ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
22 July 2002
Application code
HSC02004
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
Bomac Laboratories Limited
Purpose
To manufacture in containment B255 a new injectable
formulation containing Flunixin meglumine for product
development studies.
Date received
23 May 2002
Consideration date
3 July 2002
Considered by
The Hazardous Substances Standing Committee of the Authority
1
Summary of Decision
1.1
The application to manufacture in containment the hazardous substance, 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:

B255
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:
3
1
41
Non dispersive
Agricultural industry
Pharmaceuticals,
Subcategory: veterinary medicines
Environmental Risk Management Authority Decision: Application (HSC02004)
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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, 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.
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
The application was formally received on 23 May 2002.
3.2
The following Government Departments were advised of the receipt of the
application (in accordance with section 53(4) of the Act and clauses 2(e) and 5 of the
Methodology) and provided with an opportunity to comment.
 The Ministry of Agriculture and Forestry.
 Ministry of Health.
 Department of Conservation.
 The Occupational Safety and Health Service of the Department of Labour.
3.3
The documents available to the committee for consideration comprised:

The application, including as attachments:
Appendix 1 Manufacturing procedure (confidential)
Appendix 2 B255 Formulation (confidential)
Appendix 3 Components, common uses (confidential)
Appendix 4 Acute Oral Toxicity (confidential)
Appendix 5 Acute Dermal Toxicity (confidential)
A confidential file containing references referred to in the appendices.

The ERMA New Zealand Evaluation and Review (E & R) Report

Correspondence in response to the E & R Report as follows:
Comment from Bomac Laboratories Limited including a revised trial protocol
(different from that submitted in the application) – letter dated 25 June 2002.
Comment from ACVM Group of the New Zealand Food Safety Authority
(previously the ACVM Group of the Ministry of Agriculture and Forestry –
letter dated 2 July 2002.
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4
Consideration
Purpose of the Application
4.1
The application was lodged pursuant to section 31 for the purposes stated in sections
30(b) and 30(ba).
4.2
The Applicant intends to manufacture 200mL (in total) of two formulations
containing flunixin meglumine for research and development, which will include a
field trial in containment. The substance, B255, will be injected into cattle and
evaluated for efficacy, safety and residues. The trial also requires provisional
registration under the ACVM Act.
4.3
Information from the trials may be used in assessing B255 for both HSNO Act and
ACVM Act approvals for release.
Sequence of the Consideration
4.4
The application was considered on 3 July 2002 by a subcommittee of the Standing
Committee on Hazardous Substances of the Authority. In accordance with section
19(2)(b) of the HSNO Act 1996, the Authority appointed a Committee to determine
the application. The Committee comprised the following members of the
Authority; Mrs Jill White (Chairperson), Dr Lindie Nelson and Mr Tony Haggerty.
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 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 hazardous properties of substance were determined to be as follows:
Hazard Category
Acute oral toxicant, acute inhalation toxicant,
acute dermal effects.
Skin irritant.
Eye irritant.
Skin sensitizer.
Target organs toxicity.
Ecotoxic to terrestrial vertebrate.
4.7
Classification
6.1C
6.3B
6.4A
6.5B
6.9A
9.3C
The Committee noted that, although it was not specifically mentioned in the E & R
Report, ERMA New Zealand agreed with the Applicant’s classification of 6.4A.
Also the E & R Report identified the substance as being an acute inhalation toxicant
but this was omitted from the classification listing in Section 7.1 of that report.
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4.8
The committee also noted that although the E & R Report correctly referred to the
substance not being classified as an aquatic ecotoxicant there were incorrect
references to aquatic effects in sections 6.5.3 and 7.4.
Identification and evaluation of the Significant Risks of the Substance
4.9
The purpose of this section of the decision 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 animal remedy in containment the effects that are
considered are those associated with any release from containment.
4.10
In accordance with sections 5 and 6 of the HSNO Act and clause 9 of the
Methodology Order, the Committee has categorised the potential effects of this
application under the headings of biological and physical environment, human
welfare including health, safety and social, economic, and Maori issues and
concerns.
