
Nufarm Ltd is seeking approval to import Crest 520 for release.

Crest 520 is a herbicide containing haloxyfop-P-methyl in the form of an emulsifiable concentrate.

Crest 520 is proposed to be used as a selective post- emergence grass weed control in many broadleaf crops, orchards and forestry.

Crest 520 will be applied as a herbicide at a maximum application rate of 0.82 kg ai/ha, once per growing season.

The applicant advises that the method of application will be ground or aerial-based application.

Haloxyfop-P-methyl is present in other herbicides currently available in New
Zealand.

Haloxyfop-P-methyl is used in agricultural pesticides and was first registered in New
Zealand in 1998.
It was transferred as a single component to the full framework of the HSNO Act in 2006 (as Haloxyfop-R, methyl ester; HSR003340).

There are four HSNO approved substances containing this active ingredient. Two formulations containing haloxyfop-P-methyl were transferred as pesticides to the full framework of HSNO Act in 2004 and two formulations were approved in 2006 and
2009 under Part 5 of the HSNO Act.

Haloxyfop-P-methyl is a selective herbicide, absorbed by the foliage and roots, and hydrolysed to haloxyfop-P, which is translocated to meristematic tissues, and inhibits their growth (BCPC, 2006). Haloxyfop-P and haloxyfop-P-methyl, respectively, belong to the class of aryloxyphenoxyproponic herbicides (commonly called "FOP") such as clodinafop, fenoxaprop-P and fluazifop-P. Haloxyfop-P is taken up via leaves and roots and hinders the de novo synthesis of fatty acids by inhibition of the enzyme Acetyl-CoA carboxylase (ACCase). (EFSA, 2006).

The Agency notes that the commonly used synonym haloxyfop-R-methyl has been used in the EFSA Report (2006) however the Agency has used the ISO common name, haloxyfop-P-methyl, in this E&R report.
The key issues for this application are:

The Agency and the applicant have independently classified Crest 520 based on the available information on Crest 520 and its components. The classifications are summarised in the table below:
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 2 of 57

Hazardous Property
Flammability
Acute Toxicity (Oral)
Skin Irritancy
Eye Irritancy
Target Organ Toxicity
Aquatic Ecotoxicity
Terrestrial vertebrate ecotoxicity
Applicant’s Assessment Agency’s Assessment
3.1D 3.1D
6.1D 6.1D
6.3B 6.3B
6.4A 6.4A
6.9B 6.9B
9.1A
9.3B
9.1A
9.3B
 The Agency’s classifications are the same as the applicant’s proposed HSNO classifications.

The Agency has proposed that the default controls for Crest 520 be modified, such that:
no Tolerable Exposure Limits (T1) are set at the present time, but ADE and
PDE values are set for haloxyfop-P-methyl;
no Workplace Exposure Standards (T2) are proposed for any components of
Crest 520 at this time;
no Environmental Exposure Limits (E1) or maximum application rates (E2) are set at the present time and any default values are deleted;
the tracking control (TR1) is deleted;
control specifying the approved handler requirements be varied such that
Crest 520 must be under the control of an approved handler when the substance is being used in a wide dispersive manner or by a commercial contractor;
further controls regarding stationary containment systems, pipework and flammable liquids are added; and
a control which prohibits application of Crest 520 onto or into water is added.

The Agency notes that haloxyfop-P (the acid form of the substance) has been recently reviewed by the European Union (EFSA, 2006). This report highlighted a number of toxicological / environmental concerns. These are specified in section 5 of this E&R Report. The information contained in the EFSA (2006) review will be assessed by the Agency if there are grounds established for the reassessment of haloxyfop-P-methyl.
 The Agency’s assessment of the risks posed by Crest 520 to the environment and to human health, during the substance’s lifecycle, is based on qualitative assessment and quantitative modelling using the GENEEC2 and German BBA models.
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
The Agency considers that the risk assessments indicate that the risks associated with Crest 520 are negligible with the proposed controls in place.

The Agency has evaluated information supplied by the applicant about the benefits of Crest 520 and considers that potential benefits are likely to be realised through the release of this substance.

In conclusion, the Agency considers that there are negligible risks to human health and to the environment and potential benefits associated with the release of Crest
520. Therefore, the Agency considers that it is evident that the benefits of releasing
Crest 520 outweigh the costs and the application may be approved in accordance with clause 26.
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1 Application Details ............................................................................................................. 6
2 Legislative Criteria for the Application .............................................................................. 6
3 Application Process ............................................................................................................ 6
4 Notification and Consultation ............................................................................................. 7
5 Application Synopsis and Information Review .................................................................. 8
6 Hazardous Properties, Thresholds and Classification ....................................................... 10
7 Default Controls ................................................................................................................ 10
8 Risk Assessment ............................................................................................................... 11
9 Assessment of Beneficial Effects ...................................................................................... 17
10 Controls ............................................................................................................................. 18
11 Overall Evaluation of Risks, Costs and Benefits .............................................................. 20
12 Conclusion ........................................................................................................................ 21
Appendix 1: Decision Path ...................................................................................................... 22
Appendix 2: Hazard Classification .......................................................................................... 23
Appendix 3: Risk Assessment ................................................................................................. 25
Appendix 4: Discussion on Controls ....................................................................................... 38
Appendix 5: List of Proposed Controls for Crest 520 ............................................................. 45
Appendix 6: Scales for Qualitative Risk Assessment .............................................................. 51
Appendix 7: Government Departments, Crown Entities and Interested Parties Notified ....... 54
Appendix 8: Confidential Material .......................................................................................... 56
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 5 of 57

1
Application Code
Application Type
Applicant
Date Application Received
Submission Period
To be considered by
Purpose of the Application
HSR09042
To import or manufacture for release any hazardous substance under Section 28 of the Hazardous Substances and New Organisms Act 1996 (“the Act”)
Nufarm Ltd
20 April 2009
1 May 2009 – 15 June 2009
A Committee of the Authority (‘the Committee”)
To import or manufacture Crest 520 as a post emergence herbicide for the control of grass weeds in many broadleaf crops, orchards and forestry.
2
2.1
The application was lodged pursuant to section 28.
2.2
This report takes into account matters to be considered in section 29; matters specified under Part 2 of the Act; and the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (“the
Methodology”). Unless otherwise stated, references to section numbers in this report refer to sections of the Act and clauses to clauses of the Methodology.
3
3.1
Evaluation of the application was undertaken by the ERMA New Zealand project team (“the Agency”) which comprised the following staff members:
Jo Prankerd
Sekove Tinalevu
Apostolos Koutsaftis
Patrick Gemmell
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Senior Advisor (Kaupapa Kura Taiao).
3.2
The report was reviewed and signed out by:
Noel McCardle Senior Advisor (Hazardous Substances).
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3.3
Timeline
Application formally received
Application notified
Submission closing date
20 April 2009
1 May 2009
15 June 2009.
3.4
Due to delays in completing this E&R Report, the Authority postponed the consideration under section 58(3) until 21 August 2009.
4
4.1
The Minister for the Environment was advised of the application
1
and given the opportunity to “call-in” the application 2 . This action was not initiated.
4.2
The Department of Labour (Workplace Group) and the New Zealand Food
Safety Authority (Agricultural Compounds and Veterinary Medicines (ACVM)
Group) 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).
5.2.1 No comments or submissions were received.
4.3
Other Government departments, Crown agencies and other interested parties, as listed in Appendix 7, were provided with a copy of the application summary and given the opportunity to comment or to make a submission.
5.3.1 No comments or submissions were received.
4.4
The application was publicly notified on the ERMA New Zealand website on 1
May 2009 and subsequently advertised in The Dominion Post, the New Zealand
Herald, the Christchurch Press and the Otago Daily Times
3
.
4.4.1
No submissions were received.
1 section 53(4)(a))
2 section 68
3 section 53
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5
5.1
The applicant supplied the following documents:
 the application;
 a confidential appendix (including full formulation data and a draft label).
5.2
5.3
The confidential information on the composition of Crest 520 has been withheld at the request of the applicant for reasons of commercial sensitivity. The information is provided for the Committee in Confidential Appendices 8 and 9.
The Agency notes that data that belong to haloxyfop-P-methyl were used for the evaluation of haloxyfop-P (the acid form of the substance) by the E.U. (EFSA,
2006).
5.4
The Agency notes that haloxyfop-P-methyl is the ISO common name and that the synonym haloxyfop-R-methyl is in common use. Haloxyfop-R was used in the EFSA Report (2006); however, the Agency has used haloxyfop-P-methyl in this E&R report.
5.5
The EFSA report highlighted the following toxicological/environmental concerns:

Based on preliminary information, a high potential for ground water contamination by the metabolites of haloxyfop-P-methyl, DE-535 pyridinol and DE-535 pyridinone, which are persistent and can leach easily into the water table, with potentially negative effects on drinking water when used in field is identified. The risk assessment for groundwater contamination could not be concluded. In the case the trigger of 0.1 μg/L or 0.75 μg/L is exceeded there is a need to provide information on the toxicological properties and possibly consumer risk assessment.

Based on the available data, concerns remain as regards the risk assessment for mammals. A high first tier long-term risk to mammals was identified and needs to be further addressed.

