HRE08001
Hazardous Substances Consideration Committee
TOPIC: Consideration of Application for the Modified Reassessment of
“Ethaneperoxoic Acid, < 5% Acetic Acid and Hydrogen
Peroxide”
Introduction
1
Jaegar Australia Pty Ltd is seeking the modified reassessment of the substance identified
as “ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide”. The substance was
approved under the Hazardous Substances and New Organisms Act 1996 (“the Act”) via
the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer
Notice 2004 (as amended) and has the HSNO Approval Number of HSR001479.
2
Clause 6 of the Transfer Notice states that:
“No person may use a hazardous substance described in Schedules 1 and 2 to this notice
as a pesticide or a veterinary medicine.”
3
The proposed modification relates to the removal of this restriction on the use of the
substance as a pesticide.
4
The applicant intends that the substance will be used as a fungicide to control Botrytis on
grapevines.
Legislative Criteria for the Application
5
Unless otherwise stated, references to section numbers in this report refer to sections of
the Act and clauses to clauses of the Hazardous Substances and New Organisms
(Methodology) Order 1998 (“the Methodology”).
6
In its decision dated 20 May 2008 (Application Number: RES08001), the Authority
determined that the proposed use of the substance as a pesticide is a significant change
of use and therefore constitutes grounds for its reassessment (section 62(2)(c)).
Consequently, the applicant is able to make an application for the modified reassessment
of the substance.
7
The application was lodged on 15 August 2008 in accordance with section 63A on the
basis that─
(a)
(b)
a reassessment of the hazardous substance under section 63 is not appropriate
because the reassessment will involve only a specific aspect of the approval (i.e.
the restriction on the substances use as a pesticide); and
the amendment is not a minor or technical amendment to which section 67A
applies (i.e. a change is use is not considered a minor or technical amendment).
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
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8
9
The Authority may approve or decline an application for reassessment under this section,
as it considers appropriate, after taking into account (see section 63A(6)):
a)
all the effects associated with the reassessment; and
b)
the best international practices and standards for the safe management of
hazardous substances.
When making their decision, the Authority must follow the decision path outlined in
Appendix 1.
Notification and Consultation
10
The Minister for the Environment was advised of the application1 and given the
opportunity to “call-in” the application2. This action was not initiated.
11
The Department of Labour (Workplace Group), the New Zealand Food Safety Authority
(Agricultural Compounds and Veterinary Medicines (ACVM) Group) and the
Department of Conservation were identified as having a specific interest in the
application and were provided with a copy of the application (excluding the confidential
information but with the opportunity to access this if necessary).
11.1.
12
Other Government departments, Crown agencies and other interested parties, as listed in
Appendix 5, were provided with a copy of the application summary and given the
opportunity to comment or to make a submission.
12.1.
13
No comments or submissions were received.
No comments or submissions were received.
The application was publicly notified on the ERMA New Zealand website on 29 August
2008 and subsequently advertised in The Dominion Post, the New Zealand Herald, the
Christchurch Press and the Otago Daily Times3.
12.2.
No submissions were received.
AGENCY EVALUATION
14
To enable the Agency to consider all the effects associated with the proposed
reassessment, the Agency has undertaken an assessment of the risks, costs and benefits
associated with the proposed modification to the approval of the substance.
Risk Assessment
15
A “cost” is defined in Regulation 2 of the Methodology as “the value of a particular
adverse effect expressed in monetary or non-monetary terms”. Thus, these have been
assessed in an integrated fashion together with the risks of the adverse effects in the
following assessment.
16
As the proposed modification relates to a change in use of the substance, the Agency has
confined its risk assessment to the use phase of the substance’s lifecycle.
1
section 53(4)(a)
section 68
3
section 53
2
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17
In accordance with sections 5 and 6 and clauses 9 and 12, the Agency has assessed the
potentially non-negligible risks of the change in use of this substance in terms of risks to
the environment, to human health and safety, to the relationship of Māori to the
environment, to society and the community, to the market economy, and to New
Zealand’s international obligations.
Assessment of the risks to the environment
18
The Agency has classified “ethaneperoxoic acid, < 5% acetic acid and hydrogen
peroxide” as being very toxic to the aquatic environment (9.1A) and harmful to
terrestrial vertebrates (9.3C). Thus, a range of organisms in the environment may be
adversely affected if exposed to the substance.
19
In addition to its ecotoxic properties, the substance has been classified by the Agency as
being combustible (3.1D – low hazard). The Agency considers that there is potential for
damage to the environment to occur if the substance were to be ignited at any stage of its
lifecycle. However, the Agency considers that adherence to the HSNO controls on
flammable substances will ensure that the level of risk to the environment associated
with its flammable properties is negligible.
20
The Agency has undertaken quantitative modelling of the risks to the environment,
during the proposed use of the substance as a pesticide, using the GENEEC2 model.
This quantitative assessment of the risks to the aquatic environment shows that the use
of the substance presents an acute risk to the aquatic environment that can be mitigated
through restricted use (see Appendix 2). An estimation of the risk to the terrestrial
environment was unable to be made due to a lack of available toxicity data.
21
The Agency notes the results of the quantitative modelling and considers that application
of the following controls will reduce the level of risk to the environment to negligible:

the approved handler controls (triggered by the 9.1A classification). The Agency
considers that requiring people using the substance as a pesticide to be approved
handlers, will minimise the risks associated with exposure to the aquatic and
terrestrial environments;

prohibiting the application of the substance into or onto water;

restricting the method of application of the substance to ground-based methods
only; and

setting a maximum application rate, application frequency and minimum
application interval.
Assessment of the risks to human health and safety
22
The Agency has classified “ethaneperoxoic acid, < 5% acetic acid and hydrogen
peroxide” as being an acute oral and inhalation toxicant (6.1D), a skin corrosive (8.2B)
and eye corrosive (8.3A) and a target organ toxicant (6.9A).
23
The substance is also classified as presenting a low flammability hazard (3.1D) and thus
has the potential to cause minimal to major adverse health effects (ranging from smoke
inhalation to burns, for example). However, the Agency considers that adherence to the
HSNO controls on flammable substances will ensure that the level of risk to human
health associated with its flammable properties is negligible.
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24
The Agency did not carry out an assessment of risks to operator health using an exposure
model, because of the corrosive nature of the substance. In the case of ethaneperoxoic
acid, <5% in acetic acid and hydrogen peroxide, the substance is corrosive and personal
protective equipment is needed to address this hazard during mixing and loading.
Absorption of the active ingredients from dermal or inhalation exposure during spraying
of the material is unlikely due to the use of PPE to protect the operator from the
corrosive effects of the substance during mixing and loading or the irritant effects of the
diluted spray if it comes into contact with the body.
25
The Agency notes that PPE is triggered as a default control for ethaneperoxoic acid, <5%
in acetic acid and hydrogen peroxide as a result of its 6.1D, 8.2B, 8.3A and 6.9A
classifications.
26
The Agency also considers that workers entering crops following application of the
substance as a pesticide will also require PPE. Nevertheless, the Agency notes that the
active ingredients degrade rapidly in the environment and considers that PPE is only
likely to be needed for up to 48 hours after application.
27
The Agency has undertaken an assessment of the public health exposure and risk
associated with the use of the substance as a pesticide and concludes that aerial
application of the substance should be prohibited due to a concern that mist generated
while the substance is being used may cause harm to people in the vicinity (see
Appendix 2).
Relationship of Māori to the Environment
28
The Agency has considered this application in accordance with the clauses 9(b)(i) and
9(c)(iv) and sections 6(d) and 8. In addition, the framework contained in the ERMA
New Zealand user guide “Working with Māori under the HSNO Act 1996” has been
used to assess the effects of this application on the relationship of Māori to the
environment.