Environmental, Human Health and Welfare and Economic Risks
4.11
The Applicant has identified a number of exposure pathways through which effects
to humans or the environment may be realised. These include;
 Spillage during manufacture, loading, transport or the injection process,
 Ingestion, skin contact, eye contact or self injection,
 Release as excreted non-metabolised substance.
4.12
The Applicant considers the risk of human and environmental effects arising from
the manufacture and field trial of this substance, taking into account the exposure
pathways identified above, can be mitigated by:
 The small quantity of substance being produced and trialed. The volume released
to the environment is insignificant compared with the volume of this substance
released through legal use of currently marketed animal remedies containing
Flunixin meglumine.
 Containment of the substance in 20mL and 50mL sealed glass containers.
 Transport of the containers holding the substance to the trial site in an impactresistant carry case.
 Using trained workers and appropriate protective clothing; all experimenters are
qualified and experienced in administrating injectables to animals.
 Use of the substance as an intramuscular injection in cattle.
 Flunixin meglumine is substantially metabolised in cattle within 72 hours with
no metabolites of toxicological or ecotoxicological concern (EMEA 2000). (This
is incorrectly stated in the application but has been confirmed as correct from the
references supplied.)
 Spillages being absorbed onto paper towels and with other excess material
(product, syringes, and consumables), placed in a secure impact resistant
disposal bin for disposal by incineration by a Hazardous Waste contractor.
4.13
The Committee accepts ERMA New Zealand’s evaluation of the Applicant’s risk
assessment but considers the risk of exposure of eyes to the substance during syringe
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filling and checking needed to be noted. Effects of this type can be mitigated by
rinsing affected eyes with water.
Effect on International obligations
4.14
The applicant has identified food residue issues that are covered by the ACVM
legislation as being a potential effect. The applicant notes that this risk will be
assessed by the ACVM Group in their consideration of risks to international trade.
5
Containment and Controls
5.1
Containment controls are designed with the aim of reducing the likelihood 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 contained
hazardous substances. The controls are designed to manage the risks associated with
the manufacture and field testing of B255 in containment.
5.3
Information supplied by the Applicant with respect to containment and controls is
general and limited in detail. This is reasonable given that the active ingredient is
already used in the manufacturing facility and in animal remedies in widespread use.
5.4
The Committee noted that a revised trial protocol was submitted by the Applicant as
part of their response to the E & R Report.
5.5
The committee evaluated the adequacy of the containment arrangements of the
Applicant and the controls set out in the E & R Report and has the following
comments.
To limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances
5.6
The Committee has evaluated the information provided by the applicant and
considers that the substance can be adequately contained.
5.7
However, because there was uncertainty as to whether the trial would be carried out
on one or more farms the committee considered that there should be a control
limiting the field trial to one farm. (Control 1.3)
5.8
The Committee noted that the substance was not an aquatic ecotoxicant but that
excreted active material could be carried by water from the field trial site during the
first three days after injection. This is addressed by Control 1.4 which restricts the
grazing area during this period.
5.9
The control relating to access (Control 1.6) takes into account comments from the
Applicant.
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To exclude organisms from a facility or to control organisms within a facility
5.10
The Committee considers that the trial cattle should be kept separate from other
animals for the first three days after injection. (Control 2.1)
To exclude unauthorised people from the facility
5.11
The Committee noted the Applicant’s comments on the controls proposed in the E &
R Report and considers that the controls listed in Appendix 1 (Controls 3.1 and 3.2)
can adequately exclude unauthorised people.
To prevent unintended release of the substance by experimenters working with the
substance
5.12
The Committee considers that the unintended release of the substance by
experimenters working with the substance can be adequately prevented by adherence
to the controls (Controls 4.1 and 4.2).
To control the effects of any accidental release of the substance
5.13
The Committee considers that the effects of any accidental release of the substance
can be adequately contained with the controls (Controls 5.1 to 5.3).
