ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
16 January 2008
Application Code
HSC07038
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New Organisms
Act 1996 (“the Act”)
Applicant
Agrivet Services Limited
Purpose of the Application
To import and/or manufacture into containment animal health
formulations for field trial (generic containment).
Date Application Received
22 November 2007
Consideration Date
16 January 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of decision
1.1
The application to import into containment hazardous substances described as
Agrivet07 - Investigational Animal Health 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:
Agrivet07 - Investigational Animal Health Formulations
2 Application process
2.1
The application was formally received on 22 November 2007.
2.2
Project Team:
Elizabeth Morgan
Sekove Tinalevu
Zack Bishara
Noel McCardle
Beth Dye
2.3
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Advisor (Māori Unit)
Senior Advisor (Hazardous Substances).
Applications Manager (Hazardous Substances)
The applicant supplied the following documents:


the application, and
a confidential appendix, including a draft containment plan.
2.4
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);
The New Zealand Food Safety Authority (NZFSA) (Agricultural
Compounds and Veterinary Medicines Group (ACVM Group)).
2.5
No responses were received.
2.6
The applicant was provided with a copy of the proposed controls for Agrivet07 Investigational Animal Health Formulations and given the opportunity to
comment on them. The applicant’s comments were taken into account in
finalising the controls.
3 Consideration
Purpose of the application
3.1
The purpose of this application is to import or manufacture animal health
substances for experimental use in containment trials to provide information for
research and development of selected substances.
3.2
The field trials are proposed to take place over five years and the applicant
advises that in all situations the substances due for testing in New Zealand will
have already undergone testing overseas and in many cases they will have been
evaluated in Australia. In addition the applicant indicates that it is likely that the
same or similar substances, or one or more of their excipient components, will
already have been approved by the ACVM Group or by ERMA New Zealand.
3.3
The animal health investigational substances will include substances with the
following indications: prevention, treatment and control of infectious diseases
and pests in all animal species, treatment of endo and ectoparasites in cattle,
sheep and horses, treatment of metabolic diseases in cattle and sheep, production
stimulants in cattle and sheep and treatment of mineral deficiencies in cattle,
sheep and horses. These substances will be administered to individual animals
using specialised applicators like needles and syringes and drench guns.
3.4
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).
Lifecycle
3.5
The applicant advises that the substances will be dealt with throughout their
lifecycle in New Zealand in the following manner:
Importation and transport
3.5.1 The volume of the new substances involved in the animal studies is
expected to be 20 litres/kg per substance per annum. This equates to a
total expected volume for test products of 100 litres/kg per substance for
the five-year period of the trial.
ERMA New Zealand Decision: Application HSC07038
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3.5.2 The substances will be manufactured overseas and imported into New
Zealand. They will arrive in appropriate packaging suitable for shipment to
and within New Zealand.
3.5.3 It is intended to evaluate these substances in containment trials primarily
on the applicant’s site in Hawke’s Bay but they may also be used in other
regions of New Zealand
3.5.4 Small volumes (likely 1 litre) will be transported by specialist carriers
and used at any one time.
Storage
3.5.5 The substances will be stored in a secure facility that is suitable for the
storage of substances of this type and which has in place all the
appropriate procedures and documentation to effectively manage any
possible risks to the environment and to those handling the product.
Administration of the substances
3.5.6 The substances will be administered to animals by a suitably qualified and
trained person who has been given all the information required to handle
the substances safely. In addition, the substances will usually be
administered via a closed system (eg. injection, oral or pour-on applicator)
using suitably calibrated equipment.
3.5.7 Small volumes of substance will be administered to each animal (likely
<10mL) and up to 500 animals will be treated with the substance at any
one site.
Disposal of treated produce
3.5.8 Where a substance is administered to a food animal all treated produce will
be disposed of in accordance with the conditions set by the ACVM Group
for that substance.
Disposal of surplus substance
3.5.9 Surplus substance will be returned to the supplier; otherwise another
suitable disposal method will be employed to render the substance nonhazardous when discharged into the environment.
Hazardous properties
3.6
The Project Team notes that a containment application only requires sufficient
understanding of the hazardous properties to ensure that any risks can be
managed by the containment controls.
3.7
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 under this approval will be notified to ERMA New Zealand
prior to its trialling, and the notification will include compositional information,
a Project Plan and a Safety Data Sheet and any available hazard information.
ERMA New Zealand Decision: Application HSC07038
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3.8
The applicant expects that some of the substances involved will have hazardous
properties 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.
3.9
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.
Identification and evaluation of the significant risks of the substances in
containment
3.10
The applicant has identified and assessed potential risks and detailed proposals
for, and impacts of, risk management. The Agency 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:
Risks to the environment
3.11
The Project Team considers 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.
3.12
On the basis of the lifecycle of the substances outlined in paragraph 3.5, adverse
effects could arise from:




