ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
20 June 2002
Application code
HSC02001
Application type
To import into containment any hazardous substance under the
Hazardous Substances and New Organisms (HSNO) Act 1996.
Applicant
Purpose
Virbac Laboratories (NZ) Limited
To field test VBPOC to assess the efficacy of the substance in
controlling lice in cattle.
Date received
1 March 2002
Consideration date
31 May 2002
Considered by
The Hazardous Substances Standing Committee of the Authority
1
Summary of Decision
1.1
The application to import the substance VBPOC into containment is approved with
controls after assessment in accordance with section 31 and other relevant provisions
of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act), the
HSNO Regulations, and the HSNO (Methodology) Order 1998. The approval is for
import into containment.
1.2
The hazardous substance has been given the following unique identifier for the
ERMA New Zealand Hazardous Substances Register:
 VBPOC
1.3
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:
4
1
38
Wide dispersive use
Agricultural industry
Pesticides
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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, and 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. 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.
2.2
Unlike the HSNO Act, legislative requirements of the ACVM Act results in
registration of the applicant (proprietor of the product), not approval of the
substance. Each trial needs MAF approval under the ACVM Act and either needs
approval under Part V of the HSNO Act or needs to be transferred under the
transitional provisions of the Act.
3
Application Process
3.1
The application was formally received on 1 March 2002. On 14 March, further
information was requested from the applicant, under Section 52 of the HSNO Act,
and the application was stalled until 18 March when this information was received.
The application was verified on 18 March.
3.2
The Minister for the Environment was advised of the receipt of the application.
3.3
The information available to the Committee comprised:

The application, including as attachments:
 Appendix 1 Commercially Sensitive Information to Virbac Laboratories NZ
Ltd. Part 1 of 2
 Appendix 2 Commercially sensitive information to Virbac Laboratories NZ
Ltd. Part 2 of 2.
 A statement of assurance that VBPOC is a direct copy a parasiticide already
licensed and in use on farms in New Zealand for the past 14 years.
 The ERMA New Zealand Evaluation and Review (E&R) Report.
4
Consideration
Purpose of the Application
4.1
The application is made under section 31 of the Hazardous Substances and New
Organisms Act for approval to import any hazardous substance into containment.
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4.2
The applicant states that approval is sought to import one litre of VBPOC into
containment in order to gather local efficacy data on the control of lice on cattle to
support an application for registration under the Agricultural and Veterinary
Medicines Act 1997. It is noted that the trial also requires provisional registration
under the ACVM Act.
4.3
It is noted that the applicant has signalled the possibility (if full approval is obtained
under the HSNO and ACVM Acts) of importing VBPOC as the final product in
retail packaging for sale and distribution in New Zealand or, alternatively, may
import the active ingredient (identified as Compound A) to allow local manufacture
of VBPOC.
Sequence of the Consideration
4.4
The application was considered on 31 May 2002 by a subcommittee of the Standing
Committee on Hazardous Substances of the Authority. In accordance with section
19(2)(b) of the Hazardous Substances and New Organisms (HSNO) Act 1996, the
Authority appointed a Committee to determine the application. The Committee
comprised members of the Authority, including Mr. Tony Haggerty, Dr. Lindie
Nelson and Prof. George Clark. The subcommittee considered information in the
E&R Report and other data provided by Operations and Science and Analysis staff.
4.5
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(b)(ba) of the Act, to identify and assess the risks and costs, and to
determine whether the substance could be adequately contained.
Hazardous properties of the substance
4.6
The confidential appendices submitted by the applicant provide detailed information
on the components in the substance, or, where direct data is not available, on a
closely-related chemical analogue.
