ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
16 August 2007
Application code:
HSR05111
Application Type
To import or manufacture any hazardous substance under
Section 28A(2)(b) of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant:
Donaghys Industries Ltd
Purpose of the Application
FoliActive - to manufacture and release this viticulture foliar
spray for vine condition and control of common fungal
disease such as Powdery Mildew and Botrytis (low hazard)
Date application received:
13 April 2007
Consideration Date
16 August 2007
Considered by
Rob Forlong (Chief Executive, ERMA New Zealand)
1 Summary of decision
1.1
The application to import or manufacture FoliActive for release is approved with the
controls as set out in Appendix 1. This approval has been given in accordance with the
relevant provisions of the Act, the relevant HSNO Regulations, and the HSNO
(Methodology) Order 1998 (“the Methodology”), based on FoliActive being
formulated so that the substance has one or more hazardous properties and each
hazardous property has the least degree of hazard for that property.
1.2
The substance has been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
FoliActive
2 Legislative criteria for the application
2.1
The application was lodged pursuant to section 28. The decision was determined in
accordance with section 28A(2)(b), taking into account the requirements of that
section and matters specified under Part II 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 purpose of this application is to gain approval to import or manufacture
FoliActive as viticulture foliar spray for vine condition and control of common fungal
disease such as Powdery Mildew and Botrytis.
3.2
3.3
The application was formally received on 13 April 2007.
3.2.1
The application timeframe was extended by 48 working days as the result of a
request under section 58 for further time to process the volume of
information provided with the application.
3.2.2
The application timeframe was again extended by 30 working days under
section 58 to process further information.
The Agricultural Compounds & Veterinary Medicines Group (ACVMG) of the
New Zealand Food Safety Authority (NZFSA), the Ministry of Health, the
Department of Labour Workplace Group and the Department of Conservation 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
Sekove Tinalevu
Peter Dawson
3.5
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Principal Scientist (Hazardous Substances).
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)(d).
4 Consideration
Sequence of the consideration
4.1
Donaghys Industries Ltd seeks approval, under section 28, to import or manufacture
FoliActive for release in New Zealand.
4.2
An application can be assessed by rapid assessment procedures, under section
28A(2)(b), if it can be shown that FoliActive has one or more hazardous properties
and each hazardous property has the least degree of hazard for that property.
4.3
The approach adopted when considering this application was:
 to review the information provided;
 to identify the composition and hazardous properties of the proposed
substance, FoliActive;
 to determine whether FoliActive has one or more hazardous properties
and each hazardous property has the least degree of hazard for that
property.
4.4
And then:
 to consider whether there are any effects that mean FoliActive should not
be approved under section 28A; and
 to consider whether the controls that apply under the Act will prevent or
manage the adverse effects of FoliActive.
Environmental Risk Management Authority Decision: Application HSR05111
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Information review
4.5
The project team has reviewed the information supplied by Donaghys Industries 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 FoliActive (clauses 29 and 30).
Identification and use of FoliActive
4.6
FoliActive will be manufactured in New Zealand, made to order to lessen the risk of
overproduction and decrease the likelihood of wastage. The product is to be stored on
site until its dispatch via courier to various horticultural merchants and vineyards in
New Zealand.
4.7
FoliActive is a water-based product intended for use in vineyards as part of a normal
spray calendar for fungal pathogens and as a foliar fertiliser giving vines a low residue
boost throughout the growth cycle. The active ingredient is a bacteria naturally
occurring in the environment.
Hazardous properties of FoliActive
4.8
The project team has determined the hazard profile of FoliActive based on the
information provided by the applicant and other available information. The hazard
classifications for FoliActive are set out in Table 4.1.
Table 4.1: Hazard classifications
Hazardous Property
Eye irritancy
Biocidal use
Classification
6.4A
9.1D
Meeting the criteria for rapid assessment under section 28A(2)(b)
4.9
Based on the information presented in Table 4.1 the project team considers that the
criteria for rapid assessment under section 28A(2)(b) have been met in that FoliActive
has been classified as an eye irritant (6.4A) and a biocide (9.1D) and both of these
classifications are the least degree of hazard for that property.
4.10
The project team considers that there are no other matters which would prevent this
application for FoliActive from being rapidly assessed.
