UNITED NATIONS RC
UNEP/FAO/RC/CRC.7/6/Add.1
Rotterdam Convention on the Prior Distr.: General 22 December 2010 Informed Consent Procedure for Certain Hazardous Chemicals and English only Pesticides in International Trade
Chemical Review Committee Seventh meeting Rome, 28 March–1 April 2011 Item 4 (c) (iii) of the provisional agenda* Technical work: review of notifications of final regulatory action: endosulfan
Endosulfan
Note by the Secretariat
Addendum
Supporting documentation provided by New Zealand
The Secretariat has the honour to provide, in the annex to the present note, documentation received from New Zealand to support its notification of final regulatory action for endosulfan as a pesticide. The documentation was circulated for consideration at the Committee’s sixth meeting in documents UNEP/FAO/RC/CRC.6/7/Add.1 and Add.5 and is reproduced in the annex to the present note without change.
* UNEP/FAO/RC/CRC.7/1. K1063406 280111 UNEP/FAO/RC/CRC.7/6/Add.1 Annex
1. Environmental Risk Management Authority Decision: An application for the reassessment of endosulfan and formulations containing endosulfan under section 63 of the Act (Ref. 1)
2. Application for Reassessment of a Hazardous Substance under section 63 of the Hazardous Substances and New Organisms Act 1996: Endosulfan and formulations containing endosulfan (Ref. 2)
3. ERMA New Zealand update paper: Application for the Reassessment of a Hazardous Substance under section 63 of the Hazardous Substances and New Organisms Act 1996: endosulfan and formulations containing endosulfan
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2
ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION
10 December 2008 Application Code HRC07003 Application Type To reassess a hazardous substance under section 63 of the Hazardous Substances and New Organisms Act 1996 (“the Act”) Applicant Chief Executive of ERMA New Zealand (“the Chief Executive”)
Application Received 27 June 2008 Submission Period 27 June – 8 August 2008 Hearing dates 21-22 October 2008 Considered by A Committee of the Authority (“the Committee”) Purpose of the Application An application for the reassessment of endosulfan and formulations containing endosulfan under section 63 of the Act.
1 Summary of decision
1.1 The Committee: (a) declines to approve the further importation or manufacture of endosulfan and formulations containing endosulfan and accordingly revokes the following approvals: • endosulfan (Approval Number HSR002846); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance A) (Approval Number HSR000679); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance B) (Approval Number HSR000678); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance C) (Approval Number HSR000487); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance D) (Approval Number HSR000677),
(b) in accordance with section 66 of the Act issues a direction to prohibit the use of endosulfan or any of the above formulations for any purpose, and imposes controls on the disposal of all stocks of endosulfan.
This decision will come into effect 28 days after publication of the direction in the gazette.
1.2 The Committee considers that the decision should be implemented as soon as possible. However, the Committee also recognises that the decision must be communicated ERMA New Zealand Decision: Application HRC07003 Page 1 of 25 before it has effect. For this reason the Committee has directed that the decision should come into effect 28 days after the direction is published in the Gazette.
2 Background
2.1 This decision should be read in conjunction with the Agency’s reassessment application dated 27 June 2008 and the subsequent Update Paper provided to the Committee prior to the hearing, which summarised the submissions and new information received following notification of the application.
2.2 For the purposes of this reassessment, it is noted that only emulsifiable concentrate formulations containing 350 g/l endosulfan are approved and available in New Zealand.
2.3 In New Zealand endosulfan is used on a variety of crops including vegetables, berry fruit and ornamentals. It is also put to ‘off-label’1 uses including use on citrus, earthworm control on turf at golf courses, bowling clubs, parks, sports grounds, and at airports.
2.4 There is evidence that endosulfan use in New Zealand has been declining over the past 10 years. This has been market driven as well as resulting from the availability of some new insecticide chemistry.
2.5 Four products using endosulfan are currently approved for use in New Zealand, but only one of the three companies provided information to support the continued use of endosulfan in New Zealand. Two companies did not want to support continued use and the fourth indicated that they were only interested in importing for use in the coming season.
2.6 The Agency has evaluated the off-label uses of which it is aware (turf, airblast spray to citrus, glasshouse use) or that seem likely (back-pack application), but acknowledges that there could be other off-label uses of which it is unaware.
2.7 The Agency understands that no endosulfan formulations are marketed for domestic use in New Zealand and that aerial application does not take place in New Zealand. These potential uses were therefore not evaluated.
2.8 Horticulture New Zealand has estimated the total endosulfan market in New Zealand to be in the vicinity of 15,000 to 20,000 litres per year (approximate figure for 2007 estimated from discussion with P. Ensor, Horticulture New Zealand pers. comm.). However since endosulfan is used in response to pest levels, and in a number of cases as a measure of last resort, year on year usage can differ greatly depending on climatic conditions and pest pressure.
1 ‘Off-label use’ refers to the use of a product in a manner that was not assessed and approved when the product was registered under the ACVM Act, but which is lawful provided the user takes proper precautions to avoid breaches in residue standards on crops for human consumption.
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3 Application process
3.1 The application was publicly notified on 27 June 2008 (on ERMA New Zealand’s web site) and was advertised in the four main newspapers (New Zealand Herald, Dominion Post, Christchurch Press and Otago Daily Times).
3.2 Submissions closed on 8 August 2008, 30 working days after public notification.
3.3 Various Government departments, Crown Entities and interested parties, including the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines (ACVM) Group), the Ministry of Health and the Department of Labour Work Place Group, which in the opinion of the Authority would be likely to have an interest in the application, were notified of the receipt of the application and provided with an opportunity to comment or make a submission on the application.
3.4 The Agency received 187 submissions on this application.
3.5 In accordance with section 60 and clause 2(b), a public hearing was held 21-22 October 2008 at the Mercure Hotel, 355 Willis Street, Wellington.
3.6 An Update Paper to the application was prepared by the Agency and provided to the decision making Committee on 7th October 2008. This paper included:
• A summary of new information received; • Responses from submitters to questions raised in the application; • Summary of additional environmental (aquatic) modelling; • The Agency’s responses to issues raised in the submissions; • Ngā Kaihautū Tikanga Taiao report on the application; • NZ Sports Turf Institute submission outlining results of a survey of Councils on the acceptability of the proposed controls; • Conclusions by the Agency.
3.7 The following members of the Authority’s Hearings Committee considered the application: Helen Atkins (Chair), Richard Woods and Dr Deborah Read.
3.8 The following external experts were used in the consideration of this application: Name Title Robin Toy Ecotoxicologist Dr Martin Edwards Toxicologist
3.9 The Agency’s project team comprised the following members of ERMA New Zealand staff: Name Title Dr Susan Collier Senior Advisor Hazardous Substances Jim Waters Senior Advisor Hazardous Substances Paul Downie Administration Assistant Janet Gough Principal Analyst Michael Morris Manager, Reassessments
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4 The public hearing
4.1 The names of those who made oral presentations at the hearing are given in Appendix 2.
4.2 The Committee heard from the Agency as applicant. The Agency provided a summary of the application and a written response to the matters raised in submissions.
4.3 The Committee then heard from all those submitters who had requested to be heard over the two days of its hearing. The majority of submitters (Elizabeth Harris, Mike Eccles, David McBride, Alison Roe, Donna Bird of Many Affected Friends of Aotearoa (MAFIA), Peter Revington of Meat and Wool New Zealand, Catherine Delahunty, Sue Kedgley of Green Party of Aotearoa New Zealand, Alison White of Safe Food Campaign, Alison White on behalf of Jacqui Knight of Monarch Butterfly New Zealand Trust, Meriel Watts of Pesticide Action Network Aotearoa New Zealand, Peter Bankers, Patricia Holborow, Steffan Browning of Soil & Health Association of New Zealand) were in favour of an immediate ban on all uses of endosulfan in New Zealand. The Committee noted that those submitters supporting a ban on endosulfan use attending the hearing only represented a very small number of the overall number of submitters (182 out of 187 submitters) who supported a ban.
4.4 In relation to those submitters seeking a ban, the Committee especially wishes to thank Dr. Meriel Watts of the Pesticide Action Network for her thorough submissions and presentation of background material. Many of the other submitters (both those present and those who submitted only in written form) relied on the Pesticide Action Network's work in their submissions.
4.5 The Committee was also fortunate to hear from one of the manufacturers, Peter Chalmers of Agronica who stayed throughout the hearing and greatly assisted the Committee in relation to a number of questions and issues that arose. Mr Chalmers also supplied the Committee with a list of the forty seven countries where endosulfan is currently registered.
4.6 From industry the Committee heard from Peter Revington of Meat and Wool New Zealand that they supported an immediate ban of endosulfan due to the enormous damage the residues of the substance have had (and have the potential to have in the future) on our export trade markets.
4.7 Peter Ensor from Horticulture New Zealand supported a phasing out of the use of endosulfan. However, for practical reasons, for example the identification of alternative controls for Australian whitefly on citrus, the industry did not support an immediate ban. Some of the issues raised by Horticulture New Zealand were the issues of disposal of existing stocks of the product, the need for more work to be done on alternatives and the particular needs of the citrus industry in the benefits of endosulfan use against the Australian citrus whitefly. On the latter issue Horticulture New Zealand was supported in its presentation by representatives of the Citrus Growers.
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4.8 The Committee wishes to record its sincere thanks to Peter Ensor and the other members of the horticulture industry. Not only did Horticulture New Zealand provide detailed information to the Agency during the preparation for the review, but it continued to provide frank and direct information and advice during the course of the hearing. Mr Ensor's willingness to answer questions, some of which were difficult, is commended by the Committee and it wishes to record its formal thanks to Mr Ensor and his industry for the approach they took in relation to this application.
4.9 Finally, the Committee acknowledges that the submitters made a considerable effort and investment to be involved in the hearing and thanks them all for their attendance and involvement. The Committee appreciates their contributions which are a valuable component of the decision-making process.
5 Consideration
Legislative criteria for application
5.1 In June 2007, the Authority decided that there were grounds for reassessment of endosulfan and endosulfan formulations, because: • significant new information relating to the effects of endosulfan has become available; and • other substances with similar or improved beneficial effects and reduced adverse effects were available.
5.2 An application was lodged by the Chief Executive pursuant to section 63 following grounds for reassessment having been established under section 62 by the Authority in its decision dated 19 June 2007.
5.3 This application for the reassessment of endosulfan and substances containing endosulfan was lodged pursuant to section 63 and, as required under that section, deemed to be an application made under section 29. Section 29 requires the Authority to consider adverse and positive effects of the substance(s) and to make a decision based on whether or not the positive effects of the substance outweigh the adverse effects of the substance.
5.4 In making this decision the Authority has applied the relevant sections of the Act and followed the relevant provisions of the Methodology as detailed in the decision path attached to this decision as Appendix 1.
Information review
5.5 In the application, the Agency concluded that on the weight of the evidence, the information available to it constituted an adequate and appropriate basis for assessing the risks, costs and benefits associated with endosulfan and formulations containing endosulfan. In the absence of quantitative exposure information, the Agency used qualitative exposure assessment models to determine the levels of risk to human health
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and the environment. The Committee notes the uncertainty inherent in these assessments.
5.6 The risk management framework used by the Authority requires consideration of uncertainty. The Authority is required to be mindful of the scale and significance of the risks, costs and benefits when reviewing the information available. In addition, when there is scientific and technical uncertainty or disputed information, the Authority must determine the materiality and relevance of that uncertainty. If such uncertainty cannot be resolved the Authority is required to take into account the need for caution in managing the adverse effects of the substance.
5.7 The Committee has reviewed the available information and is satisfied that the available information is relevant and appropriate and is sufficient to demonstrate that the effects are of a sufficient magnitude to warrant attention under the Act.
5.8 In reviewing the information and reaching its decision the Committee has taken into account the ethical considerations that are associated with endosulfan and formulations containing endosulfan, and in particular those associated with the use of the substances. Specifically the Committee has applied the principles and procedural standards of the ERMA New Zealand Ethics Framework to its consideration of all the information provided.
Hazard classification
5.9 The Committee noted that the Agency classified endosulfan and formulations containing endosulfan as follows in Table 1 and Table 2:
Table 1: Summary of hazard classifications for endosulfan Toxicity Data triggering Classification Classification classification Reference Acute Oral Toxicity 6.1B SPECIES: Rat APVMA, 1998
ENDPOINT: LD50 VALUE: 22.7 mg/kg b w Acute Dermal 6.1B1 SPECIES: Rat Lewis, 1996 Toxicity ENDPOINT: LD50 VALUE: 34 mg/kg b w Acute Inhalation 6.1A SPECIES: Rat (F) APVMA, 1998 Toxicity ENDPOINT: LC50 VALUE: 13 mg/m3 (= 0.013 mg/L) Overall Acute 6.1A Acute Inhalation Toxicity Toxicity Eye Irritation 6.4A R-PHRASE: R 36 'Irritating APVMA 1998 to eyes.' Target Organ 6.9A The proposed acceptable APVMA, 1998 Systemic Toxicity daily intake (ADI) is 0.006 mg/kg/day, based on the lowest NOEL estimated in animal studies of approximately 0.6
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mg/kg/day, and using a 100- fold safety factor. This NOEL was derived from a range of effects (including decreased body weights and kidney pathology) observed in a variety of studies (namely a 78-week dietary study in mice, a 1-year dietary study in dogs, developmental study in rats and 2-year dietary study in rats).
Aquatic ecotoxicity 9.1A freshwater fish 96 hr LC50 = most sensitive 0.2 µg/l species ANZECC, 2000 freshwater invertebrates48 hr EC50 = 0.1 µg/l Soil ecotoxicity 9.2A Eisenia andrei (Earthworm) Heimbach, 1985
14 day(s) EC50 of 0.94 mg/kg-dry-weight-soil Terrestrial 9.3A SPECIES: Rat APVMA, 1998 vertebrate ENDPOINT: LD ecotoxicity 50 VALUE: 22.7 mg/kg b w Terrestrial 9.4B SPECIES: Honey bee Apis APVMA (1998) invertebrate toxicity mellifera DURATION: 48 hr
ENDPOINT: LD50 VALUE: 2 µg a.i./bee (oral), 2.4 µg a.i./bee (contact)
Table 2: Summary of hazard classifications for endosulfan formulations Emulsifiable concentrate containing 350 g/l endosulfan
MCW: Thionex Insecticide (350 g/L endosulfan) Toxicity (Substance (Substance (Substance (Substance Solvesso Classification A) B) C) D) formulation
Flammability 3.1B 3.1C 3.1D 3.1C 3.1D
Acute Oral 6.1C 6.1C 6.1C 6.1C 6.1C Toxicity
Acute Dermal 6.1B 6.1B 6.1B 6.1B 6.1B Toxicity Acute 6.1A 6.1A 6.1A 6.1A 6.1A Inhalation Toxicity Overall Acute 6.1A 6.1A 6.1A 6.1A 6.1A Toxicity Skin Irritation 6.3A 6.3B 6.3A 6.3A 6.3A Eye Irritation 6.4A 6.4A 8.3A 6.4A 6.4A
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Skin 6.5B Sensitisation Reproductive 6.8B 6.8B Toxicity Target Organ 6.9A 6.9A 6.9A 6.9A 6.9A Systemic Toxicity Aquatic 9.1A 9.1A 9.1A 9.1A 9.1A ecotoxicity Soil ecotoxicity 9.2A 9.2A 9.2A 9.2A 9.2A
Terrestrial 9.3B 9.3B 9.3B 9.3B 9.3B vertebrate ecotoxicity Terrestrial 9.4B 9.4B 9.4B 9.4B 9.4B invertebrate toxicity
5.10 The Committee notes that these classifications for endosulfan and endosulfan formulations differ from those of the previously approved substances as a result of a more thorough review by the Agency of the available toxicological and ecotoxicological data.
Controls
5.11 In the application, the Agency assessed the current controls assigned as part of the existing approvals. These controls were based on the substances’ hazardous properties as set out in the HSNO Regulations. These controls were used as a reference for evaluation in the application.
5.12 In the application, the Agency evaluated the risks, costs and benefits in association with the current controls and found that there were significant (non-negligible) risks associated with the use of endosulfan in New Zealand which potentially outweighed the benefits. Noting that it did not at that stage, have sufficient reliable information in order to properly assess or verify benefits of using the substance, the Agency made a number of recommendations including that aerial, domestic and citrus (airblast) application be prohibited, that turf use be restricted and proposing Restricted Entry Intervals (REIs), the setting of maximum application rates, a “no spray” buffer zone and requirements for personal protective equipment (PPE).
5.13 In the application, the Agency noted that the statutory public submission process afforded a further opportunity for information to be provided which could result in the Authority establishing a higher level of benefits.
5.14 Following the receipt of submissions, the Agency reviewed its original recommendations and made a number of revised recommendations in the Update Paper. These included prohibiting aerial, domestic and airblast (citrus) application with either immediate effect or following a very short phase out period. As regards other uses, the Agency noted Horticulture New Zealand’s submission proposing a phase out over a five year period and recommended that a tighter risk management regime should be adopted
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during any phase out period including, specific REIs and PPE, and a 100m “no spray” buffer zone.
5.15 For the ‘off label’ turf use, the Agency noted concerns expressed by submitters over the cost-effective application and practicability of the proposed controls, and noted that the Committee could decide to prohibit use on turf outright or phase it out over a period of time. In the case of the latter option, the Agency proposed a maximum application rate of 0.7 kg a.i./ ha, one application per season, immediate watering in and a 48 hour “stand down” period in the case of ground contact sports fields and public parks where children may play.
Areas of effect
5.16 Based on their hazardous properties and their lifecycles and use patterns, endosulfan and endosulfan formulations have the potential to cause adverse effects to: • workers involved in the manufacture of the substances; • workers and bystanders should an incident occur in transportation or storage of the substances; • users of the substances; • the public from spray drift; • the public who use any sports grounds, golf courses or bowling greens that have been treated; • the public through exposure to residues in food; • the public through long range transport, through food residues, leading to breast milk and fat tissue residues; • the environment from spillage, seepage, runoff or long range transport; • the relationship of Māori to the environment through exposure of water, soil and native flora and fauna to the substances.
Identification and assessment of the risks, costs and benefits
5.17 In its application for the reassessment of endosulfan and endosulfan formulations, the Agency identified potentially significant and therefore non-negligible risks to the environment, to human health and safety, to the relationship of Māori with the environment and to society and the community.
Environmental risk assessment 5.18 The following assessments made by the Agency in the application are noted and accepted by the Committee: • There is a high acute and chronic risk to aquatic species (fish and invertebrates) from all current uses of endosulfan in New Zealand. Exposure of non-target areas, including the aquatic environment, can be reduced by the use of buffer zones. Such buffer zones would need to be substantial, possibly extending over 100 metres. • There is a risk to earthworms when endosulfan is used in accordance with label uses.
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• Laboratory data suggest that endosulfan is toxic to bees and other non-target terrestrial invertebrates. There is uncertainty as to whether such effects occur in the field. • There may be a risk to birds feeding in fields where crops have been recently treated. There is an acute risk to birds associated with the use of endosulfan on turf. • The risk to water birds is low. • Contamination of remote regions through long-range movement of endosulfan is likely based on overseas monitoring.
5.19 As required by clause 33 of the Methodology, the Committee considered its approach to risk with respect to the high and chronic risk to aquatic species. Whilst noting that this risk could be reduced by substantial buffer zones, the Committee was of the view that this risk will persist over time and that the potential effects may be irreversible.
Human health risk assessment 5.20 The following assessments made in the application are noted and accepted by the Committee: • Risks to operators involved in mixing, loading and applying endosulfan for outdoor crops (including hand-held application) in accordance with current labelled application rates (0.7 kg a.i./ha) are estimated as acceptable, provided that adequate PPE is used. • Risks to operators involved in mixing and loading for use in glasshouses are acceptable provided adequate PPE is used (noting that application within the glasshouse is by remote means not involving operator exposures). • Risks to operators for citrus applications even if full PPE (including respiratory protection) is used are high. This is due to the application rates being higher than for the current label uses and the different application method. • Risks to workers re-entering areas treated in accordance with label uses, including glasshouse use, are estimated to be acceptable provided appropriate PPE is used or REIs are applied. • Risks to bystanders and residents are estimated as acceptable for boom application to turf and in accordance with the label uses. • Risks to bystanders and residents from air-blast application to citrus are estimated as very high. • Risks to sports people from use of endosulfan on treated turf may be acceptable if application is in accordance with the current standard practices involving watering in and only one annual treatment and an REI is applied.
5.21 Concerns raised about the practicality of the risk mitigation controls recommended have been noted by the Committee. The Committee considers these concerns to be valid and that the human health risks are significant.
5.22 In considering its approach to risk the Committee further notes that exposure to the risk is involuntary in many cases and that it will persist over time.
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Benefits 5.23 No potentially significant or non-negligible benefits were identified.
5.24 Some of the available information suggests that endosulfan is an important element in Integrated Pest Management (IPM) because it is less harmful to some non-target species including honey bees. Other information states that the lack of effects on bees in the field is unproven. This matter is therefore an area of significant uncertainty.
5.25 There are indirect health and safety benefits to air passengers from the use of endosulfan, but the extent of the benefit is unknown since this is only one element in reducing the risk of birdstrike.
5.26 Turf managers have indicated that there are social and economic benefits from the availability of endosulfan for control of earthworms. Endosulfan is required to manage and reduce earthworm numbers on turf and thereby maintain playing quality by reducing the worm casting. Endosulfan is cost effective and turf managers submit that it provides the best control of earthworms. There are social and economic benefits to horticulturalists from knowing that there is a ‘last resort’ insecticide available, and from the availability of a comparatively cheap and long lasting insecticide.
5.27 One benefit identified, is its use in the control of whitefly by the citrus industry. However, the Committee is of the view that the method of application (airblast) poses a significant risk to the operator and bystanders and greatly outweighs this benefit. The Agency had recommended in the application that the use of endosulfan be prohibited for airblast application and evidence at the hearing confirmed this as the only application method suited to the citrus industry. The Committee is of the view that there are no practical controls that could be added to adequately mitigate this risk to the health of operators and bystanders.
5.28 Endosulfan is a cheaper product than a number of other insecticides available, both from the perspective of the cost per application and also the number of applications required. However, while endosulfan is seen as a cheap and effective product the Committee did not consider that under present use conditions there were any potentially significant benefits from the use of endosulfan.
Assessment of any risks costs or benefits to New Zealand’s international obligations 5.29 The committee noted that New Zealand is party to two relevant international conventions, the Stockholm Convention on Persistent organic Pollutants and the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade. The Committee noted as follows: • In October 2008 endosulfan was accepted into the review process of the Stockholm Convention for Persistent Organic Pollutants (POPs);
• Endosulfan and endosulfan formulations are also under consideration for inclusion under the Rotterdam Convention ‘Prior Informed Consent’ , but the 4th conference of parties in October 2008 failed to reach consensus on listing in the convention;
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5.30 On the basis of these observations the Committee notes that while relevant international obligations are considering endosulfan there are no specific provisions that currently impact on this decision.
Likely effects of the substances being unavailable
5.31 The Committee notes that there are alternative products available for most of the current uses for endosulfan in New Zealand.
5.32 Upon reviewing all the information contained in the application and received from submitters and at the hearing, the Committee accepts the Agency’s evaluation of the risks to the environment and human health of endosulfan and endosulfan formulations as set out in the application and considers the risks to be high. The Committee has considered its approach to risk and notes that the nature of these risks is such that the Committee believes that there is a need for a risk averse position to be adopted.
5.33 The Committee noted the availability of alternatives to endosulfan and endosulfan formulations for most uses. Horticulture New Zealand and the Citrus Industry Council reported that endosulfan is the only compound that effectively controls broad mite on lemons and is also a possible control option for Australian citrus whitefly, a new pest of citrus.
An overall evaluation of the combined impact of all of the risks costs and benefits
5.34 The Committee is required under the Act, to consider whether or not the positive effects (benefits) of using endosulfan outweigh the negative effects (risks and costs) of its use - after taking account of all safety precautions that might be imposed and the likely effects of the substance being unavailable.
5.35 In addition to the risk averse approach adopted with respect to the risks to the environment and human health, the Committee notes that there is some uncertainty associated with the technical information provided with respect to the risks associated with endosulfan and endosulfan formulations and therefore the Committee has adopted a cautious approach as required by section 7 of the Act.
5.36 Upon reviewing all the information contained in the application and received from submitters and at the hearing, the Committee accepts the Agency’s evaluation of the risks to the environment and human health of endosulfan and endosulfan formulations as set out in the application and considers the risks to be high.
5.37 The Committee considers there are significant risks to Māori cultural wellbeing, society and the community and to New Zealand’s international relationships.
5.38 The Committee considers that there are no significant benefits associated with the availability of endosulfan and endosulfan formulations.
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5.39 Thus, the Committee considers that it is evident that the risks and costs associated with the approval of endosulfan and endosulfan formulations outweigh the benefits.
Conclusions
5.40 Taking into account, the approach to risk, the precautionary approach and the effects of the substances being unavailable, the Committee considers that the high level of adverse effects (risks and costs) to the environment, human health, the relationship of Māori to the environment and New Zealand’s international relationships outweigh any positive effects (benefits) associated with the availability of endosulfan and endosulfan formulations in New Zealand.
6 Decision
6.1 The Committee determines that, pursuant to section 29 and clause 27 the adverse effects of endosulfan and formulations containing endosulfan outweigh the positive effects.
6.2 The Committee: (a) Declines to approve the further importation or manufacture of endosulfan and formulations containing endosulfan and accordingly revokes the following approvals: • endosulfan (Approval Number HSR002846); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance A) (Approval Number HSR000679); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance B) (Approval Number HSR000678); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance C) (Approval Number HSR000487); • emulsifiable concentrate containing 350 g/litre endosulfan (Substance D) (Approval Number HSR000677),
(b) issues a direction prohibiting the use of endosulfan or any of the above formulations for any purpose and imposing controls on the collection and disposal of endosulfan. These controls are attached to this decision as Appendix 3. All endosulfan and formulations containing endosulfan must be disposed of within 12 months of this decision coming into effect.
This decision will come into effect 28 days after the direction is published in the Gazette.
6.3 The Committee considers that the decision should be implemented as soon as possible. However, the Committee also recognises that the decision must be communicated before it has effect. For this reason the Committee has directed that the decision should come into effect 28 days after the direction is published in the Gazette.
6.4 The Committee notes that an approved method of disposal will be in accordance with the Ministry for the Environment and Regional Council partnership scheme for disposal
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of rural hazardous waste (http://www.mfe.govt.nz/issues/waste/special/agrichemicals/index.html).
6.5 This scheme provides a free disposal option for holders of unused stocks of endosulfan formulations but is only currently available through the following regional councils: • Auckland • Waikato • Wellington • Canterbury • Otago.
6.6 ERMA New Zealand will be putting out an information sheet on disposal shortly.
6.7 In accordance with clause 36(2)(b), the Committee records that, in reaching these conclusions, it has applied the balancing tests in section 29 and clauses 26 and 27.
6.8 It has also applied the following criteria in the Methodology: • clause 9 – equivalent of sections 5, 6 and 8; • clause 11 – characteristics of substance; • clause 12 – evaluation of assessment of risks; • clause 13 – evaluation of assessment of costs and benefits; • clause 14 – costs and benefits accruing to New Zealand; • clause 21 – the decision accords with the requirements and regulations; • clause 22 – the evaluation of risks, costs and benefits – relevant considerations; • clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques; • clause 25 – the evaluation of risks; • clause 33 – risk characteristics; • clause 34 – the aggregation and comparison of risks, costs and benefits; • clause 35 – the costs and benefits of varying the default controls.
Helen Atkins Date: 10 December 2008
Chair
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Appendix 1: Decision path for reassessment of hazardous substances
Context This decision path describes the decision-making process for the application to import and manufacture endosulfan and formulated substances containing endosulfan. This application is made under section 63 (Reassessment) of the HSNO Act, and determined under section 29 of the Act.
Introduction The purpose of the decision path is to provide the Authority with guidance so that all relevant matters in the HSNO Act and the Methodology have been addressed. It does not attempt to direct the weighting that the Authority may decide to make on individual aspects of an application.
In this document ‘section’ refers to sections of the HSNO Act, and ‘clause’ refers to clauses of the ERMA New Zealand Methodology.
The decision path has two parts – • Flowchart (a logic diagram showing the process prescribed in the Methodology and the HSNO Act to be followed in making a decision), and • Explanatory notes (discussion of each step of the process).
Of necessity the words in the boxes in the flowchart are brief, and key words are used to summarise the activity required. The explanatory notes provide a comprehensive description of each of the numbered items in the flowchart, and describe the processes that should be followed to achieve the described outcome.
ERMA New Zealand Decision: Application HRC07003 Page 15 of 25
Decision path for applications to import or manufacture a hazardous substance, application made under section 28 of the Act and determined under section 29. For proper interpretation of the decision path it is important to work through the flowchart in conjunction with the explanatory notes.
ERMA New Zealand Decision: Application HRC07003 Figure updated: April 2008 Page 16 of 25
Figure 1 EXPLANATORY NOTES
Item 1: Review the content of the application and all relevant information Review the application, the E&R Report, and information received from experts and that provided in submissions (where relevant) in terms of section 28(2) of the Act and clauses 8, 15, 16 and 20 of the Methodology.
Item 2: Is this information sufficient to proceed? Review the information and determine whether or not there is sufficient information available to make a decision.
The Methodology (clause 8) states that the information used by the Authority in evaluating applications shall be that which is appropriate and relevant to the application. While the Authority will consider all relevant information, its principal interest is in information which is significant to the proper consideration of the application; ie information which is “necessary and sufficient” for decision- making.
Item 3: (if no) Seek additional information If there is not sufficient information then additional information may need to be sought from the applicant, the Agency or other parties/experts under section 58 of the Act (clause 23 of the Methodology).
Item 4 Sufficient? When additional information has been sought, has this been provided, and is there now sufficient information available to make a decision?
If the Authority is not satisfied that it has sufficient information for consideration, then the application must be declined under section 29(1)(c).
Item 5: (If ‘yes’ from item 2 or from item 4) Identify the composition of the substance, classify the hazardous properties, and determine default controls Identify the composition of the substance, and establish the hazard classifications for the identified substance.
Determine the default controls for the specified hazardous properties using the regulations ‘toolbox’.
Item 6: Identify all risks, costs and benefits that are potentially non-negligible2 Costs and benefits are defined in the Methodology as the value of particular effects (clause 2). However, in most cases these ‘values’ are not certain and have a likelihood attached to them. Thus costs and risks are generally linked and may be addressed together. If not, they will be addressed separately. Examples of costs
2 Relevant effects are marginal effects, or the changes that will occur as a result of the substance being available. Financial costs associated with preparing and submitting an application are not marginal effects and are not effects of the substance(s) and are therefore not taken into account in weighing up adverse and positive effects. These latter types of costs are sometimes called ‘sunk’ costs since they are incurred whether or not the application is successful.
ERMA New Zealand Decision: Application HRC07003 Page 17 of 25 that might not be obviously linked to risks are direct financial costs that cannot be considered as ‘sunk’ costs (see footnote 1). Where such costs arise and they have a market economic effect they will be assessed in the same way as risks, but their likelihood of occurrence will be more certain (see also item 11).
Identification is a two step process that scopes the range of possible effects (risks, costs and benefits).
Step 1: Identify all possible risks and costs (adverse effects) and benefits (positive effects) associated with the approval of the substance(s), and based on the range of areas of impact described in clause 9 of the Methodology and sections 5 and 6 of the Act3. Consider the effects of the substance through its lifecycle (clause 11) and include the likely effects of the substance being unavailable (sections 29(1)(a)(iii) and 29(1)(b)(iii)).
Relevant costs and benefits are those that relate to New Zealand and those that would arise as a consequence of approving the application (clause 14).
Consider short term and long term effects.
Identify situations where risks and costs occur in one area of impact or affect one sector and benefits accrue to another area or sector; that is, situations where risks and costs do not have corresponding benefits.
Step 2: Document those risks, costs and benefits that can be readily concluded to be negligible4, and eliminate them from further consideration.
Note that where there are costs that are not associated with risks some of them may be eliminated at this scoping stage on the basis that the financial cost represented is very small and there is no overall effect on the market economy.
Item 7: Assess each risk assuming controls in place. Add, substitute or delete controls in accordance with clause 35 and sections 77, 77A and 77B of the Act. The assessment of potentially non-negligible risks and costs should be carried out in accordance with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the Methodology. The assessment is carried out with the default controls in place.
Assess each potentially non-negligible risk and cost estimating the magnitude of the effect if it should occur and the likelihood of it occurring. Where there are
3 Effects on the natural environment, effects on human health and safety, effects on Māori culture and traditions, effects on society and community, effects on the market economy. 4 Negligible effects are defined in the Annotated Methodology as “Risks which are of such little significant in terms of their likelihood and effect that they do not require active management and/or after the application of risk management can be justified by very small levels of benefits.
ERMA New Zealand Decision: Application HRC07003 Page 18 of 25 non-negligible financial costs that are not associated with risks then the probability of occurrence (likelihood) may be close to 1. Relevant information provided in submissions should be taken into account.
The distribution of risks and costs should be considered, including geographical distribution and distribution over groups in the community, as well as distribution over time. This information should be retained with the assessed level of risk/cost.
This assessment includes consideration of how cautious the Authority will be in the face of uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate scenarios for lower and upper bounds for the adverse effect as a means of identifying the range of uncertainty (clause 32). It is also important to bear in mind the materiality of the uncertainty and how significant the uncertainty is for the decision (clause 29(a)).
Consider the Authority’s approach to risk (clause 33 of the Methodology) or how risk averse the Authority should be in giving weight to the residual risk, where residual risk is the risk remaining after the imposition of controls. See ERMA New Zealand report ‘Approach to Risk’ for further guidance5.
Where it is clear that residual risks are non-negligible and where appropriate controls are available, add substitute or delete controls in accordance with sections 77 and 77A of the Act to reduce the residual risk to a tolerable level. If the substance has toxic or ecotoxic properties, consider setting exposure limits under section 77B. While clause 35 is relevant here, in terms of considering the costs and benefits of changing the controls, it has more prominence in items 10 and 13
If changes are made to the controls at this stage then the approach to uncertainty and the approach to risk must be revisited.
Item 8: Undertake combined consideration of all risks and costs, cognisant of proposed controls Once the risks and costs have been assessed individually, if appropriate consider all risks and costs together as a ‘basket’ of risks/costs. This may involve combining groups of risks and costs as indicated in clause 34(a) of the Methodology where this is feasible and appropriate, or using other techniques as indicated in clause 34(b). The purpose of this step is to consider the interactions between different effects and determine whether these may change the level of individual risks.
Item 9: Are all risks with controls in place negligible? Looking at individual risks in the context of the ‘basket’ of risks, consider whether all of the residual risks are negligible.
5 http://www.ermanz.govt.nz/resources/publications/pdfs/ER-OP-03-02.pdf
ERMA New Zealand Decision: Application HRC07003 Page 19 of 25 Item 10:
(from item 9 - if ‘yes’) Review controls for cost-effectiveness in accordance with clause 35 and sections 77, 77A and 77B Where all risks are negligible the decision must be made under clause 26 of the Methodology.
Consider the practicality and cost-effectiveness of the proposed individual controls and exposure limits (clause 35). Where relevant and appropriate, add, substitute or delete controls whilst taking into account the view of the applicant, and the cost- effectiveness of the full package of controls.
Item Is it evident that benefits outweigh costs? 11: Risks have already been determined to be negligible (item 9). In the unusual circumstance where there are non-negligible costs that are not associated with risks they have been assessed in item 7.
Costs are made up of two components: internal costs or those that accrue to the applicant, and external costs or those that accrue to the wider community.
Consider whether there are any non-negligible external costs that are not associated with risks.
If there are no external non-negligible costs then external benefits outweigh external costs. The fact that the application has been submitted is deemed to demonstrate existence of internal or private net benefit, and therefore total benefits outweigh total costs6. As indicated above, where risks are deemed to be negligible, and the only identifiable costs resulting from approving an application are shown to accrue to the applicant, then a cost-benefit analysis will not be required. The act of an application being lodged will be deemed by the Authority to indicate that the applicant believes the benefits to be greater than the costs.
However, if this is not the case and there are external non-negligible costs then all benefits need to be assessed (via item 14).
6 Technical Guide ‘Risks, Costs and Benefits’ page 6 - Note that, where risks are negligible and the costs accrue only to the applicant, no explicit cost benefit analysis is required. In effect, the Authority takes the act of making an application as evidence that the benefits outweigh the costs”. See also Protocol Series 1 ‘General requirements for the Identification and Assessment of Risks, Costs, and Benefits’.
ERMA New Zealand Decision: Application HRC07003 Page 20 of 25 Item 12:
(from item 9 - if ‘no’) Establish Authority’s position on risk averseness and appropriate level of caution Although ‘risk averseness’ (approach to risk, clause 33) is considered as a part of the assessment of individual risks, it is good practice to consolidate the view on this if several risks are non-negligible. This consolidation also applies to the consideration of the approach to uncertainty (section 7)
Item Review controls for cost-effectiveness in accordance with clause 35 and 13: sections 77, 77A and 77B This constitutes a decision made under clause 27 of the Methodology (taken in sequence from items 9 and 12).
Consider whether any of the non-negligible risks can be reduced by varying the controls in accordance with sections 77 and 77A of the Act, or whether there are available more cost-effective controls that achieve the same level of effectiveness (section 77A(4)(b) and clause 35(a)).
Where relevant and appropriate, add, substitute or delete controls whilst taking into account the views of the applicant (clause 35(b)), and making sure that the total benefits that result from doing so continue to outweigh the total risks and costs that result.
As for item 7, if the substance has toxic or ecotoxic properties, consider exposure limits under section 77B.
Item (if ‘no’ from item 11 or in sequence from item 13) Assess benefits 14: Assess benefits or positive effects in terms of clause 13 of the Methodology.
Since benefits are not certain, they are assessed in the same way as risks. Thus the assessment involves estimating the magnitude of the effect if it should occur and the likelihood of it occurring. This assessment also includes consideration of the Authority’s approach to uncertainty or how cautious the Authority will be in the face of uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate scenarios for lower and upper bounds for the positive effect.
An understanding of the distributional implications of a proposal is an important part of any consideration of costs and benefits, and the distribution of benefits should be considered in the same way as for the distribution of risks and costs. The Authority will in particular look to identify those situations where the beneficiaries of an application are different from those who bear the costs7. This is important not only for reasons related to fairness but also in forming a view of just how robust any claim of an overall net benefit might be. It is much more difficult
7 This principle derives from Protocol Series 1, and is restated in the Technical Guide ‘Risks, Costs and Benefits’.
ERMA New Zealand Decision: Application HRC07003 Page 21 of 25 to sustain a claim of an overall net benefit if those who enjoy the benefits are different to those who will bear the costs. Thus where benefits accrue to one area or sector and risks and costs are borne by another area or sector then the Authority may choose to be more risk averse and to place a higher weight on the risks and costs.
As for risks and costs, the assessment is carried out with the default controls in place.
Item Taking into account controls, do positive effects outweigh adverse effects? 15: In weighing up positive and adverse effects, consider clause 34 of the Methodology. Where possible combine groups of risks, costs and benefits or use other techniques such as dominant risks and ranking of risks. The weighing up process takes into account controls proposed in items 5, 7, 10 and/or 13.
Where this item is taken in sequence from items 12, 13 and 14 (i.e. risks are not negligible) it constitutes a decision made under clause 27 of the Methodology.
Where this item is taken in sequence from items 9, 10, 11 and 14 (i.e. risks are negligible, and there are external non-negligible costs) it constitutes a decision made under clause 26 of the Methodology.
Item 16:
(if ‘yes’ from items 11 or 15) Confirm and set controls Controls have been considered at the earlier stages of the process (items 5, 7, 10 and/or 13). The final step in the decision-making process brings together all the proposed controls, and reviews them for overlaps, gaps and inconsistencies. Once these have been resolved the controls are confirmed.
ERMA New Zealand Decision: Application HRC07003 Page 22 of 25 Appendix 2: Names of those who made oral presentations at the hearing
Submission number Submitter Day 1 (20 October 2008) 10162 Andrew Mitchell, New Zealand Sports Turf Institute 10143 Elizabeth Harris Expert witnesses: Mike Eccles David McBride Alison Roe 10180 Donna Bird, Many Affected Friends of Aotearoa (MAFIA) 10235 Peter Revington, Meat and Wool New Zealand 10247 Peter Chalmers, Agronica New Zealand Ltd 10236 Catherine Delahunty 10252 Sue Kedgley, Green Party of Aotearoa New Zealand 10250 Alison White, Safe Food Campaign 10144 Alison White on behalf of Jacqui Knight, Monarch Butterfly New Zealand Trust
Day 2 (21 October 2008) 10239 Meriel Watts, Pesticide Action Network Aotearoa New Zealand 10034 Peter Bankers 10058 Patricia Holborow 10244 Steffan Browning, Soil & Health Association of New Zealand 10241 Peter Ensor, Horticulture New Zealand 10246 Simon Terry, Sustainability Council of New Zealand
ERMA New Zealand Decision: Application HRC07003 Page 23 of 25 Appendix 2: Controls on the disposal and collectors of endosulfan
Controls on the disposal of endosulfan 1. Endosulfan may be disposed of by – (a) by treating the substance using a method that changes the characteristics or composition of the substance so that the substance or any product of such treatment is no longer a hazardous substance; or
(b) by exporting the substance from New Zealand as waste for environmentally sound disposal provided that such export complies with the relevant requirements of the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal and the OECD Decision C(2001)107 on the Control of Transboundary Movement of Wastes Destined for Recovery Operations.
2. In subclause (1)(a), treating the substance does not include—
(a) application to or discharge to any environmental medium; or
(b) dilution of the substance with any other substance before discharge into the environment; or (c) depositing the substance in a landfill or a sewage facility; or
(d) depositing the substance in an incinerator unless in doing so the substance is treated in accordance with subclause (1)(a).
Controls on collectors of endosulfan 3. For formulations that have a class 3 hazard classification a collector must comply with the controls in the Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001.
4. A collector must ensure that equipment used to handle the substance complies with regulation 7 of the Hazardous Substances (Class 6, 8, and 9 Controls) Regulations 2001.
5. A collector who handles endosulfan must comply with regulation 8 of the Hazardous Substances (Class 6, 8, and 9 Controls) Regulations 2001.
6. Regulation 9 of the Hazardous Substances (Class 6, 8, and 9 Controls) Regulations 2001 applies to any quantity of endosulfan.
7. For the purposes of regulation 10 of the Hazardous Substances (Class 6, 8, and 9 Controls) Regulations 2001, no endosulfan in any quantity may be carried on any passenger service vehicle.
8. When stored for the purpose of environmentally sound disposal, endosulfan must not be mixed with any other substance.
9. The Hazardous Substances (Packaging) Regulations 2001 apply to endosulfan as if they are deemed to have a hazard classification that is class 6.1B.Transport of endosulfan by land within New Zealand shall comply with all relevant requirements of the Land Transport Rule: Dangerous Goods 1999 (Rule 45001).
ERMA New Zealand Decision: Application HRC07003 Page 24 of 25
10. Transport of endosulfan by sea within New Zealand shall comply with all relevant requirements of either the Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A) or the International Maritime Dangerous Goods Code.
11. Transport of endosulfan by air within New Zealand shall comply with all relevant requirements of Part 92 of the Civil Aviation Rules.
12. The Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 apply to endosulfan stored or transported in a tank, tank wagon or transportable container as those terms are defined in those regulations.
13. The location and movement of endosulfan must be recorded in accordance with the Hazardous Substances (Tracking) Regulations 2001.
14. The Hazardous Substances (Emergency Management) Regulations 2001 apply to endosulfan as if they are deemed to have hazard classifications that are class 6.1A and 9.1A.
15. The Hazardous Substances (Identification) Regulations 2001 apply to endosulfan as if they are deemed to have hazard classifications that are class 6.1A and 9.1A.
ERMA New Zealand Decision: Application HRC07003 Page 25 of 25
Application for Reassessment of a Hazardous Substance under section 63 of the Hazardous Substances and New Organisms Act 1996
Name of substance: endosulfan and formulations containing endosulfan
Applicant: Chief Executive ERMA New Zealand
Office use only
Application Code: Date received:____/____/_
ERMA New Zealand Contact: Initial Fees Paid: $
Application Version No:
Contents Identification of benefits (positive effects) ...... 63 4.3 Assessment of potentially significant risks, costs and benefits ...... 70 Executive Summary ...... 8 Assessment of environmental risks ...... 70 The application ...... 8 Assessment of human health risks ...... 96 Precautionary approach to determining risks ...... 8 Assessment of benefits (positive effects) ...... 136 Current use of endosulfan ...... 8 4.4 Relationship of M ori to the environment ...... 142 Overseas regulatory status of endosulfan ...... 9 Adverse effects ...... 142 Risks, costs and benefits of use in New Zealand ...... 10 Mauri ...... 142 Preliminary recommendations ...... 13 Kaitiakitanga ...... 143 Submissions ...... 15 Hauora ...... 143 Section One – Applicant Details ...... 16 Assessment...... 143 Treaty of Waitangi ...... 143 Section Two – Application Type and Related Approvals ...... 17 2.1 Application type ...... 17 Section Five – International Considerations ...... 145
2.2 Sources of information for this application and consideration of uncertainty ...... 18 Section Six – Likely Effects of the Substance Being Unavailable ...... 146
Section Three – Information on the Substances ...... 20 Section Seven – Overall Evaluation and Recommendations ...... 148 3.1 Identification of the substances ...... 20 7.1 Overall evaluation ...... 148 3.2 Chemical and physical properties of endosulfan and its formulations ...... 22 7.2 Preliminary recommendations ...... 149 3.3 Review of hazardous properties of endosulfan and endosulfan formulations ...... 24 Section Eight – Summary of Public Information ...... 151 3.4 Lifecycle of endosulfan formulations ...... 27 8.1 Names of the substances for the public register ...... 151 3.5 Manufacture ...... 27 8.2 Purpose of the application for the public register ...... 151 Importation...... 27 8.3 Use categories of the substances ...... 151 Repackaging/storage ...... 27 Transport ...... 27 References ...... 152 Disposal ...... 28 Appendices ...... 160 Use of endosulfan ...... 28 3.6 Existing controls for endosulfan and endosulfan formulations ...... 37 Appendix A – Human health hazard profile ...... 161 3.7 Controls applied under the HSNO Act ...... 37 Introduction ...... 161 3.8 Non-HSNO Act controls...... 54 Pharmacokinetics ...... 161 Agricultural Compounds and Veterinary Medicines Act 1997 ...... 54 6.1 classification – Acute toxicity ...... 161 Other requirements...... 55 6.3, 6.4 & 6.5 classification – Irritancy/sensitisation ...... 162 Section Four – Risks, Costs and Benefits ...... 56 6.6 classification – Mutagenicity/genotoxicity ...... 163 4.1 Identification of the potential risks, costs and benefits of the substances ...... 56 6.7 classification – carcinogenicity ...... 166 Risk management context ...... 56 6.8 classification – Reproductive/developmental toxicity ...... 166 4.2 Risks and costs to human health and the environment ...... 58 6.9 classification – Target organ toxicity ...... 168 Reports of adverse effects of endosulfan formulations ...... 59 Endocrine disruption ...... 171
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Endosulfan sulphate ...... 174 List of tables and figures Endosulfan residue burdens ...... 175 Use scenarios evaluated in this application ...... 10 Appendix B – Environmental hazard profile ...... 176 Table 1: Identification of endosulfan ...... 20 Table 2: Chemical and physical properties of endosulfan products ...... 23 Aquatic Toxicity ...... 176 Table 3: Summary of classifications for endosulfan ...... 24 Non-target invertebrate toxicity ...... 186 Table 4: Summary of classifications for endosulfan formulations ...... 25 Table 5: Current application rates for endosulfan ...... 29 Appendix C – Monitoring studies examined by the Agency...... 189 Table 6: Registered uses for Thionex 350EC ...... 31 Table 7: Percentage use of endosulfan in different sectors ...... 31 Appendix D – Tier II modelling of aquatic risks...... 192 Table 8: Use of endosulfan for turf management ...... 36 Table 9: Use scenarios evaluated in this application ...... 37 Appendix E – Input and results of analysis used to select worst-case sites in Table 10: Existing controls for endosulfan and formulations ...... 39 Ramanarayanan et al (1999) ...... 199 Table 11: Summary of default controls applicable to endosulfan ...... 41 Table 12: Additional HSNO controls applied to endosulfan ...... 50 Appendix F – Calculations underlying bird risk assessments ...... 201 Table 13: Agricultural Compounds and Veterinary Medicines Group conditions for endosulfan formulations ...... 54 Appendix G – Margins of exposure for re-entry to endosulfan treated crops ...... 206 Table 14: Identification of potential sources of risk ...... 58 Table 15: Summary of benefits from the use of endosulfan ...... 69 Appendix H – Control measures taken overseas of relevance to New Zealand ...... 211 Table 16: Levels of concern in environmental risk assessment ...... 71 Table 17: Aquatic risk assessment – GENEEC2 input parameters ...... 79 United States ...... 211 Table 18: Aquatic exposure as estimated by GENEEC2 model ...... 81 Canada ...... 221 Table 19: Summary of aquatic exposure ...... 82 Table 20: HC estimates of aquatic acute toxicity ...... 83 5 Australia ...... 224 Table 21: Summary of chronic aquatic toxicity ...... 84 Table 22: Acute/chronic aquatic toxicity ratios ...... 85 Appendix I – Potential alternatives to endosulfan ...... 227 Table 23: Aquatic toxicity of endosulfan metabolites ...... 85 Alternatives to endosulfan for crop pest control ...... 227 Table 24: Calculation of RQs ...... 86 Table 25: Health Canada’s estimate of buffer zones required for aquatic habitat protection from spray Alternatives to endosulfan for earthworm control on turf ...... 238 drift ...... 88 Table 26: Terrestrial invertebrate toxicity used in the risk assessment ...... 89 Appendix J – Parties contacted ...... 239 Table 27: Summary of bird toxicity data ...... 90 Table 28: Risk assessment for birds feeding on aquatic organisms ...... 95 Appendix K – Confidential appendix – Report of M Edwards on Davies (2002) dermal Table 29: NOAEL/LOAEL used by Agency and overseas regulators to estimate AOEL ...... 102 absorption study ...... 242 Table 30: Scenarios considered in the operator risk assessment ...... 107 Table 31: Operator exposure estimates ...... 108 Appendix L – Confidential appendix – Product formulations ...... 256 Table 32: Results of operator risk assessment ...... 111 Table 33: Re-entry worker exposures ...... 120 Table 34: Bystander exposure estimates ...... 133 Table B1: Aquatic toxicity data (after ANZECC, 2000) ...... 177 Table B2: Chronic toxicity summary of the ANZECC (2000) database...... 184 Table B3: Plant toxicity as in USEPA ECOTOX database ...... 185 Table B4: Test results on non-target invertebrates reported by Brasse (1985) ...... 186 Table B5: Test results on non-target invertebrates reported by Biobest (2008) ...... 188 Table C1: Summary of monitoring studies examined by the Agency ...... 189 Table D1: Comparison of Agency and USEPA aquatic exposure modelling inputs ...... 192 Table D2: Comparison of Agency and USEPA aquatic exposure concentrations ...... 193 Table D3: Exposure scenarios modelled by Ramanarayanan et al (1999) ...... 194 Table D4: Application details modelled by Ramanarayanan et al (1999) ...... 195 Table D5: Percentage drift used in modelling by Ramanarayanan et al (1999) ...... 195 Table D6: Aquatic exposure estimates made by Ramanarayanan et al (1999) ...... 196
Endosulfan Reassessment – Application June 2008 Page 5 of 244 Page 6 of 244 June 2008 Endosulfan Reassessment – Application
Table D7: Summary of the effect of a buffer zone on aquatic exposure concentrations (as modelled by Ramanarayanan et al, 1999)...... 196 Executive Summary Table D8: Comparison of Agency and Ramanarayanan et al (1999) aquatic exposure modelling inputs ...... 197 Table D9: Comparison of Agency and Ramanarayanan et al (1999) aquatic exposure estimates ..... 197 The application Table E1: Input parameters in modelling to select ‘worst-case’ scenarios (Ramanarayanan & Allen, 1999a) ...... 199 This application is made by the Chief Executive of ERMA New Zealand for the Table F1: Summary of T-REX model inputs ...... 201 reassessment under the Hazardous Substances and New Organisms Act 1996 of the Table F2: Avian acute and chronic risk quotients for a single and multiple broadcast applications of insecticide endosulfan and of products containing endosulfan. Following a submission endosulfan products based on a bobwhite quail LC50 of 805 ppm, a mallard duck NOEC of 30 ppm and a half-life of 4 days ...... 202 and hearing process, the Environmental Risk Management Authority will make a Table F3: Refined avian acute and chronic risk quotients for a single and multiple broadcast decision on the future use of endosulfan in New Zealand. The Authority’s decision will applications of endosulfan products based on a bobwhite quail LC50 of 805 ppm, a mallard be based on whether or not the positive effects (benefits) of using endosulfan outweigh duck NOEC of 30 ppm and a half-life of 0.95 days...... 202 the negative effects (risks and costs) of its use - after taking account of all safety Table F4: Body residues ( g/kg) in aquatic foodweb (USEPA, 2007c) ...... 204 precautions that might be imposed and the likely effects of the substance being Table H1: USEPA mitigation measures relevant to New Zealand: Summary of USEPA labelling unavailable. changes for endosulfan...... 212 Table H2: USEPA mitigation measures relevant to New Zealand: dietary, ecological and occupational If the benefits outweigh the risks and costs, the Authority may approve the continued risks ...... 220 use of endosulfan in New Zealand for some or all of its current uses (possibly with Table H3: PMRA Mitigation Measures Relevant to New Zealand: Proposed measures pertaining to stricter controls or with further restrictions on use). If the benefits do not outweigh the occupational and environmental risks ...... 222 risks or costs then the Authority may decide to prohibit it outright. Table H4: Current New Zealand registered uses and the APVMA review ...... 224 To assist in preparing this application, ERMA New Zealand has obtained information Table H5: APVMA review, deleted non-crop uses relevant to New Zealand ...... 224 from a variety of sources both in New Zealand and overseas. In particular, information Table H6: APVMA review, safety directions: the following amended safety instructions have been included on labels: ...... 225 from Merial Watts (Pesticides Action Network), Horticulture New Zealand, Agronica Table I1: Alternative insecticide products ...... 228 (Makhteshim), New Zealand Sports Turf Institute, PGG Wrightson, Civil Aviation Table I2: Pesticides for treatment of earthworms in turf ...... 238 Authority and New Zealand Food Safety Authority has proven to be of considerable assistance in preparing this application. Figure B1: Species Sensitivity Distributions of tabulated acute toxicity data (after ANZECC, 2000) 181
Precautionary approach to determining risks In the absence of New Zealand-specific exposure data, the assessment largely uses environmental and human health models to estimate exposure. These models use conservative assumptions and may overestimate risks. This precautionary approach is consistent with the HSNO Act and regulations. These provide that where there is scientific and technical uncertainty, the Authority must consider the materiality of the uncertainty and if the uncertainty cannot be resolved to its satisfaction, must take into account the need for caution in managing the adverse effects of the substance.
Current use of endosulfan Formulations containing endosulfan have been registered for use in New Zealand since 1963 and sold for over 50 years in more than 60 countries around the world. Endosulfan is used as a broad spectrum insecticide in many crops including cotton, soybeans, fruit tree crops and vegetables. It has excellent efficacy against a number of difficult-to-control pests, which can cause substantial crop damage and loss of yield. Because of its unique mode of action, endosulfan is used in Integrated Pest Management (IPM) and resistance management programmes.
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In New Zealand endosulfan is used on a variety of crops including vegetables, berry fruit and ornamentals. It is also put to ‘off-label’1 uses including use on citrus and earthworm control on turf at golf courses, bowling clubs, parks, sports grounds, and Risks, costs and benefits of use in New Zealand airports. There is evidence that endosulfan use in New Zealand has been declining over the past The risks to consumers exposed to endosulfan residues in food have not been 10 years. This has been market driven as well as through the availability of some new considered by ERMA New Zealand in this reassessment. Dietary exposures and risks insecticide chemistry. Three products using endosulfan are currently approved for use are evaluated by the New Zealand Food Safety Authority under the Food Act 1981. in New Zealand, but only one of the three companies has indicated it supports the Endosulfan is classified as acutely toxic (particularly when inhaled or absorbed through continued use of endosulfan in New Zealand. the skin) and very toxic to aquatic organisms. The assessment of the risks, costs and benefits of the use of endosulfan in New Zealand is based on the following use scenarios: Overseas regulatory status of endosulfan
As summarised in the table below, endosulfan products have been reviewed in a number Use scenarios evaluated in this application of countries. These reviews have resulted in restrictions, prohibitions or voluntary removal from the market. In the European Union, a 2005 European Commission (EC) Scenario Application rate/assumptions decision required authorisations for products containing endosulfan to be withdrawn by Label use – outdoor vegetables/berries Maximum application rate specified June 2006. on the label is 0.7 kg endosulfan a.i./ha. Frequency of use is not Australia and the United States have restricted the use of endosulfan products. In specified on the label, but the Agency has assumed 4 times per Australia, several of the currently registered label uses in New Zealand were deleted year with an interval of 10 days following the APVMA review final report released in 2005. In the United States, the between applications. The Agency US EPA’s review is still in progress with public consultation on updated human health has assumed a high ground based boom sprayer with medium droplet and environmental risk assessments closing in February 2008. size Canada is currently re-evaluating endosulfan. A preliminary assessment released in Label use - glasshouse 0.7 kg a.i./ha using remote trolley October 2007 indicates that a number of the proposed mitigation measures are unlikely sprayers or low-volume misters to be feasible. Turf (‘off label’ use) Maximum application rate of 2.1 kg a.i./ha, application once a year and The EC has also submitted a proposal to the Stockholm Secretariat that endosulfan be with wetting in following considered for inclusion under the Stockholm Convention on Persistent Organic application and assuming a low Pollutants (POPs). Due to a lack of data, further discussions regarding this submission boom with medium droplet size have been deferred to the next POPs Review Committee meeting in November 2008. Citrus (‘off label’ use) Maximum application rate of 1.3 kg a.i./ha, twice a year with an Further overseas action concerning endosulfan includes the recommendation from the application interval of 14 days, Rotterdam Convention Chemical Review Committee (23 March 2007), that endosulfan using an airblast sprayer be included in the Prior Informed Consent (PIC) procedure under the Rotterdam Backpack/handheld sprayer (assessed for human health risks only) 0.7kg a.i./ha Convention. This recommendation was based on the grounds that endosulfan poses unacceptable risks to the environment. Environmental risk assessment Summary of overseas regulatory reviews The environmental risk assessment of the use of endosulfan in New Zealand concludes Country Review Outcome that: European Union Use prohibited There is a high acute and chronic risk to aquatic species (fish and United States Restrictions imposed (review still in progress) invertebrates) from all current uses of endosulfan in New Zealand. This Australia Some uses prohibited; restrictions imposed on others conclusion is based on lower sensitivity environmental exposure modelling. Canada Review in progress; preliminary mitigation measures Exposure of non-target areas, including the aquatic environment, can be proposed reduced by the use of buffer zones. Such buffer zones would need to be substantial, possibly extending over 100 metres. 1 ‘Off-label use’ refers to the use of a product in a manner that was not assessed and approved when the product was registered under the ACVM Act, but which is lawful provided the user takes proper precautions to avoid breaches in residue standards on crops for human consumption.