4.7
The Committee accepts the hazard classification of the substance as presented in the
E&R Report from ERMA New Zealand, as follows:
Summary of Hazard Classification for the Substance (Mixture)
Hazard Category
Acute oral toxicity
Acute inhalation toxicity
Skin irritation
Eye irritation
Reproductive/developmental effects
Target organ systemic effects
Aquatic effects
Soil ecotoxicity
Terrestrial vertebrate toxicity
Terrestrial invertebrate toxicity
Classification
6.1D
6.1B
6.3B
6.4A
6.8B
6.9A
9.1A
9.2B
9.3A
9.4A
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Identification of the effects of the substance
4.8
The purpose of this section is to identify the risks associated with the application,
which will be decided under Section 32 of the HSNO Act. Since this application is
to field-test an agricultural chemical in containment the effects that are considered
are those associated with the escape from containment.
4.9
In accordance with sections 5,6 and 8 of the HSNO Act and clauses 9 and 11 of the
Methodology Order, ERMA New Zealand has categorised the potential risks of
escape from containment under the headings of biological and physical environment,
human welfare including health, safety and social, economic, and Māori issues and
concerns.
Environmental, Human Health and Welfare, and Economic Risks
4.10
The applicant has identified a number of activities that could provide pathways for
escape from containment. These activities are:
 Importation and transport to test site
 Storage
 Dispensing and application
 Disposal of surplus substance by export from New Zealand.
 Accidents, natural hazards and sabotage
4.11
The Committee accepts ERMA New Zealand’s evaluation of the Applicant’s risk
assessment which considered the following:
 Escape or contamination
 Control of organisms
 Exclusion of unwanted personnel
 Unintended release of substance
 Control of effects of unintended release of substance
4.12
The Committee notes that these issues are addressed in the Application (pp 23-29)
and in the Management Plan (Appendix 30 of the Application).Taken together, these
address:
 Personnel responsibilities
 Sample management, including inventory
 Importation
 Receipt, handling, sampling and storage
 Transportation of samples
 Dispensing of samples
 Sample containers, including their clean-up and disposal
 Disposal of surplus sample
 Site management, including site selection, environmental considerations,
signage, prevention of access by unauthorised personnel
 Retention of treated animals within the containment facility, until applied
product has been eliminated, before the animals are returned to the general farm
herd.
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4.13
The Project Plan (Appendix 31 of the Application) addresses the withholding period
(by reference to a registered reference product) and states that the product is not to
be used on lactating animals or within 28 days of calving.
4.14
Insecure packaging or an accident could result in spillage of the substance either on
arrival in New Zealand or during transport to or within the containment facilities.
4.15
If a spillage occurs and water is used to wash the substance away, it could reach
waterways. Wash off may similarly occur if the substance is applied to the cattle in
rainy conditions. Given the stated location of the containment site away from
waterways, the small total volume of substance to be imported, and considering any
dilution that would occur during clean up, this risk to the environment is considered
by the Committee to be very low, being unlikely to occur and if it did, to have
minimal impact. Application to animals must not be made in rainy conditions.
4.16
Given the small quantity of the substance, the Committee considers this conclusion
would also apply to transport and storage of the substance.
4.17
Unauthorised access to the trial facility, and escape of treated animals from the
containment area are adequately addressed.
4.18
The applicant has addressed potential environmental consequences and their
mitigation. In particular:








Application will be by hand-held drench gun directly to the back of the cow.
Appropriate practices are identified to protect operators from inadvertent exposure
during application to the animals.
The cows will be fenced off from commercial herds.
Discharge to surface will be limited by the small amount of substance used in the
trial. Excretion of the active ingredient occurs largely through faecal excretion as
unmetabolised compound.
Excreted unmetabolised active ingredient is bound to soil particles where it is
degraded by photolysis and by soil microorganisms (data provided on closelyrelated chemical analogue).
Discharge to ground water is considered very unlikely, either directly or
indirectly. The trial site will not be adjacent to water sources.
The trial farm is a secure facility with a secured and monitored entrance.
The trial paddock will be clearly marked and bounded by electrified deer-proof
fences.
The substance will be securely packaged in a 1L HDPE container, labelled with
the product name, and will be transported by approved carriers in accordance with
proscribed practices.
4.19
It is unlikely that bees will land on the substance. Earthworms may be affected by
unmetabolised product. It is likely that there may be very localised patches where
damage could be done to earthworms, but the overall impact of this is very low.