5 Controls and Risk Assessment
Default controls
5.1
Based on the hazard classifications determined for FoliActive, a set of associated
default controls has been identified by the project team as being applicable to the
substance. These default controls, expressed as control codes1, are listed in Table 5.1.
1 Control codes are those assigned by ERMA NZ to enable easy cross reference with the regulations. A
detailed list of these codes is contained in the ERMA New Zealand User Guide to the Controls Regulations.
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5.2
Section 77 provides for the variation of default controls. These are considered in
Paragraph 5.11 below.
5.3
Additional controls under section 77A are available to manage the risks associated with
FoliActive, which are not addressed by the default controls. These are considered in
Paragraph 5.9 below.
5.4
The following controls are not considered relevant to FoliActive and have therefore
not been listed as default controls:
5.4.1
Control T1 relates to limiting exposure to toxic substances through the
setting of Tolerable Exposure Limits (TELs). The project team notes that
regulation 111 requires an acceptable daily exposure value or RfD value to be
set for class 6 substances. However, given that the class 6 hazard
classification conferred on FoliActive is 6.4A (eye irritancy), which is not
considered to be an ‘appreciable toxic effect’, the project team considers that
this control does not apply to FoliActive under clause 11(1)(c)1 and has
therefore not been listed as a default control for FoliActive.
5.4.2
Control T2 relates to the requirement to set Workplace Exposure Standards
(WESs). The project team notes that the adverse effect of FoliActive on
humans is not produced by the inhalation or dermal exposure routes and
notes, furthermore, that the toxicological data is not sufficient to enable a
WES to be set. The project team therefore considers that this control does
not apply to FoliActive under clauses 29(1)(b)1 and (c)1 and therefore has not
been listed as a default control for FoliActive.
Table 5.1: List of default controls for FoliActive.
Toxicity Controls
T4
Requirements for equipment used to handle substances
T7
Restrictions on the carriage of toxic or corrosive substances on passenger service
vehicles
Ecotoxicity Controls
E1
Limiting exposure to ecotoxic substances through the setting of EELs
E2
Restrictions on use of substances in application areas
E6
Requirements for equipment used to handle substances
Identification Controls
I1
Identification requirements, duties of persons in charge, accessibility,
comprehensibility, clarity and durability
I9
Secondary identifiers for all hazardous substances
I11
Secondary identifiers for ecotoxic substances
I16
Secondary identifiers for toxic substances
I19
Additional information requirements, including situations where substances are in
multiple packaging
I21
General documentation requirements
I28
Specific documentation requirements for toxic substances
I29
Signage requirements
Packaging Controls
P1
General packaging requirements
P3
Criteria that allow substances to be packaged to a standard not meeting Packing
1
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
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Group I, II or III criteria
P13
Packaging requirements for toxic substances
PS4
Packaging requirements as specified in Schedule 4
Disposal Controls
D4
Disposal requirements for toxic and corrosive substances
D5
Disposal requirements for ecotoxic substances
D6
Disposal requirements for packages
D7
Information requirements for manufacturers, importers and suppliers, and persons
in charge
D8
Documentation requirements for manufacturers, importers and suppliers, and
persons in charge
Emergency Management Controls
EM1
Level 1 information requirements for suppliers and persons in charge
EM6
Information requirements for toxic substances
EM7
Information requirements for ecotoxic substances
EM8
Level 2 information requirements for suppliers and persons in charge
EM11
Level 3 emergency management requirements: duties of person in charge,
emergency response plans
EM12
Level 3 emergency management requirements: secondary containment
EM13
Level 3 emergency management requirements: signage
Assessment of the adverse effects
5.5
The project team has carried out a qualitative risk assessment to assess the adverse
effects to human health and the environment (refer Appendix 2 for qualitative
descriptors of risk).
Assessment of adverse effects to human health
5.6
With respect to human health hazards, FoliActive is classified as an eye irritant (6.4A).
The project team considers the risks to human health arising from the irritancy hazard
presented by FoliActive to be negligible. This assessment is based on the following
considerations.
5.6.1
The project team considers it is highly improbable, given adherence to
HSNO controls (e.g. packaging, identification, emergency management and
disposal) and the Health and Safety in Employment Act 1992, that exposure
to FoliActive at any stage of its lifecycle will result in adverse effects on
people.
