ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
15 July 2002
Application code
HSC02002
Application type
To Import into or Manufacture in Containment any Hazardous
Substance under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (HSNO) Act
Applicant
Elanco Animal Health
Purpose
Product development for an ectoparasiticide for use in sheep and
cattle
Date received
1 May 2002
Consideration date
24 June 2002
Considered by
Hazardous Substances Standing Committee of the Authority
1
Summary of Decision
1.1
The application to import into containment T9CNZ0102, is approved with controls in
accordance with the relevant provisions of the Hazardous Substances and New
Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and the HSNO
(Methodology) Order 1998.
1.2
The substance has been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
 T9CNZ0102
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31 of the HSNO Act. The decision was
determined in accordance with section 32, taking into account matters relevant to the
purpose of the Act, as specified under Part II of the HSNO Act. Unless otherwise
stated, references to section numbers in this decision refer to sections of the HSNO Act.
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2.2
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology). Unless
otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3
Application Process
3.1
No comments were received from Government Departments (clauses 2(e) and 5,
section 58(c)).
3.2
No external experts were used in the evaluation of this application (clauses 17 and 18).
3.3
The following further information was sought from the applicant (section 52(1) and
clause 23):
 28th March 2002 – request for a management plan, and methods of disposal
 16th April 2002 – information to establish “re-entry period”
3.4
The following information was available to the Committee for its consideration:
 The application and accompanying confidential information
 The Evaluation and Review (E&R) Report prepared by ERMA New Zealand
 Additional information supplied by applicant (residues, management plan)
3.5
The Committee considered this application at a meeting held on 24th June 2002
3.6
Members of the Hazardous Substances Standing Committee of the Authority: Tony
Haggerty, Lindie Nelson, and Jill White, considered the application (section 19(2)(b)).
3.7
ERMA New Zealand has adopted the use classification system as the basis for
recording the nature and uses of substances approved. The following use categories are
recorded for this substance:
Main category
Industry category
Function/use category
2
1
41
Non-dispersive use
Agricultural
Pharmaceuticals – Veterinary medicines
4
Consideration
4.1
In accordance with Section 32 of the Act, the approach adopted by the Committee was
to confirm whether the application was for one of the purposes specified in section 30
of the Act, to identify and assess the risks and costs, and to determine whether the
substance could be adequately contained.
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Purpose of the Application
4.2
The application is for the importation of T9CNZ0102 (an insecticide) for research and
development and for field trials. The substance T9CNZ0102 is to be used as an
ectoparasiticide for the treatment of lice on cattle and sheep in field trials in
containment, and will be evaluated for efficacy and safety in animals. Information
gathered from the trials will be used in assessing T9CNZ0102 for both HSNO and
ACVM approvals. The total amount to be imported is 100 litres in 5 and/or 20 litre
containers.
Hazardous Properties
4.3
Confidential information relating to the composition of the substance and the known
hazardous properties of the substance and individual components was provided as part
of the application. The applicant identified spinosad as the pesticidal active ingredient,
which makes up 2% of the substance (as stated in 3.1 of the application). The other
components are listed in the confidential parts (Appendix 1) of the application.
4.4
From this data, the substance’s hazardous properties were identified by the Committee
in terms of HSNO classifications as follows.
 6.3A skin irritant
 6.4A eye irritant
 6.9A Target organ toxicity
 9.1C Aquatic ecotoxicity
 9.4A Terrestrial invertebrate toxicity
4.5
This assessment of the hazardous properties differs from that supplied by the applicant.
The Committee agreed with the analysis in the E&R report (section 6.3).
Identification of the Significant Effects of the Substance
4.6
The Committee considered the potential effects posed by the importation of 100 litres
in 5 and 20 litre containers to be used in containment for trial purposes. These risks are
evaluated in sections 6.4 to 6.8 of the E&R report, and are summarized as follows:
 Risks to human health (and to skin and eye irritation in particular) in the event of
accidental spillage during transport, storage or use.
 Risks to ecosystems (and to aquatic ecosystems or terrestrial invertebrates in
particular from accidental spillage during transport, storage or use – subject to the
same comments as above.
 Risks to terrestrial invertebrates or aquatic ecosystems in the event of the substance
washing off the test animals and beyond the test site.
 Risks to the environment or to human health from inappropriate disposal of
residual product or of containers.
 Risks arising from premature removal of animals from the trial site.
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4.7
The Committee noted that the risks were reduced by the small container sizes, the
relatively viscous nature of the substance (which aids containment and retrieval of any
spill), and the fact that the active ingredient is immobile in the soil, and is rapidly
degraded in sunlight and in water. The Committee concluded that risks from target
organ systemic toxicity was not an issue for this application which involves a single
external treatment, and thus will not lead to prolonged repeated exposure.