an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances;
failure to follow correct disposal procedures as outlined in the
management plan; or
contamination of the trial site or surrounding environment through
excretion of residues from treated animals.
3.13
The applicant has specified containment provisions intended to manage these
risks. Further, the applicant advises that the faecal and urine residue risk will be
low because only small volumes of each substance will be administered to each
animal (likely <10mL) and up to 500 animals will be treated with a new
substance at any one site. In addition, metabolism of the substance by the
animal will further reduce the quantity of residues excreted.
3.14
The Project Team considers that, taking into account the likely properties of the
substances, 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.
ERMA New Zealand Decision: Application HSC07038
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Risks to human health
3.15
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.
3.16
On the basis of the lifecycle of the substances outlined in paragraph 3.5, adverse
effects could arise from:



3.17
an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances; or
failure to follow correct disposal procedures as outlined in the
management plan.
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, the Project Team
considers there are no significant risks to human health and welfare.
Māori issues and concerns
3.18
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”.
3.19
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 substances are used in accordance with the HSNO
controls established for this application, and in accordance with any other
relevant controls applying under other legislation.
3.20
In addition, the trial of these substances does not involve significant community
exposure or significant exposure to the environment. The Project Team
therefore considers that there is no requirement for the applicant to consult with
Māori regarding this application.
3.21
However, should inappropriate or accidental use, transport or disposal of the
substances 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.
4 Containment and controls
4.1
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 11);
ERMA New Zealand Decision: Application HSC07038
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