5.6.2
The project team considers that if exposure were to occur, the magnitude of
any adverse effect will be minimal as the effect would be limited to the
exposed individuals and be of a relatively short term and mild in nature.
Assessment of adverse environmental effects
5.7
FoliActive is also classified as a biocide (9.1D). The project team notes that the 9.1D
biocidal classification assigned to FoliActive was on the basis of its ability to suppress
fungal pathogens. The project team also notes that the active ingredient is a naturally
occurring bacterium in soil and therefore considers it not necessary to conduct a
quantitative environmental exposure assessment to estimate the level of risk resulting
from the intended use of FoliActive, as it is unlikely that the use of the product will
pose a high acute aquatic risk.
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5.8
A qualitative risk assessment was not carried out by the project team given that the
9.1D hazard classification was conferred on FoliActive on the basis of its biocidal
activity against its intended target pest and not based on any adverse effect to the
environment.
Additional controls under section 77A
5.9
5.10
Under section 77A, the Authority may impose as controls any obligations and
restrictions that the Authority thinks fit. Before imposing a control under this section,
the Authority must be satisfied that, against any other specified controls applying to
Unite and Tenet:
(a) the proposed control is more effective in terms of its effect on the management,
use and risks of hazardous substances; or
(b) the proposed control is more cost-effective in terms of its effect on the
management, use and risks of hazardous substances; or
(c) the proposed control is more likely to achieve its purpose.
The following additional controls have been proposed for FoliActive by the project
team:
5.10.1
The project team notes that, unless specifically allowed for, pesticides should
not be applied into or onto water, where water means water in all its physical
forms, whether flowing or not, and whether over or under ground, but does
not include water in any form while in a pipe, tank or cistern. As the default
controls do not prohibit such use, the project team considers that the
following control should be applied to FoliActive as being more effective in
terms of its effect on the use of the substance:
FoliActive shall not be applied directly onto or into water
5.10.2
The project team notes that the default controls do not address the risks
associated with stationary container systems. Accordingly, the project team
considers that the application of a control addressing these risks will be more
effective than the specified (default) controls in terms of their effect on the
management, use and risks of the substance. Such controls were applied to
pesticides on transfer to the HSNO regime. The project team considers that
this control is similarly appropriate for the management of the risks
associated with FoliActive and proposes that the following controls should
be applied to the substance:
The controls relating to stationary container systems, as set out in Schedule 8 of the
Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer
Notice 2004 (Supplement to the New Zealand Gazette, 26 March 2004, No. 35, page
767), as amended, shall apply to this substance, notwithstanding clause 1(1) of that
schedule
Variation of controls under section 77
5.11
Under section 77, the default controls triggered for the substance may be varied.
Under section 77(3), controls may be substituted or added, under section 77(4),
controls may be substituted or deleted; and under section 77(5), where a substance
triggers more than one hazard classification, controls may be combined.
5.12
The following variations have been proposed for FoliActive by the project team:
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5.13
5.12.1
Control E1 relates to limiting exposure to ecotoxic substances through the
setting of Environmental Exposure Limits (EELs). The project team notes
that the active ingredient is a biological agent that naturally occurs in the soil
environment, which would render setting an EELsoil unfeasible. Furthermore,
this control has been triggered by the 9.1D hazard classification conferred
based on FoliActive’s use as a biocide and not based on any adverse effect it
would have on the aquatic environment. The project team therefore
considers that control E1 can be deleted for FoliActive.
5.12.2
Control E2 relates to restrictions on use within an application area when an
EEL has been set. As control E2 is linked to the setting of EELs (control
E1) and control E1 can be deleted, the project team considers that control
E2 can be deleted for FoliActive.
5.12.3
The Agency considers that the following controls may be combined under
section 77(5) for FoliActive as they relate to the same requirements:
 T4 and E6 (equipment used to handle hazardous substances)
 D4 and D5 (disposal requirements).
The modifications to controls for FoliActive, as above, have been incorporated into
the list of controls for FoliActive detailed in Appendix 1.
6 Environmental user charges
6.1
The project team considers that use of controls on FoliActive is an effective means of
managing risks associated with this substance. At this time, no consideration has been
given to whether or not environmental user charges should be applied to this
substance as an alternative or additional means of achieving effective risk
management. Accordingly, no report has been made to the Minister for the
Environment.