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There is a risk to earthworms when endosulfan is used in accordance with bystanders and residents from air-blast application to citrus are estimated as very label uses. Runoff from use could lead to risks to earthworms and soil high at current application rates and procedures. arthropods outside the application area. Endosulfan is used to control Risks to sports people from use of endosulfan on treated turf are acceptable if earthworm populations under specific circumstances including use on sports application is in accordance with the current standard practices involving fields and grass areas at airports. watering in and only one annual treatment and an REI is applied (in the case of Laboratory data suggests that endosulfan is toxic to bees and other non-target “ground contact” sports such as rugby, football or hockey and public parks terrestrial invertebrates. There is uncertainty as to whether such effects occur where children may play). in the field. There is no indication of risks to plants. There may be a risk to birds feeding in fields where crops have been recently Risks to society and communities treated. There is an acute risk to birds associated with the use of endosulfan The review of the risks to society and community concludes that there is a potential on turf. effect of increased anxiety in people who are concerned about the continued use of The risk to water birds is low. Using a conservative model there is some risk endosulfan in New Zealand while its use has either been banned or severely restricted in to large water birds which feed exclusively on piscivorous fish. other jurisdictions. The size and expression of this effect cannot be fully assessed at this stage. No assessment can be made of the risk to marine mammals (seals, dolphins) due to an absence of New Zealand-based data. However, contamination of remote regions through long-range movement of endosulfan is likely based on overseas monitoring. ERMA New Zealand has not considered this aspect of Risks to the market economy the risk of use of endosulfan as part of this reassessment. It is more The review of the risks to the New Zealand market economy concludes that: appropriate for this risk to be addressed at the international level through the Stockholm and Rotterdam Conventions. While there may be adverse effects on trade from consignments being rejected because endosulfan has been used, this risk can be managed by industry.
There is the potential for an adverse effect on New Zealand’s ‘clean green’ image. Human health risk assessment The human health risk assessment concludes that: Risks to operators involved in mixing, loading and applying endosulfan for Relationship of M ori to the environment outdoor crops (including hand-held application) in accordance with current labelled application rates (0.7kg a.i./ha) are estimated as acceptable, provided The impact from the use of endosulfan on the relationship of M ori and their culture that adequate personal protective equipment (PPE) is used. The required PPE and traditions with their ancestral lands, water, sites, w hi tapu, valued flora and fauna includes gloves during mixing and loading; gloves, visor, hood, overalls and and other taonga is assessed to be moderate provided controls are complied with. boots during application. However, in the absence of good information about benefits M ori may have concerns about the ongoing use of endosulfan. Risks to operators involved in mixing and loading within glasshouses are acceptable provided adequate PPE is used. Risks to applicators within glasshouses have not been separately modelled but are assumed to be high. For that reason, application should be by remote automated systems. Assessment of benefits Risks to operators for turf and citrus applications even if full PPE (including respiratory protection) is used are high. This is due to the application rates being The environmental benefit assessment concludes that there are no verifiable potentially higher than for the current label uses for both turf and citrus and the different significant beneficial effects on the environment. application method for citrus only. The human health benefit assessment concludes that there may be a potential indirect Risks to workers re-entering areas treated in accordance with label uses, beneficial effect on human health and safety from the use of endosulfan at airfields. including glasshouse use, are estimated to be acceptable provided appropriate Endosulfan is currently used to remove earthworms and reduce the risk of birdstrike. PPE is used or Restricted Entry Intervals (REIs) are applied. The assessment of the benefits to society and community concludes that: Risks to bystanders and residents are estimated as acceptable for boom application to turf and in accordance with the label uses. However, risks to
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There is a beneficial effect to farmers, horticulturalists and turf managers from although re-entry restrictions can be specified on New Zealand labels under knowing that endosulfan is available as a ‘backstop’ product or insecticide of HSNO regulations, the clearer, more prescriptive approach recommended last resort. above is in line with requirements introduced by overseas agencies; An indirect effect of the use and availability of endosulfan for controlling consideration will need to be given to an appropriate REI for greenhouse earthworms, is the reduced risk of playing fields being closed. use; The assessment of the benefits to the market economy concludes that: consideration will need to be given to longer REIs in the case of ‘pick your own’ berry orchards to take account of the exposure of pickers; and There are direct economic benefits to agriculture and horticulture. Endosulfan is viewed as an insecticide of last resort in the horticulture industry which can REIs may not be necessary in respect of post-application turf maintenance salvage some value from a crop that would otherwise be worthless. activities (for example, mowing/rolling) unless the work involves direct exposure. Endosulfan is considered by turf managers to be the most effective product for controlling earthworms. 4. That a no-spray buffer zone around waterbodies and the edges of treated crops be introduced due to high level of risks to the aquatic environment and to soil fauna Preliminary recommendations (ERMA New Zealand currently considers a 100 m buffer zone may be appropriate on the basis of overseas’ analyses of the effectiveness of buffer zones). The recommendations set out below are preliminary only. An important part of the reassessment process is public submissions on the application. These public 5. That reduced (maximum) application rates (kg a.i./ha per application/season) submissions are likely to have an effect on the final outcome of the reassessment. and/or limits on the number of applications (for example, per season) be introduced for some uses in order to lower the risks to the environment and people On the basis of its evaluation of whether the risks associated with the use of endosulfan (noting the measures of this type proposed by some overseas agencies). in New Zealand outweigh the benefits, ERMA New Zealand proposes the following 6. That suitable PPE be stipulated for different types of application and at different preliminary recommendations to ensure that practices are safe for people and the stages of the lifecycle (mixing/loading; application). environment: Finally, if the Authority’s overall evaluation favours retention of some or all of the 1. That the use of endosulfan be prohibited for: endosulfan approvals, ERMA New Zealand recommends the following classification aerial and domestic use of the substance on the basis that these are not uses changes: to which it is currently put (and the relevant risks have not been assessed as for all formulations, replace 6.1C overall acute toxicity classification with 6.1A part of this application); and based on inhalation toxicity; airblast application for citrus on the basis that risks to operators and replace the current 6.3B classification on Substance D with a 6.3A classification; bystanders are currently assessed as very high. remove the 6.8B classification applied to Thionex Insecticide Solvesso formulation; 2. That use on turf be restricted to one annual treatment, followed immediately by watering in, with no use of the treated area in the case of “ground contact” sports replace the current 9.2C classification on endosulfan and all its formulations with use and public parks where children may play, for a period of at least 48 hours a 9.2A classification; following treatment (noting, however, that the operator exposures are high even assign an approval number to the Thionex Insecticide Solvesso formulation; with full PPE, so the feasibility of a lower application rate needs to be explored). change the packing group assigned to endosulfan and all formulations containing 3. That the following Restricted Entry Intervals (REIs) be imposed for other uses, endosulfan from PG I to PG II. where PPE is not used when re-entering: 48 hours for all crops not listed below; 3 days for sweetpotato, mustard, radish, turnip; 4 days for brassicas (broccoli, cabbage, cauliflower, brussels sprouts); 6 days for blueberries; 10 days for sweetcorn.
In respect of the issue of REIs, ERMA New Zealand notes that:
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Submissions Submissions are now invited on the appropriateness or workability of the above Section One – Applicant Details recommendations. In particular, ERMA New Zealand would like information on the following:
1. What alternative substances are available, how effective are they and what risks, Name and postal address in New Zealand of the organisation making the costs and benefits are associated with their use in New Zealand? application Name: Chief Executive 2. Can the application rate (0.7 kg a.i./ha) or frequencies for label use be reduced ERMA New Zealand without compromising efficacy? Address: P O Box 131 3. Can the application rate used on turf (2.1 kg a.i./ha) be reduced without Wellington 6015 compromising efficacy, in order to reduce operator exposure (when using full New Zealand PPE) to acceptable estimates? Phone: +64-4-916 2426 4. In order to reduce health risk to operators, most uses require the use of “full” PPE Fax: +64-4-914 0433 consisting of gloves, face shield during mixing loading and gloves, overalls, hat and boots during application. If this level of PPE were made mandatory, would continued use of the product be feasible? The applicant’s location address in New Zealand Address: BP House 5. Re-entry risks for workers (and ‘pick your own’) are estimated as high for 20 Customhouse Quay horticultural applications since these personnel do not generally use PPE. In this Wellington case, REIs represent an important means of addressing these exposure risks. Are New Zealand the REIs set out above feasible?
6. What would be the effect of a mandatory 48 hour closure period after one annual Name of the contact person for the application turf application and watering in for “ground contact” sports, such as rugby, Name: Susan Collier football or hockey and use on public parks where young children may play? Position: Senior Advisor (Hazardous Substances) Address: ERMA New Zealand 7. What would be the effect of a mandatory 100 m (or more) buffer zone to reduce PO Box 131 exposure to non-target areas including the aquatic environment? Wellington 6001 New Zealand Submissions on this application must be made within a 30 working day period. Phone: +64-4-918 4859 Electronic responses using the form on our web site are encouraged. Please return your Fax: +64-4-914 0433 submission, whether electronic or by post, fax or email to: Email: [email protected]
ERMA New Zealand PO Box 131 Wellington Fax: 04 914 0433 Email: [email protected] www.ermanz.govt.nz Please mark all submissions for the attention of: Samantha Smith. All submissions must be received by 5 pm, Friday, 8 August 2008. Submissions must state the reasons for making the submission and state whether the submitter wishes to be heard at a public hearing. The submission may also state any decision sought.
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Section Two – Application Type and Related mitigate worker and environmental risks. In a number of areas these measures impose tighter controls than the current HSNO controls. Approvals The Rotterdam Convention Chemical Review Committee, 23 March 2007, recommended that endosulfan be included in the PIC procedure under the Convention. This recommendation was based on the grounds that endosulfan poses unacceptable risks to workers and the 2.1 Application type environment. 2.1.1 This is an application for the reassessment of endosulfan and formulations There are less hazardous alternatives to endosulfan available. containing endosulfan prepared by the Chief Executive of ERMA New The reassessment of endosulfan and formulations containing it aligns Zealand (‘the Agency’) under section 63 of the Hazardous Substances and with the principles of ERMA New Zealand’s Risk Reduction Strategy. New Organisms Act (‘the Act’). 2.1.6 The Authority considered that there is new information from overseas 2.1.2 Endosulfan was placed on the Chief Executive’s Reassessment Priority List regulatory authorities relating to the effects of endosulfan and that, in the in 2006, taking into account: light of this new information, reassessment of the substance is warranted. Public concern about the use of pesticides, due to their association The Authority acknowledged that there are alternatives to endosulfan, with adverse effects in humans and the environment. An example of adding weight to the justification for a reassessment of the substance. In this was listing as a Priority 1 pesticide for Reassessment, in Petition addition, it considered that a reassessment of endosulfan and its 1999/227 of Kees Bon, presented to the Local Government and formulations aligns well with the Authority’s Risk Reduction Strategy, Environment Select Committee, September 2006. which seeks to reduce the risks New Zealanders may be exposed to via hazardous substances. Overseas action including banning, voluntary removal from markets and stricter controls applied by some regulatory agencies. 2.1.7 This application has been prepared by the Agency and will be publicly Recommendations to include in the Rotterdam Convention Prior notified for submissions for a minimum 30 working day period. The Informed Consent (PIC) procedure and to include under the submissions received, together with the application, will be taken into Stockholm Convention as a persistent organic pollutant (POP). account by the Authority in considering the reassessment. If required by any submitter, the Authority will hold a public hearing. 2.1.3 In June 2007, the Environmental Risk Management Authority (‘the Authority’) considered whether or not there were grounds for reassessing the approvals for endosulfan and formulations containing endosulfan, under 2.2 Sources of information for this application and section 62 of the Act. consideration of uncertainty 2.1.4 The Authority decided that there were grounds for reassessment based on 2.2.1 Clause 8 of the Hazardous Substances and New Organisms (Methodology) sections 62(2)(a) and 62(2)(b) of the Act, namely that: Order 1998 (the Methodology) states that the information used by the 62(2)(a) Significant new information relating to the effects of endosulfan Authority when considering an application must be relevant and appropriate has become available. to the scale and significance of the risks, costs and benefits associated with 62(2)(b) Other substances with similar or improved positive effects and the substance. reduced adverse effects are available. 2.2.2 Clause 29 of the Methodology indicates that when the Authority encounters 2.1.5 The decision was notified on 19 June 2007. In reaching its decision the scientific and technical uncertainty relating to the potential adverse effects Authority noted the following: of a substance, the Authority must determine the materiality and significance to the application of the uncertainty. Where any scientific or Formulations containing endosulfan have been registered for use in technical uncertainty is not resolved, the Authority must take into account New Zealand since 1963. Currently, three products are registered for the need for caution in managing the adverse effects of the substance agricultural use in New Zealand (Thiodan, Flavylan 350EC and (clause 30). Thionex Insecticide). Endosulfan has been voluntarily removed from the market in several 2.2.3 Where the Authority considers that there is uncertainty in relation to costs, countries and also banned in plant protection products in a number of benefits, and risks (including, where applicable, the scope for managing other countries. Australia, Canada and the US have all reassessed the those risks), the Authority must attempt to establish the range of uncertainty use of endosulfan restricted its use and put in place measures to
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and must take into account the probability of the costs, benefits and risks Section Three – Information on the Substances being either more or less than the levels presented in evidence (clause 32).
2.2.4 Because it did not have sufficient information of its own to inform the preparation of this application, the Agency circulated a draft of the 3.1 Identification of the substances application for the purpose of gathering additional information in the following areas: 3.1.1 Substance Names: The existing substances for which there are HSNO approvals and which are therefore the subject of this reassessment, are as use patterns – ie how widespread is the use of endosulfan and to what follows: crops it is applied; Endosulfan (HSR002846). ‘off label’ uses; Emulsifiable concentrate containing 350 g/litre endosulfan (Substance benefits from the use of the substance in New Zealand; A) (HSR000679). inclusion in resistance management programs; Emulsifiable concentrate containing 350 g/litre endosulfan (Substance lifecycle information. B) (HSR000678). Emulsifiable concentrate containing 350 g/litre endosulfan (Substance 2.2.5 A full list of the parties contacted for this information is set out in Appendix C) (HSR000487). J. In response to this ‘pre-notification’ consultation, information was received from the following sources: Emulsifiable concentrate containing 350 g/litre endosulfan (Substance D) (HSR000677)2. Agronica (Makhteshim) Table 1: Identification of endosulfan Pesticide Action Network Aotearoa New Zealand Common Name Endosulfan Horticulture New Zealand CAS Index Name 6,9-Methano-2,4,3-benzodioxathiepin, 6,7,8,9,10,10-hexachloro- New Zealand Sports Turf Institute 1,5,5a,6,9,9a-hexahydro-, 3-oxide PGG Wrightson Synonyms Endosulphan 5-Norbornene-2,3-dimethanol, 1,4,5,6,7,7-hexachloro-, cyclic sulfite Civil Aviation Authority New Zealand Food Safety Authority. CAS Registry Number 115-29-7 2.2.6 In addition, the Agency considered, to the extent appropriate, the numerous publicly available sources of toxicology and environmental fate and effects Molecular Formula C9H6Cl6O3S test data, studies and other references listed on pages 152-159. Molecular Weight 406.96 g/mol Structural Formula 2.2.7 Only one of the registrants of endosulfan formulations has provided information in support of the continued use of endosulfan in New Zealand. Where appropriate, this is identified throughout this application. The other registrants have indicated that they no longer wish to support the use of this product in New Zealand and that they will be voluntarily phasing out this product from their product lines. Nevertheless, this application considers all formulations with current HSNO approvals.
2 Note - the current ERMA New Zealand classification reflects the xylene-based endosulfan formulation (the change to the Solvesso formulation for Thionex 350 EC was notified to ERMA New Zealand on 27 October 2004) and the correct classification should be applied to reflect the Solvesso-based product (as presently registered by ACVM, P07281.
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Sterioisomers alpha( ) endosulfan (1) stereochemistry 3 , 5a , 6 , 9 , 9a description, Endo 350EC, was cancelled on 3 May 2006, although old stock comprises 63-70% of the technical grade may still be in use. It is also still legal to use the old formulation for non- agricultural compound use.
3.2 Chemical and physical properties of endosulfan and its formulations
3.2.1 The chemical and physical properties of endosulfan and the formulated beta ( ) endosulfan (II) stereochemistry 3 , 5a , 6 , 9 , 9a substances are shown in Table 2. comprises 28-31% of the technical grade
Metabolites Endosulfan sulphate – main metabolite in soils, biological degradation in water and some mammals Endosulfan diol – hydrolysis in water Endosulfan ether – oxidation of the diol Hydroxyl endosulfan ether – oxidation of the diol Endosulfan lactone – oxidation of the diol Common Impurities in Endosulfan alcohol Technical Grade Endosulfan Endosulfan ether Hexachlorocyclopentadiene Residual solvent
3.1.2 While all four approved emulsifiable concentrates contain 350 g/litre endosulfan the excipient components differ giving each substance a unique HSNO classification (see Table 4).
3.1.3 Trade names: This application for reassessment covers all substances fitting these definitions and includes the following trade name products: Thiodan (Bayer New Zealand Ltd) 350 g/L endosulfan; Flavylan 350EC (Adria New Zealand Ltd) 350 g/L endosulfan; and Thionex Insecticide (Agronica New Zealand Limited) 350 g/L endosulfan.
3.1.4 The endosulfan products are all emulsifiable concentrates. The full compositions of the substances are contained in confidential Appendix L.
3.1.5 There is currently no product registered with ACVM matching the substance description “Emulsifiable concentrate containing 350 g/litre endosulfan (Substance A).” The ACVM registration for the product that was given an approval upon ‘transfer’ to the HSNO regime in 2004 under this
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Table 2: Chemical and physical properties of endosulfan products
Substance Endosulfan Endo 350 EC Flavylan 350EC Thiodan Thionex 350 EC Thionex 350 EC (350 g/litre (350 g/litre (350 g/litre (350 g/litre (350 g/litre endosulfan) endosulfan) endosulfan) endosulfan) endosulfan) Substance A Substance B Substance C Substance D1 Solvesso Formulation2 Appearance (colour, Physical state: solid Physical state: Physical state: Physical state: Physical state: Colour: Clear odour, physical state Colour: off white powder; white crystalline solid liquid liquid liquid liquid pale yellow to or form) Colour: tan amber liquid Technical endosulfan flakes with a tendency to Odour: slight agglomerate; cream to tan mainly beige, yellow Odour: specific aromatic odour crystalline solid; beige slightly yellow granules odour of solvent Odour: has been described as being like sulphur dioxide or odourless pH 5.8 Approx 6 6.6 – 8.0 3 o Density 1.745 g/cm at 20 C 1.066-1.073 1.08 1.06-1.08 @ 1.072 – 1.078 @ o 1.87g/cm3 at 20oC (purified endosulfan) 20 C 20oC Vapour pressure endosulfan = 1.05 x 10-3 Pa 0.3 kPa (at 38 C) endosulfan = 1.38 x 10-4 Pa -solvent Melting / Boiling endosulfan = 109.2 oC point endosulfan = 212-213oC mixture of isomers = 76-124oC Solubility in water endosulfan = 0.41 mg/l endosulfan = 0.23 mg/l Flash point 34oC minimum 45oC > 64oC >65oC Octanol/Water endosulfan = partition log Kow 4.94 at pH 4, 20oC 4.77 at pH 7, 20oC 5.64 at pH 10, 20oC endosulfan = 4.87 at pH 4, 20oC 4.55 at pH 7, 20oC 5.65 at pH 10, 20oC 1 These properties apply to the original formulation containing xylene. 2 Additional column to show the properties of the Thionex Solvesso formulation.
Endosulfan Re-assessment June 2008 Page 23 of 244 ae2 f24 ue20 Endosulfan Reassessment – Application June 2008 Page 24 of 244 1 toxicity invertebrate Terrestrial ecotoxicity vertebrate Terrestrial Soil ecotoxicity ecotoxicity Aquatic Toxicity Systemic Target Organ Eye Irritation Toxicity Overall Acute Toxicity Inhalation Acute Toxicity Acute Dermal Reference Toxicity Acute Oral Classification Data Toxicity Summary of classifications for endosulfan triggering Table 3: classification 3.3.1 Classification Review of hazardous properties endosulfan and 3.3 See Paragraph.3.2.2. See
endosulfan formulations classification is not triggered, included in Appendices A and B. data underlying the classification, including endpoints for which appears in Tables 3 and 4 respectively. A more detailed description of the A summary of endosulfan and the formulations table of the classification 9.4B SPECIES: 9.4B SPECIES: 9.3A Honey 96 hr LC freshwater fish 9.2A Rat bee 9.1A APVMA 1998 R-PHRASE: R 36 'Irritating to eyes.' Toxicity Acute Inhalation 6.9A 6.4A SPECIES: Rat (F) 6.1A 6.1A 6.1B SPECIES: 6.1B Rat 1
SPECIES: Rat ENDPOINT: LD ENDPOINT: 48DURATION: hr LD ENDPOINT: dietary studyin rats and 2-year rats). in study developmental in dogs, study dietary year a 1- in mice, study dietary a 78-week (namely of studies a variety in observed pathology) kidney weights and body decreased (including was NOEL derived from a range of effects This mg/kg/day, and using a 0.6 animal studies of approximatelyestimated in NOEL on the lowest 0.006 mg/kg/day, based (ADI) is intake daily proposed acceptable The LC ENDPOINT: LD ENDPOINT: ENDPOINT: LD ENDPOINT: 14 day(s) EC 14 day(s) andrei Eisenia (contact) μg a.i./bee VALUE: 2 μg a.i./bee (oral), 2.4 w mg/kg b VALUE: 22.7 VALUE: 13 mg/m wVALUE: 34 mg/kg b w mg/kg b VALUE: 22.7 freshwater invertebrates48 hr EC 50 (Earthworm) of 0.94 mg/kg-dry-weight-soil of 0.94 mg/kg-dry-weight-soil 50 50 50 50 50 3
(= 0.013 mg/L) Apis mellifera 50 100-fold safety factor. 100-fold safety = 0.2 μg/l = 0.2 μg/l 50 = 0.1 μg/l
APVMA, 1998 APVMA (1998) APVMA (1998) APVMA, 1998 Lewis, 1996 APVMA, 1998 Heimbach, 1985 APVMA, 1998 2000 species ANZECC, most sensitive
Table 4: Summary of classifications for endosulfan formulations assigned to endosulfan was not a true indication of the effects, and that the results indicated that the LD50 should be lower than 500 mg/kg bw. Due to Emulsifiable concentrate containing 350 g/l endosulfan these uncertainties the 6.1B classification for endosulfan has been retained, MCW: and the lower LD50 value (34 mg/kg bw) has been used to derive the Thionex classification of the formulated products using the mixture rules (see Insecticide (350 g/L Appendix A). endosulfan) Toxicity Solvesso 3.3.3 When the endosulfan formulations were first approved a 6.1A inhalation Classification (Substance A) (Substance B) (Substance C) (Substance D) formulation classification was not applied because when sprayed the formulation has Flammability 3.1B 3.1C 3.1D 3.1C 3.1D been diluted. Current policy is that this is not relevant as there are also risks to operators during mixing and loading. Following review of the acute Acute Oral 6.1C 6.1C 6.1C 6.1C 6.1C Toxicity inhalation toxicity data for endosulfan formulations these have been assigned a 6.1A inhalation classification and therefore an overall Acute Dermal 6.1B 6.1B 6.1B 6.1B 6.1B Toxicity classification of 6.1A for the acute toxicity (6.1) subclass. In the absence of 1 1 1 1 data to determine whether or not endosulfan formulations produce a mist Acute 6.1A 6.1A 6.1A 6.1A 6.1A Inhalation under their conditions of use the 6.1A classification applies. The Agency Toxicity has extrapolated somewhat in the calculation of 6.1A as endosulfan was Overall Acute 6.1A 6.1A 6.1A 6.1A 6.1A tested as a dust, and this dust LC50 has been applied to calculate an LC50 for Toxicity the endosulfan formulations as a mist. Skin Irritation 6.3A 6.3B 6.3A 6.3A2 6.3A 3.3.4 The current classification of ‘Substance D’ is 6.3B. The classification is Eye Irritation 6.4A 6.4A 8.3A 6.4A 6.4A based on a component of this formulation (xylene). Xylene’s classification Skin 6.5B has been changed since transfer into the HSNO regime of endosulfan Sensitisation formulations from 6.3B to 6.3A. Applying the mixture rules (ERMA, 2008) Reproductive 6.8B 6.8B results in an overall classification of 6.3A for Substance D. Toxicity Target Organ 6.9A 6.9A 6.9A 6.9A 6.9A 3.3.5 A number of submissions received, from the initial consultation of the Chief Systemic Executive’s Reassessment Priority List in 2006, made claims that Toxicity endosulfan was carcinogenic. Endosulfan has not been classified as a Aquatic 9.1A 9.1A 9.1A 9.1A 9.1A carcinogen by the Agency. This accords with the other regulatory agencies ecotoxicity assessments reviewed. Endosulfan is not listed by the International Agency Soil ecotoxicity 9.2A 9.2A 9.2A 9.2A 9.2A for Research on Cancer (IARC) as a carcinogen. Reports by Health Canada Pest Management Regulatory Agency (2007), European Union (2007), Terrestrial 9.3B 9.3B 9.3B 9.3B 9.3B United States Environmental Protection Agency (2002) and the Agency for vertebrate ecotoxicity Toxic Substances and Disease Registry (2000) have all concluded that endosulfan is not carcinogenic. Terrestrial 9.4B 9.4B 9.4B 9.4B 9.4B invertebrate toxicity 3.3.6 The 9.2 classification for endosulfan shown in Tables 3 and 4 differs to that of the approved substances – 9.2C has been replaced by a 9.2A 1 See Paragraph 3.3.3. classification, since the 9.2C classification was erroneously assigned upon 2 See Paragraph 3.3.4. transfer to the HSNO Act. As endosulfan is the only component in the products that has a 9.2 classification, the 9.2A arises solely from the Issues with classification endosulfan component of the products. The supporting data of 14 d LC50 of 3.3.2 The data used to assign HSNO classifications have been compared with the 9 mg/kg dry weight soil supports a 9.2A classification as a safety factor of data used to classify overseas. The toxicity and ecotoxicity values used to 10 is incorporated to represent the extrapolation from a LC50 value to an classify are sometimes slightly different, with the exception of the value EC50 value (EC50 = 0.94 mg/kg dry weight soil). used to classify as 6.1 dermal toxicant under HSNO, 34 mg/kg bw, which appears to be well below the range of the internationally accepted values. 3.3.7 Internationally there is no agreement on whether or not endosulfan is an The most widely accepted value is 500 mg/kg body weight which would endocrine disruptor. However, endosulfan has been included in the OSPAR trigger a 6.1D classification. However, the real worker exposure testing Commission List of Potential Endocrine Disruptors. Nor is there agreement internationally on the definition of endocrine disruption. Under the HSNO carried out for the APVMA review showed that the 500 mg/kg bw LD50
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framework there is no definition or a classification category specifically for 3.5.6 In addition, for quantities greater than 50L, consignments must be placarded endocrine disruptors. Endocrine disruption is considered a mode of action according to Section 9 of the Rule. rather than an effect. A specific effect needs to be shown before a HSNO classification can be applied. Currently therefore ERMA New Zealand has 3.5.7 The Agency notes that under the HSNO Packaging Regulations, a 6.1A not classified endosulfan as an endocrine disruptor. classification triggers Packaging Group I. The HSNO Packaging Regulations for 6.1 inhalation classifications is not in line with the UN recommendations for the transportation of dangerous goods. It is proposed 3.4 Lifecycle of endosulfan formulations that the default Packing Group I is varied to a Packing Group II in line with currently accepted international packaging requirements for endosulfan and 3.4.1 Of the companies currently importing/manufacturing endosulfan formulations containing endosulfan. The WHO International Chemical formulations, the Agency has been informed that only Agronica Safety Card (ICSC 0742) for endosulfan assigns a PGII. (Makhteshim Chemical Works, MCW) wishes to support the continued use of endosulfan in New Zealand. The description of the lifecycle of endosulfan is based on information by MCW.3 Disposal 3.5.8 Empty drums are triple rinsed and delivered by end users to one of 52 3.4.2 Until such time as companies other than Agronica cancel their ACVM District Council approved “Agrecovery” recycling sites. registrations, they can continue to market their approved endosulfan formulations into the agricultural market. The Agency has assumed that the lifecycle determined from Agronica information will apply to all Use of endosulfan formulations. 3.5.9 Only emulsifiable concentrate formulations containing 350 g/l endosulfan are approved and available in New Zealand.
3.5 Manufacture 3.5.10 The Agency is aware that formulations containing endosulfan are put to 3.5.1 MCW endosulfan formulations are not currently manufactured in New several uses in New Zealand that are not specified on the label. This ‘off- Zealand. label’ use is lawful if in accordance with ACVM Group guidance (ACVM, 2006):
Importation ‘Off-label use’ refers to the use of a product in a manner and/or on a 3.5.2 MCW endosulfan formulations are imported to New Zealand distribution species of animal or plant that was not assessed and approved when sites in 10 litre HDPE drums. Quantities are imported in shipments of the product was issued its official marketing approval. In New around 5,000L. Zealand the official marketing approval is a product registration from the Approvals and ACVM Group of NZFSA or a prescribed exemption from registration. The uses recommended by the registrant of the Repackaging/storage product and approved by the Group are always provided on the label. Consequently, any use not listed on the label is called an off-label use. 3.5.3 Shipping containers are devanned and drums are labelled at point of manufacture for distribution in New Zealand. The ACVM Group (has) addressed the problem (of minor use/minor species) by providing a general registration condition that allows off- Transport label uses, provided the user takes proper precautions to avoid breaches in residue standards. 3.5.4 Transport is in compliance with the Land Transport Rule: Dangerous Goods Rule. 3.5.11 The Agency has evaluated the off-label uses of which it is aware (turf, airblast spray to citrus, glasshouse use) or that seem likely (back-pack 3.5.5 Endosulfan is classified as a Class 6.1 Toxic Substance Packaging Group II and application), but acknowledges that there could be other off-label uses of therefore a consignment must be accompanied by a Dangerous Goods which it is unaware. Declaration and must not to be loaded on the same vehicle as Class 1 Explosives or Food Items (unless transported in a segregation device) and must 3.5.12 The Agency understands that no endosulfan formulations are sold on the be separated by 3 metres from Class 5.1 Oxidising Substances and Class 5.2 New Zealand domestic market and that aerial application does not take Organic Peroxides. place in New Zealand. These potential uses have not therefore been evaluated further. 3 MCW communication dated 29 February 2008.
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Label use On citrus with a maximum application rate of 1.3 kg a.i./ha (150mL per 100L, 1500 - 2500L per ha); twice a year, August to March, with 3.5.13 The label application rates for all the currently registered endosulfan an application interval of 14 days or more usually 4-8 weeks, using an formulated products are identical. The application rates are as follows: airblast sprayer (S. Minchin, pers. comm.). Table 5: Current application rates for endosulfan 3.5.16 In its evaluation, the Agency has also considered human exposure from hand-held application since it considers this is likely to occur. Vegetable/fruit Rate Tomatoes 120-200mL or 1.2-2 L/ha 3.5.17 During pre-notification discussions with current manufacturer/importers of (equivalent to 420-700 g a.i/ha) endosulfan formulations the Agency has been informed that only Potatoes 200mL or 2 L/ha Agronica/MCW is prepared to continue supporting endosulfan formulations (equivalent to 700 g a.i/ha) in New Zealand, but MCW proposes an amended label listing use only on Cabbage, cauliflower and other vegetable brassicas 120-200mL or 1.2-2 L/ha tomatoes, potatoes, cabbage, cauliflower, broccoli, gooseberries, (equivalent to 420-700 g a.i/ha) blackcurrants, and ornamentals (out of doors only). Fodder crop seedlings 150mL or 1.5 L/ha (equivalent to 525 g a.i/ha) Maize and sweetcorn 200mL or 2 L/ha Volumes used (equivalent to 700 g a.i/ha) 3.5.18 Horticulture New Zealand has estimated the total endosulfan market in New Strawberries 150-200mL or 1.5-2 L/ha Zealand to be in the vicinity of 15 to 20,000 litres per year (approximate (equivalent to 525-700 g a.i/ha) figure for 2007 estimated from discussion with key industry players – Blackberries, boysenberries, raspberries 200mL or 2 L/ha P. Ensor pers. comm.). This figure is very seasonal and because endosulfan (equivalent to 700 g a.i/ha) is used in response to pest levels, and in a number of cases as a measure of Gooseberries, blackcurrants 200mL or 2 L/ha (equivalent to 700 g a.i/ha) last resort, year on year usage can differ greatly depending on climatic conditions and pest pressure. Ornamentals (glasshouse and outdoors) 200mL or 2 L/ha (equivalent to 700 g a.i/ha) 3.5.19 Recent endosulfan sales trends seem to indicate a decrease in the overall use of endosulfan. The main causes of this are twofold. Firstly many export 3.5.14 The maximum use rate specified on any of the labels is 0.7 kg a.i./ha. markets are dictating chemical requirements (for example, onions destined Frequency of use is not specified on the labels, but the Agency has assumed for UK and Europe cannot be treated with endosulfan). The second reason is a frequency of 4 times per year with an interval of 10 days between the use of new generation alternative chemicals. In particular long lasting applications. This assumption is based on a thrip control strategy on onions seed treatments and selective insecticides can take the place of endosulfan forwarded to the Agency by Horticulture New Zealand (P. Ensor (P. Ensor pers. comm.). pers.comm.), that specifies that each product used in the strategy should be used 3-4 times to reduce a whole generation of thrips. The Agency has 3.5.20 The volume of endosulfan used internationally has been estimated to peak at assumed that such applications will be made with a high boom and a 13000 tonnes in 2001, with a decline since 2002 due to the introduction of medium spray droplet size. new products and a phasing out from some markets (Mackay & Arnold, 2005). Worldwide it is used mainly on cotton (50%), field crops, plantation crops, soybeans (each 15%) and vegetables (5%) (Mackay & Arnold 2000). ‘Off-label’ use
3.5.15 In addition to the usage outlined above, the Agency has been notified of two Registered uses off-label uses of endosulfan: 3.5.21 Table 6 below shows the current registered uses for Thionex 350 EC. On turf (for example, sports fields, golf courses, bowling greens, airport grassed areas) with a maximum application rate of 2.1 kg a.i./ha, application once a year and with wetting in following application (B. Walmsley pers. comm.). The Agency assumes a low boom would be used for such applications. In the past, a pelleted endosulfan formulation was used for airport earthworm control and this would be the favoured formulation if authorised (R. Bodell pers. comm.). Currently no pellet formulation is authorised in New Zealand.
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Table 6: Registered uses for Thionex 350EC endosulfan in the vegetable market is mixed, with greater use in regions Crop Pest with more intensive production and higher pest pressure. The vegetable crop with the largest use of endosulfan is potatoes in the Northern half of Tomatoes Aphids, Thrips, Green vegetable bug, the North Island. Whitefly, Cutworms and other caterpillars
Potatoes (both table and seed potatoes) Potato tuber moth, Aphids, Green looper 3.5.24 The use of endosulfan in outdoor vegetable production is mixed. Crops caterpillar such as onions, potatoes and brassicas all have a range of alternative Onions (except spring onions) Onion thrips insecticide options available and although endosulfan is not used routinely by all growers, those contacted by Horticulture New Zealand in the Aphids, Diamond-back moth and White Cabbage, cauliflower and other vegetable brassicas preparation of its report were strongly of the view that endosulfan needs to butterfly caterpillars be maintained as an option. This need was illustrated during the recent hot Fodder crop seedlings (turnips, swedes, choumoellier, Nysius bug (Nysius huttoni) dry summer, when potato tuber moth numbers were particularly high. feed rape, fodder-beet, mangolds) Also brassica Growers facing this extreme tuber moth pressure had to increase chemical vegetable seedlings insecticide applications to safeguard their crops. As a result, certain regions Maize and sweetcorn (seedlings) Cutworm (for example, Pukekohe, Waikato) used more endosulfan than in a ‘normal’ Strawberries Aphids, Cyclamen (strawberry) mite year. Growers choose to use endosulfan because they know it will work and it provides another choice of chemical group (mode of action) for resistance Blackberries, Boysenberries, Raspberries Aphids, Bronze beetle, Redberry mite management purposes. Gooseberries, Blackcurrants Aphids, Bronze beetle, Currant bud mite 3.5.25 Endosulfan use in onion crops has been declining in recent years because of Ornamentals (glasshouse and out of doors) Cyclamen mite, Aphids constraints placed on growers by customers. In particular, certain markets such as Europe and the UK do not accept onions that have been grown using endosulfan. However growers and industry representatives contacted by Report on the use of endosulfan in New Zealand provided by Horticulture New Horticulture New Zealand in the preparation of its report also expressed a Zealand: desire to maintain the ability to use endosulfan should the need arise. The 3.5.22 A report was provided to the Agency by Horticulture New Zealand4 as part threat of Iris Yellow Spot Virus (Tospovirus) was put forward as another of the ‘pre-notification’ request for information from interested parties, important reason why endosulfan should remain available to onion growers. which included the following approximate breakdown of sector use in New This virus would have a major impact on onion crop yields and could Zealand: potentially be devastating for the onion seed industry. Thrips are the known vector for this virus. When a situation arises that requires immediate control of onion thrips because of this virus, the use of endosulfan may be critically Table 7: Percentage use of endosulfan in different sectors important. Crop % Use Outdoor Vegetable 35 – 40 3.5.26 Brassica growers advised Horticulture New Zealand that they have a range of insecticide options available and use of endosulfan in this area has also Greenhouse Production 30 been declining in recent years due to new product availability and IPM Turf 10 -15 practices. However, when these measures fail or conditions such as the Berry Fruit 10 recent hot dry summer produce extreme pressure, it is important to have Ornamentals 5 – 15 endosulfan available as a backstop for the control of Diamondback moth and White butterfly caterpillar. Endosulfan use was critical for some Citrus 1 growers last season and for this reason brassica growers advised Other ? Horticulture New Zealand that they do not want to see any changes to the registration of endosulfan that would limit their choices and ability to prolong the life of other chemistry through careful resistance management. Outdoor Vegetable Production 3.5.23 Horticulture New Zealand further advised that, outdoor vegetable 3.5.27 Endosulfan is not routinely used in maize and sweetcorn. production uses the greatest amount of endosulfan, accounting for approximately 30 to 40% of total endosulfan sales. Dependence on Greenhouse Vegetable Production (e.g. tomatoes, capsicum, courgette)
3.5.28 Greenhouse vegetable growers employ a range of control techniques 4 including hygiene and natural predators to control insect populations. Horticulture NZ: Endosulfan Use in New Zealand, February 2008.
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However, even with the best management systems in the world, pest Once again endosulfan use is targeted and only applied when the outbreaks do occur – in particular whitefly. Cyclamen Mite becomes an economic threat. The other miticide product that is available to strawberry growers is not as effective as 3.5.29 When whitefly numbers get out of control, Horticulture New Zealand endosulfan advises that endosulfan is the most effective product available. It is used only when absolutely needed because bees must be removed for three days Blueberry and Blackcurrant growers are not using endosulfan. (which equates to loss of production), but growers know it will work and 5 that whitefly numbers will be lowered to levels where other control options Ornamentals become effective again (for example, En-Force biological parasites). 3.5.31 Ornamentals are made up of a wide variety of non-edible crops. While it was difficult to identify common practices for this group, Horticulture New Berry Fruit Zealand was advised that endosulfan tends to be used as a clean-up spray or 3.5.30 Horticulture New Zealand advises that boysenberry and strawberry growers when insect pressure is extreme and other products have not, or would not use endosulfan to control specific mite issues and that this group would be work. Particular target insects identified are western flower thrips, whitefly severely disadvantaged if endosulfan was not available as there are no and mites. effective alternatives. The following bullet points have been taken verbatim 3.5.32 Growers of ornamentals do not have many registered insecticide options, from Horticulture New Zealand’s report: while at the same time they can suffer many problematic pests – in Boysenberry – Boysenberry growers have a particular pest problem particular western flower thrips, mites (of all kinds) whitefly and aphids. called Red Berry Mite. This mite lives in the buds of flowers and They regard endosulfan is a key backstop product in this area. causes the fruit to not ripen. Endosulfan used strategically in one application can reduce Red Berry Mite numbers below an economic Citrus threshold for up to three years. 3.5.33 Horticulture New Zealand reported that endosulfan is the only compound Geoff Langford of HortResearch in Lincoln is working on this that effectively controls broad mite on lemons and is also a possible control problem and can demonstrate that there are currently no effective option for citrus whitefly, a new pest of citrus. alternatives to endosulfan, but that strategic timing and use of one endosulfan application can reduce Red Berry Mite numbers to such 3.5.34 Endosulfan is routinely used on citrus crops (1 to 2 sprays per season) for low levels that it takes between two and three years for the population the control of Kelly’s citrus thrips, greenhouse thrips, citrus flower moth to get back up to damaging levels (when the next endosulfan and broadmite. Broadmite is of particular concern in the production of application is required). lemons and there are no other products available that can be used as an alternative. Broadmite control on lemons is an essential use of endosulfan Alternative control strategies and chemical options are being sought but it also used to some degree for control of thrips and flower moth. but the cost and time involved with this research (and eventual registration) means that endosulfan will be relied upon by 3.5.35 Endosulfan is also currently being reviewed for control of Australian citrus Boysenberry growers for some years to come. whitefly, a pest that has recently become established in New Zealand. It This is a clear example of a niche strategic application of endosulfan was first recorded in New Zealand in 2000 but has only become a major where growers are using the product wisely to maximum benefit. If commercial problem in the last two years. Controlling whitefly is endosulfan was not available Boysenberry growers would have no complicated because of its complex lifecycle. Only certain stages are effective control measures for Red Berry Mite and livelihoods would susceptible to chemical control. Endosulfan has been reported by growers to be placed at risk. be effective against whitefly adults but it is the immature stages of the insect that are of greater importance. New Zealand Citrus Growers Inc. is Strawberry – Strawberry growers are using endosulfan in specific currently funding trial work by HortResearch reviewing a number of instances where Cyclamen Mite is a problem. products, including endosulfan, against immature stages of whitefly. A recent programme targeting the health and hygiene of strawberry Results of this work are not yet available, but if whitefly does prove to be transplants has been very successful and has seen the need for susceptible to endosulfan it is likely to be considered as a key control. endosulfan use in strawberries reduce. However where plants are Because of the relatively new status of this pest, control measures are still in carried over for a second season (a common practice in the South their infancy with mandarin growers appearing to be hardest hit. Gaining Island) and when outbreaks do occur, endosulfan is the only effective long-term control of the citrus whitefly is a major issue facing the citrus control measure available to growers. industry.
5 Ornamental growers are not members of Horticulture New Zealand.
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Reports on the use of endosulfan on turf in New Zealand provided by New Zealand Table 8: Use of endosulfan for turf management Sports Turf Institute, PGG Wrightson Turf and the Civil Aviation Authority: Turf sector Estimated % of clubs using endosulfan 3.5.36 The following information was provided by the New Zealand Sports Turf Golf >80% of clubs each year Institute.6 Bowls >80% of clubs each year Councils 20 – 30% of councils each year 3.5.37 Endosulfan is primarily used within the turf sector for the control of the Croquet >60% of clubs each year following pests: Stadia >80% of stadia each year Earthworms (Allolobophora, Lumbricus sp) Race tracks 30 – 50% of race tracks Porina (Wiseana sp) Landscaping industry Negligible Greasy cutworm (Agrotis ipsilon aneituma) Sod webworm (various incl Eudonia sp). 3.5.41 B. Walmsley (PGG Wrightson Turf, pers. comm.) has reported to the Agency that endosulfan is commonly applied to turf at 3 l/ha (1.1 kg a.i./ha) 3.5.38 There are other equally effective pesticide options, other than endosulfan, where surface feeding insects such as porina are present and where a light or presently available for controlling Porina, Greasy cutworm and Sod moderate earthworm problem exists. Application at 6 l/ha (2.1 kg a.i./ha) is webworm. However in the absence of other equally effective pesticides to used for moderate to severe earthworm problems and where two or more endosulfan, this pesticide is required to manage and reduce earthworm years of control is expected. In all cases, the application is watered in. numbers on turf and thereby maintain playing quality. 3.5.42 New Zealand Civil Aviation Authority has forwarded reports to the Agency 3.5.39 The main turf areas that use endosulfan include: from four New Zealand airports indicating endosulfan is used to control earthworms to reduce bird strike and to reduce encroachment of worms onto Golf courses – greens, tees, fairways rough and other turf areas sealed runways which is deemed a ‘Foreign Object Damage’ issue. One of Bowling greens the airports reported application at 3.5 l/ha (1.2 kg a.i./ha). Sportsfields Summary of use patterns evaluated by the Agency for its risk assessment Stadia 3.5.43 Given the range of crops and application equipment used to apply Cricket outfields endosulfan, the Agency has selected a series of scenarios considered to be Racetracks representative of all uses for its risk assessment. These are set out in the Croquet lawns table below. Exposure of the environment and human health was considered for most of these applications. However, consideration of Amenity turf areas – lawns environmental exposure was not undertaken for glasshouse use since Aerodromes – runways and associated grassed areas. minimal environmental exposure is anticipated to arise. No environmental exposure was considered under back-pack use since the exposure is 3.5.40 In the absence of survey information it is difficult to estimate the actual anticipated to be lower than from vehicle-mounted equipment. amount/frequency that endosulfan is used within the turf market. However, NZSTI’s best estimate is summarised below in the table below.
6 The use and importance of endosulfan within the New Zealand turf industry (dated February 2008) and ‘Endosulfan Reassessment Report’ (dated June 2008).
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Table 9: Use scenarios evaluated in this application Hazardous Substances (Packaging) Regulations 2001: Standards for Scenario Environment Human health packaging for specific hazard classes. Label use: In New Zealand the maximum use rate specified on the Yes Yes Hazardous Substances (Disposal) Regulations 2001: Information that label is 0.7 kg a.i./ha. Frequency of use is not specified on the must be provided in relation to the disposal of specific classes of label, the Agency has assumed 4 times per year with an interval of 10 days between applications. The Agency has assumed a high hazardous substance and packaging. boom with medium droplet size. Hazardous Substances (Emergency Management) Regulations 2001: Label use: application at 0.7 kg/ha to glasshouses using remote No Yes Information requirements for the suppliers and people in charge of trolley sprayers or low-volume misters. places. The requirements are set on the basis of the quantities of Turf: maximum application rate of 2.1 kg a.i./ha, application once a Yes Yes specific hazard classes on a site, with higher-level requirements for year and with wetting in following application (B. Walmsley pers. comm.). The Agency assumes a low boom with medium droplet larger quantities and the higher hazard substances. size would be used for such applications. Hazardous Substances (Tracking) Regulations 2001: The classes of Citrus: maximum application rate of 1.3 kg a.i./ha, twice a year with Yes Yes hazardous substance that have to be under the control of an approved an application interval of 14 days, using an airblast sprayer (S. handler, and what records must be kept and for how long. Minchin, pers. comm.). Backpack: considered for risks to human health only. No Yes Hazardous Substances (Personnel Qualifications) Regulations 2001: The requirements for test certificates for approved handlers and qualifications for enforcement officers. This regulation also specifies 3.5.44 No assessment was made of aerial application or domestic use, since it is the transitional arrangements for existing licence holders. understood that neither scenario is relevant to New Zealand. Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (New Zealand Gazette Issue 35, 26 March 2004) (as amended). 3.6 Existing controls for endosulfan and endosulfan Hazardous Substances (Pesticides) Transfer Notice 2004 (New formulations Zealand Gazette Issue 72, 15 June 2004) (as amended). 3.6.1 The lifecycle and hazardous properties of endosulfan and endosulfan Hazardous Substances (Chemicals) Transfer Notice 2006 (New formulations are managed through a variety of controls. These controls are Zealand Gazette Issue 72, 28 June 2006). prescribed as part of the approval of these substances under the Act and the Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM Act), Hazardous substances regulations and through requirements for resource consents under the Resource Management Act 1991 and are discussed in the following sections. 3.7.2 Tables 10, 11 and 12 respectively, summarise the HSNO Act control codes7 and the controls and additional controls that apply to endosulfan and endosulfan formulations. The HSNO control codes are based on the 3.7 Controls applied under the HSNO Act classifications assigned to the substances (as determined at the time of transfer to the HSNO Act). 3.7.1 The controls applicable to endosulfan and endosulfan formulations are given in the following regulations made pursuant to the HSNO Act and the 3.7.3 The HSNO control codes applicable to endosulfan and endosulfan following New Zealand Gazette notices. In addition, certain transitional formulations can be broken down into those controls that manage the controls may also apply until the end of the relevant transitional period hazardous properties of the substances and those that manage the lifecycles under the Gazette notices. of the substances: Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001: Hazardous property controls are designed to manage the hazards Controls to manage (inter alia) the flammability (Class 3) and other arising from a substance’s intrinsic hazardous properties, reduce the properties of a substance. likelihood of unintended occurrence of the hazard, and limit the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001: adverse effects arising from exposure to the hazard. Controls to manage (inter alia) the toxic (Class 6) and ecotoxic Lifecycle controls focus on the lifecycle management of the (Class 9) properties of a substance, including exposure limits. substances and cover packaging, identification, emergency Hazardous Substances (Identification) Regulations 2001: In effect, requirements for labelling, material safety data sheets and workplace information, and advertising. 7 Control codes are codes ERMA New Zealand has assigned to enable easy cross-referencing to the regulations. These codes are detailed in ERMA New Zealand (2001).
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management, disposal, tracking, and the competency of people Substance Endosulfan Emulsifiable concentrate containing 350 g/l endosulfan handling highly hazardous substances. (Substance (Substance (Substance (Substance Thionex 3.7.4 Where a control has been changed from the default wording this is indicated A) B) C) D) Insecticide Solvesso by a star (*) next to the control code. The detail of this change, including Endo 350EC formulation2 deletion of a control, is listed under Changes to Controls in Table 11. Flavylan Thiodan Thionex 350EC 35EC EC350 Table 10: Existing controls for endosulfan and formulations Insecticide HSNO Control Spray1 Substance Endosulfan Emulsifiable concentrate containing 350 g/l endosulfan P13 (Substance (Substance (Substance (Substance Thionex P14 A) B) C) D) Insecticide Solvesso P15 Endo 350EC formulation2 PG2 Flavylan Thiodan Thionex 350EC 35EC EC350 PG3 Insecticide D2 HSNO Control Spray1 D4 F1 D5 F2 D6 F3 D7 F4* D8 F5 Disposal controls AH1 F6 TR1 F11 EM1 F12 EM2 F14* EM6 F16 EM7 Class 1 to 5 Controls Class 1 to 5 T1* EM8 T2* EM9 T3 EM10 T4 EM11 T5 EM12* T6* EM13 Emergency management controls T7 I1 E1* I2 E2 I3 E3 I5 E5 I8 E6 I9 E7* I10 Class 6, 8 and 9 controls 9 controls Class 6, 8 and P1 I11 P3 I13 P5 I16 Packaging controls Identification Identification controls
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Substance Endosulfan Emulsifiable concentrate containing 350 g/l endosulfan accordance with the approved safety system for the time being approved under section 6D of the (Substance (Substance (Substance (Substance Thionex Transport Services Licensing Act 1989; and A) B) C) D) Insecticide (ii) other than by rail, the person who drives, loads, and Solvesso Endo 350EC formulation2 unloads the vehicle that is transporting the substance has a current dangerous goods Flavylan Thiodan Thionex 350EC 35EC EC350 endorsement on his or her driver licence; and Insecticide (iii) in all cases, Land Transport Rule: Dangerous HSNO Control 1 Spray Goods 1999 (Rule 45001) is complied with; or I17 (b) when this substance is being transported by sea, one of I18 the following is complied with: I19 (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods (MR024A): I20 (ii) International Maritime Dangerous Goods Code; or I21 (c) when this substance is being transported by air, Part 92 I22 of the Civil Aviation Rules is complied with. I23 (2) Subclause (1)(a)— I25 (a) does not apply to a tank wagon or a transportable I28 container to which the Hazardous Substances (Tank I29 Wagons and Transportable Containers) Regulations 2004 applies; but I30 (b) despite paragraph (a), does apply to an intermediate bulk 1 These properties apply to the original formulation containing xylene. container that complies with chapter 6.5 of the UN 2 Additional column to show the properties of the Thionex Solvesso formulation. Model Regulations. (3) Subclause (1)(c)— Table 11: Summary of default controls applicable to endosulfan (a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001 aerodrome; but Code F1 Reg 7 General test certification requirements for hazardous substance (b) does not apply to— locations (i) the handling of this substance in any place that is Code F2 Reg 8 Restrictions on the carriage of flammable substances on passenger not within an aerodrome; or service vehicles (ii) the loading and managing of this substance for the purpose of aerial spraying or dropping. Code F3 Reg 55 General limits on flammable substances (4) In this regulation, UN Model Regulations means the 13th Code F4* Reg 56 Approved handler/security requirements for certain flammable revised edition of the Recommendation on the Transport of substances Dangerous Goods Model Regulations, published in 2003 by Change to default controls the United Nations. Regulation 56 of the Hazardous Substances (Classes 1 to 5 Code F5 Regs 58, 59 Requirements regarding hazardous atmosphere zones for class Controls) Regulations 2001 2.1.1, 2.1.2 and 3.1 substances The following regulation is inserted immediately after regulation Code F6 Regs 60–70 Requirements to prevent unintended ignition of class 2.1.1, 2.1.2 56: and 3.1 substances Code F11 Reg 76 Segregation of incompatible substances 56A Exception to approved handler requirement for transportation of packaged pesticides Code F12 Regs 77 Requirement to establish a hazardous substance locations if flammable substances are present (1) Regulation 56 is deemed to be complied with if: (a) when this substance is being transported on land— Code F14* Reg 81 Test certification requirements for facilities where class 2.1.1, 2.1.2 or 3.1 substances are present (i) by rail, the person who drives the rail vehicle that is transporting the substance is fully trained in
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Change to default controls Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Regulation 81 of the Hazardous Substances (Classes 1 to 5 Code T1* Regs 11 – 27 Limiting exposure to toxic substances through the setting of Controls) Regulations 2001 tolerable exposure limits (TELs) A hazardous substance location does not require a test certificate Change to default controls if— (a) the hazardous substance location is situated on a farm of not No TEL is set for this substance at this time. less than 4 hectares; and Code T2* Regs 29, 30 Controlling exposure in places of work through the setting of (b) the combined quantity of each class 3.1B or class 3.1C Workplace Exposure Standards. substance and any petrol, aviation gasoline, or racing gasoline Workplace Exposure Standards stored at the location is less than 2,000 litres; and (c) either— Under regulation 29(2) of the Hazardous Substance (Classes 6, 8, and 9 Controls) Regulations 2001, the Authority adopts as a (i) the following requirements are complied with: workplace exposure standard for this substance, and each (A) each substance is stored in 1 or more secure component of this substance, the value or values specified in the containers, each of which has a capacity of less document described in “Workplace Exposure Standards”, than 250 litres; and published by the Occupational Safety and Health Service, (B) each container complies with regulation 11 and Department of Labour, January 2002, ISBN 0-477-03660-0. Also Schedule 2 of the Hazardous Substances available at www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf. (Packaging) Regulations 2001; and Code T3 Regs 5(1), 6 Requirements for keeping records of use (C) each container is— (1) situated not less than 15 metres from any Code T4 Reg 7 Requirements for equipment used to handle substances area of high intensity land use or area of Code T5 Reg 8 Requirements for protective clothing and equipment regular habitation; and Code T6* Reg 9 Approved handler/security requirements for certain toxic (2) situated either in the open or in a well- substances ventilated building; and (3) in a compound or located so that any spillage Changes to Default Controls of the substance will not endanger any Regulation 9 of the Hazardous Substances (Classes 6, 8, and 9 building, or flow into any stream, lake, or Controls) Regulations 2001 natural water; or (ii) the following requirements are complied with: The following regulation is inserted immediately after regulation 9: (A) each substance is stored in an above ground stationary tank that complies with the Stationary 9A Exception to approved handler requirement for Container Controls in Schedule 8 of the Hazardous transportation of packaged pesticides Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004, as (1) Regulation 9 is deemed to be complied with if: amended by this Schedule; and (a) when this substance is being transported on land— (B) each of the above ground stationary tanks is (i) by rail, the person who drives the rail vehicle that is situated— transporting the substance is fully trained in (1) not less than 20 metres from any area of high- accordance with the approved safety system for the intensity land use or area of regular time being approved under section 6D of the habitation; and Transport Services Licensing Act 1989; and (2) 6 metres from any combustible materials; and (ii) other than by rail, the person who drives, loads, and unloads the vehicle that is transporting the (3) in a compound or located so that any spillage substance has a current dangerous goods of the substance will not endanger any endorsement on his or her driver licence; and building, or flow into any stream, lake, or natural water. (iii) in all cases, Land Transport Rule: Dangerous Goods 1999 (Rule 45001) is complied with; or Code F16 Reg 83 Controls on transit depots where flammable substances are present (b) when this substance is being transported by sea, one of the following is complied with:
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(i) Maritime Rules: Part 24A – Carriage of Cargoes – Changes to Default Controls for endosulfan formulations Dangerous Goods (MR024A): (ii) International Maritime Dangerous Goods Code; or Regulation 9 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001 (c) when this substance being transported by air, Part 92 of the Civil Aviation Rules is complied with. The following regulation is inserted immediately after (2) Subclause (1)(a)— regulation 9: (a) does not apply to a tank wagon or a transportable 9A Exception to approved handler requirement for container to which the Hazardous Substances (Tank transportation of packaged pesticides Wagons and Transportable Containers) Regulations 2004 applies; but (1) Regulation 9 is deemed to be complied with if: (b) despite paragraph (a), does apply to an intermediate bulk (a) when this substance is being transported on land— container that complies with chapter 6.5 of the UN (i) by rail, the person who drives the rail vehicle that is Model Regulations. transporting the substance is fully trained in (3) Subclause (1)(c)— accordance with the approved safety system for the time being approved under section 6D of the (a) applies to pilots, aircrew, and airline ground personnel Transport Services Licensing Act 1989; and loading and managing this substance within an aerodrome; but (ii) other than by rail, the person who drives, loads, and unloads the vehicle that is transporting the (b) does not apply to— substance has a current dangerous goods (i) the handling of this substance in any place that is endorsement on his or her driver licence; and not within an aerodrome; or (iii) in all cases, Land Transport Rule: Dangerous (ii) the loading and managing of this substance for the Goods 1999 (Rule 45001) is complied with; or purpose of aerial spraying or dropping. (b) when this substance is being transported by sea, one of (4) In this regulation, UN Model Regulations means the 13th the following is complied with: revised edition of the Recommendation on the transport of (i) Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous Goods Model Regulations, published in 2003 by Dangerous Goods (MR024A): the United Nations. (ii) International Maritime Dangerous Goods Code; or Code T7 Reg 10 Restrictions on the carriage of toxic or corrosive substances on (c) when this substance being transported by air, Part 92 of passenger service vehicles the Civil Aviation Rules is complied with. Code E1* Regs 32–45 Limiting exposure to ecotoxic substances through the setting of (2) Subclause (1)(a)— environmental exposure limits (EELs) (a) does not apply to a tank wagon or a transportable Changes to Default Controls container to which the Hazardous Substances (Tank Wagons and Transportable Containers) Regulations Regulation 32 of the Hazardous Substances (Classes 6, 8, and 9 2004 applies; but Controls) Regulations 2001 (b) despite paragraph (a), does apply to an intermediate bulk Regulation 32 applies as if subclause (1) and (2) were omitted. container that complies with chapter 6.5 of the UN Code E2 Regs 46–48 Restrictions on use of substances in application areas Model Regulations. (3) Subclause (1)(c)— Code E3 Reg 49 Controls relating to protection of terrestrial invertebrates eg beneficial insects (a) applies to pilots, aircrew, and airline ground personnel loading and managing this substance within an Code E5 Regs 5(2), 6 Requirements for keeping records of use aerodrome; but Code E6 Reg 7 Requirements for equipment used to handle substances (b) does not apply to— Code E7* Reg 9 Approved handler/security requirements for certain ecotoxic (i) the handling of this substance in any place that is substances not within an aerodrome; or
Changes to Default Controls for endosulfan (ii) the loading and managing of this substance for the This regulation applies as if the substance were not a class 9 purpose of aerial spraying or dropping. substance. (4) In this regulation, UN Model Regulations means the 13th revised edition of the Recommendation on the transport of
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Dangerous Goods Model Regulations, published in 2003 by Code EM10 Regs 21–24 Fire extinguisher requirements the United Nations. Code EM11 Regs 25–34 Level 3 emergency management requirements: duties of Hazardous Substances (Packaging) Regulations 2001 person in charge, emergency response plans
Code P1 Regs 5, 6, General packaging requirements Code EM12* Regs 35–41 Level 3 emergency management requirements: secondary 7(1), 8 containment Code P3 Reg 9 Criteria that allow substances to be packaged to a standard not Change to Default Controls meeting Packing Group I, II or III criteria Regulations 35-42 of the Hazardous Substances Code P13 Reg 19 Packaging requirements for toxic substances (Emergency Management) Regulations 2001 Code P14 Reg 20 Packaging requirements for corrosive substances The following subclauses are added after subclause (3) of regulation 36: Code P15 Reg 21 Packaging requirements for ecotoxic substances (4) For the purposes of this regulation, and regulations 37 Code PG2 Schedule 2 Packaging requirements equivalent to UN Packing Group II to 40, where this substance is contained in pipework Code PG3 Schedule 3 Packaging requirements equivalent to UN Packing Group III 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 Hazardous Substances (Disposal) Regulations 2001 whether a place is required to have a secondary Code D2 Reg 6 Disposal requirements for flammable substances containment system; and (b) is not required to be located in a secondary Code D4 Reg 8 Disposal requirements for toxic and corrosive substances containment system. Code D5 Reg 9 Disposal requirements for ecotoxic substances (5) In this clause, pipework— Code D6 Reg 10 Disposal requirements for packages (a) means piping that— Code D7 Regs 11, 12 Information requirements for manufacturers, importers and (i) is connected to a stationary container; and suppliers, and persons in charge (ii) is used to transfer a hazardous substance into or out of the stationary container; and Code D8 Regs 13, 14 Documentation requirements for manufacturers, importers and suppliers, and persons in charge (b) includes a process pipeline or a transfer line. Code EM13 Reg 42 Level 3 emergency management requirements: signage Hazardous Substances (Personnel Qualifications) Regulations 2001 Code AH1 Regs 4 – 6 Approved Handler requirements (including test certificate and Hazardous Substances (Identification) Regulations 2001 qualification requirements) Code I1 Regs 6, 7, 32–35, Identification requirements, duties of persons in charge, 36(1) – (7) accessibility, comprehensibility, clarity and durability Hazardous Substances (Tracking) Regulations 2001 Code I2 Reg 8 Priority identifiers for corrosive substances Code TR1 Regs 4(1), 5, 6 General tracking requirements Code I3 Reg 9 Priority identifiers for ecotoxic substances Code I5 Reg 11 Priority identifiers for flammable substances Hazardous Substances (Emergency Management) Regulations 2001 Code I8 Reg 14 Priority identifiers for toxic substances Code EM1 Regs 6, 7, 9–11 Level 1 information requirements for suppliers and persons Code I9 Reg 18 Secondary identifiers for all hazardous substances in charge Code I10 Reg 19 Secondary identifiers for corrosive substances Code EM2 Reg 8(a) Information requirements for corrosive substances Code I11 Reg 20 Secondary identifiers for ecotoxic substances Code EM6 Reg 8(e) Information requirements for toxic substances Code I13 Reg 22 Secondary identifiers for flammable substances Code EM7 Reg 8(f) Information requirements for ecotoxic substances Code I16 Reg 25 Secondary identifiers for toxic substances Code EM8 Regs 12–16, Level 2 information requirements for suppliers and persons 18–20 in charge Code I17 Reg 26 Use of generic names Code EM9 Reg 17 Additional information requirements for flammable and Code I18 Reg 27 Requirements for using concentration ranges oxidising substances and organic peroxides
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Code I19 Regs 29–31 Additional information requirements, including situations Controls Relating to the adverse effects of unintended ignition where substances are in multiple packaging Code Schedule 10 Schedule 10 of Gazette Notice Issue 35 - Hazardous Code I20 Reg 36(8) Durability of information for class 6.1 substances GN35A* Substances (Dangerous Goods and Scheduled Toxic Code I21 Regs 37–39, General documentation requirements Substances) Transfer Notice 2004 prescribes additional 47–50 requirements relating to controlling the adverse effects of unintended ignition of class 2 and 3.1 flammable substances Code I22 Reg 40 Specific documentation requirements for corrosive Change to Default Controls substances Schedule 10 of the Hazardous Substances (Dangerous Code I23 Reg 41 Specific documentation requirements for ecotoxic Goods and Scheduled Toxic Substances) Transfer Notice substances 2004 Code I25 Reg 43 Specific documentation requirements for flammable Clause 1 This clause applies as if the words “every class 2 substances and every class 3.1 hazardous substance described Code I28 Reg 46 Specific documentation requirements for toxic substances in Schedule 1” was replaced by: Code I29 Regs 51, 52 Signage requirements “this substance”. Code I30 Reg 53 Advertising corrosive and toxic substances Clause 33 This clause applies as if the words “Subject to subclause (2)” in subclause (1) were omitted. Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004 This clause applies as if subclause (2) were omitted.
