the date of this decision.
Each substance imported or manufactured under this approval shall be notified in writing to ERMA New Zealand and The Department of Labour [Attn. HSNO
Project Manager (Workplace Group) or equivalent position] prior to its use in a field trial. The notification shall include:
composition details;
a Project Plan for the trial, containing information as specified in
Appendix 2;
a Safety Data Sheet and/or any known hazard information; and
the following identifying details:
ERMA Application number HSC08007
Substance name/code
ERMA Approval number
Novartis Experimental Ecto and Endo Parasitic
Formulations
HSC000334
ERMA Applications Advisor Haydn Murdoch
7.
This approval does not apply to substances that trigger any hazardous property thresholds in classes 1, 2, 3.2, 4 or 5.
8.
The substances shall be securely packed in suitable containers that comply with the Hazardous Substances (Packaging) Regulations 2001.
9.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001. The label must also set out instructions that
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10.
any remaining substance must be returned in its original container to Novartis
New Zealand Limited for storage and ultimately disposal.
A Safety Data Sheet, compliant with the Hazardous Substances (Identification)
Regulations 2001, shall accompany each shipment and be held at the each trial site during the period of the trial.
11.
The substances shall be securely stored in accordance with good practice. This may be demonstrated by compliance with the Code of Practice for the
Management of Agrichemicals NZS 8409:2004.
12.
The substances shall be transported in accordance with good practice and where appropriate in compliance with any relevant requirements of the Land Transport
Act 1998, the Civil Aviation Act 1990 or the Maritime Transport Act 1994.
13.
Appropriate Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective clothing shall be worn by persons handling the substances during use and disposal.
14.
The trials may be carried out at a location that is not defined prior to approval, provided the applicant: a.
has written permission from the owner of the land to carry out the trial; and b.
notifies ERMA New Zealand in writing of the location in accordance with
Control 6.
15.
16.
Where collection of excreta is required under control 26, the trial sites shall be chosen so as to enable the excreta of treated animals to be collected and disposed to an appropriate facility or rendered harmless before disposal, thereby avoiding leaching or contamination into surface water or the groundwater system.
Access to the trial sites shall be by permission of the Study Director 1 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 duration of the trials. The trial sites shall be signed indicating that unauthorized access is not permitted, that the site is subject to trial, and that animals should not be removed.
17.
The trials shall be undertaken in accordance with the information provided in the application and the Project Plan which accompanies the notification of each substance. Modifications to the Project Plan or information provided in the
1 The Study Director is the individual appointed by the applicant to be responsible for the overall conduct of the trial in accordance with that proposed in the application and the approval controls.
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23.
24.
25.
18.
19.
20.
21.
22.
26.
27.
application may only be made with the prior written approval of ERMA New
Zealand and must be in compliance with the controls specified in this document.
The personnel applying the substances shall be able to demonstrate that they have the qualifications necessary to carry out the trial, for example, by being a trained veterinarian or suitably trained person. For each trial, experimental staff shall be made aware of the trial protocol, the Project Plan, and the controls in place in order to adequately manage the substances.
The substances shall be mixed, diluted or prepared in any way prior to application in accordance with good practice. This may be demonstrated by compliance with the Code of Practice for the Management of Agrichemicals
NZS8409:2004.
Only the quantity of each substance that is sufficient to treat the designated animals in the study shall be taken to the study site.
Each substance shall be applied directly to animals using standard equipment for the method of administration. Such equipment shall be suitably calibrated to deliver an accurate dose rate. Each substance shall be administered at the dose rates and in the manner approved by the ACVM Group, NZFSA, where these have been specified as part of the registration.
Administration of the substances to trial animals shall take place in accordance with good veterinary practice. This would generally be achieved through compliance with the Code of Practice for the Management of Agrichemicals
NZS8409:2004. Trials shall be conducted in such a way as to prevent the substances entering any surface water or ground water system.
The population of the trial animals shall be marked in a manner such that treated animals may be clearly identified and be distinguished from untreated animals.
Treated animals shall be confined in the trial area as defined in the provisional registration to be issued by the ACVM Group, NZFSA.
The produce from 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 ACVM Group, NZFSA.
The excreta from treated animals shall be collected for disposal if the following conditions are met:
(i) The substance contains an active ingredient which is not already present in New Zealand; and
(ii) The active ingredient, when excreted, poses a level of risk to the environment that is higher than is posed by active ingredients already approved in New Zealand and used for the same purpose.
The collected excreta shall be treated as hazardous and disposed to an appropriate facility or rendered harmless before disposal.
Documentation shall be kept that records the quantities of each substance imported, manufactured, administered, stored and ultimately destroyed. The records of use shall cover all matters referred to in Regulation 6(1) of the
Hazardous Substances (Classes 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 applies to is applied.
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28.
Any equipment used during application shall be disposed of, or treated with an appropriate detergent or decontaminant until rendered non-hazardous, and the rinsate disposed of according to the disposal provisions of the Hazardous
Substances (Disposal) Regulations 2001.
29.
Any spillage of the substance shall be contained, prevented from entering water bodies, and be absorbed with an appropriate absorbent material. The absorbent material shall be collected and placed in sealed containers for disposal at an appropriate waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance policy.
30.
Any surplus substance remaining at the end of the trials
2
shall be returned to
Novartis New Zealand Limited where it will be securely stored in a laboratory complying with the requirements set out in the Hazardous Substances (Exempt
Laboratories) Regulations 2001 for the purpose of further analysis or until disposed of. (Note that once the trials are completed the substance will not have approval to be present in New Zealand except within an exempt laboratory).
31.
32.
Any surplus substance shall ultimately be treated in a manner to render the substance, as a whole, non-hazardous or be exported from New Zealand.
Disposal shall be carried out in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001.
Containers no longer used to contain the substance and residue or rinsate from equipment used to handle the substances shall be disposed of in a manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
33.
If for any reason a breach of containment occurs, the Study 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 waterbody, the relevant iwi authorities be advised.
34.
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 6, notwithstanding its confidential nature, shall be available for inspection by any enforcement officer, upon request.
2 The end of the trials is considered to be the end of the trial programme as defined in the Project Plan for each substance.
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The Project Plan to be supplied for each substance shall contain information on the following points:
1)
2)
3)
4)
5)
Direction, including identification of the Study Director
Unequivocal identification and quantity of substance
Project title
Purpose
Trial location/s (address and contact details)
6)
7)
The security systems and containment provisions specific to the location
A copy of the trial protocol (or study plan)
8)
9)
Trial dates (start and completion)
Number and species of trial animals
10) Application method, application period, and dose rate
11) Fate of treated animals and any produce from those treated animals
12) Withholding period (where appropriate)
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