29
The Agency notes that the substance triggers a number of hazardous properties giving
rise to the potential for cultural risk including the deterioration of the mauri of taonga
flora and fauna species, the environment and the general health and well-being of
individuals and the community.
30
In addition, the introduction and use of this substance as a pesticide has the potential to
inhibit the ability of iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the
guardianship of waterways given the highly ecotoxic nature of the substance to aquatic
species, and potential risks to the mauri ora of human health under prolonged exposure
to this substance.
31
On considering the information outlined here and elsewhere in this report, the Agency
considers a minimal impact from the substance on the relationship of Māori and their
culture and traditions with their ancestral lands, water, sites, wāhi tapu, valued flora and
fauna and other taonga to be highly improbable. In addition there is no evidence to
suggest that the controlled use of the substance will breach the principles of the Treaty of
Waitangi.
32
The overall level of risk is therefore considered to be negligible assuming that the
substance will be handled, stored, transported, used, and disposed of, in accordance with
the explicitly stated default and additional controls proposed in this report, and any other
controls required by other legislation.
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33
However, the Agency notes that should inappropriate use, or accident, result in the
contamination of waterways or the environment generally, that users notify the
appropriate authorities including the relevant iwi authorities in that region. This action
should include advising them of the contamination and the measures taken to contain
and remediate.
Assessment of the risks to society and the community
34
There are not expected to be any significant adverse impacts on the social environment
with the controlled use of the substance as a pesticide, apart from the health effects and
environmental effects already discussed. Consequently, the Agency considers that this
aspect of potential risk need not be considered further.
Assessment of the risks to the market economy
35
Taking into account the level of risk to the environment and to human welfare, no
sources of additional risk have been identified that could result in an adverse economic
impact on a community.
36
The Agency notes that direct economic costs will be borne by the applicant and users of
the substance. The HSNO default controls intentionally do not manage direct economic
effects. These are for suppliers and users of the substance to address.
New Zealand’s international obligations
37
The Agency does not anticipate that the use of the substance as a pesticide will pose any
risks to New Zealand’s international obligations.
Assessment of Beneficial Effects
38
A “benefit” is defined in Regulation 2 of the Methodology as “the value of a particular
positive effect expressed in monetary or non-monetary terms”. Benefits that may arise
from any of the matters set out in clauses 9 and 11 were considered in terms of
clause 13.
39
The applicant claims that the proposed modification of the approval of the substance will
provide the following benefits:
40

At present there are few approved fungicides for use on mature grapes for the
control or suppression of botrytis in the period immediately before harvest, due to
unacceptable residues on the fruit, or the presence of disease strains resistant to
specific product chemistry. Allowing the use of the substance as a pesticide will
provide a new tool in the management of this damaging disease, thereby
increasing the potential yield of grapevines throughout New Zealand.

Increased profits and employment opportunities within Jaegar Australia Pty Ltd
and those involved in the distribution of the substance within New Zealand.
The Agency considers the economic and related benefits to be derived from the use of
the substance as a pesticide are potentially significant.
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Controls
41
As a result of the proposed modification to the approval of this substance, a number of
variations to the existing controls on the substance are necessary. Only those controls
that are affected by the proposed modification are discussed below. A full list of
controls and variations to the substance is provided in Appendix 4.
Setting of exposure limits and application rates
42
Control T1 relates to the requirement to limit public exposure to toxic substances by the
setting of Tolerable Exposure Limits (TELs), which are derived from Acceptable Daily
Exposure (ADE) values. The Agency is not proposing that any TEL values be set for the
substance at this time (see Appendix 3).
43
Control E1 relates to the requirements to limit exposure of non-target organisms in the
environment through the setting of Environmental Exposure Limits (EELs). It is
proposed that no EELs are set at this time for the substance and the default values are
deleted (see Appendix 3).
44
Control E2 relates to the requirement to set an application rate for a class 9 substance
that is to be sprayed on an area of land (or air or water) and for which an EEL has been
set. As no EEL has been proposed for the substance, the Agency is not able to propose
the setting of a maximum application rate under Regulation 48 of the Hazardous
Substances (Classes 6, 8, and 9 Controls) Regulations 2001. However, the Agency notes
that risk quotients derived from the environmental exposure modelling are above the
level of concern (refer Appendix 2). This indicates that the substance may cause adverse
environmental effects when used according to the specific parameters of the risk
assessment. The Agency, therefore, considers it appropriate to set a maximum
application rate under section 77A (see paragraph 45).
Proposed additions and modifications to controls
45
The Agency notes that the risk quotients derived from the quantitative modelling
indicate that restrictions on use are necessary to mitigate the risks to the environment
(refer Appendix 3). Accordingly, the Agency considers that the application of controls
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 (section
77A(4)(a)). Consequently, the following additional controls are proposed for the
substance to restrict the level of risk to the environment:
45.1.
When used as a pesticide, the maximum application rate for ethaneperoxoic
acid, < 5% acetic acid and hydrogen peroxide shall be 8625 g hydrogen
peroxide and 1725 g peracetic acid per ha, with a maximum application
frequency of 4 times per year and a minimum application interval of 7 days.
45.2.
When used as a pesticide, the method of application of ethaneperoxoic acid,
< 5% acetic acid and hydrogen peroxide shall be restricted to ground-based
methods only.
45.3.
Ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide shall not be
applied onto or into water.
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46.
Control E7 relates to requirements for ecotoxic substances to be under the control of an
approved handler. The Agency considers that this control should be applied to the
substance when it is being used as a pesticide. Accordingly, the Agency is proposing that
the following control be substituted for Regulation 9(1) of the Hazardous Substances
(Classes 6, 8, and 9 Controls) Regulations 2001:
46.1.
“(1). The substance must be under the personal control of an approved handler
when the substance is –
(a)
applied as a pesticide in a wide dispersive manner; or
(b)
used as a pesticide by a commercial contractor.”
Summary of controls
47.
The Agency has considered the controls imposed by the Authority in approvals given to
other pesticides under Part 5 of the Act as well as those transferred to the Act under the
Hazardous Substances (Pesticides) Transfer Notice 2004 (as amended) and considers
that the controls listed in Appendix 4 should apply to the substance.
Overall evaluation of risks, costs and benefits
48.
The Agency considers the risks of the substance to the environment and human health,
with the proposed controls in place, to be negligible.
49.
The Agency does not consider there to be significant risks to Māori cultural wellbeing,
society and the community, the market economy, or to New Zealand’s international
obligations associated with the modified reassessment.
50.
The Agency has taken the type and severity of the risks, and the characteristics of such
risks into account, and considers that the overall level of risk posed by the substance is
negligible.
51.
The Agency considers that there are benefits associated with the modified reassessment
of this substance as identified in paragraph 39 of this paper.
52.
Thus, the Agency considers that the benefits of the modified reassessment outweigh the
costs.
Best international practices and standards for the safe management of hazardous
substances
46
The requirement to consider best international practices and standards for the safe
management of hazardous substances is demonstrated by assessing the proposed
modified reassessment against:

the Globally Harmonised System of Classification and Labelling of Chemicals;

international codes of practice and standards;

overseas legislative requirements.