Controls for Stationary Container Systems These controls are set out in Schedule 8 of the Hazardous Substances (Hazardous Substances 3.7.5 In addition, the following additional controls were imposed on the (Dangerous Goods and Schedule Toxic Substances) Transfer Notice 2004. The requirements of substances: this schedule are detailed in the Compilation of Hazardous Substances Regulations and Controls (http://www.ermanz.govt.nz/hs/hs-regulations.html). Table 12: Additional HSNO controls applied to endosulfan Change to Default Controls Additional controls for endosulfan Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic 1 Prohibition on use of substances Substances) Transfer Notice 2004 (1) No person may use endosulfan for any purpose other than— Clause 1: This clause applies as if the words “a hazardous substance described in Schedules 1 (a) for research and development; or and 2” in subclause (1) was replaced by: (b) as an ingredient or component in the manufacture of another substance or “this substance”. product. Clause 100: This clause applies as if subclause (1) was replaced by: (2) Despite subclause (1)(a), research and development using endosulfan does not include investigation or experimentation in which the substance is discharged, laid (1) In this Part, existing stationary container system means a stationary container or applied in or to the outdoor environment. system to which this Schedule applies that, immediately before 1 July 2004,— 2 Specification of pesticide and veterinary medicine actives (a) was being used to contain this substance; or (1) Any person who— (b) was designed to be used to contain this substance, and construction of the stationary container system to that design had commenced. (a) manufactures or imports into New Zealand endosulfan, which that person has not previously manufactured or imported on or before 1 July 2006; or (b) had previously manufactured or imported a hazardous substance listed in Table 1 of Schedule 1 on or before 1 July 2006, but that person has since modified the manufacturing process or changed the source of manufacture for that hazardous substance, must provide to the Authority in writing the information required by subclauses (3) and (4). (2) The information required by subclause (1) must be provided— (a) in the case of a substance that is manufactured in New Zealand prior to that substance being sold to another person or used in accordance with clause 1 of Schedule 3; or
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(b) in the case of a substance that is imported into New Zealand, prior to that Approved handler requirements (control codes T6, E7 and AH1) substance being imported; and 3.7.7 The HSNO approvals for endosulfan and endosulfan formulations require (c) in the case of a substance to which subclause (1)(b) applies— these substances to be under the control of an approved handler unless the (i) each and every time the manufacturing process or source of certain transport requirements for packaged pesticides are met (for example, manufacture is changed; and the substance is transported in accordance with the Land Transport Rule). (ii) include equivalent information for the substance that was produced by Approved handler certificates are issued by test certifiers, who are the manufacturing process before it was modified, or supplied by the individuals approved by ERMA New Zealand to issue certificates in their previous source of manufacture, if such information has not previously area of competency (in this case the management and handling of been provided to the Authority. pesticides). (3) The information to be provided is— 3.7.8 The purpose of the approved handler certificate is to ensure that a person (a) the name and address of the manufacturer of the substance; handling a hazardous substance is trained in how to use or manage the (b) the specification of the substance including either— hazardous substance safely and understands the laws and controls (rules) (i) the full name, including relevant citation, of the national and/or under the Act. To become an approved handler for a substance such as international standard(s) set by an international scientific or regulatory endosulfan, a person must demonstrate: body recognised by the Authority with which the substance complies, and evidence to support this; or (ii) the manufacturer’s specifications knowledge in handling the substance: including purity of the hazardous substance, isomeric ratio where the hazards of the substance and how to prevent harm to people applicable, maximum impurity content and evidence to support these, and damage to the environment; including details of analytical methods used. Where the substance is what to do in an emergency; produced at more than one manufacturing site, this information must be provided for each site separately; practical experience and knowledge of: (c) the identity of any impurity, its origin, and the nature of its relationship to the handling the substance and operating equipment; active component— protective clothing and safety equipment required; (ii) for endosulfan when the impurity is present at a concentration of 10 g/kg or more; knowledge of the HSNO legislation: (d) the identity of any impurity that is known to be of toxicological concern, its enforcement issues and what the law is trying to achieve; origin, and the nature of its relationship to the active component— the HSNO Act classifications and regulations that apply to the (ii) for endosulfan when the impurity is present at a concentration of less substance. than 10 g/kg. (4) Information on an impurity that is required under subclause (3) must include— Tracking requirements (control code TR1) (a) its chemical name; 3.7.9 Tracking requirements are triggered for endosulfan and endosulfan (b) its Chemical Abstract Service Registry number (if available); and formulations. Tracking is the recording of what happens to these substances (c) its maximum concentration in the substance. throughout their lifecycle from importation or manufacture in New Zealand, Additional controls for endosulfan formulations to the point of use and/or disposal. The requirements placed on tracked substances are specified in the Hazardous Substances (Tracking) Application onto or into water Regulations 2001. (1) No hazardous substance containing endosulfan may be applied onto or into water. 3.7.10 The purpose of tracking requirements is to ensure appropriately trained and (2) In this clause, water means water in all its physical forms, whether flowing or not, and licensed people (ie, approved handlers) are responsible for the hazardous whether over or under ground, but does not include water in any form while in a pipe, tank or cistern. substances throughout their lifecycle in New Zealand. Tracking requirements also ensure that information is available for managing emergencies involving a hazardous substance and enables enforcement agencies to have the ability to track back who has and who should be Further explanation of HSNO Act controls responsible for the hazardous substance. 3.7.6 Two of the HSNO controls in particular warrant a more detailed explanation. 3.7.11 Tracking commences at the site of manufacture for a substance that is manufactured in New Zealand. For an imported substance tracking starts at the port. United Nations (UN) or International Civil Aviation Organisation
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(ICAO) transport documentation relating to each shipment is considered 3.8 Non-HSNO Act controls acceptable records up to the importers premises or person storing the substance on behalf of the importer. The responsibility for keeping records Agricultural Compounds and Veterinary Medicines Act 1997 lies with the person in charge8 of the site where the substance is kept. 3.8.1 Before they can be used, formulations meeting the definition of “agricultural 3.7.12 The Hazardous Substances (Tracking) Regulations 2001 specify that the compound” under the Agricultural Compounds and Veterinary Medicines following records are kept. Act 1997, must be approved by the Agricultural Compounds and Veterinary The identity of the approved handler in control of the substance, Medicines Group (ACVM Group) of the New Zealand Food Safety including the: Authority. The relevant current registrations for endosulfan formulations are: person’s name, position within the workplace and physical address of the person’s place of work; P000039 (11 October 1963) – Thiodan (Bayer New Zealand Ltd), hazard classifications and phases of the lifecycle for which the 350 g/L endosulfan. person is approved; P005794 (8 February 2001) – Flavylan 350EC (Adria New Zealand date on which the test certificate lapses or must be reviewed. Ltd), 350 g/L endosulfan. Substance information, including the: P07281 (2 June 2005) – Thionex Insecticide (Agronica New Zealand Limited), 350 g/L endosulfan. unequivocal identification of the tracked substance (eg, the trade name, common name, ERMA New Zealand approval name or 3.8.2 The ACVM Group imposes controls (referred to as conditions) on the use of number); endosulfan formulations under the ACVM Act. The generic conditions total amount of tracked substance that is under the control of the applied by the ACVM Group to the substances are detailed in Table 13; no approved handler at anyone time (amounts may vary on a daily specific conditions have been set by ACVM Group. basis depending on quantities received or dispatched); Table 13: Agricultural Compounds and Veterinary Medicines Group conditions for endosulfan location of the tracked substance; formulations batch or package number (where required). ACVM conditions Transfer to another place, including the: and obligations Description unequivocal identification of the substance and the amount 1. The product must be manufactured in accordance with ACVM Standard for Good Manufacturing Practice and to the chemistry and manufacturing specifications transferred; provided by the registrant and approved as part of the registration. address of the place and the identity of the controlled substance 2. In addition to any labelling, advertising or promotion requirements specified in the licence holder (including controlled substance licence current registration, labelling, advertising or promotion of the product must comply registration number if available) to whom the substance is being with the current ACVM - New Zealand Labelling and Advertising Guide for Plant Compounds Requiring Registration in New Zealand. sent; 3. If the product is used on any food producing plant or on or around any plant not position of the controlled substance licence holder within their used to produce food: organisation; other than those specified on the current registration; or date on which transfer occurred. in a manner not specified in the current registration, Transport of the tracked substance, including: the user must ensure that residues of any substance in the product that may occur in plant material produced from the plants treated, or in animal material produced requirements as per the Land Transport Rules or Maritime or from grazing or direct feeding of the plants treated to food producing animals, do Civil Aviation Rules. not exceed the lesser of either: the specified residue limit in the current New Zealand (Maximum Residue of Disposal or use of the tracked substance, including the: Agricultural Compounds) Food Standard and any subsequent amendments; or manner of disposal (ie, how the substance was used, consumed the default maximum residue limit in the current New Zealand (Maximum or released etc); Residue of Agricultural Compounds) Food Standard and any subsequent amount of substance disposed of and the date of disposal; amendments, when a maximum residue limit for that substance has not been specified.9 location where the substance was disposed of.
9 A Maximum Residue Limit (MRL) of 2 mg/kg has been set for endosulfan – see New Zealand (Maximum 8 The definition of “person in charge” is given in the Hazardous Substances (Classes 1 to 5 Controls) Residue Limits of Agricultural Compounds) Food Standards 2008 (http://www.nzfsa.govt.nz/policy- Regulations 2001. law/legislation/food-standards/nz-mrl-fs-2008-consolidation.pdf).
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ACVM conditions and obligations Description Section Four – Risks, Costs and Benefits 4. Ongoing obligations: The registrant must provide an annual summary of adverse events to the ACVM Group. Adverse events which have serious implications for the continued use of the product must be notified immediately. 4.1 Identification of the potential risks, costs and The registrant must also advise the ACVM Group of any new studies or data that benefits of the substances contradicts information previously supplied. 10 5. The product must only be sold or imported according to the current registration. Risk management context
4.1.1 The Authority decides whether to approve or decline hazardous substances Other requirements based on the requirements of the Act and the Methodology. The purpose of the Act is to “protect the environment and the health and safety of people 3.8.3 The Resource Management Act 1991 (RMA) regulates discharges to air, and communities, by preventing or managing the adverse effects of ground or water and potentially therefore, conditions may also be imposed hazardous substances and new organisms”. The Act and the Methodology on the use of endosulfan formulations under the RMA. These conditions therefore provide the foundation for the risk management context for the may legally be stricter than controls under the HSNO Act, if that is evaluation and review of this application which must be undertaken in 11 appropriate for the purposes of the RMA. accordance with the purpose of the Act.
3.8.4 In addition, growers and operators using endosulfan will be subject to the 4.1.2 Section 29 of the Act requires the Authority to consider adverse and positive requirements of the Health and Safety in Employment Act 1992 which effects of the substance(s) and to make a decision based on whether or not includes the obligation on employers to take all reasonably practicable steps the positive effects of releasing the substance outweigh the adverse effects to eliminate, isolate and minimise significant hazards in the workplace. of the substance. The relevant adverse and positive effects are those that are associated with the substance.
4.1.3 In particular, in accordance with section 6 of the Act, the following matters have been taken into account in assessing the risks, costs and benefits associated with the use of endosulfan in New Zealand: The sustainability of native and valued introduced flora and fauna. The intrinsic value of ecosystems. Public health. The relationship of M ori and their culture and traditions with their ancestral lands, water, sites, w hi tapu, valued flora and fauna, and other taonga. The economic and related benefits to be derived from the use of endosulfan. New Zealand’s international obligations.
Identification and assessment 4.1.4 The Agency identifies the effects associated with the substance and then undertakes a scoping exercise to determine which effects are potentially significant. Identifying adverse effects requires identifying the sources of effect (eg the hazards), the pathways for exposure, and the areas of impact (outlined below) as well as the likelihood and magnitude of effect. In 10 ACVM advises that the registrations for endosulfan formations P005794 (Flavylan 350EC) and P007281 accordance with clauses 9 and 10 of the Methodology, and sections 5 and 6 (Thionex Insecticide) still have this condition, but that ACVM advises intends to delete it as the of the Act, the adverse and positive effects are characterised in relation to registrations come up for renewal. the following areas of impact: the environment, human health and safety, 11 See section 142 of the HSNO Act.
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relationship of M ori to the environment, the market economy, and society transparency and openness and the community. a sound methodology 4.1.5 The second step is to assess the effects that have been identified as being community and expert consultation potentially significant. Those effects that are deemed to be not potentially a fair decision-making process. significant are described, but are not assessed. Assessing effects involves combining the magnitude of an effect and the likelihood of it occurring. 4.1.10 In preparing this application the Agency has applied the criteria in the procedural standards listed above to its evaluation and review of all the Ethical considerations information available to it. In preparing this application, the Agency has been conscious of the concerns expressed by parties who have supplied 4.1.6 In reviewing the information provided and identifying and assessing the information to assist in the preparation of this application, and their beliefs adverse and positive effects of endosulfan, ethical matters relevant to the use that are the basis for these concerns. When ethical dilemmas arise the of endosulfan have been taken into account. Guidance is provided by the Agency has described them in terms of the framework. ERMA New Zealand Ethics Framework Protocol.12 This framework acknowledges that individuals and communities hold a range of ethical views. It has been developed as a tool to assist all participants in the ERMA Analysis of scenarios New Zealand decision-making process to: 4.1.11 Applications for new hazardous substances are made in the context of the ask the ‘right’ questions in order to identify areas where there are existing situation in New Zealand. Therefore, the assessments of adverse ethical matters to be considered; and and positive effects need to address the additional or incremental effects of the product. In the case of a reassessment the substance is already present in use the answers to these questions to explore whether and how ethical considerations need to be addressed. New Zealand so many of its effects are known.
4.1.7 The foundation of the framework is a set of ethical principles, supported by 4.1.12 The baseline scenario considered in this assessment is the current situation procedural standards. The two general principles, which are embodied in of endosulfan 350EC being available. The risks involved in this scenario the HSNO Act and the Methodology, are: are considered under the use patterns described in Table 9. The alternative scenario in which endosulfan approvals are revoked or modified to restrict respect for the environment; and use is considered in Section 6 of this application. respect for people (including past, present and future generations). 4.1.13 These scenarios form the basis for identifying and assessing risks, costs and 4.1.8 Under these general principles is a set of specific principles: benefits (adverse and positive effects). concern for animal welfare concern for autonomy 4.2 Risks and costs to human health and the concern for co-operation environment concern for cultural identity/pluralism 4.2.1 The potential sources of risk to human health and to the environment are concern for human rights tabulated in Table 14. concern for human dignity Table 14: Identification of potential sources of risk concern for justice and equality Lifecycle Activity Associated Source of Risk concern for sustainability Repackaging An incident during repackaging or labelling concern for wellbeing/non-harm. Local transport Transport or handling incident on roads or during loading/unloading resulting in spillage and subsequent exposure of people or the environment 4.1.9 The primary mechanisms for supporting the principles outlined in the Storage Incident during storage, resulting in spillage and subsequent exposure of framework and for evaluating whether or not they are upheld are the people and/or the environment procedural standards of: Use Exposure to users, bystanders and/or the environment during dilution, honesty and integrity mixing or use, or through exposure to residues on treated vegetation Disposal Disposal of the substance or containers, resulting in release of the substance and subsequent exposure of people and/or the environment
12 December 2005, ER-PR-05-1 12/05.
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4.2.2 Because of the potential for endosulfan to cause a variety of significant cases it is not possible to determine the exposure of the affected individual adverse effects on human health, each of the lifecycle activities listed in and whether it arose from abuse or normal use. Table 14 could give rise to potentially significant risks to human health. However, the likelihood of an incident during all stages of the lifecycle 4.2.8 The Agency notes the lack of incident data which could be due either to a except use is considered to be highly improbable. Therefore an assessment lack of incidents or a lack of reporting or monitoring. B. Walmsley (PGG of risk to human health has been made only for the use stage of the lifecycle. Wrightson Turf, pers. comm.) has informed the Agency that in 30 years of advising turf managers on the safe and effective use of endosulfan he has 4.2.3 As endosulfan is extremely toxic to aquatic life, and very toxic to soil not come across any cases of anyone experiencing harm or of environmental organisms, terrestrial vertebrates and invertebrates, each of the lifecycle damage or fish deaths. activities listed in Table 14 presents potentially significant risks to the environment. However, the likelihood of an incident during all stages of the Overseas incident reports lifecycle except use is considered to be highly improbable. Therefore an assessment of risk to the environment has been made only for the use stage 4.2.9 A selection of the many reports of incidents overseas is presented below. of the lifecycle. Interpretation of the significance of these reports needs to take account of the different application methods and controls that may be applied compared Reports of adverse effects of endosulfan formulations to New Zealand. Some of the incidents will have arisen from practices considered unacceptable in New Zealand. However, in most cases it is 4.2.4 One of the grounds for reassessment of the endosulfan products was that impossible to establish such differences from the available reports. The reports of adverse effects on human health and the environment constituted Agency therefore concludes that, although incidents have been reported new information gathered since endosulfan was first registered. Such overseas, it is not possible to determine their relevance to New Zealand. reports have been considered again as part of this reassessment application. Benin: In Borgou province, endosulfan poisoning caused many human deaths during the 1999/2000 cotton season. Official records state that New Zealand incident reports at least 37 people died and a further 36 became seriously ill, although an independent report estimated that nearly 70 people actually lost 4.2.5 There is a general absence of information on incidents relating to the use of their lives. Furthermore, farmers in Benin have observed birds and endosulfan in New Zealand. frogs dying following consumption of insects sprayed with endosulfan. 4.2.6 The New Zealand Food Safety Authority (NZFSA) laid 10 charges against a Northland farmer responsible for the 2006 contamination of meat with the South Africa: Two children aged 7 and 10 died after coming into pesticide endosulfan. This represented an off-label use outside of the contact with a goat treated with endosulfan in February 2003. NZFSA guidance that products used as veterinary medicines, “must Endosulfan is sold in South Africa as a vaccination in veterinary confirm, via veterinary advice, that the use is likely to be safe, appropriate, medicine (PAN UK, Glin et al., 2006). and not cause breaches in residue standards” (ACVM, 2006). This violation Sudan: In 1988, barrels (previously containing endosulfan) were lead to a temporary suspension of exports of New Zealand beef to Korea washed in an irrigation canal and caused massive death of fish; three and the responsible farmer being fined $15, 000 plus court costs. Following people died after drinking water from the canal. In 1991, 31 people this incident NZFSA examined whether labelling requirements should be died after eating seeds treated with endosulfan (PAN UK, Glin et al., amended to specify that plant protection products should not be used on 2006). animals. This has now been implemented for Thionex Insecticide with the label specifying “This product must not be applied on or administered to an Senegal: Investigations in the cotton growing region of Velingara animal”. Labels for Thiodan and Flavylan 350EC do not contain this during 2003 and 2004 revealed 157 poisoning incidents, of which warning. 31% involved Callisulfan, an endosulfan-cypermethrin formulation. One death was reported with 23 non-fatalities (PAN UK, Glin et al., 4.2.7 Between 1 July 2002 and 16 July 2007 the National Poisons Centre received 2006). eight calls relating to endosulfan. Two calls were simply requests for Indonesia: In southern Sulawesi endosulfan was the leading cause of information. Two were regarding injuries to animals, including seizure in a pesticide poisoning between 1990 and 1993, with 32 of 153 reported dog and injuries, ranging from weight loss to death, in baby herons. There poisoning cases due to endosulfan. were four calls regarding incidents of human exposure. Of the three cases of unintentional exposure, one requested information for treatment but India: In Kerala, endosulfan has been linked to hundreds of deaths and reported no injuries, one reported swelling and a sore nose, and one reported disorders among cashew nut plantation workers and villagers. In blistered lips, nausea, abdominal pain, sweating and vomiting. No injuries Kasaragod province, where aerial spraying of endosulfan occurred for were recorded in the only reported case of an intentional exposure. In all at least 15 years, high levels of endosulfan residues have been
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detected in the blood and breast milk of villagers and cancers and Risks and costs to society and community disorders of the reproductive and central nervous systems are common. A survey of only 123 houses found 49 cancer cases, 4.2.10 One potentially significant risk to society and community was identified. 43 psychiatric cases, 23 epileptics, 9 with congenital abnormalities This relates to increased anxiety in people who are concerned about the and 23 with mental retardation. continued use of endosulfan, when its use has been either banned or severely restricted in other jurisdictions. This anxiety relates to the reported Thailand: A survey in five provinces to assess the use of endosulfan adverse effects on human health and the environment. This effect is for golden apple snail control in paddy fields showed that recognised as being real, and it is likely that some level of anxiety will occur approximately 94% of farmers used pesticides and that, of those, if current use patterns are continued. However, the breadth and depth of 60-76% of farmers used endosulfan. Death of fish and other aquatic that anxiety is not known. organisms was reported in every province. US: The National Poison Telecommunications Network (NPTN) 4.2.11 Given the lack of information about the size of this effect, it has not been ranked endosulfan 65th on their list of the top 200 active ingredients assessed further. It is expected that submissions received during the public for which calls were received from 1984 through 1991, with 53 consultation period will provide further information that will be considered incidents reported in humans. The EPA Ecological Incident by the Authority in its evaluation of the application. Information System (EIIS) has recorded 91 ecological incidents since 1971 that have been attributed to endosulfan with 96% of these Risks and costs to the market economy regarding adverse effects to the aquatic environment and 82% involving fish. The National Oceanic and Atmospheric Agency’s fish- 4.2.12 There are two potentially significant adverse effects on the market economy kill database indicated that endosulfan was responsible for more fish that should be considered if the use of endosulfan is to continue in its kills in U.S. estuaries and coastal rivers between 1980 and 1989 than present form. These are: all other currently used pesticides at that time. An incident regarding An adverse effect on New Zealand’s ‘clean green’ image resulting endosulfan runoff from cotton fields killed over 240,000 fish in from knowledge that New Zealand is continuing to use endosulfan. Alabama in 1995, despite the pesticide reportedly having been applied Adverse effects on trade resulting from incidents arising where according to label instructions. The label did not include the endosulfan is used incorrectly. instruction not to apply within 300 feet of waterways and some of the fields were slightly within this range; endosulfan was applied to 4.2.13 Both of the two adverse effects postulated above would have an adverse several farms and there was heavy rainfall following some of the effect on New Zealand trade. In 2001 a report commissioned by the applications (PANUPS, 1996). Ministry for the Environment (MfE, 2001) concluded that: Health Canada (2007) report that runoff from endosulfan-treated fields New Zealand’s ‘clean green’ image has value in terms of the way in was also strongly implicated in eight incidents of fish-kill on Prince which particular New Zealand exports benefit from positive Edward Island in 1999. perceptions about our environment; ANZECC (2000) report that fish were killed in lagoons in which the the ‘image’ is worth at least hundreds of millions of dollars (per year); endosulfan concentration was measured 3 days after the kill at 0.15 and μg/l, but in another lagoon, small native fish were found when the New Zealand is relatively “clean and green”. endosulfan concentration was 0.22 LD50 μg/l. 4.2.14 While this report focussed on the impact of products associated with ANZECC (2000) also report a study that found reductions in genetically modified organisms on New Zealand’s ‘clean green’ image, the populations of five common benthic macroinvertebrate species and a general conclusions are nevertheless relevant. relationship with endosulfan through the use of solvent-filled dialysis bags. However, it was not possible to identify the average or peak 4.2.15 A study conducted in 2007 (Knight et al, 2007) looking specifically at concentrations over the sampling period. country of origin and choice of food imports found that country of origin factors appeared largely irrelevant to large food retailers. Consumers do ANZECC (2000) also report a broad chemical and biological show high willingness to purchase from countries where the country image monitoring programme across NSW, which showed effects on some is an important positive characteristic for the product category and it may macroinvertebrate species including mayflies, but failed to establish a therefore, for example, mean that sales of New Zealand apples benefit from clear link with any particular pesticide. image perceptions reinforced by scenery shown in movies. However, a high percentage of New Zealand food exports are unbranded and country of origin is unknown. A further factor is that country of origin labelling can be
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negative, with consumers being concerned about ‘food miles’ and also food ingredients. Although new insecticides have been introduced over the last quality (having regard to distance travelled). decades, endosulfan is still appreciated by growers and recommended by extension services for the following reasons. 4.2.16 This is consistent with the point that endosulfan use in onion crops has been declining in recent years because of constraints placed on growers by 4.2.23 Broad spectrum insecticidal/ acaricidal activity - contrary to many new customers (for example, Tesco in the United Kingdom) and that some insecticides the biological efficacy of endosulfan allows to control a large markets do not accept onions that have been grown using endosulfan. spectrum of different pests : 4.2.17 Thus, while the use of endosulfan may not directly impact on New Lepidoptera : (e.g. Helicoverpa spp., Spodoptera spp., Earias, Zealand’s ‘clean green’ image as far as individual consumers are concerned Mamestra, Pieris it is likely that restrictions may increasingly be placed on products where it Coleoptera : (e.g. Hypothenemus, Leptinotarsa., Anthonomus,, is known that endosulfan has been used. At the present time this is at the Meligethes) wholesale buyer level rather than the ‘trade ban’ level and therefore can be Heteroptera : (e.g. Nezara , Piezodorus, Myridae) managed at the individual grower level. Homoptera : (e.g. Aphis spp, Bemisia spp) 4.2.18 Thus, while the use of endosulfan may have an adverse effect on trade, the Mites (Acarina) : (e.g. Eriophydae). size of the effect is probably small and able to be managed by growers and industry groups, and it has not been assessed further. All these pests are damaging particularly to tomatoes, potatoes, fruits and vegetables as well as ornamentals, which remain key uses for Identification of benefits (positive effects) endosulfan in New Zealand. None of the modern insecticides cover the comprehensive pest spectrum like endosulfan. Recent publications 4.2.19 The following reports from various user groups identify the value of have shown that newer products from the neonicitinoids and endosulfan to them. pyrethroids class are becoming less effective in their control, especially against whiteflies. These new products need to be sprayed 4.2.20 The Agency identifies that since endosulfan is valued by farmers and more frequently in order to achieve the same results and do not have horticulturalists its availability will lead to reduced stress in this group of the selectivity towards beneficial insects. For the replacement of people. endosulfan it might be necessary to use several active ingredients in alternation or mixtures, as long as resistance management (see below) Report on the identification of benefits provided by Makhteshim Chemical Works is not an issue. Further restrictions of its use or even loosing this (MCW)13 “unique mode of action” would definitely negatively impact the other product's benefits. Furthermore, endosulfan is the only tool available 4.2.21 The following paragraphs were provided by MCW identifying the benefits for certain target pests, especially in view of the minor use crop that accrue from the use of endosulfan formulations. situation (increasingly important since many organophosphates are being lossed for those uses; e.g. mites in blueberries, cyclamen mites 4.2.22 Endosulfan belongs to the unique class of “dioxathiepin” chemicals. In in strawberries, green stink bugs in tomatoes, lygus bug in New Zealand, it provides a much needed cost effective crop protection tool vegetables). Endosulfan is the only product that works on certain in a variety of situations. Because of its unique mode of action and mites in ornamentals. chemical makeup, it seems to have an unmatched importance in Integrated Pest Management (IPM) and Resistance Management programs. Because 4.2.24 Resistance management - despite the intensive use of endosulfan for more of its low toxicity to honey bees in field situations, it is often a preferred than 50 years all around the world only a few cases of temporary insect insecticide for use on cross-pollinating crops. Its spectrum of control, resistance have been reported. There are no reports about any significant particularly against adult phases of the whitefly, aphids, stink and lygus product failures due to resistance problems. Endosulfan has a unique mode bugs or potato beetles, is superior in many situations to any alternative of action different to organophosphates, carbamates, synthetic pyrethroids, product. No other insecticidal material exists that has the immediate neonicotinoids, oxadiazine carboxylate, spinosad and all other classes of population knockdown capabilities as endosulfan does against pests such as insecticides currently available or in development on the market. adult whiteflies, and at the same time is “soft” or selective on beneficial Furthermore there is no cross resistance in between endosulfan and insects, which allows the farmer to use it in IPM. As endosulfan can not be synthetic pyrethroids, organophosphate, neonicotinoids or other chemical replaced simply by other existing registered products, it takes time to find group used in crop protection. The reason for the very limited cases of suitable solutions, which mostly end up of mixtures of two active resistance is related to the multiple sites of action within the GABA receptor
13 MCW communication dated 29 February 2008.
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system, as well as specific interaction with the detoxication (sic) system of imidacloprid and buprofezin. Damage of the crop or alternatively use of pests. several products would be necessary but can not be afforded by the farmer.
For these reasons, endosulfan is an important tool in Insecticide 14 Report on the identification of benefits provided by Horticulture New Zealand Resistance Management programs preventing or overcoming resistance against other chemical classes of insecticides. Endosulfan 4.2.28 The following paragraphs were provided by Horticulture New Zealand as is the ideal product for difficult to control species such as Helicoverpa identifying the benefits that accrue from the use of endosulfan formulations. armigera and white fly in vegetables and ornamentals, where resistance against other insecticides has occurred. The loss of 4.2.29 Specific Insect Control – endosulfan is one of the only pesticides available endosulfan would increase the overuse of other products or for control of some insects and mites. combinations of them with the consequence of increasing resistance. Furthermore, due to the lack or restricted use of organophosphates, Mite species belonging to the family Tarsonemidae and super family endosulfan will become even more important within the resistance Eriophyoides (gall mites) are not usually controlled by modern miticides strategies for the future. developed for control of Tetranychidae. New Zealand Tarsonemidae and gall mites that are controlled by endosulfan include: 4.2.25 Selectivity on pollinators and beneficials - endosulfan provides high Broad mite – (Polyphagotarsonemus latus) a pest of many crops, selectivity in favour of beneficial insects and pollinating insects. This especially greenhouse crops. allows predators and parasites of important pests to play an economic role in pest control, where honey bees and bumble-bees continue to be a vital Cyclamen mite (Phytonemus pallidus) a pest of strawberries and some part in agriculture/ horticulture through their activities as pollinators. In flower crops. many countries (see labelling), endosulfan is authorised for use during the Peach bud mite (Tarsonemus waitei) a pest of fruit trees and flowering/blooming period. greenhouse tomatoes. To optimise the efficacy and selectivity of endosulfan, the product Red berry mite (Acalitus essigi) a pest of boysenberries and some should be sprayed during the early growth stage of the crop Rubus species. (beginning of the spraying campaign). In this case both with the help Current bud mite (Cecidophyopsis ribis) causes big bud on black of the “beneficials” the pest infestation levels will be kept below the currents. economic threshold levels. A specific detoxification system identified in beneficial insects: previous studies performed in Germany have There are also species that affect grapes, pipfruit and citrus. demonstrated that endosulfan is actively detoxified by several species However, to date they do not appear to require specific chemical of beneficial insects via the Glutathion-S-Transferase System (GSTs), control measures. which conjugates the molecule of endosulfan to the three-peptide The white fly and thrip families are another two groups of insects that are glutathion, thus making the molecule unable to bind its target, the particularly difficult to control. Although there are some alternative GABA receptor. On the other hand, the GST system has demonstrated insecticides available for control of these groups they are limited in number, a lower activity in most of the target pests. quick to develop resistance and endosulfan works very well. 4.2.26 Multicrop product due to excellent crop tolerance - since its introduction, 4.2.30 Broad Spectrum Control/Mode of Action - endosulfan is a broad spectrum endosulfan has shown exceptionally good plant compatibility and tolerance. insecticide. This ability to control a wide range of damage causing insects Reports about phytotoxic effects are extremely scarce and mostly due to is a key reason why the desire is expressed that endosulfan be available for uncontrolled tank mixtures with products which were not recommended for growers to use in the future. mixing with endosulfan. Being a broad spectrum insecticide also offers tremendous advantages 4.2.27 Cost effectiveness - depending on the pest and crop the dose rates for should new strains of insects develop (e.g. the new strain of white fly Thionex Insecticide (350g/l EC) differ from to 1 to 2 litre product/ha. That affecting tomato growers) or when new pest incursions occur (e.g. citrus means product costs for one treatment at farmer level are in the range of 18 white fly). These are very real threats to all growers and having a product to 36NZ$/ha which is by far less compared to product cost for other such as endosulfan available when a situation such as this occurs is vitally insecticides with similar spectrum of activity. Alternative products like important to the horticultural industry. chlorpyrifos, diazinon, methamidaphos, alpha-cypermethrin, deltamethrin, lambda-cyhalothrin, do not cover all pests. Because endosulfan has a different mode of action it extremely valuable as resistance management tool in prolonging the usefulness of other insecticides such as fipronil, 14 Horticulture New Zealand: Endosulfan use in New Zealand, February 2008.
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4.2.31 Resistance Management Strategies - endosulfan belongs to the Mode of manage this situation, maintain the usefulness of all current chemicals and Action group 2 - GABA-gated chloride channel antagonists, Subgroup A, have the ability to act quickly should a new resistance or pest occur. chemical group cyclodiene organochlorines. Overseas, it has shown some Endosulfan is a key component of this strategy. cross-resistance in some pests to fipronil, (which is also in the Mode of Action group 2 - GABA-gated chloride channel antagonists, but is Subgroup 4.2.32 Strategic Applications - endosulfan is not widely or routinely used by all B, chemical group fipronil; fipronil does not appear to have a label claim growers and all crops, but having it available to use strategically when and for mite control on plants, although there is one paper claiming control of if the situation arises is crucial to some. broad mite - Nick Martin, Crop and Food Research, Personal Communication). Submissions received from growers during pre-notification consultation for this application, acknowledged the use of endosulfan as a backstop Endosulfan (2A) provides an alternative Mode of Action group for rotation application. Endosulfan is often not a first choice chemistry due to the with other insecticides/miticides. It is included in the following resistance effect on IPM programmes, beneficial insects and bees. However, growers management strategies: believe that when pest numbers do get out of control endosulfan will be effective. For this reason it is often used strategically, only once or twice a Diamond back moth (fipronil (2B) also has a label claim for use on season, when insect pest numbers are very high. brassicas) Tomato fruitworm Another strategic use of endosulfan is between crops. This is used primarily by greenhouse and ornamental growers but is not limited to these groups. Thrips, including onion thrips, and western flower thrips, (fipronil At the end of a crop cycle before the next crop a strategic one off (2B) also has a label claim for onion thrips control on onions) application of endosulfan may be made to ‘clean up’ the area making sure Whitefly that insect pressure is not carried over from one crop to the next. This is an important practice for many growers and with one spray of endosulfan they Melon aphid can reduce their need for insecticides during the subsequent crop life cycle. Green peach aphid. This aphid could be exposed to fipronil (2B) in brassica crops. Identification of benefits by the turf industry Lettuce aphid. 4.2.33 As discussed above, endosulfan is also used in the turf industry for the No resistance to endosulfan has been reported in New Zealand to any of control of earthworms, Porina, Greasy cutworm and Sod webworm. these pests (Nick Martin pers comm.). 4.2.34 While there are other equally effective pesticide options available for Due to new insecticidal chemistry being very selective in mode of action, controlling Porina, Greasy cutworm and Sod webworm, there are none resistance can develop very quickly. If we are to be good stewards of these available for earthworms. Endosulfan is used to manage and reduce new products and prolong their useful life there must be other products to earthworm numbers on turf and thereby maintain playing quality.
use in rotation with them. Endosulfan as demonstrated above is one such 15 product. 4.2.35 In a report received from the New Zealand Sports Turf Institute, the Institute advised that the New Zealand turf industry wishes to retain the use Synthetic Pyrethroid (SP) resistance is widespread in a number of insects of endosulfan as it provides a cost-effective control of earthworms and thus and crops. It has been demonstrated that if the use of SP’s is stopped for a assists in providing quality playing areas for sports users. NZSTI identified period of time (length of time will be different for each insect population – the following aspects of the problem posed by earthworms in New Zealand: but at least several years) this resistance in the insect population can New Zealand’s mild maritime climate ensures adequate soil moisture diminish to a level where SP’s become effective again. There must be a enabling earthworms to thrive. range of products with different modes of action for growers to choose from if this is to occur. Endosulfan is one such product. New Zealand soils have “significant” organic matter which helps support a large earthworm population. Resistance develops when an insect population is exposed to the same New Zealand’s predominant earthworm species have a surface casting chemistry (or chemistry with the same mode of action) repeatedly. Those habit. insects that survive or escape the insecticide pass on the genetic code or ability that enabled their survival. If only a limited number of insecticides are used this ‘selection’ for resistance can occur quite quickly. We do not know what resistances will develop in the future – but we can maintain a 15 wide range of chemical options available for growers so that they can Endosulfan Reassessment Report dated June 2008.
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New Zealand’s soils are generally poorly drained silt and clays which 4.3 Assessment of potentially significant risks, costs can be further compromised by the activities of surface casting worms. and benefits A large part of New Zealand’s sporting calendar occurs during 4.3.1 The potentially significant adverse effects, costs and benefits arising from winter/spring when soil conditions are wet. It is as this time that they the events identified in Table 14 are considered with respect to: are most vulnerable to compaction and surface sealing. The safeguarding of the life-supporting capacity of air, water, soil and 4.2.34 NZSTI advised that similar issues apply in Britain, where organo chloride ecosystems. products for control of earthworms were removed from the market in 1992, The maintenance and enhancement of people and communities to thus requiring reliance on more expensive, less effective alternatives such as provide for their own economic, social, and cultural wellbeing and for carbendazim. This has apparently led to a reduction in turf quality in the reasonable foreseeable needs of future generations. Britain. NZSTI wishes to avoid these problems and the additional costs associated with reduced longevity of sports turf assets and/or in mitigating 4.3.2 The analysis during the use phase of the lifecycle used modelling to or addressing earthworm problems without the ability to use endosulfan. estimate exposure. For all other stages of the lifecycle, the assessment was NZSTI also pointed out the “social cost” of sportspeople not being able to qualitative and determined that the likelihood of an incident was highly play due to unacceptable conditions/venue closure. improbable and therefore no further analysis was performed.
Summary of benefits identified by users in discussions during the development of Assessment of environmental risks this application 4.3.3 An estimation of environmental risks has been made on the basis of 4.2.36 The following table summarises the potential benefits from the use of available information on the use of endosulfan using standard modelling endosulphan identified by users, grouped into effects on the environment, tools to estimate exposure concentrations in combination with the data on effects on human health and safety, effects on society and community and the ecotoxicity of the substance and its main metabolite endosulfan sulphate. effects on the market economy. 4.3.4 For Class 9 substances, irrespective of the intrinsic hazard classification, the Table 15: Summary of benefits from the use of endosulfan ecological risk can be assessed for a substance or its components by calculating a risk quotient (RQ) based on measured or estimated exposure Area of effect Description Accrues to ... concentrations. Estimated exposure concentrations (EEC) are calculated Benefits to the A lack of adverse effects on non-target species Horticulturalists taking into account use scenarios (including spray drift, application rates Environment has been claimed by some parties but not others and frequencies), and the fate of the product including half-lives of the (including honey bees) component(s) in soil and water. Dividing an EEC by the LC50 or EC50 Benefits to Human Reduced risks to people from ability to control Individuals (ranging from Health and Safety earthworms and reduce castings which can cause sport players to vehicle generates an acute RQ whilst dividing the EEC by the NOEC generates a injury through uneven surfaces occupants) chronic RQ as follows: Reduced risk to air travellers from reduction in risk Air travellers, airport of birdstrike authorities Acute RQ = EEC Chronic RQ = EEC Benefits to Society Reduced stress to horticulturalists and farmers Horticulturalists LC50 or EC50 NOEC and Community from knowing that there is a good backstop product available Reduced concern on part of managers of sports Sports managers and 4.3.5 If the RQ exceeds a predefined level of concern (see below), it may be facilities and sports participants participants appropriate to refine the risk assessment or apply controls to ensure that Reduced risk of playing areas being Turf Managers and appropriate matters are taken into account to minimise off-site movement of closed/enhanced turf quality for sports participants the substance. Conversely, if a worst-case scenario is used, and the level of Benefits to the Reduced cost of control of insects in the Horticulturalists concern is not exceeded, then in terms of the environment, there is a Market Economy agricultural and horticultural sectors presumption of low risk which is able to be adequately managed by existing Reduced cost of control of earthworms (range of Turf Managers controls. possible costs) and less need to resurface areas Reduced cost of control of earthworms at airports Airport authorities 4.3.6 Levels of concern (LOC) developed by the USEPA (Urban & Cook, 1986), and adopted by ERMA New Zealand, to determine whether a substance Reduced cost of development and testing of new Horticulturalists products as pests don’t develop resistance poses an environmental risk are shown in Table 16. Ability to be able to ‘salvage’ crops Horticulturalists
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Table 16: Levels of concern in environmental risk assessment
Level of Concern Presumption (LOC) Aquatic (fish, invertebrates) Acute RQ 0.5 High acute risk 0.1–0.5 Risk can be mitigated through restricted use <0.1 Low acute risk Chronic RQ 1 High chronic risk Plants (aquatic and terrestrial) Acute RQ 1 High acute risk Mammal and birds Acute dietary or oral 0.5 High acute risk RQ Chronic RQ 1 High chronic risk
Ecotoxicity 4.3.7 There is a large body of ecotoxicity data on endosulfan and its metabolites. This has been extensively reviewed by other bodies (ANZECC 2000; GFEA-U, 2007; USEPA, 2002, 2007c; APVMA, 1998; Health Canada 2007). In most cases, the ecotoxicity data used by the Agency for risk assessment have been taken from these reviews, particularly ANZECC (2000) and USEPA (2002) and have not been further reviewed for data quality. The ecotoxicity values used for risk assessment are shown in the sections relating to the different compartments below.
Environmental fate 4.3.8 Exposure is a product of use patterns and fate parameters. Fate in the different environmental compartments is discussed below. Environmental
fate has been discussed extensively in other reviews of endosulfan (USEPA, 2002; APVMA, 1998). Only a summary is presented here. Fate in water 4.3.9 The degradation products of endosulfan in the environment, as shown in 4.3.10 Endosulfan is photolytically stable in water, apart from some APVMA (1998) are illustrated below. The formation of the various photoisomerisation of the - to the -isomer (APVMA, 1998). metabolites in the different environmental compartments is described under the relevant sections below. 4.3.11 Hydrolysis of endosulfan is pH dependent, half-lives at pH 5.5 and 8.0 at 22 C of 150 and 1 day respectively (CalEPA, 2007). At pH7, the half-life of -endosulfan is estimated to be 19 days and this has been used in the USEPA (2007c) modelling of environmental fate.16 Endosulfan diol is the only product detected during endosulfan hydrolysis studies (APVMA, 1998).
4.3.12 APVMA (1998) report that total endosulfan residues in a pH7.2-7.9 river water/sediment system (98% sand, 0.5% organic carbon, 22 C, incubated in
16 Note that USEPA (2002) report 19 days to be the half-life of -endosulfan (11 days for -endosulfan) and this appears more likely given that the -isomer degrades more quickly than the -isomer (Guerin & Kennedy, 1992).
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the dark) had a half-life of about 2 weeks. Degradation was initially by respectively (APVMA, 1998). Half-lives for - and -isomers, in acidic to biological oxidation to endosulfan sulphate. Endosulfan sulphate amounted neutral aerobic soils range from 1-3 months and 3-9 months for the - and to about 20% of applied endosulfan after 1 day, largely in the water phase, -isomers (USEPA, 2002). These figures are assumed to be for degradation increasing to 30-50% after 8 days when it was split approximately equally rather than dissipation. APVMA give degradation half-lives of 80-128 days between the water and sediment, then decreasing to 10% after 7 weeks (the for the - and -isomers and of 288 days to 2241 days for the combined - final sampling), when it was associated primarily with the sediment. and -isomers and the sulphate in 5 soils (sandy loam, loamy sand and silty Hydrolysis appeared to follow the initial biological oxidation, with loam) with mineralisation ranging from 0.4-9.7% after a year. It is noted endosulfan hydroxycarboxylic acid increasing from low levels at Day 4 to that long-term laboratory degradation studies may be affected by the 30% at Day 16, before reducing to 10% after 7 weeks. The difficulty of maintaining viable microbial communities over long periods in hydroxycarboxylic acid was associated with the water phase. Non- the laboratory. extractable sediment residues increased to about 20-27% after 7 weeks. Less than 1% of the applied endosulfan was recovered as CO2 indicating 4.3.18 Under field conditions, dissipation including by degradation, transport and slow mineralisation. APVMA (1998) state that this is the one study for uptake, suggests half-lives of weeks to months (USEPA, 2002). The which the results can be considered reliable. Ramanarayanan & Allen combined half-life (assumed to be a dissipation half-life) of parent and (1999a) analyse what appears to be the same study and derive a dissipation sulphate is estimated to be 9 months to 6 years (USEPA, 2002). half-life of 21 days. Ramanarayanan et al (1999) derive a half-life of 19 days based on Ramanarayanan & Allen (1999a) and use this in their 4.3.19 Baedelt et al (1992) looked at field dissipation in two soils, a silty loam and modelling of endosulfan fate. The Agency used a dissipation half-life value a sandy, silty loam and observed average half-lives of 27 days for parent of 19 days in the aquatic exposure modelling since it is for total endosulfan endosulfan, 175 days for parent plus sulphate metabolite. residues from a study reported to be reliable. It is unclear how Ramanarayanan et al (1999) made the conversion from 21 days to 19 days, 4.3.20 Kennedy et al (2001) describe a 2-phase dissipation process, with half-lives but in practice the difference has very little impact on estimated in foliage and soil of 1.6 and 7.1 days for the first phase, 9.5 and 82 days for environmental concentrations as modelled by the Agency. the second.
4.3.13 USEPA (2007c) use an aquatic metabolism half-life of 2671 days, this being 4.3.21 The soil half-life used in exposure modelling by the USEPA (2007c) is 1336 twice the soil metabolism half-life, but the hydrolysis half-life of 19 days is days, this being the upper 90% confidence limit of endosulfan and its also inputted to their modelling. metabolites in soil metabolism studies. 4.3.22 Given the equivalent toxicity of endosulfan and endosulfan sulphate, the 4.3.14 The high Koc values of endosulfan, 10600 and 13600 L/kg for the - and - isomers (USEPA, 2002) indicate that it will tend to sorb to solids, although Agency has used half-lives reflecting the degradation of parent and as described above, rapid biotic oxidation to endosulfan sulphate occurs and metabolite in estimating environmental concentrations. A value of 1336 this will remain in the water column for several weeks. days has been used in the modelling in accordance with USEPA (2007c).
4.3.23 Endosulfan - and -isomers have average Koc values of 10600 and 13600 Fate in soil (USEPA, 2002) indicating strong sorption. Endosulfan sulphate has a 4.3.15 Endosulfan is photolytically stable on soil and plant surfaces. Endosulfan similar Koc to endosulfan, 7300-11400, but endosulfan diol sorbs less sulphate is found on plant surfaces but is thought to occur from thermal strongly 990-1200 (APVMA, 1998). Strong sorption does not preclude run- rather than photolytic degradation (APVMA, 1998). off of endosulfan bound to soil particles and this may be an important route of water body contamination. Leaching studies confirm these high Koc 4.3.16 Laboratory studies of soil microorganisms in nutrient solutions have shown values with practically no endosulfan or its metabolites being found in the that fungi tend to degrade endosulfan to endosulfan sulphate, while bacteria leachate (APVMA, 1998). degrade it to endosulfan diol. Endosulfan diol has been shown to degrade further via the ether to hydroxyether and then to the lactone (APVMA, Fate in air 1998). Soil degradation studies have shown endosulfan sulphate to be the -3 main metabolite. For example, in one study using soils from several sites, 4.3.24 Endosulfan has a vapour pressure of 1.7E Pa, (GFEA-U, 2007) and Henry’s Law constant variably measured at 0.7-12.9 ( -isomer) and 0.04- endosulfan sulphate reached 34-77% of applied endosulfan after a year, with -3 -1 the diol and lactone generally reaching <2%. 2.12 ( -isomer) Pa.m .mol (GFEA-U, 2007). Wind tunnel experiments (21-22 C, 50% humidity, air speed 1 m/second) have given half-lives of 4.3.17 Endosulfan sulphate degrades more slowly than endosulfan. In one study technical endosulfan from foliage and soil of one and three days using a soil at pH7.1, 5.1% organic matter, first half-lives of 23, 58 and 100- respectively (APVMA 1998). Endosulfan sulphate has a lower tendency to 150 days were derived for - and -isomers and endosulfan sulphate volatilise (APMA, 1998). Aerial transport of endosulfan sorbed to dust may
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be another transport route (USEPA, 2002). Deposition from air to water 4.3.32 The USEPA modelling also looked at biomagnification factors (BMF) that may be expected given the high water-air partition coefficients, 700 for the express concentrations in an organism compared to those in its diet on a -isomer, 14000 for the -isomer, 56000 for endosulfan sulphate, all at 25 C lipid-normalised basis. All aquatic BMF are estimated to be less than one, (APVMA, 1998). except for piscivorous fish (1.38), indicating that biomagnification is unlikely to occur in aquatic food webs. 4.3.25 A half-life of 3.9 to 8.4 days has been calculated for reaction of endosulfan with hydroxyl radicals in air based using a hydroxyl radical concentration of 4.3.33 Kelly et al (2007) predict that for substances like endosulfan with a 8.3-18x105 per mL (APVMA, 1998). tendency to partition from air into organisms as given by a high octanol air partition coefficient (log KOA 6 and log Kow between 2-5), 4.3.26 Raupach et al (2001) describe a model for the dissipation of endosulfan and biomagnification in terrestrial (air-respiring) organisms may be greater than its metabolites from cotton fields. The model stresses that spray drift and for aquatic ones. This is presumed to be due to their greater ability to volatilisation from plants and soil will give rise to airborne endosulfan that assimilate food from their diet due to differences in digestive tract will provide a ‘steady drizzle’ onto non-target areas, while run-off from physiology and temperature and their lower ability to eliminate the heavy rain events will give rise to peak inputs to adjacent non-target areas. chemicals by respiration. The predictions for -endosulfan are for BMF values <1 for water-respiring organisms, 10 for seabirds, 22 for marine 4.3.27 APVMA (1998) state that endosulfan will be a regional rather than a global mammals. USEPA (2007c) compare these predictions to measured residue air pollutant as its volatility is too low to enable global distribution, although data from beluga (whales) and ringed seals. The measured data indicate it is noted that endosulfan has been detected in the Canadian Arctic BMF for male and female beluga of 7 and 3, while for male and female snowpack, suggesting widespread distribution. Shen et al (2005) quote ringed seals the BMF are 2 and 1. USEPA (2007c) stress the preliminary three models predicting that characteristic travel distances of -endosulfan nature of this comparison, given the paucity of residue data and assumptions will be of the order of 658, 665 and 3520 km. made about the diet of beluga and ringed seal. Mackay & Arnold (2005) also analyse fish to mammal BMF based on measured residues in Arctic Bioconcentration/bioaccumulation/biomagnification fauna and stress the variability around their estimate for -endosulfan (10.2 ± 16.4). 4.3.28 The log Kow of the -isomer, -isomer and endosulfan sulphate are 3.55- 4.74, 3.62-4.78 and 3.66 respectively (USEPA, 2007c), suggesting a 4.3.34 The above analysis for Arctic wildlife indicates that biomagnification potential for bioconcentration. resulting from global distribution of endosulfan may occur. The model of Kelly et al (2007) appears to confirm the residues in biota of many high 4.3.29 USEPA (2007c) provide a preliminary assessment of bioconcentration KOA, medium-to-high Kow substances, but the data are lacking to confirm factors (BCF) from laboratory studies. The data from the best quality its suitability for endosulfan. Furthermore, the exposure of seabirds or studies have BCF in the range of 1000-3000 for fish and 20-600 for marine mammals will be largely determined by global emissions of invertebrates. These BCF are from studies that analysed -isomer, -isomer endosulfan, the control of which falls outside this risk assessment. The food and endosulfan sulphate. web of Arnot and Gobas (2004) is used to analyse the risk to waterbirds (see below). 4.3.30 USEPA (2007c) note that depuration of endosulfan and endosulfan sulphate by fish appears to be relatively rapid with clearance half-lives ranging from 2-6 days, although, assuming first-order kinetics, this is somewhat at odds Use Patterns with studies that show steady-state was not reached in 3-4 weeks. The 4.3.35 Use patterns are discussed in detail in Section 3 above. In the assumption of first-order kinetics may be an over-simplification. Studies of environmental risk assessment risks from the following uses are evaluated: depuration in invertebrates suggests a range of clearance half-lives of 1.5 days to 2 weeks, although these studies do have limitations. Label use: 0.7 kg a.i./ha, application 4 times/year using high boom. Turf use: 2.1 kg a.i./ha, application once a year with a low boom and 4.3.31 No bioaccumulation factors (BAF, exposure through food as well as by with wetting in following application respiration) have been measured for fish, but for the invertebrates Crassostrea virginica and Daphnia magna, they are about 600. In the Citrus use: 1.3 kg a.i./ha, twice a year with an application interval of absence of measured data, the USEPA modelled bioaccumulation using the 14 days, using an airblast sprayer. food web model of Arnot & Gobas (2004). The model estimates correlate well with measured values where they are available (BCF for fish and invertebrates and BAF for invertebrates). Predicted BAF for fish, for which there are no measured values, are up to 1800 for piscivorous fish.