Haloxyfop-P-methyl is very toxic to fish and risk mitigation measures comparable to 5 m buffer zones are required.
5.6
As a result of the above data gaps, it was not possible to conclude on the basis of the information available that haloxyfop-P meets the criteria for inclusion in
Annex I to Directive 91/414/EEC (E.U., 2007).
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5.7
The Agency considers the concerns identified above in paragraphs 5.3 to 5.5 to be sufficiently mitigated through the proposed addition of controls under section
77A, and does not consider that they will influence decision making relating to the potential adverse effects of Crest 520
4
. The Agency also considers that the information contained in the EU (2006) review will be assessed upon reassessment of haloxyfop-P-methyl. Therefore, the Agency considers that the information constitutes an adequate and appropriate basis for considering the application
5
.
5.8
Crest 520 is a selective post emergence herbicide containing 520 g/L haloxyfop-
P-methyl in the form of an emulsifiable concentrate. Crest 520 is proposed to be used for the control of grass weeds in many broadleaf crops, orchards and forestry.
Manufacture/Importation
5.9
The applicant has indicated that Crest 520 will be imported into New Zealand fully formulated and pre-packed. Crest 520 will be shipped from Australia to
New Zealand and from the border the substance will be transported to the
Nufarm warehouse in Auckland.
5.10
The applicant indicates that while it is not planned for Crest 520 to be manufactured in New Zealand, it is possible that the substance could be manufactured in New Zealand in the future. Consequently, the risks associated with the manufacture of Crest 520 have been evaluated, so that approval of this substance will be applicable to both the import and manufacture of Crest 520.
Transport, storage and packaging
5.11
Crest 520 will be packaged in HDPE containers in sizes ranging from 250 ml to
200 litres.
5.12
Crest 520 will be stored in the Nufarm warehouse until it is distributed by carriers with experience in transporting similar herbicide products to retailers.
The applicant notes that the storage area is secure and has prominent signage to denote the substances being held.
5.13
Once the substance has been despatched to retailers, the applicant indicates
Crest 520 will be stored on shelves before it is sold to the end user.
Use
5.14
Crest 520 will be applied as a herbicide at application rates varying from 95 ml to 1450 ml Crest 520/ha depending on the weed type.
4 clauses 29 and 30
5 clause 8
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5.15
The applicant advises that the method of application will be ground or aerialbased application and it is intended that the substance will be used by commercial growers only.
Disposal
5.16
The applicant advises that the normal method of disposal will be via its use according to the label directions. The packaging of this substance should be triple rinsed and recycled by Agrecovery, or crushed and buried at an approved landfill.
5.17
In all cases, the substance and its packaging will be disposed of in accordance with the Hazardous Substances (Disposal) Regulations 2001 and the Resource
Management Act 1991.
6
6.1
The Agency has evaluated the information supplied by the applicant and also referred to other data sources in assessing the hazardous properties of Crest 520.
This assessment is attached as Appendix 2.
6.2
6.3
The applicant’s and the Agency’s classification of the hazard profiles of Crest
520 are listed in Table 6.1.
Table 6.1: Summary of applicant’s and Agency’s HSNO classification of Crest 520
Hazardous Property
Flammability
Applicant’s
Assessment
3.1D
Agency’s Assessment
3.1D
Acute Toxicity (Oral)
Skin Irritancy
6.1D
6.3B
6.1D
6.3B
Eye Irritancy
Target Organ Toxicity
Aquatic Ecotoxicity
6.4A
6.9B
9.1A
6.4A
6.9B
9.1A
Terrestrial vertebrate ecotoxicity 9.3B 9.3B
The Agency’s classifications are the same as the applicant’s proposed HSNO classifications.
7
7.1
7.2
Based on the hazard classification shown in Table 6.1, the set of associated controls has been identified. These default controls are listed in Appendix 4.
The Authority is able to vary the default controls and impose controls under sections 77 and 77A to produce a set of controls relevant to Crest 520.
Variations and additional controls for Crest 520 are considered in Section 10 of this report.
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8
8.1
Potentially non-negligible risks were identified for evaluation following clauses
9 and 11, which incorporate sections 5, 6 and 8.
8.2
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.
8.3
The applicant has identified potential sources of risk to the environment and to human health and safety through release, spillage or exposure throughout the lifecycle of the substance. The Agency has also identified potential sources of risk and these, along with those identified by the applicant, are tabulated in
Table 8.1.
Table 8.1: Potential sources of risks associated with Crest 520
Lifecycle Activity Associated Source of Risk
Manufacture / Import An incident during the manufacture or importation of Crest 520 resulting in spillage and subsequent exposure of people or the environment to the substance.
Packing
Transport or storage
An incident during the packing of Crest 520 resulting in spillage and subsequent exposure of people or the environment to the substance.
An incident during the transport or storage of Crest 520 resulting in spillage and subsequent exposure of people or the environment to the substance.
Use
Disposal
Application of Crest 520 resulting in exposure of users or bystanders or the environment; or an incident during use resulting in spillage and subsequent exposure of users or the environment to the substance.
Disposal of Crest 520 or packaging resulting in exposure of people or the environment to the substance.
8.4
In accordance with sections 5 and 6 and clauses 9 and 12, the Agency has assessed the potentially non-negligible risks 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.
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8.5
The Agency notes that the evidence provided by the applicant and additional evidence found by the Agency, relating to the hazardous properties of Crest 520, is largely scientific in nature 6 . However, as some of the evaluation of risks, costs and benefits has been carried out on a qualitative basis, it is recognised that there is a degree of uncertainty in the risk analysis.
8.6
The analysis of risk takes into account the controls that derive from the HSNO
Regulations (in particular the default controls identified in Appendix 4) and from other legislation such as the Resource Management Act 1991 and the
Health and Safety in Employment Act 1992. That is, the analysis assumes controls are in place.
8.7
A quantitative risk assessment has been carried out to evaluate the level of risk to operators and the environment arising from the use of Crest 520 (see
Appendix 3).
8.8
A qualitative assessment has been undertaken for all other stages of the lifecycle. In these cases, the level of risk has been evaluated on the basis of the magnitude and likelihood of adverse effects occurring to people or the environment (see Appendix 3).
8.9
The Agency has classified Crest 520 as being very toxic in the aquatic environment (9.1A) and toxic to terrestrial vertebrates (9.3B). Haloxyfop-Pmethyl is considered to not be rapidly degradable in the environment. Thus, a range of organisms in the environment may be adversely affected if exposed to
Crest 520.
8.10
In addition to its ecotoxic properties, Crest 520 has been classified by the
Agency as being flammable (3.1D – low hazard). The Agency considers that there is potential for damage to the environment to occur if Crest 520 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 .
8.11
The Agency considers that the likelihood of exposure to the environment is greatest during use of the substance.
8.12
This quantitative assessment of the environmental risks associated with the use of Crest 520 show that it presents a low acute risk to fish, crustacea and algae, but that no estimation of the aquatic chronic risk was able to be made (see
Appendix 3).
8.13
The Agency notes the results of the quantitative modelling and considers that application of the following controls will address the uncertainty caused by the lack of chronic aquatic organism data and reduce the level of risk to the environment to negligible :
6 clause 25(1)
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
The requirement for people using the substance to be approved handlers when the substance is being used in a wide dispersive manner or by a commercial contractor; and