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Globally Harmonised System
47
The controls applied to the substance as a result of the modified reassessment are based
on the HSNO Regulations. These regulations specify a number of controls aimed at
managing the risk posed by hazardous substances throughout their lifecycle, such as the
requirement for protective clothing and provision of appropriate information, disposal
and emergency management requirements. These regulations have previously met the
requirements of section 141(1)(b) on best international practices and standards for the
safe management of hazardous substances. In particular, the Globally Harmonised
System of Classification and Labelling of Chemicals (GHS), published by the United
Nations, forms the basis of the HSNO hazard classification system and the requirements
for the provision of information on hazards.
International Codes of Practice and Standards
48
The transportation controls on the substance requiring the segregation of incompatible
substances are cross-references to the requirements of the Land Transport Rule, the
Maritime Rule and the Civil Aviation Rule, which are themselves based on the
International UN Transport of Dangerous Goods Model Regulations, the International
Maritime Dangerous Goods Code and the International Civil Aviation Organization
Regulations.
Overseas Legislative Requirements
49
The Agency notes that the substance is approved for use as a pesticide by a number of
overseas regulators, including the Australian Pesticides and Veterinary Medicines
Authority (APVMA). The controls proposed by the Agency are consistent with those
imposed by the APVMA.
Conclusions
50
Jaegar Australia Pty Ltd is seeking the modified reassessment of the substance identified
as “ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide” to allow its use as a
pesticide.
51
The Agency considers that there are negligible risks to the environment and human
health, with the proposed controls in place, and benefits associated with the modified
reassessment of the substance.
52
The Agency considers that the modified reassessment meets the requirements of best
international practices and standards for the safe management of hazardous substances.
53
The Agency considers that the application for the modified reassessment meets the
requirements of section 63A(6) and, therefore, may be approved in accordance with
clause 26.
54
The Agency considers that the controls listed in Appendix 4 should apply to
ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide.
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APPENDIX 1 DECISION PATH
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APPENDIX 2 RISK ASSESSMENT
Environmental exposure and risk assessment
For Class 9 substances, irrespective of the intrinsic hazard classification, the ecological risk
can be assessed for a substance by calculating a risk quotient based on an estimated exposure
concentration. Such calculations incorporate toxicity values, exposure scenarios (including
spray drift, application rates and frequencies), and the half lives of the component(s) in soil
and water. The calculations provide an Estimated Environmental Concentration (EEC) which,
when divided by the LC50 or EC50, gives a risk quotient (RQ).
Acute RQ =
EECshort term
LC50 or EC50
Chronic RQ = EEClong term
NOEC
If the RQ exceeds a predefined level of concern, this suggests that it may be appropriate to
refine the assessment or to apply the approved handler (AH1) control and/or other controls to
ensure that appropriate matters are taken into account to minimize off-site movement of the
substance. Conversely, if a worst-case scenario is used, and the level of concern is not
exceeded, then in terms of the environment, there is a presumption of low risk which is able to
be adequately managed by such things as label statements (warnings, disposal). The AH1
control can then be removed on a selective basis.
Levels of concern (LOC) developed by the US EPA (Urban and Cook 1986) and adopted by
the Agency, to determine whether a substance poses an environmental risk are provided in
Table A2.1.
Table A2.1: Levels of concern as adopted by the Agency.
Endpoint
LOC
Presumption
Aquatic (fish, invertebrates)
Acute RQ≥
0.5
High acute risk
Acute RQ
0.1-0.5 Risk can be mitigated through restricted use
Acute RQ<
0.1
Low risk
Chronic RQ≥
1
High chronic risk
Plants (aquatic and terrestrial)
Acute RQ≥
1
High acute risk
Mammals and birds
Acute dietary
0.5
RQ≥
Acute oral dose 0.5
[granular
products] RQ≥
Chronic RQ≥
1
High acute risk
High acute risk
High chronic risk
Aquatic risk
The Agency used the application rate and frequency information of Peratec Fungicide to
assess the risks. This product is just one of the products that is covered by the approved
substance described as Ethaneperoxoic acid, < 5% in acetic acid and hydrogen peroxide.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
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Assessment of Expected Environmental Concentration
The Agency has used the Generic Estimated Environmental Concentration Model v2
(GENEEC2) surface water exposure model (US EPA 2001) to estimate the EEC of hydrogen
peroxide and peracetic acid in surface water which may potentially arise as a result of spray
drift and surface runoff from the applicant’s proposed New Zealand use pattern.
The parameters of hydrogen peroxide used in the GENEEC2 modeling are listed in Table
A2.2 and represent the recommended use on grapes.
Table A2.2: Input parameters of hydrogen peroxide for GENEEC2 analysis.
Application rate
hydrogen
peroxide
8.625 kg ai/ha
Application frequency
4
Application interval
7 days
Koc
1.58
(log Koc= 0.2)
Aerobic soil DT50
0.625 days
Pesticide wetted in?
no
Methods of application
Option 1: airblast
Reference
Label information of Peratec
Fungicide provided by Jaeger
Australia Pty Ltd
EU risk assessment report 2003;
hydrogen peroxide
EU risk assessment report 2003;
hydrogen peroxide
Option 2: aerial
application
‘No spray’ zone
0
Water solubility
Miscible in water
(estimated value
10,000)
Aerobic aquatic DT50
5 days
EU risk assessment report 2003;
hydrogen peroxide
Aqueous photolysis
DT50
0.833 days
Degussa AG Frankfurt am Main
[IUCLID]
Output from the GENEEC2 model.
Hydrogen peroxide
Option 1: Airblast
RUN No. 1 FOR hydrogen
ON grapes
* INPUT VALUES *
-------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM )
(%DRIFT) (FT) (IN)
-------------------------------------------------------------------------------------------------------7.679( 7.682)
4 7
1.610000.0
VINYAR( 1.5) .0 .0
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FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)
--------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED
(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)
---------------------------------------------------------------------------------------------------.63
2
N/A
.83- 103.29
5.00
4.77
GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001
--------------------------------------------------------------------------------------------------PEAK
MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC
AVG GEEC
AVG GEEC
AVG GEEC
AVG GEEC
-------------------------------------------------------------------------------------------------57.29
51.60
29.29
12.50
8.40
Option 2: aerial
RUN No. 2 FOR hydrogen
ON grapes
* INPUT VALUES *
---------------------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM )
(%DRIFT) (FT) (IN)
--------------------------------------------------------------------------------------------------------7.679( 7.682)
4 7
1.610000.0
AERL_B( 13.0) .0 .0
FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)
--------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED
(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)
--------------------------------------------------------------------------------------------------.63
2
N/A
.83- 103.29
5.00
4.77
GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001
-------------------------------------------------------------------------------------------------PEAK
MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC
AVG GEEC
AVG GEEC
AVG GEEC
AVG GEEC
-----------------------------------------------------------------------------------------------136.15
126.13
72.11
30.80
20.69
The Estimated Environmental Concentration (EEC) for hydrogen peroxide as estimated by
GENEEC2 are:
Peak EEC :
airblast 0.05729 mg/l, aerial 0.13615 mg/l
Chronic EEC (21 days):
airblast 0.02929 mg/l, aerial 0.07211 mg/l
Assessment of acute risk
The Estimated Environmental Concentration (EEC) for hydrogen peroxide as estimated by
GENEEC2 are shown in Table A2.3, along with the aquatic data for hydrogen peroxide for
the most sensitive species tested (further details on these toxicity data are included in Table
A2.4). The acute toxicity values used for the risk assessment are shown in Table A2.3.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
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Table A2.3: Aquatic Ecotoxicity endpoints to be used in risk assessment.
Fish
96 h semistatic
LC50= 16.4 mg/L
48 h semistatic
EC50 =2.4 mg/L
Pimephales
promelas
Invertebrates
Shurtleff LE (1989). Interox America Sodium
Percarbonate and Hydrogen Peroxide - Acute
Toxicity to the
Freshwater Fish Pimephales Promelas. Burlington
Research, INC, Burlington, North Carolina, USA.