4.8
The Committee noted that, while there were Māori interests in relation to some of the
possible adverse effects identified, these interests were not such as to materially
influence the risk management systems required to adequately contain the substance.
Adequacy of the Proposed Containment Controls
4.9
The Committee considered the containment controls proposed by the applicant, and
evaluated in the E&R report (sections 6.9.1 to 6.9.9). The Committee was satisfied that
the controls, and the Management Plan in particular, were generally appropriate for the
effective containment of the substance. It addressed each of the matters contained in
Part III of the Third Schedule to the Act, as follows in relation to the controls proposed
in the E&R Report:
To limit the likelihood of escape of any contained hazardous substances or contamination
by hazardous substances:
4.9.1 The Committee agreed that the controls were adequate, except that it considered that
burning of residual product was inappropriate. The Committee decided that any
residual product be either returned to the manufacturer, or be buried at a landfill
approved for and capable of handling this type of waste. It augmented the proposed
controls to more specifically address the potential for runoff to waterways, and the
holding of stock in the yards for one hour immediately following treatment in order that
the substance is dry before the stock are released from the yards.
To exclude organisms from a facility or to control organisms within a facility
4.9.2 The Committee was satisfied that the proposed controls were adequate, subject to
clarifying the period for which other animals (not part of the trial) must be excluded.
To exclude unauthorised people from the facility
4.9.3 The Committee was satisfied that the proposed controls were adequate.
To prevent unintended release of the substance by experimenters working with the
substance
4.9.4 The Committee did not agree to the proposed condition allowing surplus product to be
diluted and applied to land.
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To control the effects of any accidental release of the substance
4.9.5 The Committee did not agree to the proposed condition allowing spilled product to be
diluted and applied to land.
Inspection and monitoring requirements
4.9.6 The Committee considered that the proposed controls were appropriate.
4.10 The controls, as amended, are adequate to control the identified risks and it is the view
of the Committee that the substance can be adequately contained.
5
Controls
5.1
Containment controls are designed with the aim of reducing the probability of any
release from containment. However, such controls cannot totally eliminate the
possibility that unintended release will occur, as complete compliance cannot be
guaranteed.
5.2
The containment controls listed in Appendix 1 are grouped according to matters
addressed under the Third Schedule of the HSNO Act (Part III) for containment
controls for contained hazardous substances. The controls are designed to manage the
risks associated with the importation of T9CNZ0102 into containment.
6
Decision
6.1
The Committee has considered this application under section 31 of the Act to import
into containment, T9CNZ0102 , a hazardous substance, and pursuant to section 32 of
the Act, the Committee is satisfied that this application is for one of the purposes
specified in section 30(1) of the Act, being section 30(ba) - importing a hazardous
substance into containment for research and development on any hazardous
substance.
6.2
The Committee is satisfied that given the controls imposed, the substance can be
adequately contained.
6.3
In accordance with clause 36(b) of the Methodology the Committee records that, in
reaching this conclusion, it has applied the criteria specified in section 32 of the Act.
6.4
It has also applied the following criteria in the Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance; and
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques;
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The application to import into containment the hazardous substance T9CNZ0102 is thus
approved, with controls, as given in Appendix 1
Mr Tony Haggerty
Deputy Chair of Hazardous Substances Committee
Date 15th July 2002
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Appendix 1 - Controls
1
TO LIMIT THE LIKELIHOOD OF ESCAPE OF ANY CONTAINED
HAZARDOUS SUBSTANCE OR CONTAMINATION BY HAZARDOUS
SUBSTANCE
1.1
The trials shall be undertaken in accordance with the Project Plan and Management
Plan which accompanied the application except where the following controls direct
otherwise. Modifications to the Project Plan or Management Plan may be approved in
writing by ERMA New Zealand providing that they comply with the following
controls.
1.2
The substance will be applied by using standard methods, with a commercial applicator
specifically designed for the product. It will be applied along the skin of the back
taking care to avoid excess run-off on to the soil or concrete yards.
1.3
The trial sites1 chosen will not be contiguous to any water source. There should be no
capacity for run off into water ways. T9CNZ0102 should not be applied if it is raining.
1.4
All trial sites must be isolated by at least 50 metres from farm dwellings.
1.5
Treated animals must be kept in the yards (application site) for one hour or until the
substance has dried. They must not be released from the containment (trial) site for one
month after treatment.
1.6
Treated animals will be subject to controls under the ACVM Act in terms of entering
the human food chain.
