ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
5 May 2009
Application Code
HSC09006
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
Stockguard Laboratories (NZ) Ltd
Purpose of the
Application
To manufacture in containment, Strepcin Ultra High Potency
Milking Cow, in order to conduct a residue trial to be carried
out in a small group of dairy cows (field trial).
Date Application
Received
7 April 2009
Consideration Date
5 May 2009
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand.
1 SUMMARY OF DECISION
1.1
The application to manufacture in containment the hazardous substance,
Strepcin Ultra High Potency Milking Cow, is approved with controls in
accordance with the relevant provisions of the Act and the HSNO
(Methodology) Order 1998 (“the Methodology”).
1.2
The substance has been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
Strepcin Ultra High Potency Milking Cow
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 7 April 2009.
3.2
Project Team:
Haydn Murdoch
Patrick Gemmell
Noel McCardle
3.3
The applicant supplied the following documents:
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3.4
Advisor (Hazardous Substances)
Senior Advisor (Kaupapa Kura Taiao)
Senior Advisor (Hazardous Substances).
the application;
a confidential appendix including the formulation and finished product
specifications.
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:
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
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 Strepcin
Ultra High Potency Milking Cow 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
completion of a residue trial, so that a milk with-holding period can be set for
Strepcin Ultra High Potency Milking Cow. Approval is sought to manufacture a
small quantity (750 g) of Strepcin Ultra High Potency Milking Cow for use in
the residue trial.
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 HSC09006
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Lifecycle
4.5
The applicant advises that the substance will be dealt with throughout its
lifecycle in New Zealand in the following manner:
4.5.1
The product will be manufactured at the Hamilton premises of
Stockguard Laboratories (NZ) Ltd. The small quantity of product
required for the trial will be manufactured in the laboratory rather than
through the large-scale production equipment.
4.5.2
After manufacture, the required quantity (240 syringes) will be couriered
direct to the Study Director at Pharma Pacifica Ltd (a contract research
company in the Manawatu, who will be carrying out the trial) where it
will be kept under lock and key.
4.5.3
On the treatment days, the required number of syringes (80) will be
removed from the locked cabinet and taken by the Study Director1 to the
trial site.
4.5.4
The syringes will be administered by the Study Director, the Assistant
Study Director or the Veterinarian.
4.5.5
At the completion of each day’s treatment a reconciliation of the
syringes administered with the number taken to the site will be carried
out to ensure no unused syringes are left behind. At the completion of
the study, any unused syringes will be returned to Stockguard for
disposal.
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. The scope of the hazard information will
often be limited for containment applications, as the substance for which
approval is sought is experimental.
4.7
The Project Team considers that Strepcin Ultra High Potency Milking Cow will
trigger the following hazard classifications:
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

4.8
1
6.3A skin irritancy
6.5B skin sensitisation
9.1A aquatic ecotoxicity.
The Project Team has reviewed the summary data and other information
supplied by the applicant and considers that the information is sufficient to
determine that any risks posed within the defined lifecycle of the substance in
New Zealand can be managed through the application of containment controls.
The Study Director is the individual appointed by the applicant to be responsible for the overall conduct of the
trial in accordance with the approval controls.
ERMA New Zealand Decision: Application HSC09006
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Identification and evaluation of the significant risks of the
substance in containment
4.9
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
4.10
If released into the environment the substance has the potential to cause adverse
effects.
4.11
On the basis of the lifecycle of the substance, adverse environmental effects
could arise from:



an accident during storage, use or transportation, resulting in release of the
substance;
failure to follow the correct operational procedures as set out in the controls
and as described in the application, resulting in release of the substance; or
failure to follow correct disposal procedures.
4.12
The Project Team notes that a limited quantity of the substance will be
manufactured (up to 750 g) and released into containment for field trials which
are to be conducted over a limited period of time (no more than 5 years).
4.13
The Project Team considers that, taking into account the hazardous properties of
the substance, the limited quantity involved, the containment controls in
Appendix 1 and controls in place under other legislation, there are no significant
risks to the environment from these trials.
Risks to human health and welfare
4.14
The Project Team considers that adverse effects to human health and welfare
may result from exposure to the substance.
4.15
On the basis of the lifecycle of the substance, adverse effects could arise from:



4.16
an accident during storage, use or transportation, resulting in release of the
substance;
failure to follow the correct operational procedures as set out in the
controls and the application, resulting in personnel exposure while
contained, or bystander exposure if released; or
failure to follow correct disposal procedures.
Taking into account the quantity of substance involved in the trials, the
containment regime proposed by the applicant, and the containment controls
proposed in Appendix 1, the Project Team considers that there are no significant
risks to human health.
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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 Strepcin Ultra High
Potency Milking Cow 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:

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

5.2
to limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances (for example, control 6);
to exclude organisms from a facility (for example, control 20);
to exclude unauthorized people from the facility (for example, control 13);
to prevent unintended release of the substances by experimenters working
with the substance (for example, control 15);
to control the effects of any accidental release of the substance (for
example, control 24);
inspection and monitoring requirements (for example, control 30); and
qualifications required of the person responsible for implementing the
controls (for example, control 14).
The Project Team is satisfied that, with adherence to the controls listed in
Appendix 1 and those controls in place under other legislation the substance
identified as Strepcin Ultra High Potency Milking Cow can be adequately
contained.
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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 Strepcin Ultra High
Potency Milking Cow, I am satisfied that the controls imposed, including those
in place under other legislation, will result in the substance 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:
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

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
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 in containment the hazardous substance Strepcin
Ultra High Potency Milking Cow is thus approved pursuant to section 32, with
controls as set out in Appendix 1.
Rob Forlong
Date: 5 May 2009
Chief Executive of ERMA New Zealand
Strepcin Ultra High Potency Milking Cow
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC09006
HSC000371
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APPENDIX 1:
LIST OF CONTROLS THAT APPLY TO THE
HAZARDOUS SUBSTANCE - Strepcin Ultra High
Potency Milking Cow
General
1.
The trials shall be undertaken in accordance with section 4 of the application.
Modifications of these procedures may be approved in writing by ERMA New
Zealand, providing that they comply with the following controls.
2.
This approval remains in place for the term of any concurrent approval required
under the Agricultural Compounds and Veterinary Medicines Act 1997, to a
maximum of five years.
3.
This approval excludes the application of this substance directly into the
environment.
4.
Notwithstanding the requirements of control 1 above, the trials shall also comply
with the following controls:
Manufacture
5.
Under this approval, Stockguard Laboratories (NZ) Ltd may manufacture a
maximum of 750 g of Strepcin Ultra High Potency Milking Cow for storage,
testing and use at trial sites.
Packaging and information
6.
The substance shall be securely packed in suitable containers that comply with
the Hazardous Substances (Packaging) Regulations 2001.
7.
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 Stockguard
Laboratories (NZ) Ltd for storage and ultimately disposal.
8.
A Safety Data Sheet, compliant with the Hazardous Substances (Identification)
Regulations 2001, shall accompany each consignment of syringes and be held at
each trial site during the period of the trial.
Storage
9.
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 and meet the requirements of the
Act and the Resource Management Act 1991.
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Transport
10.
The substance shall be transported in accordance with good practice and 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
11.
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
12.
The trials shall be carried out at the sites selected for this purpose by Stockguard
Laboratories (NZ) Ltd. The Study Director shall notify ERMA New Zealand in
writing of the location of the trials, in accordance with Control 28.
13.
Access to the trial sites shall be by permission of the Study Director 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.
Field trial conditions
14.
The personnel applying the substance 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. Experimental staff shall be made aware
of the trial protocol and the controls in place in order to adequately manage the
substance.
15.
The substance 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.
16.
Only the quantity of substance that is sufficient to treat the designated animals in
the study shall be taken to the study site.
17.
The substance shall be applied directly into the udder of the animals using single
–dose syringes. The syringes shall be suitably calibrated to deliver an accurate
dose rate. The 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.
ERMA New Zealand Decision: Application HSC09006
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18.
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. Trials shall be conducted in such a way as to prevent the
substances entering any surface water or ground water system.
19.
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.
20.
Treated animals shall be confined in the trial area as defined in the provisional
registration to be issued by the ACVM Group, NZFSA.
21.
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.
22.
Documentation shall be kept that records the quantities of Strepcin Ultra High
Potency Milking Cow which is 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 is applied.
23.
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
24.
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
25.
Any surplus substance remaining at the end of the field trials shall be returned to
Stockguard Laboratories (NZ) 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).
26.
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.
27.
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.
ERMA New Zealand Decision: Application HSC09006
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Notification and inspection
28.
The Department of Labour [Attn. HSNO Project Manager (Workplace Group) or
equivalent position] and ERMA New Zealand shall be informed in writing (by
letter, fax or email) of the location, start, and completion of the trials.
Notifications shall include the following details:
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
Strepcin Ultra High Potency Milking Cow
HSC09006
HSC000371
Haydn Murdoch
29.
If for any reason a breach of containment occurs, the Study 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.
30.
The Authority or its authorised agent or properly authorised enforcement
officers, may inspect the facilities and trial sites at any reasonable time. Trial
documentation shall be available for inspection by any enforcement officer,
upon request.
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