Shurtleff LE (1989). Interox America Sodium
Percarbonate and Hydrogen Peroxide - Acute
Toxicity to the
Daphnia pulex
Freshwater Invertebrate Daphnia Pulex. Burlington
Research, INC., Burlington, North Carolina, USA.
Algae/
72h
EbC50 =2.5 mg/L
Aquatic plants
Degussa AG (1991). Algenwachstumshemmtest mit
Wasserstoffperoxid 35% G. Geschäftsbereich
Industrie- und
Feinchemikalien, Frankfurt am Main.
Chlorella
vulgaris
Table A2.4: Acute risk quotients derived from the GENEEC2 model and toxicity data.
Peak EEC from
LC50 or EC50
RQ (Acute)
GENEEC2 (mg/L)
(mg/L)
EEC/ LC50 or EC50
airblast
0.05729
Fish
16.4
0.0035
Crustacea
2.4
0.024
Algae
2.5
0.023
Fish
16.4
0.0083
Crustacea
2.4
0.057
Algae
2.5
0.054
0.13615
aerial
When compared against the relevant acute levels of concern (Table A2.1), the acute RQs
derived from the GENEEC2 modeling for hydrogen peroxide indicate the acute risk for
aquatic organisms is low. There is no difference between the application methods.
As no chronic ecotoxicity data was available for hydrogen peroxide, no estimation of chronic
risk was able to be made.
The parameters of peracetic acid used in the GENEEC2 modeling are listed in Table A2.5 and
represent the recommended use on grape.
Table A2.5: Input parameters of peracetic acid for GENEEC2 analysis.
Application rate
Application frequency
Peracetic acid
1.725 kg ai/ha
4
Reference
Label information of Peratec
Fungicide provided by Jaeger
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Application interval
7 days
Australia Pty Ltd
Koc
4
Meylan WM et al, Environmental
Science & Technology 26;1560-67
(1992)
Aerobic soil DT50
0
default
Pesticide wetted in?
no
Methods of application
Option 1: airblast
Option 2: aerial
application
‘No spray’ zone
0
Water solubility
≥ 100 mg/L at 19oC
(very soluble)
Aerobic aquatic DT50
3 days
Aqueous photolysis
DT50
0 default
information provided by Jaeger
Australia Pty Ltd
ECETOC (2001) Peracetic acid (cas no 7921-0) and its equilibrium solutions. JACC no.
40 ECETOC Brussels 2001
Output from the GENEEC2 model.
Peracetic acid
Option 1: airblast
RUN No. 3 FOR peracetic
ON grapes
* INPUT VALUES *
--------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)
-------------------------------------------------------------------------------------------1.536( 6.143)
4 7
4.0 100.0
VINYAR( 1.5) .0 .0
FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)
------------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED
(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)
-------------------------------------------------------------------------------------------------------.00
2
N/A
.00- .00 3.00 3.00
GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001
------------------------------------------------------------------------------------------------PEAK
MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC
AVG GEEC
AVG GEEC
AVG GEEC
AVG GEEC
-----------------------------------------------------------------------------------------------340.96
284.75
126.67
47.61
31.76
Option 2: aerial
RUN No. 4 FOR peracetic
ON grapes
* INPUT VALUES *
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 14 of 36
---------------------------------------------------------------------------------------------RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)
--------------------------------------------------------------------------------------------1.536( 6.143)
4 7
4.0 100.0
AERL_B( 13.0) .0 .0
FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)
---------------------------------------------------------------------------------------------------METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED
(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)
-------------------------------------------------------------------------------------------------.00
2
N/A
.00- .00
3.00
3.00
GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001
-----------------------------------------------------------------------------------------------PEAK
MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC
AVG GEEC
AVG GEEC
AVG GEEC
AVG GEEC
------------------------------------------------------------------------------------------------338.33
283.43
126.18
47.43
31.64
The Estimated Environmental Concentration (EEC) for peracetic acid as estimated by
GENEEC2 are:
Peak EEC :
airblast 0.34096 mg/l, aerial 0.33833 mg/l
Chronic EEC (21 days)
airblast 0.12667 mg/l, aerial 0.12618 mg/l
Assessment of acute risk
The Estimated Environmental Concentration (EEC) for peracetic acid as estimated by
GENEEC2 are shown in Table A2.7, along with the aquatic data for peracetic acid for the
most sensitive species tested (further details on these toxicity data are included in Table
A2.6). It was hard to find toxicity information and the figures quoted are the most applicable
figures to Peratec Fungicide.
Table A2.6: Aquatic Ecotoxicity endpoints to be used in risk assessment.
Fish
96 h
Lepomis
macrochirus
5.2% peracetic acid, 20%
hydrogen peroxide, not stated
HOAc
ECETOC (2001) Peracetic acid (cas no
79-21-0) and its equilibrium solutions.
JACC no. 40 ECETOC Brussels 2001
LC50 = 1.1 mg peracetic acid/L
Invertebrates
Daphnia magna
48 h
Composition
15% peracetic acid, 14%
hydrogen peroxide, 28% HOAc
ECETOC (2001) Peracetic acid (cas no
79-21-0) and its equilibrium solutions.
JACC no. 40 ECETOC Brussels 2001
EC50 = 0.5 mg peracetic acid/L
5.2% peracetic acid, 20%
hydrogen peroxide, not stated
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 15 of 36
HOAc
EC50 = 0.73 mg peracetic acid/L
Algae/
72h
Aquatic plants
ECETOC (2001) Peracetic acid (cas no
79-21-0) and its equilibrium solutions.
JACC no. 40 ECETOC Brussels 2001
Composition
18% peracetic acid, 0.3 %
hydrogen peroxide, not stated
HOAc
Selenastrum
capricornutum
EC50 <1.0 mg peracetic acid
Table A2.7: Acute risk quotients derived from the GENEEC2 model and toxicity data.
Peak EEC from
LC50 or EC50
RQ (Acute)
GENEEC2 (mg/L)
(mg/L)
EEC/ LC50 or EC50
airblast
0.34096
Fish
1.1
0.310
Crustacea
0.73
0.467
Algae
1
0.341
Fish
1.1
0.308
Crustacea
0.73
0.463
Algae
1
0.338
0.33833
aerial
When compared against the relevant acute levels of concern (Table A2.1), the acute RQs
derived from the GENEEC2 modeling for peracetic acid indicate the following:
For fish, crustacean and algae: the acute risk can be mitigated through restricted use.
There is no difference between the application methods.
Assessment of chronic risk
As no chronic ecotoxicity data was available for peracetic acid, no estimation of chronic risk
was able to be made.
Conclusion aquatic risk
Based on the acute RQs for fish and crustacean, the Agency considers it appropriate to retain
the approved handler controls when the substance is used in a wide dispersive manner, or by a
commercial contractor. Further, the Agency considers that the application rate proposed by the
applicant and used in the modeling should be set as a maximum application rate.
Terrestrial risk
With respect to the risk to the terrestrial environment, no estimation of this risk was able to be
made due to the lack of available toxicity data.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 16 of 36
Overall conclusion for Ethaneperoxoic acid, < 5% in acetic acid and hydrogen peroxide
Based on the use pattern of Peratec Fungicide the Agency considers there is a potential risk
for aquatic organisms when Ethaneperoxoic acid, < 5% in acetic acid and hydrogen peroxide
is used in a wide dispersive manner. Due to a lack of terrestrial ecotoxicity data the Agency
was not able to assess the risk to terrestrial organisms neither for Peratec Fungicide nor for
Ethaneperoxoic acid, < 5% in acetic acid and hydrogen peroxide. Due to the outcome of the
risk assessment the Agency proposes to set additional controls when the substance is used in a
wide dispersive manner (see Appendix 3). At this stage the Agency is not able to set extra
controls to deal with the uncertainties with regard to terrestrial organisms as this has been the
policy of the Agency for similarly applied products.