Prohibiting the application of Crest 520 into or onto water.
8.14
The risks of Crest 520 to the environment (with controls in place) at various stages of its lifecycle are summarised below in Table 8.2 and discussed more fully in Appendix 3.
Table 8.2: Level of risk of Crest 520 to the environment.
Lifecycle Stage
Manufacture, importation, transport and storage
Use
Potential Adverse
Effect
Spillage resulting in death or adverse effects to aquatic or terrestrial organisms in the environment.
Use resulting in death or adverse effects to aquatic organisms in the environment.
Likelihood of
Adverse Effect
Occurring
Highly improbable
Magnitude of
Adverse
Effect
Moderate
Level of
Risk
Negligible
Quantitative assessment indicated that the acute risk to fish, crustacea and algae in the aquatic environment is low during use. An estimation of the chronic risk was unable to be made. The
Agency notes the results of this quantitative assessment and considers that the application of controls will reduce this risk to negligible.
Disposal
Use resulting in death or adverse effects to terrestrial vertebrates.
Disposal resulting in death or adverse effects to aquatic or terrestrial organisms in the environment.
No terrestrial risks were identified in the ecological risk assessment.
Highly improbable
Minor Negligible
8.15
The Agency has classified Crest 520 as an acute oral toxicant (6.1D), a skin irritant (6.3B) an eye irritant (6.4A) and a target organ toxicant (6.9B).
8.16
In the Agency’s opinion, chronic hazards normally require repeated exposure to the substance for the adverse effects to occur and are therefore most relevant to the end-users.
8.17
Crest 520 is 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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8.18
The Agency assessed the health risk to operators on the basis of the German
BBA model predictions for exposure estimates. The quantitative modelling indicates that at the highest application rates the exposure to Crest 520, when used as recommended on the label, is not likely to present a high health risk to the mixers or applicators as long as “full” Personal Protective Equipment (PPE) is worn during mixing, loading and applying the substance. The use of respirators is not required.
8.19
The Agency notes that the requirement for PPE is triggered as a default control for Crest 520 as a result of its 6.1D and 6.9B classifications. The Agency, therefore, concludes that the health risk to operators, with controls in place, is negligible . Further details on this quantitative assessment are given in
Appendix 3.
8.20
The Agency assessed the re-entry worker exposures to haloxyfop-P-methyl from the use of Crest 520 using guidance provided by the Chemicals Regulation
Directorate: Pesticides (CRD) website. The Agency concluded that the intake of haloxyfop-P-methyl for the re-entry worker may be associated with about 16 times the acceptable intake level. Consequently, the Agency recommends that the label should contain information to address this exposure risk (refer to
Appendix 3).
8.21
The Agency assessed the risk to public/bystanders using the United Kingdom
Pesticide Safety Directorate’s (PSD) current formula. The quantitative modelling indicates that at the highest application rates the exposure to Crest
520, when used as recommended on the label, will present an acceptable level of risk.
8.22
The Agency notes that the main potential source of exposure to the general public from Crest 520 is via spray drift and that spray drift from aerial applications is likely to be greater than for ground based applications. The
Agency notes the results of the quantitative modelling which indicates there is a risk to operators from the use of Crest 520 if full PPE is not worn. The Agency notes the levels of risk posed by ground based application to the general public are considered to be at acceptable levels.
8.23
The Agency notes that based on a risk quotient of 1.49, bystander risk is considered not acceptable from aerial applications. However, the Agency considers that Crest 520 is unlikely to be an unacceptable risk to bystanders considering that the use of risk quotients is a tool, the proposal is for the substance to be applied once a year and that bystanders will be exposed to the diluted product. The Agency, therefore, concludes that the health risk to bystanders is negligible (refer to Appendix 3).
8.24
The risks of Crest 520 to human health and safety (with controls in place) at various stages of the lifecycle are summarised below in Table 8.3 and discussed more fully in Appendix 3.
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Table 8.3: Level of risk of Crest 520 to human health and safety.
Lifecycle stage Potential
Adverse Effect
Likelihood of
Adverse
Effect
Occurring
Magnitude of
Adverse
Effect
Level of Risk
Manufacture/packing Acute oral toxicity
Skin irritation
Eye irritation
Highly improbable
Highly improbable
Importation, transport or storage
Use
Moderate
Minimal
Negligible
Negligible
Target organ toxicity
Quantitative assessment indicates that the chronic risks to human health and safety are acceptable when PPE is worn. This reduces the level of risk to negligible.
Acute oral toxicity Highly improbable
Moderate Negligible
Skin irritation
Eye irritation
Highly improbable
Minimal Negligible
Target organ toxicity
Not addressed
Acute effects: operators & bystanders (qualitative assessment)
Acute oral toxicity Highly improbable
Skin irritation
Eye irritancy
Highly improbable
Moderate
Minimal
Chronic effects: operators (quantitative assessment)
Negligible
Negligible
Target organ toxicity
Quantitative assessment indicated that the chronic risks to human health and safety are acceptable only if PPE is worn during mixing, loading and application. The use of PPE reduces the level of risk to negligible.
Chronic effects: bystanders (quantitative assessment)
Disposal
Target organ toxicity
Quantitative assessment indicated that the chronic risks to bystander human health and safety are acceptable and the level of risk is considered to be negligible.
Moderate Negligible Acute oral toxicity Highly improbable
Skin irritation
Eye irritation
Highly improbable
Minimal Negligible
Target organ toxicity
The Agency considers the chronic risk to human health during disposal of Crest 520 to be negligible as it less likely, than during use, that workers or bystanders could be repeatedly exposed to Crest 520 to such an extent that target organ toxicity effects occur.
8.25
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
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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.
8.26
The Agency notes that Crest 520 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.
8.27
In addition, the introduction and use of this substance 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.
8.28
On considering the information outlined here and elsewhere in this report, the
Agency considers a minimal impact from Crest 520 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 Crest 520 will breach the principles of the Treaty of Waitangi.
8.29
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.
8.30
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.
8.31
There are not expected to be any significant adverse impacts on the social environment with the controlled use of Crest 520, 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.
8.32
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.
8.33
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.
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8.34
The Agency does not anticipate that Crest 520 will pose any risks to New
Zealand’s international obligations.
9
9.1
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.
9.2
The applicant claims that the approval of Crest 520 will provide the following benefits:
9.2.1
Growers will have more flexibility in the choices they have for weed control in their crop, orchard and forestry.
9.2.2
As Crest 520 is a higher strength substance, the environment will be exposed to fewer non-active chemicals and the amount of packaging used and disposed of will be reduced.
9.2.3
More commercial competition in the market should ultimately benefit the end user by reducing the cost.
9.2.4
Nufarm Ltd will benefit as it will add to the current product range and lead to an increase in profits.
9.3
The Agency considers that economic and related benefits may be derived from the use of Crest 520.
9.4
In accordance with section 29, consideration has been given to the likely effects of Crest 520 being unavailable.
9.5
9.6
The Agency notes that there are similar herbicide products already available in
New Zealand with a comparable range of hazards.
The likely effects of Crest 520 being unavailable would thus be a reduction in consumer choice for end-users, as well as a reduction in sales for Nufarm Ltd and employment opportunities in the company.
9.7
The applicant has not provided information on any significant risk reduction implications for the import or manufacture of Crest 520 for release. The
Agency notes that there are other herbicides available in New Zealand which contains the same active ingredient.
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10
10.1
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 Crest 520 until implementation of a pending review of setting such values under section 77B (See Appendix 4).
10.2
The Agency notes that an ADE of 0.0003 mg/kg bw/day has already been set for haloxyfop-P-methyl in a previous Part 5 application. The following PDE values for haloxyfop-P-methyl were also set in that application: PDE food
=
0.00024 mg/kg bw/day and PDE drinking water
=0.00006 mg/kg bw/day . The
Agency proposes that these values are set for haloxyfop-P-methyl in Crest 520.
10.3
Control T2 relates to the requirement to limit worker exposure to toxic substances by the setting of Workplace Exposure Standards (WESs). No WES values are proposed for any components of Crest 520 at this time (See Appendix
4).
10.4
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 Crest 520 and the default values are deleted (see Appendix 4) .
10.5
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 Crest 520, the Agency is not able to propose the setting of a maximum application rate under this regulation.
10.6
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 control is proposed for Crest 520 to restrict the level of risk to the environment:
10.6.1
“Crest 520 shall not be applied onto or into water.”
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 18 of 57

10.7
The Agency notes that the specified controls do not address the risks associated with stationary container systems, nor do they allow for dispensation where it is unnecessary for any associated pipework to have secondary containment.
They also do not address all the risks associated with the unintended ignition of flammable substances. 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
7
. The proposed controls are shown in Table 5.1 of Appendix 5.
10.8
Control E7 relates to requirements for ecotoxic substances to be under the control of an approved handler. Noting the outcome of the environmental risk assessment, the Agency proposes to retain approved handler requirements for
Crest 520. It is proposed that the following control is substituted for Regulation
9(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations
2001 in accordance with Regulation 11(4)(b):
10.8.1
(1) Crest 520 must be under the control of an approved handler when the substance is –
(a) applied in a wide dispersive manner; or
(b) used by a commercial contractor.
10.9
Control TR1 relates to the requirements for a substance to be tracked and is triggered for Crest 520 only by virtue of its ecotoxicity. Consequently, the
Agency considers that any risks that may arise during its lifecycle are adequately managed by other controls such as approved handler, packaging, labelling and emergency management requirements. Thus, this control may be deleted.
10.10
The Agency considers that the following controls may be combined
8
for Crest
520 as they relate to the same requirements:
10.10.1
Controls F2 and T7 which relate to restrictions on the carriage of hazardous substances on passengers service vehicles.
10.10.2
Controls T4 and E6 which relate to requirements for equipment used to handle hazardous substances.
10.10.3
Controls P13 and P15 which relate to requirements for packaging hazardous substances.
10.10.4
Controls D2 , D4 and D5 which relate to requirements for disposal of
Crest 520.
7 section 77A(4)(a)
8 section 77(5)
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 19 of 57

10.11
The Agency considered the Authority’s approvals given to 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) .
10.12
The Agency considers that the customised controls listed in Appendix 5 should apply to Crest 520.
10.13
Section 96 provides that the Authority may identify and report to the Minister where it considers that a reduction in the likely occurrence of adverse effects similar to that achieved by the controls attached to any substance could be achieved by any environmental user charge, or a combination of an environmental user charge and controls.
10.14
The Agency considers that use of controls is the most effective means of managing the risks throughout the lifecycle of Crest 520. The imposition of an environmental user charge instead of, or in combination with controls, is therefore not required at this time.
11
11.1
The Agency considers the risks of Crest 520 to human health to be negligible.
11.2
While the Agency’s use quantitative and qualitative assessments identified a low acute risk to the aquatic environment during the use of Crest 520, uncertainty relating to a lack of chronic aquatic organism data means that a nonnegligible risk may exist. However, the Agency considers that the use of approved handlers, in conjunction with prohibiting the application of the substance into or onto water, will reduce the level of these risks to negligible .
11.3
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.
11.4
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 .
11.5
The Agency considers that there are potential benefits associated with the release of Crest 520 as are specified in Section 9 of this report.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 20 of 57