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Aquatic risk assessment endosulfan was applied at 0.75 kg a.i./ha, 3 or 4 times a year. The soils were grey cracking clays (vertosols) which are strong, friable and Aquatic exposure – monitoring prone to forming large deep cracks from the surface when drying. The soils were 60-65% clay, 17-25% silt, 13-16% sand and about 1% 4.3.36 There are many literature reports of environmental monitoring for organic carbon. Some of the soils had patches of red soils with lower endosulfan from different parts of the world. The Agency has reviewed clay content and higher sand content. pH was 7.7-8.7. The analysis some of these studies, selected to include all New Zealand monitoring and a showed that: up to 70% of the endosulfan volatilised in the first few variety of environmental media in other parts of the world (Appendix C) days after application; only 2% of the endosulfan dissipated through and makes the following observations: run-off (even for this irrigated crop); 25-30% was degraded either by There appear to be only two published reports of monitoring in New the crop itself or in soil; 1% remained in the soil, largely as endosulfan Zealand, and these relate to six bark samples taken at three sites sulphate, at the start of the succeeding year. The authors stress the (Simonich & Hites, 1995, 1997). There is no information in these sensitivity of the mass-balance to heavy rainfall in the days reports concerning the selection of sampling sites. succeeding application and to interception of the spray by the crop, with applications early in the season leading to higher soil residues It is possible that other bodies, such as Regional Councils, may hold and potential for run-off losses. more information from environmental monitoring. Regional Councils were approached for information as part of the ‘pre-notification’ Some of the monitoring has analysed for endosulfan sulphate as well consultation undertaken earlier this year, but such monitoring data was as - and -endosulfan but much has not. Given the similarity in not provided. toxicity between the sulphate and parent isomers and the greater persistence of the sulphate, this is a significant shortcoming of those Monitoring of remote regions relevant to New Zealand showed studies that do not include the sulphate. endosulfan metabolites in Antarctic ice, location of sampling unreported (Deger et al, 2003). Endosulfan has also been detected in Given the comparatively small number of studies examined by the the blubber of Antarctic wildlife (Miranda-Filho et al, 2007). Agency, and the variety of media and locations sampled, it is not Monitoring of overseas remote regions (see for example, Carrera et al, possible to summarise concentrations of endosulfan monitored in 2002; Brun et al, 2007) would suggest that New Zealand’s remote environmental media. regions would receive endosulfan originating from New Zealand’s use APVMA (2005) reports on the effectiveness of measures taken to of endosulfan and from global long-range transport of endosulfan. reduce endosulfan contamination of waterways in cotton growing High regional cropland intensity (within 150 km of site), assumed to areas, as determined by monitoring. The percentage of water samples be associated with high use of endosulfan, has been correlated with with endosulfan detected remained fairly constant at around 50% higher residues in remote regions such as the Rocky Mountain throughout the 1990’s. However, after 1999, when the measures were National Park (Usenko et al, 2007). Insufficient information is introduced, the percentage of samples with detectable residues available to the Agency to enable it to quantify concentrations in New dropped, to around 5% in 2001/2 the most recent year for which data Zealand’s remote regions but New Zealand’s remoteness will limit were reported. This drop was attributed to additional control regional (international) input and domestic use of 5-7 tonnes a.i./year, measures, but it is noted that endosulfan usage also dropped from is very low compared to global use (decreasing from a 2001 peak of about 2.6 kg a.i./ha in 1993/1994, to 0.5-1.0 kg a.i./ha in 2002/2003 about 13000 tonnes (Mackay & Arnold, 2005)). Concentrations in (on non-GM cotton) and therefore the direct effects of the measures remote regions of New Zealand are therefore unlikely to exceed those taken is difficult to evaluate. seen in remote areas elsewhere. It is noted that Antarctic regions have lower concentrations of many organochlorines and PCBs than Arctic 4.3.37 The Agency concludes that: regions (Miranda-Filho et al, 2007). In evaluating monitoring reports, it is necessary to consider local With few exceptions, the overseas reports examined by the Agency (within a few km), regional (100’s of kms) and global depositions of have not enabled concentrations monitored to be related to local use of endosulfan. endosulfan, due to an absence of information on use in relation to the monitoring sites. It is for this reason that the Agency has not reviewed Extensive overseas monitoring has demonstrated volatilisation and more of the available overseas monitoring literature. One notable regional and global distribution of endosulfan, but, by virtue of the exception is the study of Kennedy et al (2001) of endosulfan way the information has been reported, this cannot be used to relate application to cotton in Australia. While the crop and environment are local use to local environmental concentrations and hence risk. different to the New Zealand use scenario this study does demonstrate Analyses for endosulfan have not been reported from remote regions aspects of the fate of endosulfan in the environment. This was a 3- of New Zealand (including New Zealand’s sub-Antarctic islands, year, mass-balance study of endosulfan fate from two fields to which marine areas, mountain areas), although reports from similar
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environments overseas would suggest low concentrations would be Scenario 2 – ‘off-label’ turf use expected. Model Parameter Reference New Zealand’s use of endosulfan will contribute to global emissions Application rate 2.1 kg a.i./ha B. Walmsley (pers.comm.) and global contamination of remote areas. The Agency lacks the tools (maximum rate)
to manage such long-range transport but it is being addressed at the Application frequency 1 time a season international level, in particular by the United Nations Environment Application method Low boom, medium Programme Persistent Organic Pollutants Review Committee. droplet size Pesticide wetted in? Yes 4.3.38 Consideration of environmental exposure in this risk assessment has focused on local scale emissions. As the Agency is unaware of local monitoring, its local risk assessment is based on modelling estimated environmental Scenario 3 – ‘off-label’ citrus use concentrations. Model Parameter Reference Application rate 1.3 kg a.i./ha S. Minchin (pers.comm.) Aquatic Exposure – modelling (maximum rate) 4.3.39 Environmental exposure has been estimated by the Agency using the Application frequency 2 times a season GENEEC2 model (USEPA, 2001). More refined assessment has been Application interval 14 included in overseas reviews and provided by Makhteshim (MCW). Application method Airblast, orchard However, no such higher tier modelling has yet been performed to reflect New Zealand conditions and use patterns, although MCW has indicated that Pesticide wetted in? No it may be able to provide this data during the period available for public submissions. All scenarios Model Parameter Reference GENEEC2 modelling of New Zealand endosulfan use Koc 10600 USEPA (2007c) -isomer 1 4.3.40 The Agency used the GENEEC2 surface water exposure model (USEPA, Aerobic soil DT50 1336 days USEPA (2007c) 2001) to estimate the EEC of endosulfan in surface waters which could arise ‘No spray’ zone None as a result of spray drift and surface run-off from the use of endosulfan formulations in New Zealand. Water solubility 0.33 ppm APVMA (1998a) 1 Aerobic aquatic DT50 19 days Ramanarayanan et al (1999)
4.3.41 Parameters used in the GENEEC modelling of environmental exposure are Aqueous photolysis DT50 Stable APVMA (1998) listed below. Use rates represent the highest rate for recommended uses. 1 half-life of endosulfan and endosulfan sulphate Half-lives relate to the degradation of parent and the sulphate metabolite.
Table 17: Aquatic risk assessment – GENEEC2 input parameters 4.3.42 MCW has suggested that the Agency should use a shorter half-life in soil Scenario 1 – Use according to label based on Baedelt et al (1992) who report on the results of field trials in which the concentration of endosulfan sulphate reached a peak after 91 days Model Parameter Reference and had decreased to 50% of this concentration after a further 175 days. Application rate 0.7 kg a.i./ha Label for all products sold in New Zealand Irrespective of the validity of an assessment based on one field trial at one Application frequency 4 times per season Max rate 200mL/100L or 2L/ha (equivalent to site (the trial involved two sites, but the data were too variable at one of 0.7 kg a.i/ha), the maximum number of Application interval 10 days applications per season is not given, them to determine a DT50), the GENEEC model is little affected by half-life Application method High boom, medium therefore a conservative estimate of 4 of this duration. A half-life of 266 days gives EEC values very similar to droplet size applications per season has been used for those derived with a half-life of 1336 days. modelling, minimum application interval 10 Pesticide wetted in? No days. 4.3.43 The output from the GENEEC modelling is shown in Tables 18 and 19.
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Table 18: Aquatic exposure as estimated by GENEEC2 model
Scenario 1 –Use at label rate FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) ------RUN No. 1 FOR Endosulfan ON Label * INPUT VALUES * METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ------(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ------ONE(MULT) INTERVAL Koc (PPB ) (%DRIFT) (FT) (IN) 1336.00 2 N/A .00- .00 19.00 19.00 ------.623( 2.474) 4 10 10600.0 330.0 GRHIME( 1.2) .0 .0 GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001 ------FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY ------GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ------(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) 16.45 15.56 11.12 6.04 4.28 ------1336.00 2 N/A .00- .00 19.00 19.00 Table 19: Summary of aquatic exposure
GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001 EEC (µg/l) Peak EEC ------Scenario (µg/l) 4 day 21 day 60 day 90 day PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC Max use rate as on 13.2 12.4 8.9 4.8 3.4 ------label 13.23 12.42 8.85 4.79 3.39 Off-label turf use 10 9.4 6.7 3.6 2.6
Off-label citrus use 16.5 15.6 11.1 6.0 4.3 Scenario 2 –Use on turf
RUN No. 2 FOR Endosulfan ON Turf * INPUT VALUES * ------4.3.44 The GENEEC model is a deterministic model that calculates run-off and RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP drift under standard conditions. Local conditions may differ from these ONE(MULT) INTERVAL Koc (PPB ) (%DRIFT) (FT) (IN) standard conditions; certainly there will be variability that gives rise to a ------probability distribution of exposure concentrations. More sophisticated 1.870( 1.870) 1 1 10600.0 330.0 GRLOME( .8) .0 .0 modelling has been conducted overseas to take account of such variability and this is described below. FIELD AND STANDARD POND HALFLIFE VALUES (DAYS) ------4.3.45 Labels for endosulfan products in New Zealand specify no additional METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED precautions, such as buffer zones, that should be taken to avoid (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND) environmental contamination although the label for Thionex Insecticide ------1336.00 0 N/A .00- .00 19.00 19.00 specifies that a strategy should be employed to minimise spray drift. Where such strategies are employed (and the approved handler control should ensure they are) the drift assumptions of the GENEEC model will GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001 overestimate exposure. ------PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC Tier II exposure modelling ------9.97 9.35 6.66 3.61 2.55 4.3.46 No Tier II modelling has yet been performed to reflect New Zealand conditions and use patterns although as stated above, MCW may be able to provide New Zealand-relevant data during the public submissions period. Scenario 3 – Use on citrus Modelling performed overseas is not directly applicable to New Zealand.
RUN No. 3 FOR Endosulfan ON Citrus * INPUT VALUES * Nevertheless, the Agency has reviewed such modelling and includes a ------summary in Appendix D. RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT) INTERVAL Koc (PPB ) (%DRIFT) (FT) (IN) 4.3.47 Subject to the caveat that overseas modelling is not directly applicable to ------New Zealand conditions or use patterns, this review highlights that under 1.157( 2.306) 2 14 10600.0 330.0 ORCHAR( 9.7) .0 .0
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US use conditions, USEPA (2007c) estimates of concentrations in receiving which there were insufficient data to generate a species sensitivity waters are similar to those estimated using Tier I modelling in New Zealand. distribution, were no more sensitive than fish and crustacea. The New Zealand use scenario most closely resembling the aerial application to tomatoes modelled by USEPA, is airblast application to 4.3.52 The HC5 values show that for acute exposures, freshwater crustacea are citrus, giving rise to 9.7% and 5% spray drift respectively. twice as sensitive as freshwater fish to endosulfan, but there is no difference between marine fish and crustacea. Marine taxa are more sensitive than 4.3.48 The expected environmental concentrations estimated by Ramanarayanan et freshwater. al (1999), also for US use, are much lower due to their much lower estimates of spray drift. 4.3.53 For the risk assessment the acute HC5 values for the freshwater fish (0.33 μg/l) and crustacea (0.16 μg/l) have been used. Marine taxa have been Effects on aquatic organisms excluded on the grounds of reduced likelihood of exposure. Inclusion of marine data would increase the risk quotients by a maximum factor of 1.4 4.3.49 The extensive database prepared by ANZECC 2000 has been used to (derived as fishfreshwater HC5/fishmarine, freshwater HC5 = 0.33/0.24). determine effects concentrations for use in the risk assessment. The Agency used these data to determine HC5 values for those higher taxa/compartment 4.3.54 A summary of chronic aquatic toxicity data is shown in Table 21. The combinations (fish marine, fish freshwater, crustacea marine, crustacea Agency notes that ANZECC derived a ‘high reliability’ (chronic) HC5 from freshwater) with more than 8 species. These values are set out in Table 20 these data of 0.02 μg /l. However, ANZECC recommend the use of the HC1 below. Acute HC5 values are concentrations at which the acute toxicity of 0.03 μg /l, since the chronic HC5 fails to protect some important LC50/EC50 is exceeded for 95% of species tested. Australian species from acute toxicity.
Table 20: HC5 estimates of aquatic acute toxicity Table 21: Summary of chronic aquatic toxicity
Species count Species count
Total 4.3.51 HC5 values derived from these curves are summarised below. Lowest LC50 values have also been included which demonstrates that those taxa for Endosulfan Reassessment – Application June 2008 Page 83 of 244 Page 84 of 244 June 2008 Endosulfan Reassessment – Application Table 22: Acute/chronic aquatic toxicity ratios sulphate. The Agency used DT50 values in the GENEEC2 modelling that took account of dissipation of both endosulfan and endosulfan sulphate. Acute LC50 Chronic NOEC Species (µg/l) (µg/l) Acute/chronic ratio Solubility and Koc were based on endosulfan which is slightly more Ceriodaphnia dubia 188 10 19 hydrophobic than endosulfan sulphate (solubility and log Kow, 0.48 mg/l and 3.66 for endosulfan sulphate (experimental values from EPIWIN Daphnia magna 161 2.7 60 database), 0.33 mg/l and 4.55-4.77 for endosulfan. The difference in Moinodaphnia macleayi 215 20 11 hydrophobicity between endosulfan and endosulfan sulphate will result in an underestimate of the expected environmental concentrations. 4.3.57 Given the lack of taxonomic diversity of species with both acute and 4.3.62 The Agency has calculated risk quotients using the GENEEC2 estimates of chronic data, there is considerable uncertainty in extrapolating this environmental concentrations. Use of the USEPA (2007c) estimates would acute/chronic ratio to other taxa. An acute/chronic ratio of 10 is considered have little effect on the Agency’s analysis given the similar EEC. Use of more typical by the Agency. Applying this ratio to the acute HC values 5 the MCW’s EEC values would give rise to lower risk quotients primarily gives chronic NOECs of 0.033 μg/l (fish) and 0.016 μg/l (crustacea). due to the much lower estimates of percentage drift (6-300 times lower). 4.3.58 The Agency has used chronic NOECs of 0.033 μg/l (fish) and 0.016 μg/l However, this is not applicable since these estimates incorporate a 31-91 m (crustacea) based on application of an acute/chronic value to the acute HC . drift buffer zone around the crop which is not currently mandated in New 5 Zealand. This compares to the ANZECC guideline value based on an HC1 of 0.03 μg/l. 4.3.63 The time-relevant EEC for risk assessment should be selected based on the 4.3.59 The Agency notes the ANZECC (2000) report that fish were found in one duration of the toxicity tests. For an acute exposure assessment it is lagoon with an endosulfan concentration of 0.22 μg/l, but in another lagoon appropriate to compare the peak EEC to the acute HC5. When a chronic sampled three days after a fish kill, the concentration was 0.15 μg/l. NOEC is derived from a specific test, the duration of the exposure used to derive the risk quotient, should be the duration of the toxicity test or as close 4.3.60 There are few data available on the ecotoxicity of the metabolites of to it as possible. The Agency has elected to use a 21 day EEC, this being endosulfan and very few for species for which data are also available on the duration of a chronic Daphnia study and the closest time period to the endosulfan. Species for which a direct comparison can be made are shown duration of a standard fish early-lifestage test (35 days). in Table 23 and indicate comparable toxicity. USEPA (2007c) includes information on the toxicity of endosulfan sulphate to additional species for 4.3.64 The resultant risk quotients are shown in Table 24. which data on endosulfan are not available. The Agency concludes that Table 24: Calculation of RQs endosulfan sulphate appears as toxic as endosulfan, but data are too few to Acute ecotoxicity HC5 reach a conclusion on other degradates. Peak EEC from GENEEC2 (µg/L) Species Value (µg/l) RQ (acute) Table 23: Aquatic toxicity of endosulfan metabolites Label use 13 Fish 0.33 39 Endosulfan Endosulfan Crustacea 0.16 81 Species Endpoint Endosulfan sulphate diol 2 1 Turf use 10 Fish 0.33 30 Lepomis macrochirus 96 h LC50 (μg/l) 3.3 3.8 (bluegill sunfish) Crustacea 0.16 63 2 1 Cyprinodon variegates 96 h LC50 (μg/l) 1.4 3.1 Citrus use 17 Fish 0.33 52 (sheepshead minnow) Crustacea 0.16 110 2 3 Daphnia magna 48 h EC50 (μg/l) 188 580 1 USEPA (2007c) 21 day EEC from Chronic ecotoxicity (0.1 x acute HC5) RQ 2 Appendix B GENEEC2 (mg/L) (chronic) Species Value (mg/l) 3 Health Canada (2007), duration not specified in report, assumed to be 48 h. Label use 8.9 Fish NOEC 0.033 270 Crustacea 0.016 560 Aquatic Risk Quotients Turf use 6.7 Fish NOEC 0.033 200 4.3.61 The small amount of information on the toxicity of endosulfan sulphate Crustacea 0.016 420 suggests it is as toxic as the parent isomers. It is therefore appropriate that Citrus use 11.1 Fish NOEC 0.033 340 the exposure assessment take account of both endosulfan and endosulfan Crustacea 0.016 700 Endosulfan Reassessment – Application June 2008 Page 85 of 244 Page 86 of 244 June 2008 Endosulfan Reassessment – Application 4.3.65 When compared against the relevant levels of concern (LOC) listed in Table Table 25: Health Canada’s estimate of buffer zones required for aquatic habitat protection from 16, the RQs derived from the GENEEC 2 modelling for endosulfan indicate spray drift high acute and chronic risk to freshwater fish and invertebrates. Buffer zone (m) required for the protection of aquatic habitats (non- exceedance of levels of concern) at water depths: 4.3.66 Monitoring of residues in marine mammals has been reported overseas. The Freshwater habitat Estuarine/marine habitat Agency is unaware of any information on seawater or biota concentrations Method of application <1 m 1–3 m >3 m <1 m 1-3 m 3 m of endosulfan in waters around New Zealand. This area of potential risk has therefore not been assessed. Field sprayer 120 120 70 120 120 120 Airblast (early season) 80 70 60 100 90 80 Overseas risk assessments Airblast (late season) 70 60 50 90 80 70 USEPA Australia 4.3.67 USEPA (2007c) estimate freshwater RQ based on the EEC described in Appendix D, the ranges reflecting the different use patterns for which 4.3.72 APVMA (1998) estimate that spray drift from an application of 700 g a.i/ha exposure was estimated as follows: would need to be reduced to less than 0.1% to prevent effects in a 15 cm deep water body. Their estimate is that this would require a buffer zone Fish Invertebrate exceeding 150 m. Acute 15–28 2.1–4.0 Chronic 36–62 79–133 Makhteshim (MCW) 4.3.73 Ramanarayanan et al (1999) superimpose an acute toxicity species sensitivity distribution (HC5 approximately 0.09 μg/l) on their EEC 4.3.68 These RQs are lower than those calculated by the Agency for New Zealand. th This arises from differences in the toxicity measures used, particularly for probability distribution, based on a 91 m buffer zone. The highest 90 acute invertebrate toxicity, since the exposure concentrations are similar. percentile peak EEC for any crop is 0.37 μg/l, at which concentration it is estimated 13.3% of species would be affected. Ramanarayanan et al (1999) USEPA used lowest LC50/EC50 and NOEC values from a more limited dataset than the ANZECC (2000) database used by the Agency. claim that, since the distributions of exposure and effects are independent, the overall probability of any organism being affected will be the product of Canada the probability of exposure and effect, i.e. 0.1x13.3 = 1.3%. However, the Agency is of the view that the critical issue is whether any species would be 4.3.69 Health Canada (2007) performed separate exposure analyses for the risks affected, rather than whether there is a probability of a specific species posed by runoff and spray drift arguing that different measures might be being affected. The estimate that 13.3% of species would be affected at the taken to control the different routes of input. 90th percentile peak EEC is therefore the critical parameter. 4.3.70 PRZM/EXAMS was used to calculate runoff contamination of water bodies adjacent to application sites (i.e. drift in the model was set to zero). Terrestrial Risk Assessment Exposure under eight combinations of location, crop and application rate were modelled probabilistically. Species sensitivity distributions of acute Terrestrial exposure – monitoring LC50 and of chronic NOEC values were used to determine the percentage of 4.3.74 Monitoring of the terrestrial environment is included in the studies listed in species expected to be affected. The combined analysis indicated that for all Appendix C. but one of the scenarios there was a high probability of effects, for example, a 40% probability of exceeding the acute LC50 in 50-90% of freshwater fish, a 98-99.9% probability of exceeding the chronic NOEC for freshwater fish. Terrestrial Exposure – modelling Health Canada add that given the persistence of endosulfan and endosulfan Soil invertebrates sulphate in soil, a buffer zone may not be effective in avoiding run-off risks to aquatic habitats, and national trials of the effectiveness of vegetative 4.3.75 The strong sorption of endosulfan to soil will tend to reduce movement of strips to reduce contamination would be needed to clarify this. the substance and its metabolites in the soil column. The Agency has assumed that endosulfan residues will mix within the top 5 cm of the soil. 4.3.71 Health Canada’s estimates of the size of buffer zones required for the Assuming a dry soil density of 1.5 and a maximum treatment rate of 4 protection of aquatic habitats from spray drift are set out in Table 25 below. applications at 0.7 kg a.i./ha, the maximum concentration in soil within a treated field would be 3.7 mg/kg soil (dry weight). The surface litter concentration, on which some earthworms feed, would be expected to be Endosulfan Reassessment – Application June 2008 Page 87 of 244 Page 88 of 244 June 2008 Endosulfan Reassessment – Application higher, possibly as high as 160 mg/kg based on the short grass category of the publication, and effects are reported subjectively, varying from ‘none to Fletcher et al (1994), although it would decrease quite rapidly due to ‘severe’. Biobest (2008) also report the relative toxicity of endosulfan to volatilisation. many species of non-target invertebrates, it is thought under laboratory conditions although it is stated that results were verified in trials under field 4.3.76 Adjacent to a treated field, the concentration derived from spray drift would conditions. Biobest (2008) do state that their list is based on results decrease with distance from the field reflecting the deposition pattern. The obtained under Western European horticultural and climatic conditions, but concentration derived from run-off would be spatially highly variable the application rates used are not stated. Their results suggest >75% death depending on the flow of particles from the field, with a maximum of 3.7 in many species particularly parasitoids (Appendix B). mg/kg soil (dry weight). 4.3.81 Boller et al (2005) report that endosulfan is toxic to parasitoids Bees and other terrestrial invertebrates (Trichogramma cacoeciae) under laboratory conditions, but not to 4.3.77 Bees, and other invertebrates, may be directly exposed if present in a field lacewings (Chrysoperla carnea) under laboratory conditions, The IOBC that is sprayed or off-field due to drift. Deposition from spraying at 0.7 (Boller et al 2005) indicate that endosulfan is not toxic to bees. Bastos et al kg/ha would amount to about 7μg/cm2 which is about the area of a bee (2006) also report toxicity to the parasitoid, Trichogramma pretiosum in (Davis & Williams, 1990). Such insects would also be subsequently laboratory tests in which host eggs were treated by dipping in 2.92 g a.i./l exposed by contact with sprayed surfaces and volatilised endosulfan. solution for 5 seconds. Conversely, volatilisation of endosulfan from plant surfaces will reduce 4.3.82 MCW has reported to the Agency that a specific detoxification system has direct exposure over time. been identified in beneficial insects (species not specified) by which endosulfan is actively detoxified via the Glutathion-S-Transferase System Terrestrial effects – plants, terrestrial invertebrates, soil micro-organisms and birds (GSTs), which conjugates the molecule of endosulfan to the three-peptide 4.3.78 There are few studies investigating effects of endosulfan on plants. glutathion, thus making the molecule unable to bind its target, the GABA USEPA’s ECOTOX database lists studies with 11 species under a variety of receptor. The GST system has demonstrated a lower activity in most of the conditions. The records provide few details, for example, in most cases the target pests. Kern (1990) reports that endosulfan is metabolised more formulation tested is not recorded (Appendix B). The Agency has not rapidly and effectively in the honey bee than the cabbage white butterfly and examined the source documents for these studies, but the overall impression also that bees have notably active mixed function oxidase and GST enzyme is of a lack of plant toxicity at the concentrations tested. The Agency systems. Endosulfan is also reported to have little insecticidal action against performed no analysis of the risk to plants. ladybirds (Coccinella septempunctata) and some parasitic hymenoptera (Cephalonomia stephanoderes and Prorops nasuta) (Kern 1990). Nath et al 4.3.79 Reports of endosulfan concentrations that cause effects in laboratory tests (1985) report metabolic pathways of endosulfan, with excretion via are shown in Table 26. These data are used in the Agency’s risk assessment conjugates of endosulfan diol, endosulfan ether and endosulfan and qualified by field observations. hydroxyether, but do not comment on the relative abilities of bees and other non-target organisms versus pest species. Table 26: Terrestrial invertebrate toxicity used in the risk assessment 4.3.83 Effects concentrations used by the Agency in the bird risk assessment are Taxon Exposure route Result Reference set out in Table 27 below. Earthworms (Eisenia andrei) Laboratory 14 d LC50 = 9.4 mg/kg Heimbach (1985) artificial soil Table 27: Summary of bird toxicity data Earthworm (Lumbricus Laboratory, 14 d LC50 = 9 mg/kg Haque and Enbing terrestris) natural soil 1983, cited in Exposure Heimbach 1985 Species route Test results Reference Bees (Apis mellifera) Laboratory APVMA (1998) Endosulfan Endosulfan sulfate Oral 48 h LD50 = 2 μg/bee Contact 48 h LD50 = 2.4 μg/bee Mallard (Anas Oral Acute LD50 28 mg/kg APVMA, 1998 platyrhynchos) bw Diet Acute LC50 1053 USEPA, 2002; 4.3.80 The toxicity of endosulfan to non-target invertebrates other than bees and mg/kg diet earthworms has been reported in several publications, but critical Diet 24 week, chronic USEPA, 2002; information needed to evaluate these reports is lacking (Appendix B). For NOAEC 30 mg/kg diet APVMA, 1998 LOEC 60 mg/kg diet – example, Brasse (1985) reviews information on toxicity to a wide range of growth and egg non-target invertebrates but details of the endosulfan formulation used, production affected concentrations causing effects and the nature of the effects are not clear in Endosulfan Reassessment – Application June 2008 Page 89 of 244 Page 90 of 244 June 2008 Endosulfan Reassessment – Application Exposure Risk to plants Species route Test results Reference 4.3.87 There are no data indicating toxicity of endosulfan to plants and the Agency Diet Acute LC 1642 mg/kg diet USEPA 2007c 50 is unaware of any reports of phytotoxicity from the field. Therefore, the NOEC 170 mg/kg diet risks to plants from exposure to endosulfan have not been evaluated. [clinical signs of toxicity, bodyweight, feed consumption] Risk to bees and other non-target invertebrates 2 Northern Diet Acute LC50 805 mg/kg USEPA, 2002; 4.3.88 Deposition onto a 1 cm bee from an application at 0.7 kg a.i./ha would bobwhite quail diet (Colinus amount to about 7 μg/bee, which is more than the laboratory contact LD50 virginianus) (2.4 μg a.i./bee). Effects on bees might therefore be expected. One early Oral Acute LD50 44 mg/kg bw USEPA 2007c study from New Zealand (Palmer-Jones et al, 1959) in which 1 acre of a 25 acre crop of brassicas treated at 1.3 kg/ha showed 60-67% mortality of bees NOEL 35 mg/kg bw [feed consumption] picked from the crop in the 30 hours following application, dropping to 8% by 6 days after application. However, no effects were observed at the hives. Diet Acute LC50 >3528 mg/kg USEPA 2007c diet The authors stress that only 4% of a larger crop was treated. Another study NOEC 367 mg/kg diet with an application rate of 2.2 kg/ha appeared to show a deterrent effect on [bodyweight and feed bees released one hour after treatment which persisted for >3 hours (Palmer- consumption] Jones, 1959). Other trials in Germany, at lower application rates, showed no effects and a review of 3947 reports of damage to bees in Germany over a 14 year period in the 1970’s and early 1980’s indicated only one report Terrestrial Risk attributable to endosulfan (Brasse, 1985). MCW has reported to the Agency Risk to soil organisms that endosulfan is favoured in integrated pest management programmes for its relative lack of effect on beneficial invertebrates (Makhteshim, 4.3.84 Comparison of the 14 day earthworm laboratory LC50 9 mg/kg with the EEC pers.comm.). based on four field applications of 0.7 kg a.i./ha and mixing of endosulfan into the top 5 cm of soil (EEC = 3.7 mg/kg) would suggest that acute effects 4.3.89 The extent of the risk to other non-target terrestrial invertebrates is similarly are unlikely. Chronic toxicity data are not available for effects on unclear. Laboratory data (Appendix B) suggest toxicity, particularly to earthworms. However, treatment at rates as low as 1.1 kg/ha is used to parasitoids, but field observations suggest this toxicity may not occur at control moderate to severe earthworm problems (B. Walmsley pers.comm.). current application rates. The difference between what is expected on the basis of laboratory toxicity and what may be seen in the field may be due either to earthworms feeding 4.3.90 APVMA (1998) report that endosulfan is less of a hazard (sic) to non-target on the litter layer with higher residues than are assumed based on organisms than alternative insecticides due to rapid dissipation through homogeneous residues within the top 5 cm of soil, or to differences in the volatilisation. degradation rates in laboratory tests and the field compared to the relative toxicity of endosulfan and its degradates. Effects on earthworm populations 4.3.91 The Agency concludes that endosulfan is toxic to bees and many non-target under labelled application rates (0.7 kg a.i/ha, which may be repeated), are organisms in laboratory testing, but there is uncertainty as to whether such therefore to be expected. effects occur in the field. Risk to birds feeding in fields 4.3.85 Joy & Chakravorty (1991) report that populations of collembola and total microarthropods were significantly reduced 45 days after an application 4.3.92 Based on the LD50 value of 28 mg/kg bw to Mallard ducks (Anas (dose given as 0.33%, but the application rate is not stated). After 75 days, platyrhynchos) of endosulfan is considered highly toxic to birds on an acute soil residual toxicity remained to the larvae of the mite genus Lancetoppia exposure basis. Chronic toxicity data on ducks (NOEC = 30 mg/kg diet) (41% mortality) and the collembolan genus Cyphoderus (43% mortality). revealed that reproduction and growth were the most sensitive endpoints (USEPA, 2002). 4.3.86 Vig et al (2008) report on the populations of microbes in fields treated sequentially with a series of insecticides including endosulfan, but the text 4.3.93 The EEC values were derived using the USEPA Terrestrial Residue and figures are conflicting. The Agency has not used this report in its Exposure (T-Rex) Model version 1.2.3.17 assessment. 17 http://www.epa.gov/oppefed1/models/terrestrial/index.htm Endosulfan Reassessment – Application June 2008 Page 91 of 244 Page 92 of 244 June 2008 Endosulfan Reassessment – Application 4.3.94 The values for this model are derived from the Kenaga nomograph, as 4.3.102 APVMA, however, concluded that an application rate of 2.1 kg/ha would modified by Fletcher et al. 1994. Risk quotients are based on the most leave a dietary residue approximating half the dietary LC50 and concluded sensitive LC50 (805 mg/kg diet, Bobwhite quail) and NOEC (30 mg/kg diet, that the risk to birds is low. Mallard duck) for birds (Table 27). 4.3.103 The conclusion drawn by the Agency from these analyses is that, using the 4.3.95 Acute and chronic risk quotients were calculated following the procedure foliar dissipation input data value from the USEPA (USEPA 2002), the outlined in Appendix F and were compared to levels of concern (LOCs) acute RQ exceeded the LOC for birds feeding on short grass following ‘off outlined in Table 16. label’ use for turf. However, each use pattern examined led to the chronic RQ (peak EEC) exceeding the LOC for the majority of feeding scenarios. 4.3.96 Acute high risk LOCs (Table F1, Appendix F) were exceeded for birds for Following refinement to the 56 mean EEC, each use pattern still had at least one of the three use patterns modelled (turf use) (RQ range: 0.01 - 0.56). one feeding scenario that exceeded the chronic LOC. Chronic LOCs were exceeded (RQ range: 0.38 – 14.99) for all use patterns modelled when the peak EEC was used. When the 56 day mean EEC was 4.3.104 This above model was further refined by using the foliar dissipation data used, chronic LOCs, although lower, were still exceeded for all use patterns value recommended by MCW. Although the acute RQ still exceeded the examined (RQ range: 0.1–2.20). LOC for birds as above, no chronic RQ exceeded the LOC for any use pattern examined when the 56 day EEC was used with this foliar dissipation 4.3.97 As a result of the exceeded LOCs using the USEPA sourced foliar data value. dissipation half-life of 4 days (USEPA 2002), the Agency refined the assessment by using the minimum foliar dissipation half-life of 0.95 days 4.3.105 Validation of this refinement option via the assessment of the primary sourced by MCW (Ramanarayanan et al, 1999a). reference source required before any firm conclusion of the chronic risk to birds can be drawn. Regardless, there is an acute risk to birds associated 4.3.98 The source of the USEPA foliar dissipation half-life of 4 days is based on with the ‘off-label’ use of endosulfan on turf. the upper 90th percent confidence interval value for the mean of 8 reported half-life studies on a variety of crops including: cotton, grapes, pears, Risk to birds feeding in water tobacco, alfalfa, beets, and leafy vegetables. However, the reported results 4.3.106 USEPA (2007c) includes an assessment of risk to birds feeding in water did not distinguish between foliar degradation, plant uptake, wash-off, or (belted kingfisher, herring gull, osprey, mallard, great blue heron, bald volatilisation as routes of dissipation (USEPA, 2002). eagle) and aquatic mammals (mink, river otter). The analysis uses a food 4.3.99 The addition of this factor did not significantly alter the acute and chronic web model (Arnot & Gobas, 2004) to estimate the concentration in food RQs when the peak EECs were used (Table F2, Appendix F). However, items in various aquatic trophic levels, using the 60 day average when the 56 day mean EEC was used chronic LOCs, no longer exceeded the concentrations derived from PRZM/EXAMS modelling as the water LOC (RQ range: 0.03 – 0.68). exposure concentration. The model has the following stages: Monte Carlo simulation (10000 trials) was used to predict the range 4.3.100 USEPA (2002) used RQs to assess the risk to birds (and mammals). Only (mean, standard deviation and 90 percentile) of body residues, BCF the results of the analysis are presented and the conclusion is that even a and BAF values at each trophic level. The analysis showed that single application of 1.14 kg/ha will give rise to a concentration on short endosulfan body residues are not predicted to increase across aquatic grass that will lead to a risk that could be mitigated by restricted use. The trophic levels when lipid-normalised; report stresses there is uncertainty in this conclusion due to lack of data on interception and subsequent dissipation from leaves. However, the analysis The derived body residue concentrations were applied to estimate the was for parent endosulfan only and, as mentioned above, the sulphate exposure through food of the birds and mammals mentioned metabolite may be similarly toxic. The TER derived from multiple previously; applications (3 x 1.14 kg/ha at 7-day intervals) indicates acute risks that may Exposure through water intake is added to estimate the total dietary be mitigated through restricted use and chronic risks. exposure; 4.3.101 Health Canada performed a similar analysis and estimated that passerines of Acute and chronic toxicity data for tested bird species (northern the size of sparrows may be at risk because it would take 0.2-1 hours bobwhite quail and mallard) were normalised by bodyweight; consumption of food from an area contaminated with endosulfan to reach Risk quotients for both dose-based (μg endosulfan/kg-bw/day) and the acute oral NOEL. Chronic risks are expected for birds the size of dietary-based (μg pesticide/day) exposure were calculated with LOCs mallard following repeat applications at a rate of 800 g a.i./ha. specified as 0.1 (acute toxicity) and 1.0 (chronic toxicity). Endosulfan Reassessment – Application June 2008 Page 93 of 244 Page 94 of 244 June 2008 Endosulfan Reassessment – Application 4.3.107 The analysis resulted in exceedence of the acute LOC at the 90th percentile 4.3.110 The Agency has not undertaken a risk assessment for birds feeding on exposure concentration using a dose-based analysis but not a diet-based earthworms. analysis, for belted kingfisher (and mink, and river otter). Chronic exposures were all less than the LOC, reflecting the relative differences of Conclusion to environmental risk assessment acute LD50/chronic NOEC compared to the acute/chronic LOC. 4.3.111 The Agency concludes: 4.3.108 The relevance of this analysis to New Zealand is summarised as follows: There is a high acute and chronic risk to aquatic species (fish and The aquatic exposure concentrations used in the USEPA (2007c) analysis used a range of 0.1–5.0 μg/l compared to the Agency derived invertebrates) from all current uses of endosulfan in New Zealand. values of about 4.0 μg/l. This conclusion is based on lower sensitivity environmental exposure modelling. The Agency converted the results of the bird analyses to relevant New Zealand species using bodyweights and diet of New Zealand species Exposure of non-target areas, including the aquatic environment, can as listed in Heather & Robertson (1996), and the food residues and be reduced by the use of buffer zones. Such buffer zones would need algorithms given in USEPA, 2007c. This analysis is shown in to be substantial, possibly extending over 100 metres. Appendix F. The results of this analysis are set out in Table 28. There is a risk to earthworms when endosulfan is used in accordance with label uses. Runoff from use could lead to risks to earthworms Table 28: Risk assessment for birds feeding on aquatic organisms and soil arthropods outside the application area. Endosulfan is used to Residue in Risk Quotient control earthworm populations under specific circumstances including diet items use on sports fields and grass areas at airports. (from Acute Chronic Bird USEPA, Dose Dietary Dietary Laboratory data suggests that endosulfan is toxic to bees and other Diet modelled weight (g) Species Typical food 2007c) non-target terrestrial invertebrates. There is uncertainty as to whether Piscivorous fish 550 White-faced Fish, frogs, 90 0.069 0.0013 0.034 such effects occur in the field. heron (male) tadpoles, percentile aquatic and There is no indication of risks to plants. pasture insects, spiders, There may be a risk to birds feeding in fields where crops have been earthworms and mice recently treated. There is an acute risk to birds associated with the use of endosulfan on turf. Piscivorous fish 1100 Australasian Fish, aquatic 90 0.11 0.0040 0.11 Crested Grebe inverts percentile The risk to water birds is low. Using a conservative model there is Piscivorous 1100 Australasian Fish, aquatic 90 0.10 0.0038 0.10 some risk to large water birds which feed exclusively on piscivorous fish, benthic Crested Grebe inverts percentile fish. invertebrates (75:25) 4.3.112 No assessment can be made of the risk to marine mammals (seals, dolphins) Piscivorous fish 1100 Australasian Fish, aquatic Mean 0.043 0.0016 0.043 due to an absence of New Zealand-based data. However, contamination of Crested Grebe inverts remote regions through long-range movement of endosulfan is likely based Phytoplankton 1300 Mallard (male) Aquatic 90 0.041 0.0018 0.048 on overseas monitoring. ERMA New Zealand has not considered this zooplankton, invertebrates percentile aspect of the risk of use of endosulfan as part of this reassessment. It is benthic plants more appropriate for this risk to be addressed at the international level invertebrates (34:33:33) through the Stockholm and Rotterdam Conventions. Invertebrates 600 Brown teal Invertebrates 90 0.024 0.00050 0.013 (male) percentile Assessment of human health risks 4.3.109 The risk quotients derived for New Zealand species show that, other than for a large water bird feeding exclusively on piscivorous fish, and assuming a 90 percentile residue concentration based on US use patterns, the risk to Introduction aquatic birds would not exceed the LOC (0.1 for acute, 1.0 for chronic). 4.3.113 Human health risks occur as a result of the inherent toxicity of the substance The risk is therefore considered low. and exposure to the substance in various scenarios. For the lifecycle of endosulfan, the activities and associated sources of risk have been identified in Table 14. Endosulfan Reassessment – Application June 2008 Page 95 of 244 Page 96 of 244 June 2008 Endosulfan Reassessment – Application 4.3.114 The risks to consumers exposed to endosulfan residues in food have not 4.3.122 The NOAEL/LOAELs are usually derived from short or medium term been considered by the Agency in this reassessment, as dietary exposures animal studies with the appropriate uncertainty factors and are designed to and risks are evaluated by the New Zealand Food Safety Authority under protect against repeat exposure over several months. NOAEL/LOAELs the Food Act 1981. with lower uncertainties may be preferred. 4.3.115 Potentially significant risks to human health might arise from accidents 4.3.123 As New Zealand endosulfan formulation labels do not specify the frequency during importation, transportation or storage. However, the likelihood of of use during the growing season, the Agency has noted that the information such accidents is deemed to be highly improbable, and the first response to supplied which indicates one or two applications per year. However, such accidents is likely to be by facility staff and/or emergency personnel spraying contractors may be exposed intermittently over the whole spraying trained in the containment and disposal of hazardous substances. season. Therefore the AOEL has been based on studies of short (1-30 days) to intermediate (1-6 months) duration. 4.3.116 Risks associated with the disposal stage of the lifecycle were also assessed as being very low on the basis that responsible disposal of empty containers 4.3.124 Relevant NOAEL/LOAELs from the endosulfan toxicology data packages or un-used product by the user (agri- or horticulturalists; turf consultants considered by the Agency are as follows: etc) will occur. These users are required to hold Approved Handler and ® Dietary developmental neurotoxicity (DNT) study in rats (Gilmore et GROWSAFE certificates that cover safe use and disposal. The empty al., 2006 in Cal DPR, 2008) drums can be returned through one of 52 District Council approved “Agrecovery” recycling sites. LOAEL = 3.74, based on decreased pup weight; NOAEL not established. 4.3.117 Conversely, the probability of possible exposure during normal agricultural Uncertainty factors: 10x interspecies; 10x intraspecies; 3x use is relatively high, and the risks have been estimated for various LOAEL NOAEL. occupational activities (during mixing/loading and application, and post- application) and bystanders/residents in different scenarios (at application 100% oral absorption factor [US EPA used 100%; Cal DPR and post-application), and are described in the following sections. used 100%]. AOEL = 0.012 mg/kg b.w./day [using uncertainty factors of Scenarios evaluated: 300]. 4.3.118 Use patterns are discussed in detail in Section 3. In the human health risk 21-day inhalation toxicity study in rats (Hollander et al., 1984 in Cal assessment risks from the following uses are evaluated: DPR, 2008) Label use: 0.7 kg a.i./ha, using boom sprayer with hydraulic nozzles; NOEL = 0.2 mg/kg b w/day, LOAEL = 0.002 mg/L, based on decreased body weight gain and alterations in haematology and Turf use: 2.1 kg a.i./ha, using boom sprayer with hydraulic nozzles; clinical chemical parameters. Citrus use: 1.3 kg a.i./ha, using an airblast sprayer; Uncertainty factors: 10x interspecies; 10x intraspecies. Application by hand-held sprayer: 0.7 kg a.i./ha using a hand-held 100% inhalation dose to absorbed dose. [US EPA used 100%; sprayer with hydraulic nozzles. Cal DPR used 100%]. AOEL = 0.002 mg/kg b.w./day [using uncertainty factors of Acceptable Operator Exposure Level (AOEL): 100]. 4.3.119 Occupational exposures are compared against a health benchmark, the 21-day dermal toxicity rat study (Ebert, Leist & Kramer, 1985 in Cal Acceptable Operator Exposure Level (AOEL), to give an estimate of risk. DPR, 2008) 4.3.120 The AOEL is based on the most sensitive, relevant NOAEL or LOAEL, in NOAEL = 9 mg/kg b w/day, LOAEL = 27 mg/kg b w/day based terms of duration, target population, and dose/exposure route available for on mortality. the substance. Uncertainty factors: 10x interspecies; 10x intraspecies. 4.3.121 Factors are applied to modify the NOAEL/LOAEL to account for the 0.5% dermal absorption for concentrates i.e. mixing/loading, uncertainties in extrapolating from test species to humans, and to account 1.52% for spraying. [US EPA used 45%; PMRA, 47%; Cal for any differences in duration, route etc. DPR, 47.3%]. AOEL = 0.0045 mg/kg b.w./day [using uncertainty factors of 100, and a dermal absorption factor of 0.5%]. Endosulfan Reassessment – Application June 2008 Page 97 of 244 Page 98 of 244 June 2008 Endosulfan Reassessment – Application [Note: a previous 21-day dermal toxicity rat study (Ebert, AOEL = 0.0057 mg/kg b.w./day [using uncertainty factors of Weigand & Kramer, 1985 in Cal DPR, 2008) gave NOAEL = 12 100]. mg/kg b w/day, LOAEL = 48 mg/kg b w/day based on mortality, but was repeated due to technical problems.] [Also 4.3.125 The Agency concludes the DNT study used by US EPA incurs additional see Thevenaz, et al., 1988 in Cal DPR, 2008 using a 33.3% EC uncertainty, as no NOAEL was established, whilst the dermal studies formulation.] involve uncertainty around dermal absorption factors, as expressed by the lack of an international consensus. The 21-day inhalation study (Hollander 13-week dietary study in rats (Barnard et al., 1985 in Cal DPR, 2008) et al., 1984 in Cal DPR, 2008) was considered to be of too short duration to NOEL = 1.92 mg/kg b w/day, LOAEL = 3.85 mg/kg b w/day adequately cover possible seasonal exposures. increases in kidney weights and granular formation in kidney proximal tubule cells. 4.3.126 Among the dietary studies, referred to above, the 13 week study of Barnard et al (1985 in Cal DPR, 2008) is robust in comparison to other available Uncertainty factors: 10x interspecies; 10x intraspecies. values, duration of the study (seasonal), and target population (male and 100% oral absorption factor [US EPA used 100%; Cal DPR female workers). Therefore the Agency has used the NOAEL of 1.92 mg/kg used 100%]. b w/day from the 13-week dietary study in rats (Barnard et al., 1985 in Cal DPR, 2008) as the relevant benchmark for occupational exposures of AOEL = 0.019 mg/kg b.w./day [using uncertainty factors of 100]. workers on short-term and seasonal basis. 2-generation dietary study in rat (Edwards et al., 1984 in Cal DPR, 4.3.127 As the AOEL is a measure of total systemic exposure or absorbed dose, an 2008) oral absorption factor is required to extrapolate from a NOAEL derived from an oral animal study. A 100% oral absorption factor seems to be the NOEL = 1.18 mg/kg b w/day, LOAEL = 6.18 mg/kg bw day based on increased relative liver and kidney weights, decreased most robust on available evidence and has been used by US EPA and Cal food consumption & decreased body weights. DPR. Uncertainty factors: 10x interspecies; 10x intraspecies. 4.3.128 The Agency’s use of the NOAEL of 1.92 mg/kg b w /day from the 13-week dietary study in rats (Barnard et al., 1985 in Cal DPR 2008) incurs the 100% oral absorption factor [US EPA used 100%; Cal DPR used 100%]. minimum level of uncertainty for an animal model to estimate an absorbed dose: uncertainty factors of 10 and 10 to account for intra- and interspecies AOEL = 0.012 mg/kg b.w./day [using uncertainty factors of variation, with no correction factor for oral absorption since it is considered 100] to be 100%: Combined chronic/carcinogenicity study in rats (Ruckman et al., 1989 in Cal DPR, 2008) AOEL = (1.92 mg/kg bw/day) = 0.0192 mg/kg b.w./day NOEL = 0.6 mg/kg b w/day, LOAEL = 2.9 mg/kg b w/day based on reduced body weight gain, increased incidences of (10 x 10) marked progressive glomerulonephrosis and blood vessel aneurysms in male rats. 4.3.129 Overseas regulators have used other studies to set their occupational Uncertainty factors: 10x interspecies; 10x intraspecies. benchmarks. [Note: The BBA occupational exposure model out-puts total 100% oral absorption factor [US EPA used 100%; Cal DPR systemic exposure, which can be compared against the AOEL. However, used 100%]. the US models keep the exposures separated by route and are compared to route specific NOAELs, and the Margin of Exposure (MOE, equivalent to AOEL = 0.006 mg/kg b.w./day [using uncertainty factors of the Risk Quotient (RQ)) incorporate any uncertainty factors]: 100]. 1-year dietary dog study (Brunk, 1989 in Cal DPR, 2008) USEPA (2007) has argued that the DNT LOAEL is the most suitable short-term and intermediate benchmark for assessing dermal NOEL = 0.57 mg/kg b w/day, LOAEL = 2.09 mg/kg b w/day exposures and ingestion, as this value is protective of the most based on premature deaths (not spontaneous), neurotoxicity. sensitive population (young women), plus testing through gestation Uncertainty factors: 10x interspecies; 10x intraspecies. and lactation. An additional factor of 3 was used to account for using 100% oral absorption factor [US EPA used 100%; Cal DPR an LOAEL instead of an NOAEL. used 100%]. Endosulfan Reassessment – Application June 2008 Page 99 of 244 Page 100 of 244 June 2008 Endosulfan Reassessment – Application “Previously, two available 21-day dermal toxicity rat studies Critical Subchronic (seasonal) Oral NOEL (used for dermal were the basis of quantifying dermal risk. The dermal NOAEL MOE) was 1.18 mg/kg/day (Edwards et al., 1984; 2-generation was 12 mg/kg/day with a LOAEL of 48 mg/kg/day based on dietary study in rat). Two studies were considered acceptable mortality. However, the results of the recently submitted DNT according to FIFRA Guidelines (13-week dietary study in rats, shows concern for offspring toxicity (decreased pre-weaning Barnard et al., 1985; 2-generation dietary study in rat, Edwards body weight) which is not evaluated in the 21-day dermal study et al., 1984), the reproduction study is preferable because it (conducted in adult animals only). Additionally, the DNT was provides the lower NOEL. Therefore, the reproduction study in examined to address the concern for changes in the uterine and rat was selected as the definitive study. pituitary weights that were seen in adults at the highest dose Critical Subchronic (seasonal) Inhalation NOEL was 0.194 only (6.2 mg/kg/day) in the two-generation reproduction study. mg/kg/day (Hollander et al., 1984; rat subchronic inhalation The use of an offspring endpoint from the DNT study (LOAEL = study). 3.7 mg/kg/day) is the most appropriate endpoint in order to be protective of the most sensitive population (female workers). For Cal DPR, the DNT study removes a data gap that caused them to This decision is supported by the pup weight decrements being use a 3x factor in their Food Quality Protection Act (FQPA) risk observed only during lactation (i.e., the pup body weights were assessment calculations. They did not consider, in contrast to the US not affected at birth AND the pups recovered after post-weaning EPA, that it represented the key study for short-term and intermediate (PND 22)) and therefore are likely due to nursing. Furthermore, assessment of dermal exposures and ingestion. the 2-generation reproduction study (MRID 00148264) noted a Health Canada PMRA: similar effect (decrease litter weight) during the lactation to weaning period in both matings in the F0 generation, which was Short- and intermediate-term dermal exposure. An overall significant at the high dose (6.18 mg/kg) level in the first mating NOAEL of 3 mg/kg bw/day from several repeat-dose (21–28- and at the mid (1.23 mg/kg) and high dose (6.18 mg/kg) levels in day) dermal toxicity study in rats was selected, based on spasms the second mating. Since a NOAEL was not established in the and tremors at 4 mg/kg bw/day and mortality in female rats at DNT, a LOAEL to NOAEL factor is necessary for the dermal 12 mg/kg bw/day. The target margin of exposure (MOE) is 300; assessment. Based on the degree of pup weight loss in the DNT 10-fold for interspecies and 10-fold for intraspecies variations, and pup weight loss in the 2-generation reproduction study, a with an additional safety factor of 3-fold for potential sensitivity 3X is most appropriate. The dermal absorption factor of 45% in the young and the lack of a developmental neurotoxicity remains consistent with the 2002 assessment” [quote US EPA, study in rats. Because a dermal NOAEL was selected, a dermal 2007]. absorption factor is not required for route-to-route extrapolation. As US EPA use different NOAELs for dermal and inhalation Inhalation exposure scenarios. The NOAEL of 0.2 mg/kg exposures of each time duration, a NOAEL of 0.2 mg/kg bw/day from bw/day from a 21-day rat inhalation study was chosen for all a 21-day rat inhalation study was chosen for short- and seasonal- inhalation exposure scenarios, based on decreased body-weight inhalation exposure scenarios. gain and reduced leucocyte counts at 0.4 mg/kg bw/day. The target MOE is 300, 10-fold for interspecies and 10-fold for APVMA: For OHS risk assessment the 13-week dietary study in rats intraspecies variations and an additional 3-fold for potential (Barnard et al., 1985) is considered relevant to compare total systemic sensitivity in the young and the lack of a developmental exposure as endosulfan is used on a seasonal basis. The toxicology neurotoxicity study in rats. There was no apparent increase in review concluded the NOEL to be 1.92 mg/kg b w/day LOEL = 3.85 toxicity with duration; therefore, an additional safety factor to mg/kg b w/day [APVMA, 1998]. This key study was kept for the account for use of a short-term study to extrapolate to a longer 2005 re-assessment [APVMA, Vol2 2005 OHS]. term scenario was not required. Cal DPR: Use different NOAELs for dermal and inhalation exposures. All Agencies accepted NOAELs from the 1-year dietary dog study Critical Acute Oral NOEL (used for dermal MOE (Brunk, 1989; NOAEL = 0.57 mg/kg/day) and from the combined determination) = 0.7 mg/kg (Rabbit Developmental study (Nye, chronic/carcinogenicity study in rats (Barnard et al., 1985; NOEL = 1981): salivation, convulsions/thrashing, noisy/rapid breathing, 0.6 mg/kg/day) for long-term (life time) dietary and dermal exposures. hyperactivity salivation and nasal discharge). The inter-agency comparison is set out in the following table: Critical acute Inhalation NOEL was 0.194 mg/kg/day (Hollander et al., 1984; rat subchronic inhalation study). Table 29: NOAEL/LOAEL used by Agency and overseas regulators to estimate AOEL Comparison of critical NOAEL/LOAEL used for occupational Endosulfan Reassessment – Application June 2008 Page 101 of 244 Page 102 of 244 June 2008 Endosulfan Reassessment – Application exposure health benchmarks (mg/kg b.w./day) 4.3.134 To estimate risks to users and workers entering the sprayed areas post- Intermediate Long-term application, exposures are predicted under likely use patterns, taking into Short-term (Seasonal, (Annual, consideration the time worked, use of mitigation (personal protective Agency Acute (1–30 Days) 1–6 Months) >6 Months) equipment, PPE), and for post-application, any time before re-entry. APVMA (1998) Oral NOEL = 1.92 Oral NOEL = 1.92 4.3.135 Estimated exposures based on models are compared to relevant health PMRA (2007) Dermal NOAEL = Dermal NOAEL = 3 Oral NOEL = 0.6 3 hazard benchmarks (AOELs) derived above that have been derived from Inhalation NOEL = Inhalation NOEL = appropriate NOAEL described in the toxicology data package on the Inhalation NOEL = 0.2 0.2 0.2 substance. The NOAELs are selected to match the duration of exposure (acute for intermittent daily exposure or subchronic for seasonal exposures), US EPA (2007) Oral NOAEL = 1.5 Oral LOAEL = 3.7 Oral LOAEL = 3.7 Oral NOEL = 0.6 the target adult population, and route of exposure (dermal or inhalation). Inhalation NOEL = [Inhalation NOEL = Inhalation - no risk Factors are applied to the NOAELs to account for the uncertainties involved 0.2 0.2] in extrapolating data derived from animal test models to humans. A Cal DPR (2008) Oral NOEAL = 0.7 Oral NOEL = 0.7 Oral NOEL = 1.18 Oral NOEL = 0.57 NOAEL of less uncertainty may be preferred over another that appears a Inhalation NOEL = Inhalation NOEL = Inhalation NOEL = Inhalation NOEL = better match, for example in terms of duration, but has greater uncertainties. 0.194 0.194 0.194 0.0194 ERMA (2008) Oral LOAEL = Oral LOAEL = 1.92 1.92 Exposure of operators to spray: 4.3.136 For occupational situations the main routes of exposure are assumed to be through the skin (dermal) or by inhalation. Ingestion of pesticide is not Conclusion on AOEL: considered in occupational estimates, as it should not occur in a trained 4.3.130 The Agency derived an AOEL of 0.0192 mg/kg b.w./day based on the work force. NOAEL of 1.92 mg/kg/day from the 13-week dietary study in rats (Barnard et al., 1985). 4.3.137 The BBA model calculates total systemic exposure or the total absorbed dose from both routes. The default assumption is that 100% of the inhaled material is absorbed, and for endosulfan this default value is used. Conclusion on ADE: However, estimation of dermal absorption (skin penetration) is more 4.3.131 The Agency bases its Acceptable Daily Exposure (ADE) of 0.006 mg/kg complex and, indeed, overseas jurisdictions have applied different dermal b.w./day based on the NOAEL of 0.6 mg/kg/day from the 1-year dietary dog absorption factors for endosulfan. study (Brunk, 1989) and from the combined chronic/carcinogenicity study in rats (Barnard et al., 1985). 4.3.138 The Agency notes that all four recent risk assessments for endosulfan (APVMA, 2005; US EPA, 2002 & 2007; PMRA, 2007; and Cal DPR, 2008) appear to use the same in-vivo rat studies as the basis for their dermal Occupational Exposure and Risk absorption factors. The US EPA (2007), PMRA (2007) and Cal DPR (2008) 4.3.132 The work activities for which exposure is estimated are mixing, loading derived dermal absorption factors of 45%, 47% and 47.3% based on the (usually grouped) and application. Exposure of workers entering the spray studies of endosulfan penetration through rat skin of Craine, 1986 and 1988 area after application, for example, to weed the crop (post-application or re- [as quoted in US EPA (2007) and Cal DPR (2008)]. Also, the APVMA , entry activities), are also estimated. also using Craine, 1986 and 1988 [as quoted in APVMA (1998 & 2005)] derived dermal absorption factors for rat skin of 46% for diluted spray mix 4.3.133 As the Agency has no actual exposure data measured in the field under New and 20% for concentrate. Zealand conditions, operator (mixer/loader/applicator) exposures are “In the second rat study (Craine, 1988), radiolabelled endosulfan in an EC estimated using the United Kingdom Pesticide Safety Directorate’s (UK formulation was applied to the skin (10.8 cm2) of female rats (mean bw 18 PSD) interpretation of the German BBA Model. The derived values 240 g) at 0.09, 0.98 and 10.98 mg/kg (equal to 22, 235, 2640 g/animal or consider both dermal and inhalation exposure routes using the geometric 2.0, 22, 244 g/cm2). The test compound was then washed off after 10 hours. mean model. Animals were sacrificed at 24, 48, 72 hours or 7 days after the dose application to determine absorption and distribution of endosulfan. Mean recovery of radiolabel ranged between 96 – 108%. Initial absorption into the skin was related inversely to dose, with skin washings removing 30, 45 18 2 Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products. Biologische and 66% of the applied radiolabel at 2, 22 and 244 g/cm , respectively. 2 Bundesanstalt für Land- und Forstwirtschaft, Bundesgesundheitsamt, und Industrieverband Agrar e.V. Movement through the skin was slow. In the 2, 22 and 244 g/cm groups ISBN 3489-27700-7. 