Human health risk assessment
Operator exposure assessment
The Agency did not carry out an assessment of risks to operator health using an exposure
model, because of the corrosive nature of the substance. The United Kingdom Pesticide
Safety Directorate’s interpretation of the German BBA Model estimates operator exposure to
active ingredients during the use of the substance. This model estimates the exposure of
workers to a pesticide during mixing, loading and during spray application, in mg/kg
person/day (http://www.pesticides.gov.uk/index.htm).
In the case of ethaneperoxoic acid, <5% in acetic acid and hydrogen peroxide, the substance is
corrosive and personal protective equipment is needed to address this hazard during mixing
and loading. Absorption of the active ingredients from dermal or inhalation exposure during
spraying of the material is unlikely due to the use of PPE to protect the operator from the
corrosive effects of the substance during mixing and loading or the irritant effects of the
diluted spray if it comes into contact with the body.
The derivation of an acceptable operator exposure limit (AOEL) was not appropriate, and no
comparison of the systemic exposure against a derived AOEL was carried out. In the case of a
corrosive/irritant substance it is not the absorption of the active ingredient which causes the
hazard, so use of an AOEL is not appropriate.
The Agency notes that the use of appropriate PPE is essential when handling the concentrate
and when applying the diluted substance due to the corrosive nature of the active ingredients.
It is necessary to protect the operator from the skin and eye corrosivity of the substance and
from the harmful effects of inhalation of the mist.
The Agency notes that PPE is triggered as a default control for ethaneperoxoic acid, <5% in
acetic acid and hydrogen peroxide as a result of its 6.1D, 8.2B, 8.3A and 6.9A classifications.
The Agency also considers that workers entering crops following application of Peratec will
also require PPE. Nevertheless, the Agency notes that the active ingredients degrade rapidly
in the environment and considers that PPE is only likely to be needed for up to 48 hours after
application.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
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Public health exposure and risk assessment
The main potential source of exposure to the general public from ethaneperoxoic acid, <5% in
acetic acid and hydrogen peroxide (other than via food residues which will be considered as
part of the registration of this substance under the Agricultural Compounds and Veterinary
Medicines (ACVM) Act 1997) is via spray drift.
Although no operator exposure modeling was done for ethaneperoxoic acid, <5% in acetic
acid and hydrogen peroxide, the Agency assumes that operators from are required to wear
PPE to protect against the corrosive nature of the substance. The Agency notes that any
potential bystanders will not be wearing PPE, but they will not be directly handling the
substance during mixing and loading. The bystanders are only likely to be exposed to the
diluted material which is an irritant, not corrosive. Applications will need to be done under
suitable weather conditions to minimise spray drift into areas where bystanders may be
present.
The applicant proposed that the application would be made using ground-based methods. The
Agency considered the possibility that aerial application of formulations covered by the
description ethaneperoxoic acid, <5% in acetic acid and hydrogen peroxide might be
undertaken if aerial application is not proscribed. The Agency notes that undiluted material is
both a skin and eye corrosive. After dilution 1:50 in water, the diluted material would be a
skin and eye irritant. Bearing in mind the proximity of some crop areas to places where
members of the public may legally be during spraying, the Agency recommends the addition
of a control that prohibits aerial application of the product, due to concern that mist may cause
harm to people in the vicinity.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
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APPENDIX 3 DISCUSSION ON CONTROLS
Toxicity Controls
Setting of TELs (Control Code T1)
Tolerable Exposure Limits (TELs) are designed to limit the extent to which the general public
is exposed to hazardous (toxic) substances. A TEL represents the maximum concentration of
a substance legally allowable in a particular medium, and can be set as either a guideline value
or an action level that should not be exceeded. For the purposes of setting TELs, an
environmental medium is defined as air, water, soil or a surface that a hazardous substance
may be deposited onto.
TELs are established from PDE (potential daily exposure) values, which are themselves
established from ADE (acceptable daily exposure) values or reference doses (RfD) which are
similar to an ADE but are used to protect against a specific toxic effect of concern.
Human exposure may also occur through food or drinking water. Exposure through food is
managed via the establishment of Maximum Residue Limits (MRLs) as set by the Minister of
Food Safety on the advice of the New Zealand Food Safety Authority (NZFSA). Exposure
through drinking water is managed via the establishment of Maximum Acceptable Values
(MAVs) as set by the Ministry of Health. MRLs and MAVs are also established from ADE
values.
Setting of PDEs
If an ADE or RfD value is set for a substance, or component of a substance, a PDE value for
each relevant exposure route must also be set. A PDE is an amount of substance (mg/kg
bodyweight/day), calculated in accordance with Regulation 23, that estimates the relative
likelihood of particular exposures. A PDE for any single exposure route is a fraction of the
ADE or RfD, and the sum of all PDE values from all possible exposures must be less than or
equal to the ADE or RfD.
The main routes of exposure considered are ingestion (food, water, air, soil), inhalation (air)
and skin contact (surface deposition, water, soil).
Setting of ADEs
An ADE is an amount of a hazardous substance (mg/kg bodyweight/day), that, given a
lifetime of daily exposure, would be unlikely to result in adverse human health effects. An
RfD (reference dose) is a similar measure that can be used to protect against a specific toxic
effect of concern.
Regulation 11(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations
2001 determines when an ADE/RfD is required to be set:
(1)
This regulation applies to a class 6 substance if(a)
it is likely to be present in(i) 1 or more environmental media; or
(ii) food; or
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 19 of 36
(b)
(c)
effect.
(iii) other matter that might be ingested; AND
it is a substance to which a person is likely to be exposed on 1 or more
occasions during the lifetime of the person; AND
exposure to the substance is likely to result in an appreciable toxic
If all three requirements of regulation 11(1) are met, then an ADE/RfD should be set for the
relevant component(s), and PDE and TEL values subsequently established for each relevant
exposure route.
The toxicity (Class 6) classifications of ethaneperoxoic acid, <5% in acetic acid and hydrogen
peroxide that trigger the need to consider setting a TEL are 6.1D, 8.2B, 8.3A, 6.9A.
Where a substance is a pesticide or veterinary medicines active ingredient that is new to New
Zealand and it is intended for use on a food crop or animal, the Agency usually proposes an
ADE regardless of whether the requirements of Regulation 11 are met as this information may
be of use to NZFSA in setting MRLs. The Agency notes that due to the chemical reactivity of
the peroxy derivatives the active ingredients will break down rapidly, so that it is unlikely that
it is necessary for ACVM to establish MRLs. The Agency notes that this view is supported by
the observation that MRLs have not been set for peracetic acid or hydrogen peroxide by the
US EPA due to the high reactivity and rapid degradation of these components. This is the
case, even though they are used as sanitisers in food processing plants (EPA, RED, Peroxy
compounds, 1993). Therefore, the Agency proposes not to set ADEs, PDEs or TELS for any
components of the substance at this time.
Setting of WES (Control Code T2)
Workplace exposure standards (WES) are designed to protect persons in the workplace from
the adverse effects of toxic substances. A WES is an airborne concentration of a substance
(expressed as mg substance/m3 of air, or ppm in air), which must not be exceeded in a
workplace and only applies to places of work (Regulation 29(2), Hazardous substances
(Classes 6, 8, and 9 Controls) Regulations 2001).