11.6
Thus, the Agency considers that it is evident that the benefits of releasing Crest
520 outweigh the costs.
12
12.1
Nufarm Ltd has applied for approval to import for release in New Zealand the substance identified as Crest 520.
12.2
The Agency considers Crest 520 triggers the following hazard classifications:

3.1D Flammability

6.1D Acute oral toxicity

6.3B Skin irritancy

6.4A Eye irritancy

6.9B Target organ systemic toxicity

9.1A Aquatic ecotoxicity

9.3B Terrestrial vertebrate ecotoxicity.
12.3
The Agency considers that there are negligible risks to the environment and human health and potential benefits associated with the release of Crest 520.
Therefore, the Agency considers that it is evident that the benefits of releasing
Crest 520 outweigh the costs and the application may be approved in accordance with clause 26.
12.4
The Agency considers the controls listed in Appendix 5 should apply to Crest
520.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 21 of 57

1
Review the content of the application and all relevant information
2
Is this information sufficient to proceed?
Yes
5
Identify the composition of the substance, classify the hazardous properties of the substance, and determine default controls
6
Identify all risks, costs and benefits that are potentially non-negligible
7
Assess each risk assuming controls in place.
Add, substitute or delete controls in accordance with clause 35 and sections77,
77A, 77B
8
Undertake combined consideration of all risks and costs, cognisant of proposed controls
No
3
Seek additional information
Yes
4
Sufficient?
9
Are all risks with controls in place negligible?
Clause 26
Yes
10
Review controls for cost-effectiveness in accordance with clause 35 and sections 77,
77A, 77B
Clause 27
No
12
Establish position on risk averseness and appropriate level of caution
13
Review controls for cost-effectiveness in accordance with clause 35 and sections 77, 77A, 77B
No
Decline
(section 29(1)(c))
11
Is it evident that benefits outweigh costs?
No
14
Assess benefits
Yes
16
Confirm and set controls
Approve
(section 29(1)(a))
Yes
15
Taking into account controls, do positive effects outweigh adverse effects?
No
Decline
(section 29(1)(b))
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 22 of 57

Data from effects testing of the formulation were not provided for all endpoints of
Crest 520. Where no data were available, classification was estimated using mixture rules based on information on the components. A summary of the physical, toxicity and ecotoxicity hazard classification associated with Crest 520 and its components is provided in Table A9.1 to A9.3 in Confidential Appendix 9. Formulation test data are detailed in these tables where applicable. The relevant sections of the User Guide to
Thresholds and Classifications under the HSNO Act (ERMA 2008a) that describe the mixture rules are listed in Table A2.1.
The Agency has adopted the Klimisch et al (1997) data reliability scoring system for evaluating data used in the hazard classification and risk assessment of chemicals
(section 1.2.4 in ERMA 2008a). The data used by the Agency to classify Crest 520 are predominantly the classifications which have been officially gazetted during the transfer process and are publicly available through the HSNO Chemical Classification
Information Database (CCID) (ERMA 2008b). Overall, the toxicity data are medium to high quality by current international standards. The available ecotoxicity data
(acute) concerning haloxyfop-P-methyl can be considered of high quality by current international standards but due to the lack of chronic aquatic ecotoxicity data the overall data quality is low.
The Agency acknowledges that there are frequently data gaps in the hazard classification for chemicals which have been in use internationally for a long time.
International programmes such as the OECD High Production Volume programme
(OECD 1990) and REACH (EU 2006) are progressively working towards filling these data gaps. As new information becomes available, and resources permit, the Agency will endeavour to update the HSNO classifications for those substances.
The effect of the lower quality data in CCID on the overall evaluation of the effects of
Crest 520 was significant because there are no chronic aquatic ecotoxicology data for the active ingredient. Current policy is to update these data pending reassessment of the substance.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 23 of 57

Table A2.1: Location of mixture rules within the User Guide to the Thresholds and Classifications in the HSNO Act (V2.0. March 2008) (ERMA 2008a).
Hazard User Guide to HSNO
Thresholds and
Subclass 6.1 Acute Toxicity
Subclass 6.3/8.2 Skin Irritancy/Corrosivity
Classifications Reference
Part V, Chapter 10, Page 12
Part V, Chapter 11, Page 7
Subclass 6.4/8.3 Eye Irritancy/Corrosivity Part V, Chapter 12, Page 9
Subclass 6.5 Contact and Respiratory Sensitisation Part V, Chapter 13, Page 8
Subclass 6.6 Mutagenicity
Subclass 6.7 Carcinogenicity
Part V, Chapter 14, Page 5
Part V, Chapter 15, Page 8
Subclass 6.8 Reproductive Developmental Toxicity Part V, Chapter 16, Page 11
Subclass 6.9 Target Organ Systemic Toxicity Part V, Chapter 17, Page 10
Subclass 9.1 Aquatic Ecotoxicity
Subclass 9.2 Soil Ecotoxicity
Subclass 9.3 Terrestrial Vertebrate Ecotoxicity
Part VI, Chapter 19, Page 18
Part VI, Chapter 20, Page 8
Part VI, Chapter 21, Page 7
Subclass 9.4 Terrestrial Invertebrate Ecotoxicity
References
Part VI, Chapter 22, Page 5
ERMA New Zealand (2008a) User Guide to HSNO Thresholds and Classifications.
ERMA New Zealand, Wellington.
ERMA New Zealand (2008b) HSNO Chemical Classification Information Database
(CCID) http://www.ermanz.govt.nz/hs/compliance/chemicals.html
European Union (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), establishing a European
Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as
Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC . http://reach.jrc.it/
Klimisch, HJ, Andreae, E, Tillman, U (1997). A systematic approach for evaluating the quality of experimental and ecotoxicological data. Regulatory Toxicology and
Pharmacology 25: 1–5.
OECD (1990) Manual for Investigation of HPV Chemicals. http://www.oecd.org/document/21/0,3343,en_2649_34379_1939669_1_1_1_1,00.htm
l Retrieved 23 January 2008.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 24 of 57

Quantitative risk assessments have been carried out to evaluate the level of risk to operators, bystanders and the environment arising from the use of Crest 520.
Qualitative assessments have been undertaken for all other stages of the lifecycle. In these cases, the level of risk has been evaluated on the basis of the magnitude and likelihood of adverse effects occurring to people or the environment (see Appendix 6 for a description of the scales used for qualitative assessment).
Assessment of risks to human health - manufacture
The Agency has qualitatively assessed the risks of Crest 520 to human health and safety during manufacture and considers the risks to be negligible .
This assessment is based on the following considerations:

The Agency considers that, while Crest 520 has the potential to cause a major adverse effect through its oral toxicity, workers handling the substance will be aware of the hazards and the measures that need to be undertaken to ensure their own safety and will not ingest sufficient substance to result in a major adverse effect. Even a moderate effect is highly improbable .

The Agency considers that it is highly improbable that workers will suffer skin or eye irritancy from Crest 520, given requirements for personal protective equipment (PPE), and compliance with HSNO information provisions (e.g. labels, advertising, Safety
Data Sheets (SDS)). Furthermore, the magnitude of skin/eye irritancy is considered minimal , given the temporary nature of effects.

Quantitative assessment of the chronic risks to human health associated with exposure to Crest 520 during use indicated an acceptable level of risk as long as PPE was used.
As workers involved in manufacture of Crest 520 will be required to comply with the requirements for PPE as well as comply with Department of Labour (DoL) requirements for health and safety, the Agency considers the level of risk to workers to be negligible .

The Agency considers the risk of repeated exposure to bystanders during manufacture is sufficiently remote that it is not necessary to address, given that the general public are normally excluded from manufacturing facilities.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 25 of 57

Assessment of risks to human health – importation, storage and transport
The Agency has qualitatively assessed the risk of Crest 520 to human health and safety during importation, transportation and storage and considers the risks to be negligible .
This assessment is based on the following considerations:

Workers and bystanders could only be exposed to the substance during transport and storage in isolated incidents where spillage occurs.

In these circumstances, the Agency considers it highly improbable that workers or bystanders will ingest sufficient Crest 520 to result in a moderate adverse effect.

The Agency considers that it is highly improbable that a spillage of Crest 520 will occur during importation, transport or storage and workers or bystanders will suffer skin or eye irritancy, given adherence to the HSNO controls (e.g. packaging, identification and emergency management) and the Land Transport Rule 45001, Civil
Aviation Act 1990 and Maritime Transport Act 1994 (as applicable). Furthermore, the magnitude of skin/eye irritancy is considered minimal , given the temporary nature of effects.

The Agency considers repeated exposure to the substance would be required in order to elicit target organ effects. As such, the Agency considers the risk of target organ effects from Crest 520 during importation, transport or storage to be sufficiently remote that it is not necessary to address, given that exposure could only occur in isolated spillage incidents.
Assessment of risks to human health - disposal
The Agency has qualitatively assessed the risk to human health and safety during disposal of
Crest 520, and considers the risks to the health and safety of people to be negligible .
This assessment is based on the following considerations:

If Crest 520 is disposed of by means other than use, this will be in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001 and the
Resource Management Act 1991.