7 Decision
7.1
Pursuant to section 28A, I have considered this application to import or manufacture a
hazardous substance for release made under section 28.
7.2
Having considered the composition, hazardous properties and use for FoliActive, I am
satisfied that the proposed substances meet the criteria for rapid assessment under
section 28A(2)(b) in that it has one or more hazardous properties and each hazardous
property has the least degree of hazard for that property.
7.3
Because the risks posed by FoliActive are negligible, I consider that applying the
HSNO default controls to FoliActive, with the additions and amendments proposed
under paragraphs 5.9 to 5.11 (inclusive), will ensure adequate management of any
adverse effects of FoliActive.
7.4
In this consideration, I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 12 – risk assessment;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques;
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 clause 25 – the evaluation of risks; and
 clause 35 – the costs and benefits of varying the default controls.
7.5
The application for importation and manufacture of the hazardous substance,
FoliActive for release is thus approved with controls as detailed in Appendix 1.
Rob Forlong
Chief Executive, ERMA New Zealand
ERMA New Zealand Approval Code:
FoliActive
Environmental Risk Management Authority Decision: Application HSR05111
Date: 16 August 2007
HSR007829
Page 8 of 16
Appendix 1: Controls applying to FoliActive
The controls imposed on FoliActive are as follows. The regulations cited should be referred to for
definitions and exemptions. The ERMA New Zealand publication User Guide to Control Regulations
provides useful guidance on the controls.
Table A1.1: Controls for FoliActive – codes, regulations and variations
Control Regulation2 Topic
Variations
Code1
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls
Controls T4 and E6 are combined.
T4/E6
7
Requirements for equipment used
to handle hazardous substances
T7
10
Restrictions on the carriage of
hazardous substances on passenger
service vehicles
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35,
General identification requirements
36 (1)-(7)
Regulation 6 – Identification duties of
suppliers
Regulation 7 – Identification duties of
persons in charge
Regulations 32 and 33 – Accessibility
of information
Regulations 34, 35, 36(1)-(7) –
Comprehensibility, Clarity and
Durability of information
I9
18
I11
20
I16
25
I19
29-31
Secondary identifiers for all
hazardous substances
Secondary identifiers for ecotoxic
substances
Secondary identifiers for toxic
substances
Alternative information in certain
cases
Regulation 29 – Substances in fixed
bulk containers or bulk transport
containers
Regulation 30 – Substances in multiple
packaging
Regulation 31 – Alternative
information when substances are
imported
I21
37-39, 47-50
Documentation required in places
of work
Regulation 37 – Documentation duties
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
2 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and
exemptions. The accompanying explanation is intended for guidance only.
1
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of suppliers
Regulation 38 – Documentation duties
of persons in charge of places of work
Regulation 39 – General content
requirements for documentation
Regulation 47 – Information not
included in approval
Regulation 48 – Location and
presentation requirements for
documentation
Regulation 49 – Documentation
requirements for vehicles
Regulation 50 – Documentation to be
supplied on request
I28
46
Specific documentation
requirements for toxic substances
I29
51-52
Duties of persons in charge of
places with respect to signage.
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
P3
9
Criteria that allow substances to be
packaged to a standard not meeting
Packing Group I, II or III criteria
P13
19
Packaging requirements for
FoliActive
PS4
Schedule 4
This schedule describes the
minimum packaging requirements
that must be complied with for
FoliActive when packed in limited
quantities.
Hazardous Substances (Disposal) Regulations 2001
Controls D4 and D5 are combined.
D4
8
Disposal requirements for
D5
9
FoliActive
D6
10
Disposal requirements for packages
D7
11, 12
Disposal information requirements
D8
13, 14
Disposal documentation
requirements
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management
information: General requirements
EM6
8(e)
Information requirements for toxic
substances
EM7
8(f)
Information requirements for
ecotoxic substances
EM8
12-16, 18-20 Level 2 emergency management
documentation requirements
EM11
25-34
Level 3 emergency management
requirements – emergency
response plans
EM12
35-41
Level 3 emergency management
requirements – secondary
containment
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EM13
42
Level 3 emergency management
requirements – signage
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
The Hazardous Substances (Tank Wagons and Transportable Containers)
where applicable
Regulations 2004 prescribe a number of controls relating to tank wagons and
transportable containers and must be complied with as relevant.