Regulation 29(1) of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001
determines when a WES is required to be set. If all three of the requirements of this regulation
are met then a WES is required to be set.
Regulation 29 states:
(1) This regulation and regulation 30 apply to a class 6 substance if,(a) under the temperature and pressure the substance is to be used in, it can become
airborne and disperse in air in the form of inspirable or respirable dust, mists,
fumes, gases or vapours; AND
(b) human exposure to the substance is primarily through the inhalation or dermal
exposure routes; AND
(c) the toxicological and industrial hygiene data available for the substance is
sufficient to enable a standard to be set.
When setting WES, the Authority must either adopt a value already proposed by the
Department of Labour or already set under HSNO or derive a value by taking into account the
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 20 of 36
matters described in Regulation 30(2) of the Hazardous Substances (Classes 6, 8 and 9
Controls) Regulations.
The Agency typically adopts WES values listed in the Workplace Exposure Standards
(Effective from 2002) document (refer to the link below).
http://www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf
The Agency notes that Department of Labour and/or HSNO WES values have been set for
peracetic acid and hydrogen peroxide in “Ethaneperoxoic acid, <5% in acetic acid and
hydrogen peroxide” and that these values were adopted in clause 7 of the Notice. The Agency
confirms that the WES values should continue to apply to the substance. The values are listed
in Table A3.1.
Table A3.1 - WES values for components of Ethaneperoxoic acid, <5% in acetic acid
and hydrogen peroxide.
Component
WES TWA@
WES STEL@
3
Acetic acid
10 ppm
25 mg/m
15 ppm
37 mg/m3
(CAS 64-19-7)
Hydrogen
1 ppm
1.4 mg/m3
-#
-#
peroxide (CAS
7722-84-1)
@ TWA
#
= time weighted average, STEL = short term excursion limit.
No WES STEL value has been established.
The Agency notes that the DOL booklet lists hydrogen peroxide as an “A3 Carcinogen”. The
Agency did not consider it appropriate to review the class 6.7 classification for hydrogen
peroxide based on this information at this time. This application is only considering hydrogen
peroxide in the context of its presence in a particular mixture with peracetic acid, and the
application considers the implications for its horticultural use. A review of the
carcinogenicity of hydrogen peroxide should consider approvals for other formulations of the
substance.
WES values for other components in ethaneperoxoic acid, <5% in acetic acid and hydrogen
peroxide may be reviewed at a later date under s77B of the Act.
Ecotoxicity Controls
Setting of EELs (Control code E1)
Regulation 33 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
specify that an environmental exposure limit (EEL) may be set for a class 9 substance for one
or more environmental media if organisms that live in that environment may be exposed to the
substance. An EEL is the (maximum) concentration of a substance in an environmental
medium that will present a negligible risk of adverse environmental effects to organisms
(excluding humans) in non-target areas.
As specified by regulation 32, a default EEL of 0.1 µg/L water is set for any class 9.1
substance, and 1 µg/kg soil (dry weight) for any class 9.2 substance.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
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For the purposes of setting EELs, an environmental medium is defined as water, soil or
sediment where these are in the natural environment, or a surface onto which a hazardous
substance may be deposited.
An EEL can be established by one of three means:

Applying the default EELs specified in regulation 32

Adopting an established EEL as provided by regulation 35(a)

Calculating an EEL from an assessment of available ecotoxicological data as
provided by regulation 35(b).
The Hazardous Substances and New Organisms (Approvals and Enforcement) Act 2005
added a new section (s77B) to the HSNO Act, which, amongst other things provided the
Authority with the ability to set EELs as guideline values, rather than the previous pass/fail
values.
However, until the Agency has developed formal policy on the implementation of s77B, it
proposes not to set EELs for ethaneperoxoic acid, <5% in acetic acid and hydrogen peroxide
at this time. It is also proposed that the default EEL water value be deleted until the policy
has been established.
Approved Handler Controls- Highly ecotoxic substances (AH1, E7)
Approved handler requirements have been triggered for ethaneperoxoic acid, <5% in acetic
acid and hydrogen peroxide as a result of its 9.1A classification. The outcome of the
ecological risk assessment (refer Appendix 2) indicates that there is potential for acute adverse
environmental effects on aquatic organisms if the substance moves off-target (i.e. RQ > LOC).
The Agency considers it is therefore appropriate to retain the approved handler control as
provided by section 77(3)(a).
This approach is consistent with the Authority’s policy on approved handler and tracking
controls for class 9 substances (November 2003).
Setting of Application Rate (Control Code E2)
These regulations relate to the requirement to set an application rate for a class 9 substance
that is to be sprayed or applied to an area of land (or air or water) and for which an EEL has
been set.
Although no EEL has been set for ethaneperoxoic acid, <5% in acetic acid and hydrogen
peroxide, the Agency proposes setting the maximum application rate of 8625 g hydrogen
peroxide and 1725 g peracetic acid per ha. The maximum application frequency per year is 4
with an interval of 7 days. This rate was used in the ecological risk assessment.
Other controls required as a result of the ecological risk assessment

This substance is not to be applied onto or into water.
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Identification controls
Identification of Toxic and/or Corrosive Components on
Labels/Documentation (SDS)
The Hazardous Substances (Identification) Regulations 2001 specify that certain toxic and/or
corrosive components are required to be specified on the product label and on SDS
documentation.
Identification of toxic components on labels
Regulations 25(e) and 25(f) require that certain toxic components are required to be specified
on the product label.
Regulation 25(e) states:
...a toxic substance must be identified by...
'information identifying, by its common or chemical name, every ingredient, that would,
independently of any other ingredient, give the substance a hazard classification of 6.1A,
6.1B, 6.1C, 6.5, 6.6, 6.7, 6.8 or 6.9, and the concentration of that ingredient in the substance."
Regulation 25(f) states:
...a toxic substance must be identified by...
"information identifying (other than an ingredient referred to in paragraph (E)) that would,
independently of any other ingredient, give the substance a hazard classification of 6.1D, and
the concentration of the ingredient that would contribute the most to that classification."
Identification of corrosive components on labels
Regulation 19(f) requires that certain corrosive components are required to be specified on the
product label.
Regulation 19(f) states:
...a corrosive substance must be identified by...
"If the substance contains any ingredient in such a concentration that the ingredient would,
independently of any other ingredient, cause the substance to be classified as class 8.2 or
class 8.3, in respect of each such ingredient,(i)
its common or chemical name; and
(ii)
a statement of its concentration in the substance.”
Identification of toxic and/or corrosive components on SDS
Regulation 39(5) of the Hazardous Substances (Identification) Regulations 2001, states that
certain corrosive and toxic components are required to be specified on documentation.
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Regulations 39(5) states:
"The requirements of regulation 19(f) or (as the case requires) regulation 25(e) apply to all
documentation; but any ingredient required by that provision to be identified (other than an
ingredient to which regulation 26 applies) must also be identified by any Chemical Abstract
Services number allocated to it."