to exclude organisms from a facility (for example, control 23);
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 30);
inspection and monitoring requirements (for example, control 34); and
qualifications required of the person responsible for implementing the
controls (for example, control 18).
5 Conclusion
5.1
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), namely research and development on any hazardous substance.
5.2
Having considered the risks associated with the lifecycle of Agrivet07 Investigational Animal Health Formulations, I am satisfied that the controls
imposed, including those in place under other legislation, will result in the
substances being adequately contained.
5.3
The application to import into containment the hazardous substances Agrivet07 Investigational Animal Health Formulations is thus approved with controls in
accordance with the relevant provisions of the Act and the Methodology as more
specifically set out in Appendix 2.
signed
Rob Forlong
Date: 16 January 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC07038
HSC000306
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APPENDIX 1.1: LIST OF CONTROLS THAT APPLY
TO AGRIVET07 - INVESTIGATIONAL ANIMAL
HEALTH FORMULATIONS
General requirements and restrictions
1.
This approval covers the contained importation and trialling of experimental
animal health formulations, as notified to ERMA New Zealand pursuant to
Control 6.
2.
This approval applies exclusively and is limited to products being trialled by or
on behalf of Agrivet Services Ltd.
3.
The maximum total quantity of each animal health formulation that may be
imported under this approval is 100 kg or 100 L.
4.
This approval applies only to direct administration of substances to trial animals,
and therefore excludes the application of any substance directly into the
environment.
5.
This approval remains in place for five years from the date of this decision.
6.
Each substance imported 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 1.2;
a Safety Data Sheet and/or any known hazard information; and
the following identifying details:
7.
ERMA Application number
HSC07038
Substance name/code
Agrivet07 - Investigational Animal Health
Formulations
ERMA Approval number
HSC000306
ERMA Applications Advisor
Elizabeth Morgan
This approval does not apply to substances that trigger any hazardous property
thresholds in classes 1, 2, 3.2, 4 or 5.
Packaging and information
8.
The substances shall be securely packed in suitable containers that comply with
the Hazardous Substances (Packaging) Regulations 2001.
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9.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001. The label must also set out instructions that
any remaining substance must be returned in its original container to Agrivet
Services Ltd. for storage and ultimately disposal.
10.
A Safety Data Sheet, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each shipment and be held at the each trial
site during the period of the trial.
Storage
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.
Transport
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 and the Maritime Transport Act 1994.
General handling of the substances
13.
Appropriate Personal Protective Equipment (PPE), for example, safety glasses,
gloves and protective clothing shall be worn by persons handling the substances
during manufacture, use and disposal.
Trial site requirements
14.
The trials shall be carried out at the research facilities of Agrivet Services Ltd or
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.
Where collection of excreta is required (refer Control 26), the trial site 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.
16.
Access to the trial sites shall be by permission of the Trial Director1 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, and that animals should not be removed.
1
The Trial 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.
ERMA New Zealand Decision: Application HSC07038
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Trial conditions
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
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.
18.
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.
19.
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 or a Standard Operating Procedure retained as part of the
applicant’s trial records.
20.
Only the quantity of each substance that is sufficient for the trial work in the
study shall be taken to the study site. However, a pre-measured backup sample
of each treatment may be taken where a trial is some distance away from the
chemical storage site.
21.
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, if these have
been specified as part of the registration.
22.
Administration of the substance 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 or a Standard Operating Procedure retained as part of the
applicant’s trial records.
23.
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.
24.
Treated animals shall be confined in the trial area as defined in the provisional
registration to be issued by the ACVM Group, NZFSA.
25.
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.
26.
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
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(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.
27.
The collected excreta shall be treated as hazardous and disposed to an
appropriate facility or rendered harmless before disposal.
28.
Documentation shall be kept that records the quantities of the substances
imported, manufactured, administered, stored and ultimately destroyed.
29.
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.
Emergency management
30.
Any spillage of a 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.
Disposal
31.
Any surplus substance remaining at the end of a trial2 shall be returned to
Agrivet Services Ltd. 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).
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.
33.
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.
2
The end of the trial is considered to be the end of the trial programme as defined in the project plan for each
substance.
ERMA New Zealand Decision: Application HSC07038
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Notification and inspection
34.
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 waterbody, the relevant iwi authorities be advised.
35.
Trial documentation, as described in Control 6, notwithstanding its confidential
nature, shall be available for inspection by any enforcement officer, upon
request.
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APPENDIX 1.2: CONTENTS OF PROJECT PLAN
The Project Plan to be supplied for each substance shall contain information on the following
points:
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
Direction, including identification of the Trial Director
Unequivocal identification and quantity of substance
Project title
Purpose
Trial location/s (address and contact details)
The security systems and containment provisions specific to the location
A copy of the trial protocol (or study plan)
Trial dates (start and completion)
Number and species of trial animals
Application method, application period, and dose rate
Fate of treated animals and meat products from treated animals.
Withholding period
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APPENDIX 2: LEGISLATIVE CRITERIA FOR THE
APPROVAL
A2.1.
Unless otherwise stated, references to section numbers in this decision refer to
sections of the Act and references to clauses refer to clauses in the Methodology.
A2.2.
The application was lodged pursuant to section 31. The decision was made 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
(including the Methodology) and the provisions of Part III of the Third Schedule
of the Act.
A2.3.
Government departments with an interest in this type of application were
advised of the receipt of the application in accordance with clause 2(2)(e).
A2.4.
This application was considered by the Chief Executive of ERMA New Zealand
under delegation from the Authority (section 19(2)(e)).
A2.5.
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 (Clauses 9, 12, 13, 14, 22,
24, 25) 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.
A2.6.
In accordance with clause 36(2)(b), it is recorded that, in reaching his decision,
the Chief Executive applied the criteria specified in section 32.
A2.7.
The Chief Executive also applied the following criteria in the Methodology:

clause 11 – characteristics of substance;

clause 21 – the decision accords with the requirements of the Act and
regulations;

clause 26 – all risks negligible;

clause 35 – the costs and benefits of the controls.
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