ENVIRONMENTAL RISK
MANAGEMENT AUTHORITY
DECISION
28 May 2007
Application Code
HSC07011
Application Type
To import or manufacture a hazardous substance in containment under
Section 31 of the Hazardous Substances and New Organisms Act 1996
Applicant
Bomac Laboratories Limited
Purpose of the Application
BOMNZNC0307: to import or manufacture experimental animal health
formulations for the purpose of testing in animals under tightly
controlled containment conditions (field trial).
Date Application Received
16 March 2007
Consideration Date
28 May 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, BOMNZNC0307, 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:
BOMNZNC0307
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.
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3
APPLICATION PROCESS
3.1
The application was formally received on 16 March 2007.
3.2
Project Team:
Bella Whittle
Chris Geering
Zack Bishara
3.3
The applicant supplied the following documents:


3.4
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Advisor (Māori Unit)
the application
a confidential appendix including information on the life cycle 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 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
BOMNZNC0307 and given the opportunity to comment on them. The comments
provided were taken into account in the setting of 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.
4.4
The applicant advises that the substances may include products for treatment of
animals with the following indications: control and prevention of mastitis in cows;
treatment of endoparasites and ectoparasites in cattle, sheep and horses; treatment
ERMA New Zealand Decision: Application HSC07011
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of metabolic diseases in cattle and sheep; treatment of mineral deficiencies in cattle
and sheep; and treatment of diarrhoea in cattle, sheep and horses.
4.5
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 thoughout their lifecycle
in New Zealand in the following manner:
4.6.1 The substances will be imported into, or manufactured in New Zealand.
4.6.2 Manufacturing will take place in a secure facility by skilled people according
to Good Manufacturing Practice (GMP). 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 A maximum of 100 L or 250 kg of each substance will be imported or
manufactured for the duration of this approval.
4.6.4 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.
4.6.5 Transport of the substances within New Zealand will occur between the site
of import or manufacturing facility to the trial site, and then to and from the
trial site. Transport will be carried out by approved carriers, such as Chem
Couriers.
4.6.6 The substances will be administered to animals by a suitably qualified and
trained person. Animals will be treated individually using specialised
applicators. Equipment will be suitably calibrated to deliver an accurate dose
rate. The applicant states that animals will be treated at the dose and manner
approved by the ACVM Group for each substance.
4.6.7 Surplus substance will be disposed of by incineration or another suitable
disposal method. Surplus substance will be in a form that is non-hazardous
before being discharged into the environment. It is anticipated that disposal
will involve only very small volumes of test substances.
4.6.8 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; and 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 will be treated as hazardous and disposed of in a manner compliant
with the disposal controls of this approval.
4.6.9 Where a substance is administered to a food producing animal, the applicant
will comply with the conditions set by the ACVM Group for that substance
with respect to treated produce.
ERMA New Zealand Decision: Application HSC07011
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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 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.
4.10
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- 4.6.9,
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.
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;
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.
4.15
The project team considers that, taking into account the likely properties of the
substance, the quantities involved, the containment regime proposed by the
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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 4.6-4.6.9,
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 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.
4.21
In addition, the trial of this substance 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
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
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 8);
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





5.2
6
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
BOMNZNC0307 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 BOMNZNC0307, 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:





6.5
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.
The application to manufacture or import into containment the hazardous
substances BOMNZNC0307 is thus approved pursuant to section 32, with controls
as set out in Appendix 1.
Rob Forlong
Chief Executive of ERMA New Zealand
Date
BOMNZNC0307
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC07011
HSC000278
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APPENDIX 1:
LIST OF CONTROLS THAT APPLY TO THE
HAZARDOUS SUBSTANCES BOMNZNC0307
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 Bomac Research or Bomac Laboratories Limited.
The maximum total quantity of each veterinary medicine that may be manufactured
or imported under this approval is 100 litres or 250 kg.
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
HSC07011
Substance name/code
BOMNZNC0307
ERMA Approval number
HSC000278
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 Bomac
Laboratories Limited for storage and ultimately disposal.
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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 or 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 shall be
made aware of the trial protocol, the Project Plan, and the controls in place in order
to adequately manage the substances.
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
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19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
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
appropriate waste disposal facility (which may include a landfill), subject to the
facility’s waste acceptance policy.
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Disposal
30.
31.
32.
Any surplus substance remaining at the end of the trials2 shall be returned to
Bomac Laboratories 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).
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
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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
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