Concentration cut-offs for component identification
Consistent with the guidance provided by GHS, the Hazardous Substances Standing
Committee (HSSC) agreed that the concentration cut-offs triggering the requirement for
identification of components on labels and documentation are:
HSNO Classification
6.5A, 6.5B, 6.6A, 6.7A
6.6B
6.7B
6.8A, 6.8C
6.8B
6.9A, 6.9B
Cut-off for label (% w/w) Cut-off for SDS (% w/w)
0.1
0.1
1
1
1
0.1
0.3
0.1
3
0.1
10
1
Ethaneperoxoic acid, <5% in acetic acid and hydrogen peroxide - Components
requiring identification
Under these regulations, as determined by the HSSC (March 2006), the name and
concentration of the following components need to be specified on the label and
documentation:
Label
Peracetic Acid
Hydrogen peroxide
Documentation
Peracetic Acid
Hydrogen peroxide
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APPENDIX 4: LIST OF REVISED CONTROLS FOR
ETHANEPEROXOIC ACID, < 5% ACETIC ACID AND
HYDROGEN PEROXIDE
Table A4.1: Revised controls for ethaneperoxoic acid, < 5% acetic acid and hydrogen
peroxide – codes, regulations and variations.
Control Regulation5 Topic
Variations
Code4
Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001
F2/O2
8
General public transportation
restrictions and requirements for all
class 1 to 5 substances
F6
60-70
Requirements to prevent unintended
ignition of class 2.1.1, 2.1.2 and 3.1
substances
F11
76
Segregation of incompatible
substances
O1
7
General test certification
requirements for hazardous
substance locations
O3
88
General limits on class 5.1.1 and
5.1.2 substances
O4
89
Approved handler/security
requirements for certain class 5.1.1
and 5.1.2 substances
Controls F2, O2 and T7 are
combined.
Exception to approved handler
requirement for transportation
of packaged substances
(1) Regulation 89 is deemed to be
complied with if—
(a)
in the case of a hazardous
substance being
transported on
land—
(i)
in the case of a
hazardous
substance being
transported by rail,
the person who
drives the rail
vehicle that is
transporting the
substance is fully
trained in
accordance with the
approved safety
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.
5 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions.
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4
Control
Code4
Regulation5
Topic
Variations
system under
section 6D of the
Transport Services
Licensing Act 1989
or a safety system
which is referred to
in an approved
safety case under
the Railways Act
2005; and
(ii)
in every other case,
the person who
drives, loads,
and unloads the
vehicle that is
transporting the
substance—
(A) for hire or
reward, or in
quantities
that exceed
those set out
in Schedule 1
of the Land
Transport
Rule
45001/1:
Dangerous
Goods
2005, has a
current
dangerous
goods
endorsement
on his or her
driver’s
licence; or
(B)
in every other
case, the
Land
Transport
Rule
45001/1:
Dangerous
Goods 2005
is complied
with; or
(b)
in the case of a hazardous
substance being
transported by
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Control
Code4
Regulation5
Topic
Variations
sea, one of the following
is complied with:
(i)
Maritime Rules:
Part 24A –
Carriage of
Cargoes –
Dangerous Goods
(MR024A); or
(ii)
International
Maritime
Dangerous Goods
Code; or
(c) in the case of a hazardous
substance being
transported by air, Part
92 of the Civil Aviation
Rules is complied with.
(2) Subclause (1)(a)—
(a)
does not apply to a tank
wagon or a transportable
container to which the
Hazardous Substances
(Tank Wagons and
Transportable
Containers) Regulations
2004 applies; but
(b)
despite paragraph (a),
does apply to an
intermediate bulk
container that complies
with chapter 6.5 of the UN
Model Regulations.
(3) Subclause (1)(c)—
(a) applies to pilots, aircrew,
and airline ground
personnel loading and
handling a hazardous
substance within an
aerodrome; but
(b)
does not apply to the
storage and handling of a
hazardous substance in
any place that is not
within an aerodrome, or
within an aerodrome by
non-airline ground
personnel.
(4) In this regulation, UN Model
Regulations means the 14th revised
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 27 of 36
Control
Code4
Regulation5
Topic
Variations
edition of the Recommendation on the
Transport of Dangerous Goods
Model Regulations, published in 2005
by the United Nations.
O5
91
Requirements to prevent unintended
combustion or explosion of class
5.1.1 and 5.1.2 substances
O6
92
Requirements for protective clothing
and equipment
O7
93
Requirements to control adverse
effects of spills or failure of
containers
O8
94 - 97
Controls on hazardous substance
locations where class 5.1.1 or 5.1.2
substances are present
This regulation applies to this
substance as if, in regulation 95(1)(c),
the words “but excluding electrical
equipment” were inserted after the
words “ignition sources”.
This regulation applies to this
substance as if regulation 95(1)(f)
was replaced by:
(f) The location is designed and
managed so that any moisture or any
vapour, gas, or particulate matter of
class 5.1.1 or 5.1.2 substances does
not present a hazard in respect of
electrical equipment that may be
present.
O9
98 - 100
Test certification requirements for
hazardous substance locations where
class 5.1.1 or 5.1.2 substances are
present
O10
101
Controls on transit depots where
class 5.1.1 or 5.1.2 substances are
present
O11
102, 103
Requirements to control adverse
effects of intended combustion or
explosion of class 5.1.1 or 5.1.2
substances, including requirements
for protective clothing and
equipment.
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
T1
11-27
Limiting exposure to toxic
substances
No ADE or TEL values are set at this
time.
T2
29, 30
Controlling exposure in places of
work
WES values are set for peracetic acid
and hydrogen peroxide.
T3/E5
5, 6
Requirements for keeping records of
Controls T3 and E5 are combined.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 28 of 36
Control
Code4
Regulation5
Topic
Variations
use
T4/E6
7
Requirements for equipment used to
handle hazardous substances
Controls T4 and E6 are combined.
T5
8
Requirements for protective clothing
and equipment
T7
10
Restrictions on the carriage of toxic
or corrosive substance on passenger
service vehicles
Controls F2, O2 and T7 are
combined.
E1
32-45
Limiting exposure to ecotoxic
substances
No EEL values are set at this time
and the default EELs are deleted.
E2
46-48
Restrictions on use within
application area
As no EELs have been set, no
application rate is able to be set under
this regulation.
However, an application rate is set as
an additional control under section
77A.
E7
9
Approved handler requirements
The following control is substituted
for Regulation 9(1) of the Hazardous
Substances (Classes 6, 8, and 9
Controls) Regulations 2001:
(1). The substance must be under the
personal control of an approved
handler when the substance is (a) applied as a pesticide
in a wide dispersive
manner; or
(b) used as a pesticide by
a commercial
contractor.
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35,
36 (1)-(7)
General identification requirements
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
I2
8
Priority identifiers for corrosive
substances
I3
9
Priority identifiers for ecotoxic
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 29 of 36
Control
Code4
Regulation5
Topic
Variations
substances
I5
11
Priority identifiers for flammable
substances
I7
13
Priority identifiers for oxidising
substances
I8
14
Priority identifiers for toxic
substances
I9
18
Secondary identifiers for all
hazardous substances
I10
19
Secondary identifiers for corrosive
substances
I11
20
Secondary identifiers for ecotoxic
substances
I13
22
Secondary identifiers for flammable
substances
I15
24
Secondary identifiers for oxidising
substances
I16
25
Secondary identifiers for toxic
substances
I17
26
Use of Generic Names
I18
I19
27
29-31
Use of Concentration Ranges
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
I20
36(8)
I21
37-39, 47-50
Durability of information for class
6.1 substances
Documentation required in places of
work
Regulation 37 – Documentation
duties of suppliers
Regulation 38 – Documentation
duties of persons in charge of places
of work
Regulation 39 – General content
requirements for documentation
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 30 of 36
Control
Code4
Regulation5
Topic
Variations
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
I22
40
Specific documentation requirements
for corrosive substances
I23
41
Specific documentation requirements
for ecotoxic substances
I25
43
Specific documentation requirements
for flammable substances
I27
45
Specific documentation requirements
for oxidising substances
I28
46
Specific documentation requirements
for toxic substances
I29
51-52
Duties of persons in charge of places
with respect to signage
I30
53
Advertising corrosive and toxic
substances
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
Regulation 5 – Ability to retain
contents
Regulation 6 – Packaging markings
Regulation 7(1) – Requirements
when packing hazardous substance
Regulation 8 – Compatibility
P3
9
P11
17
P13
19
P14
20
P15
Regulation 9A and 9B – Large
Packaging
Packaging requirements for
substances packed in limited
quantities
Packaging requirements for
ethaneperoxoic acid, < 5% acetic
acid and hydrogen peroxide
Controls P11, P13, P14 and P15 are
combined.