1992; http://www.pesticides.gov.uk/index.htm. Endosulfan Reassessment – Application June 2008 Page 103 of 244 Page 104 of 244 June 2008 Endosulfan Reassessment – Application respectively, penetration of radiolabel reached 22, 16 and 4% of the applied pers. comm. 2008). However, according to a draft protocol for deriving dose by 24 hours, when 41, 39 and 33% of applied radiolabel was still dermal absorption factors currently being adopted by US EPA, PMRA and bound to the skin. At 48 hours, penetration of radiolabel had attained 35, 36 Cal DPR, the available in vitro studies would not be adequate to elaborate a and 11% in the three respective groups. Penetration attained 45, 46 and human absorption factor from the rat data (Sheryl Beauvais pers. comm. 20% by 7 days, by which time only 1 – 2% of the dose remained bound to 2008). the skin.” (APVMA Vol2, 2005) 4.3.144 After obtaining a copy of Davies, 2002, the Agency had this reviewed by 4.3.139 The Agency concurs that the in vivo rat dermal absorption data appears Dr M Edwards PhD of Toxicology Consulting Limited. Dr Edwards’ report sound, and that available data indicates that concentrated material is is attached as confidential Appendix K. In the light of Dr Edwards’ report, relatively less well absorbed through the skin than spray mixes and that, the Agency concluded that the Davies 2002 study does not provide a firm human skin is less permeable to endosulfan than rat skin. basis for using a greatly reduced figure for the proportion of endosulfan 4.3.140 The APVMA used in vitro study data (Noctor and John, 1995 as quoted in absorption in humans, for the following reasons: APVMA, 1998 and Davies, 2002 as quoted in APVMA, 2005) that The study does not include results for other test substances of similar compared the rates of endosulfan penetration though rat and human skin lipophilicity to endosulfan. samples. The data from Davies (2002) was applied to the in vivo rat dermal The source of human skin used in the experiment is not given, which absorption factors (Craine 1998) to derive dermal absorption factors for raises questions around the relevance for persons exposed. humans of 0.5% for concentrates i.e. mixing/loading, and 1.52% for spraying and re-entry activities used in the 2005 APVMA OHS risk The comparison of data for the absorption of endosulfan in rats in assessment. vitro (based on Davies, 2002) and in vivo (based on Craine, 1998) shows a marked difference, which calls into question the validity of “From further consideration of these submitted studies …………., it is the in vitro results. apparent that endosulfan is less well absorbed across rat skin in vivo The study assumes that endosulfan retained on the epidermis should than in vitro. Under identical experimental conditions, human not be included as absorbed material, in contrast to the OECD epidermis is at least 30-fold less permeable to endosulfan than rat guidelines on this issue (OECD, 2004), although the Agency notes epidermis. that this does not appear to greatly change the outcome. In light of these new findings the previous worker exposure estimates Therefore, the Agency used 46% as the proportion of endosulfan in diluted where dermal absorption figures were derived from animal spray that would be absorbed from exposed skin and 20% for the endosulfan experimentation results and applied to human exposure scenarios concentrate which is based on Craine. were revisited. A dermal absorption factor of 0.5% for concentrates i.e. mixing/loading, and 1.52% for spraying and re-entry activities has Activity Scenarios been used in the OHS risk assessment.” (APVMA Vol2, 2005) 4.3.145 In all scenarios, exposure to a liquid, 350 g a.i./l formulation, by a 70 kg 4.3.141 Derivation of the dermal absorption factors values is described: operator with dermal absorption of 20% for concentrates (mixing/loading), and 46% for spraying is modelled: “Consistent with the EC Guidance Document on Dermal Absorption, factors for endosulfan can be calculated by adjusting the rat in vivo absorption values by the ratio of the human to the rat in vitro absorption. The dermal absorption factor for concentrate exposure will be 20% x 0.025 = 0.50%, while the factor for exposure to spray mixture will be 46% x 0.033 = 1.52%.” (APVMA Vol2, 2005) [Where 20% and 46% were the penetration rates through rat skin for the concentrate and spray mix; and, 0.025 and 0.033 express the difference in penetration rate between rat and human skin.] 4.3.142 The Agency considered whether or not to follow the same approach as the APVMA and noted that the US EPA had not taken this approach. 4.3.143 Whilst the US EPA was aware of the study by Noctor and John, 1995 (US EPA, 2002), the study by Davies (2002) does appear not to have been available to them or the Cal DPR for their assessments (Sheryl Beauvais Endosulfan Reassessment – Application June 2008 Page 105 of 244 Page 106 of 244 June 2008 Endosulfan Reassessment – Application Table 30: Scenarios considered in the operator risk assessment Table 31: Operator exposure estimates Application Occupational Exposure Estimates a Rate Scenario (1): Endosulfan 350 EC at maximum label rate Scenario Equipment (g a.i./ha) Work rate (ha/day)* tractor mounted/trailed boom sprayer: hydraulic nozzles 1 Label use 700 20 Dermal Inhalation Total operator Tractor mounted/trailed boom sprayer: absorbed absorbed dose exposure c 2 Turf hydraulic nozzles 2100 dose (mg/day) (mg/kg (off-label) (mg/day) b b.w./day)d 3 Citrus Boom sprayer: air-assisted sprayer (air-blast) 1300 8 Mixing/loading: A1P2 + gloves 0.067 e 0.00017 e 0.0089 (off-label) f f Application: A1P2 + hood/visor + overalls + boots 0.555 0.00028 4 Hand-held (off- Hand-held sprayer: hydraulic nozzles, 700 1 + gloves label) outdoors high level target Mixing/loading: FFP2SL or P2 + gloves 0.067 0.00042 0.0089 5 Greenhouse Remote trolley sprayers or low-volume 700 (semi-) automated Application: FFP2SL or P2 + hood/visor + overalls 0.555 0.00028 misters + boots + gloves * In all scenarios the default value for the German BBA model is used in the absence of specific work rate Mixing/loading: A1P2 + gloves 0.067 0.00017 0.011 data in the New Zealand context. Application: A1P2 + hat + overalls + boots + 0.69 0.00028 gloves 4.3.146 For the first of the four activities, 11 levels of PPE are considered, and 6 for the remaining three. Note that the greenhouse application is by remote or Mixing/loading: FFP2SL or P2 + gloves 0.067 0.00042 0.011 automated sprayers so that workers are normally involved only in mixing Application: FFP2SL or P2 + hat + overalls + 0.694 0.00028 boots + gloves and loading at rates already modelled in scenario 1. Mixing/loading: gloves 0.067 0.0084 0.0093 Operator exposure Application: hood/visor + overalls + boots + 0.559 0.014 gloves 4.3.147 As can be seen in Table 31 below, in scenario 1 (Endosulfan 350 EC at Mixing/loading: gloves 0.067 0.0084 0.012 maximum label rate), gloves at mixing/loading and application make a large Application: hat + overalls + boots + gloves 0.733 0.014 impact on estimated exposures, as does adding overalls, boots and head gear. The improvement in using a hood and visor over a broad-rimmed hat Mixing/loading: gloves 0.067 0.0084 0.15 is less marked in terms of estimated exposures, but may be significant for Application: gloves 10.7 0.014 eye protection and comfort. Mixing/loading: no PPE 6.7 0.0084 0.25 Application: gloves 10.7 0.014 4.3.148 The use of A1P2 respirators, instead of no RPE during mixing/loading Mixing/loading: A1P2 + gloves 0.067 0.00017 0.19 appears to have little impact on the calculated absorbed dose of endosulfan. Application: no PPE 13.1 0.014 However, the A1P2 should be protective where solvent vapours result from the other excipients. Mixing/loading: gloves 0.067 0.0084 0.19 Application: no PPE 13.1 0.014 4.3.149 The use of A1P2 respirators instead of FFP2SL or P2 has little impact on Mixing/loading: no PPE 6.7 0.0084 0.28 the calculated inhalation absorbed dose of endosulfan. However, the A1P2 Application: no PPE 13.1 0.014 should be more protective where solvent vapours result from the other a UK PSD interpretation of the German BBA Model – geometric mean excipients. b Assumes 20% dermal absorption for concentrates i.e. mixing/loading, 46% for spraying c Assumes 100% inhalation absorption d Assumes 70kg body weight, mixing/loading/application e Mixing/Loading f Application Endosulfan Reassessment – Application June 2008 Page 107 of 244 Page 108 of 244 June 2008 Endosulfan Reassessment – Application a Occupational Exposure Estimates a UK PSD interpretation of the German BBA Model – geometric mean b Scenario (2): Endosulfan 350 EC on turf at 2.1kg a.i./ha Assumes 20% dermal absorption for concentrates i.e. mixing/loading, 46% for spraying tractor mounted/trailed boom sprayer: hydraulic nozzles c Assumes 100% inhalation absorption Dermal absorbed Inhalation Total operator d Assumes 70kg body weight, mixing/loading/application dose absorbed dose exposure e (mg/day) b (mg/day) c (mg/kg b.w./day)d Mixing/Loading f Mixing/loading: A1P2 + gloves 0.202 e 0.0005 e 0.027 Application f f Application: A1P2 + hood/visor + 1.7 0.0008 overalls + boots + gloves a Mixing/loading: gloves 0.202 0.025 0.028 Occupational Exposure Estimates Application: hood/visor + overalls 1.7 0.042 Scenario (4): Endosulfan 350 EC off-label at 0.7kg a.i./ha + boots + gloves Hand-held; hydraulic nozzles; outdoors, high level target Mixing/loading: gloves 0.202 0.025 0.46 Dermal Inhalation Total operator absorbed dose absorbed dose exposure Application: gloves 32.2 0.042 (mg/day) b (mg/day) c (mg/kg b.w./day)d Mixing/loading: no PPE 20.2 0.025 0.75 Mixing/loading: A1P2 + gloves 0.287 e 0.0007 e 0.011 f f Application: gloves 32.2 0.042 Application: A1P2 + hood/visor + 0.50 0.0042 Mixing/loading: gloves 0.202 0.025 0.57 overalls + boots + gloves Application: no PPE 39.4 0.042 Mixing/loading: gloves 0.287 0.035 0.015 0.514 0.21 Mixing/loading: no PPE 20.2 0.025 0.85 Application: hood/visor + overalls + boots + gloves Application: no PPE 39.4 0.042 a Mixing/loading: gloves 0.287 0.035 0.15 UK PSD interpretation of the German BBA Model – geometric mean 9.6 0.21 b Assumes 20% dermal absorption for concentrates i.e. mixing/loading, 46% for spraying Application: gloves c Assumes 100% inhalation absorption Mixing/loading: no PPE 28.7 0.035 0.55 d Assumes 70kg body weight, mixing/loading/application Application: gloves 9.6 0.21 e Mixing/Loading Mixing/loading: gloves 0.287 0.035 0.19 f Application Application: no PPE 13.0 0.21 Mixing/loading: no PPE 28.7 0.035 0.60 Occupational Exposure Estimates a Application: no PPE 13.0 0.21 Scenario (3): Endosulfan 350 EC on citrus at 1.3kg a.i./ha a UK PSD interpretation of the German BBA Model – geometric mean tractor mounted/trailed boom sprayer: air-assisted sprayer b Assumes 20% dermal absorption for concentrates i.e. mixing/loading, 46% for spraying Dermal absorbed Inhalation Total operator c Assumes 100% inhalation absorption dose absorbed dose exposure (mg/day) b (mg/day) c (mg/kg b.w./day)d d Assumes 70kg body weight, mixing/loading/application Mixing/loading: A1P2 + gloves 0.050 e 0.00013 e 0.038 e Mixing/Loading f f f Application: A1P2 + hood/visor + 2.6 0.0038 Application overalls + boots + gloves Mixing/loading: gloves 0.050 0.0063 0.041 4.3.150 Comparison of exposure estimates between reviews carried out by other Application: hood/visor + overalls + 2.6 0.19 boots + gloves agencies has not been performed due to the different models employed, the inclusion/exclusion of measured data, the PPE requirements in each Mixing/loading: gloves 0.050 0.0063 0.75 jurisdiction, and the use patterns/label claims in each case. Application: gloves 52.2 0.19 Mixing/loading: no PPE 5.04 0.0063 0.82 Application: gloves 52.2 0.19 Mixing/loading: gloves 0.050 0.0063 0.80 Application: no PPE 55.6 0.19 Mixing/loading: no PPE 5.04 0.0063 0.87 Application: no PPE 55.6 0.19 Endosulfan Reassessment – Application June 2008 Page 109 of 244 Page 110 of 244 June 2008 Endosulfan Reassessment – Application Risk Quotients: 4.3.151 To assess occupational risks the Agency has divided the estimated exposure Risk Quotient (RQ) and Acceptable Operator Exposure Level (AOEL) values by the AOEL to derive a risk quotient (RQ) for each exposure Scenario (2): Endosulfan 350 EC on turf at 2.1kg a.i./ha scenario. Total operator exposure AOEL (mg/kg b.w./day) a (mg/kg b.w./day) b RQ c RQ = Estimated Occupational Exposure Gloves at mixing / loading 0.027 0.0192 1.4 AOEL +A1P2 resp+gloves+ hood/visor+overalls+ boots at application A RQ>1 indicates the likelihood of a high risk to those exposed. The results Gloves at mixing / loading 0.028 1.5 for each scenario are set out in Table 32 below. +Gloves+ hood/visor + overalls + boots at Table 32: Results of operator risk assessment application Risk Quotient (RQ) and Acceptable Operator Exposure Level (AOEL) Gloves at mixing / loading 0.46 24 Scenario (1): Endosulfan 350 EC at maximum label rate / application Total operator AOEL Gloves at application 0.75 39 exposure (mg/kg Gloves at mixing / loading 0.57 30 (mg/kg b.w./day) a b.w./day) b RQ c No PPE 0.85 44 Gloves at mixing / loading +A1P2 resp+gloves+ 0.0089 0.0192 0.46 hood/visor+overalls+ boots at application a UK PSD interpretation of the German BBA Model – geometric mean Gloves at mixing / loading +Gloves+ 0.0093 0.48 b From NOAEL = 1.92 mg/kg b w/day (13-week dietary study in rats; Barnard et al., 1985); uncertainty hood/visor+overalls +boots at application factors 10x & 10x; 100% oral absorption factor Gloves at mixing / loading / application 0.15 8 c RQ = Total Estimated Occupational Exposure / AOEL Gloves at application 0.25 13 d RQ > 1 indicates the likelihood of an unacceptable risk to those exposed Gloves at mixing / loading 0.19 10 No PPE 0.28 15 Risk Quotient (RQ) and Acceptable Operator Exposure Level (AOEL) a UK PSD interpretation of the German BBA Model – geometric mean Scenario (3): Endosulfan 350 EC on citrus at 1.3kg a.i./ha b From NOAEL = 1.92 mg/kg b w/day (13-week dietary study in rats; Barnard et al., 1985); uncertainty factors 10x & 10x; 100% oral absorption factor Total operator exposure AOEL (mg/kg b.w./day) a (mg/kg b.w./day) b RQ c c RQ = Total Estimated Occupational Exposure / AOEL d Gloves at mixing / loading 0.038 0.0192 2 RQ > 1 indicates the likelihood of an unacceptable risk to those exposed +A1P2 resp+gloves+ hood/visor+overalls+ boots at application Gloves at mixing / loading 0.041 2 +Gloves+ hood/visor + overalls +boots at application Gloves at mixing / loading 0.75 39 / application Gloves at application 0.82 43 Gloves at mixing / loading 0.80 42 No PPE 0.87 45 a UK PSD interpretation of the German BBA Model – geometric mean b From NOAEL = 1.92 mg/kg b w/day (13-week dietary study in rats; Barnard et al., 1985); uncertainty factors 10x & 10x; 100% oral absorption factor c RQ = Total Estimated Occupational Exposure / AOEL d RQ > 1 indicates the likelihood of an unacceptable risk to those exposed Endosulfan Reassessment – Application June 2008 Page 111 of 244 Page 112 of 244 June 2008 Endosulfan Reassessment – Application exposure (for a certain activity) depends on the amount of residue on Risk Quotient (RQ) and Acceptable Operator Exposure Level (AOEL) foliage, the intensity of contact with the foliage and the duration of contact. Scenario (4): Endosulfan 350 EC at maximum label rate – handheld Similarly, the dermal route is also expected to be the significant route of exposure for members of the public entering treated crops (for example, for Total operator exposure AOEL pick-your-own). (mg/kg b.w./day) a (mg/kg b.w./day) b RQ c Gloves at mixing / loading 0.011 0.0192 0.57 4.3.156 Inhalation exposure may potentially occur from residual vapour and +A1P2 resp+gloves+ airborne aerosols. Movement of the crop may also result in inhalation hood/visor+overalls+ exposure to aerosol/vapour as well as dust during re-entry activities. For boots at application outdoor situations there will be more rapid dissipation of vapour and Gloves at mixing / loading 0.015 0.78 aerosols, leading to lower inhalation potential than from indoor treatments, +Gloves+ hood/visor +overalls +boots at such as those made to protected crops grown in glasshouses. application 4.3.157 Most re-entry activities are not expected to result in pesticide exposure Gloves at mixing / loading 0.15 8 / application throughout the year, as endosulfan is not applied all year in all crops, and Gloves at application 0.55 29 many activities are performed only seasonally. Gloves at mixing / loading 0.19 10 4.3.158 For re-entry exposure the extent of dermal absorption has been assessed by No PPE 0.60 31 APVMA (2005) to be closely similar to that which has been estimated for a UK PSD interpretation of the German BBA Model – geometric mean endosulfan in diluted spray mixture, rather than the extent of absorption b From NOAEL = 1.92 mg/kg b w/day (13-week dietary study in rats; Barnard et al., 1985); uncertainty from exposure to concentrated formulations. Noting this view, the Agency factors 10x & 10x; 100% oral absorption factor has applied a dermal absorption factor of 46% for re-entry exposure c RQ = Total Estimated Occupational Exposure / AOEL assessment. d RQ > 1 indicates the likelihood of an unacceptable risk to those exposed 4.3.159 The Agency has used the UK PSD Guidance for Post-Application (Re-Entry Worker) Exposure Assessment (2008a) to model exposures for some New 19 Conclusions on Risk Quotient (RQ) and Occupational Exposure Estimates for Zealand activities. Mixer/Loaders and Applicators: 4.3.152 Only in scenarios 1 and 4 where full PPE is used (gloves at mixing/loading Dermal Exposures: + gloves + hood/visor + overalls + boots at application) with or without Dislodgeable foliar residue (DFR) respirators (A1P2), were the calculated Risk Quotients (RQ) less than 1. The RQs for ground-boom applications and air-blast applications to citrus 4.3.160 The amount of residue on foliage depends on several factors, for example, were unacceptable even with full PPE. the application rate, targeting and retention of spray, crop type and the amount of foliage (leaf area index). Moreover, dissipation of residues on 4.3.153 Gloves should be used for mixing/loading for greenhouse applications crop foliage over time depends on the physical and chemical properties of (Total Mixer/Loader Exposure = 0.0011mg/kg bw/day; RQ = 0.06), where the applied active substance as well as on environmental conditions. Where applications are done remotely using automated systems. experimentally determined dislodgeable foliar residue data are not available, a worse case assessment of the initial DFR (DFR0), in a first tier assessment, assumes 3 micrograms of active substance/square centimetre of Occupational post-application or re-entry worker exposures foliage/per kg a.s. applied/hectare (UK PSD, 2008a). 4.3.154 The routes of exposure during post-application activities are analogous to Transfer coefficient (TC) those for the operator, i.e. dermal and inhalation. However, the sources are different: foliage, soil and dust may contribute as treated surfaces cause 4.3.161 The transfer of residues from the plant surface to the clothes or skin of the pesticide residues to be transferred to the skin. Oral exposure may also worker can be regarded as more or less independent of the kind of product occur as a consequence of dermal exposure, i.e. through hand to mouth applied and the level of exposure will depend on the intensity and duration activities, but is usually ignored except for children. of contact with the foliage. This is also determined by the nature and duration of the activity during re-entry. Therefore, it is possible to group 4.3.155 Most maintenance activities include frequent contact with the foliage of the crop. Therefore, dermal exposure is considered to be the most important 19 exposure route during these re-entry activities. The amount of resulting http://www.pesticides.gov.uk/approvals.asp?id=2422&link=%2Fuploadedfiles%2FWeb%5 FAssets%2FPSD%2FRe%2Dentry%2520worker%2520guidance%5Ffinal%2520version%2Epdf Endosulfan Reassessment – Application June 2008 Page 113 of 244 Page 114 of 244 June 2008 Endosulfan Reassessment – Application various crop habitats and re-entry activities. The EUROPOEM Group Re-entry scenarios recommended the following indicative TC values for potential dermal Re-entry by a worker to hand-harvest citrus: dermal exposure exposure for four different harvesting scenarios. These TC values assume harvesting is performed with bare hands and dermal exposure to the body is 4.3.171 Assuming an application of 375 ml endosulfan 350 EC in 100 litres water reduced ten fold by clothing worn by the worker. (1.30 mg/ml) that may be applied twice, therefore the maximum total dose is 2.6 kg a.s./ha. 4.3.172 This estimate assumes no dissipation of residues between treatments. 4.3.173 A working day of 8 hours is assumed to account for hand-harvesting. 4.3.174 For the transfer of residues from foliage to the clothes or skin of a worker, a TC value of 4500 cm2/hr is used for hand-harvesting citrus, as recommended by the EUROPOEM Group. 4.3.162 For other re-entry scenarios, TC data may be extrapolated where the scenarios are considered to be comparable, i.e. the intensity and duration of 4.3.175 A DFR value of 3 g/cm2 per kg as/ha applied is assumed. contact with the foliage is similar (UK PSD, 2008a). 4.3.176 Predicted exposure for this scenario based on the PSD equation (by adding a factor for dermal exposure and dividing by the worker’s body weight) gives: Inhalation Exposures: 4.3.163 Although in many cases inhalation exposure will be less significant for the D = DFR x TC x % absorbed x WR x AR x P / BW exposure assessment than dermal exposure, the EUROPOEM Group have proposed task-specific factors that may be used for the first tier of an Where: exposure assessment relating to harvesting ornamentals and to the re-entry of greenhouses approximately 8-16 hours after treatment. Inhalation D = Dermal Exposure [ g a.s./person*d] exposure for this re-entry scenario may be predicted from the following DFR = Dislodgeable Foliar Residue per kg a.s./ha = 3.0 g a.s./cm² per kg model (algorithm) (UK PSD, 2008a): a.s./ha TC = Transfer Coefficient [cm²/person/h] = 4500 [cm²/person/h] mg a.s./hr inhaled = kg/a.s./ha applied x Task Specific Factor % absorbed = percentage dermal absorption (46%) WR = Work Rate [8 hours/day] 4.3.168 The indicative Task Specific Factors proposed for the first tier of the AR = Application Rate [2.6 kg a.s./ha] exposure assessment are: P = clothing such as a long sleeved shirt is taken into account 0.1 for cutting ornamentals; BW = bodyweight (60 kg) 0.01 for sorting and bundling of ornamentals; D = 3 x 4500 x 0.46 x 8 x 2.6 x 1 0.03 for re-entering greenhouses after low-volume-mist application; 60 0.15 for re-entering greenhouses after roof fogger application. 4.3.177 Dermal Exposure (D) is 2153 g a.s./kg bw/day or 2.153 mg a.s./kg bw/day. 4.3.169 This approach may be used for non-volatile pesticides, where levels of This is equivalent to an estimated RQ of >10. inhalation exposure (vapour and dust) would be expected to be low in comparison with dermal exposure (UK PSD, 2008a). Re-entry by a worker to hand-harvest berries: dermal exposure 4.3.170 The New Zealand representative re-entry activities modelled are: 4.3.178 Assuming an application of 200 ml endosulfan 350 EC in 100 litres water (0.70 mg/ml) that may be applied twice, therefore the maximum total dose hand-harvesting citrus: dermal exposure; is 1.4 kg a.s./ha. hand-harvesting berries: dermal exposure; 4.3.179 This estimate assumes no dissipation of residues between treatments. cutting ornamentals: dermal and inhalation exposures; and, 4.3.180 A working day of 8 hours is assumed to account for hand-harvesting. hand-harvesting greenhouse tomatoes: dermal and inhalation exposures. Endosulfan Reassessment – Application June 2008 Page 115 of 244 Page 116 of 244 June 2008 Endosulfan Reassessment – Application 4.3.181 For the transfer of residues from foliage to the clothes or skin of a worker, a 4.3.190 Predicted exposure for this scenario is thus: TC value of 3000 cm2/hr is used for hand-harvesting berries, as D = DFR x TC x % absorbed x WR x AR x P / BW recommended by the EUROPOEM Group. Note that for hand-harvesting vegetables a lower TC value of 2500 cm2/hr is recommended by the EUROPOEM Group (UK PSD, 2008a). Where: D = Dermal Exposure [ g a.s./person*d] 4.3.182 A DFR value of 3 g/cm2 per kg as/ha applied is assumed. DFR = Dislodgeable Foliar Residue per kg a.s./ha = 3.0 g a.s./cm² per kg a.s./ha 4.3.183 Predicted exposure for this scenario is thus (using different TC value and application rates from those above for citrus): TC = Transfer Coefficient [cm²/person/h] = 5000 [cm²/person/h] % absorbed = percentage dermal absorption (46%) D = DFR x TC x % absorbed x WR x AR x P / BW WR = Work Rate [8 hours/day] AR = Application Rate [1.4 kg a.s./ha] Where: P = clothing such as a long sleeved shirt is taken into account D = Dermal Exposure [ g a.s./person*d] BW = bodyweight (60 kg) DFR = Dislodgeable Foliar Residue per kg a.s./ha = 3.0 g a.s./cm² per kg D = 3 x 5000 x 0.46 x 8 x 1.4 x 1 a.s./ha 60 TC = Transfer Coefficient [cm²/person/h] = 3000 [cm²/person/h] % absorbed = percentage dermal absorption (46%) 4.3.191 Dermal Exposure (D) is 1288 g a.s./kg bw/day or 1.288 mg a.s./kg bw/day. WR = Work Rate [8 hours/day] This is equivalent to an estimated RQ of >10. AR = Application Rate [1.4 kg a.s./ha] P = clothing such as a long sleeved shirt is taken into account Re-entry by a worker to cut ornamentals: inhalation exposure BW = bodyweight (60 kg) 4.3.192 Assuming an application of 200 ml endosulfan 350 EC in 100 litres water D = 3 x 3000 x 0.46 x 8 x 1.4 x 1 (0.70 mg/ml) that may be applied twice, but this estimate assumes 60 dissipation of residues between treatments. Predicted exposure is calculated thus: 4.3.184 Dermal Exposure (D) is 773 g a.s./kg bw/day or 0.773 mg a.s./kg bw/day. This is equivalent to an estimated RQ of >10. mg a.s./hr inhaled = kg/a.s./ha applied x Task Specific Factor Re-entry by a worker to cut ornamentals: dermal exposure Where: 4.3.185 Assuming an application of 200 ml endosulfan 350 EC in 100 litres water indicative Task Specific Factors = 0.1 for cutting ornamentals; (0.70 mg/ml) that may be applied twice, therefore the maximum total dose WR = Work Rate [8 hours/day] is 1.4 kg a.s./ha. AR = Application Rate [0.7 kg a.s./ha] 4.3.186 This estimate assumes no dissipation of residues between treatments. BW = bodyweight (60 kg) 4.3.187 A working day of 8 hours is assumed to account for hand-harvesting. mg a.s./hr inhaled = 0.7 x 0.1 = 0.07 mg a.s./hr 4.3.188 For the transfer of residues from foliage to the clothes or skin of a worker, a Inhalation Exposure (I) = mg a.s./hr inhaled x WR / BW TC value of 5000 cm2/hr is used for cutting, sorting, bundling or carrying ornamentals, as recommended by the EUROPOEM Group (UK PSD, I = (0.07 x 8) / 60 = 0.0093 mg/kg bw/day 2008a). 4.3.193 Inhalation Exposure (I) is 0.0093 mg a.s./kg bw/day. This is equivalent to 4.3.189 A DFR value of 3 g/cm2 per kg as/ha applied is assumed. 49% of the AOEL of 0.0192 mg/kg bw/day. The combined dermal and inhalation exposure gives an RQ of >10. Endosulfan Reassessment – Application June 2008 Page 117 of 244 Page 118 of 244 June 2008 Endosulfan Reassessment – Application Re-entry by a worker to hand-harvest greenhouse tomatoes: dermal exposure indicative Task Specific Factors = 0.15 after roof fogger application; 4.3.194 Assuming an application of 200 ml endosulfan 350 EC in 100 litres water WR = Work Rate [8 hours/day] (0.70 mg/ml) that may be applied twice, therefore the maximum total dose AR = Application Rate [0.7 kg a.s./ha] is 1.4 kg a.s./ha. BW = bodyweight (60 kg) 4.3.195 This estimate assumes no dissipation of residues between treatments. mg a.s./hr inhaled = 0.7 x 0.15 = 0.105 mg a.s./hr 4.3.196 A working day of 8 hours is assumed to account for hand-harvesting. Inhalation Exposure (I) = mg a.s./hr inhaled x WR / BW 4.3.197 For the transfer of residues from foliage to the clothes or skin of a worker, a I = (1.05 x 8) / 60 = 0.014 mg/kg bw/day TC value of 5000 cm2/hr is used for cutting, sorting, bundling or carrying ornamentals, as recommended by the EUROPOEM Group (UK PSD, 2008a). 4.3.202 Inhalation Exposure (I) is 0.014 mg a.s./kg bw/day. This is equivalent to 73% of the AOEL of 0.0192 mg/kg bw/day. The combined dermal and 4.3.198 A DFR value of 3 g/cm2 per kg as/ha applied is assumed. inhalation exposure gives an RQ of >10. 4.3.199 Predicted exposure for this scenario is thus: Summary of re-entry worker exposures in some representative activities: D = DFR x TC x % absorbed x WR x AR x P / BW Table 33: Re-entry worker exposures Where: Re-entry worker exposure estimates compared to AOELa D = Dermal Exposure [ g a.s./person*d] Estimated Exposure Predicted RQ (mg/kg bw/day) DFR = Dislodgeable Foliar Residue per kg a.s./ha = 3.0 g a.s./cm² per kg b a.s./ha Hand-harvesting citrus : 2.153 >10 dermal exposure TC = Transfer Coefficient [cm²/person/h] = 5000 [cm²/person/h] Hand-harvest berries c: 0.773 >10 % absorbed = percentage dermal absorption (46%) dermal exposure WR = Work Rate [8 hours/day] Cutting ornamentals d: 1.288 >10 dermal exposure AR = Application Rate [1.4 kg a.s./ha] inhalation exposure 0.0093 0.49 P = clothing such as a long sleeved shirt is taken into account Hand-harvesting greenhouse 1.288 >10 BW = bodyweight (60 kg) tomatoes e: dermal exposure 0.014 0.73 inhalation exposure D = 3 x 5000 x 0.46 x 8 x 1.4 x 1 a 60 AOEL = 0.0192 mg/kg bw/day b field application rate, 1.3 kg a.i./ha x 2 applications c field application rate, 0.7 kg a.i./ha x 2 applications 4.3.200 Dermal Exposure (D) is 1288 g a.s./kg bw/day or 1.288 mg a.s./kg bw/day. d field application rate, 0.7 kg a.i./ha x 2 applications: but only single rate considered for inhalation This is equivalent to an estimated RQ of >10. exposure e field application rate, 0.7 kg a.i./ha x 2 applications: but only single rate considered for inhalation Re-entry by a worker to hand-harvest greenhouse crops: inhalation exposure after exposure roof fogger application. 4.3.201 Assuming an application of 200 ml endosulfan 350 EC in 100 litres water Conclusions on re-entry worker exposure estimates in some representative New (0.70 mg/ml) that may be applied twice, but this estimate assumes Zealand activities: dissipation of residues between treatments. Re-entry of greenhouses is 4.3.203 Re-entry worker exposure estimates for some representative New Zealand assumed to be approximately 8-16 hours after treatment. occupational activities were modelled using the UK PSD Guidance for Post- mg a.s./hr inhaled = kg/a.s./ha applied x Task Specific Factor Application (Re-Entry Worker) Exposure Assessment (2008a). 4.3.204 In each scenario the estimated dermal exposures exceeded the AOEL. Where: Endosulfan Reassessment – Application June 2008 Page 119 of 244 Page 120 of 244 June 2008 Endosulfan Reassessment – Application 4.3.205 The models did assume re-entry as soon as the spray had dried; no applications have been reported by Lloyd and Bell, 1983 and Lloyd et al, dissipation of residues between treatments; the largest Task Specific 1987 [in UK PSD 2008b]. Factors; and, the UK PSD default values. The Agency does not currently have the information necessary to refine these exposure estimates. Broadcast air assisted and knapsack sprayers – orchard application 4.3.212 For orchard sprayer applications the average potential dermal exposure Bystander exposure (PDE) for a bystander, positioned 8 metres downwind from the sprayer and the average amount of spray passing through the breathing zone were 3.7 ml Introduction spray/person and 0.002 ml spray/person. 4.3.206 The main potential source of exposure to the general public (bystander or “Allowing for a realistic headland of 5m within the orchard, for resident) from endosulfan (other than via food residues) is via spray drift. machinery to operate within, at the boundary of a neighbouring area Bystander exposures would be intermittent in comparison to exposure of the level of fallout (from early season applications when leaves are workers, who are handling the pesticide throughout the application. In not present) could be equivalent to about 20% of the field rate. The addition, spray densities, and hence exposure levels drop off with distance level of deposit would decline away from the orchard boundary to just from spraying operations. over 5% at 10 metres4. An estimate of the average level of fallout over the whole area from the boundary to 10 metres would be about 10%. 4.3.207 The Agency notes that any potential bystanders will not be directly handling This would give a deposit of about 1 g/cm2/kg applied/ha. Later the substance, and they will not be wearing PPE. season fall out levels, would be lower as a result of the crop canopy. 4.3.208 No New Zealand monitoring studies of airborne endosulfan at application {4 Rautmann, D; Streloke, M, Winkler, R, (2001): New basic drift values in the authorisation sites are available to estimate possible public exposure. procedure for plant protection products. In Forster, R.; Streloke, M. Workshop on Risk Assessment and Risk Mitigation Measures in the Context of the Authorization of Plant 20 Protection Products (WORMM). Mitt.Biol.Bundesanst.Land-Forstwirtsch. Berlin-Dahlem, 4.3.209 UK PSD Bystander Exposure Guidance Document (2008b ) gives models Heft 381.} [in UK PSD 2008b]” for estimating bystander exposure in three circumstances: 4.3.213 Using these data total systemic exposure from spray drift at the time of Exposure from spray drift at the time of application; application can be estimated as follows for broadcast air assisted and Exposure from inhalation of pesticide which volatilises from the crop knapsack sprayers – Orchard application: or soil surface after the application has been made; and Exposure through contact with spray drift contaminated surfaces. Systemic exposure = (PDE x SC x % absorbed + PIE x SC x 100%)/BW 4.3.210 The Agency has applied these models to three potential New Zealand use Where: patterns: PDE = potential dermal exposure (ml spray) Broadcast air assisted and knapsack sprayers – Orchard application: to PIE = potential inhalation exposure (ml spray) simulate use in citrus (noting that any knapsack sprayer use is likely to produce no worse exposure than that predicted for air-blast SC = concentration of active substance in spray (1.30 mg a.s./ml spray) application); % absorbed = percentage dermal absorption (46%) Field crop (boom) sprayers: to simulate turf application; and, BW = bodyweight (60 kg) Field crop (boom) sprayers: to simulate label uses: (3.7 x 1.30 x 0.46) + (0.002 x 1.30 x 1.00) = 0.037 mg/kg bw/day 60 Exposure from spray drift at the time of application 4.3.211 The levels of spray drift deposited on the body of a bystander/ resident and 4.3.214 Assuming an application of 375 ml endosulfan 350 EC in 100 litres water that which may be in the breathing zone can be estimated. From this the (1.30 mg/ml), no protection from clothing and 100% inhalation, retention amount of active substance available for dermal absorption and which may and absorption of potential inhalation exposure (PIE), the estimated be inhaled can be calculated. It should be assumed that no action is taken to bystander exposure is 0.037 mg/kg bw. This is equivalent to an RQ of 1.92 avoid or control exposure and that little clothing is worn. Measurements of bystander exposure during UK field crop spraying and orchard spraying 4.3.215 This estimate of exposure for applications from broadcast air assisted sprayers is expected to represent a worse case for equivalent applications of 20 http://www.pesticides.gov.uk/approvals.asp?id=2428&link=%2Fuploadedfiles%2FWeb%5 endosulfan 350 EC using knapsack sprayers. FAssets%2FPSD%2FBystander%2520exposure%2520guidance%5Ffinal%2520version%2Epdf Endosulfan Reassessment – Application June 2008 Page 121 of 244 Page 122 of 244 June 2008 Endosulfan Reassessment – Application Field crop (boom) sprayers: to simulate turf application SC = concentration of active substance in spray (0.7 mg a.s./ml spray) 4.3.216 For boom sprayers the average potential dermal exposure (PDE) for a % absorbed = percentage dermal absorption (46%) bystander, positioned 8 metres downwind from the sprayer and the average BW = bodyweight (60 kg) amount of spray passing through the breathing zone were 0.1 ml spray/person and 0.006 ml spray/person, respectively. (0.1 x 0.7 x 0.46) + (0.01 x 0.7) = 0.0007 mg/kg bw/day 60 “An estimate of bystander exposure has been made by this evaluation, based on a published UK study (Lloyd and Bell, 1983) in which 4.3.220 Assuming an application of 600 ml endosulfan 350 EC in 100 litres water measurements of simulated bystander exposure were made during (0.7 mg/ml), no protection from clothing and 100% inhalation, retention and field crop spraying operations. The average potential dermal absorption of PIE, the estimated bystander exposure is 0.0007 mg/kg bw. exposure for a bystander, positioned 8 metres downwind from the This is equivalent to 3.4% of the AOEL of 0.0192 mg/kg bw/day. sprayer and the average estimated amount of spray passing through the breathing zone were 0.1 and 0.006 ml spray/person, respectively. Using these data total systemic exposure can be estimated as follows: Exposure from inhalation of pesticide which volatilises from the crop or soil surface [UK PSD 2008b]” after the application has been made 4.3.221 The potential exists for longer term exposure to pesticide vapour which may 4.3.217 Using these data total systemic exposure from spray drift at the time of occur after the plant protection product has been applied, for example application can be estimated as follows for field crop (boom) sprayers – turf residents who live adjacent to an area that has been treated with a plant application: protection product and who might be in this location for 24 hours per day. A Systemic exposure = (PDE x SC x % absorbed + PIE x SC x 100%)/BW large number of non-UK studies have been published which report the monitoring of outdoor air concentrations of pesticides after they have been applied to crops. From these studies the highest 24 hour time weighted Where: average concentration in air for orchard sprayers (and a 21 hour time PDE = potential dermal exposure (ml spray) weighted average value for boom sprayer applications) have been PIE = potential inhalation exposure (ml spray) determined. These values may be used generically [UK PSD 2008b]. SC = concentration of active substance in spray (2.10 mg a.s./ml spray) Broadcast air assisted and knapsack sprayers – orchard application % absorbed = percentage dermal absorption (46%) BW = bodyweight (60 kg) 4.3.222 Indicative exposures for adults and children to endosulfan vapour post- application following applications of endosulfan 350 EC made via broadcast (0.1 x 2.10 x 0.46) + (0.01 x 2.10) = 0.002 mg/kg bw/day air assisted sprayers is predicted using a surrogate value for residues in air 60 adjacent to treated crops from Californian Environmental Protection Agency studies. Monitoring of chlorpyrifos residues in air over 72 hours adjacent to a 24 ha orange orchard provided a highest time weighted average estimate 4.3.218 Assuming an application of 600 ml endosulfan 350 EC in 100 litres water of 15 g/m3/24h during application using air assisted sprayers. Time (2.10 mg/ml), no protection from clothing and 100% inhalation, retention weighted average estimates for each of the 24 hour periods monitored were and absorption of PIE, the estimated bystander exposure is 0.002 mg/kg bw. of 13, 15 and 4.9 g/m3/24h. The meteorological conditions recorded This is equivalent to 10% of the AOEL of 0.0192 mg/kg bw/day. during the chlorpyrifos study included wind speeds up to 20 km/h during Field crop (boom) sprayers: to simulate label uses application (the application was stopped on the first day of application due to rising wind speeds) and temperatures up to 42°C. These data are expected 4.3.219 Using these data total systemic exposure from spray drift at the time of to represent a worse case for endosulfan as chlorpyrifos (vapour pressure 2.3 application can be estimated as follows for field crop (boom) sprayers – x 10-3 Pa at 25 °C) is a more volatile compound than endosulfan which has label uses: a lower vapour pressure ( endosulfan = 1.05 x 10-3 Pa ; endosulfan = 1.38 x 10-4 Pa). Systemic exposure = (PDE x SC x % absorbed + PIE x SC x 100%)/BW 4.3.223 An adult weighing 60 kg and a 3-5 year old child weighing 15 kg,21 22 Where: breathing 15.2 and 8.3 m3/day, respectively, of air containing 15 PDE = potential dermal exposure (ml spray) 21 PIE = potential inhalation exposure (ml spray) Adults 60 kg is the 50th percentile for UK 16-24 yrs females, children 15 kg is the average values for UK 2 and 3 yrs males and females: 1995-7 Health Surveys for England. Endosulfan Reassessment – Application June 2008 Page 123 of 244 Page 124 of 244 June 2008 Endosulfan Reassessment – Application g/m3/24h would potentially be exposed to 0.0038 and 0.0083 mg/kg potentially be exposed to 0.000253 and 0.0006 mg/kg bw/day. The highest bw/day. Whilst the children’s indicative exposure is below the AOEL (43% of these is 3% of the AOEL (0.0192 mg/kg bw/day for endosulfan). of 0.0192 mg/kg bw/day), in view of the differences in volatility between chlorpyrifos and endosulfan this exposure model is expected to over Exposure through contact with spray drift contaminated surfaces estimate air residues of endosulfan post-application. It is also noted that the “It is possible that spray drift fallout from applications may be 15 g/m3/24h TWA value was the highest of the three concurrent 24 hour deposited in private gardens adjacent to treated areas, and periods monitored and repeated exposure would not be expected at these air individuals in such locations may become exposed through contact levels. with such deposits. A possible scenario that illustrates a significant Field crop (boom) sprayers: to simulate turf application opportunity for exposure would be children playing in a garden which has been subject to spray drift fallout. It is possible to estimate such “For applications made using field crop (boom) sprayers, exposure to exposures using spray drift fallout values used for aquatic risk vapour post application is predicted from studies conducted in assessment purposes (Rautmann et al, 2001) and the approach used Germany, where lindane (vapour pressure = 5.6 x 10-3 Pa at 25 C), by the United States Environmental Protection Agency to estimate parathion (1.3 x 10-3 Pa at 25 C) and pirimicarb (4 x 10-3 Pa at 25 residential exposure from contact with treated lawns (USA EPA 1998 C) were applied in field trials to provide measurements of residues in / 1999 / 2001). The exposure assessment reported … considers the air adjacent to treated crops (Siebers et al 2000). Each active scenario of a small child playing on a lawn … substance was applied at the same rate (g a.s./ha) and in the same water volume. Applications were achieved using field crop sprayers For products which may be applied to crops on more than one fitted with 12 metre booms. Monitoring of residues in air over 21 occasion the theoretical worse case is to consider children’s exposure hours, 10 metres downwind of treated barley plots, provided 21 hour from the maximum total dose which may be applied, i.e. to assume time weighted air concentrations of 0.29 and 0.58 g/m3 (lindane), that there is no dissipation in foliar residues between successive 0.07 and 0.12 g/m3 (parathion) and <0.02 and 0.04 g/m3 treatments. This approach may be refined where data are available to (pirimicarb). The meteorological conditions during the trial included refine the estimated residues.” [quoted from UK PSD 2008b] wind speeds of up to 23.4 km/h and temperatures up to 28°C. The study authors report wind speeds in the second trial (Trial B) were 4.3.226 The small child playing on a lawn leads to three potential exposures: dermal significantly higher (2 to 3X) than in the first trial (Trial A) and this is (skin contact); hand-to-mouth (sucking contacted fingers and thumbs); and, expected to have contributed to the variability of these results. It is object-to-mouth (eating/sucking soil, grass etc.). noted that the higher 21 hour TWA value for each active substance was determined from Trial B.” [quote from UK PSD 2008b] Broadcast air assisted and knapsack sprayers – orchard application 4.3.224 In view of the small size of this data set (2 trials for each of the three active Children’s dermal exposure substances) a precautionary approach is to use a value of 1 g/m3 to predict 4.3.227 Systemic exposures via the dermal route were calculated using the above bystander exposure from vapour after application of the spray [UK PSD drift fallout values and the following equation for broadcast air assisted and 2008b]. An adult weighing 60 kg and a 3-5 year old child weighing 15 kg, knapsack sprayers – orchard application: breathing 15.2 and 8.3 m3/day, respectively, of air containing this residue level, would potentially be exposed to 0.000253 and 0.0006 bw/day. The SE(d) = AR x DF x TTR x TC x H x DA highest of these is 3% of the AOEL (0.0192 mg/kg bw/day for endosulfan). BW -3 [Note: endosulfan vapour pressure: endosulfan = 1.05 x 10 Pa ; SE(d) = 26 x 0.10 x 0.05 x 5200 x 2 x 0.46 = 41.5 g/kg bw -4 endosulfan = 1.38 x 10 Pa] 15 Field crop (boom) sprayers: to simulate label uses Where: 4.3.225 Noting the same limited data set is used: SE(d) = systemic exposure via the dermal route An adult weighing 60 kg and a 3-5 year old child weighing 15 kg, breathing AR = field application rate, 1.3 kg/ha x 2 applications = 26 g/cm2 15.2 and 8.3 m3/day, respectively, of air containing this residue level, would DF = drift fallout value, i.e. assumed average of 10% from broadcast air assisted sprayer applications TTR = turf transferable residues – the EPA default value of 5% was used in 22 the estimate Long term inhalation rates (mean values) for adult males (19-65 + yrs) for children 3-5 yrs: US EPA Exposure Factors Hand Book.}[UK PSD 2008b]. Endosulfan Reassessment – Application June 2008 Page 125 of 244 Page 126 of 244 June 2008 Endosulfan Reassessment – Application TC = transfer coefficient – the standard EPA value of 5200 cm2/h was used Children’s object-to-mouth exposure for the estimate 4.3.229 Object to mouth exposures were calculated using turf transferable residue H = exposure duration for a typical day (hours) – this has been assumed to levels using the following equation for broadcast air assisted and knapsack be 2 hours which matches the 75th percentile for toddlers playing on grass sprayers – orchard application: in the EPA Exposure Factors Handbook DA = percent dermal absorption (46%) SE(o) = AR x DF x TTR x IgR BW = body weight - 15kg which is the average of UK 1995-7 Health BW Surveys for England values for males and females of 2 and 3 yrs SE(o) = 26 x 0.10 x 0.20 x 25 = 0.87 g/kg bw 15 Children’s hand-to-mouth exposure 4.3.228 Hand-to-mouth exposures were calculated using turf transferable residue levels using the following equation for broadcast air assisted and knapsack Where: sprayers – orchard application: SE(o) = systemic exposure via mouthing activity AR = field application rate, 1.3 kg/ha x 2 applications = 26 g/cm2 SE(h) = AR x DF x TTR x SE x SA x Freq x H DF = drift fallout value, i.e. assumed average of 10% from broadcast air BW assisted sprayer applications TTR = turf transferable residues the default value of 20% transferability SE(h) = 26 x 0.10 x 0.05 x 0.50 x 20 x 20 x 2 = 3.47 g/kg bw from object to mouth assessments was used 15 IgR = ingestion rate for mouthing grass/day – this was assumed to be 2 of grass/day Where: equivalent to 25cm BW = body weight – 15kg which is the average of UK 1995–7 Health SE(h) = systemic exposure via the hand-to-mouth route 2 Surveys for England values for males and females of 2 and 3 yrs. AR = field application rate, 1.3 kg/ha x 2 applications = 26 g/cm DF = drift fallout value, i.e. assumed average of 10% from broadcast air assisted sprayer applications Children’s total exposure from broadcast air assisted and knapsack sprayers – TTR = turf transferable residues – the EPA default value of 5% derived orchard application from transferability studies with wet hands was used in the estimate 4.3.230 Children’s total exposure was estimated as the sum of the dermal, hand-to- SE = saliva extraction factor – the default value of 50% was used mouth, and object to mouth exposures, which was 0.0458 mg/kg bw/day SA = surface area of the hands – the assumption used here is that 20 cm2 of (45.84 g/kg bw/d). This total exposure represents 239% of the AOEL skin area is contacted each time a child puts a hand in his or her mouth (this (0.0192 mg/kg bw/day). is equivalent to the palmar surface of three figures and is also related to the next parameter) Freq = frequency of hand to mouth events/hour – for short term exposures Field crop (boom) sprayers: to simulate turf application the value of 20 events/hours is used, this is the 90th percentile of Children’s dermal exposure observations that ranges from 0 to 70 events/hour H = exposure duration (hours) – this has been assumed to be 2 hours which 4.3.231 Systemic exposures via the dermal route were calculated using the above matches the 75th percentile for toddlers playing on grass in the EPA drift fallout values and the following equation for field crop (boom) sprayers Exposure Factors Handbook – turf application: BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys for England values for males and females of 2 and 3 yrs SE(d) = AR x DF x TTR x TC x H x DA BW SE(d) = 21 x 0.01 x 0.05 x 5200 x 2 x 0.46 = 3.35 g/kg bw 15 Endosulfan Reassessment – Application June 2008 Page 127 of 244 Page 128 of 244 June 2008 Endosulfan Reassessment – Application Where: H = exposure duration (hours) – this has been assumed to be 2 hours which SE(d) = systemic exposure via the dermal route matches the 75th percentile for toddlers playing on grass in the EPA 2 Exposure Factors Handbook AR = field application rate, 2.10 kg/ha x 1 applications = 21 g/cm BW = body weight - 15kg which is the average of UK 1995-7 Health DF = drift fallout value, i.e. assumed average of 1% from field crop (boom) Surveys for England values for males and females of 2 and 3 yrs sprayer applications TTR = turf transferable residues – the EPA default value of 5% was used in the estimate Children’s object-to-mouth exposure TC = transfer coefficient – the standard EPA value of 5200 cm2/h was used for the estimate 4.3.233 Object to mouth exposures were calculated using turf transferable residue levels using the following equation for field crop (boom) sprayers – turf H = exposure duration for a typical day (hours) – this has been assumed to application: be 2 hours which matches the 75th percentile for toddlers playing on grass in the EPA Exposure Factors Handbook DA = percent dermal absorption (46%) SE(o) = AR x DF x TTR x IgR BW BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys for England values for males and females of 2 and 3 yrs SE(o) = 21 x 0.01 x 0.20 x 25 = 0.07 g/kg bw 15 Children’s hand-to-mouth exposure 4.3.232 Hand-to-mouth exposures were calculated using turf transferable residue Where: levels using the following equation for field crop (boom) sprayers – turf application: SE(o) = systemic exposure via mouthing activity 2 AR = field application rate, 2.10 kg/ha x 1 applications = 21 g/cm SE(h) = AR x DF x TTR x SE x SA x Freq x H DF = drift fallout value, i.e. assumed average of 1% from field crop (boom) BW sprayer applications TTR = turf transferable residues the default value of 20% transferability SE(h) = 21 x 0.01 x 0.05 x 0.50 x 20 x 20 x 2 = 0.28 g/kg bw from object to mouth assessments was used 15 IgR = ingestion rate for mouthing grass/day – this was assumed to be equivalent to 25cm2 of grass/day BW = body weight - 15kg which is the average of UK 1995-7 Health Where: Surveys for England values for males and females of 2 and 3 yrs. SE(h) = systemic exposure via the hand-to-mouth route AR = field application rate, 2.10 kg/ha x 1 applications = 21 g/cm2 DF = drift fallout value, i.e. assumed average of 1% from field crop (boom) Children’s total exposure from field crop (boom) sprayers – turf application sprayer applications 4.3.234 Children’s total exposure was estimated as the sum of the dermal, hand-to- TTR = turf transferable residues – the EPA default value of 5% derived mouth, and object to mouth exposures, which was 0.0037 mg/kg bw/day from transferability studies with wet hands was used in the estimate (3.7 g/kg bw/d). This total exposure represents 19% of the AOEL (0.0192 SE = saliva extraction factor – the default value of 50% was used mg/kg bw/day). 2 SA = surface area of the hands – the assumption used here is that 20 cm of Field crop (boom) sprayers: to simulate label uses skin area is contacted each time a child puts a hand in his or her mouth (this is equivalent to the palmer surface of three figures and is also related to the Children’s dermal exposure next parameter) 4.3.235 Systemic exposures via the dermal route were calculated using the above Freq = frequency of hand to mouth events/hour – for short term exposures drift fallout values and the following equation for field crop (boom) sprayers the value of 20 events/hours is used, this is the 90th percentile of – label uses: observations that ranges from 0 to 70 events/hour SE(d) = AR x DF x TTR x TC x H x DA BW Endosulfan Reassessment – Application June 2008 Page 129 of 244 Page 130 of 244 June 2008 Endosulfan Reassessment – Application Freq = frequency of hand to mouth events/hour – for short term exposures SE(d) = 14 x 0.01 x 0.05 x 5200 x 2 x 0.46 = 2.23 g/kg bw the value of 20 events/hours is used, this is the 90th percentile of 15 observations that ranges from 0 to 70 events/hour H = exposure duration (hours) – this has been assumed to be 2 hours which Where: matches the 75th percentile for toddlers playing on grass in the EPA SE(d) = systemic exposure via the dermal route Exposure Factors Handbook AR = field application rate, 0.7 kg/ha x 2 applications = 14 g/cm2 BW = body weight - 15kg which is the average of UK 1995-7 Health DF = drift fallout value, i.e. assumed average of 1% from field crop (boom) Surveys for England values for males and females of 2 and 3 yrs sprayer applications TTR = turf transferable residues – the EPA default value of 5% was used in Children’s object-to-mouth exposure the estimate TC = transfer coefficient – the standard EPA value of 5200 cm2/h was used 4.3.237 Object to mouth exposures were calculated using turf transferable residue for the estimate levels using the following equation for field crop (boom) sprayers – label uses: H = exposure duration for a typical day (hours) – this has been assumed to be 2 hours which matches the 75th percentile for toddlers playing on grass in the EPA Exposure Factors Handbook SE(o) = AR x DF x TTR x IgR DA = percent dermal absorption (46%) BW BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys for England values for males and females of 2 and 3 yrs SE(o) = 14 x 0.01 x 0.20 x 25 = 0.05 g/kg bw 15 Children’s hand-to-mouth exposure Where: 4.3.236 Hand-to-mouth exposures were calculated using turf transferable residue SE(o) = systemic exposure via mouthing activity levels using the following equation for field crop (boom) sprayers – label 2 uses: AR = field application rate, 0.7 kg/ha x 2 applications = 14 g/cm DF = drift fallout value, i.e. assumed average of 1% from field crop (boom) sprayer applications SE(h) = AR x DF x TTR x SE x SA x Freq x H BW TTR = turf transferable residues the default value of 20% transferability from object to mouth assessments was used SE(h) = 14 x 0.01 x 0.05 x 0.50 x 20 x 20 x 2 = 0.19 g/kg bw IgR = ingestion rate for mouthing grass/day – this was assumed to be 15 equivalent to 25cm2 of grass/day BW = body weight - 15kg which is the average of UK 1995-7 Health Surveys for England values for males and females of 2 and 3 yrs. Where: SE(h) = systemic exposure via the hand-to-mouth route Children’s total exposure from field crop (boom) sprayers – label uses AR = field application rate, 0.7 kg/ha x 2 applications = 14 g/cm2 DF = drift fallout value, i.e. assumed average of 1% from field crop (boom) 4.3.238 Children’s total exposure was estimated as the sum of the dermal, hand-to- sprayer applications mouth, and object to mouth exposures, which was 0.0025 mg/kg bw/day TTR = turf transferable residues – the EPA default value of 5% derived (2.47 g/kg bw/d). This total exposure represents 13% of the AOEL from transferability studies with wet hands was used in the estimate (0.0192 mg/kg bw/day). SE = saliva extraction factor – the default value of 50% was used SA = surface area of the hands – the assumption used here is that 20 cm2 of skin area is contacted each time a child puts a hand in his or her mouth (this is equivalent to the palmer surface of three figures and is also related to the next parameter) Endosulfan Reassessment – Application June 2008 Page 131 of 244 Page 132 of 244 June 2008 Endosulfan Reassessment – Application Summary of bystander and residential risk from spray drift close (about 10 metres) from the orchard boundary which is a relatively unlikely scenario. The Agency also notes that the comparison is made with Table 34: Bystander exposure estimates the AOEL, which is the health benchmark appropriate for regular daily Bystander Exposure Estimates Compared to AOEL a exposure for about 3 months. Such a comparison is likely to overestimate Broadcast Air the risk for the bystander exposed on an occasional basis. Field crop (boom) sprayers Assisted b c d Scenario Label uses Turf application Citrus Exposure from treated sports turf Exposure from spray drift at the time of 0.0007 e 0.002 0.037 application 4.3.242 The Agency is aware that one of the current uses of endosulfan in New 3.4% 10% 192% Zealand is to suppress earthworms in sport turf, to prevent cast. Exposure from Adult (60kg) 0.000253 0.000253 0.0038 inhalation of volatilised 1.3% 1.3% 20% 4.3.243 To try and assess any risks to users from this use of endosulfan, the UK pesticide Child (15kg) 0.0006 0.0006 0.0083 PSD Bystander Exposure Guidance Document (2008b) model to estimate systemic exposures via the dermal route has been used. Several factors have 3% 3% 43% been changed from those used to estimate children’s exposures above: Exposure through Children’s dermal 2.23 3.35 41.5 contact with spray exposure f drift contaminated SE(d) = AR x DF x TTR x TC x H x DA surfaces Children’s hand-to- 0.19 0.28 3.47 mouth exposure f BW Children’s object-to- 0.05 0.07 0.87 mouth exposure f SE(d) = 21 x 1.00 x 0.05 x 43000 x 2 x 0.46 = 593.4 g/kg bw Children’s total 0.0025 0.0037 0.046 70 exposure e 13% 19% 239% a AOEL = 0.0192 mg/kg bw/day Where: b field application rate, 0.7 kg a.i./ha x 2 applications SE(d) = systemic exposure via the dermal route 2 c field application rate, 2.1 kg a.i./ha x 1 applications AR = field application rate, 2.10 kg/ha x 1 applications = 21 g/cm d field application rate, 1.3 kg a.i./ha x 2 applications DF = drift fallout value, assumed average of 100% as no loss is anticipated e from direct application (rather than from drift) mg/kg bw/day f TTR = turf transferable residues – the EPA default value of 5% was used in g/kg bw the estimate TC = transfer coefficient – the 20-minute Jazzercise activity EPA value of Conclusions on bystander and residential exposure estimates from spray drift: 43,000 cm2/h was used for the estimate (see below) 4.3.239 Table 34 above summarises bystander and residential exposure estimates. H = exposure duration for a typical day (hours) – this has been assumed to The estimated exposures from the UK PSD models for boom sprayers over be 2 hours which matches the 75th percentile for toddlers playing on grass field crops, to simulate label and turf use patterns, indicate that absorbed in the EPA Exposure Factors Handbook [Assume same for sports people] doses may reach up to 19% of the AOEL. This suggests little risk to DA = percent dermal absorption (46%) bystanders during application, to residents from volatilised residues, or to BW = body weight - 70kg default adult children playing on contacted lawns. Transfer Coefficient (TC): 4.3.240 However, the estimated exposures from the UK PSD models for broadcast air-assisted sprayers in orchards, to simulate citrus use patterns, indicate that The dermal transfer coefficient was set from Jazzercise studies of adults in contact with treated surfaces for 20 minutes, resulting in a normalised absorbed doses may reach up to 192% of the AOEL for bystanders during 2 application, and the risks to residents, particularly children from volatilised hourly dermal transfer coefficient of 43,000 cm /hr. The 20-minute residues and residues deposited on lawns etc would be high (children: Jazzercise activity represents a 1-hour activity for short-term exposure or a volatilised exposure, 43% of AOEL; plus, surface residues, 239%). 2-hour activity for intermediate-term exposure. (CARES 1.0; March 20, 2002). The 20-minute Jazzercise TC appears to be the best available data to 4.3.241 The Agency notes that the model assumptions are conservative, in that they cover New Zealand field sports, such as soccer, touch, cricket and hockey assume that the spray from two applications is cumulative in the case of when used in full for a 2 hour period. It is noted that this TC may orchard air blast spraying and that the child is exposed to the dermal, hand significantly underestimate exposures from sports such as rugby or league to mouth and object to mouth exposures for a period of 2 hours, relatively when greater ground contact is made. Endosulfan Reassessment – Application June 2008 Page 133 of 244 Page 134 of 244 June 2008 Endosulfan Reassessment – Application activities can be supplied to the Agency, the worker exposure estimates can 4.3.244 Sports person’s total exposure was estimated as 0.59 mg/kg bw/day (593.4 be refined to New Zealand use patterns. g/kg bw/d), which represents >1000% of the AOEL (0.0192 mg/kg 4.3.253 Risks to operators involved in mixing, loading and applying endosulfan for bw/day). outdoor crops (including hand-held application) in accordance with current 4.3.245 The Agency has been advised that watering-in is recommended after labelled application rates (0.7kg a.i./ha) are estimated as acceptable, applying endosulfan to sports turf, which could significantly reduce provided that adequate (PPE) is used. The required PPE includes gloves exposures: during mixing and loading; gloves, visor, hood, overalls and boots during application. “When used in turf for earthworm control, endosulfan is watered in 4.3.254 Risks to operators involved in mixing and loading within glasshouses are immediately after application by a sprinkler irrigation system acceptable provided adequate PPE is used. Risks to workers within applying 12mm of irrigation without runoff. It is therefore washed off glasshouses have not been separately modelled but are assumed to be the turf surface, minimizing the risk of dislodgeable residues affecting unacceptable. For that reason, application should be by remote automated turf users. In the soil its very high organic carbon partitioning systems. coefficient adsorbs it to the soil organic matter (and clay particles). It 4.3.255 Risks to operators for turf and citrus applications even if full PPE (including is then held very tightly and doesn’t move much.” (Walmsley, B., in respiratory protection) is used are high. This is due to the application rates Sports Field Forum New Zealand Monthly Newsletter April 2008 Vol being higher than for the current label uses for both turf and citrus and the 3 (3)). different application method for citrus only. 4.3.246 However, the Agency does not currently have the necessary information to 4.3.256 Risks to workers re-entering areas treated in accordance with label uses, further refine this risk estimate for sports turf. including glasshouse use, indicate that risks are acceptable provided appropriate PPE is used or REIs are applied. Conclusions on the risks to sports people after the use of endosulfan on turf: 4.3.257 Risks to bystanders and residents are estimated as acceptable for boom 4.3.247 Although sports people’s total exposure is estimated under the models to be application to turf and in accordance with the label uses. However, risks to >1000% of the AOEL, the Agency notes that watering-in could significantly bystanders and residents from air-blast applications in citrus are estimated reduce the estimated exposures. This, together with the reported current as unacceptably high at current application rates and procedures. practice of no more than one annual treatment and an appropriate Restricted Entry Interval (REI) in the case of “ground contact” sports, may result in the 4.3.258 Risks to sports people from use of endosulfan on treated turf are acceptable risks being acceptable. if application is in accordance with the current standard practices involving watering in and one annual treatment and an appropriate REI is applied (in Conclusions on human health risk assessment the case of “ground contact” sports such as rugby, football or hockey and for public parks where children may play). 4.3.248 The toxicology profile of endosulfan has been well addressed internationally, and few significant data gaps remain. Assessment of benefits (positive effects) 4.3.249 Endosulfan has high acute oral and inhalation toxicity, but is less toxic via Assessment of benefits to the environment the dermal route due to relatively incomplete absorption. Neurotoxicity is the primary effect observed both acutely and chronically in both humans Reduced adverse effects on non-target species (including honey bees) and animals. 