ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
21 October 2008
Application Code
HSC08011
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
Seneca Holdings Ltd
Purpose of the
Application
To import and manufacture (into containment) new veterinary
medicines for the purpose of testing in animal studies under
tightly controlled conditions (field trials).
Date Application
Received
16 September 2008
Consideration Date
21 October 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 SUMMARY OF DECISION
1.1
The application to import into or manufacture in containment the hazardous
substances, Seneca Holdings Experimental Animal Health Compounds, 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:
Seneca Holdings Experimental Animal Health Compounds
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 16 September 2008.
3.2
Project Team:
Haydn Murdoch
Noel McCardle
3.3
The applicant supplied the following documents:


3.4
Advisor (Hazardous Substances)
Senior Advisor (Hazardous Substances).
the application;
a confidential appendix including information on the lifecycle of the test
substances and proposed controls.
The following Government departments were advised of the receipt of the
application (in accordance with clause 2(2)(e)) and given the opportunity to
comment:


The Department of Labour (Workplace Group);
The New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines Group (ACVM Group)).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for Seneca
Holdings Experimental Animal Health Compounds 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
According to the applicant, the purpose of this application is to allow the
manufacture and/or importation of novel products for local efficacy and safety
testing. The efficacy studies will involve testing against local endo and ecto
parasites in farm and domestic animals. Approval is also sought to allow the
development of manufacturing procedures for the new substances and to
produce product for stability testing.
4.4
The Project Team considers that the purpose stated by the applicant amounts to
“research and development on any hazardous substance” and therefore qualifies
for consideration under section 30(ba).
ERMA New Zealand Decision: Application HSC08011
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Lifecycle
4.5
The applicant advises that the substances will be dealt with throughout their
lifecycle in New Zealand in the following manner:
4.5.1
Where the substances are imported, a maximum of 100 L or 250 kg of
each test substance will be imported into New Zealand and transported
to secure sites under the control of Seneca Holdings Ltd.
4.5.2
Where the substances are manufactured, a maximum of 2000 L or
250 kg of each test substance will be manufactured in New Zealand.
The manufacturing site will be GMP accredited and meet the
requirements of HSNO and the Resource Management Act 1991.
4.5.3
Packaging and labelling of imported test substances will meet
international requirements for air/sea transportation with regards to
packaging etc., and with New Zealand domestic transportation
requirements.
4.5.4
Packaging will suitably and securely contain the test substances during
transport and storage. Documentation will accompany the test
substances outlining the safe handling, transport and storage of the
substances.
4.5.5
Storage of the test substances before transportation to the containment
study locations will be appropriate and will be in a suitable facility that
is approved for this purpose.
4.5.6
Transport of test substances to the field trial sites will be undertaken by
persons experienced in the transport of hazardous substances and in
compliance with New Zealand’s transport legislation.
4.5.7
The test substances will be administered to trial animals by suitably
trained and qualified persons. The test products will be dosed using an
essentially closed administration system and only relatively small
volumes will be administered to each animal. In each case the volume
of test substance used will be fully documented and accounted for.
4.5.8
No treated animals will be offered for sale or slaughtered for human
consumption until the withholding requirements stipulated by the
ACVM Group, as part of the conditions of the provisional registration or
research approval for the test substance, have been fulfilled.
4.5.9
Surplus test substance will be returned to Seneca Holdings Ltd. The
product will then either be sent overseas, destroyed using a method
know to render the substance non hazardous or it will be stored until
approvals for its full release under the provisions of the HSNO Act and
ACVM Act have been granted. Container and packaging disposal will
meet the requirements of the Hazardous Substances (Disposal)
Regulations 2001.
ERMA New Zealand Decision: Application HSC08011
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Hazardous properties
4.6
The Project Team notes that the understanding of the hazardous properties of the
substance only needs to sufficient enough to ensure that any risks can be
managed by the containment controls.
4.7
It is also noted that the scope of the hazard information will often be limited, as
the substances will be experimental and may not be commercialised. Each
substance imported or manufactured under this approval will be notified to
ERMA New Zealand prior to its trialling, and the notification will include
compositional information, a Project Plan, a Safety Data Sheet and any available
hazard information.
