ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
23 November 2007
Application Code
HSC07029
Application Type
Importation or manufacture of a hazardous substance in
containment under Section 31 of the Hazardous Substances and
New Organisms (HSNO) Act 1996.
Applicant
NZ Laboratory Services Ltd
Purpose of the Application
To import into or manufacture in containment small amounts of
persistent organic pollutants (POPs) for use as analytical
standards or for research in a laboratory.
Date Application Received
10 October 2007
Consideration Date
23 November 2007
Considered by
Rob Forlong
Chief Executive
Environmental Risk Management Authority (ERMA)
New Zealand
1
Summary of Decision
1.1
The application to import into or manufacture in containment small amounts of
POPs for use as analytical standards or for research in a laboratory is approved
with the controls set out in Appendix 1. This approval has been given in
accordance with the relevant provisions of the Hazardous Substances and New
Organisms Act 1996 (the Act) and the Hazardous Substances and New
Organisms (Methodology) Order 1998 (the Methodology).
1.2
The substances covered by this approval have been given the following unique
identifier for the ERMA New Zealand Hazardous Substances Register:
POP Standards, NZ Laboratory Services Ltd, Auckland Site, 2007
2
Legislative Criteria for Application
2.1
Unless otherwise stated, references to section numbers in this decision refer to
sections of the Act. The application was lodged pursuant to section 31. The
decision was determined in accordance with the requirements specified in
sections 25A, 30 and 32, taking into account additional matters to be considered
in those sections and matters specified under Part II of the Act and the
provisions of Part III of the Third Schedule of the Act.
2.2
Unless otherwise stated, references to clauses in this decision refer to clauses of
the Methodology. Consideration of the application followed the relevant
provisions of the Methodology.
3
Application Process
3.1
The purpose of the application is to import into or manufacture in containment
small amounts of POPs for use as analytical standards or for research in a
laboratory.
3.2
The application was formally received on 10 October 2007.
3.3
The Department of Labour Workplace Group (OSH), the Ministry of Health and
the Ministry for the Environment were advised of the application (clause
2(2)(e)).
3.3.1
3.4
No responses were received.
Evaluation of the application was undertaken by the ERMA New Zealand
project team, which comprised the following staff members:
Margaret Keane
Beth Dye
4
Advisor (Hazardous Substances)
Applications Manager (Hazardous Substances)
3.5
The applicant was provided with a copy of the proposed controls and given the
opportunity to comment on them in accordance clause 35(b). The applicant
raised no issues with the proposed controls.
3.6
The application was considered by the Chief Executive of ERMA New Zealand
as provided for by a delegation from the Environmental Risk Management
Authority (the Authority) under section 19(2)(e).
Consideration
Sequence of the Consideration
4.1
NZ Laboratory Services Ltd seeks approval, under section 31, to import into or
manufacture in containment small amounts of POPs for use as analytical
standards or for research in a laboratory.
4.2
The approach adopted when considering this application was:
 to review the information provided;
 to identify the POPs and their hazardous properties; and
 to determine whether the application is for one of the purposes specified in
section 30 as required by section 25A;
4.3
And then:
 to identify the lifecycle of the POPs and assess the risks;
 to consider whether there are any other effects that mean the POPs should not
be contained; and
 to determine whether the POPs could be adequately contained by controls
that provide for each of the matters specified in Part III of the Third Schedule
of the Act.
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Information Review
4.4
The project team notes that a containment application must provide sufficient
information to confirm that the substance can be adequately contained.
4.5
The project team has reviewed the information supplied by NZ Laboratory
Services Ltd, and considers that the information constitutes an adequate and
appropriate basis for assessing the application (clause 8). They also consider that
there are no significant uncertainties (ie sufficient to influence decision making)
in the scientific and technical information relating to the risks of POP Standards,
NZ Laboratory Services Ltd, Auckland Site, 2007 (clauses 29 to 32).
Identification of the POPs
4.6
Information on the quantities and names of the POPs covered by this application
as provided in Section 3.1 of the application form are as follows:
Substance
Aldrin
Chlordane
DDT
Dieldrin
Endrin
Heptachlor
Hexachlorobenzene
Mirex
Toxaphene
Polychlorinated
biphenyls
CAS No.