1.7
Access to the trial sites(s) is by permission of the Trial Director or owner of the
property on which it is located. The site(s) will be secured by stock proof fencing and
all potential access points shall be signed indicating that unauthorised access is not
allowed, that the site is subject to a trial, and that the animals should not be removed or
disturbed.
1.8
The substance will be securely packed in containers of 5 and 20 litres being identified
in accordance with the Hazardous Substances (Identification) Regulations 2001 and a
MSDS will accompany each shipment.
1.9
The transportation of the substance will comply with The Land Transport Rule:
Dangerous Goods 1999.
1
The trial site is that area of the property where the animals will be contained for not less than one month
following the application of the substance, and includes the yards (the application area) where the substance is
applied tot eh animals.
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1.10 Storage will be in accordance with the Code of Practice for the Management of
Agrichemicals NZS8409:1999.
1.11 Any portion of the substance surplus to requirements will be disposed of by one of the
following methods:
 Returned to Elanco for re-use;
 Disposed in an appropriate local authority landfill, with the approval of the
appropriate Local Authority (pre-treatment at a hazardous waste facility may be
required).
1.12 The trial site boundaries will be clearly marked and distinctly visible from outside the
trial site throughout the life of the trial(s). The existence of the trial will be clearly
marked to avoid unauthorised access or removal of treated stock .
2
TO EXCLUDE ORGANISMS OR CONTROL ORGANISMS
2.1
Grazing animals, not part of the trial, must be excluded from all trial sites for the
duration of the trial period, that is one month after the trial animals are treated.
2.2
The yards used for the application of the substance (the application site) shall not be
used for other stock for a period of 24 hours following treatment.
3
TO EXCLUDE UNAUTHORISED PEOPLE
3.1
Access to each trial site in the first instance will be by access to the privately owned
property through the main entrance. The final entrance allowing access to the trial will
be clearly marked by a sign indicating such, and allowing no access without permission
of the Trial Director or property owner/manager.
3.2
The number of entrances will be determined by the nature of the secure boundaries, and
location of the site therein.
3.3
A log of all persons accessing the trial sites shall be maintained and be available for
inspection by the Trial Director.
4
TO PREVENT UNINTENDED RELEASE OF THE SUBSTANCE BY
EXPERIMENTERS WORKING WITH THE SUBSTANCE
4.1
The amount of material taken into each trial site will be pre-determined at the storage
facility so as to be sufficient for application to the number of animals to be treated.
4.2
Unused material, if any, will be returned to the applicant’s contact person. Handling
and disposal of any wastes will be carried out in such a way as not to jeopardise the
integrity of the studies, including provision for appropriate collection, storage and
disposal facilities, and decontamination and transportation procedures.
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4.3
The equipment used will be rinsed after use with the appropriate detergent or chlorine
based decontaminant, and rinsate disposed of in accordance with control 1.11 above.
Use of secure labelled containers will be standard procedure.
5
TO CONTROL THE EFFECTS OF ANY ACCIDENTAL RELEASE OF THE
SUBSTANCE
5.1
Any accidental spillage of the unmixed substance shall be mixed either with sand or
earth, and then disposed of in accordance with 1.11 at an approved landfill.
5.2
To minimise the effects of any accidental release of the substance, the container label
will carry appropriate safety precautions and relevant first aid measures for immediate
action pending medical attention.
5.3
Normal precautions will be observed should an accidental release and exposure occur,
such as the careful washing of hands, face and clothing.
6
INSPECTION AND MONITORING REQUIREMENTS
6.1
The Trial Director is required to keep track of all use of the substance as per section
5.9.1 of Code of Practice for the Management of Agrichemicals NZS8409: 1999.
6.2
Occupational Safety & Health2 (OSH) and ERMA New Zealand are to be informed in
writing of the locations, start, and completion of the field trials.
6.3
If for any reason a breach of containment occurs, the Trial Director will notify OSH1
and ERMA New Zealand immediately the event is noticed (and at least within 24 hours
of the breach being detected).
6.4
The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
6.5
The applicant shall provide a completion report to ERMA New Zealand and OSH
within one month of the end of each season’s trial, and a final report at the conclusion
of the approval period, being three years from the date of this decision.
7
QUALIFICATIONS REQUIRED OF THE PERSON RESPONSIBLE FOR
IMPLEMENTING THE CONTROLS
7.1
The personnel applying the substance to the crops will be under the supervision of a
person who is GROWSAFE certified including Unit 6274 (Apply agrichemicals to
control external parasites in livestock) or equivalent (e.g. a registered Veterinarian).
2
Head Office, Attention HSNO Project Manager (or equivalent position)
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