Section 77A Additional Controls
The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous Substances
(Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New
Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, are proposed for these substances,
notwithstanding clause 1(1) of that schedule
FoliActive shall not be applied directly onto or into water
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Appendix 2: Scales for qualitative risk assessment
Qualitative descriptors are indicative only and they are primarily intended to be used to rank risks
and benefits for the purposes of balancing risks and costs against benefits, and so that risks can be
prioritised for management. The ‘descriptor’ words should not be seen in any absolute senses – they
are simply a means of differentiating levels of significance.
Assessing risks, costs and benefits qualitatively
This section describes how the Agency staff and the Authority address the qualitative assessment of
risks, costs and benefits.
Risks and benefits are assessed by estimating the magnitude and nature of the possible effects and
the likelihood of their occurrence. For each effect, the combination of these two components
determines the level of the risk associated with that effect, which is a two dimensional concept.
Because of a lack of data, risks are often presented as singular results. In reality, they are better
represented by ‘families’ of data which link probability with different levels of outcome (magnitude).
Describing the magnitude of effect
The magnitude of effect is described in terms of the element that might be affected. The qualitative
descriptors for magnitude of effect are surrogate measures that should be used to gauge the end
effect or the ‘what if’ element.
Tables A2.1 and A2.2 contain generic descriptors for magnitude of adverse and beneficial effect.
These descriptors are examples only, and their generic nature means that it may be difficult to use
them in some particular circumstances. They are included here to illustrate how qualitative tables
may be used to represent levels of adverse and beneficial effect.
The sample qualitative descriptors for effects on the market economy listed in the ERMA New
Zealand technical guide to decision making1 include representative numbers. These ‘economic’
descriptors were developed prior to the publication of the technical guide on identification and
assessment of effects on the market economy,2 which refines the approach that ERMA New
Zealand applies to identifying and assessing economic effects. These numbers do not align well
with the qualitative descriptors in the other categories (effects on the environment, effects on
human health, and effects on society and communities), as they relate more to an event than an
effect. In particular the numbers are unclear about how they take account of time (are they annual,
or over the life of the activity) and they do not have a local, regional or national context.
ERMA New Zealand has adopted a revised set of qualitative descriptors for the magnitude of effect
on the market economy, as shown over the page.
1
2
ERMA New Zealand. 2004. Decision Making: A Technical Guide to Identifying, Assessing and Evaluating Risks, Costs and
Benefits, ER-TG-05-01. Wellington: Environmental Risk Management Authority.
ERMA New Zealand. 2005. Assessment of Economic Risks, Costs and Benefits: Consideration of Impacts on the Market
Economy, ER-TG-06-01. Wellington: Environmental Risk Management Authority.
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Table A2.1: Magnitude of adverse effect (risks and costs).
Descriptor Examples of descriptions: ADVERSE
Minimal
Mild reversible short term adverse health effects to individuals in highly localised area
Highly localised and contained environmental impact, affecting a few (less than ten) individuals
members of communities of flora or fauna, no discernible ecosystem impact
Local/regional short-term adverse economic effects on small organisations (businesses, individuals),
temporary job losses
No social disruption
Minor
Mild reversible short term adverse health effects to identified and isolated groups
Localised and contained reversible environmental impact, some local plant or animal com munities
temporarily damaged, no discernible ecosystem impact or species damage
Regional adverse economic effects on small organisations (businesses, individuals) lasting less than six
months, temporary job losses
Potential social disruption (community placed on alert)
Moderate
Minor irreversible health effects to individuals and/or reversible medium term adverse health effects to
larger (but surrounding) community (requiring hospitalisation)
Measurable long term damage to local plant and animal communities, but no obvious spread beyond
defined boundaries, medium term individual ecosystem damage, no species damage
Medium term (one to five years) regional adverse economic effects with some national implications,
medium term job losses
Some social disruption (e.g. people delayed)
Major
Significant irreversible adverse health effects affecting individuals and requiring hospitalisation and/or
reversible adverse health effects reaching beyond the immediate community
Long term/irreversible damage to localised ecosystem but no species loss
Measurable adverse effect on GDP, some long term (more than five years) job losses
Social disruption to surrounding community, including some evacuations
Massive
Significant irreversible adverse health effects reaching beyond the immediate community and/or deaths
Extensive irreversible ecosystem damage, including species loss
Significant on-going adverse effect on GDP, long term job losses on a national basis
Major social disruption with entire surrounding area evacuated and impacts on wider community
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Table A2.2: Magnitude of beneficial effect (benefits).