309-00-2
57-74-9
50-29-3
60-57-1
72-20-8
76-44-8
118-74-1
2385-85-5
8001-35-2
-
Held at
31 July 2007
Amount (mg)
New Import

250


250
100

250







Max amount
per year (mg)
250
250
250
250
250
250
250
New Manufacture
Max amount
per year (mg)
Hazardous Properties
4.7
POPs are both toxic and ecotoxic, i.e. they will trigger hazard classifications in
classes 6 and 9. Also of note is that these substances are environmentally
persistent, and are known to bioaccumulate.
Meeting the criteria for containment under section 30
4.8
Based on the application purpose in Paragraph 3.1, the project team considers
that the criteria for containment under sections 30(a)(ii) and (ba) of the Act have
been met.
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5
Risk Assessment
Lifecycle
5.1
The applicant has identified the following process for importation or
manufacture of POPs into containment.
Purchase
5.1.1
POPs are to be ordered through an approved supplier.
5.1.2
The supplier is responsible for the import and transportation of POPs.
5.1.3
Each time a POP is imported, the laboratory shall notify ERMA New
Zealand in writing of quantities and nature of the substance.
Receipt
5.1.4
On receipt POPs are to be booked in using a chemical database,
following the instructions in SOP8.17, as a chemical standard. A
unique chemical ID and lot # are assigned.
Storage
5.1.5
The POP is transferred to the Drug safe in the company safe room.
5.1.6
Knowledge of the combination of the safe is limited to Manager –
Chemistry & Pharmaceutical Services and Senior AnalystPharmaceutical.
POP register
5.1.7
A register is held by Manager – Chemistry & Pharmaceutical Services
of all POP standards in our possession.
5.1.8
The register has an index at the front detailing POP and page number
of records.
5.1.9
When a POP is used or emptied, details of this must be recorded in the
register.
Use of POP standards
5.1.10
MSDSs shall be obtained and held in the laboratory work area for all
relevant POPs.
5.1.11
All staff using POPs must be trained in POP handling.
5.1.12
When a member of staff needs to use a POP standard, they must get
the authorised person to open the safe. The POP register must be
completed at this time and the standard must be returned to the safe
immediately after use.
5.1.13
POP standards must stay in original containers provided by the
supplier.
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5.1.14
POP standards must not be transferred to another facility unless
authorised by ERMA New Zealand.
5.1.15
Work must be performed in a chemical fumehood, wearing chemical
resistant gloves and safety goggles.
Disposal
5.1.16
Management must inform ERMA New Zealand as soon as there is no
longer a requirement to hold any POP standards and arrange for
environmentally sound disposal.
5.1.17
Standard solutions should be disposed of in hazardous solvent waste
drums.
Breach of containment
5.1.18
If a breach in containment occurs, Manager-Chemistry &
Pharmaceutical services shall notify OSH & ERMA New Zealand
within 24 hours of the breach being detected.
Spillage of POP standards
5.1.19
Wear PVC/rubber gloves, a full-face class P3 respirator or an air-line
respirator, coveralls, and apron & boots.
5.1.20
Ventilate and clear the area of all unprotected personnel.
5.1.21
Absorb with sand or similar, collect and place in sealable container for
disposal.
Stocktake
5.1.22
Every 6 months a stocktake shall be undertaken to ensure the POP
register is accurate.
Identification and Evaluation of the Significant Risks of the Substance
in Containment
5.2
Under the approval sought in this application, small amounts of persistent
organic pollutants are to be used as analytical standards or for research in a
laboratory. In accordance with sections 5, 6, and 8 and clauses 9 and 11, the
potential risks of these substances to the environment, human health and welfare,
and to Māori have been assessed.
Environmental and Human Health Risks
5.3
The project team notes that the risks associated with persistent organic pollutants
over their lifecycle are well understood, and are addressed in the Stockholm
Convention amendment made to the Act.
5.4
The project team has evaluated the adequacy of the management plan proposed
by the applicant and taken into account the small quantities of substances
involved and the controls listed in Appendix 1. The project team considers that
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these meet the conditions of Part III of the Third Schedule of the Act as required
under section 32(2)(a), to:
 limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances;
 exclude organisms from a facility;
 exclude unauthorized people from the facility;
 prevent unintended release of the substances by experimenters working with
the substances;
 control the effects of any accidental release of the substances; and
 specify inspection and monitoring requirements.