4.8
The applicant expects that some of the substances involved are likely to have
hazardous properties and that trigger the minimum degrees of hazard for each
allowable hazard category, as defined the Hazardous Substances (Minimum
Degrees of Hazard) Regulations 2001 and as limited in Appendix 1.
4.9
After taking into account the substances’ potential hazardous properties, the
Project Team considers that the information provided is sufficient to determine
that any risks can be managed by the containment controls proposed in
Appendix 1.
Identification and evaluation of the significant risks of the
substances in containment
4.10
The applicant has identified and assessed potential risks and detailed proposals
for, and impacts of, risk management. The Project Team has reviewed the
applicant’s assessment of the risks to the environment, human health and welfare
and Māori issues and concerns as set out below:
Risks to the environment
4.11
The Project Team consider that if released, excreted or discharged into the
environment the substances have the potential to result in adverse effects within
the environment. As the ecotoxic hazards are not identified at this stage, the
Project Team assumes that the substances could cause adverse effects within the
aquatic, soil, or above-ground terrestrial environments.
4.12
The applicant has identified risks that could occur within the environment
throughout the trials. Risks include spillage at any stage of the substance
lifecycle; discharge to the environment through disposal; and ecotoxic residues
present in the excreta of treated animals. The applicant has specified
containment provisions intended to manage these risks.
4.13
The Project Team considers that, taking into account the likely properties of the
substance, the 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 HSC08011
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Risks to human health and welfare
4.14
If the substances are ingested or inhaled, or come in contact with skin or eyes
they have the potential to cause adverse effects on human health.
4.15
On the basis of the lifecycle of the substances outlined in paragraph 4.5.1 - 4.5.9,
adverse effects could arise from:



4.16
an accident during storage, use or transportation, resulting in release of the
substances;
failure to follow correct disposal procedures as outlined in the controls and
project plan; or
failure to follow the correct operational procedures as set out in the
controls and project plans, resulting in release of the substances.
The Project Team considers that, taking into account the properties of the
substances, 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
4.17
The Project Team considered the potential Māori cultural effects of this
application in accordance with sections 6(d) and 8, and the assessment
framework contained in the ERMA New Zealand User Guide “Working with
Māori under the HSNO Act 1996”.
4.18
From the information provided, and considering that the application is for
containment, the Project team considers that it is unlikely to have an impact on
the relationship between Māori culture and their traditions with their ancestral
lands, water, sites, waahi tapu, valued flora and fauna and other taonga. This is
on the condition that the substance is used in accordance with the HSNO
controls established for this application, and in accordance with any other
relevant controls applying under other legislation.
4.19
The Project Team has no evidence to suggest that the use of Seneca Holdings
Experimental Animal Health Compounds in containment will breach the
principles of the Treaty of Waitangi.
4.20
The Project Team therefore considers that there is no requirement for the
applicant to consult with Māori regarding this application. However, should
inappropriate or accidental use, transport or disposal of the substance result in
the contamination of waterways, it is suggested that the applicant notify the
appropriate authorities including the relevant iwi authorities in the region. This
action should include advising them of the contamination and the measures
taken in response.
5 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 11);
ERMA New Zealand Decision: Application HSC08011
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





5.2
to exclude organisms from a facility (for example, control 27);
to exclude unauthorized people from the facility (for example, control 19);
to prevent unintended release of the substances by experimenters working
with the substance (for example, control 22);
to control the effects of any accidental release of the substance (for
example, control 32);
inspection and monitoring requirements (for example, control 37); and
qualifications required of the person responsible for implementing the
controls (for example, control 21).
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 Seneca Holdings Experimental Animal Health Compounds can be
adequately contained.
6 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 Seneca Holdings
Experimental Animal Health Compounds, 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 import into or manufacture in containment the hazardous
substances Seneca Holdings Experimental Animal Health Compounds is thus
approved pursuant to section 32, with controls as set out in Appendix 1.