4.20
The Committee considers that disposal risks are adequately addressed in the risk
assessment, Management and Project Plans.
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4.21
Removal by contamination of unauthorised visitors or animals accessing the site, or
from product being moved from the site by water, air, or carried on workers’
clothing, may also lead to risks to the environment. The Committee considers that
these risks are appropriately addressed in the Applicant’s risk assessment,
Management and Project Plans.
Māori Issues and Concerns
4.22
The applicant has addressed issues of potential concern to Māori, and as identified
impacts are small or negligible, the applicant considered that no consultation was
necessary.
4.23
The Committee concurs there are no significant issues of concern to Māori in terms
of sections 6(d) or 8.
Effect on International Obligations
4.24
The reference product has been assessed and is in use in the USA, Australia and
New Zealand. The subject of this application is also registered for use in Australia.
There are no international obligations material to this consideration.
Adequacy of Controls and Containment System proposed by the applicant
Controls proposed by the applicant
4.25
The applicant has identified controls to manage the assessed risks to the environment
and to people. The Committee considered whether or not the controls are adequate to
contain the substance and whether they should be amended and/or supplemented to
reduce the likelihood of escape.
4.26
The Committee has evaluated the adequacy of the controls and containment system
proposed by the applicant (refer pp 23-24 and 28-29 of Application, Management
and Project Plans) and has the following comments.
4.27
4.28
4.29
To limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances
The Committee has evaluated the controls proposed by the applicant to address these
issues and considers that with adherence to them the substance can be adequately
contained.
To exclude organisms from a facility or to control organisms within a facility
As the substance is applied in small volume directly to the backs of cows, and as
excreted product is degraded by photolysis or bound to soil until broken down by
soil bacteria, the Committee considers the risk to bees to be very unlikely, and thus
while the effects may be high, the risk is ‘insignificant’.
There is some risk to earthworms through their access to faecal material on the
containment site. However, taking into account the maximum volume of substance
to be applied (1L) to a limited number of animals (up to 50 mL per animal), the
Committee considers the risk to earthworms to be ‘insignificant’.
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4.30
4.31
To exclude unauthorised people from the facility
The Committee considers that with adherence to the proposed controls, unauthorised
people can be adequately excluded from the facility.
To prevent unintended release of the substance by experimenters working with
the substance
There is some risk of spillage while the product is being dispensed or applied. The
Committee notes that processes for handling of the product will be in accordance
with the MSDS, NZS 8409:1999 and Management Plan requirements, and considers
that, with adherence to these, unintended release by people working with the
substance can be adequately prevented.
4.32
To control the effects of any accidental release of the substance
Given adherence to proposed controls the Committee considers that the effects of
any accidental release can be adequately contained.
4.33
Inspection and monitoring requirements
The Committee considers that inspection and monitoring requirements are sufficient
to demonstrate the adequacy for containment of the substance.
4.34
Discretionary controls
The Committee considers that the personnel responsibilities (refer Management
Plan) appear sufficient to ensure adequate containment of the substance.
4.35
Overall Evaluation
The controls proposed by the applicant are considered 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 VBPOC into containment.
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6
Decision
6.1
The Committee has considered this application made under section 31 of the Act to
import into containment 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 of the Act, being section 30(ba) of the Act being Research
and development on any hazardous substance.
6.2
The Committee is satisfied that given the controls, 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 12 – evaluation of assessment of risks;
 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;
 clause 25 – the evaluation of risks;
6.5
The application to import into containment the hazardous substance VBPOC is thus
approved, with controls, as given in Appendix 1.
Mr Tony Haggerty
Deputy Chair of Hazardous Substances Committee
Date 20th June 2002
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Appendix 1 Controls
1.
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
1.11
1.12
1.13
TO LIMIT THE LIKELIHOOD OF ESCAPE OF ANY CONTAINED
HAZARDOUS SUBSTANCE OR CONTAMINATION BY HAZARDOUS
SUBSTANCE
The trials shall be undertaken within a containment facility in accordance with the
Project Plan and Management Plan which accompanied the application except where
the following controls direct otherwise. Modifications of the Project Plan or
Management Plan may be approved in witting by ERMA New Zealand providing that
they comply with the following controls.