Māori issues and concerns
5.5
The project team has 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 Act 1996”.
6
7
5.6
The project team considers that the substance is unlikely to have an impact on
the relationship of Māori and their culture and 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 controls in
Appendix 1, and in accordance with any other relevant controls applied under
other legislation.
5.7
It is suggested that if a breach in containment results in contamination of a
waterway, the relevant iwi authorities be advised.
Controls
6.1
As provided for in section 32(2)(b), the project team has also included in
Appendix 1 further controls that provide for other matters not addressed by Part
III of the Third Schedule of the Act, in order to give effect to the purpose of the
Act.
6.2
The project team is satisfied that, with adherence to the controls listed in
Appendix 1 and those controls in place under other legislation, the POPs can be
adequately contained.
Decision
7.1
I have considered this application under section 31 to import into or manufacture
in containment POP Standards, NZ Laboratory Services Ltd, Auckland Site,
2007, and pursuant to section 32, and am satisfied that this application is for the
purpose specified in sections 30(a)(ii) and (ba) as required by section 25A.
7.2
Having considered the risks associated with the lifecycle of these POPs, I am
satisfied that the controls imposed, including those in place under other
legislation, will result in the substance being adequately contained.
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7.3
In accordance with clause 36(2)(b) of the Methodology, I record that in reaching
this conclusion, I have applied the criteria specified in section 32 of the Act.
7.4
I have also applied the following criteria in the Methodology:
 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.
7.5
The application to import into or manufacture in containment POP Standards,
NZ Laboratory Services Ltd, Auckland Site, 2007 is thus approved with controls
as set out in Appendix 1.
Rob Forlong
Chief Executive, ERMA New Zealand
Date: 23 November 2007
POP Standards, NZ Laboratory Services Ltd, Auckland Site, 2007
ERMA New Zealand Approval Code: HSC000297
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APPENDIX 1: CONTROLS APPLYING TO THE USE
OF POPS AS ANALYTICAL STANDARDS OR FOR
RESEARCH IN A LABORATORY
Interpretation
1.
Persistent organic pollutant (POP), Laboratory and Stockholm Convention have
the meanings given in section 2 of the Hazardous Substances and New Organisms Act
(the Act).
2.
Passenger service vehicle has the same meaning as in the Transport Services Licensing
Act 1989.
3.
Environmentally sound disposal, in relation to a substance that is a persistent organic
pollutant, means disposal in accordance with directions given by the Authority in the
New Zealand Gazette Issue no 174, 22 December 2004, Hazardous Substances (Storage
and Disposal of POPs) Notice 2004. Disposal in an environmentally sound manner has
the same meaning as environmentally sound disposal.
General
4.
This approval applies only to POPs approved in accordance with section 32 of the Act
for use as analytical standards or for research in a laboratory.
5.
The use of POPs as analytical standards or for research in a laboratory shall comply
with the requirements of the Emergency Response Plan submitted by the applicant as
part of the application under section 31 of the Act, along with the controls imposed by
the Authority below.
6.
A laboratory that has approval to import or manufacture a POP under section 32 of the
Act shall not sell, gift or otherwise transfer the substance to another laboratory that does
not have an approval under section 32 of the Act for those substances, and, unless
otherwise authorised by the Authority, shall not transfer the substance to any other
person unless such transfer is for the purpose of environmentally sound disposal.
7.
This approval expires five years from date of approval.
8.
There must be compliance with the requirements of the Hazardous Substance (Exempt
Laboratories) Regulations 2001.
Limiting the likelihood of escape of or contamination by a POP
9.
A POP shall be transported only to a laboratory that has approval to import or
manufacture it. A Safety Data Sheet shall accompany each shipment.
10.
A POP shall be packaged for transportation in a container within a container (secondary
containment) and that secondary container shall be sufficient to contain any release if
the primary container should leak. The containers shall comply with the Hazardous
Substances (Packaging) Regulations 2001 or Regulation 12 of the Hazardous
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Substances (Exempt Laboratories) Regulations 2001 as relevant. Outer packages
should be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001.