4.3.259 Information provided by industry during the preparation of this application 4.3.250 Endosulfan has not been proven to be mutagenic, carcinogenic, or a suggests that honeybees and ladybirds are less susceptible to endosulfan reproductive or developmental toxicant. than some pest species due to more rapid metabolism to inactive metabolites (Kern,1990). This allows predators and parasites of important pests to play 4.3.251 The Agency has set an AOEL = 0.0192 mg/kg bw/day and, confirmed the an economic role in pest control, where honey bees and bumble-bees play a ADE = 0.006 mg/kg bw/day. vital part in agriculture/ horticulture through their activities as pollinators. In some countries, endosulfan is authorised for use during the 4.3.252 No New Zealand exposure data for endosulfan are available for mixers, flowering/blooming period. However, despite laboratory data that suggest loaders, applicators, re-entry workers, bystanders or residents, so estimates that endosulfan is toxic, there is uncertainty as to whether such effects occur of exposure have been modelled where possible. If further information on in the field (see assessment of environmental risks above). the effects of Restricted Entry Intervals (REIs) and PPE during re-entry Endosulfan Reassessment – Application June 2008 Page 135 of 244 Page 136 of 244 June 2008 Endosulfan Reassessment – Application Conclusions on environmental benefit assessment: one benefit of endosulfan was the length of protection that it provided. However, no comparative analysis was provided. 4.3.260 One potentially significant positive effect on the environment identified by industry while preparing this application was reduced adverse effects on non-target species, including honey bees. Evidence supporting this included Conclusions on human health and safety benefit assessment: information about countries where endosulfan is authorised for use during 4.3.264 It appears that there are health and safety benefits to air passengers from the flowering periods. The assessment of risks to bees and non-target use of endosulfan, however the full extent of its use in New Zealand is not organisms noted that there was uncertainty regarding effects in the field and known. It is known that some airports use endosulfan to control earthworms that the results were inconclusive. It is expected that there will be similar and thus indirectly reduce the risk of birdstrike but the significance or uncertainty about any positive effects, and therefore such effects are not able relative importance of endosulfan is not known. Since earthworm control is to be considered further. This remains an area of significant uncertainty. a precaution, the direct effect is not able to be assessed. Assessment of benefits to human health and safety Assessment of benefits to society and community Reduced risks to people from ability to control earthworms and reduce castings which Reduced stress to farmers, horticulturalists and turf managers knowing that endosulfan can cause injury through uneven surfaces is available as a backstop product 4.3.261 The inability to control earthworms and more importantly their castings can 4.3.265 Endosulfan is used in a range of areas including agriculture, horticulture and create or exacerbate potential safety issues on turfed areas. Essentially turf management. The information available suggests that it has value in wormcasts make surfaces more uneven and more slippery. The most particular circumstances in all of these areas (see also beneficial effects on common safety issues relate to: the market economy). Variable and unpredictable ball bounce particularly for summer sports such as cricket and softball; 4.3.266 It is evident, as mentioned earlier, that while endosulfan may not be a first choice in agriculture and horticulture, it is seen as a backstop application. Variable and unpredictable footing for both winter and summer sports. There is thus a social and community benefit accruing to users of reduced For example, increased incidence of collapsed scrums; stress from knowing that if (or when) pest numbers get out of control Loss of vehicular control by staff and user groups (golfers using carts endosulfan is available and will be effective. or motor bikes) on undulating/hilly sites such as golf courses. Note: Most vehicles used on turf facilities are fitted with turf type tyres Reduced concern on part of managers of sports facilities and sports participants which lack the traction associated with agricultural equipment; 4.3.267 There is an indirect positive effect on society and community that accrues to Increased risks for jockeys and horses from poor traction on race managers of sports facilities and sports participants associated with knowing tracks associated with muddy surfaces. that these facilities can be kept in good condition such that injury is less likely to occur from worm activity. 4.3.262 It is possible that people may be injured in this way, however no evidence is available to indicate the number and extent of injuries caused by earthworm activity on sports fields, race courses and golf courses (etc) and similarly no Reduced risk of playing areas being closed/enhanced turf quality for sports evidence to support an assessment of the degree to which endosulfan 4.3.268 This indirect effect is linked to the previous positive effect. reduces health impacts. Conclusions on society and community benefit assessment: Reduced risk to air travellers from reduction in risk of bird strike 4.3.269 The first of these three effects is a direct effect, while the second two are indirect effects. While they are all valid positive effects or benefits of the 4.3.263 Bird strike is a major concern for airports around the world, and the availability of endosulfan, it is not clear how the second two might be presence of worms in grassed areas is considered to be a hazard since it assessed in terms of the marginal effect. The direct effect of reduced stress encourages birds. The primary concern of airport managers is to ensure the is probably the most important of the three. Additional information from safety of travellers. During the preparation of this application, several New submissions may provide evidence to support the size of this effect and the Zealand airports stressed to the Agency the importance of endosulfan to likelihood of it being realised. control earthworms and hence deter birds. It is not known to what degree airports rely on endosulfan and whether it is a preferred product or simply used because it is one of a range of possible products. It was indicated that Endosulfan Reassessment – Application June 2008 Page 137 of 244 Page 138 of 244 June 2008 Endosulfan Reassessment – Application Assessment of benefits to the market economy 4.3.276 On sand-based fields, increased volumes of sand are required to counter the negative effects of earthworm casting. However, sand is becoming Reduced cost of control of insects in the agricultural and horticultural sectors increasingly expensive and difficult to source. 4.3.270 Endosulfan belongs to the unique class of “dioxathiepin” chemicals. In 4.3.277 This information is supported by relative costs of control of earthworms, New Zealand, it has been stated that it provides a much needed cost indicating that the only other products on the market at present are more effective crop protection tool in a variety of situations, and that it is than twice the cost per hectare, and require considerably more frequent important in IPM and Resistance Management programmes. Because it is application. claimed to have low toxicity to honey bees in field situations, it may be a preferred insecticide for use on cross-pollinating crops. Reduced cost of control of earthworms at airports 4.3.271 Endosulfan has a wide spectrum of control and has immediate population 4.3.278 The health and safety aspect of control of earthworms at airports has been knockdown capabilities. Some industry representatives state that it is “soft” considered above. The costs aspect of this control is not known as no on beneficial insects, which allows the farmer to use it in IPM. However information is available about costs of alternative means of either removing robust information which shows a lack of effects on bees in the field has not earthworms or using other techniques for removing birds. been provided to the Agency. 4.3.272 Information received indicates that the ‘last resort’ aspect of the use of Reduced cost of development and testing of new products as pests do not develop resistance endosulfan is of particular importance to the citrus industry , however the size of the positive effect of the availability of endosulfan is not known in 4.3.279 As discussed in the identification section despite intensive use of endosulfan terms of the size of the industry and the proportion of the crop that would be only a few cases of temporary insect resistance have been reported. threatened if endosulfan were not available. For example, it has been Endosulfan has a unique mode of action with respect to all other currently reported that endosulfan may be essential when insect populations are used insecticides available on the New Zealand market. extreme. For example, the very high potato tuber moth pressure during the hot dry conditions this past (2007/8) summer would have put the crop at 4.3.280 The industry notes that due to new insecticidal chemistry being very risk, if endosulfan had not been available. selective in mode of action, resistance can develop very quickly. To prolong the useful life of such products there must be other products to use Reduced cost of control of earthworms (range of possible costs) and less need to in rotation with them. User groups have indicated they believe endosulfan resurface areas is valuable in this context and that the loss of endosulfan could increase the overuse of other products or combinations of them with the consequence of 4.3.273 Information received from the turf industry during the preparation of this increasing resistance. application, states that endosulfan provides the most cost effective and reliable means presently available for controlling earthworms. 4.3.281 Industry has claimed that due to the development of resistance or restricted use of organophosphates, endosulfan will become even more important 4.3.274 Treatment with endosulfan allows expensive, modern drainage systems such within the resistance strategies for the future. Synthetic Pyrethroid (SP) as sand carpet fields to perform to expectation and for their full anticipated resistance is widespread in a number of insects and crops. It has been lifespan of approximately 15 years (construction cost: approx demonstrated that if the use of SPs is stopped for a period of time (length of $180,000/field). In the event that earthworms are not controlled, the time will be different for each insect population – but at least several years) drainage rate of a sand carpet sports field and hence the performance of the this resistance in the insect population can diminish to a level where SPs field can be severely compromised within 1 – 2 years of construction. become effective again. There must be a range of products with different modes of action for growers to choose from while SPs are unavailable and Reduced maintenance costs endosulfan is one such product. 4.3.275 The industry also submits that if endosulfan were not available maintenance 4.3.282 While the value of endosulfan as a product that can be used in this way to costs for a sand field would increase by approximately 125% p.a. combat resistance, there is no evidence to support a significant effect Anecdotal evidence indicates that the maintenance costs for soil-based fields (benefit) on the market economy. It is further noted that whether endosulfan will also be significantly higher (50-100% p.a. – approx) than where remains available or not is unlikely to have an impact on the development of earthworms are treated. new products since such decisions will be made based on a range of drivers of which the existence of this product will be only one. Endosulfan Reassessment – Application June 2008 Page 139 of 244 Page 140 of 244 June 2008 Endosulfan Reassessment – Application Ability to be able to ‘salvage’ crops 4.3.289 There are indirect health and safety benefits to air passengers from the use of endosulfan, but the extent of the benefit is unknown since this is only one 4.3.283 Growers have indicated that endosulfan has value in that it can be used to element in reducing the risk of birdstrike. ‘salvage’ crops when all other means of insect control have failed. While the use of endosulfan may mean that a crop is not able to be exported to the 4.3.290 Turf managers have indicated that there are social and economic benefits intended market because of residue testing, the crop may be able to be sold from the availability of endosulfan for control of earthworms. Endosulfan is to a different market, possibly including a local market, that does not require cost effective and turf managers submit that it provides the best control. such stringent testing. It would be very difficult to estimate any value for There are social and economic benefits to agriculturalists and this positive effect and there may be an ethical concern about changing a horticulturalists as well from knowing that there is a ‘last resort’ insecticide market for these reasons. available, and from the availability of a comparatively cheap and long lasting insecticide. Conclusions on market economy benefit assessment Reduced cost of control of insects in the agricultural and horticultural sectors 4.4 Relationship of M ori to the environment 4.3.284 Five potential positive effects (benefits) have been identified and discussed. 4.4.1 The Agency used the framework contained in the ERMA New Zealand User These are: Guide “Working with M ori under the HSNO Act 1996” to assess this Reduced cost of control of insects in the agricultural and horticultural application. sectors; Reduced cost of control of earthworms and less need to resurface Adverse effects areas; 4.4.2 The Agency notes that endosulfan triggers a number of hazardous properties Reduced cost of control of earthworms at airports; 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 Reduced cost of development and testing of new products as pests do health and well-being of individuals and the community. not develop resistance; Ability to be able to ‘salvage’ crops. 4.4.3 In addition, the use of this substance has the potential to inhibit the ability of iwi/M ori to fulfil their role as kaitiaki, particularly in relation to the 4.3.285 Endosulfan is a cheaper product than a number of other insecticides guardianship of waterways given the highly ecotoxic nature of the substance available, both from the perspective of the cost per application and also the to aquatic environments. number of applications required. However, without developing and costing a range of specific scenarios it is not possible to place a value on the size of the effect that accrues to the agriculture and horticulture sectors and to turf Mauri managers. 4.4.4 The Agency notes that agrichemical trespass and or inappropriate persistence in the environment may result in adverse effects to the mauri of 4.3.286 Reduced cost of development and testing of new products is a commercial taonga and people. Biophysical effects associated with the use of the decision that would be made by chemical companies and cannot easily be substance have been well described elsewhere in Section 4 and will not be included in this assessment without further information. It should also be repeated here other than to note that significant uncertainty exists relating to noted that it is a private cost. any flow on effects of an intangible cultural nature. 4.3.287 The ability to be able to salvage crops is potentially important, but examples 4.4.5 Mauri is the indivisible quality of the totality of an organism enabling it to of how this has been applied would be needed for it to be assessed properly. move and live in accordance with the conditions and limits of its existence (Durie, 2003). It is the mauri that binds the physical and spiritual essence of Summary of assessment of benefits things together. The mauri is therefore a form of energy, generating, regenerating, upholding creation and ensuring harmony and balance to the 4.3.288 Some of the information suggests that endosulfan is an important element in processes of the earths ecosystems. M ori assert that the use of toxic IPM because it is less harmful to some non-target species including honey substances disrupts mauri and interferes with the basic structure of bees. Other information states that the lack of effects on bees in the field is relationships between generations and between species. The potential long unproven. This matter is therefore an area of significant uncertainty. term effects of this disruption remain unknown. The Agency considers there currently to be insufficient evidence to provide an appropriate degree Endosulfan Reassessment – Application June 2008 Page 141 of 244 Page 142 of 244 June 2008 Endosulfan Reassessment – Application of certainty that the use and management of endosulfan does not adversely relevance to this application is the principle of active protection affirmed by effect mauri even with appropriate controls in place. the Court of Appeal in the Lands case (1987). 4.4.12 It refers to the Crown’s obligation to take positive steps to ensure that M ori Kaitiakitanga interests are protected, and to consider them in line with the interests 4.4.6 The role of M ori as kaitiaki has been formally recognised (including in the guaranteed to M ori in Article II of the Treaty. Specifically the Court noted Resource Management Act 1991) as guardians and/or stewards of New that “… the duty of the Crown is not merely passive but extends to active protection of M ori people in the use of their lands and waters to the fullest Zealand’s natural resources. Kaitiakitanga is the undertaking of duties and obligations inherited from the atua (gods) over the realms of those atua in extent practicable” (Cooke 1987). accordance with M ori protocols and traditions (ERMA New Zealand 2004). Understanding traditional M ori knowledge relating to the dynamics 4.4.13 Taking into account the principle of active protection requires this of mauri and the relationships of the natural world, including being able to application to provide sufficient evidence to show that the use of endosulfan recognise and address issues, are key to the role of kaitiaki. poses no risk of adverse effects to native/endemic species and/or other taonga species, ecosystems and traditional M ori values, practices, health 4.4.7 The occurrence of adverse effect to the mauri of taonga species or people, and well-being. In considering the level of uncertainty described in relation places increased pressure on kaitiaki in terms of their ability to continue to to the adverse effects noted above, the Agency considers that this oversee the natural resources within their region. The Agency considers that application may currently be viewed as being inconsistent with the principle the relative levels of uncertainty relating to adverse effects arising from the of active protection. use and management of endosulfan may raise concern over the ability of kaitiaki to recognise and address issues as they arise. Hauora 4.4.8 Effects on human health and wellbeing are described elsewhere in Section 4. The Agency considered whether M ori were disproportionately affected by the adverse effects arising. The absence of data made this difficult to assess though it is likely that any effect would be similar to those impacting on communities generally. Assessment 4.4.9 M ori were not specifically consulted regarding this application. However the Agency has received clear messages at several hui with iwi/M ori resource managers that unless substances provide clear benefits to outweigh potential risk, they generally oppose the ongoing use of the substance. It is likely that, in the absence of further information regarding benefits, submissions from M ori would seek the revocation of the approvals for endosulfan. 4.4.10 Having regard to the information outlined here and elsewhere in this application, the Agency considers a moderate impact from the use of endosulphan on the relationship of M ori and their culture and traditions with their ancestral lands, water, sites, w hi tapu, valued flora and fauna and other taonga assuming that existing controls are complied with. Treaty of Waitangi 4.4.11 Section 8 of the Act requires the Authority, when considering applications, to take into account the principles of the Treaty of Waitangi. Of particular Endosulfan Reassessment – Application June 2008 Page 143 of 244 Page 144 of 244 June 2008 Endosulfan Reassessment – Application Section Five – International Considerations Section Six – Likely Effects of the Substance Being Unavailable 5.1.1 Endosulfan products have been removed from the market in a number of countries. The European Union (2005) withdrew authorisation for plant 6.1.1 Endosulfan is used as an insecticide registered for use on the crop/pest protection products containing endosulfan, except in four countries where a combinations shown in Table 6. ‘Off label’ uses include turf management number of essential uses were authorised until 30 June 2007. The authorised and citrus. uses were: Greece, cotton, tomato, peppers, pears, potato, alfalfa; Spain, hazel nut, cotton, tomato; Italy, hazel nut; Poland, hazel nut, strawberry, 6.1.2 With the exception of bronze beetle on berries, other products are registered gerbera, ornamental bulbs. These reviews and subsequent action were based for all of these crop/pest combinations (Appendix I). The Agency notes that on the unacceptable risks to workers and the fate and behaviour of a number of these products are themselves listed on the Chief Executive’s endosulfan in the environment, in particular its lack of degradation, Reassessment Priority List and that it does not currently have sufficient persistence, potential for long range transport and potential to information to know whether these apparent alternative substances are bioaccumulate. practicable alternatives, or whether there are issues that would prevent their use, such as local resistance. It is expected that submissions will provide 5.1.2 The USEPA (2002), Australian APVMA (2005) and Canadian PMRA more information that can then be considered by the Authority in its (2004) have all reassessed the use of endosulfan and restricted its use and evaluation of the application. put in place measures to mitigate worker and environmental risks. 6.1.3 The Agency has been advised that endosulfan has a number of important 5.1.3 A summary of the control measures taken as a part of these reviews (and a advantages that are not recognised simply by listing the existence of comparison against existing HSNO controls) is included in Appendix H. alternatives. These are described in Section 4, but can be summarised as 5.1.4 Further overseas action concerning endosulfan includes the recommendation follows: from the Rotterdam Convention Chemical Review Committee, 23 March Broad spectrum insecticidal/ acaricidal efficacy on difficult to control 2007, that endosulfan be included in the Prior Informed Consent (PIC) target pests. procedure under the Rotterdam Convention. This recommendation was Useful for resistance management as it belongs to a different class of based on the grounds that endosulfan poses unacceptable risks to the chemicals with a unique mode of action. environment. A draft decision to formalise the inclusion of endosulfan in the Convention has been prepared and its adoption will be considered at a Tool for IPM due to high selectivity on pollinators and many beneficial Conference of the Parties in Rome in October 200823. insects. Relatively non-toxic to beneficial insects. 5.1.5 In July 2007, the European Commission submitted a proposal to the Stockholm Secretariat that endosulfan be considered as a candidate for Excellent crop tolerance – no phytotoxicity. inclusion under the Stockholm Convention on Persistent Organic Pollutants (POPs). The proposal concluded that endosulfan is likely, as a result of its 6.1.4 Therefore if endosulfan was unavailable other problems could arise: long-range environmental transport, to lead to significant adverse human Combinations and mixtures of other insecticides would be necessary health and environmental effects. The proposal was discussed at the third to control the pests. meeting of the Persistent Organic Pollutants Review Committee (POPRC-3: November 2000) which concluded that vital information required for its Depending on the alternatives chosen a significant effect on non-target consideration of endosulfan was missing and deferred further consideration invertebrates could be expected, leading to pest infestation increases until the POPRC-4 meeting in November 2008. or to higher use of other insecticides. The risk of development of resistance to other insecticides is possible. 5.1.6 The Agency notes these overseas reviews and other international initiatives and is of the view that they support this application for the reassessment of Increased cost to users/industry. endosulfan. 6.1.5 Alternative products for the treatment of turf are also available. Baker et al (1998) list carbaryl, carbendazim and gamma-HCH+ thiophanate-methyl, although there is some doubt as to the effectiveness of some of these products.24 In this respect, the Agency also notes that carbaryl and 23 24 UNEP/FAO/RC/COP.4/9 http://www.oxfordcroquet.com/care/worms/index.asp Endosulfan Reassessment – Application June 2008 Page 145 of 244 Page 146 of 244 June 2008 Endosulfan Reassessment – Application carbendazim (with benomyl) are substances on the Chief Executive’s Section Seven – Overall Evaluation and Reassessment Priority List. Carbendazim is very ecotoxic in the aquatic and soil environment and is also persistent. It is not approved for use in the Recommendations United States, and uses in other countries such as Canada are restricted. Carbaryl has the potential to cause adverse effects to the nervous system in humans at low concentrations. It is also suspected of being carcinogenic and is very ecotoxic to fish and honeybees. The United States, United Kingdom, 7.1 Overall evaluation Canada and Australia have reviewed, and imposed more stringent measures to mitigate the risks posed by carbaryl products. 7.1.3 Under section 29 of the Act, the Authority may approve this application if, after taking into account: 6.1.6 The New Zealand Sports Turf Institute has also advised25 that the following any controls which may be imposed on the substance; and non-chemical (physical) means have been used overseas where endosulfan is not available: all effects of the substance during its lifecycle; and acidification of the soil profile to reduce earthworm populations. the likely effects of the substance being unavailable, However, this has implications for the availability of plant nutrients and the survival of some grass types; the positive effects of the substance outweigh the adverse effects. Conversely, if the adverse effects outweigh the positive effects, the greater reliance on heavier sand topdressing to discourage earthworm Authority may decline the application (and thus prohibit the use of feeding activity and dilute castings. However, use of sand in the way endosulfan). in New Zealand would impose substantial costs on sports users. 7.1.4 In the absence of exposure information, the Agency has used quantitative exposure assessment models to determine the levels of risk to human health and the environment. This exposure modelling has produced indicative levels of risk that, in many cases, are high. 7.1.5 On the basis of this information, the Agency’s interim evaluation is that there are significant (non-negligible) risks associated with the use of endosulfan in New Zealand which potentially outweigh the benefits. 7.1.6 This evaluation takes into account that the Agency does not currently have sufficient reliable information in order properly to assess or verify: the benefits of using the substance; and/or the likely effects of the substance being unavailable. 7.1.7 Although some information on these matters has been provided to the Agency in the course of preparing this application, the statutory public submissions period allows a further opportunity for information to be provided which could result in the Authority establishing a higher level of benefits. 7.1.8 In addition, there is the following uncertainty in the assessment of the adverse effects: There is a lack of New Zealand-relevant environmental exposure data, including geographic locations of use in relation to aquatic environments. Higher tier modelling performed overseas is not directly applicable to New Zealand conditions and use patterns. To date, no such modelling has yet been performed to reflect New 25 Zealand conditions and use patterns. NZSTI report dated June 2008. Endosulfan Reassessment – Application June 2008 Page 147 of 244 Page 148 of 244 June 2008 Endosulfan Reassessment – Application There is also a lack of New Zealand-relevant human exposure data. In 6 days for blueberries; the absence of such data, exposure modelling has been used to 10 days for sweetcorn. determine the human health risks associated with the use of endosulfan products, and it is noted that the modelling includes In respect of the issue of REIs, ERMA New Zealand notes that: conservative assumptions, so that the risks may be overestimated. although re-entry restrictions can be specified on New Zealand labels under HSNO regulations, the clearer, more prescriptive approach recommended 7.1.9 Clauses 29 and 30 of the Methodology26 provides that where there is above is in line with requirements introduced by overseas’ agencies; scientific and technical uncertainty, the Authority must consider the consideration will need to be given to an appropriate REI for greenhouse materiality of the uncertainty and if it cannot be resolved to its satisfaction, use; the Authority must take into account the need for caution in managing the adverse effects of the substance. consideration will need to be given to longer REIs in the case of ‘pick your own’ berry orchards to take account of the exposure of pickers; and 7.1.10 Given the information currently before it, and taking account of the need for REIs may not be necessary in respect of post-application turf maintenance caution, the Agency proposes the preliminary recommendations set out activities (for example, mowing/rolling) unless the work involves direct below. exposure. 4. That a no-spray buffer zone around waterbodies and the edges of treated crops be 7.2 Preliminary recommendations introduced due to high level of risks to the aquatic environment and to soil fauna (ERMA New Zealand currently considers a 100 m buffer zone may be appropriate The following recommendations are preliminary only. An important part of the on the basis of overseas’ analyses of the effectiveness of buffer zones). reassessment process is public submissions on the application. These public submissions are likely to have an effect on the final outcome of the reassessment. 5. That reduced (maximum) application rates (kg a.i./ha per application/season) and/or limits on the number of applications (for example, per season) be On the basis of its evaluation of whether the risks associated with the use of endosulfan introduced for some uses in order to lower the risks to the environment and people in New Zealand outweigh the benefits, ERMA New Zealand proposes the following (noting the measures of this type proposed by some overseas agencies). preliminary recommendations to ensure that practices are safe for people and the environment: 6. That suitable PPE be stipulated for different types of application and at different stages of the lifecycle (mixing/loading; application). 1. That the use of endosulfan be prohibited for: aerial and domestic use of the substance on the basis that these are not uses Finally, if the Authority’s overall evaluation favours retention of some or all of the to which it is currently put (and the relevant risks have not been assessed as endosulfan approvals, ERMA New Zealand recommends the following classification part of this application); and changes: airblast application for citrus on the basis that risks to operators and for all formulations, replace 6.1C overall acute toxicity classification with 6.1A bystanders are currently assessed as very high. based on inhalation toxicity; replace the current 6.3B classification on Substance D with a 6.3A classification; 2. That use on turf be restricted to one annual treatment, followed immediately by remove the 6.8B classification applied to Thionex Insecticide Solvesso watering in, with no use of the treated area in the case of “ground contact” sports formulation; use and public parks where children may play, for a period of at least 48 hours following treatment (noting, however, that the operator exposures are high even replace the current 9.2C classification on endosulfan and all its formulations with with full PPE, so the feasibility of a lower application rate needs to be explored). a 9.2A classification; assign an approval number to the Thionex Insecticide Solvesso formulation; 3. That the following Restricted Entry Intervals (REIs) be imposed for other uses, where PPE is not used when re-entering: change the packing group assigned to endosulfan and all formulations containing endosulfan from PG I to PG II. 48 hours for all crops not listed below; 3 days for sweetpotato, mustard, radish, turnip; 4 days for brassicas (broccoli, cabbage, cauliflower, brussels sprouts); 26 Hazardous Substances and New Organisms (Methodology) Order 1998 (SR 1998/217). Endosulfan Reassessment – Application June 2008 Page 149 of 244 Page 150 of 244 June 2008 Endosulfan Reassessment – Application References Section Eight – Summary of Public Information Agency of Toxic Substances and Disease Registry (ATSDR). 2000. Toxicological Profile for Endosulfan. http://www.atsdr.cdc.gov/toxprofiles/tp41.html 8.1 Names of the substances for the public register Aleem A, Malik A. 2005. Genotoxicity of the Yamuna River water at Okhla (Delhi), India. Ecotox Environ Saf. 61(3):404–12. Endosulfan CAS 115-29-7 (HSR002846) Amaraneni SR. 2006. Distribution of pesticides, PAHs and heavy metals in prawn Emulsifiable concentrate containing 350 g/litre endosulfan (Substance ponds near Kolleru lake wetland, India. Environ Int 32(3):294–302. A) (HSR000679) Emulsifiable concentrate containing 350 g/litre endosulfan (Substance ANZECC. 2000. Water Quality Guidelines. B) (HSR000678) http://www.mincos.gov.au/__data/assets/pdf_file/0020/316136/gfmwq-guidelines-vol2- 8-3b.pdf Emulsifiable concentrate containing 350 g/litre endosulfan (Substance C) (HSR000487) APVMA. 1998. The NRA review of endosulfan, Section 7, Environmental Assessment. Emulsifiable concentrate containing 350 g/litre endosulfan (Substance D) (HSR000677) APVMA. 1998a. The NRA review of endosulfan, Section 3, Chemistry Assessment. APVMA. 2005. The reconsideration of approval of the active constituent endosulfan, 8.2 Purpose of the application for the public register registrations of products containing endosulfan and their associated labels. Final review report and regulatory decision, Review Series 2. 8.2.1 An application for the reassessment of endosulfan and formulations containing endosulfan under section 63 of the Act. This arises from a Arnot JA, Gobas FAPC. 2004. A food web bioaccumulation model for organic decision by the Environmental Risk Management Authority that there are chemicals in aquatic ecosystems. Environ Toxicol Chem 23(10):2343–2355. grounds for reassessment of this substance, under section 62(3) of the Act (RES07003). Arrebola FJ, Martinez Vidal JL, Fernandez-Gutierrez A. 2001. Analysis of endosulfan and its metabolites in human serum using gas chromatography-tandem mass spectrometry. J Chromatogr Sci 39(5):177–82. 8.3 Use categories of the substances Baedelt, H, Idstein, Dr. H, Krebs, B. 1992. 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Levels of environmental contaminants in human follicular fluid, serum, and seminal plasma of couples undergoing in vitro fertilization. Arch Environ Contam Toxicol 43(1): 121–126. Endosulfan Reassessment – Application June 2008 Page 159 of 244 Page 160 of 244 June 2008 Endosulfan Reassessment – Application Appendix A – Human health hazard profile The acute toxicity classifications for the formulations of endosulfan have been derived using the HSNO mixture rules based on the concentration of endosulfan present. Acute oral toxicity Introduction Using the endosulfan LD50 (oral) rat 22.7 mg/kg bw (Table 3) and a concentration of The information on the human health hazards of endosulfan available to the Agency for 350g/L, the mixture calculation gives LD50 (mix) = (100/35) * 22.7 = 64.9 mg/kg bw. this reassessment, whether or not submitted, has been screened for relevance to the This value is in the range 50 – 300 mg/kg bw, so the mixtures classify as 6.1C based on HSNO Act; scientific, particularly regulatory scientific rigour; and, whether or not the the endosulfan content. information with a positive or negative outcome adds significantly to the existing knowledge base. Acute dermal toxicity The Act and Regulations made under it set out the parameters for each of the Using the endosulfan LD50 (dermal) 34 mg/kg bw (Table 3) the mixture calculation for classifications of potential human health hazards. The Act also indicates a hierarchy of dermal gives LD50 (mixture) = 100/35 * 34 = 97 mg/kg bw. Since the 6.1B (dermal) test protocols within each Classification to help, where necessary to determine where range is 50 – 200 mg/kg bw, the mixtures classify as 6.1B based on the endosulfan the weight-of-evidence lies. The Act defines relevance for the reassessment. content. HSNO human health classifications are based on adverse effects. So, for a substance to Acute inhalation toxicity receive a HSNO classification a relevant adverse effect must be shown in a 3 scientifically sound manner. Using the LC50 for endosulfan 13 mg/m = 0.013 mg/L (Table 3), the mixture calculation gives LC50 (mixture) = (100/350) * 0.013 = 0.037 mg/L. Since the vapour Unfortunately, much of the information made available to the Agency for this pressure of the triggering component endosulfan is relatively low (vapour pressure of -3 -4 application, did not meet these screening requirements, particularly that of relevancy to endosulfan = 1.05 x 10 Pa, and endosulfan = 1.38 x 10 Pa, Table 2) it is appropriate the Act. to assess the mixture LC50 against the range for dust/mist. The range for 6.1A (as dust/mist) is <0.05 mg/L so the mixtures trigger classification as 6.1A based on the endosulfan content. Pharmacokinetics The majority of endosulfan, regardless of exposure route, is excreted rapidly in faeces, with virtually no retention in tissues, despite the lipophilicity of endosulfan and its 6.3, 6.4 & 6.5 classification – Irritancy/sensitisation primary metabolite, endosulfan sulfate. Enterohepatic circulation, conjugation and Endosulfan was moderately irritating to the eyes but was not a dermal irritant in rabbits, elimination in the urine, is not a major route for endosulfan metabolism. At 120 hours, nor was it a skin sensitiser in Guinea pigs. 88% of -[14C]endosulfan and 87% of -[14C] endosulfan had been eliminated. The default policy for DPR is that if oral absorption is 80% or greater, the absorption is No data were identified relating to the respiratory sensitisation potential of endosulfan, assumed to be 100%. After endosulfan was dermally administered to rats, within 5 days the deficiency of data in that area is noted. 47.3% of the dose was absorbed and 95% of the absorbed material was eliminated. Fatty tissues had the highest endosulfan concentrations after dermal treatment. After oral Endosulfan Formulations treatment in rats, liver and kidney were the sites of greatest endosulfan concentration. These organs are likely the primary sites of biotransformation, since their weights The skin irritation classifications of the formulated products are driven by the increase after treatment, as do the concentrations and activities of xenobiotic combination of components to give rise to the classifications in Table 4. metabolising enzymes such as P450s and glutathione-transferases [Cal DPR, 2008]. The eye irritation/corrosivity classifications of the formulated products are driven by a combination of endosulfan (an eye irritant) and other components to give rise to the 6.1 classification – Acute toxicity classifications in Table 4. Endosulfan is highly acutely toxic via the oral and inhalation routes in rats. It was also highly toxic via the dermal route in rabbits, but generally less toxic in other test species. Skin sensitisation (6.5B) is triggered in Substance A by a mixture component other than Female rats were much more sensitive to the acute oral and dermal effects of endosulfan endosulfan. than males. The key acute toxicity end points for endosulfan are given in Table 3. Endosulfan Reassessment – Application June 2008 Page 161 of 244 Page 162 of 244 June 2008 Endosulfan Reassessment – Application 6.6 classification – Mutagenicity/genotoxicity For genotoxicity, numerous studies have been performed in bacteria, yeast, mammalian cells in culture and in vivo in laboratory animals. The overall assessment of genotoxic potential of endosulfan shows that tests are either positive or negative: bacterial systems (14/18 negative), micronucleus (2/2 negative), dominant lethal mouse (1/2 negative; positive only at 9.8 mg/kg b w/day and higher); in vitro cellular systems (mouse, rat, human; 3/7 negative; 2/7 equivocal) and in vivo (2/8 negative). There is some evidence for genotoxicity with endosulfan, especially in tests for chromosomal effects. However, in order to identify a positive effect in vivo, animals were treated at doses that exceed the maximally tolerated dose (MTD). Mortality would occur at the MTD thereby preventing tumour development through early death [Cal DPR, 2008]. Some studies were reported to be positive in the published literature (Chaudhuri et al., 1999; McGregor et al., 1988; Yadav et al., 1982; L’vova, 1984; Velazquez et al., 1984; Sobti et al., 1983; Sharma and Gautam, 1991; Martins, 2003, Daniel et al., 1986; Dubois et al., 1996 in Cal DPR, 2008), however, none was acceptable by FIFRA Guidelines (Tables 15 and 16). USEPA does not consider oral exposure (in vivo tests) of rats to be genotoxic; stating that “the data are inconclusive” (USEPA, 2000b in Cal DPR, 2008). USEPA also states that induction of chromosomal aberrations and gene mutations in Drosophila melanogaster (Velazquez et al., 1984 in Cal DPR, 2008) and in mice (Usha Rana and Reddy, 1986 in Cal DPR, 2008) complicate data analysis because some of the formulations of endosulfan may have contained epichlorohydrin, a known genotoxin, as a stabiliser (see Tables 14 and 15; USEPA, 2000b; Hoechst, 1990 in Cal DPR, 2008). [Cal DPR, 2008] Endosulfan Reassessment – Application June 2008 Page 163 of 244 Page 164 of 244 June 2008 Endosulfan Reassessment – Application 6.7 classification – carcinogenicity Hepatocyte gap junctional intercellular communication was inhibited by endosulfan, as well as by the sulfate, lactone and ether metabolite. Gap junctional intercellular communication was also inhibited by both - and - isomers in primary Sprague- Dawley rat hepatocytes, as well as WB-F344 rat liver cell lines. While gap junctional intercellular communication might be considered to be a tumor promotional event, all studies reporting this effect were performed in vitro. In studies performed in vivo there has been no evidence to indicate that endosulfan is a tumor promotor [Cal DPR, 2008]. For evaluation of chronic toxicity and oncogenicity of endosulfan, there were 3 rat, 2 mouse and 1 dog dietary study, in addition to 1 dog study performed with endosulfan in capsules. One rat combined (chronic and oncogenicity), 1 mouse oncogenicity and 1 chronic dog study (all dietary) were acceptable based on FIFRA Guidelines. The primary effects in the rat studies were to the vascular system, and the kidney, along with a decrease in body weight gain. The mouse oncogenicity study showed mortality as the primary effect. In the mouse studies, a target organ was not identified. The primary effects observed in the chronic, dog-dietary study were mortality (premature termination) and neurotoxicity. The lowest NOEL for chronic studies was 0.57 mg/kg b w/day obtained in the chronic dog study (M: 0.57 mg/kg b w/day; F: 0.65 mg/kg b w/day) based on increased mortality, and neurotoxicity. Results for oncogenicity studies performed in the rat and the mouse showed no tumor incidence that was treatment- related, dose-related or otherwise different in incidence across dose groups. Endosulfan is categorised as “A4” (not classifiable as a human carcinogen) by the American Conference of Governmental Industrial Hygienists (Substances and Physical Agents and Biological Exposure Indices, Cincinnati, OH, 2005 in Cal DPR, 2008). USEPA states: “Cancer Determination: The carcinogenicity issue has been considered by the Health Effects Division--Cancer Peer Review Committee. The Committee agreed that 'there was no evidence of carcinogenicity' for endosulfan” Endosulfan is placed in Group E: Evidence of non-carcinogenicity for humans (Revision of Occupational and Residential Exposure/Risk Assessment for the Endosulfan Reregistration Eligibility Decision Document (RED); Revised; Docket number: EPA - HQ- OPP- 2005 – 0459; USEPA, 2007 in Cal DPR, 2008). The Canadian Preliminary Risk and Values Assessment for Endosulfan states “Endosulfan was not carcinogenic in mice or rats and was not genotoxic,” (PMRA, 2007 in Cal DPR, 2008). Endosulfan is not listed by the International Agency for Research on Cancer (IARC) as a carcinogen. Reports by Health Canada Pest Management Regulatory Agency (2007), [Cal DPR, 2008] European Union (2007), United States Environmental Protection Agency (2002) and the Agency for Toxic Substances and Disease Registry (2000) have all concluded that endosulfan is not carcinogenic. 6.8 classification – Reproductive/developmental toxicity There were no reproductive effects related to treatment observed in studies that were well-designed with peer-reviewed protocols, studies with reproducible data and/or historical controls. Some studies in the open literature examined the effects of endosulfan on neonatal reproductive tract development, as well as effects on mature male reproductive tract. Most effects observed, however, were systemic, rather than reproductive. Effects in the acceptable FIFRA Guideline reproduction study were systemic (liver and kidney) and there were no effects in the reproductive parameters for Endosulfan Reassessment – Application June 2008 Page 165 of 244 Page 166 of 244 June 2008 Endosulfan Reassessment – Application either sex. Many of the studies performed in the open literature had major deficiencies Developmental toxicity but supported the lack of reproductive effects in neonates, pups or adults of either sex In acceptable FIFRA Guideline developmental studies, the rabbit had no fetal effects, [Cal DPR, 2008]. only maternal neurotoxicity and death at greater than 0.7 mg/kg/day. Rats, however, had decreased fetal weights and percent of live fetuses at greater than 2.0 mg/kg/day. In addition to studies using regulatory protocols, the potential reproductive toxicity of Maternal toxicity occurred at doses lower than or equal to doses showing fetal effects. endosulfan has been tested in various areas, and contributed to Cal DPR’s conclusions: In addition to the developmental studies summarised below, a dietary developmental Neonatal/Prepubertal Reproductive Organs and Sex Hormones neurotoxicity study in rat was reviewed (Gilmore et al., 2006, Sheets, and Hoss, 2006 in Cal DPR, 2008). Gavage in Females During Pregnancy and Lactation, Sexual Development in Males Gavage in Adult Male Rats, Assessment of Reproductive Tract 6.9 classification – Target organ toxicity Endocrine Effects on Human Reproductive Systems (Epidemiological Studies) Oral In vitro Effects on Steroidogenesis and Spermatogenesis The effects observed in laboratory animals from chronic dietary exposure to endosulfan In Vivo Effects on Steroidogenesis and Spermatogenesis are summarised in Table 13. Effects observed in the rat were different from those observed in the dog. In the rat, the chronic dietary NOEL was 0.6 mg/kg/day for males Estrogenicity in In Vivo/In Vitro Assays and 0.7 mg/kg/day for females based on decreased body weight gain, kidney Physiological Compensation in Mammalian Females enlargement, progressive glomerulonephrosis and glomerulonephritis, proteinuria, aneurysms (Ruckman et al., 1989 in Cal DPR, 2008). This study was acceptable For example: according to FIFRA Guidelines [Cal DPR, 2008]. “An epidemiological study was performed to assess potential effects of aerial spraying of endosulfan on sexual maturation in children (Saiyed, et al., 2003). Endosulfan was the only pesticide that had been used (sprayed 2 - 3 times/year for 20 years) on cashew nut plantations located on hilltops in villages in northern Kerala, India. The village school children were exposed to endosulfan via air, water (runoff from irrigation) and soil. Control children (comparable status) were from a village 20 km away without any history of aerial endosulfan spraying. Male children (study n = 117; controls n = 90) aged 10 -19 years were to receive an examination for sexual maturity rating (SMR, pubic hair, testes and penis), a blood test to assess testosterone (T), luteinizing hormone (LH), follicle-stimulating hormone (FSH) and endosulfan residues ( -, - and sulfate). Non participation in the SMR was 57% for the study and 33% for controls; [Cal DPR, 2008] however, in the 43% (n = 50) and 76% (n = 68), respectively, that did participate there was a statistically significant decrease in SMR for pubic In dogs, neurotoxicity was the most sensitive endpoint for chronic oral endosulfan hair, testicular and penis development with regard to R2, intercept (b0), age toxicity. The chronic study in dogs was performed with endosulfan administered in diet. (b1) and aerial exposure to endosulfan (AEE b3: Score = b0 + b1age ) In the dog, the chronic dietary NOEL was 0.57 mg/kg/day for males and 0.65 b2AEE). The study males with tested blood samples (n = 67) had lower than mg/kg/day for females, based on clinical signs of violent contractions of the upper expected testosterone levels, considering age and LH in blood, compared to abdomen and convulsive movements, extreme sensitivity to noise, frightened reactions the control males (n = 46). In fact, the main study males had higher than to optical stimuli and jerky or tonic contractions in facial muscles, chaps and extremities expected LH levels, when compared to controls. Endosulfan residues -, - and impairment of the reflex excitability and postural reactions (Brunk, 1989 in Cal and sulfate individually, as well as total endosulfan, were all statistically DPR, 2008). It was necessary to sacrifice some of the dogs prematurely due to the significantly increased in the study males (n = 70), compared to controls (n clinical signs of neurotoxicity. In addition, body weights and food consumption were = 45). The authors concluded that a follow-up should be performed on the decreased. This study was acceptable according to FIFRA Guidelines [Cal DPR, 2008]. children to understand the implications of the findings, in addition to performing a study with a larger sample size to validate the study findings. The dog appears to be very slightly more sensitive than the rat with regard to chronic The study was acknowledged by the authors to be preliminary. effects. However, the dog study, with a critical NOEL of 0.57 mg/kg/day was similar to Supplemental.” [quote from Cal DPR, 2008]. the NOEL obtained in the chronic dietary rat study (0.6 mg/kg/day). The two studies were performed by different methods, despite the fact that they are both considered oral, dietary studies. The dog study, with endosulfan administered in diet, was selected as the Endosulfan Reassessment – Application June 2008 Page 167 of 244 Page 168 of 244 June 2008 Endosulfan Reassessment – Application definitive study. However, mortality and neurotoxicity occurred in dogs at 2.0 greater and in females at 3 mg/kg and greater, lasting for 1 day. This mg/kg/day, where this dose was tolerated in rats. At 2.9 mg/kg/day in male rats and at difference between the sexes was also observed in the subchronic dietary 3.8 mg/kg/day in female rats (highest doses tested), kidney enlargement and neurotoxicity study in rats where the systemic NOELs were 37.2 mg/kg/day glomerulonephritis in females and aneurysms in males were increased. Rat mortality, (HDT) for males and 16.6 mg/kg/day for females. The neurotoxicity however, at these high doses was comparable to the controls. Rats received the parameters showed no treatment-related effects on FOB or motor activity in endosulfan treatment in their diet, and this may account for the apparent interspecies either sex at any dose. Other studies showed endosulfan interacts directly in sensitivity differential. The chronic dog study was selected as the definitive study with a the central nervous system to affect monoaminergic systems in different critical NOEL of 0.57 mg/kg/day since it appeared to be the more sensitive species parts of the brain. This, in turn, affects memory and the learning operant when tested in an acceptable FIFRA Guideline study. The chronic rat study NOEL, paradigm. Endosulfan decreased sleeping time induced by chlorpromazine virtually the same at 0.6 mg/kg/day, served to support the value obtained in the dog and was also shown in 3 studies to induce kindling, a model of secondary study. The chronic dietary NOEL of 0.57 will be used to determine MOE for both generalized epilepsy from repeated, low intensity electrical stimulation of dietary and worker exposure (Table 13) [Cal DPR, 2008]. limbic foci in the brain. Endosulfan also was shown to inhibit a noncompetitive blocker site for the GABAA receptor in rat. Most of the open literature studies reported below were performed at toxic doses to examine Dermal specific effects in the nervous system, primarily brain, therefore NOELs and There were no FIFRA Guideline, nor were their open literature studies that were LOELs were not achieved. Endosulfan is a chlorine channel blocker in the acceptable for chronic dermal exposure to endosulfan technical. Therefore, the CNS, and shows no direct affect on brain cholinesterase in rats. There was procedure is to use the chronic oral NOEL in dog (0.57 mg/kg/day) for determinations a decrease in serum ChE in female rats at toxic doses (50% and 49% at of MOEs for chronic dermal occupational exposures and for exposures to swimmers in 13.7 and 37.3 mg/kg/day, respectively) but RBC and brain ChE remain surface water [Cal DPR, 2008]. unaffected (males also unaffected). These apparent effects on ChE are inconsistent, occur only at high doses and are likely secondary to systemic toxicity.” [quote from Cal DPR, 2008]. Inhalation An acceptable chronic inhalation exposure study was not available from the open Cal DPR (2008) reviewed a dietary developmental neurotoxicity study by Gilmore et al. literature or studies submitted by registrants to obtain a chronic inhalation NOEL. (2006) that covered a key data gap in previous risk assessments of endosulfan: Therefore, an acceptable subchronic rat inhalation study with a NOEL of 0.0010 mg/L (0.194 mg/kg/day) was used to calculate the potential for chronic inhalation exposure to “Endosulfan technical (99.1% pure) was fed in diet to mated female Wistar workers, and for exposure to endosulfan for bystander air (Hollander et al., 1984 in Cal rats (30/dose) at 0, 50, 150 or 400 ppm (0, 3.74, 10.8, and 29.8 mg/kg/day) DPR, 2008). In this study, endosulfan was administered by aerosol (nose-only) for 21 from gestation day (GD) 6 through lactation day (LD) 21 (Gilmore et al., days at 6 hours per day, followed by a 29-day recovery. The NOEL for inhalation was 2006). The concentration of endosulfan in the dietary preparations was based on emaciation, pale skin, squatting position and high-legged position, decreased adjusted to the expected food consumption during the lactation period in bodyweight gain and food consumption, increased water consumption, and clinical order to maintain a reasonably constant level of test material consumption. chemistry parameters (reversed during recovery) [Cal DPR, 2008]. Offspring from 23 litters in the control, 50 and 150 ppm groups and pups from 21 litters in the 400 ppm groups were assessed neurologically up to 75 days post-natal in the functional observational battery (FOB), measurement Neurotoxicity of motor activity, auditory startle response, passive avoidance learning and The primary target of endosulfan is the central nervous system, as was observed in memory and water maze learning and memory assessments. The motility, numerous studies, primarily in the rat. Endosulfan is a strong neurotoxin in animals numbers and morphology of sperm from male pups were evaluated. The (rabbits, rats, dog, mice, cow, cat, pig and lamb) as well as humans (see Illness Reports neuropathologic examination and morphometric analysis of selected in Beauvais, 2008; Volume II in Cal DPR, 2008) as well as studies throughout the neurological tissues from the pups were performed. The mean body weight Toxicology Profile) but it does not induce delayed neurotoxicity in hens [Cal DPR, of the dams was decreased in a dose-related manner during gestation. This 2008]. effect persisted through the lactation period with the mean body weights of the dams at 150 and 400 ppm significantly less than that of the controls “The acute gavage neurotoxicity study in rat showed a systemic NOEL of through LD 7. The mean food consumption was likewise affected for all of 12.5 mg/kg for males and 1.5 mg/kg for females, based on an increase in the treatment groups during gestation. The report stated that the decrease in clinical signs (mortality, tonoclonic convulsions, coarse tremor, food consumption, while transitional, was likely due to palatability. The uncoordinated gait, increased salivation, stupor, prone position, increased treatment did not affect the gestation of the fetuses. The mean body weights fright reaction, squatting posture, stilted gait, irregular respiration, of the pups in all of the treatment groups during lactation were decreased straddled hind limbs, decreased spontaneous activity, panting, bristled coat, but there was no treatment-related effect on the live birth, viability or flanks drawn in and narrowed palpebral fissure) in males at 25 mg/kg and lactation indices. For the developmental landmarks, the preputial Endosulfan Reassessment – Application June 2008 Page 169 of 244 Page 170 of 244 June 2008 Endosulfan Reassessment – Application separation was marginally delayed (4-5%) for the male pups at 150 and 400 ppm (0 = 44.9 days; 50 = 44.8 d; 150 = 47.1 d; 400 = 46.8 d). The time to Recent regulatory reviews that examined in some depth the putative endocrine vaginal opening for the female pups was not affected in a dose-related disruptive effects of endosulfan differed in their conclusions as a result of the manner. Sperm motility, count and morphology of the male pups were not differences in their working definitions of what constitutes an endocrine disruptor. The affected by the treatment. No treatment-related effects were noted in the two approaches may be termed the American and the Australian. FOB for either the dams or the pups. The motor activity assessment of the pups did not reveal any treatment-related effects. The auditory startle response, passive avoidance learning and memory and water maze learning American working definition and memory assessments did not indicate any treatment-related effects on The working definition used in the final report of the US EPA Endocrine Disruptor the pups. No neuropathological lesions were noted in either the 21-day old Screening and Testing Advisory Committee (1998) for an endocrine disruptor is “an pups or the 70-day old adults. Morphometric analysis of the brain of these exogenous chemical or mixture that alters the structure or function(s) of the endocrine animals did not demonstrate any treatment-related effects. The maternal system and causes adverse effects at the level of the organism, its progeny, populations NOEL was less than 3.74 mg/kg/day, based upon lower mean body weights or subpopulations of organisms, based on scientific principles, data, weight-of-evidence, (5 - 6%) and lower food consumption (12%) at 3.74 mg/kg/day. While these and the precautionary principle”. The National Research Council of the USA has decreases are marginal, the trend is dose-related and therefore considered adopted the term hormonally active agents, in place of the term endocrine disruptor to be a treatment-related effect. The developmental NOEL was less than chemicals (1999) [APVMA, 2005]. 3.74 mg/kg/day based upon the lower mean body weights (8% on post- partum day 11 only) of the offspring at 50 ppm. Body weight gain for pups The US EPA (2002) review concluded on the putative endocrine disruption potential: was also decreased on post-partum day 11, however this effect was reversed. The developmental neurotoxicity NOEL was 29.8 mg/kg/day, “Exposure to endosulfan has resulted in both reproductive and based upon the lack of neurological effects in the offspring at the highest developmental effects in nontarget animals. Endosulfan exposure resulted in dose tested. This study was acceptable.” [quote from Cal DPR, 2008]. impaired development in amphibians, reduced cortisol secretion in fish, impaired development of the genital tract in birds and reduced hormone The Agency’s own review of Gilmore et al. (2006) concurred with Cal DPR’s levels and sperm production and produced testicular atrophy in mammals. conclusions, noting particularly: Additionally, endosulfan has been demonstrated to bind to the human estrogen receptor and exhibit significant estrogenic activity. Whether the The dams were offered treated feed from gestation day 6 and during lactation, toxicity endpoints are a result of endocrine disruption is not known. exposing the pups in utero and via milk – the only observed developmental effects However, it is clear that organisms treated with endosulfan did exhibit some (delays) occurred with signs of maternal toxicity; toxic effects that have historically been associated with endocrine disrupting The motility, count and morphology of sperm from the male pups was assessed – chemicals, e.g., developmental and reproductive effects.” no treatment-associated effects were noted; Endosulfan was not a developmental neurotoxicant in this test. The Cal DPR (2008) review concluded on the putative endocrine disruption potential: “Although endosulfan has effects in the male reproductive system as has been described in this document, doses that would protect for neurotoxicity Endocrine disruption and other systemic effects would also protect for endocrine disruption The potential for endosulfan to cause endocrine disruption has been widely reported. (observed only at higher doses). The USEPA has revised their position on This interest is due in part because any such effects could give insight to the endosulfan as an endocrine disruptor and on the use of FQPA [Food mechanisms of action resulting in other toxicological endpoints. Such endpoints could Quality Protection Act] safety factors such that the FQPA SF for endosulfan include reproductive and developmental toxicity, carcinogenicity, and mutagenicity / is currently equal to 1 (USEPA, 2007). Additionally, while there were no genotoxicity. Conversely, the demonstrated neurotoxicity of endosulfan could result in inhalation studies performed where fetuses, pups or neonates were exposed, some or any putative endocrine disruption. all data from the acceptable rat inhalation study indicated that young adolescent/adults (age 7-9 week) show systemic toxicity in the absence of “The OECD (1998) defines an endocrine disruptor as “an exogenous histopathological effects to any reproductive organs in either sex. The No substance or mixture that alters function(s) of the endocrine system and Observed Effect Level (NOEL) for inhalation (0.194 mg/kg/day) is consequently causes adverse health effects in an intact organism, or its considered protective of all age groups and data do not warrant the use of progeny, or (sub)populations. A potential endocrine disruptor is an additional uncertainty factors at this time [Cal DPR, 2008].” exogenous substance or mixture that possesses properties that might be expected to lead to endocrine disruption in an intact organism, or it progeny or (sub)populations”“ [quote from APVMA, 2005]. Endosulfan Reassessment – Application June 2008 Page 171 of 244 Page 172 of 244 June 2008 Endosulfan Reassessment – Application “Uncertainty associated with the data gaps has been addressed with the Under the HSNO framework there is no definition or a classification category submission of the USEPA-requested studies (subchronic neurotoxicity & specifically for endocrine disruptors, therefore endocrine disruption is considered to be DNT [Developmental Neurotoxicity] studies—both dietary). The concern a mode of action rather than an effect. A specific adverse health effect needs to be for endosulfan-induced adverse developmental effects in male offspring in shown before a HSNO classification can be applied. utero or via milk was alleviated by the DNT study. No effects to F1 sperm parameters or neurotoxicity occurred in the DNT study at doses up to 29.8 Endosulfan formulations (6.6, 6.7, 6.8 and 6.9) mg/kg/day [Cal DPR, 2008]. The conclusion that endosulfan does not trigger mutagenicity (6.6), carcinogenicity There was no quantitative or qualitative evidence of increased susceptibility (6.7) or reproductive/developmental toxicity (6.8), means that the formulations of to fetuses, neonates or adolescents following in utero or neonatal exposures endosulfan do not trigger these classifications, except for Substance A and D for which of rats or rabbits to endosulfan during gestation or throughout reproduction other components of the mixture trigger reproductive/developmental toxicity (6.8). cycles. The USEPA does not maintain the need for an FQPA safety factor (FQPA = 1x; USEPA, 2007) [Cal DPR, 2008].” For all the endosulfan formulations, target organ systemic toxicity (6.9A) is triggered by the endosulfan based on the 6.9A classification from oral (dietary) studies. Australian working definition Endosulfan sulphate Australian agencies consider that endocrine disruption is not considered to be an adverse end-point per se, but rather is a mode or mechanism of action potentially Various studies have indicated that endosulfan sulphate is the only metabolite to result leading to other toxicological or eco-toxicological outcomes, for example, reproductive, in mammal tissues at significant levels (Deema et al., 1966; Gupta, 1978 in Cal DPR, developmental, carcinogenic or ecological effects [APVMA, 2005]. 