The substance will be applied by way of drench equipment directly to the backs of
animals held in specifically-designated and marked areas.
The site chosen will not be contiguous to any water source.
Application to animals must not be made in rainy conditions.
The trial site must be at least 50 metres from buildings where people live or work
(commercial and research glasshouses being an exception).
NZS 8409:1999 Code of Practice for the Management of Agrichemicals shall be
adhered to at all times during use of the substance.
No treated animals shall be consumed by people or animals or offered for sale before
expiry of the withholding period specified for the reference material.
The product is not to be used on lactating animals or within 28 days of calving.
Access to the 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 to avoid
escape and prevent other animals getting in and all potential access points shall be
signed indicating that unauthorised access is not allowed, that the site is subject to a
trial.
The substance will be securely packed in containers being identified in accordance
with the Hazardous Substances (Identification) Regulations 2001 and a MSDS will
accompany each shipment.
The transportation of the substance will comply with The Land Transport Rule:
Dangerous Goods 1999
Any portion of the substance surplus to requirements will be retained in the original
packaging and exported back to the point of origin.
The trial site boundaries will be clearly marked and distinctly visible from outside the
trial site throughout the life of the trial.
2.
2.1
TO EXCLUDE ORGANISMS OR CONTROL ORGANISMS
Grazing animals other than those being treated in the trial must be excluded from all
trial sites including for the duration of the trial period and relevant withholding
period.
3.
3.1
TO EXCLUDE UNAUTHORISED PEOPLE
Access to the trial site will be controlled by locked barrier. Any person entering the
site must report to either the Trial Director or farm manager with delegated authority
to manage site security for this trial.
A log of all persons accessing the trial containment facilities shall be maintained and
be available for inspection by the Trial Director.
3.2
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4.
4.1
4.2
4.3
4.4
5.
5.1
5.2
5.3
6
6.1
6.2
6.3
6.4
6.5
7
7.1
TO PREVENT UNINTENDED RELEASE OF THE SUBSTANCE BY
EXPERIMENTERS WORKING WITH THE SUBSTANCE
Unused material will be retained in the original packaging. Handling and disposal of
any wastes will be carried out in such a way as to minimise any environmental impact
within the containment site.
Drench equipment used to administer the substance will be rinsed after use with an
appropriate detergent. The rinsate will be disposed of by dilution and dispersal within
a non-grazed area of the site.
Use of secure labelled containers will be standard procedure.
The dispensing, if any, of the substance from the original imported container will be
in a controlled environment to minimise inadvertent release, spillage, and unnecessary
exposure.
TO CONTROL THE EFFECTS OF ANY ACCIDENTAL RELEASE OF THE
SUBSTANCE
Any accidental spillage of the substance shall be contained and then either diluted
with water, sand or earth, and then spread over a marked and designated non-grazed
area at the site.
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.
Normal precautions for personal protection will be observed should an accidental
release and exposure occur, such as the careful washing of hands, face and clothing.
INSPECTION AND MONITORING REQUIREMENTS
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
Occupational Safety & Health1 (OSH) and ERMA New Zealand are to be informed in
writing of the locations, start, and completion of the field trials.
If for any reason a breach of containment occurs, the Trial Director will notify OSH
and ERMA New Zealand immediately the event is noticed (and at least within 24
hours after the breach being detected).
The Authority or its authorised agent or properly authorised enforcement officers,
may inspect the facilities and trial sites at any reasonable time
The applicant shall provide a completion report to ERMA New Zealand and OSH
within four months of the end of the trial.
QUALIFICATIONS REQUIRED OF THE PERSON RESPONSIBLE FOR
IMPLEMENTING THE CONTROLS
The Trial Director shall ensure that personnel applying the substance demonstrate
their knowledge of the application of NZS 8409:1999 Code of Practice for the
Management of Agrichemicals prior to commencement of the trial.
1 Head Office, Attention HSNO Project Manager (or equivalent position)
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