11.
Transport of POPs by land within New Zealand shall comply with all relevant
requirements of the Land Transport Rule: Dangerous Goods 1999 (Rule 45001).
12.
Transport of POPs by sea within New Zealand shall comply with all relevant
requirements of either the Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous
Goods (MR024A) or the International Maritime Dangerous Goods Code.
13.
Transport of POPs by air within New Zealand shall comply with all relevant
requirements of Part 92 of the Civil Aviation Rules.
14.
Within the laboratory, all POPs shall be stored, handled and labelled in accordance with
Regulation 10 of the Hazardous Substances (Exempt Laboratories) Regulations 2001.
15.
A person must not carry any quantity of a POP on a passenger service vehicle.
To exclude organisms from the facility
16.
The laboratory manager shall at all times ensure that the laboratory is adequately
secured so as to exclude unwanted organisms and shall monitor for their presence as
appropriate.
To exclude unauthorised people from the facility
17.
The laboratory manager shall at all times exclude unauthorised persons from the
laboratory in accordance with Regulation 8 of the Hazardous Substances (Exempt
Laboratories) Regulations 2001.
To prevent unintended release of a persistent organic pollutant from the
facility
18.
The design of the laboratory must comply with Regulations 5 to 8 of the Hazardous
Substances (Exempt Laboratories) Regulations 2001.
19.
Procedures must be in place to ensure that no person in the facility is exposed to a level
of POPs that may cause harm to that person.
20.
At all times a POP shall be prevented from entering any surface water or groundwater
system.
To control the effects of any accidental release of a persistent organic
pollutant
21.
Breach of Containment
All laboratories must have an emergency response plan, irrespective of the quantities of
hazardous substance present. The plan must meet the requirements of Part 4 of the
Hazardous Substances (Emergency Management) Regulations 2001. The laboratory
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manager must ensure that all other relevant requirements of the Emergency
Management Regulations are complied with at all times.
22.
23.
24.
25.
If for any reason a breach of containment occurs, the laboratory manager shall notify
OSH and ERMA New Zealand within 24 hours of the breach being detected.
Disposal
The laboratory manager must inform ERMA New Zealand as soon as there is no longer
a requirement to hold any POP for the approved purposes. The approval holder may at
this time—
 request approval to transfer the substance to another laboratory within New Zealand
that at the time also holds approval for the same purposes. The request shall
identify the laboratory and the relevant HSNO approval number, the substance or
substances to be transferred and their amounts; or
 request approval to transfer the POPs to an overseas laboratory in accordance with
any relevant requirements of relevant international Conventions to which
New Zealand is a party; or
 arrange for environmentally sound disposal.
Environmentally sound disposal
Upon cessation of the requirement to hold any POP for the approved purposes, or upon
expiry of this containment approval, if not transferring the substance in accordance with
Paragraph 23, the substance must be disposed of in accordance with directions for
environmentally sound disposal given by the Authority by notice in the New Zealand
Gazette Issue no 174, 22 December 2004, Hazardous Substances (Storage and Disposal
of POPs) Notice 2004.
Environmentally sound disposal also applies to anything that contains a POP
following—
 treatment of any equipment used to contain a POP; or
 treatment of any spillage of a POP
Recording, inspection and monitoring requirements
26.
A record shall be kept of the quantities of POPs held in the laboratory. The record must
be kept for at least 12 months after the substance has been used up or removed from the
laboratory.
27.
Each time a POP is imported or manufactured, the laboratory shall notify ERMA
New Zealand in writing of the quantities and nature of the substance(s) concerned.
28.
The Authority, or its authorised agent or properly authorised enforcement officers, may
inspect the laboratory at any reasonable time under section 108 of the Act.
Qualifications required of the person responsible for implementing the
controls
29.
The laboratory must be managed by a laboratory manager with relevant qualifications,
skills and knowledge, in accordance with Regulations 13 and 14 of the Hazardous
Substances (Exempt Laboratories) Regulations 2001.
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30.
All personnel handling any POP must be provided with all relevant information about
the POPs they are handling, as prescribed by Regulation 15 of the Hazardous
Substances (Exempt Laboratories) Regulations 2001.
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