ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
18 October 2006
Application Code
HSC06020
Application Type
To import or manufacture hazardous substances in
containment under Section 31 of the Hazardous Substances
and New Organisms Act 1996
Estendart Limited
C/0 Massey University
Private Bag 11-222
Palmerston North
ML-1,640,471,609E: to import a veterinary medicine in
containment to research target animal safety (field trials)
Applicant
Purpose of the Application
Date Application Received
26 September 2006
Consideration Date
Considered by
1
Rob Forlong, Chief Executive of ERMA New Zealand
SUMMARY OF DECISION
1.1
The application to manufacture in containment the hazardous substance, ML1,640,471,609E, 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 has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
ML-1,640,471,609E
2
LEGISLATIVE CRITERIA FOR APPLICATION
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 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 26 September 2006.
3.2
Project Team:
David Hodge
Advisor (Hazardous Substances)
Chris Geering
Advisor (Hazardous Substances)
Zack Bishara
Advisor (Māori Unit)
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
The applicant was provided with a copy of the proposed controls for ML1,640,471,609E and given the opportunity to comment on them.
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)).
4.2
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
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.
ERMA New Zealand Decision: Application HSC06020
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Purpose of the application
4.3
The application has been submitted to cover the importation of a small quantity of
the substance, ML-1,640,471,609E, into containment for administration to cattle,
under trial conditions, to determine the substance’s safety.
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).
Life cycle
4.5
This application covers the request for approval to import a small quantity (circa
500 mL) of an injectable formulation (ML-1,640,471 609E) to be used for a
controlled safety study in the target animal (cattle) at a single study site.
4.6
The study will be directed by a veterinarian according to GLP guidelines. Estendart
Ltd, the contract research organisation with responsibility for conducting the study,
is GLP-IANZ accredited.
4.7
The formulation contains ML-1,640,471 609E which is a well characterized
veterinary anti-parasitic agent. It will be provided in a sealed container and will be
used strictly for the purposes outlined above. The formulation will be stored under
GLP-containment provisions.
4.8
The qualified individual using the formulation will follow appropriate safety
precautions and wear appropriate protective clothing. Given the broad experience
with this active ingredient, its extremely restricted and controlled proposed use, it is
considered to be of low risk to the physical environment and human beings.
4.9
Containment of substance will be in the Test Substance Store at Jennersmead
Research Farm. The test substance store is a transition facility as per our NZFSA
certification. Substances will be recorded on arrival; any movement of the
substance, disposal or return of test substance will be documented.
4.10
No personnel other then approved staff members are allowed to enter Jennersmead
Farm. Chubb Security monitors this farm by way of alarm system and night patrols.
All buildings are securely locked 24 hours a day, seven days a week.
4.11
Estendart Ltd has a Quarantine Manual, which documents the methods of
containment. Treatments will be given under the Study Director’s supervision only.
Withholding periods will be as per ACVM Provisional Registration, responsibilities
from the manager of the Source Farm with respect to the study, indicating that
treated animals and their produce will not be sold. This form will be signed by the
Jennersmead Research Farm’s manager, NZ registered veterinarian, Study Director
and Director from Estendart Ltd.
4.12
After completion of the animal phase the control animals will be retained at
Jennersmead Research Farm until the withholding periods has expired as per
ERMA New Zealand Decision: Application HSC06020
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ACVM Provisional Registration, thereafter the animals will be returned to a normal
farm management or will be destroyed as per ACVM approval.
4.13
Animals that die during the study will be necropsied before disposal by
incineration. Animals in poor health as a result of any illness will be humanely
euthanased and disposed by incineration. All ML-1,640,471,609E treated animals
are to be incinerated.
4.14
Following finalization of the study, all remaining formulation will be destroyed.
4.15
Jennersmead farm is audited internally by the applicant’s Quality Assurance
Department and by the following regulatory authorities:
Current Compliance
OECD Principles of Good
Laboratory Practice
Certificate of GMP Compliance
as a Manufacturer
- Partial Manufacture (in-vivo
QC Tests for Batch Release and
Clinical Trials)
Scientific Material Operators
Approval
Certificate of Approval as an
Operator of a Transitional and
Containment Facility
Certificate of Approval as a
Transitional Facility
Certificate of Approval as a
Containment Facility
Registered Exporter Under the
Animal Products Act 1999
Good Manufacturing Practice
Certificate
Compliance Monitor
International Accreditation New
Zealand
Ministry of Agriculture and
Forestry/New Zealand Food Safety
Authority
New Zealand Food Safety Authority
Ministry of Agriculture and
Forestry
Ministry of Agriculture and
Forestry
Ministry of Agriculture and
Forestry
New Zealand Food Safety Authority
Medsafe
Hazardous properties
4.16
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.
4.17
The applicant has examined the hazardous nature of the substance, ML1,640,471,609E, and considers it to be acutely toxic. The applicant’s toxicity
assessment indicates that personal protective equipment should be used when
handling the substance.
4.18
The applicant has also stated that while ML-1,640,471,609E has a high ecotoxicity,
little of the substance will enter the environment through its use.
ERMA New Zealand Decision: Application HSC06020
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4.19
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
4.20
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
4.21
If released into the environment the substance has the potential to result in adverse
effects within the environment.
4.22
On the basis of the lifecycle of the substance, 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;
 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.
4.23
The Project Team considers that the contained import and trialling of ML1,640,471,609E 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
4.24
Given the level of detail and related uncertainty involved in studies conducted for
the experimental substances such as ML-1,640,471,609E the Project Team
considers that adverse effects to human health and welfare may result from
exposure(s) to the substance.
4.25
On the basis of the substance’s lifecycle, exposure resulting in adverse effects could
arise from:
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 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.
4.26
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 ML1,640,471,609E 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
4.27
The Project Team has considered the potential effects that the contained import and
trialling of ML-1,640,471,609E may have on Māori culture in accordance with
clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8. 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.
4.28
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 ML1,640,471,609E will breach the principles of the Treaty of Waitangi and see no
requirement for the applicant to consult with Māori regarding this application.
4.29
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);
ERMA New Zealand Decision: Application HSC06020
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 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, ML-1,640,471,609E, can be
adequately contained.
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 ML-1,640,471,609E.
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), 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 containment the hazardous substance, ML1,640,471,609E, is thus approved pursuant to section 32, with the controls set out in
Appendix 1.
Rob Forlong
Date 18 October 2006
Chief Executive of ERMA New Zealand
ML-1,640,471,609E
ERMA New Zealand Approval Code: HSC000248
ERMA New Zealand Decision: Application HSC06020
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
THE HAZARDOUS SUBSTANCE, ML-1,640,471,609E
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. Estendart Limited may import approximately 5 L of the substance, ML-1,640,471,609E,
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 Estendart 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.
ERMA New Zealand Decision: Application HSC06020
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Trial Conditions
10. This approval applies to the subcutaneous administration of the substance, ML1,640,471,609E, using specialised equipment to cattle 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 cattle 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 injectable anthelmintics 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 subcutaneous injection to test beef cattle using 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 mob 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.
ERMA New Zealand Decision: Application HSC06020
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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 Estendart
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
ML-1,640,471,609E
HSC06020
HSC000248
David Hodge
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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