Inspection and monitoring requirements
5.14
The Committee considers the controls (Control 6.4 to 6.5) are adequate to ensure
containment of the substance. Comments from the applicant were noted but not
taken into account in considering the controls.
Qualifications required of the person responsible for implementing the controls
5.15
The Committee considers the qualifications of the person specified in the controls
(Control 7.1) are adequate to ensure containment of the substance. Comments from
the applicant were noted but not taken into account in considering this control.
Overall Assessment
5.16
The Committee is satisfied that with the controls listed in Appendix 1 the substance
can be adequately contained.
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6
Decision
6.1
The Committee has considered this application under section 31 of the Act to
manufacture in 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 sections 30(b) and 30(ba).
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;
6.5
The application to manufacture in containment the hazardous substance B255 is thus
approved, with controls, as set out Appendix 1.
______________________________________
________________
Mrs Jill White
Hazardous Substances Standing Committee of the Authority
Date
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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 manufacture and field trials of B255 shall be undertaken in accordance with the
planned procedures set out in the application and the trial protocol attached to the
letter from Bomac of 25 June 2002, except where the following controls direct
otherwise. Future modifications of the procedures may be approved in writing by
ERMA New Zealand providing that they comply with the following controls.
1.2
A registered veterinarian, using best current practice, shall inject the substance
intramuscularly into the trial cattle.
1.3
Treated animals shall be retained on the field trial site (being a single farm) for 91
days.
1.4
The cattle shall not be grazed in an area that is bounded by or traversed by a
watercourse for the first three days after injection.
1.5
Treated animals shall be subject to controls under the ACVM Act in terms of
entering the human food chain.
1.6
During the first three days after injection access to the paddock in which the trial
cattle are held is by permission of the supervisor of the property. The cattle shall be
secured for the 91 days of the trial by stock-proof fencing.
1.7
The substance shall be securely packed in containers identified in accordance with
the Hazardous Substances (Identification) Regulations 2001 and a MSDS shall
accompany each shipment.
1.8
The transportation of the substance shall comply with The Land Transport Rule:
Dangerous Goods 1999.
1.9
Any portion of the substance surplus to requirements along with any contaminated
equipment, consumables and spillage residues shall be disposed of by incineration at
a properly approved facility.
2
To Exclude Organisms or Control Organisms
2.1
Trial cattle must be kept separate from other animals for the three days after
injection.
3
To Exclude Unauthorised People
3.1
No unauthorised persons are allowed into the Bomac Laboratories Ltd factory or
Research and Development facility.
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3.2
During the first three days after injection the paddock in which the trial cattle are
held is to be kept under surveillance by the permanent staff and no people are to
enter the paddock without the permission of the property supervisor.
4
To Prevent Unintended Release of the Substance by
Experimenters Working with the Substance
4.1
The amount of material taken into the trial site shall be pre-determined at the
Research and Development facility so as to be sufficient for application to the
number of animals to be treated.
4.2
Unused material, used equipment and spillage residues shall be returned to the
Research and Development facility, prior to being sent for approved disposal.
5
To Control the Effects of any Accidental Release of
the Substance
5.1
Any accidental spillage shall be absorbed onto paper towels and disposed of
according to Control 1.9.
5.2
To minimise the effects of any accidental release of the substance appropriate safety
precautions and relevant first aid measures for immediate action pending medical
attention shall accompany the substance.
5.3
Normal precautions for personal protection shall 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 Research and Development Veterinarian shall keep track of use and disposal of
the substance.
6.2
Occupational Safety & Health (OSH)1 and ERMA New Zealand shall be informed in
writing of the location, start, and completion of the field trials.
6.3
If for any reason a breach of containment occurs, the Research and Development
Veterinarian shall notify OSH and ERMA New Zealand immediately the event is
noticed (and not more than 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 the trial.
1
Head Office, Attention HSNO Project Manager (or equivalent position)
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7
Qualifications Required of the Person Responsible
for Implementing the Controls
7.1
The person overseeing the manufacture of the substance and the field trial shall be
the Research and Development Veterinarian.
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