Application for approval to import or manufacture Tui Disease Eliminator for release

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EPA STAFF EVALUATION AND REVIEW REPORT

Application for approval to import or manufacture Tui Disease Eliminator for release

APP202057

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Application for approval to import and manufacture Tui Disease Eliminator for release (APP202057)

Executive Summary

1. Tui Products Limited has applied for approval to manufacture Tui Disease Eliminator, containing

chlorothalonil as the active ingredient. Tui Disease Eliminator is intended for use as a fungicide to control disease in fruits, vegetables, and flowers.

2. Tui Disease Eliminator is intended to be sold to the general public for use in home gardens. It will be applied using a hand-held, low pressure spray. It will be sprayed at high volume onto plants.

3. The staff have classified Tui Disease Eliminator based on its composition and the effects of its components as follows:

Hazard endpoint HSNO classification

Acute toxicity (oral) 6.1D

Eye corrosion 8.3A

Contact sensitisation 6.5B

Carcinogenicity 6.7B

Reproductive/developmental toxicity 6.8B Target organ systemic toxicity (oral) 6.9B

Aquatic toxicity 9.1A

Terrestrial vertebrate ecotoxicity 9.3C

4. The staff consider, on the basis of human health assessments detailed in this report, that the risks associated with Tui Disease Eliminator cannot be mitigated to negligible levels through the application of the controls in Appendix B.

5. The staff do not consider that the benefits of Tui Disease Eliminator outweigh the risks.

6. On the basis of this assessment the staff consider that this application should be declined in accordance with section 29 (1) (b) of the Act.

7. The applicant was advised of the staff’s recommendation to decline the application and further discussions were held to consider options.

8. This resulted in the staff advising the applicant that they could request a hearing to allow them to put their case to the decision makers.

9. This E&R report has been prepared in response to this request.

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Application for approval to import or manufacture Tui Disease Eliminator for release (APP202057)

1. Summary

Application code APP202057 – Tui Disease Eliminator

Application type To import or manufacture for release any hazardous substance under Section 28 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Application sub-type Non notified - Category A

Applicant Tui Products Limited

Purpose of the application

To manufacture Tui Disease Eliminator, containing 90 g/L chlorothalonil in the form of a suspension concentrate for use as a non-systemic foliar fungicide for the control of various diseases on fruit, vegetables, flowers and ornamentals by non-professional users

Date application received 17 February 2014 Information request and time

waiver

The staff requested further information under section 58 of the Act.

The consideration was posponed under section 59 of the Act.

2. Background

2.1. Tui Disease Eliminator is a foliar fungicide containing chlorothalonil as the active ingredient. It is intended to be used in domestic gardens on vegetables, fruit, flowers and ornamental plants.

2.2. Other substances containing the active ingredient chlorothalonil have been approved under the Act.

These approvals are for agricultural pesticides and timber treatment chemicals.

2.3. The applicant has described the lifecycle of the substance as below.

Importation, transport and storage

2.3.1. Tui Disease Eliminator will be manufactured in New Zealand. The substance will be

packaged in 50 ml high density polyethylene (HDPE) bottles with child resistant screw tops.

2.3.2. Tui Disease Eliminator will be transported by road, sea and rail. The applicant has stated that the substance will be transported as a Class 9 dangerous good under the relevant transport regulations.

2.3.3. The substance will be stored at manufacturing, distribution and retail sites, and at the buyer’s home. At retail sites, the substance would be stored in sealed, labelled packaging. The packets would be stored in cardboard boxes on shelving or pellets.

Use

2.3.4. Tui Disease Eliminator is intended to be used as a fungicide in domestic gardens. The substance is intended to be sprayed onto the leaves of vegetables, fruit, flowers and ornamental plants. It will be applied using a hand-held, low pressure spray. It is designed to be sprayed in high volumes, until the spray runs off the leaf.

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Disposal

2.3.5. Any leftover product can be disposed of through agricultural waste collection or an appropriate waste management company.

2.3.6. The empty container will be triple-rinsed and the rinsate added to the spray tank. The container should be wrapped in paper and disposed of with household rubbish.

3. Process, consultation and notification

3.1. The application was lodged pursuant to section 28 of the Act, and was formally received on 17 February 2014.

3.2. The Ministry of Health, WorkSafe New Zealand and the Agricultural Compounds and Veterinary Medicines (ACVM) Group of the Ministry of Primary Industries were advised of the application on 19 February 2014 and invited to comment. No comments were received.

3.3. Initially, the application did not contain sufficient information for the staff to undertake a full assessment of the substance from a scientific and technical perspective.

3.4. The staff asked for more information on the formulation of Tui Disease Eliminator, under section 58 of the Act, on 3 March 2014. This information was provided on 7 April 2014.

3.5. The staff carried out the risk assessment, which showed high risks to human health. Because of these risks, the staff advised the applicant on 17 April 2014 that they would be recommending that the application be declined.

3.6. The staff and the applicant discussed the situation, and the applicant asked whether any other options were available. The staff subsequently advised the applicant that they may be able to request a hearing in front of a decision-making committee to put the applicant’s benefits case forward.

3.7 On 20 June 2014, the applicant formally requested a hearing.

4. Hazardous properties

4.1. The staff determined the hazard profile of Tui Disease Eliminator based on the information provided by the applicant and other available information, as documented in Appendix A.

Table 1: Hazard classification of Tui Disease Eliminator

Hazard endpoint Applicant Staff

Acute toxicity (oral) 6.1D 6.1D

Eye corrosion 8.3A 8.3A

Contact sensitisation 6.5B 6.5B

Carcinogenicity 6.7B 6.7B

Reproductive/developmental toxicity 6.8B 6.8B

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Target organ systemic toxicity (oral) 6.9B 6.9B

Aquatic toxicity 9.1A 9.1A

Soil ecotoxicity 9.2C ND

Terrestrial vertebrate ecotoxicity 9.3C 9.3C

4.2. The applicant assigned a 9.2C classification (soil ecotoxicity) to Tui Disease Eliminator. The staff did not classify the substance as a soil ecotoxicant. Chlorothalonil was recently reclassified from 9.2B to 9.2C. Due to this reclassification, the quantity of chlorothalonil in Tui Disease Eliminator does not trigger a classification for soil ecotoxicity.