21
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 31 of 36
Control
Code4
PG2
Regulation5
Topic
Schedule 2
The tests in Schedule 2 correlate to
the packaging requirements of UN
Packing Group II (UN PGII).
PS4
Schedule 4
This schedule describes the
minimum packaging requirements
that must be complied with when a
substance is packaged in limited
quantities
Variations
Hazardous Substances (Disposal) Regulations 2001
D2
D3
D4
D5
D6
D7
D8
6
7
8
9
10
11, 12
13, 14
Disposal requirements for
ethaneperoxoic acid, < 5% acetic
acid and hydrogen peroxide
Controls D2, D3, D4 and D5 are
combined
Disposal requirements for packages
Disposal information requirements
Disposal documentation
requirements
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
EM2
8(a)
EM5
8(d)
EM6
8(e)
EM7
8(f)
EM8
12-16, 18-20
EM9
17
EM10
EM11
21-24
25-34
EM12
35-41
Level 1 emergency management
information: General requirements
Information requirements for
corrosive substances
Information requirements for
oxidising substances and organic
peroxides
Information requirements for toxic
substances
Information requirements for
ecotoxic substances
Level 2 emergency management
documentation requirements
Additional information requirements
for flammable and oxidising
substances and organic peroxides
Fire extinguisher requirements
Level 3 emergency management
requirements – emergency response
plans
Level 3 emergency management
requirements – secondary
containment
The following subclauses shall be
added after subclause (3) of
regulation 36:
(4) For the purposes of this
regulation, and regulations
37 to 40, where this
substance is contained in
pipework that is installed and
operated so as to manage
any loss of containment in
the pipework it—
(a) is not to be taken into
account in determining
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 32 of 36
Control
Code4
Regulation5
Topic
Variations
(5)
EM13
42
whether a place is
required to have a
secondary containment
system; and
(b) is not required to be
located in a secondary
containment system.
In this clause, pipework—
(a) means piping that—
(i) is connected to a
stationary
container; and
(ii) is used to transfer a
hazardous
substance into or
out of the
stationary
container; and
(b) includes a process
pipeline or a transfer line.
Level 3 emergency management
requirements – signage
Hazardous Substances (Personnel Qualification) Regulations 2001
AH1
4-6
Approved Handler requirements
See E7.
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
where applicable
The Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004 prescribe a number of controls relating to tank wagons and
transportable containers and must be complied with as relevant.
Section 77 and 77A Additional Controls
The controls relating to stationary container systems, secondary containment and unintended ignition of
flammable substances, as set out in Schedules 8, 9 and 10 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 Schedules 8 and 9 and clause 1 of Schedule 10.
Addition of subclauses after subclause (3) of Regulation 36 of the Hazardous Substances (Emergency
Management) Regulations 2001, refer control EM12.
Ethaneperoxoic acid, < 5% acetic acid and hydrogen peroxide shall not be applied onto or into water.
When used as a pesticide, the maximum application rate for Ethaneperoxoic acid, < 5% acetic acid and
hydrogen peroxide shall be 8625 g hydrogen peroxide and 1725 g peracetic acid per ha with a maximum
application frequency of 4 times per year and a minimum application interval of 7 days.
When used as a pesticide, the method of application of ethaneperoxoic acid, < 5% acetic acid and
hydrogen peroxide shall be restricted to ground-based methods only.
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 33 of 36
APPENDIX 5: GOVERNMENT DEPARTMENTS,
CROWN ENTITIES AND INTERESTED PARTIES
NOTIFIED
Aakland Chemicals (1997) Limited
AgBio Research Limited
Agcarm Incorporated
AgResearch Limited
Agronica New Zealand Limited
Ancare New Zealand Limited
ARPPA
BASF New Zealand Limited
Bayer New Zealand Limited
BOC Limited
Bomac Laboratories Limited
Caltex New Zealand Limited
Central Hawkes Bay District Council
Chancery Green
Chemagro New Zealand Limited
Chemsafety Limited
Crown Public Health
CSD Consultancy Ltd
Donaghys Industries Limited
Dow AgroSciences (New Zealand) Limited.
DuPont (New Zealand) Limited
Environment Southland
Environment Waikato
Evonik Industries
Far North District Council
Federated Farmers of New Zealand (Incorporated)
Fish and Game Council of New Zealand
Fish and Game Eastern Region
Franklin District Council
GE Free (Wairarapa)
General Cable New Zealand Limited
Greater Wellington - The Regional Council
Green Party of Aotearoa New Zealand
Horticulture and Food Research Institute
(HortResearch)
HQ Joint Forces New Zealand
Human Rights Commission
Hunt Agencies Limited
IMCD New Zealand Limited
Intervet Limited
Jordens Nurseries
Kaipara District Council
Kawerau District Council
Landcorp Farming Limited
Lowndes Associates
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 34 of 36
Mackenzie District Council
MAF Biosecurity New Zealand (MAFBNZ)
Matamata-Piako District Council
Merial New Zealand Limited
Ministry of Research Science and Technology
(MoRST)
Muaupoko Co-operative Society
Napier Health Centre - Public Health Unit
National Aquarium of New Zealand
National Institute of Water and Atmospheric Research
Limited (NIWA)
New Plymouth District Council
New Zealand Chemical Industry Council Inc
New Zealand Customs Service
New Zealand Meatworkers Union
New Zealand Press Association
New Zealand Society of Gunsmiths Inc
New Zealand Veterinary Association Inc
New Zealand Bee Industry Group - Federated Farmers
Ngati Kahungunu Iwi Incorporated
Northern Chemical Workers Union
Northland Health
Northland Regional Council
Nufarm New Zealand Limited
Nursery and Garden Industry Association of New
Zealand Inc
Otago District Health Board
Pacific Growers Supplies Limited
Pesticide Action Network Aotearoa New Zealand
Pfizer New Zealand Limited
PharmVet Solutions
Physicians and Scientists for Global Responsibility
(PSGR)
Rangitikei District Council
Reckitt Benckiser
Royal Forest and Bird Protection Society of New
Zealand Inc.
Rural and Associated Contractors Federation of New
Zealand
South Taranaki District Council
Spraywatchers Group
Sustainability Council of New Zealand
Syngenta Crop Protection Limited
Tairawhiti District Health
Taranaki Regional Council
Tasman District Council
Te Pataka Matauranga Charitable Trust
Technical Strategy Group Limited
Television New Zealand
Thames Coromandel District Council
The Green Party of Aotearoa New Zealand Inc
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 35 of 36
The National Beekeepers Association of New Zealand
TMP Consultancy
University of Auckland
Veg-Gro Supplies Limited
Venco Ltd
ViaLactia Biosciences (New Zealand) Limited
Virbac Laboratories New Zealand Limited
Yates Australia
Zelam Limited
10 private individuals
Consideration Paper – HRE08001 Modified Reassessment of Ethaneperoxoic Acid, <5% Acetic Acid and Hydrogen Peroxide
Page 36 of 36