The Agency considers that it is highly improbable that users or bystanders could inadvertently ingest sufficient Crest 520 during disposal to result in an acute moderate effect, given that Crest 520 will generally be disposed of by use or in accordance with
HSNO controls for disposal (e.g. disposal information requirements on labels and
SDS).

The Agency considers that it is highly improbable that workers will suffer skin or eye irritancy from Crest 520 during disposal, given that Crest 520 will generally be disposed of by use. Furthermore, the magnitude of skin/eye irritancy is considered minimal , given the temporary nature of effects.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 26 of 57


The Agency notes that quantitative assessment of the chronic risks to operators associated with exposure to Crest 520 during use indicated an acceptable level of risk as long as PPE is used. This assessment includes the possibility of prolonged and repeated exposure to Crest 520 during use. The Agency considers it is less likely that workers or bystanders could be repeatedly exposed to Crest 520 during disposal to such an extent that target organ toxicity effects occur and therefore considers the chronic risk to human health during disposal of Crest 520 to be negligible .
Assessment of risks to human health - use
The Agency has qualitatively assessed the acute risks of Crest 520 to human health and safety during use and considers the risks to be negligible .
This assessment is based on the following considerations:

The Agency considers that it is highly improbable that users or bystanders could inadvertently ingest sufficient Crest 520 during use to result in an acute moderate effect, given that Crest 520 will be used in accordance with HSNO controls (e.g. PPE, approved handlers).

The Agency considers that it is highly improbable that users will suffer skin or eye irritancy from Crest 520, given the HSNO requirements for PPE, approved handlers and provision of hazard and precautionary information on the product label.
Furthermore, the magnitude of skin/eye irritancy is considered minimal , given the temporary nature of the effects.
Operator exposure assessment
The Agency has undertaken an assessment of risks to operator health using the United
Kingdom Pesticide Safety Directorate’s interpretation of the German BBA Model to estimate operator exposure to haloxyfop-P-methyl during the use of Crest 520. 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). The derived values consider both dermal and inhalation exposure routes.
The BBA model can use either the geometric mean or the 95th percentile model - the geometric mean was used for assessing Crest 520 as it was considered appropriate for regulatory use. The BBA model provides for a range of different spray applications (tractormounted/trailed sprayers and hand-held sprayers) and formulation types (liquid, wettable powder and wettable granule). Additionally, the BBA model also allows flexibility to vary protective clothing (hands, head and body). Five different scenarios were modeled for Crest
520 as shown in Table A3.1.
The applicant states that the maximum application rate of Crest 520 is as follows:

1.45L Crest 520/ha (equivalent to 0.82 kg a.i./ha).
The Agency has used this maximum application rate for conducting an operator exposure assessment. Table A3.1 details the estimated exposure for each scenario modeled. The following points have been taken into account for the purposes of calculating the estimated
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 27 of 57

exposure. For each model only the conservative scenario as described below, has been addressed:
 an application rate of 0.82 kg ai/ha;
 the substance is sprayed using a tractor mounted/ boom sprayer with hydraulic nozzles;
 a work rate of 20 hectares per day (the default value for boom sprayers used in the
German BBA model) is used in the absence of specific work rate data in the New
Zealand context;

7% and 12% percutaneous absorption values were used for the concentrate and diluted substance, respectively ( EFSA Report: Conclusion regarding the peer review of the pesticide risk assessment of the active substance haloxyfop-P (haloxyfop-R), 28 July
2006.); and
 the bodyweight for operators is set at 70 kg.
Table A3.1: Estimated exposure to haloxyfop-P-methyl for 70 kg operator under five different exposure scenarios as predicted from the UK PSDs interpretation of the BBA
Model
Exposure scenario Estimated operator Exposure (mg/kg bw/day)
No personal protective clothing and equipment (PPE) during mixing, loading and application
0.097
Gloves only during mixing and loading 0.058
Gloves only during application 0.086
Full PPE during mixing, loading and application (excluding respirator)
0.003
Full PPE during mixing, loading and application (including respirator)
0.0028
Calculation of Acceptable Operator Exposure Level (AOEL)
The toxicological endpoint for assessment of occupational (worker) and bystander risks is the
AOEL (Acceptable Operator Exposure Level). The AOEL is the maximum daily dose considered to be without adverse health effect for operators, workers and bystanders. It is based on the most appropriate NOAEL from relevant studies and is calculated by dividing the
NOAEL by one or more uncertainty (safety) factors selected on the basis of the extent and quality of the available data, the species for which data are available and the nature of the effects observed.
AOEL = NOEL (most relevant study)
Safety Factors
Selection of NOEL:
From the 1 year dog study a NOAEL of 0.5 mg/kg bw/d was derived based on increased liver weights.
With respect to assigning an appropriate NOAEL to calculate the AOEL, the Agency has taken the likely duration and frequency of worker exposure into consideration. Given these factors, the Agency considers it appropriate to use the NOAEL of 0.5 mg/kg bw/day from the
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 28 of 57

study detailed above. This is consistent with the EFSA (European Food Safety Authority)
2006 report on their calculation of the AOEL.
In calculating the AOEL, the Agency has used a combined safety factor of 100 to account for intra- and interspecies variation. In the absence of specific oral absorption data for haloxyfop-
P-methyl, the Agency has assumed 100% oral absorption.
AOEL = 0.5 mg/kg bw/day x 100% = 0.005 mg/kg bw/day .
100
Calculation of Risk Quotients and operator risk assessment
To assess the risks to operators the Agency has divided the estimated exposure values as calculated from the exposure modeling by the AOEL to derive a risk quotient (RQ) for each exposure scenario modeled (Table A3.2).
RQ = Estimated Operator (or Bystander) Exposure
AOEL
An RQ > 1 indicates the likelihood of a risk to the operator (or bystander).
Table A3.2: Risk quotients determined for each exposure scenario for Crest 520.
Exposure scenario Estimated operator
RQ
No PPE during mixing, loading and application exposure (mg/kg bw/day)
0.097 19.4
Gloves only during mixing and loading
0.058 11.6
Gloves only during application 0.086
Full PPE during mixing, loading 0.003 and application (excluding respirator)
0.0028 Full PPE during mixing, loading and application (including respirator)
17.2
0.6
0.56
The only exposure situations in which risks to operators is considered to be acceptable (RQ <
1) is when full PPE is worn during mixing, loading and applying the substance, either with or without a respirator. This indicates full PPE should be worn by operators when mixing, loading and/or applying Crest 520. The Agency notes that PPE is triggered as a default control for Crest 520 as a result of its 6.1D and 6.9B classifications.
Re-entry Time following use
The Agency assessed the re-entry worker exposures to haloxyfop-P-methyl from the use of
Crest 520, but using the guidance provided by the Chemicals Regulation Directorate:
Pesticides (CRD) on the following web site:
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 29 of 57

http://www.pesticides.gov.uk/applicant_guide.asp?id=1246&link=%2Fuploadedfiles%2FWeb
%5FAssets%2FPSD%2FRe%2Dentry%2520worker%2520guidance%5Ffinal%2520version%
2Epdf
The formula applied is:
D = DFR x TC x WR c AR x P
Where:
D =
Dermal exposure [µg a.s./person/day] (a.s. represents the “active substance” in this case, haloxyfop-P-methyl)
DFR = Dislodgeable Foliar Residue per kg a.s./ha
TC = Transfer coefficient [cm2/hour]
WR =
AR =
Work rate [8 hours/day]
Application rate [kg a.s./ha]
P = Protection factor (for use of clothing) [A value of 1 is used assuming no clothing such as a long sleeved shirt is worn to protect the skin from exposure.]
In the case of Crest 520, since the product is an herbicide it is assumed that use near time of harvest is unlikely. The TC value of 2,500 cm2/hr for vegetables “reach and pick” has been used from the Guidance document (rather than higher values for activities associated with more foliage contact):
Therefore the values are:
DFR = the default value has been applied, 3 µg of a.s./square cm of foliage/kg a.s per hectare.
0.82 kg a.i./ha is the highest application rate. This assumes only a single application is made.
As there are no available experimental data for the decay of the active ingredient on crops, this estimate assumes no decay of residues during treatments.
TC = 2500 cm2/h
WR = 8 hours per day
P = 1
So D = DFR x TC x WR x AR x P
= (3 x 2,500 x 8 x 0.82 x 1)
= 49,200 µg a.s. per person per day (as a dermal exposure)
If the assumption is made that 12% of the haloxyfop-P-methyl that reaches the skin is absorbed (as previously), the intake for the re-entry worker from this estimate on a per kg bw basis assuming a 70 kg body weight and converting µg to mg is:
[49,200 x 0.12]/[1000 x 70]
= 0.08 mg/kg bw/day
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 30 of 57