5. Risk, cost and benefit assessment

5.1. The staff identification and assessment of risks and costs (adverse effects) and benefits (positive effects) is set out in this section and supported by the information in Appendix A.

Risks and costs

Human health

5.2. The staff classified Tui Disease Eliminator as acutely toxic by oral ingestion (6.1D), an eye corrosive (8.3A), a contact sensitiser (6.5B), suspected human carcinogen (6.7B) and harmful to target organs or systems by oral ingestion (6.9B).

5.3. Chlorothalonil is approved for use in New Zealand. However, the staff note that it is on the Chief Executive-initiated Reassessment Programme (CEIR).

5.4. If the EPA has new information suggesting that the approval for a substance may need to be reassessed, then the Chief Executive (after considering factors such as the hazardous properties of the substance and estimates of the potential level of exposure) may add them to the CEIR list.

5.5. Previous approvals for chlorothalonil are for commercial, agricultural use. Tui Disease Eliminator is intended to be sold to the general public for use in home gardens. This is a different use pattern, with different risks. Therefore, a quantitative human health risk assessment was carried out.

5.6. This quantitative assessment looked at the use of the substance, entry into treated areas, and effects on bystanders.

5.7. The risks of Tui Disease Eliminator to human health and safety at various stages of its lifecycle as determined by the staff are summarised in Table 2.

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Environmental

5.8. The staff have classified Tui Disease Eliminator as an aquatic toxicant (9.1A) and toxic to terrestrial vertebrates (9.3C) on the basis of mixture rules as described in the User Guide to Thresholds and Classifications¹.

5.9. Previous approvals for chlorothalonil are for commercial, agricultural use. Tui Disease Eliminator is intended to be sold to the general public for use in home gardens. This is a different use pattern.

However, the concentration of chlorothalonil expected to reach the environment in home gardens would be much lower than other uses approved for the same active ingredient.

5.10. The staff have evaluated the potential of Tui Disease Eliminator to cause adverse effects to the environment during all stages of the substance’s lifecycle using a qualitative risk assessment methodology.

5.11. The risks of Tui Disease Eliminator to the environment at various stages of its lifecycle are summarised in Table 3.

1http://www.epa.govt.nz/Publications/ER-UG-03-2.pdf

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Table 2: Assessment of risks to human health for Tui Disease Eliminator

2The applicant intends to manufacture (not import) Tui Disease Eliminator. However, it is possible that the substance could be imported into New Zealand in the future.

Consequently, the risks associated with the manufacture of Tui Disease Eliminator have been evaluated so the approval of this substance will be applicable to both the import and manufacture of Tui Disease Eliminator.

Lifecycle Description Likelihood Magnitude Matrix Comment Level of

risk Manufacture,²

transport, storage and packaging

Acute toxicity (oral) Highly improbable Major Low Manufacturing and packaging facilities in New Zealand will be required to meet the HSNO requirements for equipment, emergency management and Personal Protective Equipment (PPE). Compliance with HSNO information provisions (e.g. labels, advertising, Safety Data Sheets (SDS), and WorkSafe health and safety requirements will also apply.

Negligible

Eye corrosion Highly improbable Major Low Negligible

Contact sensitisation

Highly improbable Minor to moderate depending on individual

Negligible Negligible

Carcinogenicity The risk of chronic effects from exposure during importation, transport and storage is sufficiently remote that the level of risk will be negligible.

Negligible

Target organ toxicity

Negligible

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Use Acute toxicity (oral) Quantitative assessment has indicated a high level of risk to human health to operators and bystanders. In addition, the hazard classifications for Tui Disease Eliminator trigger requirements to wear PPE. As Tui Disease Eliminator is intended for use by home gardeners, it cannot be assumed that users will wear the correct PPE. The quantitative assessment calculations are shown in Appendix A.

Non- negligible

Eye corrosion Non-

negligible Contact

sensitisation

Non- negligible

Carcinogenicity Non-

negligible Target organ

toxicity

Non- negligible

Disposal

Acute toxicity (oral) Disposal of Tui Disease Eliminator is most likely to be through the use as a foliar fungicide product. Should any leftover substance require disposal, this is required to be carried out in accordance with the Hazardous Substances (Disposal) Regulations 2001 and the Resource Management Act 1991. The acute and chronic toxic properties of this substance could cause major adverse effects. As Tui Disease Eliminator is for home garden use, users may not have the necessary knowledge or use the appropriate PPE.

Non- negligible

Eye corrosion Non-

negligible

Contact sensitisation

Non- negligible

Carcinogenicity Non-

negligible

Target organ toxicity

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Table 3: Assessment of risks to the environment for Tui Disease Eliminator Lifecycle Description Likelihoo

d

Magnitude Matrix Comment Level of risk

Manufacture³, importation, transport and storage

Death or adverse effects on aquatic or terrestrial organisms

Highly improbable

Moderate Negligible Provided there is adherence to the HSNO controls (and the Land Transport Rule 45001, the Civil Aviation Act 1990 and the Maritime Transport Act 1994 (as applicable)) the staff consider a spill to be highly improbable. Furthermore, provided importers, manufacturers and those handling the substance adhere to the HSNO controls relating to storage and bunding requirements, a spill is only likely to lead to localised effects.

Negligible

Use Death or adverse

effects on aquatic organisms

The staff note that Tui Disease Eliminator is intended to be used in domestic gardens only. Therefore, the amount of substance expected to reach the environment is low. The staff consider that the controls will adequately manage most of the risks to the aquatic and terrestrial environments.

Negligible

Death or adverse effects on non- target plants

Negligible

Negligible Death or adverse

effects on terrestrial vertebrates

Negligible

3The applicant intends to manufacture (not import) Tui Disease Eliminator. However, it is possible that the substance could be imported into New Zealand in the future. The risks associated with the importation of Tui Disease Eliminator have been evaluated so the approval of this substance will be applicable to both the import and manufacture Tui Disease Eliminator.