2008 p31&33). The APVMA (2005) review concluded on the putative endocrine disruption potential: Like endosulfan, its metabolites were more or less toxic [oral LD50] according to the vehicle used and the species exposed. In general, the toxicity of the lactone and sulfate “It is concluded from the APVMA re-examination of possible endocrine metabolites was similar to or less than that of the parent compound, while the disruption caused by endosulfan that, from a public health perspective, hydroether, ether, and, in particular, the diol were far less toxic. The clinical signs of there are no compelling reasons to change the conclusions of the APVMA poisoning were similar to those induced by the parent compound and included interim report on the endocrine disrupting potential of endosulfan. While piloerection, salivation, hyperactivity, respiratory distress, diarrhoea, tremors, hunching, the effects seen in wildlife indicate that endosulfan may have endocrine and convulsions (JMPR, 1998). disrupting potential in some species, the overall weight of evidence is that endosulfan has limited endocrine disrupting potential in mammals. Dorough et al. (1978 in Cal DPR, 2008) indicated that endosulfan sulfate, the main Furthermore, while endosulfan may be relatively persistent in the metabolite, contributes to the acute endosulfan neurotoxicity, manifested by clonic environment and is capable of long-range transfer, it does not appear to convulsions in rats. [Cal DPR, 2008 p85]. bioaccumulate. The endocrine disrupting potential of endosulfan is not a significant risk to public health under the risk management controls and Bajpayee et al. (2006 in Cal DPR, 2008) assayed an isomeric mixture of - and - health standards established by the recent review.” endosulfan, and endosulfan metabolites (including sulphate) for potential to induce DNA damage in Chinese hamster ovary (CHO) cells and human lymphocytes using the Comet assay. They were also assayed with Salmonella typhimurium strains TA98, TA97a, TA102, TA104 and TA100 (+/- S9 metabolic activation) for mutagenic Agency assessment: potential. The authors reported that all compounds induced statistically significant (p < The essential difference between the two approaches is that the APVMA report suggests 0.01) dose-related increases in DNA damage in both CHO cells and in human that endosulfan does not appear to be an endocrine disruptor in mammals, whereas the lymphocytes. The tested compounds also were mutagenic with the S. typhiurium strains US EPA proposes that the weight of evidence from all studies supports the designation (p < 0.05), primarily TA98. [Cal DPR, 2008 p69] The sulphate was not noted as being of endosulfan as a potential endocrine disruptor. more effective than the isomeric mixture. In the APVMA, US EPA and Cal DPR risk assessments, it has been concluded that In the 2008 reassessment, Cal DPR concluded that: endosulfan has not been proven to be an endocrine disruptor in humans; and, the appropriate NOAELs set for neurotoxicological effects are protective for all other “The acute and chronic commodity endosulfan values were not modified adverse health effects in all human (sub)populations. using any type of toxicological equivalency factor (TEF) method applied to the endosulfan -, - or sulfate forms separately because of their same relative toxicity [Cal DPR, 2008 p175]” Endosulfan Reassessment – Application June 2008 Page 173 of 244 Page 174 of 244 June 2008 Endosulfan Reassessment – Application Appendix B – Environmental hazard profile The New Zealand MRL residue definition is for the sum of - and -endosulfan plus endosulfan sulphate, reflecting that the toxicity of endosulfan sulphate is considered to be similar to that of the parent isomers. The Agency concurs that: as endosulfan sulphate is the primary metabolite in mammals, Aquatic Toxicity its toxicity has been adequately evaluated in the submitted regulatory toxicity studies on The ANZECC (2000) acute toxicity database was used by the Agency to derive HC5 endosulfan technical; and, specific studies using endosulfan sulphate indicate that the values (concentrations at which the acute toxicity LC50/EC50 is exceeded for 95% of metabolite appears no more toxic than the parent isomers. species tested). The data are tabulated below. The data are also shown plotted as acute toxicity species sensitivity distributions for fish (freshwater and marine) and crustacea (freshwater and marine) and a combination of acute toxicity data for all species. Endosulfan residue burdens The Agency used these data to determine HC5 values for those higher taxa/compartment Submitter(s) included a number of papers reporting levels of endosulfan residues found combinations (fish/marine, fish/freshwater, crustacea/marine, crustacea/freshwater) with in various human matrices (blood, adipose, etc.) (Cerrillo et al., 2006; Torres et al., more than 8 species. The BurrliOZ software of ANZECC (2000) was used to determine 2006; Bouvier et al., 2006; Lopez-Espinosa et al., 2007; Lino et al., 2006; Botella et al., which particular Burr Type III statistical distribution best fits the data. The software 2004; Sanghi et al., 2003 ; Shen et al., 2007; Cerrillo et al., 2005; Campoy et al., 2001a; calculates the HC5 from the distribution. Prior to calculating HC5 values, the Agency Burke et al., 2003; Campoy et al., 2001b; Fukata et al., 2005; Carreno et al., 2007; excluded all data in which the toxicity value exceeded a water solubility of 0.33 mg/l Hernandez et al., 2002; Shen et al., 2008; Arrebola et al., 2001; Cooper et al., 2001). and calculated a geometric mean where there was more than one datum for a species. The presence of residues is not, per se an adverse health effect under the scope of the HSNO Act. A summary of the ANZECC (2000) chronic toxicity database is also shown. Several submitted papers did try to link endosulfan exposure to an adverse health effect, but each was deficient: for example, were unable to show causality due to multiple chemical exposures (Damgaard et al., 2006; Martinez Vidal et al., 2002; Younglai et al., 2002). Endosulfan Reassessment – Application June 2008 Page 175 of 244 Page 176 of 244 June 2008 Endosulfan Reassessment – Application Table B1: Aquatic toxicity data (after ANZECC, 2000) 27 28 Taxon Species Medium Test Type Duration(h) Endpoint Effect Ecotoxicity value (µg/l) # tests ( Fish Anabas testudineus Freshwater Acute 48 LC50 MORT 1.63 3 3 Fish Anguilla anguilla Freshwater Acute 48 LC50 MORT 34.04 18 18 Fish Barbus conchonius Freshwater Acute 48 LC50 MORT 21.36 1 1 Fish Barbus sophore Freshwater Acute 48 LC50 MORT 1.09 4 4 Fish Barbus stigma Freshwater Acute 96 LC50 MORT 1.93 1 1 Fish Bidyanus bidyanus Freshwater Acute 96 LC50 MORT 2.35 2 2 Fish Caridina weberi Freshwater Acute 48 LC50 MORT 10.56 12 12 Fish Catla catla Freshwater Acute 48 LC50 MORT 1.67 6 9 Fish Channa gachua Freshwater Acute 48 LC50 MORT 9.16 12 12 Fish Channa punctatus Freshwater Acute 48 LC50 MORT 6.18 10 11 Fish Cirrhinus mrigala Freshwater Acute 96 LC50 MORT 2.50 1 1 Fish Clarias batrachus Freshwater Acute 48 LC50 MORT 7.30 8 8 Fish Cyprinus carpio Freshwater Acute 48 LC50 MORT 2.47 9 9 Fish Cyprinus carpio carpio Freshwater Acute 48 LC50 MORT 33.60 1 1 Fish Cyprinus carpio Freshwater Acute 96 LC50 MORT 5.20 1 1 Fish Gambusia holbrooki Freshwater Acute 48 LC50 MORT 3.46 18 18 Fish Gambusia patruelis Freshwater Acute 48 LC50 MORT 63.00 1 1 Fish Gasterosteus aculeatus Freshwater Acute 48 LC50 MORT 6.00 1 1 Fish Heteropneustes fossilis Freshwater Acute 48 LC50 MORT 9.45 36 36 Fish Hypseleotris galii Freshwater Acute 96 LC50 MORT 2.20 1 1 Fish Ictalurus punctatus Freshwater Acute 96 LC50 MORT 1.50 2 2 Fish Labeo rohita Freshwater Acute 96 LC50 MORT 1.17 2 2 Fish Lepidocephalus thermalis Freshwater Acute 96 LC50 MORT 30.00 1 1 27 Ecotoxicity value is the geometric mean of test results on each species excluding those that are greater than the water solubility (0.33 μg/l) 28 LoS – limit of solubility Endosulfan Reassessment – Application June 2008 Page 177 of 244 27 28 Taxon Species Medium Test Type Duration(h) Endpoint Effect Ecotoxicity value (µg/l) # tests ( Fish Lepomis macrochirus Freshwater Acute 48 LC50 MORT 3.32 13 13 Fish Macquaria ambigua Freshwater Acute 96 LC50 MORT 0.39 2 2 Fish Melanotaenia duboulayi Freshwater Acute 96 LC50 MORT 2.57 5 5 Fish Morone saxatilis Freshwater Acute 96 LC50 MORT 0.22 7 7 Fish Mystus cavasius Freshwater Acute 96 LC50 MORT 1.90 1 1 Fish Mystus vittatus Freshwater Acute 48 LC50 MORT 0.52 3 3 Fish Nematolosa erebi Freshwater Acute 96 LC50 MORT 0.20 1 1 Fish Nuria danrica Freshwater Acute 48 LC50 MORT 17.49 2 2 Fish Oncorhynchus mykiss Freshwater Acute 48 LC50 MORT 0.85 56 56 Fish Oreochromis aureus Freshwater Acute 96 LC50 MORT 2.75 2 2 Fish Pimephales promelas Freshwater Acute 48 LC50 MORT 1.31 37 37 Fish Poecilia reticulata Freshwater Acute 48 LC50 MORT 6.49 5 5 Fish Rasbora sp Freshwater Acute 96 LC50 MORT 0.20 2 2 Fish Tilapia aurea Freshwater Acute 72 LC50 MORT 2.73 14 14 Fish Tilapia mossambica Freshwater Acute 48 LC50 MORT 6.49 17 17 Fish Tilapia nilotica Freshwater Acute 48 LC50 MORT 2.32 2 2 Fish Tilapia zillii Freshwater Acute 48 LC50 MORT 1.33 2 2 crustacea Alonella sp Freshwater Acute 48 LC50 MORT 0.20 2 2 crustacea Barytelphusa guerini Freshwater Acute 96 LC50 MORT 1 crustacea Caridinides sp Freshwater Acute 48 EC50 IMM 3.97 3 3 crustacea Ceriodaphnia dubia Freshwater Acute 48 EC50 IMM 161.00 1 3 crustacea Cypria sp Freshwater Acute 48 LC50 MORT 0.90 2 2 crustacea Daphnia carinata Freshwater Acute 48 EC50 IMM 180.00 1 2 crustacea Daphnia longispina Freshwater Acute 48 LC50 MORT 0.30 1 1 crustacea Daphnia magna Freshwater Acute 48 EC50 IMM 188.22 28 46 crustacea Diaptomus sp Freshwater Acute 48 LC50 MORT 0.60 2 2 crustacea Eucyclops sp Freshwater Acute 48 LC50 MORT 0.10 2 2 Page 178 of 244 June 2008 Endosulfan Reassessment – Application 27 28 Taxon Species Medium Test Type Duration(h) Endpoint Effect Ecotoxicity value (µg/l) # tests ( crustacea Gammarus lacustris Freshwater Acute 48 LC50 MORT 5.94 4 4 crustacea Macrobrachium Freshwater Acute 48 LC50 MORT 4.71 3 3 crustacea Macrobrachium lamarrei Freshwater Acute 48 LC50 MORT 3.89 3 3 crustacea Macrobrachium Freshwater Acute 48 LC50 MORT 6.24 4 4 crustacea Moinodaphnia macleayi Freshwater Acute 48 EC50 IMM 215.00 1 1 crustacea Oziotelphusa senex senex Freshwater Acute 48 LC50 MORT 13 crustacea Paratelphusa Freshwater Acute 48 LC50 MORT 0.22 3 3 crustacea Paratya australiensis Freshwater Acute 48 EC50 IMM 9.47 6 6 crustacea Potamonautes sp Freshwater Acute 48 LC50 MORT 1 crustacea Procambarus clarki Freshwater Acute 96 LC50 MORT 24.00 1 2 crustacea Enallagma sp Freshwater Acute 48 LC50 MORT 19.17 2 2 crustacea Notonecta sp Freshwater Acute 48 EC50 IMM 0.72 2 2 crustacea Pteronarcys californica Freshwater Acute 48 LC50 MORT 3.09 3 3 crustacea Sigara alternata Freshwater Acute 48 LC50 MORT 12.30 1 1 Molluscs Lamellidens corrianus Freshwater Acute 96 LC50 MORT 31.04 3 3 Molluscs Lamellidens marginalis Freshwater Acute 96 LC50 MORT 20.52 3 3 Molluscs Lymnaea natalensis Freshwater Acute 48 LC50 MORT 1 Molluscs Melanopsis dufouri Freshwater Acute 96 LC50 MORT 3 Amphibians Rana tigrina Freshwater Acute 48 LC50 MORT 1.90 2 2 Fish Atherinops affinis Marine Acute 96 LC50 MORT 1.30 1 1 Fish Cymatogaster aggregata Marine Acute 96 LC50 MORT 1.10 2 2 Fish Cyprinodon variegatus Marine Acute 96 LC50 MORT 1.38 18 18 Fish Fundulus heteroclitus Marine Acute 96 LC50 MORT 1.15 2 2 Fish Lagodon rhomboides Marine Acute 96 LC50 MORT 0.30 1 1 Fish Leiostomus xanthurus Marine Acute 48 LC50 MORT 0.26 3 3 Fish Menidia beryllina Marine Acute 96 LC50 MORT 1.50 1 1 Fish Morone saxatilis Marine Acute 96 LC50 MORT 0.10 2 2 Endosulfan Reassessment – Application June 2008 Page 179 of 244 27 28 Taxon Species Medium Test Type Duration(h) Endpoint Effect Ecotoxicity value (µg/l) # tests ( Fish Mugil cephalus Marine Acute 48 LC50 MORT 1.55 8 8 Fish Mugil curema Marine Acute 48 LC50 MORT 0.60 1 1 Fish Oncorhynchus kisutch Marine Acute 96 LC50 MORT 2.10 1 1 crustacea Acartia tonsa Marine Acute 96 LC50 MORT 0.14 6 6 crustacea Callinectes sapidus Marine Acute 48 EC50 IMM 19.67 2 2 crustacea Cancer magister Marine Acute 96 EC50 IMM 1.96 2 2 crustacea Crangon septemspinosa Marine Acute 96 LC50 MORT 0.69 3 3 crustacea Mysidopsis bahia Marine Acute 96 LC50 MORT 0.97 21 21 crustacea Palaemonetes pugio Marine Acute 96 LC50 MORT 0.80 24 24 crustacea Penaeus aztecus Marine Acute 48 EC50 IMM 0.21 2 2 crustacea Penaeus duorarum Marine Acute 96 LC50 MORT 0.17 1 1 crustacea Penaeus indicus Marine Acute 48 LC50 MORT 1.29 3 3 crustacea Penaeus monodon Marine Acute 48 LC50 MORT 17.73 5 5 crustacea Scylla serrata Marine Acute 48 LC50 MORT 92.06 2 3 Molluscs Crassostrea madrasensis Marine Acute 48 LC50 MORT 17.38 3 3 Molluscs Crassostrea sp. Marine Acute 96 EC50 GRO 65.00 1 1 Molluscs Crassostrea virginica Marine Acute 96 EC50 GRO 52.25 2 2 Molluscs Katelysia opima Marine Acute 48 LC50 MORT 15.37 3 3 Molluscs Meretrix casta Marine Acute 48 LC50 MORT 16.01 3 3 Molluscs Paphia laterisulca Marine Acute 96 LC50 MORT 1.96 1 1 Annelids Dinophilus gyrociliatus Marine Acute 48 LC50 MORT 6 Annelids Neanthes Marine Acute 96 LC50 MORT 196.60 4 4 Page 180 of 244 June 2008 Endosulfan Reassessment – Application Fish, marine, acute Figure B1: Species Sensitivity Distributions of tabulated acute toxicity data (after ANZECC, 2000) Fish, freshwater, acute Crustacea, marine, acute Crustacea, freshwater, acute Endosulfan Reassessment – Application June 2008 Page 181 of 244 Page 182 of 244 June 2008 Endosulfan Reassessment – Application All taxa, acute # tests (all) 30) # tests ( Effect MORT 230.00 MORT 1 1 50 Endpoint Endpoint Duration(h) Duration(h) Test Type Type Test Medium Freshwater Chronic 144 Freshwater Chronic 1512 Freshwater Chronic NOEC 336 Freshwater Chronic NOEC HAT 1536 39.00 Freshwater Chronic REP 0.20 NOEC 336 Freshwater Chronic NOEC REP 336 10.00 Freshwater Chronic 2.70 MORT 120 NOEC 120 Marine Chronic REP LC 336 NOEC 80.00 20.00 Marine Chronic REP GRO NOEC NOEC 2 GRO 100.00 1 1 1 1 2 1 1 1 1 1 1 1 1 1 the ANZECC (2000) database (2000) database ANZECC the Species Sarotherodon dubia Ceriodaphnia Daphnia magna Moinodaphnia macleayi Chlorella vulgaris aurelia Paramecium Strongylocentrotus parvula Champia Melanotaenia fluviatilis of solubility LoS – limit Ecotoxicity of test results on each value is the geometric species excludingmean those that are greater than the water solub Echinoderms algae Red crustacea Green algae Protozoa Fish crustacea crustacea Taxon Taxon Fish Page 184 of 244 244 Page 184 of May 2008 – Application Endosulfan Re-assessment 29 30 Table B2: of toxicity summary Chronic Endosulfan Reassessment – Application June 2008 Page 183 of 244 Reports of plant toxicity from USEPA ECOTOX – original documents not sourced by the Agency Table B3: Plant toxicity as in USEPA ECOTOX database Lifestage Duration Concentrations treated (days) tested Endpoint Effects Lactuca sativa Seeds 7-14 14 d EC50 > 1000 ug/g (germination ) Field Cajanus cajan ? spray ? harvest NOEL (biomass) 360 g ai/ha 96% survival after 14 days Lycopersicon ? 1 month Repeat 1 month NOEL 1 lb/acre (1.14 (greenhouse) esculentum applications at 1 (abundance) kg/ha) lb/acre Hordeum vulgare Seeds 1.25 days 0.05% & 0.1% Cell damage None mitotic 25% at 0.05%; abnormality 43% at 0.1% Lagenaria Whole plant 7 days 0.03% General damage 27% siceraria Exposure route Cucumis Whole plant 7 days 0.03% General damage None contact sativus Citrullus linatus Whole plant 7 days 0.03% General damage None Lab Ribes sp Whole plant 28 days 0.05% Chlorosis None Malus Whole plant 7 days 1.23 g/l Photosynthesis None domestica Result Sorghum Whole plant 3 years 0.16-0.5 kg Seed yield None bicolor ai/ha, x/year (enhanced 31 yield in 3rd year) Adverse effect Adverse effect – oralLow exp Food effectLow No effect Adverse effect No effects Adverse effect No effects No adverse effects No adverse effects Brassica Male 7 days 50 l/ha Sterility 18% Average to severe effect Contact oleracea gametophytes (adult) No mortality Directly sprayed (adult) >50% survival after 72 h Directly sprayed + (larvae) toxicity Low Contact (larvae) 100% mortality after 150-200 h Food andcontact (larvae) Severe adverse effect (adults) effect Low effect Low Lindorus lophanthae Cryptolaemus montronzieri Brumus Harpalus affinis Amara spp Chrysoperla carnea S. vitripennis Species Hippodamia convergens Chrysoperla spp Epistrophe balteata Aphelinus mali Philonthus fuscipennis Tachyporus hypnorum Pterostichus melanarius Bembidion quadricmaculatum oppositum Coccinella novemnotata Results are reported (dose and/or application rate) are not given. treatment as comments as in Brasse (1985), 31 244 Page 186 of June 2008 – Application Endosulfan Reassessment Hymenoptera Hymenoptera Chrysopidae (lacewings) Syrphidae (hoverflies) Carabidae (ground beetles) Staphylinidae beetles) (rove Family Coccinelidae (ladybirds) Table B4: Table B4: (1985) by Brasse reported invertebrates on non-target Test results Non-target invertebrate toxicity Non-target invertebrate toxicity are shown in Section XXX. non-target invertebrate risk assessment Effects concentrations used by the Agency in the and Biobest (2008) as follows: is provided by Brasse (1985) Additional information May 2008 Endosulfan Re-assessment – Application Page 185 of 244 Lab Field Family Species Result Exposure route Metaphycus luteolus Low toxicity Oral Aphytis melinus Severe toxicity Contact Trichogramma cacoeciae Severe toxicity Phygadeuon trichops Encarsia formosa Coccygomimus turionellae Leptomastix dactylopii Low toxicity Apis mellifera Toxic Little adverse effect Predatory mites Typhlodromus tiliae No or low adverse effect T. tiliarum Bryobia rubrioculus (adult & eggs) Amblyseius fallacis No or low adverse effects No adverse effect A. potentillae Slightly toxic Typhlodromus pyri No or low adverse effects Increase in population, then reduction after population 7 d Endosulfan Reassessment – Application June 2008 Page 187 of 244 8 My20 Endosulfan Re-assessment – Application 2008 May 188 32 Test results on non-target invertebrates Table B5: Phytoseiulus persimilis persimilis Phytoseiulus Paecilomyces fumosoroseus / Orius laevigatus Orius insidiosus Macrolophus caliginosus & H. aculeifer miles Hypoaspis Eretmocerus ssp. Encarsia formosa isaea / Diglyphus sibirica Dacnusa Coleoptera Chrysopa carnea Bombus spp persicae / Therodiplosis aphidimyza Aphidoletes ssp. Aphidius nemoralis Anthocoris Amblyseius swirskii degenerans Amblyseius Amblyseius cucumeris Amblyseius californicus Species Lifestage Toxicity classification Treatment (dose) unknown, but stated that list is climatic Treatment (dose) unknown, but stated that list horticultural and European based on Western Toxic, >75% death toxic, 50-75% death; toxic, 25-50% death; Moderately Non-toxic, <25% death; Slightly conditions. non-toxic non-toxic toxic Nymph/Adult toxic Adult toxic Adult moderately Nymph/Adult slightly Adult toxic toxic Adult toxic Adult toxic toxic Adult toxic Adult Colony Not toxic Adult toxic Adult moderately Adult compatible Nymph/Adult toxic Nymph/Adult toxic Nymph/Adult slightly Nymph/Adult toxic toxic Nymph moderately moderately Nymph Nymph toxic toxic Larva non-toxic Larva non-toxic Larva slightly moderately Larva toxic toxic reported by Bio reported by best (2008) 32 Appendix C – Monitoring studies examined by the Agency Table C1: Summary of monitoring studies examined by the Agency Metabolites Matrix Where included Concentration Number samples Local endosulfan use Reference air North America & Up to 158 pg/m3 Many Highest concentrations found in Shen et al major fruit-growing area. 2005 rain Newfoundland, New & 1.2-3.8 ng/l (median) 4 sites; Unknown. 3 of 4 sites in National Brun et al 2007 Brunswick, Nova Scotia 28-241 samples Parks assumed to have no endosulfan usage. One site at least has no cultivation in the State. rain Great lakes & & 1.2 ng/l (geomean, 1 site), 5 sites; approx Unknown. Distance to use sites not Carlson et al sulphate other sites only shown in figure monthly sampling recorded, but stated that (2004) concentrations generally higher at closer sites. rain 'Remote mountain sites' in & & 0.2-340 ng/m2/month2 3 sites; sampled Unknown. Deposition highest in Carrera et al Alps, Pyrenees and sulphate up to 24 x over 2 Southern European sites, reflecting 2002 Caledonian Mtns (Norway) years usage pattern. rain Great lakes & Mostly 1-10 ng/l 7 sites Unknown. Distance to use sites not Sun et al 2006 recorded, but stated that concentrations generally higher at closer sites. Ice Antarctica & , sulphate, 0.3 μg/l (ice) 1 Presumed to be none Deger et al ether & lactone 2003 River water India ? 114 +/-20 ng/l 20 Unknown. River receives large Aleem & Malik volume of domestic and industrial 2005 waste. Runoff water Australia -, - & 2.5-45 μg/l 671 water Samples from cotton fields to which Kennedy et al sulphate 782 soil endosulfan applied 3 or 4x at 0.75 kg (2001) 58 sediment a.i./ha Endosulfan Reassessment – Application June 2008 Page 189 of 244 Metabolites Matrix Where included Concentration Number samples Local endosulfan use Reference Surface water Australia -, - & 0.05-0.1 μg/l with higher peaks ? Cotton growing district, location of Raupach et al sulphate up to about 1.5 μg/l sample points in relation to 2001 application areas not given. Surface water Uluabat lake, Turkey Endosulfan & ND-51.4 μg/l (water) 6 sites; Unknown. Agricultural area. Sites Barlas et al sediment 107.8 ng/g (sediment) 5 samples selected with high sedimentation or 2006 industrial activity. Surface water Various river basins in & 0.36 μg/l (max water) Various rivers Unknown, but stated to be Cerejeira et al groundwater Portugal Not detected (groundwater) agricultural areas. 2003 Marine Hugli estuary, India Endosulfan & ND-0.4 ug/g dw 30 sampling Unknown – estuary receives Bhattacharya sediment sulphate occasions untreated sewage, industrial effluents et al 2003 mining & agricultural runoff Marine Alexandria harbour, Egypt ? <0.25-22 ng/g dw 23 Unknown. Sampling from areas with Barakat et al sediment freshwater and wastewater input and 2002 'pristine' areas. Suspended Lourens River estuary, & & 18.6 ug/kg (90 %ile) Every 14 d for 2 Unknown - catchment includes Bollmohr et al solids South Africa sulphate years vineyards, apple, pear and plum (2007) orchards with application rates of 158 kg/ha [sic]. Suspended Brittany, France 137.5, 17.9 ug/kg dry weight, 16 sites Streams adjacent to agricultural Schafer et al particles & 14 non-detects production, but use of endosulfan 2007 sediment unknown. groundwater Morocco Yes 0.006-0.2 μg/l 6 sites; Agricultural area (strawberries, El Bakouri soil 5.7 ug/g dw (avg) # samples potatoes, industrial tomatoes, citrus 2007 unknown fruits, groundnuts, sugar cane). Endosulfan use unknown. Lake water Prawn farms in coastal ? 99 ng/l (max - water) 6 Endosulfan used directly in prawn Amaranemi Lake sediment lake, India 90-238 ug/g dw (sediment) ponds. Lake receives industrial 2006 Prawns 28 ug/g ww (max prawns) effluents, sewage and agricultural waste. Page 190 of 244 June 2008 Endosulfan Reassessment – Application Metabolites Matrix Where included Concentration Number samples Local endosulfan use Reference Precipitation & Rocky Mountain & Glacier Up to 2.5 ng/l (snow) 16 sites Not locally. Distance to use sites not Mast et al 2007 sediment NP, North America 0 to 0.44 ug/kg (sediment) (precipitation) recorded. 21 sites (sediment) Fish Mar Chiquita coastal & & 1-14 ng/g wet weight for ? Sampling site is nature reserve, Menone et al lagoon, Argentina sulphate different tissues endosulfan use unrestricted in 2000 Argentina, Elephant seal Elephant Island, Antarctic & & 0.9, 2.0, 2.7, 3.0 ng/g lipid 66 animals Presumed not locally. Distance to Miranda-Filho blubber peninsula sulphate (pups, juveniles, adult females, use sites not recorded. et al, 2007 adult subdominant males respectively) Bark 32 countries incl 3 sites in 10-100 ng/g lipid Unknown Simonich & New Zealand Hites 1995 Bark 32 countries, 6 samples 42 ng/g lipid (avg) Unknown Simonich & from New Zealand Hites, 1997 Endosulfan Reassessment – Application June 2008 Page 191 of 244 ae12o 4 Jn 08 Endosulfan Reassessment – Application 15 Sept & Jan June 2008 N/A PRZM/EXAMS II) (Tier Page 192 of 244 soil DT Aerobic I) GENEEC2 (Tier Koc 10600 date Application frequency/season Application 10600 a.i./ha) rate (kg Application Max Use Model Comparison of Agency and Table D1: New below. Most notable are: modelled by USEPA for US use and the Agency New Zealand differ as shown from surface runoff and leaching to groundwater and spraydrift. The scenarios USEPA (2007c) use PRZM/EXAMS to model environmental concentrations resulting USEPA performed by the Agency. performed for New Zealand is instructive, and helps to position the Tier 1 modelling Nevertheless, a comparison of the outcomes with those from the Tier I analysis appropriate caution. and a direct comparison of Tier I and II analyses must therefore be made with application, Tier I and II analyses are not available for New Zealand use conditions which Tier II modelling is applied should be the same as that analysed in Tier I. In this conclusions of the more conservative Tier I model. In this context, the use scenario to Tier II modelling is normally a refinement of Tier I and is performed to clarify the use patterns used in these analyses and those New Zealand. relate to the use of endosulfan in US. There are significant differences between the (USEPA, 2007c) and one from Makhteshim (Ramanarayanan et al 1999), both of which The Agency has reviewed two Tier II analyses of aquatic risk, one from the USEPA patterns. No Tier II modelling has been performed to reflect New Zealand conditions and use Appendix D – Tier II modelling of aquatic risks drift. The method of application is different, giving rise to different estimates of spray parameters. model which is simpler than the Tier II PRZM/EXAMS model with fewer input GENEEC2, used by the Agency for analysis of use in New Zealand is a Tier I 50 (as 13 1336 1336 (days) with label with label in accordance use Zealand Label . . . 1.12 0.7 2.1 1.3 3 4 1 2 ERMA New ERMA New Zealand USEPAex aquatic off-label use use off-label Max advised Turf off-label use use off-label Max advised posure modelling inputs Citrus California) California) in Florida & strawberry in (tomato in USA Max use USEPA (2007c) ERMA New Zealand USEPA (2007c) (Ramanarayanan et al 1999). These analyses take account of both ‘realistic’, as defined Label Turf Citrus by market research, and label-specified usage patterns. The estimates also model the effect of buffer zones. Methods of application Boom sprayer Boom sprayer Airblast Aerial (high) (low) Exposure was modelled using PRZM, EXAMS and AgDrift (Ramanarayanan et al % drift 1.2% 0.8% 9.7% 5% (1999). PRZM estimates the endosulfan load into a 1 ha, 2 m deep pond adjacent to a (default values for application method) treated 10 ha field, EXAMS simulates the fate and transformations of endosulfan in the Water solubility (mg/l) 0.33 3.333 pond and AgDrift estimates off-target spray deposition. Preliminary analyses Aerobic aquatic DT50 19 (dissipation) 2671 (aerobic aquatic) (Ramanarayanan & Allen 1999a) investigated the sensitivity of the models to input (days) 19 (hydrolysis) parameters and the output of this analysis was used to select conservative scenarios for the full analysis. A summary of the preliminary analysis is given in Appendix D. Aqueous photolysis DT50 Stable Stable In the full analysis (Ramanarayanan et al, 1999), the five major US crops were identified and, within the regions where they are grown, potentially high runoff and The results of USEPA (2007c) compared to those from the Agency’s prediction for erodible soils were identified (Ramanarayanan & Allen, 1999b), based on the results of New Zealand: preliminary sensitivity analyses (Ramanarayanan & Allen, 1999a). Exposure estimates were made for each of these crop/soil scenarios: Table D2: Comparison of Agency and USEPA aquatic exposure concentrations Expected Environmental Concentrations (µg/l) Table D3: Exposure scenarios modelled by Ramanarayanan et al (1999) ERMA New Zealand USEPA Crop Region Soil Label Turf Citrus Tomato, (first Strawberry (first Apples Ontario Plains and Finger Lakes (NY) Collamer silty loam application 15 application Output Sept) 15 Jan) Cucurbits (cantaloupes) Sacramento & San Joaquin Valley Garces silty loam (CA) Peak EEC 13 10 17 23 12 Cotton Southern Mississippi Silty uplands Loring silty loam 21 day average EEC 8.9 6.7 11.1 9.3 5.5 (LA) 60 day average EEC 4.8 3.6 6 6.8 3.9 Potatoes Central Snake River Plains (ID) Rad silty loam Tomatoes South Florida Flatwoods (FL) Pomello fine sand The New Zealand citrus scenario is most similar to the United States analysis in terms of use pattern, differing most significantly in a higher drift figure. Despite these Analyses were performed using both label-specified application rates and frequencies differences, the output of the United States and New Zealand modelling is broadly and ‘realistic’ application rates and frequencies as identified by market research: similar. Australia APVMA (1998) model the effect that vapour transport could have on endosulfan concentrations in a 50 cm deep river 1 km downwind from a 1 km2 cotton field to which endosulfan was applied. This analysis suggests that a concentration of 0.1 μg/l could be derived by vapour transport, as compared to 0.2 μg/l by runoff and 1.4 μg/l by drift. The corresponding water quality guideline is 0.03 μg/l for slightly to moderately disturbed freshwaters (ANZECC, 2000). APVMA (1998) do not give the temperature at which this analysis was performed, but it would be expected to have an influence on the relative importance of the different routes of environmental transport. Makhteshim Makhteshim has provided the Agency with environmental exposure modelling performed for endosulfan usage in the USA, based on a wide variety of crops/application methods and site-specific meteorological and hydrological conditions 33 Model input is 10 times actual water solubility, in accordance with guidance for the model. Endosulfan Reassessment – Application June 2008 Page 193 of 244 Page 194 of 244 June 2008 Endosulfan Reassessment – Application Table D4: Application details modelled by Ramanarayanan et al (1999) Table D6: Aquatic exposure estimates made by Ramanarayanan et al (1999) Scenario Label-specified application Realistic application Runoff 90% Expected Environmental Application buffer zone Concentration (µg/l) Rate per (300’, 91 application Rate per 34 Peak 96 h 21 day 90 day lb a.i./acre application Crop Method Rate (kg/ha) m) (kg a.i./ha) Applications per year lb a.i./acre (kg/ha) Applications per year Apple Airblast 3 x 1.12 Label No 0.25 0.17 0.075 0.028 Apples 1.0 (1.1) 3 1.5 (1.7) 1 1 x 1.68 Realistic No 0.33 0.22 0.080 0.028 Cantaloupes 1.0 (1.1) 3 1.1 (1.2) 1 Cantalou Boom 3 x 1.12 Label No 0.23 0.15 0.064 0.03 pe Cotton 1.0 (1.1) 3 0.4 (0.45) 3 1 x 1.23 Realistic No 0.15 0.049 0.013 0.003 Potatoes 1.0 (1.1) 3 0.8 (0.91) 1 Cotton Aerial 3 x 1.12 Label No 3.5 2.4 1.2 0.49 Tomatoes 0.5 (0.57) 6 0.75 (0.85) 1 3 x 1.12 Label Yes 0.89 0.59 0.27 0.13 3 x 0.45 Realistic Yes 0.37 0.24 0.11 0.050 The effects of a run-off buffer zone are not built into the PRZM model, but were Potato Aerial 3 x 1.12 Label No 0.68 0.48 0.22 0.10 included in the analysis of Ramanarayanan et al (1999) using a method developed by Waterborne International Inc. (Ramanarayanan et al, 1999). These developments have 1 x 0.9 Realistic No 0.46 0.32 0.15 0.051 been validated in a field trial of endosulfan run-off from cotton in South Carolina Tomato Aerial 6 x 0.56 Label No 4.1 2.7 1.0 0.48 (Ramanarayanan et al, 1999). The model was used to determine the effects of a 300’ 6 x 0.56 Label Yes 0.61 0.40 0.17 0.082 (90 m) buffer zone on the expected environmental concentration in a pond receiving 1 x 0.84 Realistic Yes 0.34 0.22 0.08 0.03 runoff from a treated field. Boom 6 x 0.56 Label No 4.2 2.8 1.0 0.49 The results of the AgDrift estimates of deposition on a water body separated from the 6 x 0.56 Label Yes 0.78 0.51 0.21 0.088 treated field by buffer zones of different sizes are shown in Table D5. On the basis of 1 x 0.84 Realistic Yes 0.23 0.15 0.063 0.026 these data, drift was input to the PRZM model as 0.03% for airblast applications, 0.19% for ground applications and an amount varying between 0.23% and 0.62% depending on crop for aerial application. These % drift figures compare to PRZM default values of Summarising information in the above table, the effect of the 300’ (90 m) buffer is to 5% for aerial and 1% for ground applications. reduce the total endosulfan ( - and -isomers and endosulfan sulphate) loading to the pond through runoff and erosion as follows: Table D5: Percentage drift used in modelling by Ramanarayanan et al (1999) Drift to a Standard Water Body (% of applied)1 Table D7: Summary of the effect of a buffer zone on aquatic exposure concentrations (as Method of modelled by Ramanarayanan et al, 1999) application Crop 30’ (9.1 m) buffer 100’ (31 m) buffer 300’ (91 m) buffer Crop Application % reduction in endosulfan loading Ground Various 0.55 0.36 0.19 Method Rate (kg/ha) Mean Max Min Airblast Various 0.08 0.03 0.0006 Cotton Aerial 3 x 1.12 81 88 61 Aerial Cotton – – 0.62 Tomato Aerial 6 x 0.56 81 86 74 Potato – – 0.23-0.25 Boom 6 x 0.56 85 89 70 Tomato – – 0.48-0.52 1 Figures in bold represent the % drift used in estimating EEC in waterbodies. The Agency notes that the effectiveness of any buffer zone will depend not only on its width, but its topography and vegetation cover. The models enabled a probabilistic estimate of exposure concentration to be made. Such an approach estimates the probability of a concentration distribution, enabling In terms of use pattern (application rate and method), the apple scenario modelled by estimation of the chance of an environmental concentration greater than a particular Ramanarayanan et al (1999) is most similar to the citrus scenario modelled by the value. The 90% estimates were: Agency and the cantaloupe and tomato boom scenarios are most applicable to the Agency’s ‘label’ scenario. The turf scenario modelled by the Agency is not comparable 34 Although the data are presented (Ramanarayanan et al 1999, Appendix 14) as being with or without a buffer zone, the spray drift contribution to the endosulfan loading was input assuming there is a buffer zone of 300’ (91 m) for boom applications, 100’ (31 m) for airblast applications, and a variable size for aerial applications dependent on the crop and meteorological conditions at the time of application. Endosulfan Reassessment – Application June 2008 Page 195 of 244 Page 196 of 244 June 2008 Endosulfan Reassessment – Application to any of Ramanarayanan et al’s analyses. Values for the input parameters used by the The concentrations determined by the Ramanarayanan et al (1999) analysis are lower Agency are compared to those used in the analysis of Ramanarayanan et al (1999) than those determined by the Tier 1 analysis performed by the Agency. The difference below: in percentage drift contributes a large part of this difference, and this difference arises Table D8: Comparison of Agency and Ramanarayanan et al (1999) aquatic exposure modelling because of the more specific information used in AgDrift (compared to GENEEC) and inputs because Ramanarayanan et al (1999) include a 100-300’ (31-91 m) buffer zone in their estimation of drift. To relate the detail of analyses such as these to New Zealand, or to ERMA New Zealand Ramanarayanan et al (1999) run such models for the New Zealand scenario, it would be necessary to compare hydrological and soil physical parameters to the conditions in which the chemical is Label Citrus Canteloupe Tomato Apple used in New Zealand. The Agency has work underway to enable such a detailed (4x0.7 kg (2x1.3 kg Label Realistic Label Label Realistic analysis, but this work is insufficiently advanced to apply it to this application. For the a.i./ha) a.i./ha) current analysis, the Agency has merely drawn broad conclusions from the analysis of (3x1.12 (1x1.23 (6x0.56 (3x1. (1x1.68 kg kg kg 12 kg kg Ramanarayanan et al (1999), as follows: a.i./ha) a.i./ha) a.i./ha) a.i./h a.i./ha) a) Actual use patterns may differ very significantly from label specifications. The Agency has based its assessment on label directions and also on industry estimates Model GENEEC PRZM/EXAMS 2 of actual usage rates for off-label use. Application rate (kg 0.7 1.3 1.12 1.23 0.56 1.12 1.68 As expected, greater use of site-specific input data, for example estimates of a.i./ha) percentage drift, results in lower EEC values. This explains the difference between the estimates made for tomatoes in USEPA (2007c), peak EEC 23 μg/l Application 4 2 3 1 6 3 1 frequency/season compared to the estimates in Ramanarayanan et al (1999), peak EEC 4.1 μg/l. Koc 10600 10660 The modelling of the effects of a buffer zone indicate that a 90 m buffer zone will Aerobic soil DT50 1336 150 reduce the average endosulfan loading by more than 80% under the conditions (days) modelled. Method of application Boom Airblast Boom Airblast (high) % drift 1.2% 9.7% 0.19% 0.03% Water solubility 0.33 0.33 (mg/l) Aerobic aquatic DT50 19 19 (days) Aqueous photolysis Stable Stable DT50 A comparison of the output from the Agency and Ramanarayanan et al’s analyses shows: Table D9: Comparison of Agency and Ramanarayanan et al (1999) aquatic exposure estimates ERMA New Zealand Ramanarayanan et al (1999) Apple Canteloupe Tomato Label Citrus Label Realistic Label Realistic Label (4x0.7 (2x1.3 (3x1.1 (1x1.68 (3x1.12 (1x1.23 (6x0.56 kg kg 2 kg kg a.i./ha) kg kg a.i./ha) kg a.i./ha) a.i./ha) a.i./ha) a.i./ha) a.i./ha) Peak EEC 13 16 0.25 0.33 0.23 0.15 4.1 21 day average EEC 8.3 10.3 0.075 0.08 0.064 0.013 1.0 60 day average EEC 4.2 5.3 0.036 0.033 0.036 0.004 0.56 Endosulfan Reassessment – Application June 2008 Page 197 of 244 Page 198 of 244 June 2008 Endosulfan Reassessment – Application Appendix E – Input and results of analysis used to This emphasises the need for information on regional/local conditions to draw firm conclusions from higher tier modelling. select worst-case sites in Ramanarayanan et al (1999) Using EXAMS, the dissolved and sorbed sediment concentrations were most sensitive to PRBEN and least sensitive to Koc. Physicochemical input parameters used in this analysis were: Using AgDrift, the deposition into a pond 300’ from the edge of a treated field was sensitive to all three meteorological conditions, but particularly relative Table E1: Input parameters in modelling to select ‘worst-case’ scenarios (Ramanarayanan & humidity. Allen, 1999a) a Details of the derivation of these parameters are given in Ramanarayanan (1999a) Preliminary analyses (Ramanarayanan & Allen, 1999a) were performed to determine the sensitivity of the models to specific input parameters, information that was then used to select scenarios likely to lead to high endosulfan concentrations in non-target waters. The preliminary analyses were performed using cotton grown on silty loam as an example and were performed for years representing the median and 90 percentile rainfall. The input parameters investigated were: For PRZM seven hydrological and physical parameters and four compound specific parameters For EXAMS, partition coefficient, degradation rate and the proportion of sorbed sediment sinking to the benthic zone (PRBEN). For AgDrift, the meteorological parameters, wind speed, temperature and humidity. The results showed: Using PRZM, the endosulfan loading to the surface water bodies is more sensitive to hydrological and soil physical parameters than the properties of endosulfan. Endosulfan Reassessment – Application June 2008 Page 199 of 244 Page 200 of 244 June 2008 Endosulfan Reassessment – Application Table F2: Avian acute and chronic risk quotients for a single and multiple broadcast Appendix F – Calculations underlying bird risk applications of endosulfan products based on a bobwhite quail LC50 of 805 ppm, a assessments mallard duck NOEC of 30 ppm and a half-life of 4 days Use Rate Food Items Peak 56 day Acute RQ Chronic RQ c No. Apps. EEC mean (EEC/LC50) (EEC/NOEC) Calculations underlying the field feeding bird risk assessment: Min. (mg/kg) EEC c Interval (mg/kg) peak 56-day EEC/NOEC EEC/NOEC b b Table F1: Summary of T-REX model inputs Label Use Short Grass 181.86 65.91 0.23 6.06 2.20 b b Label Off-label Off-label Off-label Off-label Use 0.7 kg ai/ha Tall Grass 83.35 30.21 0.1 2.78 1.01 Use Label Use Use Turf Use Turf Use Citrus Citrus Broadleaf 102.30 37.07 0.13 3.41 b 1.24 b Input Category USEPA Makhteshim USEPA Makhteshim USEPA Makhteshim 4 Apps. plants/Insects %A.I. 35 35 35 35 35 35 10 days Seed 11.37 4.12 0.01 0.38 0.14 Application 1.784 1.784 5.352 5.352 3.31 3.31 rate (lbs/Acre) Off -label Short Grass 449.57 49.57 0.56 a 14.99 b 1.65 b Half-life (days) 4 0.95 4 4 4 0.95 Use Tall Grass 206.05 22.72 0.26 6.87 b 0.76 Application 10 10 NA NA 14 14 Turf interval (days) Broadleaf 252.88 27.88 0.31 8.43 b 0.93 2.1 kg ai/ha plants/Insects Number of 4 4 1 1 2 2 Applications 1 Apps.– Seed 28.10 3.10 0.03 0.94 0.1 days Avian LD50 28 28 28 28 28 28 (mg.kg bw) Off-label Short Grass 302.62 61.30 0.38 10.09 b 2.04 b Use b Avian LC50 805 805 805 805 805 805 Tall Grass 138.70 28.09 0.17 4.62 0.94 (mg.kg diet) Citrus Broadleaf 170.22 34.48 0.21 5.67 b 1.15 b Avian LD50 30 30 30 30 30 30 1.3 kg ai/ha plants/Insects (mg.kg bw) 2 Apps. Seed 18.91 3.83 0.02 0.63 0.13 Mineau scaling 1.15 1.15 1.15 1.15 1.15 1.15 14 days factor a exceeds acute high LOC b exceeds chronic LOC Application Broadcast Broadcast Broadcast Broadcast Broadcast Broadcast type c estimated environmental concentrations predicted using 1st-order degradation model based on foliar dissipation. Product Liquid Liquid Liquid Liquid Liquid Liquid physical form Fluid ounces 25.33 25.33 76.00 76.00 47.05 47.05 Table F3: Refined avian acute and chronic risk quotients for a single and multiple broadcast product/Acre applications of endosulfan products based on a bobwhite quail LC50 of 805 ppm, a Assumptions: mallard duck NOEC of 30 ppm and a half-life of 0.95 days. All products contain the active ingredient, endosulfan, at a concentration of 35% w/w; Chronic RQ Use Rate 56 day (EEC/NOEC) Density of all products = 1.08 g/ml; No. Apps. Peak mean Min. EEC c EEC c Acute RQ peak 56-day Conversion of kg/ha to lb/A = multiply by 0.892; Interval Food Items (mg/kg) (mg/kg) (EEC/LC50) EEC/NOEC EEC/NOEC 1 pound = 14.20 ounces (US liquid) accounting for product density; b Label Use Short Grass 149.96 20.31 0.19 5.00 0.68 The foliar dissipation half-life of endosulfan = 4 days (USEPA 2002); 0.7 kg ai/ha Tall Grass 68.73 9.31 0.09 2.29 b 0.31 The foliar dissipation half-life of endosulfan = 0.95 days (Makhteshim). 4 Apps. Broadleaf 84.35 11.42 0.10 2.81 b 0.38 plants/Insects 10 days Seed 9.37 1.27 0.01 0.31 0.04 Off -label Short Grass 449.57 15.23 0.56 a 14.99 b 0.51 Use Tall Grass 206.05 6.98 0.26 6.87 b 0.23 Endosulfan Reassessment – Application June 2008 Page 201 of 244 Page 202 of 244 June 2008 Endosulfan Reassessment – Application Chronic RQ Choosing which process controls the degradation rate and which half-life to use in Use Rate 56 day (EEC/NOEC) No. Apps. Peak mean terrestrial exposure calculations is open for debate and should be done by a Min. EEC c EEC c Acute RQ peak 56-day qualified scientist. Interval Food Items (mg/kg) (mg/kg) (EEC/LC50) EEC/NOEC EEC/NOEC Turf Broadleaf 252.88 8.57 0.31 8.43 b 0.29 T= time, in days, since the start of the simulation. The initial application is on day 0. plants/Insects 2.1 kg ai/ha The simulation is set to run for 365 days. The program calculates concentration on Seed 28.10 0.95 0.03 0.94 0.03 1 Apps. – each type of surface on a daily interval for one year. The maximum concentration days during the year and the average concentration during the first 56 days are calculated. Off-label Short Grass 278.05 18.84 0.35 9.27 b 0.63 Use Calculations underlying aquatic feeding bird risk assessment Tall Grass 127.44 8.63 0.16 4.25 b 0.29 Body residues and equations from USEPA (2007c) used to estimate Toxicity Exposure Citrus Broadleaf 156.40 10.60 0.19 5.21 b 0.35 Ratios (TER) for New Zealand birds feeding in water, are presented. 1.3 kg ai/ha plants/Insects 2 Apps. Seed 17.38 1.18 0.02 0.58 0.04 Predicted concentrations of endosulfan in aquatic organism tissues ( g/kg) at different 14 days trophic levels (Table 14 in USEPA 2007c, Attachment B). The percentile a exceeds acute high LOC concentrations are the result of Monte Carlo simulations to derive residue distributions. b exceeds chronic LOC c estimated environmental concentrations predicted using 1st-order degradation model based on foliar Table F4: Body residues ( g/kg) in aquatic foodweb (USEPA, 2007c) dissipation. Trophic Level Mean SD 25th% 75th % 90th % Phytoplankton 1,279 1,290 383 1,739 3,233 Spreadsheet-based Terrestrial Exposure Values (USEPA, 2002) Zooplankton 1,280 1,307 376 1,742 3,237 A first order decay assumption is used to determine the concentration at each day after Benthic Invertebrates 1,282 1,271 399 1,749 3,188 initial application based on the concentration resulting from the initial and additional applications. The decay is calculated from the first order rate equation: Filter Feeders 1,411 1,588 407 1,857 3,476 Small Forage Fish 3,346 3,755 950 4,477 8,461 -kT CT = Cie Medium Forage Fish 3,447 3,684 960 4,648 8,856 Piscivorous Fish 4,682 20,306 1,051 5,860 11,925 or in log-transformed: The Agency used the mean and 90th percentile information in the above table to ln (CT/Ci) = -kT estimate the exposure of aquatic-feeding birds using the following equations. Equation numbers below refer to USEPA 2007c, Attachment B. Where: = concentration at time T CT Food ingestion rate (FI, kg dry food/kg-bw day) Eq.A.12 FI = 0.0582*Wt0.651 Ci = concentration in parts per million (ppm) present initially (on day zero) on the Fw surfaces. Ci is calculated based on Kanega and Fletcher by multiplying the application rate, in pounds active ingredient per acre, by 240 for short grass, 110 Where Wt is animal body weight (kg); for tall grass, and 135 for broad-leaf plants/insects and 15 for seeds. Additional Fw is food dry weight as a proportion of wet weight (0.2 for ducks and applications are converted from pounds active ingredient per acre to PPM on the 0.25 for heron and grebe). plant surface and the addition mass added to the mass of the chemical still present Note In USEPA (2007c), the denominator in this equation is incorrectly on the surfaces on the day of application. written as Wt, rather than Fw. k= degradation rate constant determined from studies of hydrolysis, photolysis, Drinking water intake (DW) microbial degradation, etc. Since degradation rate is generally reported in terms of Eq.A.14 DW = (0.059 * Wt 0.67) half-life, the rate constant is calculated from the input half-life (k = ln 2/T1/2) instead of being input directly. Where DW is the water intake (litre/day) Note In USEPA (2007c), animal body weight (kg) is referred to as either Wt or BW. Endosulfan Reassessment – Application June 2008 Page 203 of 244 Page 204 of 244 June 2008 Endosulfan Reassessment – Application Total exposure (EEC) 35 Eq.A.15 Dose-based exposure (μg/kg-bw/day) = (% prey*CBprey)*FI + CWTO*DW Wt Where %prey is the estimated proportion of the diet comprised of each food item; CBprey is the concentration in each prey item (μg/kg; Table above); CWTO is the bioavailable concentration in the water (μg/l; assumed equivalent to the Estimated Environmental Concentration (4.8 μg/l) under New Zealand label conditions); 36 DW is the water intake (litre/day; from USEPA, 1993). Eq.A.16 Dietary-based exposure (μg/day) = (% prey*CBprey)*FI*Wt + (CWTO*DW) The overseas authorities have and ADE. used 100, or >300 if the uncertainty factors applies is Estimated toxicity to New Zealand species es. To enable comparison with the RQ where a The toxicity of endosulfan to New Zealand species for which toxicity tests have not been performed is calculated as follows: Dietary-based toxicity – use the available toxicity values (μg/day) Dose-based toxicity (μg/kg-bw/day): (x-1) Eq.A.18 AT=LD50(AW/TW) Where AT is the adjusted toxicity value (toxicity to species for which there are no test data); AW is the body weight of the bird (species) for which a toxicity value is to be estimated; TW is the body weight of the bird (species) for which there are test data; x is the Mineau scaling factor (1.15 used). Risk Quotients Dietary-based Dietary-based exposure (μg/day) Dietary-based toxicity (μg/day) Dose-based Dose-based exposure (μg/kg-bw/day) AT (μg/kg-bw/day) 35 USEPA (2007c) refer to this as Dose-based EEC, but for ease of understanding, the Agency prefers the value >1 is acceptable, MOE result the MOEmust be >100 if is a reciprocal expression. the uncertainty The factors applies are 300. Several overseas Agencies used a higherthan the 100 the Agency 300 rather uncertainty used in deriving its AOEL factors, various NOEL values, sometime a dermal NOEL in there MOE estimates. term Dose-based exposure. Similarly in Eq.A.16, the Agency has substituted the USEPA term Dietary- The results here health are assessed for the human significant using of exposure in accordance with themargin overseas sourc Page 206 of 244 244 Page 206 of June 2008 – Application Endosulfan Re-assessment 36 Appendix G – Margins of exposure for re-entry to endosulfan treated crops Appendix G – Margins of exposure APVMA (2005) based EEC with Dietary-based exposure. Endosulfan Reassessment – Application June 2008 Page 205 of 244 Canada (PMRA, 2007) Endosulfan Reassessment – Application June 2008 Page 207 of 244 Page 208 of 244 June 2008 Endosulfan Re-assessment – Application California (Cal DPR, 2008) Endosulfan Reassessment – Application June 2008 Page 209 of 244 Page 210 of 244 June 2008 Endosulfan Re-assessment – Application Appendix H – Control measures taken overseas of relevance to New Zealand The following discussion includes controls taken to manage risks inherent to the manufacturing of endosulfan formulations. It is noted that currently endosulfan is not manufactured or formulated in New Zealand, but the existing approvals permit such manufacturing and therefore these overseas controls are listed for completeness. United States control Existing HSNO equivalent The USEPA released their Reregistration Eligibility Decision for Endosulfan in Currently Currently no HSNO control. A control could be applied under s77A of the Act. November 2002. restriction that it can only be used for research and development or as an ingredient in the manufacture of another substance or product. The substance endosulfan cannot be used as a pesticide veterinary or medicinebe but may used in the formulation of a pesticide or medicine.veterinary The USEPA did not ban endosulfan but they did place stricter controls on the use of endosulfan formulations. The following table summarises the mitigation measures adopted by the USEPA. for endosulfan. Placement on Label Placement on Directions for Use. Precautionary Statements. Identification and disposal controls apply. Directions for Use. The substance endosulfan currently has a use ]. [fill USEPA labelling changes products for any productsadditional for any for the following use(s)” quirements regarding support previously notifying the local discharge effluent containing this are being supported by MP registrant Spray drift management instructions Labelling Labelling insecticide relevant to New Zealand: Summary of Summary New Zealand: relevant to product to sewer systems systems without product to sewer sewage treatment For guidance plant authority. contact your Water Board or Regional Office of the EPA.” “This toxic product is extremely invertebrates to fish and aquatic and to or to areas directly water, toxic to birds and mammals. Do not apply where surface is present,water the or to intertidal areas below mean mark. high water be hazardous to aquaticDrift and runoff may organisms in water adjacent to treated areas. See under “Directions for use. Do not contaminate disposing water when or rinsate.” of equipment wash waters “Environmental Hazards” “Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or unless in accordance other with waters the requirements of a National Pollutant Discharge Elimination System (NDPES) permit and the permitting authority has been notified in Do not to discharge. writing prior “Only for formulation into an “Only blank only with those uses that be used to formulate products“This for specific product may use(s) has user group, or grower not listed on the MP label if the formulator, complied U.S. EPA submission re with of such use(s).” be used to formulate “This product may the formulator, user group, or use(s) not listed on the MP label if U.S.grower has complied EPA submission requirements with regarding support of such use(s).” Page 212 of 244 244 Page 212 of June 2008 – Application Endosulfan Reassessment Environmental Hazards Statements Required the by RED and Agency Label Policies One of these statements be addedmay to a label to reformulationallow of the product for a specific use or all additional uses a formulator supported by or user group. Manufacturing-Use Products (MUP) Formulation instructions required for all MUP labels. Table H1: Table H1: measures USEPA mitigation Description Endosulfan Reassessment – Application June 2008 Page 211 of 244 Description Labelling Placement on Label Existing HSNO equivalent control End-Use Products Intended for Occupational Use Handler PPE Guidelines Note the following information when preparing labelling for all end use Handler PPE Statements. Appropriate PPE required and identification (all formulations) products: requirements. For sole-active-ingredient end-use products that contain endosulfan, the product label must be revised to adopt the handler personal protective equipment (PPE)/engineering control requirements set forth in this section. Any conflicting PPE requirements on the current label must be removed. PPE that will be established on the basis of Acute Toxicity testing on end-use products undergoing product reregistration must be compared with the active ingredient PPE specified below by the RED. The more protective PPE must be placed in the product labelling. For guidance on which PPE is considered more protective, see PR Notice 93- 7. RUP Statement “RESTRICTED USE PESTICIDE” Approved Handler requirement. Required for All “Due to acute toxicity to humans, aquatic organisms, and avian Formulations species.” “For retail sale to and use only by certified applicators or persons under their direct supervision, and only for those uses covered by the certified applicator's certification. PPE Established by the “Personal Protective Equipment (PPE)” Precautionary Statements: Appropriate PPE required. RED for liquid formulations. “Some materials that are chemical-resistant to this product are Immediately following/below (registrant inserts correct chemical-resistant material). Hazards to Humans and Domestic Animals. “If you want more options, follow the instructions for category” [registrant inserts A,B,C,D,E,F,G, or H] “on an EPA chemical- resistance category selection chart.” “All handlers except those using engineering controls must wear: Respirator with an organic-vapour removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or Endosulfan Reassessment – Application June 2008 Page 213 of 244 Description Labelling Placement on Label Existing HSNO equivalent control a NIOSH approved respirator with an (OV) cartridge or a canister with any N,R,P or HE filter. IN ADDITION: Mixers and loaders supporting aerial applications who are not using engineering controls (see engineering requirements below), handlers supporting or using high pressure handwand equipment and flaggers must wear: Coveralls over long-sleeved shirt and long pants Chemical resistant footwear plus socks Chemical resistant gloves (except when flagging) Chemical resistant head gear when exposed overhead Chemical resistant apron when mixing and loading All other mixers, loaders applicators and handlers must wear: Long-sleeved shirt and long pants; Socks and shoes; Chemical resistant gloves except, for applicators using enclosed cabs or cockpits, Chemical resistant apron when mixing and loading, applying dips cleaning up spills or cleaning/repairing equipment. A respirator of the type specified above for all handlers except for those using engineering controls.” User Safety Requirements “Follow manufacturer's instructions for cleaning/maintaining PPE. If no Precautionary Statements: Identification requirements apply. such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.” Immediately following the PPE requirements. “Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this product’s concentrate. Do not reuse them.” Engineering Controls for “Engineering Controls” Precautionary Statements: Appropriate PPE required. No mandatory Liquid Formulations closed cab requirements. A means of “Mixers and loaders supporting aerial applications at the rate of more Immediately following the compliance is given in the Code of Practice than 1.5 lbs/ai per acre or supporting applications to alfalfa, cotton, User Safety Requirements. NZS 8409. barley, rye oats and wheat must use a closed system that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4)] for dermal and Page 214 of 244 June 2008 Endosulfan Reassessment – Application Description Labelling Placement on Label Existing HSNO equivalent control inhalation protection, and must: wear long-sleeved shirt, long pants, shoes, socks, chemical resistant gloves and chemical apron, wear long-sleeved shirt, long pants, shoes, socks, and be provided and have immediately available for use in an emergency, such as a broken package, spill, or equipment breakdown coveralls, chemical resistant footwear and the type of respirator specified in the PPE.” “Applicators using airblast equipment on all crops except ornamental trees and shrubs must use an enclosed cab that meets the definition in the Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In addition, such applicators must: wear the personal protective equipment required in the PPE section of this labelling, either wear the type of respirator specified in the PPE section of this labelling or use an enclosed cab that is declared in writing by the manufacturer or by a government agency to provide at least as much respiratory protection as the type of respirator specified in the PPE section of this labelling, be provided and must have immediately available for use in an emergency when they must exit the cab in the treated area: coveralls, chemical-resistant footwear, chemical-resistant headgear, if overhead exposure, and, if using an enclosed cab that provides respiratory protection, a respirator of the type specified in the PPE section of this labelling, take off any PPE that was worn in the treated area before re- entering the cab, and store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of the inside of the cab.” “Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)];” “When handlers use closed systems and enclosed cabs, in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler Endosulfan Reassessment – Application June 2008 Page 215 of 244 Description Labelling Placement on Label Existing HSNO equivalent control PPE requirements may be reduced or modified as specified in the WPS.” User Safety “User Safety Recommendations” Precautionary Statements: Appropriate PPE required and identification Recommendations requirements. A means of compliance is given “Users should wash hands before eating, drinking, chewing gum, Immediately following in the Code of Practice NZS 8409. using tobacco, or using the toilet.” Engineering Controls). “Users should remove clothing/PPE immediately if pesticide gets Must be placed in a box. inside. Then wash thoroughly and put on clean clothing.” “Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.” Environmental Hazards “Environmental Hazards” Precautionary Statements: Into/ onto water control. No default control for drift other than Approved Handler. Spray drift “This product is extremely toxic to fish and aquatic invertebrates and Immediately following the management is covered in the Code of toxic to birds and mammals. Do not apply directly to water, or to areas User Safety Practice NZS 8409. where surface water is present, or to intertidal areas below the mean Recommendations. high water mark. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. See Spray drift management instructions under “Directions for use. Do not contaminate water when disposing of equipment wash waters or rinsate.” Restricted Entry Interval “Do not enter or allow worker entry into treated areas during the Directions for Use in the Currently no restricted entry intervals set. (REI) restricted entry interval (REI).” Agricultural Use Requirements Box. Restricted Entry Intervals All crops except for the crops listed below have an REI of 48 hours. Directions for Use next to the Currently no restricted entry intervals set. (REI) for EC Formulations application instructions for The following crop has an REI of 3 days: sweet potato. each crop. The following crops grown for seed have an REI of 3 days: collard greens, kale, mustard greens, radish, rutabaga, and turnip. The following crops NOT grown for seed have an REI of 4 days: kohlrabi, broccoli and cabbage. The following crops also have an REI of 4 days: brussel sprouts and cauliflower. The following crops have an REI of 6 days: blueberries. Page 216 of 244 June 2008 Endosulfan Reassessment – Application Description Labelling Placement on Label Existing HSNO equivalent control The following crops grown for seed have an REI of 7 days: kohlrabi, broccoli and cabbage The following crops have an REI of 17 days: sweet/fresh corn. Early Entry PPE “PPE required for early entry to treated areas that is permitted under Directions for Use in the Currently no specific HSNO control. The the Worker Protection Standard and that involves contact with Agricultural Use requirement for the use of PPE under both anything that has been treated, such as plants, soil, or water, is: Requirements Box. HSNO and HSE Acts would still apply. coveralls, chemical-resistant gloves made of any waterproof material, shoes plus socks, protective eyewear. Double Notification “Notify workers of the application by warning them orally and by Directions for Use in the Currently no specific HSNO control. However, posting warning signs at entrances to treated area.” Agricultural Use could be addressed by precautionary Requirements Box. statements required to be on label. Application Restrictions “Do not apply this product in a way that will contact workers or other Place in the Directions for Currently no specific HSNO control. However, persons, either directly or through drift. Only protected handlers may Use. the approved handler control, the use of NZS be in the area during application.” 