The AOEL is 0.005 mg/kg bw/day, so the above estimate suggests that the intake for the reentry worker may be associated with an RQ value of 16, which is about 16 times the acceptable intake level.
The Agency considers it is appropriate to address this exposure risk; however, to remain consistent with previous decisions on substances with a similar use pattern and hazard, the
Agency is not proposing to add this as a section 77A control. The Agency recommends that the label should contain a statement similar to that stated below to address this exposure risk:
“If re-entry work is required within 24 hours of application personal protective equipment should be worn”
Public health exposure and risk assessment
The main potential source of exposure to the general public from Crest 520 (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 spraydrift. The results from the quantitative modeling of operator exposure indicate there is a risk to operators from Crest 520 if full PPE is not worn.
The Agency has undertaken an assessment of risks to public/bystander health using the
United Kingdom Chemicals Regulation Directorate, Pesticides (CRD) current formula to assess public/bystander exposure for pesticides which are of low volatility and which are typically applied as sprays either by boom sprayers, broadcast air assisted sprayers or hand held sprayers http://www.pesticides.gov.uk/applicant_guide.asp?id=1246&link=%2Fuploadedfiles%2FWeb
%5FAssets%2FPSD%2FBystander%2520exposure%2520guidance%5Ffinal%2520version%
2Epdf (PSD 2008)
Systemic exposure = {(PDE x SC x %absorbed) + (PIE x SC x 100%)}/BW
PDE
(potential dermal exposure)
SC
(concentration of haloxyfop-
P-methyl in
% absorbed
(percentage dermal
PIE
(potential inhalation exposure)
BW (bodyweight
(70 kg).
Tractormounted/trailed boom sprayer: hydraulic
0.1 ml spray spray)
1.87 mg/ml absorption)
12% 0.006 ml spray
70 kg nozzles
SC calculation: Draft label recommends maximum application rate: 1450 ml product/ha with 400 L of water/ha.
SC (haloxyfop-P-methyl) =1450/400 x % a.i/100
= 1450/400 x 51.5/100
= 1.87 g/L or 1.87 mg/ml
The following measurements as used by CRD have been adopted by the Agency for the purposes of calculating the estimated exposure from spray drift:

For boom spray, the average potential dermal exposure for a bystander, positioned 8 meters downwind from the sprayer and the average estimated amount of spray passing through the breathing zone are 0.1 and 0.006 ml spray/person, respectively.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 31 of 57

Using these data, exposure to haloxyfop-P-methyl from the use of Crest 520 can be estimated as follows assuming no protection from clothing and 100% inhalation, retention and absorption of PIE:
Systemic exposure = (PDE x SC x % absorbed) + (PIE x SC x 100%).
BW
= (0.1 x 1.87 x 0.12)+ (0.006 x 1.87 x 1)
70
= 0.00048 mg/kg bw/day
RQ = Systemic exposure/AOEL (0.005 mg/kg bw/day) = 0.096
Risks to the general public are considered to be at acceptable levels (RQ < 1) from ground based applications.
Risks from Aerial Application
As noted for risks to bystanders, the Chemicals Registration Directorate (CRD)’s Bystander
Model does not consider risk arising from aerial application of a substance. The Agency acknowledges that spray drift from aerial applications is likely to be greater than for ground based applications, potentially increasing bystander exposure. The Agency notes that although any potential bystanders will not be wearing PPE, they will not be directly handling the substance. Applying a drift factor of 13% (aerial/high boom spray) determined in the
GENEEC 2 environmental exposure modeling, the Agency initially estimates the exposure of bystanders to be 13% of the operator exposure in the BBA Model above.
Bystander exposure is therefore estimated to be 13/100 x 0.097 mg/kg bw/day = 0.013mg/kg bw/day. When this value is divided by the AOEL for haloxyfop-P-methyl (0.005 mg/kg bw/day), RQ of 2.5 is determined which would suggest that the risk exceeds acceptable level for bystanders (RQ < 1). However, the Agency notes that this estimate assumes the bystander is exposed during mixing/loading, which is not the case. Bystanders will be exposed during spray activities.
The BBA model indicates that the total systemic exposure for spray activities is 4 mg/day
Taking 13% of exposure from the spray activity only gives an estimated intake for the bystander of:
(13/100 x 4)/70 = 0.0074 mg/kg bw/day.
This systemic dose divided by the AOEL (0.005 mg/kg bw/day) gives a revise RQ estimate of
1.49.
Based on the risk quotient of 1.49, bystander exposure is still NOT acceptable. However, the
Agency notes that the risk quotient is a tool and considering that if rounding was employed it would be 1. The proposal is for the substance to only be applied once a year and that the bystanders will be exposed to diluted product (and thus what the bystanders may be exposed
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 32 of 57

to may no longer be irritant etc). Therefore it is considered that Crest 520 is not going to be an unacceptable risk to bystanders.
Summary and conclusions of the human risk assessment
The outcome of the quantitative assessment of risks posed to operators from the use of Crest
520 indicates that a significant risk to health of operators is likely to be posed without full
PPE. Therefore, full personal protective equipment is required which will be provided for on the label and in the T5 control. A significant risk is also estimated to be possible from reentry unless personal protective equipment is worn.
Quantitative assessments of risks posed to the general public from the use of Crest 520 are considered to be at acceptable levels and the default controls triggered by the toxicity hazards associated with the substance are sufficient to mitigate risks, and this applies whether to both ground and aerial application.
Assessment of environmental risks - manufacture, importation, transport and storage
The Agency has qualitatively assessed the risks to the environment of Crest 520 during manufacture, importation, transportation and storage and considers the risks to be negligible.
This assessment is based on the following considerations:

The magnitude of adverse effects on the environment from a spillage during manufacture, importation, transport or storage are considered by the Agency to be moderate , as although the substance is very toxic to the aquatic environment and toxic to terrestrial vertebrates, any spill would involve small quantities which would lead to localised effects only.

The Agency also considers such an event to be highly improbable given adherence to the HSNO controls (e.g. packaging, identification and emergency management) and the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act
1994 (as applicable).
Assessment of environmental risks – disposal
The Agency has qualitatively assessed the risks to the environment of disposal of Crest 520 and considers the risks to be negligible .
This assessment is based on the following considerations:

Crest 520 will generally be disposed of by normal use as a herbicide.

If Crest 520 is disposed of by means other than use, this will be in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001 and the
Resource Management Act 1991. The Agency considers the likelihood of adverse effects to the environment arising from disposal to be highly improbable and the magnitude of such effects minor .
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 33 of 57

Assessment of environmental risks - use
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 LC
50
or EC
50
, gives a risk quotient (RQ).
Acute RQ = EEC short term
LC
50
or EC
50
Chronic RQ = EEC long 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 control (AH) 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 AH control can then be removed on a selective basis.
Levels of concern (LOC) developed by the USEPA (Urban and Cook 1986) and adopted by the Agency, to determine whether a substance poses an environmental risk are provided in
Table A3.3.
Table A3.3: 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
Chronic RQ≥
1
Low risk
High chronic risk
Plants (aquatic and terrestrial)
Acute RQ≥
1 High acute risk
Mammals and birds
Acute dietary
RQ≥
0.5
Acute oral dose 0.5
[granular products] RQ≥
Chronic RQ≥
1
High acute risk
High acute risk
High chronic risk
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 34 of 57

Aquatic risk
Assessment of Expected Environmental Concentration
The Agency has used the Generic Estimated Environmental Concentration Model v2
(GENEEC2) surface water exposure model (USEPA 2001) to estimate the EEC of haloxyfop-
P-methyl 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 used in the GENEEC2 modeling are listed in Table A3.4 and represent the recommended use on Pampas grass (highest rate) a conservative estimate.
Table A3.4: Input parameters for GENEEC2 analysis.
Haloxyfop-P-methyl Reference
Application rate 0.82 kg ai/ha Product label
Application frequency
Application interval
K oc
Aerobic soil DT
50
Pesticide wetted in?
Methods of application
Once per season
NA
75
14
No
Aerial
Boom
NA
9.08
Applicant
NA
CCID 2008
CCID 2008
Product label
Product label
‘No spray’ zone
Water solubility CCID 2008
Aerobic aquatic DT
50
48 CCID 2008
Aqueous photolysis DT
50
No Data
Output from the GENEEC2 model.
The Estimated Environmental Concentration (EEC) for haloxyfop-P-methyl as estimated by
GENEEC2 are:
RUN No. 1 FOR Haloxyfop-R-meth ON Weeds * INPUT VALUES *
--------------------------------------------------------------------
RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)
--------------------------------------------------------------------
.730( .730) 1 1 75.0 9.1 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)
--------------------------------------------------------------------
14.00 2 N/A .00- .00 48.00 48.00
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
--------------------------------------------------------------------
36.36 35.95 33.56 28.83 25.80
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 35 of 57