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Lifecycle Description Likelihoo d

Magnitude Matrix Comment Level of risk

Disposal Death or adverse effects on aquatic or terrestrial organisms

Highly improbable

Minor Negligible The substance must be disposed of in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001.

Negligible

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Relationship of Māori to the Environment

5.12. The potential effects on the relationship of Māori to the environment have been assessed in accordance with sections 6(d) and 8 of the HSNO Act. Under these sections all persons exercising functions, powers, and duties under this Act shall take into account the relationship of Māori and their culture and traditions with their ancestral lands, water, taonga and the principles of the Treaty of Waitangi (Te Tiriti o Waitangi). Those potential effects include risks, costs and/or benefits which may impact on Māori.

5.13. This section covers:

 The potential effects to the relationship of Māori to the environment

 The relevance of principles of the Treaty of Waitangi

Potential Effects

5.14. The staff have considered the potential of Tui Disease Eliminator to cause adverse effects to the relationship of Māori to the environment. Given the hazard classification noted in Table 1 there is potential for the use and management of Tui Disease Eliminator to lead to the deterioration of the health and well-being of people (individually and collectively), and of waterways. In doing so, it also has the potential to inhibit the ability of Māori to fulfil their kaitiakatanga duty to manage the health and wellbeing of their people and taonga for future generations.

5.15. The magnitude of cultural impact is uncertain given the lack of engagement with Māori and the absence of cultural assessment information provided in the application. One of the Outcomes of Importance to Māori identified in the EPA policy ‘Engaging with Māori for Applications to the EPA’ is a health and well-being outcome focussed on spiritual, mental, relational and physical health and well- being. Given the non-negligible risk to human health⁴ associated with Tui Disease Eliminator along with the intended use pattern, the staff consider the potential for adverse effect to this outcome of importance to Māori to be non-negligible, even with default and additional controls in place.

5.16. The aquatic ecotoxicity classification raises the potential for adverse effect to the integrity or mauri of waterways, the taonga species within, and the consequent impact to kaitiakitanga. However, the staff note that the intended use pattern, default and additional controls will adequately manage risks to aquatic environments minimising the potential for such effects.

Principles of the Treaty of Waitangi

5.17. Section 8 of the HSNO Act 1996 requires decision-makers to take into account the principles of the Treaty of Waitangi. Of particular relevance to this application is the principle of active protection affirmed by the Court of Appeal in the Lands case (1987)⁵. It refers to the Crown’s obligation to take positive steps to ensure that Māori interests are protected, and to consider them in line with the

4 outlined in Table 2 p 9 and section 5.2

5New Zealand Māori Council v Attorney-General, [1987] 1 NZLR 641 (CA)

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interests guaranteed to Māori in Article II of the Treaty. Specifically, Justice Cooke noted that “…the duty of the Crown is not merely passive but extends to active protection of Māori people in the use of their lands and waters to the fullest extent practicable.”

5.18. The Waitangi Tribunal also noted that “the Treaty of Waitangi obliges the Crown not only to recognise Māori interests specified in the Treaty, but actively to protect them. It follows that the omission to provide that protection is as much a breach of the Treaty as an act that removes those rights”

(Waitangi Tribunal 1987).

5.19. The staff consider that “taking into account the principle of active protection” requires the provision of sufficient evidence to show that Tui Disease Eliminator does not pose significant risk of adverse effect to Māori. This includes taonga species, mahinga-kai, rongoa, ecosystems and traditional Māori values and practices. Significant risks identified then need to be appropriately and adequately defined and managed in such a way as to mitigate potential adverse effects arising from the use of Tui Disease Eliminator.

5.20. Given the assessment of environmental effects outlined in this report, the staff do not consider the use of Tui Disease Eliminator in accordance with controls, to be inconsistent with the principles of the Treaty of Waitangi. However the assessment of effects to human health and the absence of effective mitigation may be considered inconsistent with the principle of active protection as it relates to the active protection of Māori people and their interests.

Assessment of risks to society and the community and the market economy

5.21. There are not expected to be any significant adverse impacts on the social environment with the controlled use of Tui Disease Eliminator, apart from the health effects and environmental effects already discussed. Consequently, the staff consider that this aspect of potential risk need not be considered further.

New Zealand’s international obligations

5.22. The staff did not identify any international obligations that may be affected by the approval of Tui Disease Eliminator.

Overall assessment of risks

5.23. The staff consider that, assuming compliance with the proposed controls (detailed in Section 7),:

 the risks to human health associated with Tui Disease Eliminator are not able to be mitigated and are non-negligible;

 the risks to the environment associated with Tui Disease Eliminator are able to be mitigated and are negligible;

 the risks to the relationship of Māori are non-negligible; and

 the overall level of risk is therefore non-negligible.

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Identification of benefits

5.24. The applicant has stated that the use of Tui Disease Eliminator will provide the following benefits:

 availability of a new fungicide from a different supplier to home gardeners;

 the small pack size will allow consumers to purchase only what they need, resulting in fewer product needing to be stored and disposed of; and

 application is by hand held sprayers, so there will be less risk of breathing in spray mist.

The effects of the substances being unavailable

5.25. If Tui Disease Eliminator were unavailable, the benefits associated with the availability of the substance would not be realised.

Overall assessment of benefits

5.26. The staff are satisfied that the availability of Tui Disease Eliminator will provide some (i.e. non- negligible) beneficial effects for some businesses and users of the substance. Tui Disease Eliminator would provide a new fungicide product to home gardeners. The small pack size means less product would need to be stored and disposed of. However, the risk assessment shows application of Tui Disease Eliminator by hand held sprayers has high risks to human health.

6. Controls

6.1. Based on the hazard classification determined for Tui Disease Eliminator, a set of default controls is applicable. The default controls form the basis of the controls set out in Appendix B. Based on their risk assessment, the staff consider that the additions and variations set out below are also applicable to Tui Disease Eliminator. However, the staff consider that, even with these controls in place, the risks to human health are not properly managed.

6.2. The full list of controls that were considered as risk mitigation methods for Tui Disease Eliminator are detailed in Appendix B.

