ENVIRONMENTAL RISK
MANAGEMENT AUTHORITY
DECISION
14 August 2007
Application Code
HSC07019
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New Organisms
Act 1996
Applicant
Virbac New Zealand Limited
Purpose of the Application
Virbac 101: to import or manufacture experimental veterinary
medicines for the purpose of testing in animals under containment
conditions (field trial).
Date Application Received
13 August 2007
Consideration Date
14 August 2007
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
under the application code, Virbac101, is 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 substances have been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
Virbac101
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 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 13 August 2007.
3.2
Project Team:
Bella Whittle
Sekove Tinalevu
Zack Bishara
3.3
The applicant supplied the following documents:

3.4
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Advisor (Māori Unit)
the application.
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 (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for Virbac101
and given the opportunity to comment on them. The applicant accepted the
proposed controls.
4
CONSIDERATION
Sequence of the consideration
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)).
Purpose of the application
4.3
The purpose of this application is to import or manufacture veterinary medicines
for the purpose of testing in animals in field trials under containment conditions.
The applicant advises that the aim of the trials is to collect data (e.g. efficacy,
safety and residue data) that will be used to help identify the candidate
formulations that will be selected for further development. It is proposed that
under the current application a number of pilot and larger scale field trials will
be carried out over a period of up to 5 years.
4.4
The applicant advises that the substances may include products for the following
uses:

control and prevention of mastitis in cows;
ERMA New Zealand Decision: Application HSC07019
Page 2 of 12






4.5
prevention, treatment and control of infectious diseases in all animal
species;
treatment of endoparasites and ectoparasites in cattle, sheep and horses;
treatment of metabolic diseases in cattle and sheep;
production stimulants in cattle and sheep;
treatment of mineral deficiencies in cattle and sheep;
treatment of diarrhoea in cattle, sheep and horses.
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).
Life Cycle
4.6
The applicant advises that the substances will be dealt with throughout their
lifecycle in New Zealand in the following manner:
4.6.1 The substances will be imported into, or manufactured in New Zealand.
Manufacturing will take place in a secure facility by skilled people
according to Good Manufacturing Practice (GMP). A maximum of 100 L
or 250 kg of veterinary medicines (in total) will be imported or
manufactured for the duration of this approval.
4.6.2 Packaging used will be known to be secure and suitable for the purposes of
containing the substances under normal conditions of transport and
storage.
4.6.3 The substance and the raw materials used in its manufacture will be stored
in a secure facility that is approved for the storage of substances of this
type. The applicant advises that the facility will have all of the appropriate
procedures and documentation in place to effectively manage any possible
risks to the environment and people handling the substances.
4.6.4 Transport of the substances within New Zealand will occur between the
site of arrival into New Zealand or between the manufacturing facility and
the trial site. Transport will be carried out by approved carriers.
4.6.5 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 product safely. Animals will be treated individually using specialised
applicators. Equipment will be suitably calibrated to deliver an accurate
dose (as approved by the ACVM Group) for each substance.
4.6.6 Surplus substance will be disposed of by incineration or another suitable
disposal method. Surplus substance will be in a form that is nonhazardous before being discharged into the environment. It is anticipated
that disposal will involve only small volumes of test substances.
4.6.7 A risk assessment is undertaken (by the applicant) at the time of writing
each trial protocol. This assessment identifies any situations where
contaminated equipment or ecotoxic residues might occur (e.g.
contamination of the trial site via faecal or urine excretion) and details how
any risks will be managed. Management might include identifying all
equipment that will be used in the trial, choosing trial sites that have
ERMA New Zealand Decision: Application HSC07019
Page 3 of 12
adequate containment facilities and detailing appropriate disposal and
cleaning requirement for both the substance and equipment being used.
Hazardous properties
4.7
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.
4.8
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.
4.9
The applicant expects that some of the substances involved are likely to 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.
4.10
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
4.11
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
4.12
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.
4.13
On the basis of the lifecycle of the substances outlined in paragraphs 4.6- 4.6.7,
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
management plan;
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances;
contamination of the trial site or surrounding environment through
excretion of residues from treated animals.
ERMA New Zealand Decision: Application HSC07019
Page 4 of 12
4.14
The applicant has identified risks that could occur within the environment
throughout the trials. Risks include spillage at any stage of the substance
lifecycle and discharge to the environment through disposal. The applicant has
specified containment provisions intended to manage these risks. Further, the
applicant advises that risks associated with ecotoxic residues from excreta will
be appropriately managed, e.g. by trial site selection.
4.15
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.
Risks to human health and welfare
4.16
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.
4.17
On the basis of the lifecycle of the substances outlined in paragraph 4.6-4.6.7,
adverse effects could arise from:



4.18
an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow correct disposal procedures as outlined in the
management plan; or
failure to follow the correct operational procedures as set out in the
controls, management plan and project plans, resulting in release of the
substances.
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.
Māori issues and concerns
4.19
ERMA New Zealand considered the potential Māori cultural effects of this
application in accordance with sections 6(d) and 8 of the HSNO Act 1996, and
the assessment framework contained in the ERMA New Zealand User Guide
“Working with Māori under the HSNO Act 1996”.
4.20
From the information provided, and considering that the application is for
containment, ERMA New Zealand 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.
4.21
In addition, the trial of these substances does not involve significant community
exposure or significant exposure to the environment. ERMA New Zealand
therefore considers that there is no requirement for the applicant to consult with
Māori regarding this application.
4.22
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
ERMA New Zealand Decision: Application HSC07019
Page 5 of 12
in the region. This action should include advising them of the contamination
and the measures taken in response.
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:







5.2
6
to limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances (for example, control 8);
to exclude organisms from a facility (for example, control 23 and 24,
noting that while there is no specific control excluding organisms from the
facility, the substance will be administered to trial animals individually
and this herd shall be tagged and contained, thereby avoiding direct
exposure to non-target animals);
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 21);
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 Virbac101 can be adequately contained.
DECISION
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
Having considered the risks associated with the lifecycle of Virbac101, 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.
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.
ERMA New Zealand Decision: Application HSC07019
Page 6 of 12
6.5
The application to manufacture or import into containment the hazardous
substances Virbac101 is thus approved pursuant to section 32, with controls as
set out in Appendix 1.
Rob Forlong
Chief Executive of ERMA New Zealand
Date
Virbac101
ERMA New Zealand Approval
Code:
ERMA New Zealand Decision: Application HSC07019
HSC000288
Page 7 of 12
APPENDIX 1:
LIST OF CONTROLS THAT APPLY TO THE
HAZARDOUS SUBSTANCES VIRBAC101
General requirements and restrictions
1.
2.
3.
4.
5.
6.
7.
This approval covers the contained importation, manufacture and field trialling
of experimental veterinary medicines, as notified to ERMA New Zealand
pursuant to Control 6.
This approval applies exclusively and is limited to products being studied by or
on behalf of Virbac New Zealand Ltd.
The maximum total quantity of veterinary medicines that may be manufactured
or imported under this approval is 100 litres or 250 kg in total.
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.
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
HSC07019
Substance name/code
Virbac101
ERMA Approval number
HSC000288
ERMA Applications Advisor
Bella Whittle
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.
9.
The substances shall be securely packed in suitable containers that comply with
the Hazardous Substances (Packaging) Regulations 2001.
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 Virbac
New Zealand Ltd. for storage and ultimately disposal.
ERMA New Zealand Decision: Application HSC07019
Page 8 of 12
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 substance 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 substance 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 substance
during manufacture, use and disposal.
Trial site requirements
14.
15.
16.
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.
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 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, that the site is subject to a trial, and that trial animals should not
be removed.
Trial conditions
17.
18.
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.
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
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.
1
ERMA New Zealand Decision: Application HSC07019
Page 9 of 12
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
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 or a Standard Operating Procedure retained as part of the
applicant’s trial records.
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 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.
The population of the trial herd 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 will record the quantities of the substance
manufactured, administered, stored and ultimately destroyed.
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
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
ERMA New Zealand Decision: Application HSC07019
Page 10 of 12
appropriate waste disposal facility (which may include a landfill), subject to the
facility’s waste acceptance policy.
Disposal
30.
31.
32.
Any surplus substance remaining at the end of the trials2 shall be returned to
Virbac New Zealand 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).
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.
Notification and inspection
33.
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.
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.
The end of the trials is considered to be the end of the trial programme as defined in the project plan for each
substance.
2
ERMA New Zealand Decision: Application HSC07019
Page 11 of 12
Appendix 2:
Contents of Project Plan
The Project Plan to be supplied for each substance shall contain information on the
following points:
1)
Direction, including identification of the Trial Director
2)
Unequivocal identification and quantity of substance
3)
Project title
4)
Purpose
5)
Trial location/s (address and contact details)
6)
The security systems and containment provisions specific to the location
7)
A copy of the trial protocol (or study plan)
8)
Trial dates (start and completion)
9)
Number and species of trial animals
10)
Application method, application period, and dose rate
11)
Fate of treated produce
12)
Withholding period
ERMA New Zealand Decision: Application HSC07019
Page 12 of 12