Peak EEC: 36.36 µg/L or 0.03939 mg/L (aerial spray)
Chronic EEC: No chronic toxicity data available
Assessment of acute risk
Table A3.5: Aquatic Ecotoxicity endpoints to be used in risk assessment.
Acute risk Chronic risk
Species
Fish
Crustacea
LC/EC
50
(mg/L) Species
0.7 Fish
6.12 Crustacea
NOEC (mg/L)
No data
No data
Algae 1.72
Table A3.6: Acute risk quotients derived from the GENEEC2 model and toxicity data.
Peak EEC from
GENEEC2 (mg/L)
LC
50
or EC
50
(mg/L)
RQ (Acute)
EEC/ LC
50
or EC
50
Fish 0.03636 0.7
0.0519
Crustacea 6.12 0.0059
Algae 1.72
0.0211
When compared against the relevant acute levels of concern (Table A3.3), the acute RQs derived from the GENEEC2 modeling for haloxyfop-P-methyl indicate the following:
For fish and crustacean: the acute risk is low
For algae: the acute risk is low
Aerial application was modeled as it will give the worst case scenario. From the acute assessment low risk is shown where data are present, therefore ground application was not modeled.
Assessment of chronic risk
As no chronic ecotoxicity data was available for haloxyfop-P-methyl, no estimation of chronic risk was able to be made.
From EFSA (2006):
“Haloxyfop-R methyl ester is very toxic to aquatic organisms, fish being the most sensitive group of organisms. Risk mitigation comparable to 5 m buffer zones is required to meet the
Annex VI trigger.”
Terrestrial Risk
Haloxyfop-P-methyl is sprayed at a maximum application rate of 0.82 kg a.i./ha or 82 mg a.i./m 2 .
If it assumed that haloxyfop-P-methyl is dispersed to a depth of 0.05 m and the density of soil is 1500 kg/m
3
, then the 82 mg a.i./m
2
haloxyfop-P-methyl will be dispersed within 75 kg of soil/m
2
giving 82/75 = 1.093 mg/kg.
If it is assumed that 13% (spray scenario, ie aerial/high boom) of the haloxyfop-P-methyl will reach directly outside the target area (an assumption based on GENEEC2 modeling), then the
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 36 of 57

concentration of haloxyfop-P-methyl adjacent to a sprayed field would be 1.093 x 0.13 =
0.14213 mg/kg soil.
Haloxyfop-P-methyl generates an EC
50
value of 1343 mg/kg for earthworms. Consequently, haloxyfop-P-methyl (aerial) results in a risk quotient of EEC/EC
50
= 0.00011 (outside the target area).
No evaluated studies are available to conclude on the risk to non-target plants (EFSA 2006).
Summary and conclusions of the ecological risk assessment
Based on the risk assessment for the aquatic and terrestrial environment as set out above, no risks to aquatic and terrestrial risks have been identified.
However, a high degree of uncertainty has been caused by the lack of chronic aquatic ecotoxicity data for haloxyfop-P-methyl. In addition, this active ingredient is not rapidly degradable and there is the potential for adverse environmental effects on fish if the substance moves off-target (EFSA, 2006).
The Agency considers it is appropriate to introduce the approved handler control due to the uncertainty caused by the lack of chronic aquatic organism data.
EFSA (2006) 87, 1-96. Conclusion on the peer review of haloxyfop-R
ERMA New Zealand (2008a) User Guide to HSNO Thresholds and Classifications.
ERMA
New Zealand, Wellington.
Urban DJ, Cook, NJ (1986) Hazard Evaluation Division Standard Evaluation Procedure:
Ecological Risk Assessment . EPA 540/9-85-001. United States Environmental Protection
Agency Office of Pesticide Programs, Washington DC, USA.
USEPA (2001) Generic Estimated Environmental Concentration Model v2 (GENEEC2).
United States Environmental Protection Agency Office of Pesticide Programs, Washington
DC, USA http://www.epa.gov/oppefed1/models/water/index.htm#geneec2
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 37 of 57

Based on the hazard classification as shown in Table 6.1, the set of associated controls has been identified. These default controls, expressed as control codes 9 , are listed in Table A4.1.
Table A4.1: List of default controls for Crest 520
Flammability Controls
F2 Restrictions on the carriage of flammable substances on passenger service vehicles
F6 Requirements to prevent unintended ignition of class 2.1.1, 2.1.2 and 3.1 substances
F11 Segregation of incompatible substances
Toxicity Controls
I20
I21
I23
I25
I28
I29
I30
I3
I5
I8
I9
I11
I13
I16
I17
I18
I19
T1
T2
T4
T5
Limiting exposure to toxic substances through the setting of TELs
Controlling exposure in places of work through the setting of WESs.
Requirements for equipment used to handle substances
Requirements for protective clothing and equipment
T7 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles
Ecotoxicity Controls
E1
E2
Limiting exposure to ecotoxic substances through the setting of EELs
Restrictions on use of substances in application areas
E5
E6
Requirements for keeping records of use
Requirements for equipment used to handle substances
E7 Approved handler/security requirements for certain ecotoxic substances
Identification Controls
I1 Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability
Priority identifiers for ecotoxic substances
Priority identifiers for flammable substances
Priority identifiers for toxic substances
Secondary identifiers for all hazardous substances
Secondary identifiers for ecotoxic substances
Secondary identifiers for flammable substances
Secondary identifiers for toxic substances
Use of generic names
Requirements for using concentration ranges
Additional information requirements, including situations where substances are in multiple packaging
Durability of information for class 6.1 substances
General documentation requirements
Specific documentation requirements for ecotoxic substances
Specific documentation requirements for flammable substances
Specific documentation requirements for toxic substances
Signage requirements
Advertising corrosive and toxic substances
9 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.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 38 of 57

Packaging Controls
P1
P3
P13
P15
General packaging requirements
Criteria that allow substances to be packaged to a standard not meeting Packing Group I,
II or III criteria
Packaging requirements for toxic substances
Packaging requirements for ecotoxic substances
PG3
PS4
Packaging requirements equivalent to UN Packing Group III
Packaging requirements as specified in Schedule 4
Disposal Controls
D2
D4
D5
D6
D7
Disposal requirements for flammable substances
Disposal requirements for toxic or corrosive substances
Disposal requirements for ecotoxic substances
Disposal requirements for packages
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
EM6
EM7
EM8
EM9
EM10
EM11
EM12
EM13
Tracking
Level 1 information requirements for suppliers and persons in charge
Information requirements for toxic substances
Information requirements for ecotoxic substances
Level 2 information requirements for suppliers and persons in charge
Additional information requirements for flammable and oxidising substances and organic peroxides
Fire extinguisher requirements
Level 3 emergency management requirements: duties of person in charge, emergency response plans
Level 3 emergency management requirements: secondary containment
Level 3 emergency management requirements: signage
TR1 General tracking requirements
Personnel Qualifications
AH1 Approved Handler requirements (including test certificate and qualification requirements)
Tank Wagon and Transportable Containers Controls
The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a number of controls relating to tank wagons and transportable containers.
Those controls which require calculations, derivations or extended discussion are considered in the following sections.
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.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 39 of 57

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 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.
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).
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
(iii) other matter that might be ingested; AND
(b) 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
(c) exposure to the substance is likely to result in an appreciable toxic effect.
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.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 40 of 57

The toxicity (Class 6) classifications of Crest 520 that trigger the need to consider setting a
TEL are 6.1D, 6.3B, 6.4A, 6.9B.
For Crest 520, the Agency considers that haloxyfop-P-methyl fulfill the requirements of
Regulation 11(1)(a), (b) and (c), and therefore notes that an ADE is required to be set for this component. Given the specific use of Crest 520, the Agency considers that the principal source of exposure of the general public to the substance is via food residues, an exposure route managed by the NZFSA through the setting of MRLs. The Agency notes that MRLs have been set for haloxyfop-P-methyl and is applicable to the use of Crest 520.
The Agency notes that an ADE of 0.0003 mg/kg bw/day has already been set for haloxyfop-
P-methyl in a previous Part 5 application (application number HSR05077). The following
PDE values for haloxyfop-P-methyl were also set in that application: PDE food
= 0.00024 mg/kg bw/day and PDE drinking water
= 0.00006 mg/kg bw/day . The Agency proposes that these values are set for haloxyfop-P-methyl in Crest 520. The Agency is intending to review the setting of ADEs, PDEs and TELS under section 77B of the Act and until this review is complete, the Agency proposes not to set any TELs for haloxyfop-P-methyl.
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/m
3
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 matters described in Regulation 30(2) of the Hazardous Substances (Classes 6, 8 and 9
Controls) Regulations 2001.
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
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 41 of 57

The Agency notes that no Department of Labour and/or HSNO WES values have been set for any of the components of Crest 520. Also, no values have been found to have been set by any relevant overseas body that the Agency monitors. This indicates that the conditions of
Regulation 29(1)(c) are not met as the Agency is not aware of industrial hygiene data for
Crest 520 that would enable a WES to be set for any of the constituent components.
Therefore no WES values are proposed for any components of Crest 520 at this time.
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.
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 any components of Crest 520 at this time. It is also proposed that the default EEL water and soil values be deleted until the policy has been established.
Approved handler requirements have been triggered for Crest 520 as a result of its 9.1A classification. The outcome of the ecological risk assessment (refer Appendix 3) indicates that there is low potential for acute adverse environmental effects on aquatic and terrestrial organisms if the substance moves off-target. However, there is a high degree of uncertainty caused by the lack of chronic aquatic ecotoxicity data for haloxyfop-P-methyl and therefore the Agency considers it is appropriate to retain the approved handler control.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 42 of 57

This approach is consistent with the Authority’s policy on approved handler and tracking controls for class 9 substances (November 2003).
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.
The Agency has not set an application rate for Crest 520 based on the controls placed on similar products.
Other controls required as a result of the ecological risk assessment.