The setting of exposure limits

6.3. Tolerable Exposure Limits (TELs) can be set to control hazardous substances entering the environment in quantities sufficient to present a risk to people. No TELs have been set for any component of Tui Disease Eliminator at this time.

6.4. The EPA typically adopts Workplace Exposure Standard (WES) values listed in the WorkSafe New Zealand WES Document⁶ to control exposure in places of work. As Tui Disease Eliminator is not to be used in places of work, no WES values are applicable.

6http://www.business.govt.nz/healthandsafetygroup/information-guidance/all-guidance-items/workplace-exposure-standards- and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdf

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6.5. The default controls allow the setting of Environmental Exposure Limits (EELs) to control hazardous substances entering the environment in quantities sufficient to present a risk to the environment. EELs have not been proposed for any component of Tui Disease Eliminator. In addition, the default EEL values have been deleted.

6.6. The default controls require the EPA 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 Tui Disease Eliminator, a maximum application rate is not required to be set under regulation 48 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001.

Variation and deletion of controls

6.7. The default controls include requirements for secondary containment of pooling substances. It is considered that the risks associated with the containment of substances which are not class 1 to 5 substances (i.e. do not ignite or explode) are different to those associated with class 1 to 5

substances. Consequently the secondary containment requirements can be reduced.

6.8. In addition, the default controls do not allow for dispensation where it is unnecessary for any pipework associated with the stationary container systems to have secondary containment. A variation has been applied to the controls to allow this.

6.9. It is considered that these reduced secondary containment measures are adequate to manage the risks of a spill of Tui Disease Eliminator.

6.10. The default controls include requirements for ecotoxic substances to be under the control of an approved handler. The following control has been substituted for Regulation 9(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001:

(1) This substance 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.

6.11. These proposed variations are more cost-effective in terms of managing the risks of the substance than the default controls. The revised controls are shown in Appendix B

Additional controls

6.12. The staff note that the environmental risk assessment indicates that restrictions on use are necessary to ensure that the risks Tui Disease Eliminator presents to the aquatic environment are negligible.

Therefore, it is considered that the application of controls addressing these risks will be more effective than the default controls in terms of their effects on the management, use and risks of the substance.

Consequently, the following additional control is applied to Tui Disease Eliminator to restrict the level of risk to the environment:

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Tui Disease Eliminator must not be applied into, onto, or over water.⁷

6.13. The staff note that the specified controls do not address the risks associated with storage or use of the substances within stationary container systems (e.g. tanks). These risks include the failure of primary containment resulting in a large spill of the substance into the environment. See Appendix B for the control which has been applied to manage these risks.

6.14. The active ingredient chlorothalonil contains impurities which are of toxicological concern. In order to manage the risks of these impurities, the following controls apply:

 the maximum content of hexachlorobenzene allowed in chlorothalonil is 0.04 g/kg or lower, and

 the maximum content of decachlorobiphenyl allowed in chlorothalonil is 0.03 g/kg or lower.

6.15. The staff consider that the application of these controls will be more effective than the specified (default) controls in terms of their effect on the management, use and risks of Tui Disease Eliminator (section 77A(4)(a)).

Environmental user charges

6.16. It was not considered necessary to apply environmental user charges to this substance as an alternative or additional means of achieving effective risk management. Accordingly, no report has been made to the Minister for the Environment.

Review of controls for cost-effectiveness

6.17. The staff consider that the proposed controls are the most cost-effective means of managing the identified potential risks and costs associated with this application.

7. Overall evaluation and recommendation

7.1. The staff’s risk assessment shows that use of Tui Disease Eliminator presents non-negligible risk to human health, even assuming compliance with the proposed controls.

7.2. In addition, as Tui Disease Eliminator is for home garden use, it cannot be assumed that users will comply with the controls.

7.3. The staff’s risk assessment indicates that use of Tui Disease Eliminator presents negligible risk to the environment, provided there is compliance with the proposed controls.

7.4. The staff consider that, even with controls in place, the risks to human health are not properly managed. Although there will be benefits associated with the release of Tui Disease Eliminator, the staff do not consider that they will be greater than the risks. Therefore, the staff consider that the application should be declined.

7Where ‘water‘ means water in all its physical forms, whether flowing or not, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application

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Appendix A: Staff classification and risk assessment of Tui Disease Eliminator

Tui Disease Eliminator was classified using information on the effects of the individual components and application of mixture rules.

The mixture rules used for classifying substances can be found in the User Guide to Thresholds and Classifications⁸.

The classifications of Tui Disease Eliminator are shown in Table 1.

Table 1.Summary of the applicant’s and staff’s hazard classification

Hazard Class/Subclass

Mixture classification Method of classification

Remarks Applicant’s

classification

Staff’s classification

Mixture data Read across Mixture rules9

Class 1 Explosiveness No No

Class 2, 3 & 4 Flammability No No Class 5 Oxidisers/Organic

Peroxides No No

Subclass 8.1 Metallic

corrosiveness No ND

Subclass 6.1 Acute toxicity (oral) 6.1D 6.1D

Chlorothalonil, Components I1, and I2

Subclass 6.1Acute toxicity

(dermal) No No

Subclass 6.1 Acute toxicity

(inhalation) No No

Subclass 6.1 Aspiration hazard No ND Subclass 6.3/8.2 Skin

irritancy/corrosion No No

Subclass 6.4/8.3 Eye

irritancy/corrosion 8.3A 8.3A

Subclass 6.5A Respiratory No ND

8http://www.epa.govt.nz/Publications/ER-UG-03-2.pdf

9Use of mixture rules may not adequately take into account interactions between different components in some circumstances and must be considered of lower reliability than data on the mixture itself.