Descriptor Examples of descriptions: BENEFICIAL
Minimal
Mild short term positive health effects to individuals in highly localised area
Highly localised and contained environmental impact, affecting a few (less than ten) individuals
members of communities of flora or fauna, no discernible ecosystem impact
Local/regional short-term beneficial economic effects on small organisations (businesses, individuals),
temporary job creation
No social effect
Minor
Mild short term beneficial health effects to identified and isolated groups
Localised and contained beneficial environmental impact, no discernible ecosystem impact
Regional beneficial economic effects on small organisations (businesses, individuals) lasting less than six
months, temporary job creation
Minor localised community benefit
Moderate
Minor health benefits to individuals and/or medium term health impacts on larger (but surrounding)
community and health status groups
Measurable benefit to localised plant and animal communities expected to pertain to medium term.
Medium term (one to five years) regional beneficial economic effects with some national implications,
medium term job creation
Local community and some individuals beyond immediate community receive social benefit.
Major
Significant beneficial health effects to localised community and specific groups in wider community
Long term benefit to localised ecosystem(s)
Measurable beneficial effect on GDP, some long term (more than five years) job creation
Substantial social benefit to surrounding community, and individuals in wider community.
Massive
Significant long term beneficial health effects to the wider community
Long term, wide spread benefits to species and/or ecosystems
Significant on-going effect beneficial on GDP, long term job creation on a national basis
Major social benefit affecting wider community
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Determining the likelihood of the end effect
Likelihood in this context applies to the composite likelihood of the end effect, and not either to the
initiating event, or any one of the intermediary events. It includes:
 the concept of an initiating event (triggering the hazard), and
 the exposure pathway that links the source (hazard) and the area of impact (public health,
environment, economy, or community).
Thus, the likelihood is the likelihood of the specified adverse effect1 resulting from that initiating
event. It will be a combination of the likelihood of the initiating event and several intermediary
likelihoods2. The best way to determine the likelihood is to specify and analyse the complete
pathway from source to impact.
Likelihood may be expressed as a frequency or a probability. While frequency is often expressed as
a number of events within a given time period, it may also be expressed as the number of events per
head of (exposed) population. As a probability, the likelihood is dimensionless and refers to the
number of events of interest divided by the total number of events (range 0–1). (See Table A2.3.)
Table A2.3: Likelihood.
Descriptor
Description
1
Highly improbable Almost certainly not occurring but cannot be totally ruled out
2
Improbable
(remote)
Only occurring in very exceptional circumstances.
3
Very unlikely
Considered only to occur in very unusual circumstances
4
Unlikely
(occasional)
Could occur, but is not expected to occur under normal operating conditions.
5
Likely
A good chance that it may occur under normal operating conditions.
6
Very likely
Expected to occur if all conditions met
7
Extremely likely
Almost certain
1
2
The specified effect refers to scenarios established in order to establish the representative risk, and may be as
specific as x people suffering adverse health effects, or y% of a bird population being adversely affected. The risks
included in the analysis may be those related to a single scenario, or may be defined as a combination of several
scenarios.
Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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Using magnitude and likelihood to construct the level of risk and benefit
Using the magnitude and likelihood tables a matrix representing a level of effect can be constructed
(Table A2.4).
Table A2.4: Level of risk.
Magnitude of effect
Likelihood
Minimal
Minor
Moderate
Major
Massive
Highly improbable
A
A
B
C
D
Improbable
A
B
C
D
E
Very unlikely
B
C
D
E
E
Unlikely
C
D
E
E
F
Likely
D
E
E
F
F
Very likely
E
E
F
F
F
Extremely likely
E
F
F
F
F
The Agency considers that, for this substance, the level of risk/benefit can be assigned as follows in
Table A2.5.
Table A2.5: Assignment of level of risk/benefit.
Code
Level of risk/benefit
A&B
Negligible
C
Low
D
Medium
E
High
F
Extreme
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