Rob Forlong
Date: 21 October 2008
Chief Executive of ERMA New Zealand
Seneca Holdings Experimental Animal Health Compounds
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC08011
HSC000342
Page 6 of 12
APPENDIX 1:
LIST OF CONTROLS THAT APPLY TO THE
HAZARDOUS SUBSTANCES - Seneca Holdings
Experimental Animal Health Compounds
General requirements and restrictions
1.
This approval covers the contained importation, manufacture and field trialling
of experimental veterinary medicines, as notified to ERMA New Zealand
pursuant to Control 9.
2.
This approval applies exclusively and is limited to products being studied by or
on behalf of Seneca Holdings Ltd.
3.
The maximum total quantity of each veterinary medicine that may be imported
under this approval is 100 litres or 250 kg.
4.
The maximum total quantity of each veterinary medicine that may be
manufactured under this approval is 2000 litres or 250 kg. Manufacturing will
be confined to the manufacturing site specified in the application (Appendix 1 Confidential Section).
5.
The maximum total quantity of each veterinary medicine that may be
administered to animals under this approval is 100 litres or 50 kg.
6.
Any excess veterinary medicine which is produced during pilot formulation
trials or for the purpose of stability testing, will be confined to the manufacturing
site until such time as the substance is approved for release or the substance is
disposed of in accordance with Control 34.
7.
This approval excludes the application of any substance directly into the
environment.
8.
This approval remains in place for five years from the date of this decision.
9.
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
HSC08011
Substance name/code
Seneca Holdings Experimental Animal Health
Compounds
ERMA Approval number
HSC000342
ERMA Applications Advisor
Haydn Murdoch
ERMA New Zealand Decision: Application HSC08011
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10.
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
11.
The substances shall be securely packed in suitable containers that comply with
the Hazardous Substances (Packaging) Regulations 2001.
12.
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 Seneca
Holdings Ltd for storage and ultimately disposal.
13.
A Safety Data Sheet, compliant with the Hazardous Substances (Identification)
Regulations 2001, shall accompany each shipment and be held at each trial site
during the period of the trial.
Storage
14.
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
15.
The substances shall be transported in accordance with good practice and where
appropriate in compliance with any relevant requirements of the Land Transport
Act 1998, the Civil Aviation Act 1990 or the Maritime Transport Act 1994.
General handling of the substances
16.
Appropriate Personal Protective Equipment (PPE), for example, safety glasses,
gloves and protective clothing shall be worn by persons handling the substances
during use and disposal.
Field trial site requirements
17.
The field 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 9.
18.
Where collection of excreta is required under control 29, 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.
ERMA New Zealand Decision: Application HSC08011
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19.
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 trial, and that animals should not be
removed.
Field trial conditions
20.
The field 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.
21.
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.
22.
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.
23.
Only the quantity of each substance that is sufficient to treat the designated
animals in the study shall be taken to the study site.
24.
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.
25.
Administration of the substances to trial animals shall take place in accordance
with good veterinary practice. This would generally be achieved through
compliance with the Code of Practice for the Management of Agrichemicals
NZS8409:2004. Trials shall be conducted in such a way as to prevent the
substances entering any surface water or ground water system.
26.
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.
27.
Treated animals shall be confined in the trial area as defined in the provisional
registration to be issued by the ACVM Group, NZFSA.
28.
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.
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 HSC08011
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29.
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.
30.
Documentation shall be kept that records the quantities of each substance
imported, manufactured, administered, stored and ultimately destroyed. The
records of use shall cover all matters referred to in Regulation 6(1) of the
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001 and must
be kept for not less than 3 years after the date on which the substance that the
record applies to is applied.
31.
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
32.
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.
Disposal
33.
Any surplus substance remaining at the end of the field trials2 shall be returned
to Seneca Holdings 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).
34.
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.
35.
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 trials is considered to be the end of the trial programme as defined in the Project Plan for
each substance.
ERMA New Zealand Decision: Application HSC08011
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Notification and inspection
36.
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.
37.
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 9, notwithstanding its confidential
nature, shall be available for inspection by any enforcement officer, upon
request.
ERMA New Zealand Decision: Application HSC08011
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Appendix 2:
Contents of Project Plan
The Project Plan to be supplied for field trials on any 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 any produce from those treated animals
Withholding period (where appropriate)
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