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Hazard Class/Subclass

Mixture classification Method of classification

Remarks Applicant’s

classification

Staff’s classification

Mixture data Read across Mixture rules9

sensitisation

Subclass 6.5B Contact

sensitisation 6.5B 6.5B

Subclass 6.6 Mutagenicity No ND

Subclass 6.7 Carcinogenicity 6.7B 6.7B Chlorothalonil

Subclass 6.8 Reproductive/

developmental toxicity No ND

Subclass 6.8 Reproductive/

developmental toxicity (via lactation)

No ND

Subclass 6.9 Target organ

systemic toxicity (oral route) 6.9B 6.9B Chlorothalonil

Subclass 9.1 Aquatic ecotoxicity 9.1A 9.1A Chlorothalonil

Subclass 9.2 Soil ecotoxicity 9.2C ND Subclass 9.3 Terrestrial

vertebrate ecotoxicity 9.3C 9.3C Chlorothalonil

Subclass 9.4 Terrestrial

invertebrate ecotoxicity No ND

NA: Not Applicable --> For instance when testing is technically not possible: testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the substance required in certain studies may not be possible.

ND: No Data or poor quality data (according to Klimisch criteria¹⁰) --> There is a lack of data for one or more components.

No: Data are available for the formulation or for all components and classification is not triggered.

10Klimisch, H-J., Andrear, M., & U. Tillmann, 1997. A systematic approach for evaluating the quality ofexperimental toxicological and ecotoxicological data. Reg. Toxicol. Pharmacol. 25, 1–5 (1997)

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Human health risk assessment

Quantitative worker (operator) risk assessment

Critical endpoint definition

An AOEL for chlorothalonil had already been set by EFSA (European Food Safety Authority).This AOEL is accepted by the EPA.

Table 1 Existing AOEL for chlorothalonil¹¹

Available international AOELs

Key systemic effect

NOAEL (LOAEL) mg/kg bw/day

Uncertainty factors

AOEL mg/kg bw/day

Staff’s

modifications

EFSA

Chronic studyrat; 1.8 mg/kg bw/day (30% oral absorption).

Kidney and (fore)stomach (pre-neoplastic and

neoplasticlesio ns). Most relevant NOAEL for setting the AOEL: 2.7 mg/kgbw/day

2.7 100 0.009 none

11See Appendix C for link to EU Pesticides Database.

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Other inputs for human worker (operator) and re-entry exposure modelling¹²

Table 2 Derivation of dermal absorption value in humans

Active ingredient

Physical

form Concentration of active (%)

Maximum application rate (for each active, for each method of application) g a.i./ha

Dermal absorption (%)

AOEL mg/kg bw/day Concentrate Spray

Chlorothalonil Liquid liquid 90 0.01 0.02 0.34

Output of human operator spraying exposure modelling (UK Predictive Operator Exposure Model) for Tui Disease Eliminator

Exposure Scenario Estimated operator

exposure (mg/day)

Exposure Duration (mins)

Dermal 0.420 30

Inhalation 0.473 30

Total 0.893 30

OPERATOR EXPOSURE (mg/kg bw/day) 0.0148824

This is 166% of the AOEL for Chlorothalonil

12The Staff have 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. 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 Staff typically uses the geometric mean model. The BBA model provides for a range of different spray applications (tractor-mounted/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).

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Outcomes of the worker (operator) exposure assessment:

The risks to operators are not acceptable for spray application for 30 minutes or more, as exposure to the active ingredient chlorothalonil exceeds the AOEL by 166%.

Also, based on the corrosive and skin sensitiser properties of the product, PPE is recommended (protective gloves, eye/face protection).

In a home use setting, we are not able to assume that people will wear the correct PPE.

Outcomes of the re-entry exposure assessment:

Table 4Re-entry exposure modelling¹³

Active

Internal (absorbed) dose available for systemic distribution

(mg/kg bw/8 hours)

AOEL

(mg/kg bw/day) Risk Quotient

Re-entry Activity

Internal (absorbed) dose available for systemic distribution

(mg/kg bw/8 hours)

AOEL

(mg/kg bw/day)

Risk Quotient at 24 hours without gloves

Vegetables -

reach/pick 0.0079 0.009 0.88

Fruits (from trees) -

search/reach/pick 0.0142 0.009 1.58

Ornamentals -

Cut/sort/bundle/carry 0.0158 0.009 1.76

Berries - reach/pick 0.0095 0.009 1.05

3.1.1 Outcomes of the re-entry exposure

The Risk Quotient (RQ) for Fruits and Ornamentals is > 1, this means the use of PPE for early crop entry (<24h) is recommended as necessary. The Risk Quotient (RQ) for Vegetables and Berries is ≤ 1, for these activities no re-entry control is recommended as necessary to reduce the level of re-entry risk. (Note: RQ of 1.05 is considered acceptable)

The risks for re-entry at 24 hours without gloves are not acceptable for two activities. The correct PPE (gloves) is recommended as necessary to reduce the risk, in a home setting we cannot assume people will wear gloves when re-entering the area.

13The staff assessed the re-entry worker exposures using the generic exposure model for “Maintenance and harvesting activities: Dermal exposure” provided by the UK Health & Safety Executive chemical Regulation Directorate, on the following web site:

http://www.pesticides.gov.uk/applicant_guide.asp?id=1246&link=%2Fuploadedfiles%2FWeb%5FAssets%2FPSD%2FRe

%2Dentry%2520worker%2520guidance%5Ffinal%2520version%2Epdf.

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Quantitative bystander risk assessment

¹⁴

Critical endpoints definition

3.1.2 Critical endpoints definition

The AOEL derived for operator and re-entry worker assessment above is also used for the bystander assessment calculations. The uncertainty factor for interspecies and intraspecies used for the derivation of the AOEL is sufficient to protect the larger part of the population, including children.

3.1.3 Output of human bystander mixing, loading and application exposure modelling¹⁵ As Tui Disease Eliminator is intended for home use, bystander risks were calculated based on direct contact of a toddler with treated surfaces, rather than risks from spray drift. For this reason the use of boom rather than backpack as the application method in the exposure scenario does not impact on the risk assessment:

the risks directly relate to the amount of active ingredient applied to the treated area.