This substance is not to be applied onto or into water.
The Hazardous Substances (Identification) Regulations 2001 specify that certain toxic 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 toxic 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.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 43 of 57

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
Cut-off for label (% w/w) Cut-off for SDS (% w/w)
0.1 0.1
1 1
6.7B
6.8A, 6.8C
6.8B
6.9A, 6.9B
1
0.3
3
10
0.1
0.1
0.1
1
Crest 520 - 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
Haloxyfop-P-methyl
Documentation
Haloxyfop-P-methyl
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 44 of 57

Table A5.1: Proposed controls for Crest 520 – codes, regulations and variations.
Control
Code 10
Regulation
11
Topic Variations
Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001
F2 8 General public transportation restrictions and requirements for all class 1 to 5 substances
Controls F2 and T7 are combined.
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
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
T1 11-27
T2 29, 30
T4/E6 7
T5
T7
E1
E2
8
10
32-45
46-48
Limiting exposure to toxic substances
No TEL values are set at this time.
The following ADE and PDE values are set for Haloxyfop-R-methyl:
ADE = 0.0003 mg/kg bw/day
PDE food
= 0.00024 mg/kg bw/day
PDE drinking water
= 0.00006 mg/kg bw/day
No WES values are proposed for any components of Crest 520 at this time.
Controls T4 and E6 are combined.
Controlling exposure in places of work
Requirements for equipment used to handle hazardous substances
Requirements for protective clothing and equipment
Restrictions on the carriage of toxic or corrosive substance on passenger service vehicles
Limiting exposure to ecotoxic substances
Restrictions on use within application area
Controls F2 and T7 are combined.
No EEL values are set at this time and the default EELs are deleted.
As no EELs have been set, no application rate is required to be set under this control at this time.
10 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.
11 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 45 of 57

Control
Code 10
E5
Regulation
11
5(2), 6
Topic Variations
E7 9
Requirements for keeping records of use
Approved handler/security requirements for certain ecotoxic substances
The following control is substituted for Regulation 9(1) of the Hazardous
Substances (Classes 6, 8, and 9
Controls) Regulations 2001:
(1) Crest 520 must be under the personal control of an approved handler when the substance is -
(a) applied in a wide dispersive manner; or
(b) used by a commercial contractor.
Hazardous Substances (Identification) Regulations 2001
I1
I3
I5
I8
I9
I11
I13
I16
I17
I18
I19
6, 7, 32-35,
36 (1)-(7)
9
11
14
18
20
22
25
26
27
29-31
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
Priority identifiers for ecotoxic substances
Priority identifiers for flammable substances
Priority identifiers for toxic substances
Secondary identifiers for all hazardous substances
Secondary identifiers for ecotoxic substances
Secondary identifiers for flammable substances
Secondary identifiers for toxic substances
Use of Generic Names
Use of Concentration Ranges
Alternative information in certain cases
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 46 of 57

Control
Code 10
Regulation
11
I20
I21
I23
I25
I28
I29
I30
36(8)
37-39, 47-
50
41
43
46
51-52
53
Topic
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
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
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
Specific documentation requirements for ecotoxic substances
Specific documentation requirements for flammable substances
Specific documentation requirements for toxic substances
Duties of persons in charge of places with respect to signage
Advertising corrosive and toxic substances
Variations
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 47 of 57

Control
Code 10
Regulation
11
Topic
Hazardous Substances (Packaging) Regulations 2001
Variations
P1
P3
P13
P15
PG3
PS4
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
Regulation 9A and 9B – Large
Packaging
9 Packaging requirements for substances packed in limited quantities
19
21
Packaging requirements for Crest
520
Schedule 3 The tests in Schedule 3 correlate to the packaging requirements of UN
Packing Group III (UN PGIII).
Schedule 4 This schedule describes the minimum packaging requirements that must be complied with when a substance is packaged in limited quantities
Controls P13 and P15 are combined.
Hazardous Substances (Disposal) Regulations 2001
D2
D4
D5
D6
D7
D8
6
8
9
10
11, 12
13, 14
Disposal requirements for Crest 520
Disposal requirements for packages
Disposal information requirements
Disposal documentation requirements
Controls D2, D4 and D5 are combined
Hazardous Substances (Emergency Management) Regulations 2001
EM1
EM6
EM7
EM8
EM9
6, 7, 9-11
8(e)
8(f)
12-16, 18-
20
17
Level 1 emergency management information: General requirements
Information requirements for toxic substances
Information requirements for ecotoxic substances
Level 2 emergency management documentation requirements
Additional information requirements for flammable and oxidising
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 48 of 57

Control
Code 10
Regulation
11
Topic Variations
EM10 21-24
EM11 25-34
EM12 35-41 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 whether a place is required to have a secondary containment system; and
(b) is not required to be located in a secondary containment system.
(5) 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.
EM13 42 Level 3 emergency management requirements – signage
Hazardous Substances (Personnel Qualifications) Regulations 2001
AH1 4 - 6 Approved handler requirements
(including test certificate and qualification requirements)
Refer control 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
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 49 of 57

Control
Code 10
Regulation
11
Topic Variations 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.
Crest 520 shall not be applied onto or into water.
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 50 of 57

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 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).
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 1 and 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.
Table 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 communities 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
Major 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)
Significant irreversible adverse health effects affecting individuals and requiring hospitalisation
Massive 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
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 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
Minor
Local/regional short-term beneficial economic effects on small organisations (businesses, individuals), temporary job creation
No social effect
Mild short term beneficial health effects to identified and isolated groups
Localised and contained beneficial environmental impact, no discernible ecosystem impact
Moderate
Regional beneficial economic effects on small organisations (businesses, individuals) lasting less than six months, temporary job creation
Minor localised community benefit
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
Massive
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.
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
The likelihood 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 not the likelihood of an organism escaping, or the frequency of accidents for trucks containing hazardous substances, but the likelihood of the specified adverse effect 12 resulting from that initiating event. It will be a combination of the likelihood of the initiating event and several intermediary likelihoods
13
. 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).
12 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.
13 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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Table 3 Likelihood
Descriptor Description
Highly improbable Almost certainly not occurring but cannot be totally ruled out
Very unlikely Considered only to occur in very unusual circumstances
Could occur, but is not expected to occur under normal operating conditions.
Unlikely (occasional)
Likely
A good chance that it may occur under normal operating conditions.
Highly likely
Almost certain, or expected to occur if all conditions met
Using the magnitude and likelihood tables a matrix representing a level of risk/benefit can be constructed.
In the example shown in Table 4, four levels of risk/benefit are allocated: A (negligible), B
(low), C (medium), and D (high). These terms have been used to avoid confusion with the descriptions used for likelihood and magnitude, and to emphasise that the matrix is a tool to help decide which risks/benefits require further analysis to determine their significance in the decision making process.
For negative effects, the levels are used to show how risks can be reduced by the application of additional controls. Where the table is used for positive effects it may also be possible for controls to be applied to ensure that a particular level of benefit is achieved, but this is not a common approach. The purpose of developing the tables for both risk and benefit is so that the risks and benefits can be compared.
Table 4 Level of risk
Likelihood
Highly improbable
Very unlikely
Unlikely
Likely
Highly likely
Magnitude of effect
Minimal
A
Minor
A
A
A
B
B
A
B
B
C
Moderate
A
B
B
C
C
Major
B
B
C
C
D
Massive
B
C
C
D
D
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 53 of 57

Aakland Chemicals (1997) Limited
AgBio Research Limited
Agcarm Incorporated
AgResearch Limited
Agronica New Zealand Limited
ARPPA
BALDWINS
BASF New Zealand Limited
Bayer New Zealand Limited
BOC Limited
Chancery Green
Chemagro New Zealand Limited
Chemsafety Limited
Crown Public Health
DuPont (New Zealand) Limited
Far North District Council
Federated Farmers of New Zealand (Incorporated)
Fish and Game Eastern Region
Grayson Wagner Company Ltd
Greater Wellington - The Regional Council
Green Party of Aotearoa New Zealand
Hawkes Bay Regional Council
IMCD New Zealand Limited
Kaipara District Council
Kawerau District Council
Landcorp Farming Limited
Lowndes Associates
MAF Biosecurity New Zealand (MAFBNew Zealand)
Ministry of Research Science and Technology (MoRST)
Napier Health Centre - Public Health Unit
New Zealand Bee Industry Group - Federated Farmers
New Zealand Chemical Industry Council Inc
New Zealand Customs Service
New Zealand Meatworkers Union
New Zealand Press Association
New Zealand Society of Gunsmiths Inc
Ngati Kahungunu Iwi Incorporated
Northland Health
Nufarm New Zealand Limited
Pacific Building Steel Group
Pacific Growers Supplies Limited
ERMA New Zealand Evaluation and Review Report: Application HSR09042 Page 54 of 57

Pesticide Action Network Aotearoa New Zealand
PharmVet Solutions
Physicians and Scientists for Global Responsibility (PSGR)
Rangitikei District Council
Reckitt Benckiser
Selleys Pty Ltd (ORICA)
South Taranaki District Council
Sustainability Council of New Zealand
Syngenta Crop Protection Limited
Taranaki Regional Council
Tasman District Council
Technical Strategy Group Limited
Television New Zealand
The National Beekeepers Association of New Zealand
The New Zealand Institute for Plant and Food Research Limited
TMP Consultancy
Wellington City Council
Zelam Limited
6 Private Individuals
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