Table 5Output of human bystander mixing, loading and application exposure modelling¹⁶

Exposure Scenario

Estimated exposure of 15 kg toddler exposed through contact to surfaces 8 m from an application area

Risk Quotient

Boom

High spray(coarse droplets) 52.67 5.85

Low spray(coarse droplets) 52.44 5.83

14The Staff considers that the main potential source of exposure to the general public for substances of this type (other than via food residues which will be considered as part of the registration of this substance under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997) is via spray drift. In terms of bystander exposure, toddlers are regarded as the most sensitive sub-population and are regarded as having the greatest exposures. For these reasons, the risk of bystander exposure is assessed in this sub-population. The AOEL is used as the exposure criterion.

15Exposure is estimated using the equations from the UK Heath & Safety Chemical Regulation Directorate which account for dermal exposure, hand-to-mouth exposure and object-to-mouth exposure

(http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Bystander%20exposure%20guidance_final%20version.pd f Accessed 27/01/2010a). In addition, incidental ingestion of soil is taken into account using a modified exposure equation from the United States Environmental Protection Agency (USEPA, 2007, Standard Operating Procedures (SOPs) for Residential Exposure Assessments, Contract No. 68-W6-0030, Work Assignment No. 3385.102). Spray drift is estimated using models specific to the type of application equipment. For pesticides applied by ground boom or air blast sprayer, the AgDrift model is used. Spray drift deposition from aerial application is estimated using the AGDISP model along with appropriate New Zealand input parameters

16Exposure is estimated using the equations from the UK Heath & Safety Chemical Regulation Directorate which account for dermal exposure, hand-to-mouth exposure and object-to-mouth exposure

(http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Bystander%20exposure%20guidance_final%20version.pd f Accessed 27/01/2010a). In addition, incidental ingestion of soil is taken into account using a modified exposure equation from the United States Environmental Protection Agency (USEPA, 2007, Standard Operating Procedures (SOPs) for Residential Exposure Assessments, Contract No. 68-W6-0030, Work Assignment No. 3385.102). Spray drift is estimated using models specific to the type of application equipment. For pesticides applied by ground boom or air blast sprayer, the AgDrift model is used. Spray drift deposition from aerial application is estimated using the AGDISP model along with appropriate New Zealand input parameters

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Outcomes of the bystander exposure assessment

The Risk Quotient (RQ) for the exposure of a toddler is more than 5 times higher than the acceptable RQ of 1. So the risks to bystanders (e.g. children) from the use of Tui Disease Eliminator are not acceptable.

Summary and conclusions of the human health risk assessment

Tui Disease Eliminator contains an active ingredient used in different ways in other approved substances.

Therefore a quantitative human health risk assessment was performed. The substance is intended to be sold to the general public and for use in home gardens. The staff used the United Kingdom Pesticide Safety Directorate’s interpretation of the German BBA Model and the UK Predictive Operator Exposure Model (POEM) for amateur (home garden) use.

The risk assessment indicates that the risks to operators during the use of Tui Disease Eliminator is not acceptable for spray application, as exposure to the active ingredient, chlorothalonil, exceeds the AOEL by 166%.Also, based on the corrosive and skin sensitiser properties of the product, PPE is recommended. In a home use setting, we are not able to assume that people will wear the correct PPE.

The risks for re-entry at 24 hours without gloves are not acceptable for two activities. The correct PPE (gloves) is recommended as necessary to reduce the risk, in a home setting we cannot assume people will wear gloves when re-entering the area.

The Risk Quotient (RQ) for the exposure of a toddler is more than 5 times higher than the acceptable RQ of 1. So the risks to bystanders (e.g. children) from the use of Tui Disease Eliminator are not acceptable.

Qualitative ecological risk assessment Summary and conclusions

The EPA staff recognizes that there is an area of significant weakness in modeling Estimated

Environmental Concentrations (EECs) related to residential uses, namely use by home gardeners. The models assume that large areas (hectares) are treated with the product; this is clearly not relevant for domestic uses in garden. In addition, it is very difficult to estimate what could be the extent of use in a residential area, as it could be highly variable from an area to another. Therefore, the EPA used a hypothetical scenario to address the environmental impact of Tui Disease Eliminator.

Due to the proposed use pattern of Tui Disease Eliminator, environmental exposure may occur. However, EPA staff acknowledge that products containing the same active ingredient exist on the New Zealand market, and are used as agrichemicals for spray in broad fields, at similar application rate/frequencies.

The staff consider that any potential ecological risks are sufficiently mitigated by the HSNO controls applied to them. A quantitative environmental exposure and ecological risk assessment was not

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performed due to the proposed use pattern of the product (home garden fungicide), but a qualitative evaluation of the risks was carried out.

Ecotoxicity to the aquatic environment

All data for chlorothalonil, its metabolite SDS-3701 and substances containing chlorothalonil were sourced from the EPA database.

For the qualitative risk assessment the following assumption was made: the predicted exposure was considered to be equivalent to a maximum of 100 mL of Tui Disease Eliminator (9 g of chlorothalonil) per application, corresponding to 2 containers. This value represents a scenario of best practice for domestic use and was based on the information provided by the applicant. The applicant recommends that 50 mL (one container) are to be diluted in 3 litres of water and that 1 L of the diluted substance would be sufficient to treat a 10 m2 size plot assuring full coverage of leaves of the plant target. It is assumed that the cost of the product will deter gardeners having large areas to be treated from buying this product, so 2 containers was considered to be representative.

The risk of chlorothalonil to the aquatic environment has been assessed previously by the EPA staff, in applications where chlorothalonil was applied in a wide-dispersive manner and at application rates far above the predicted for Tui Disease Eliminator. The Environmental Risk Assessment conducted for a substance applied at 634 g chlorothalonil per hectare identified risks to the aquatic environment, however the risks were considered to be mitigated by the application of additional controls to the substance. The application rate stated above is equivalent to 140 containers of Tui Disease Eliminator applied to a 1 ha home garden.

The primary metabolite of chlorothalonil, SDS-3701 is less toxic to fish and aquatic invertebrates than the parent molecule, chlorothalonil. Therefore, the EPA Staff consider that SDS-3701 will not represent a significant risk to aquatic organisms.

The level of risk to the environment from the use of Tui Disease Eliminator as a foliar fungicide in home gardens are considered to be negligible, given that the concentration expected to reach the environment would be much lower than other use/applications approved for the same active ingredient. Therefore, due to the proposed pattern of use of Tui Disease Eliminator it is not anticipated a high risk to aquatic

organisms. However, since Tui Disease Eliminator is classified as a 9.1A substance the following additional controls should be applied to the substance:

1) This substance must not be applied onto, into or over water.

3.2.2 Ecotoxicity to terrestrial vertebrates

Tui Disease Eliminator is classified as 9.3C (substance that is harmful to terrestrial vertebrates).

Chlorothalonil is not acutely toxic to birds as a result of oral or short-term dietary exposure. However, the degradation product SDS-3701 is more toxic to birds and mammals than the parent compound, with a LD50 158 mg/kg bodyweight and LC50 2000 mg/kg diet observed for the with mallard duck, and LC50 of

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1746 mg/kg diet for bobwhite quail. Chronic exposure to SDS-3701 caused reduction in eggshell thickness at 100 mg/kg diet in mallard ducks, with the NOEL 50 mg/kg diet.

The maximum amount of the metabolite SDS-3701 after the degradation of chlorothalonil is estimated as 40% of the parent compound, the degradation to the metabolite occurs mainly via soil. Therefore, the maximum amount of SD-3701 for the current application would be equal to 3.6 g of SDS-3701 (assuming the application of 2 containers, equivalent to 9 g of chlorothalonil).The estimated 3.6 g of SDS-3701can be considered a worst case scenario, hence it is assumed both the maximum degradation and the immediately availability of the metabolite after application. The application of Tui Disease Eliminator using a hand held low pressure garden spray is not expected to lead to a large burden of chlorothalonil into the soil. Both the parent compound and the metabolite are not systemic; therefore translocation from the soil to the plant organs is not expected to occur.

It should also be noted, that due to the limited surface that will be treated, birds will easily have access to other non-treated food source in the same area. Due to that and the low concentrations of chlorothalonil in Tui Disease Eliminator, the EPA staff considers that the acute risks to birds can be considered to be negligible. A chronic risk to birds is not envisaged due to the proposed use pattern and concentrations of the metabolite after the application of Tui Disease Eliminator.

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Appendix B: Controls proposed for Tui Disease Eliminator

Notes

The controls for a substance apply for the indefinite duration of the approval of the substance.

Please refer to the Hazardous Substances Regulations¹⁷ for the requirements prescribed for each control and the modifications listed as set out in Section 7 of this document.

Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001 Code Regulation Description Variation T1 11 – 27 Limiting exposure to toxic substances

through the setting of TELs

No TEL values are set for any component of the substance at this time.

T2 29, 30 Controlling exposure in places of work through the setting of WESs

No WES values are set for any component of Tui Disease Eliminator.

T4 7 Requirements for equipment used to handle substances

T5 8 Requirements for protective clothing and equipment

T7 10 Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles

E1 32 – 45 Limiting exposure to ecotoxic substances through the setting of EELs

No EEL values are set at this time and the default EEL values are deleted.

E2 46 – 48 Restrictions on use of substances in application areas

A maximum application rate is not set at this time.

E5 5(2), 6 Requirements for keeping records of use

E6 7 Requirements for equipment used to handle substances

E7 9 Approved handler/security

requirements for certain ecotoxic substances

The following control is substituted for Reg 9(1) of the Hazardous

Substances (Classes 6,8 and 9 Controls) Regulations 2001:

(1) The substance must be under the personal control of an approved

17The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz

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Code Regulation Description Variation

handler when the substance is:

(a) applied in a wide dispersive manner; or

(b) used by a commercial contractor.

Hazardous Substances (Identification) Regulations 2001

Code Regulation Description Variation I1 6, 7, 32 –

35, 36(1) – (7)

Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability

I2 8 Priority identifiers for corrosive substances

I3 9 Priority identifiers for ecotoxic substances

I8 14 Priority identifiers for toxic substances

I9 18 Secondary identifiers for all hazardous substances

I10 19 Secondary identifiers for corrosive substances

I11 20 Secondary identifiers for ecotoxic substances

I16 25 Secondary identifiers for toxic substances

I17 26 Use of generic names

I18 27 Requirements for using concentration ranges

I19 29 – 31 Additional information requirements, including situations where

substances are in multiple packaging I20 36(8) Durability of information for class 6.1

substances I21 37 – 39, 47

– 50

General Documentation requirements

I22 40 Specific documentation requirements for corrosive substances

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Code Regulation Description Variation I23 41 Specific documentation requirements

for ecotoxic substances

I28 46 Specific Documentation requirements for toxic substances

I29 51, 52 Signage requirements

I30 53 Advertising corrosive and toxic substances

Hazardous Substances (Packaging) Regulations 2001

Code Regulation Description Variation P1 5, 6, 7(1), 8 General packaging requirements

P3 9 Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria P13 19 Packaging requirements for toxic

substances

P14 14 Packaging requirements for corrosive substances

P15 21 Packaging requirements for ecotoxic substances

PG3 Schedule 3 Packaging requirements equivalent to UN Packing Group III

PS4 Schedule 4 Packaging requirements as specified in Schedule 4

Hazardous Substances (Disposal) Regulations 2001

Code Regulation Description Variation D4 8 Disposal requirements for toxic and

corrosive substances

D5 9 Disposal requirements for ecotoxic substances

D6 10 Disposal requirements for packages D7 11, 12 Information requirements for

manufacturers, importers and suppliers, and persons in charge D8 13, 14 Documentation requirements for

manufacturers, importers and suppliers, and persons in charge

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Hazardous Substances (Emergency Management) Regulations 2001 Code Regulation Description Variation EM1 6, 7, 9 – 11 Level 1 information requirements for

suppliers and persons in charge EM2 8(a) Information requirements for corrosive

substances

EM6 8(e) Information requirements for toxic substances

EM7 8(f) Information requirements for ecotoxic substances

EM8 12 – 16, 18 – 20

Level 2 information requirements for suppliers and persons in charge EM11 25 – 34 Level 3 emergency management

requirements: duties of person in charge, emergency response plans EM12 35 – 41 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

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(b) includes a process pipeline or a transfer line.

The following subclauses are added at the end of regulation 37:

(2) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in containers each of which has a capacity of 60 litres or less—

(a) if the place’s total pooling potential is less than 20,000 litres, the secondary containment system must have a capacity of at least 25% of that total pooling potential:

(b) if the place’s total pooling potential is 20,000 litres or more, the secondary containment system must have a capacity of the greater of—

(i) 5% of the total pooling potential; or

(ii) 5,000 litres.

(3) Pooling substances to which subclause (2) applies must be segregated where appropriate to ensure that leakage of one substance may not adversely affect the container of another substance.

The following subclauses are added at the end of regulation 38:

(2) If pooling substances which do not have class 1 to 5 hazard classifications are held in a place above ground in containers 1 or more of which have a capacity of more than 60 litres but none of which have a capacity of more than 450 litres—

(a) if the place’s total pooling

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potential is less than 20,000 litres, the secondary containment system must have a capacity of either 25% of that total pooling potential or 110% of the capacity of the largest container, whichever is the greater:

(b) if the place’s total pooling potential is 20,000 litres or more, the secondary containment system must have a capacity of the greater of—

(i) 5% of the total pooling potential; or

(ii) 5,000 litres (3) Pooling substances to which

subclause (2) applies must be segregated where appropriate to ensure that the leakage of one substance may not adversely affect the container of another substance.

EM13 42 Level 3 emergency management requirements: signage

Hazardous Substances (Personnel Qualifications) Regulations 2001 Code Regulation Description Variation AH 1 Regs 4 – 6 Approved Handler requirements

(including test certificate and qualification requirements)

See E7

Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004 Code Regulation Description

Tank Wagon

4 to 43 as applicable

Controls relating to tank wagons and transportable containers.

Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004

Code Regulation Description ^Variation

Sch 8 Schedule 8 This schedule prescribes the controls for stationary container systems. The

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Code Regulation Description Variation

requirements of this schedule are detailed in the consolidated version of the

Hazardous Substances (Dangerous Goods and Schedule Toxic Substances) Transfer Notice 2004, available from http://www.epa.govt.nz/Publications/Trans fer-Notice-35-2004.pdf

Additional controls

Code Regulation Description

Water s77A This substance must not be applied into, onto or over water¹⁸ Maximum

impurity ( in chlorothalonil)

s77A The maximum content of hexachlorobenzene allowed in chlorothalonil is 0.04 g/kg

Maximum impurity ( in chlorothalonil)

s77A The maximum content of decachlorobiphenyl allowed in chlorothalonil is 0.03 g/kg

18Where "‘water"‘ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application or water used in the dilution of the substance prior to application or water used to rinse the container after use

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www.epa.govt.nz

Appendix C: References

Data for chlorothalonil, its metabolite SDS-3701 and substances containing chlorothalonil were sourced from the EPA database.

In addition, information from the EU Pesticides Database:

http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=activesubstance.detail was used.

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Appendix D: Standard terms and abbreviations

ai active ingredient

ALD50 approximate median lethal dose, 50%

AOEL acceptable operator exposure level

ARfD acute reference dose

as active substance

BCF bioconcentration factor bfa body fluid assay

BOD biological oxygen demand BSAF biota-sediment accumulation

factor

bw body weight

c centi- (x10^-2)

CA controlled atmosphere CI confidence interval CL confidence limits CNS central nervous system COD chemical oxygen demand DFR dislodgeable foliar residue

DO dissolved oxygen

DOC dissolved organic carbon DT50 period required for 50 percent

dissipation (define method of estimation)

DT90 period required for 90 percent dissipation (define method of estimation)

dw dry weight

ED50 median effective dose ERC environmentally relevant

concentration

F field

F0 parental generation F1 filial generation, first F2 filial generation, second

fp freezing point

G glasshouse

GAP good agricultural practice

GC gas chromatography

GC-EC gas chromatography with electron capture detector GC-FID gas chromatography with flame

ionization detector

GC-MS gas chromatography-mass spectrometry

GC-MSD gas chromatography with mass- selective detection

GLC gas liquid chromatography GLP good laboratory practice

GM geometric mean

H Henry’s Law constant (calculated as a unitless value) (see also K)

ha hectare

Hb haemoglobin

HCG human chorionic gonadotropin Hct haematocrit

HPLC high pressure liquid chromatography or high performance liquid chromatography HPLC-MS high pressure liquid

chromatography - mass spectrometry

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www.epa.govt.nz

I indoor

I50 inhibitory dose, 50%

IC50 median immobilization concentration or median inhibitory concentration 6 ID ionization detector

Im intramuscular

inh inhalation ip intraperitoneal

IPM integrated pest management

iv intravenous

IVF in vitro fertilization

K Kelvin or Henry’s Law constant (in atmospheres per cubic meter per mole) (see also H)

Kads adsorption constant

Kdes apparent desorption coefficient Koc organic carbon adsorption

coefficient

Kom organic matter adsorption coefficient

kg kilogram

LC liquid chromatography LC-MS liquid chromatography- mass

spectrometry

LC50 lethal concentration, median LCA life cycle analysis

LC-MS- MS

liquid chromatography with tandem mass spectrometry LD50 lethal dose, median; dosis letalis

media

LDH lactate dehydrogenase

LOAEC lowest observable adverse effect concentration

LOAEL lowest observable adverse effect level

LOD limit of detection LOEC lowest observable effect

concentration

LOEL lowest observable effect level LOQ limit of quantification

(determination) LPLC low pressure liquid

chromatography

LSC liquid scintillation counting or counter

LSS liquid scintillation spectrometry

LT lethal threshold

M molar

μm micrometer (micron) MDL method detection limit MFO mixed function oxidase

μg microgram

MLT median lethal time

MLD median lethal dose

mol Mole(s)

MOS margin of safety

mp melting point

MS mass spectrometry

MSDS material safety data sheet NAEL no adverse effect level

nd not detected

NEL no effect level

ng nanogram

nm nanometer

NOAEC no observed adverse effect concentration

Application for approval to import or manufacture Tui Disease Eliminator for release

EPA STAFF EVALUATION AND REVIEW REPORT