8109, adherence to label statements would address this. There are also the requirements of the HSE and RMA which cover this. Could set a TEL. Other Risk Mitigation Reduced Application Rates (maximum a.i. per acre or per gallon per Directions for Use under Currently no application rates set. A control application) application instructions could be applied under s77A of the Act or set and/or restrictions. an EELs which require setting of application Tree bark application: 0.005 lb/ai gallon rates. Broccoli, kohlrabi, cabbage and cauliflower not grown not for seed: 1.0 lb ai/acre Strawberries: 1.0 lb ai/acre Cotton (ground applications) and blueberries: 1.5 lb ai/acre Pome fruit, stone fruit, nonbearing citrus, pecans and ornamental trees and shrubs: 2.5 lb ai/acre. Reduce Seasonal Application Rate (maximum amount a.i./acre that can be applied in a single season) Sweet/fresh corn, cotton (aerial application) and blueberries: Reduce to 1.5 lbs ai/acre per season Endosulfan Reassessment – Application June 2008 Page 217 of 244 Description Labelling Placement on Label Existing HSNO equivalent control Melons, cucumbers, squash, pumpkins, lettuce, tomatoes, sweet potato, cotton (ground applications), broccoli, cauliflower, cabbage, kohlrabi, brussel sprouts, strawberries, filberts, walnuts, almonds, macadamia nuts, peppers, egg plant, potatoes, carrots, dried beans, dried peas and tobacco: Reduce to 2.0 lbs ai/acre per season. Pome fruit, stone fruit, nonbearing citrus and pecans: Reduce to 2.5 lbs ai/acre per season. Reduce Number of Applications/Season (max. # of applications that can be made in one season) Broccoli, brussels sprouts, cauliflower, cabbage, cotton, dry deans, dry peas, kohlrabi, lettuce, strawberry, sweet potatoes, tobacco: Reduce to 2 applications per season. Melons, cucumber, squash and pumpkins: Reduce to 4 applications per season except for CA where the maximum number of applications per season is 3. Potatoes, tomatoes: Reduce to 4 applications per season. Application Equipment/Method Deletions: For all formulations, prohibit use of high pressure hand wand on all sites except to bark treatment or tobacco drench. Spray Drift Labelling “Do not allow spray to drift from the application site and contact Directions for Use under Currently no buffer zones applied. Approved people, structures people occupy at any time and the associated General application handler requirements apply. Good agricultural property, parks and recreation areas, non-target crops, aquatic and instructions and/or practice expected from approved handler to wetland areas, woodlands, pastures, rangelands, or animals.” restrictions. control spray drift. A buffer zone control could be applied under s77Aof the Act. There are “A 30 ft. vegetative buffer strip must be maintained between all areas also the requirements of the RMA which cover treated with this product and rivers, natural ponds, lakes, streams, this. reservoirs, marshes, estuaries and commercial fish ponds.” “For ground boom applications, do not apply within 100 feet of rivers, natural ponds, lakes, streams, reservoirs, marshes, estuaries and commercial fish ponds. Apply with nozzle height no more than 4 feet above the ground or crop canopy and when wind speed is 10 mph or less at the application site as measured by an anemometer. Use (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomiser nozzles.” Page 218 of 244 June 2008 Endosulfan Reassessment – Application Description Labelling Placement on Label Existing HSNO equivalent control “For orchard/vineyard airblast applications, do not apply within 100 feet of rivers, natural ponds, lakes, streams, reservoirs, marshes, estuaries and commercial fish ponds. Direct spray above trees/vines and turn off outward pointing nozzles at row ends and outer rows. Apply only when wind speed is 3 –10 mph at the application site as measured by an anemometer outside of the orchard/vineyard on the upwind side.” “For aerial applications, do not apply within 300 feet of rivers, natural ponds, lakes, streams, reservoirs, marshes, estuaries and commercial fish ponds. The boom width must not exceed 75% of the wingspan or 90% of the rotary blade. Use upwind swath displacement and apply only when wind speed is 3 -- 10 mph as measured by an anemometer. Use _____ (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomiser nozzles. If application includes a nospray zone, do not release spray at a height greater than 10 feet above the ground or the crop canopy.” “For overhead chemigation, do not apply within 100 feet of rivers, natural ponds, lakes, streams, reservoirs, marshes, estuaries and commercial fish ponds. Apply only when wind speed is 10 mph or less.” “The applicator also must use all other measures necessary to control drift.” Endosulfan Reassessment – Application June 2008 Page 219 of 244 Table H2: USEPA mitigation measures relevant to New Zealand: dietary, ecological and occupational risks Dietary (Drinking Water) and Ecological Risk: Several mitigation measures are needed to reduce the potential for contamination of drinking water. Reduce maximum seasonal application rate from 3 lbs./ai/A to 2 lbs./ai/A for melons, cucurbits, HSNO equivalent: Currently no application rates set for endosulfan lettuce, tomatoes, sweet potatoes, cotton (ground), broccoli, cauliflower, cabbage, kohlrabi, formulations brussels sprouts, strawberries, filberts, walnuts, almonds, macadamia nuts, peppers, eggplant, potatoes, carrots, dry beans, dry peas, and tobacco. Reduce maximum seasonal application rate from 3 lbs./ai/A to 1.5 lbs./ai/A for sweet corn, cotton HSNO equivalent: Currently no application rates set for endosulfan (aerial) and blueberries. formulations Require 100 ft. spray buffer for ground applications between a treated area and water bodies. HSNO equivalent: Into/ onto water control applies to endosulfan formulations. Currently no buffer zones applied for endosulfan formulations. Require 30 ft. maintained vegetative buffer strip between a treated area and water bodies. HSNO equivalent: Currently no vegetative buffer strips applied for endosulfan formulations. Require all products to be Restricted Use. HSNO equivalent: Users of endosulfan formulations required to be Approved Handlers Occupational Risk Require closed mixing/loading systems for aerial application using the EC formulation on pome HSNO equivalent: Currently no requirement for closed mixing/loading fruits, stone fruits, citrus, sweet corn, sweet potatoes, cotton, collard greens (seed), kale (seed), systems for endosulfan formulations. mustard greens (seed), radish (seed), turnip (seed), rutabaga (seed), broccoli, (seed), cauliflower (seed), kohlrabi (seed), cabbage (seed), blueberries, small grains, alfalfa (seed), filberts, walnuts, almonds and macadamia nuts. Require closed cabs for airblast applications on pome fruits, stone fruits, citrus, filberts, walnuts, HSNO equivalent: Currently no requirement for closed cabs for endosulfan almonds and macadamia nuts. formulations. Prohibit use of high pressure handwands with rates greater than 0.005 lbs/ai/gal. HSNO equivalent: Currently no restrictions on handwands for endosulfan formulations. Increase REI to 48 hours for all crops except as noted in the following bullets; HSNO equivalent: Currently no re entry intervals set for endosulfan Increase REI for EC products to 4 days for broccoli, cauliflower, kohlrabi, cabbage, and brussels formulations. sprouts; Increase REI for EC products to 6 days for blueberries; Increase REI for EC products to 7 days for broccoli (seed), kohlrabi (seed), and cabbage (seed); and Increase REI for EC products to 17 days for sweet corn. Page 220 of 244 June 2008 Endosulfan Reassessment – Application Canada Canada is currently in the process of reassessing endosulfan. As part of the review they have proposed a number of mitigation measures. Appropriate PPE Appropriate Currently no Currently The following section summarises the mitigation measures being assessed by Canada no Currently HSNO no Currently and the preliminary risk assessment as to the possible effectiveness of the measures. be applied of the under s77A Canada’s Pest Management Regulatory Agency (PMRA) is proposing to implement the ks following measures, as a precautionary approach to reduce occupational and environmental exposure to endosulfan. Preliminary assessment of these mitigation measures was published October 2007. Where assessed the feasibility report is given. Existing HSNO equivalent control: Existing HSNO equivalent application HSNO. rates set under control: Existing HSNO equivalent required. Existing HSNO equivalent control: Existing HSNO equivalent application HSNO. rates set under control: Existing HSNO equivalent control could control. A re-entry Act. ing to occupational and environmental ris environmental and to occupational ing (PPE) is to be used to reduce exposure to workers. eggplants, peppers and Feasibility: unlikely toes, pepper, eggplant, potatoes, beans, peas and es, beans, peas, lettuce, s, chemical-resistant footwear, chemical-resistants, chemical-resistant gloves and an evant to New Zealand: Proposed measures measures pertain to Proposed evant New Zealand: application. In additionapplication. to this protective equipment, a chemical- In wear cabbages and cauliflower; cabbages The following personal protective equipment per season must not exceed: handwand equipment: approved vapour respiratororganic during resistant apron during mixing/loading, clean-up, repair and all other handling activities. strawberries; Feasibility: likely strawberries; and strawberries; Wear coveralls over a long shirt and long pant 2 for broccoli,cabbag Brussels sprouts, cauliflower, 1 for corn. 2.8 kg a.i./ha for apples, pears, apricots, peaches, plums and cherries; and 1.1 kg a.i./ha for celery. 4 for melons, cucumbers, squashes, pumpkins, potatoes and tomatoes; 1.1 kg a.i./ha for strawberries. Feasibility: likely 1.7 kg a.i./ha for corn; Feasibility: unknown 2.2 kg a.i./ha for melon, cucumber, squash, pumpkin, toma 48 hours for all other crops. 2.8 kg a.i./ha for pome fruit, stone fruit, ornamental trees and shrubs; Feasibility: unknown 16 days for Brussels sprouts, broccoli, 10 days for sweet corn; and Feasibility: unknown Use a maximum rate of 0.6 g a.i./L endosulfanwhen is applied high pressurewith handwand equipment. The maximum seasonal application rate must not exceed: Page 222 of 244 244 Page 222 of June 2008 – Application Endosulfan Reassessment Workers using high-pressure Equipment (PPE): Personal Protective The maximum rate per application must not exceed: Establish intervals the following re-entry (REIs) entering treated for workers areas: Table H3: Table H3: Rel Measures PMRA Mitigation Intervals Rates and Re-Entry Application The maximum of applicationsnumber Endosulfan Re-assessment – Application June 2008 Page 221 of 244 Applicators using airblast equipment on pome and stone fruit crops: Existing HSNO equivalent control: Appropriate PPE required. A control specifying a closed cab could be applied Applicators using airblast equipment on pome and stone fruit crops must use enclosed cabs and wear a long- under s77A of the HSNO Act. sleeved shirt, long pants shoes plus socks and either an approved organic vapour respirator or an enclosed cab that provides as much respiratory protection as an organic vapour respirator. When exiting the cab in the treated area, applicator must wear coveralls, chemical-resistant footwear, chemical-resistant headgear and an approved organic vapour respirator. Those PPE must be taken off before re-entering the cab and stored in a chemical-resistant container to prevent contamination of the inside of the cab. Early entry to treated areas: Existing HSNO equivalent control: Currently no equivalent specific HSNO control. There is a general If early entry into treated areas is required (i.e., prior to the specified REI), workers must wear coveralls over requirement for PPE (also under HSE Act) and label long-sleeved shirt and long pants, chemical-resistant gloves, shoes plus socks and goggles or a face shield. warning. All other workers: Wear a long-sleeved shirt, long pants, shoes plus socks, chemical-resistant gloves and an approved organic vapour respirator during mixing/loading, clean-up, repair, application and all other handling activities. In addition to this protective equipment, wear a chemical-resistant apron during mixing/loading, application of dips, clean- up and repair activities. To Mitigate Contamination of Aquatic Environments Require a 10 metre vegetative buffer strip be maintained between all areas treated with endosulfan and Existing HSNO equivalent control: Currently no sensitive freshwater habitats (such as lakes, rivers, sloughs, ponds, coulees, prairie potholes, creeks, marshes, equivalent specific HSNO control. A buffer zone control could streams, reservoirs and wetlands), and estuarine/marine habitats. be applied under s77A of the Act or EELs could be set. Require a 30 metre buffer zone between the point of direct application and the closest downwind edge of sensitive freshwater habitats (such as lakes, rivers, sloughs, ponds, coulees, prairie potholes, creeks, marshes, streams, reservoirs and wetlands), and estuarine/marine habitats. [Note: endosulfan products are currently restricted to application with ground equipment]. Existing HSNO equivalent control: Currently no HSNO control. An application method control could be applied under s77A of the Act. Removal of Unsupported Uses: Certain uses for endosulfan were unsupported by registrants in the U.S. and cancelled in that country prior to publication of the USEPA RED document. The registrants of technical grade endosulfan for Canada (Bayer CropScience Inc. and Makhteshim-Agan of North America Inc.) have withdrawn support for the following similar uses in Canada: Greenhouse ornamentals Existing HSNO equivalent control: Currently no HSNO Residential uses control. A control restricting uses could be applied under s77A of the Act. The approved handler and tracking controls These uses of endosulfan will be phased out. effectively rule out residential use. Endosulfan Reassessment – Application June 2008 Page 223 of 244 of the APVMA review. The following table compares the current New Zealand registered uses and the outcome ae24o 4 Jn 08 Endosulfan Reassessment – Application June 2008 Page 224 of 244 (No data) Delete (No data) Delete Australia. risk) (Trade Delete in use garden for home are not registered products Endosulfan (No data) Delete Delete risk) (Trade Delete (No data) Delete Lawn/turf APVMA review, deleted non-crop uses relevant to New Zealand Table H5: Retain Ornamentals blackcurrants Gooseberries, Blackberries, boysenberries, raspberries Strawberries and (head) cabbage for broccoli, Retain sweetcorn Maize and seedlings Fodder crop brassicas vegetable other and cauliflower Cabbage, Onions Potatoes Retain Tomatoes Z current New Crop with Current New Zealandregisteredand the APVMAreviewuses H4: Table Endosulfan MUST NO LONGER be used: Zealand to New Australian Mitigation Measures Relevant adopted by Australia. endosulfan formulations. The following section summarises the mitigation measures Australia did not ban endosulfan but they place stricter controls on the use of In Australia the APVMA released their Final Review Document on Endosulfan in 2005. Australia medic crops and vetch. on any pasture, forage and fodder species including clover, lucerne, chou moellier, for post-emergent uses on cereals, pulses and oil seeds (except cotton); [except cabbage (head) broccoli and cauliflower]; peanuts, legume vegetables, bulb sweet corn, or cole vegetables on leafy vegetables, berry fruits (including grapes), bananas, sorghum & maize, ealand registration control effectively rules this out. handler the approved use Although garden for home products endosulfan is currently no restriction on There Existing HSNO equivalent controls use of endosulfan products on turf. is currently no restriction on the There Existing HSNO equivalent controls vegetables for other cole deleted cauliflower Australian Outcome Review : : Table H6: APVMA review, safety directions: the following amended safety instructions have The following limits on the number of applications of endosulfan Existing HSNO equivalent controls: been included on labels: must be observed: Currently no application rates or limits on number of applications set under for all crops except orchard crops, the limit is two full RE-ENTRY PERIODS: The following re-entry period has Existing HSNO equivalent controls: HSNO for endosulfan products.. been added to endosulfan product labels. Re-entry: Do not There is currently no HSNO control coverage sprays of endosulfan per crop per growth season allow re-entry into treated areas until the spray has dried. applying a re-entry period. unless irrigation and storm runoff water (25 mm) is captured on farm. Very dangerous, particularly the concentrate product. Existing HSNO equivalent controls: Users of endosulfan products must keep records according Undiluted product poisonous if absorbed by skin contact, Appropriate PPE controls and Existing HSNO equivalent controls: to instructions found on the new approved label. These inhaled or swallowed. Will damage eyes. Will irritate the precautionary labelling requirements HSNO tracking control currently applies records must be kept for two years. nose and throat and skin. Avoid contact with eyes and skin. apply to endosulfan products. These to all endosulfan products. Do not inhale vapour. If clothing becomes contaminated are not as specific as the Australian The following livestock feeding restraints have been included on Existing HSNO equivalent controls: with product or wet with spray remove clothing immediately. instructions. all product labels where appropriate: Controls of this nature set by ACVM. If product on skin, immediately wash area with soap and water. If product in eyes, wash it out immediately with Do not feed treated tomato crops to livestock. water. When opening the container and preparing spray, wear cotton overalls buttoned to the neck and wrist [or equivalent clothing], elbow-length PVC gloves, and a full facepiece (or half facepiece and goggles) respirator. When using the prepared spray, wear cotton overalls buttoned to the neck and wrist [or equivalent clothing]. After use and before eating, drinking or smoking, wash hands, arms and face thoroughly with soap and water. After each day’s use, wash gloves, respirator (and if rubber wash with detergent and warm water), goggles and contaminated clothing Precautionary statement: For aerial application, support Existing HSNO equivalent controls: workers/markers should be protected by enclosed cabs. There is currently no HSNO control specifying a requirement for closed cabs. Precautionary statements on how to avoid exposure are required on labels. All supply and use of endosulfan products must be as Existing HSNO equivalent controls: directed on currently approved product labels. There are currently no use restrictions specified for the HSNO approvals of endosulfan products. Use restrictions apply to areas of use covered by ACVM but this does not cover home garden or turf use. Endosulfan products must only be purchased and used by Existing HSNO equivalent controls: Authorised Persons. For the purposes of s.94 of the Agvet Approved handler control applied to all Codes, the APVMA advises that an “Authorised Person” is one endosulfan products. who: conducts the business of selling or supplying agricultural chemical products; or are current State licensed pesticide applicators; or hold a current Spray Safe Certificate for successful completion of the Chemical Handling Manual for Agricultural Aviation under Operation Spray Safe issued by the Aerial Agricultural Association of Australia (AAAA); or hold a current Certificate (AQF level 3 or above) or statement of attainment issued by a Registered Training Organisation for the following two competency units: RTC3705A Transport, handle and store chemicals RTC3704A Prepare and apply chemicals. Endosulfan Reassessment – Application June 2008 Page 225 of 244 Page 226 of 244 June 2008 Endosulfan Reassessment – Application Appendix I – Potential alternatives to endosulfan Alternatives to endosulfan for crop pest control Alternative insecticide products currently registered for the crop/pest combinations for which endosulfan is registered (Section 6) include, but are not necessarily limited to, those shown in Table I1. This information was sourced from the New Zealand Agrichemical Manual 2007 with uses confirmed on the ACVM database of currently registered Veterinary Medicines, Plant Compounds and Vertebrate Toxic Agents. Scud, Fastac Zenith, Dominex 100, Alpha- Chess WG Chess WG Trifon Pirimor 50, Prohive , PirimisectPirimax 500, Aphidex , WG Insecticide Talstar 80 SC, Venom, Talstar 100 EC Malathion 50EC Diazinon 50W, DEW 500, Diazinon 800, Jolyn DIGRUB, Diazol Diazinon 50W, DEW 500, Diazinon 800, JolynDiazinon DIGRUB , Diazonyl 60EC , pyrethroids Synthetic alpha-cypermethrin – Carbamates pirimicarb – Pyridine azomethine pymetrozine – Other – Key Pyrethrum pyrethrum Organophosphates Organophosphates diazinon – Diazol Organophosphates trichlorfon – Pyridine azomethine pymetrozine – Organophosphates Organophosphates bifenthrin – diazinon – maldison – Currently Registered Alternatives Aphids Aphids Thrips Thrips bug vegetable Green Whitefly PEST Page 228 of 244 244 Page 228 of June 2008 – Application Endosulfan Reassessment Table I1: Table I1: products insecticide Alternative CROP Tomatoes Endosulfan Reassessment – Application June 2008 Page 227 of 244 CROP PEST Currently Registered Alternatives Cutworms Organophosphates chlorpyrifos – Lorsban 50EC trichlorfon – Trifon Synthetic pyrethroids lambda-cthalothrin – Karate Zeon esfenvalerate – Sumi-Alpha Macrocyclic lactone spinosad – SUCCESS *NATURALYTE* INSECT CONTROL , Entrust Naturalyte Insect Control other caterpillars Organophosphates methamidaphos – Tamaron, Methafos 600 diazinon – Diazinon 50W, DEW 500, Diazinon 800, Jolyn DIGRUB, Diazol malathion 50EC – maldison acephate – Orthene , Lancer 750 DF Carbamates carbaryl – Carbaryl 50F, Sevin Flo Potatoes (both table and seed potatoes) Potato tuber moth Organophosphates methamidaphos – Tamaron, Methafos 600 acephate – Orthene , Lancer 750 DF phorate, – Nufarm Phorate, Crop Care Phorate 20G, Disect, Thimet 20G Synthetic pyrethroids deltamethrin – Ballistic, Decis Forte, Deltaphar 25EC lambda-cyhalothrin – Karate Zeon Endosulfan Reassessment – Application June 2008 Page 229 of 244 CROP PEST Currently Registered Alternatives Carbamates carbaryl – Carbaryl 50F, Sevin Flo Macrocyclic lactone spinosad – SUCCESS *NATURALYTE* INSECT CONTROL, Entrust Naturalyte Insect Control Aphids Organophosphates methamidaphos – Tamaron, Methafos 600 pirimicarb – Pirimor 50, Prohive, Pirimisect, Pirimax 500, Aphidex WG Insecticide acephate – Orthene, Lancer 750 DF Dimethoate – ROGOR E, PERFEKTHION S, DIMEZYL 40EC Chloronicotinyl imidacloprid – Gaucho Pyridine azomethine pymetrozine – Chess WG Other pyrethrum – Key Pyrethrum Green looper caterpillar Carbamates carbaryl – Carbaryl 50F, Sevin Flo Onions (except spring onions) Onion thrips Organophosphates methamidaphos – Tamaron, Methafos 600 chlorpyrifos – Toppel, Pyrinex dichlorvos – Nuvos diazinon – Diazinon 50W, DEW 500, Diazinon 800, Jolyn DIGRUB, Diazonyl 60E, Diazol Page 230 of 244 June 2008 Endosulfan Reassessment – Application CROP PEST Currently Registered Alternatives Synthetic pyrethroids deltamethrin – Ballistic, Decis Forte, Deltaphar 25EC lambda-cyhalothrin – Karate Zeon alpha-cypermethrim – Alpha-Scud, Bestseller 100EC, Fastac, Dominex 100, Cypher tau-fluvalinate – Mavrik Aquaflo, Mavrik flo esfenvalerate – Sumi-Alpha Chloronicotinyl imidacloprid – Confidor, Pilarking 200SL Mixed actives imidacloprid and cyfluthrin – Confidor Supra Cabbage, cauliflower and other vegetable Aphids Chloronicotinyl brassicas imidacloprid – Confidor thiacloprid – Calypso Organophosphates methamidaphos – Tamaron, Methafos 600 chlorpyrifos – Toppel, Pyrinex dichlorvos – Nuvos, Divap diazinon – Diazinon 50W, DEW 500, Diazinon 800, Diazonyl 60E, Diazol chlorpyrifos – Lorsban 50EC, Chlorpyrifos 48EC maldison – Malathion 50EC phorate, – Nufarm Phorate, Crop Care Phorate 20G , Disect, Thimet 20G Carbamates pirimicarb – Pirimor 50, Prohive , Pirimisect , Pirimax 500, Aphidex WG Insecticide Endosulfan Reassessment – Application June 2008 Page 231 of 244 CROP PEST Currently Registered Alternatives Pyridine azomethine pymetrozine – Chess WG Biological bacillus thuringiensis – Agree WDG Other pyrethrum – Key Pyrethrum Diamond-back moth Organophosphates methamidaphos – Tamaron, Methafos 600 acephate – Orthene, Lancer 750 DF maldison – Malathion 50EC trichlorfon – Trifon Synthetic pyrethroids alpha-cypermethrim – Alpha-Scud , Fastac , Dominex 100 deltamethrin – Ballistic, Decis Forte, Deltaphar 25EC lambda-cyhalothrin – Karate Zeon tau-fluvalinate – Mavrik flo cypermethrin – Ripcord esfenvalerate – Sumi-Alpha bifenthrin – Talstar 80 SC, Venom Macrocyclic lactone spinosad – Success Naturalyte Insect Control, Entrust Naturalyte Insect Control Phenyl pyrazole fipronil – Ascend Page 232 of 244 June 2008 Endosulfan Reassessment – Application CROP PEST Currently Registered Alternatives Biological Bacillus thuringiensis – Agree WDG, Xen Tari WDG , Delfin WDG Mixed Actives trichlorfon and cypermethrin – Partna Oxadiazine indoxacarb – Steward 150 SC White butterfly caterpillars Organophosphates methamidaphos – Methafos 600 dichlorvos - Nuvos diazinon - Diazinon 50W, DEW 500 , Diazinon 800, Diazonyl 60EC, , Diazol acephate - Orthene , Lancer 750 DF maldison - Malathion 50EC trichlorfon - Trifon Synthetic pyrethroids alpha-cypermethrim - Alpha-Scud , Bestseller100EC, Fastac , Dominex 100, Zenith deltamethrin – Ballistic, Decis Forte, Deltaphar 25EC lambda-cyhalothrin - Karate Zeon mavrik flo – tau-fluvalinate cypermethrin - Ripcord esfenvalerate - Sumi-Alpha bifenthrin - Talstar 80 SC, Venom Mixed actives partna – trichlorfon and cypermethrin Endosulfan Reassessment – Application June 2008 Page 233 of 244 CROP PEST Currently Registered Alternatives Carbamates carbaryl - Carbaryl 50F, Sevin Flo Macrocyclic lactone spinosad – Success Naturalyte Insect Control, Entrust Naturalyte Insect Control Phenyl pyrazole fipronil - Ascend Oxadiazine indoxacarb - Steward 150 SC Biological bacillus thuringiensis - Agree WDG , Xen Tari WDG, Delfin WDG Fodder crop seedlings (turnips, swedes, Nysius bug (Nysius huttoni) Organophosphates choumoellier, feed rape, fodder-beet, mangolds) chlorpyrifos - Lorsban 50EC Also brassica vegetable seedlings fenitrothion - Caterkil 1000 terfufos - Counter phorate, - Nufarm Phorate, Crop Care Phorate 20G , Disect, Thimet 20G Chloronicotinyl imidacloprid - Gaucho Maize and sweetcorn (seedlings) Cutworm Organophosphates chlorpyrifos - Lorsban 50EC ,Pyrinex , Toppel Synthetic pyrethroids alpha-cypermethrim - Alpha-Scud, Bestseller 100EC, Fastac , Dominex 100 deltamethrin - Ballistic , Decis Forte , Deltaphar 25EC lambda-cyhalothrin - Karate Zeon Page 234 of 244 June 2008 Endosulfan Reassessment – Application CROP PEST Currently Registered Alternatives alpha-cypermethrin - Cypher esfenvalerate - Sumi-Alpha Carbamates carbaryl - Carbaryl 50F, Sevin Flo methomyl - Lannate L Strawberries Aphids Organophosphates dichlorvos – Nuvos diazinon - DEW 500, Diazol dimethoate - Dimexyl 40 EC, Perfekthion S phorate, - Nufarm Phorate, Crop Care Phorate 20G , Disect, Thimet 20G Carbamate methomyl - Lannate L Biological aphidoletes aphidimyza- Aphidoletes Chlorinated hydrocarbon dicofol - Kelthane 35 Other pyrethrum – Key Pyrethrum Cyclamen (strawberry) mite Organophosphates dichlorvos – Nuvos Endosulfan Reassessment – Application June 2008 Page 235 of 244 CROP PEST Currently Registered Alternatives Blackberries, Boysenberries, Raspberries, Aphids Organophosphates Gooseberries, Blackcurrants dichlorvos – Nuvos, Divap dimethoate - Rogor E, Perfekthion S Other pyrethrum – Key Pyrethrum Bronze beetle Redberry mite Organophosphates dichlorvos – Nuvos, Divap Ornamentals (glasshouse and out of doors) Cyclamen mite Organophosphates dichlorvos – Nuvos, Divap phorate, - Nufarm Phorate, Crop Care Phorate 20G , Disect, Thimet 20G Aphids Organophosphates dichlorvos – Nuvos, Divap phorate, - Nufarm Phorate, Crop Care Phorate 20G , Disect, Thimet 20G diazinon - Diazinon 50W acephate - Orthene , Lancer 750 DF chlorpyriphos – chlorpyriphos WP maldison - Malathion 50EC Synthetic pyrethroids tau-fluvalinate - Mavrik Aquaflo, Nursery Maverik bifenthrin – Talstar 80 SC Page 236 of 244 June 2008 Endosulfan Reassessment – Application CROP PEST Currently Registered Alternatives Biological Aphidius colemani – Aphidus , Aphipar Aphidoletes aphidimyza – Aphidoletes Chloronicotinyl imidacloprid – Confidor Other azadirachtin – Neemazal – T/S pyrethrum – Key Pyrethrum Endosulfan Reassessment – Application June 2008 Page 237 of 244 alternatives are summarised in Table I2. and effectiveness in a field situation New Zealand are presently unknown. The main ae28o 4 Jn 08 Endosulfan Reassessment – Application June 2008 Page 238 of 244 earthwormsin turf of Pesticides for treatment I2: Table 9see A number of pesticides have been identified as having the potential to kill earthworms Alternatives to endosulfan for earthworm control on turf Acute dermalLD rats 400mg/kg Acute oral LD 500gai/L Carbendazim Acute oral LD 500gai/L Carbaryl Rate/ha Acute oral LD 350gai/L Endosulfan Product Potential pesticide options presently available Acute dermal LD 6400mg/kg rats Acute dermal LD 80–110mg/kg rats 500mg/kg rats 500mg/kg >10000mg/kg rabbits rabbits >10000mg/kg rabbits 359mg/kg http://www.oxfordcroquet.com/care/worms/index.asp 50 50 50 50 50 50 10–30L 209–627 209–627 10–30L 4–8L 112–224 112–224 4–8L 2L 60 60 2L Product cost /aComments $/ha within New Zealand for controlling earthworms New within Repeated drenches of carbendazim increase Repeated drenches of carbendazim increase of group to benzimidazole Resistance will that carbendazim, Research indicates Turfclear) Product labels overseas (eg Scotts Executive Chief Zealand’s On ERMA New Research of field use limited has been there Although Executive Chief Zealand’s On ERMA New typically year is per application A single to endosulfan has shown Field experience control than carbendazim. control than carbendazim. of duration a shorter provide effective and occurring. occurring. to a range of fungi the risk of resistance well documented. is fungicides of group within the benzimidazole resistance cross Zealand turf facilities. Furthermore well on New documented is spot and Fusarium to Dollar Benlate™ in particular and fungicides improvement. to achieve the desired levelof casting suppression be inadequate would Except in minor outbreaks this level of withwill the level of control taper off time. 35% for 3months and thereafter approximately the amount of casting that occurs bysuppress 3 months every this to be applied require List for Reassessment. Priority of earthworms. partial control inconsistent or shown it to provide has experience field of endosulfan) availability (given carbaryl List for Reassessment. Priority 90–95% approximately by to reduce casting adequate of earthworms. effective control the most reliable and provide 3 has shown carbaryl to be less shown carbaryl has ) . However, their efficacy Appendix J – Parties contacted Northland Regional Council Whangarei District Council Opotiki District Council Central Government Local Government: South Island New Zealand Food Safety Authority Department of Labour Ashburton District Council Mackenzie District Council Ministry of Health Buller District Council Marlborough District Council Local Government: North Island Central Otago District Council Nelson City Council Auckland City Council Otorohanga Regional Council Chatham Islands Council Otago Regional Council Auckland Regional Council Palmerston North City Council Christchurch City Council Queenstown Lakes District Council Carterton District Council Papakura District Council Clutha District Council Selwyn District Council Central Hawkes Bay District Council Porirua City Council Dunedin City Council Southland District Council Environment Bay of Plenty Rangitikei District Council Environment Canterbury Tasman District Council Environment Waikato Rodney District Council Environment Southland Timaru District Council Far North District Council Rotorua District Council Gore District Council Waimakariri District Council Franklin District Council Ruapehu District Council Grey District Council Waimate District Council Gisborne District Council South Taranaki District Council Hurunui District Council Waitaki District Council Greater Wellington Regional Council South Waikato District Council Hamilton City Council South Wairarapa District Council Invercargill City Council West Coast Regional Council Hastings District Council Stratford District Council Kaikoura District Council Westland District Council Hauraki District Council Taranaki Regional Council CEIR Submitters who referred to endosulfan Hawkes Bay Regional Council Tararua District Council Breast Cancer Network NZ Inc (Barbara Horizons Regional Council Taupo District Council Mason, Gillian Woods) Horowhenua District Council Tauranga City Council NZ Sports Turf Institute (Brian Way) Hutt City Council Thames–Coromandel District Council Pesticide Action Network Aotearoa New Zealand (Meriel Watts) Kaipara District Council Upper Hutt City Council Soil and Health Association of New Kapiti Coast District Council Waikato District Council Zealand (Steffan Browning) Kawerau District Council Waipa District Council Safe Food Campaign (Alison White) Manawatu District Council Wairoa District Council Turf Manukau City Council Waitakere City Council Evans Turf Supplies (Tony Evans) PGG Wrightson Turf (Bill Walmsley) Masterton District Council Waitomo District Council Aviation Matamata–Piako District Council Wanganui District Council New Zealand Agricultural Aviation Auckland Airport Napier City Council Wellington City Council Association New Plymouth District Council Western Bay of Plenty District Council Civil Aviation Authority of New Zealand North Shore City Council Whakatane District Council Endosulfan Reassessment – Application June 2008 Page 239 of 244 Page 240 of 244 June 2008 Endosulfan Reassessment – Application Registrants Appendix K – Confidential appendix – Report of M Bayer NZ Ltd Agronica NZ Ltd (Makhteshim) Edwards on Davies (2002) dermal absorption study Adria NZ Ltd Others National Poison Centre Horticulture NZ New Zealand Chemical Industry Council New Zealand Association for Animal Federated Farmers Health and Crop Protection (AGCARM) Spraywatch The International Stewardship Centre for Endosulfan (Sherman Friedman) SPCA Auckland (Bob Kerridge) Endosulfan Reassessment – Application June 2008 Page 241 of 244 Page 242 of 244 June 2008 Endosulfan Reassessment – Application Appendix L – Confidential appendix – Product formulations Page 256 of 244 June 2008 Endosulfan Reassessment – Application ERMA New Zealand Update paper Application for the Reassessment of a Hazardous Substance under section 63 of the Hazardous Substances and New Organisms Act 1996 Name of substance: endosulfan and formulations containing endosulfan Application Number: HRC07003 Prepared for the Environmental Risk Management Authority Contents Section One – Summary of new information received...... 3 2.1 Responses to questions raised in the application ...... 3 2.2 Tier II environmental (aquatic) modelling...... 6 2.3 Amendment to section 3.1.5 of the application ...... 6 2.4 International legal action ...... 6 2.5 Residues...... 7 2.6 Ferry sinking - Philippines...... 7 Section Two - Summary of submissions and ERMA New Zealand responses ...... 8 Summary of issues raised in submissions ...... 8 Section Three – Conclusions ...... 26 Appendix A – Summary of additional aquatic exposure modelling...... 31 Appendix B – Preliminary recommendations included in the application ...... 37 Appendix C – NGĀ KAIHAUTŪ TIKANGA TAIAO REPORT ...... 39 Appendix D - Council Survey from NZ Sports Turf Institute Submission ...... 41 Endosulfan Reassessment – Update Paper October 2008 Page 2 of 41 Section One – Summary of new information received ERMA New Zealand’s application for the reassessment of endosulfan and formulations containing endosulfan was publicly notified on 27 June 2008. Submissions were accepted until 8 September 2008. A total of 187 submissions were received. ERMA New Zealand has summarised the issues raised in the submissions under topic headings and commented on each of the issues (see table, Section 2 below). The full text of the submissions is available as a separate document upon request. In addition to submissions received, the following information has been received since the application was publicly notified. 2.1 Responses to questions raised in the application In the Executive Summary of the application ERMA New Zealand requested information on a number of areas. The following summarises the responses received: 1. What alternative substances are available, how effective are they and what risks, costs and benefits are associated with their use in New Zealand? Pesticide Action Network: The claim by Horticulture NZ that there is no alterative to endosulfan for Red Berry mite is not accepted; there are safer alternative substances: Management of Red Berry mite can be achieved by use of lime sulphur: for varieties that retain a leaf canopy through the winter, begin lime sulfur applications at bud break and continue at 3-week intervals up to 12 days before the start of harvest. For varieties that naturally defoliate over the winter, apply lime sulfur before buds break dormancy but then not again until canes have a full leaf canopy and first bloom appears. Horticultural oils, when used at the rate of 1.2 to 2% volume to volume, applied after green fruit or first pink fruit stage in four consecutive applications spaced 2 or 3 weeks apart give significant control of Red Berry mite. (UC 2008) There are also safer alternatives to endosulfan for Cyclamen mite in strawberries: Management of cyclamen mite requires carefully timed sprays of miticides that do not harm natural enemy populations. Prevent its introduction into strawberry fields by following good cultural practices. Propagating nursery stock free of cyclamen mites is essential to prevent introducing populations to fruit-producing fields. Cultural Control - dip trays of long-term cold storage (28°F) transplants into a hot water bath for 7 minutes right before planting to prevent infestation. Prepare plants for this treatment by thoroughly washing them to remove all dirt; then place them in a circulating water bath that is held at a constant temperature of 120°F. Afterwards, submerge them in very cold water and then plant them as soon as possible. Avoid second-year plantings in problem areas. To slow the spread of infestations, remove infested plants as soon as symptoms appear. Two naturally occurring predatory mites of cyclamen mite are Typhlodromus bellinus and T. reticulatus, but their populations build up too slowly to provide economic control. Early season releases of the commercially available predatory mite, Amblyseius californicus, may be able to control this pest mite. When pest populations become large, the six spotted thrips, minute pirate bugs, and western predatory mite (Galendromus occidentalis) all feed on cyclamen mites. All of these beneficial insects are damaged by endosulfan. Endosulfan Reassessment – Update Paper October 2008 Page 3 of 41 Abamectin is a safer alternative spray. (UC 2008). Broadmite on citrus can be controlled by sulphur (UC 2008). Endosulfan is not essential. 2. Can the application rate (0.7 kg a.i./ha) or frequencies for label use be reduced without compromising efficacy? Makhteshim: The rate of 2L/ha (0.7kg a.i/ha) is the maximum label rate currently on Thionex Insecticide. This rate is a robust rate and has proved effective with growers in many crop situations. As has occurred with other pesticides, such as SPs and OPs, the use of lower rates has accelerated resistance issues. We would strongly recommend that robust rates be maintained to avoid an acceleration of insecticide resistance. 3. Can the application rate used on turf (2.1 kg a.i./ha) be reduced without compromising efficacy, in order to reduce operator exposure (when using full PPE) to acceptable estimates? Makhteshim: Turf is an off-label use and we offer no comment. NZ Sports Turf Institute response: The answer to this is that the turf industry could achieve the desired level of earthworm control with endosulfan applied at 613-700g a.i./ha/application. The quoted application rate of Thiodan, Thionex or Flavylan at 6L/ha (2.1kg a.i./ha/application) on turf is extraordinarily high and does not reflect the norm for the turf industry. Although there will inevitably be some variation as to the rates with which endosulfan is applied to turf (1.5-2.5L/ha), the norm or industry standard is 2L/ha (0.57kg a.i/ha/application). The basis of the industry standard for endosulfan can be traced back to 1976 when endosulfan had a turf registration for controlling both earthworms (613ga.i./ha) and Porina (525-700ga.i./ha). This was originally published in: “A Guide to Agrichemicals” 1975 Agricultural Chemicals Board – and then reformatted for the turf industry where it was published in the Sports Turf Review No.111, October 1977. 4. In order to reduce health risk to operators, most uses require the use of “full” PPE consisting of gloves, face shield during mixing loading and gloves, overalls, hat and boots during application. If this level of PPE were made mandatory, would continued use of the product be feasible? Makhteshim: Agronica believes that most commercial operators understand the importance of and follow the guidelines for use of PPE. We do not believe that making the use of “full” PPE mandatory will be a major issue as this is generally current good agricultural practice used with Endosulfan. NZ Sports Turf Institute: For turf, these requirements would not pose a problem and would generally be regarded as the norm for most turf managers applying an agrichemical. 5. Re-entry risks for workers (and ‘pick your own’) are estimated as high for horticultural applications since these personnel do not generally use PPE. In this case, REIs Endosulfan Reassessment – Update Paper October 2008 Page 4 of 41 represent an important means of addressing these exposure risks. Are the REIs set out above feasible? Makhteshim: We would propose to adopt recommendation of the REIs and place this information on our label. 6. What would be the effect of a mandatory 48 hour closure period after one annual turf application and watering in for “ground contact” sports, such as rugby, football or hockey and use on public parks where young children may play? Makhteshim: Turf is an off-label use and we offer no comment. NZ Sports Turf Institute: The general consensus amongst councils is that this would require additional planning but would be workable (see Appendix D below for Council survey results). 7. What would be the effect of a mandatory 100 m (or more) buffer zone to reduce exposure to non-target areas including the aquatic environment? Makhteshim: We have provided a Tier II modeling study that has not been considered before issuing the Application Summary. The proposed mitigation measure of 100m buffer zone is not justified for ground applications. The Tier II analysis demonstrated that the percent of protected species is very high using the worst case application scenario even without a buffer zone in place. We believe that the addition of a moderate buffer zone of 30m is a more acceptable and practical risk mitigation measure that delivers an acceptable ecological risk mitigation outcome. US EPA has requested a 30m buffer zone for ground boom spray applications. PAN The aquatic risk assessment and the setting of a potential buffer zone should also take into account the frequent flooding New Zealand experiences, which will wash residues into the aquatic environment. Flooding is not an unusual event – it is part of everyday life, it happens every year. Therefore endosulfan should not be used in any area where flooding can occur. NZ Sports Turf Institute: The general consensus from our council survey is that a 100m buffer zone between treated areas and any waterways, would restrict the treatment of a number of venues or facilities that could be treated for earthworms. For the most part (although there are exceptions) councils could accept a 50m buffer zone. A 100m buffer zone would pose significant problems for many golf clubs and would inevitably prevent them treating some fairways. For golf courses, the preferred maximum buffer zone would be 20m. This buffer zone would still create issues for some golf courses. The industry would question the need for such a large (100m) buffer zone in that with the exception of fairways and in isolated instances golf greens, the risks of runoff of endosulfan posed from the turf industry are considered minimal as: i. Surface contours on sports fields, bowling greens, croquet lawns etc are essentially “flat” and therefore except in extreme rainfall events, runoff is unlikely. Endosulfan Reassessment – Update Paper October 2008 Page 5 of 41 ii. The pesticide is applied in close proximity to the ground (0.5m approx) by a boom sprayer. iii. The pesticide is washed in after application, further reducing the risk of run off. iv. For the most part, the pesticide would be applied to a situation with full turf cover and significant thatch (organic matter layer), that both adsorbs the pesticide and minimises risk of runoff (typically associated with soil particles on cropping situations. For safety reasons, it is normal to have a grass cover or shrubbery between waterways and most turf areas. 2.2 Tier II environmental (aquatic) modelling In the application, ERMA New Zealand noted risks to the aquatic environment as being “high” and also noted that there was a degree of uncertainty about this that might be resolved by further exposure modelling. Makhteshim Chemical Works (one of the registrants) provided further exposure modelling on 2 July 2008 (Schupner & Mackay, 2008) and ERMA New Zealand also commissioned HortResearch to review the new modelling and to run its SPASMO model that estimates runoff losses following application for New Zealand use scenarios. HortResearch’s report on this work was received on 26 August 2008 (Müller et al, 2008). In both cases, the additional modelling supports ERMA New Zealand’s conclusion of high risk to the aquatic environment. ERMA New Zealand’s summary of the two modelling reports is included in Appendix A. 2.3 Amendment to section 3.1.5 of the application The trade name product ENDO 350EC was registered with ACVM on18 June 2008 (shortly before the application was publicly notified). As noted in the application (section 3.1.5) a product by the same name already has an approval under HSNO Act under the substance description emulsifiable concentrate containing 350 g/litre endosulfan (Substance A). ERMA New Zealand has received no submissions on this application from this registrant. 2.4 International legal action 2.4.1 On July 24 2008, a coalition of farm workers, public health, and environmental groups filed a lawsuit against the US Environmental Protection Agency (EPA) to stop the continued use of endosulfan. The coalition is demanding action from the EPA to protect children, farm workers, and endangered species. 2.4.1 On August 20 2008 the EPA placed notice on the Federal Register: (Volume 73, Number 162) relating to Petitions to Revoke All Tolerances Established for Endosulfan. The notice asked for public comment on requests from the Natural Resources Defense Council (NRDC) and Pesticide Action Network North America (PANNA) that the EPA revoke all tolerances for the organochlorine pesticide endosulfan. In addition, this notice solicits information on endosulfan residues in or on commodities consumed by Alaska Natives. http://www.epa.gov/fedrgstr/EPA-PEST/2008/August/Day-20/p19166.htm Endosulfan Reassessment – Update Paper October 2008 Page 6 of 41 2.5 Residues 2.5.1 On 23 July 2008, the Soil and Health Association reported endosulfan residues in both New Zealand and Australian tomatoes based on random samples purchased from supermarkets and fruit and vegetable retailers. 2.5.2 On 4 July 2008, New Zealand beef exports to South Korea were reported to have been put at risk due to reports of endosulfan resides being found in New Zealand beef by Korean officials. Investigation by the New Zealand Food Safety Authority did not identify a source of contamination. 2.6 Ferry sinking - Philippines 2.6.1 21 June 2008 MV Princess of the Stars sank three kilometres from the shores of Sibuyan Island, in central Philippines, with a toxic cargo containing endosulfan. 2.6.2 The search for hundreds of bodies feared trapped on the capsized ferry was halted after it was discovered that there was 9 tonnes of toxic pesticides on board. 2.6.3 An expert team from the Philippines Government and United Nations conducted a general environmental and health risks posed by the wreck. Till the time of the report no leakage of chemicals (including endosulfan) from the wreck has been detected. Endosulfan Reassessment – Update Paper October 2008 Page 7 of 41 Section Two - Summary of submissions and ERMA New Zealand responses 2.1 All issues raised by submitters will be taken into account by the Authority when it considers this application. A summary of the main issues raised by submitters, and ERMA New Zealand’s response to them, is set out in the table below. As stated above, the full text of the submissions is available as a separate document upon request. 2.2 References to paragraphs in the table are references to paragraphs in the application. Summary of issues raised in submissions Topic: Recommendations Issue # 1 Hort New Zealand proposes phase-out over 5 years covering 3 years continued purchase followed by a 2 year stock use up period. ERMA Horticulture New Zealand proposes a phase-out over 5 years, but does not Response say on what basis it makes this recommendation. In the application ERMA New Zealand noted some uses (aerial, domestic, airblast application) as being of particular concern and recommended prohibition of those uses. Although no timeframe was discussed in the application ERMA New Zealand recommends that approval for these uses is revoked with immediate effect. As regards other uses, ERMA New Zealand notes Horticulture New Zealand’s proposal. The option of an immediate ban or a phase out over a period of time is also available to the Authority. Either option would address concerns expressed by some submitters. If the Authority does consider that the approvals should be phased out over time, ERMA New Zealand recommends that a tighter risk management regime be adopted in the meantime. Issue # 2 If the manufacturer is prepared to support use on only tomatoes, potatoes, cabbage, cauliflower, broccoli, gooseberries, blackcurrants, and outdoor ornamentals, it is entirely inappropriate for ERMA to be supporting uses beyond that – particularly turf, sweet potatoes, mustard, radish, turnip, blueberries, sweetcorn. These uses should automatically be prohibited. ERMA The reassessment is carried out on a risk basis. There is no evidence to Response suggest that there is a higher level of risk for the unsupported crops. Issue # 3 Endosulfan should apply a precautionary approach and ban endosulfan ERMA Revoking the approvals for endosulfan is an option which the Authority Response will consider. Issue # 4 If it were not ERMA itself applying, one would have thought there would have been a good chance of the application being declined on the grounds of lack of required information. ERMA ERMA New Zealand believes there is sufficient information for the Response Authority to consider the application. Endosulfan Reassessment – Update Paper October 2008 Page 8 of 41 Issue # 5 We recommend that ERMA withdraw this reassessment application and negotiate with the Minister for the Environment a funding package sufficient to make good on the promise to undertake the group reassessment of organochlorines. ERMA Further funding for the reassessment programme has been made available Response with effect from 1 July 2008. Issue # 6 Greater accountability in the use of Endosulfan on public parks and sports grounds is sort. The use of Endosulfan on a publicly owned and managed sportsground or playground should be publicly notified and a hearing held by the local Territorial Authority to determine whether the local community support the use of Endosulfan as an insecticide. ERMA The preliminary recommendations in the application proposed a number of Response new controls to manage the risks associated with endosulfan use for turf management, namely limiting it to one annual treatment followed immediately by watering in, with a 48 hour “stand down” period in the case of use at “ground contact” sports fields and public parks where children may play. ERMA New Zealand notes the requirement in the Methodology (clause 35(b)) to invite comment on the “cost-effective” application of controls to achieve a specified level of risk management and that some submitters have indicated that these controls may not be practical. In the light of these comments, ERMA New Zealand considers that there may be valid concerns about the practicality of these controls and notes that, in reaching its decision, the Authority may conclude that these recommendations are no longer appropriate. Issue # 7 The use of endosulfan on fodder crops should be prohibited. ERMA This is a residue issue. As detailed in section 4 of the application, dietary Response exposure and risks from residues of endosulfan in food are evaluated by the New Zealand Food Safety Authority under the Food Act 1981. Issue # 8 The Tier II modelling study analysis demonstrated that a 30m buffer zone is a more acceptable and practical mitigation measure. ERMA As outlined in Appendix A to this paper, ERMA New Zealand does not Response agree with this assessment. Issue # 9 All policy development on the use of endosulfan should be aligned with Australian policy ERMA ERMA New Zealand is required under the HSNO Act to make a case-by- Response case assessment of the adverse and positive effects of the use of a substance in New Zealand. Information from other jurisdictions is taken into account in the assessment and evaluation processes. Some Australian uses and circumstances of use are not applicable to New Zealand conditions. Topic: Costs vs Benefits Issue # 10 A number of submitters expressed their concern that the risks of using endosulfan appear to outweigh the benefits and that there are no benefits to society. ERMA The Authority will make the decision as to whether the benefits (positive Response effects) outweigh the risks and costs (adverse effects). In making this decision the Authority will consider all the potential effects of endosulfan including effects on the environment, effects on human health and safety, effects on Maori cultural and spiritual values, effects on society and community and effects on the market economy. Endosulfan Reassessment – Update Paper October 2008 Page 9 of 41 Issue # 11 Economic costs and benefits are not measured against a baseline (as required by ERMA's guidance material) ERMA In a reassessment, the 'with' (baseline) scenario is known and the 'without' Response scenario is predicted. In this instance there is little quantitative evidence to develop the 'without' scenario therefore ERMA New Zealand has adopted a precautionary approach in assessing benefits of the substance. Issue # 12 The weighing up of adverse and beneficial effects is unfairly weighted in favour of spurious benefits against real costs and risks (no consideration of effects on marine mammals). ERMA ERMA New Zealand acknowledges the concern expressed by the submitter Response but is of the view that the benefits that have been admitted are valid. It should be noted that the benefits are not considered to be significant in the longer term. Issue # 13 Lack of evidence that alternative substances and practices would be more expensive ERMA ERMA New Zealand has relied on the available information which Response indicates that this would be the case. Any further information on this issue would be of assistance. Issue # 14 Shorter term gains should not be given precedence over long term harms. ERMA ERMA New Zealand agrees with the submitter. Response Issue # 15 There is significant uncertainty about both adverse effects and beneficial effects ERMA Agreed. ERMA New Zealand has considered the uncertainty associated Response with adverse and beneficial effects as part of its assessment and evaluation process. Where adverse effects are uncertain the Authority will apply the criteria in the Methodology to determine whether it will be more or less risk averse. Issue # 16 Adverse effects do happen (however improbable) ERMA The Authority makes decisions based on the weighing up of adverse and Response beneficial effects. All effects are measured in terms of magnitude and likelihood. Controls are applied that reduce one or both of these components. Issue # 17 Stress to horticulturalists who don't use endosulfan products and psychological and emotional damage to pregnant and breastfeeding women not taken into account. ERMA These are valid considerations and will be taken into account by the Response Authority. Topic: Banned in Other Countries Issue # RT18 Submitters drew attention to the banning or strengthening of restriction of endosulfan in many overseas countries and stated that New Zealand should follow suit. ERMA As part of the reassessment, ERMA New Zealand has reviewed Response developments in other jurisdictions; indeed action taken overseas was one of the grounds for reassessment. Decisions on appropriate risk management for New Zealand are based on the risks associated with the presence and use of the substance in New Zealand. Many of the use patterns used overseas are not applicable to New Zealand, for example aerial application or use on cotton. Therefore it is not appropriate simply to Endosulfan Reassessment – Update Paper October 2008 Page 10 of 41 copy action taken overseas without consideration of the applicability to New Zealand. The Authority will take account of action overseas and the risks assessed for New Zealand in considering this application. Issue # 19 ERMA should obtain information from countries that have banned endosulfan. ERMA ERMA New Zealand has obtained information from countries that have Response banned endosulfan. Topic: Persistent Organic Pollutants (POPs) List Issue # 20 Endosulfan has been proposed for inclusion on the Stockholm Convention POPs list. On these grounds alone it should be banned in New Zealand. One submitter also mentioned that endosulfan is also to be discussed under the Rotterdam Convention Prior Informed Consent list and the New Zealand government has said it will support this decision. ERMA In the application ERMA New Zealand discusses developments under the Response Rotterdam and Stockholm Conventions to manage the international trade and use of endosulfan. Indeed this information was one of the grounds triggering reassessment of endosulfan. Such international action may take several years to resolve. The Authority will take this international action into account when considering this application. The fact that action is being considered at the international level does not require or preclude the Authority from taking action based on local risks. Topic: Alternatives Issue # 21 We don't need endosulfan to produce good food ERMA ERMA New Zealand did consider whether crops can be produced without Response endosulfan (see Section 6 of the application). Issue # 22 If there are alternatives available why do we need endosulfan ERMA ERMA New Zealand did consider whether crops can be produced without Response endosulfan. See Section 6 of the application Issue # 23 Horticulture New Zealand acknowledges that for all uses on crops such as onions, potatoes and brassicas there are alternatives available, and that endosulfan is not needed although some growers like to have it because they know it will work. This is not a justification for continuing its registration. Many growers of crops such as onions have shown that they can manage without endosulfan. ERMA Horticulture New Zealand represents the interests of all registered uses of Response endosulfan and it is significant to note that they accept that there are alternatives available and that endosulfan is not critical for the industry. ERMA New Zealand considers this a significant new information from the industry. Issue # 24 The claim by Horticulture NZ that there is no alterative to endosulfan for Red Berry mite, Broadmite on citrus and Cyclamen mite in strawberries is not accepted. (Information on alternatives given) ERMA In its submission Horticulture New Zealand accepts that there are Response alternative available and that endosulfan is not critical for the industry. Issue # 25 Submitters proposed a range of specific alternatives (chemical and non chemical) that could be used in particular situations. Endosulfan Reassessment – Update Paper October 2008 Page 11 of 41 ERMA ERMA New Zealand welcomes the information provided by submitters on Response specific alternatives. Issue # 26 Submitters noted the need to keep options open while alternatives such as biological control agents are explored ERMA The Authority will consider all options for the future use of the substance Response in New Zealand based on the risk assessment and information received by way of submissions and presented at the hearing. If the Authority decides that a phase out of endosulfan is appropriate, this could expedite the need for users to consider alternative substances or methods of control. Topic: Enforcement Issues Issue # 27 How can we have confidence that there will be no non-compliance with the controls placed on endosulfan products? ERMA Products containing endosulfan have a tracking control and an approved Response handler control. These controls (as explained in paras 3.7.7 - 3.7.12) have been applied to ensure that appropriately trained and licensed people are responsible for hazardous substances. Records of use throughout the lifecycle of these substances must be kept. Enforcement agencies have the power to check records to ensure that hazardous substances are being used in an appropriate manner. Topic: Turf Uses/Public Areas Issue # 28 Endosulfan is toxic to humans it should not be used on sports field, playgrounds or golf courses. Children and people of all ages are being put at risk by continued use. ERMA A number of controls were proposed to reduce the risks of exposure to Response endosulfan under these conditions. Based on the modelling data ERMA New Zealand considers that these controls would significantly reduce the risks, although there may be issues over the practicality of the controls. It is open to the Authority when reaching its decision, to ban use on turf. Issue # 29 Other countries manage their sports fields and turf without endosulfan. ERMA It is reported that earthworms can be managed successfully without Response endosulfan by using acidifying fertilisers such as ammonium sulphate, ammonium nitrate, or iron sulphate, and by improving drainage (Kirby & Baker 1995). Appendix I to the application lists a number of alternatives to endosulfan for earthworm control on turf. Issue # 30 The practitioners in the turf industry have come to rely on endosulphan to control earthworm populations ERMA Use of endosulfan on turf is an ‘off label’ use. As such there are no current Response set application rates. The preliminary recommendations in the application proposed a number of new controls to manage the risks associated with endosulfan use for turf management, namely limiting it to one annual treatment followed immediately by watering in, with a 48 hour “stand down” period in the case of use at “ground contact” sports fields and public parks where children may play. ERMA New Zealand notes the requirement in the Methodology (clause 35(b)) to invite comment on the “cost-effective” application of controls to achieve a specified level of risk management and that some submitters have indicated that these controls may not be practical. In the light of these comments, ERMA New Zealand considers that there may be valid concerns about the practicality of these Endosulfan Reassessment – Update Paper October 2008 Page 12 of 41 controls and notes that, in reaching its decision, the Authority may conclude that these recommendations are no longer appropriate. Issue # 31 If the manufacturer is prepared to support use on only tomatoes, potatoes, cabbage, cauliflower, broccoli, gooseberries, blackcurrants, and outdoor ornamentals, it is entirely inappropriate for ERMA to be supporting uses beyond that – particularly turf, sweet potatoes, mustard, radish, turnip, blueberries, sweet corn. These uses should automatically be prohibited. ERMA The reassessment is carried out on a risk basis. There is no evidence to Response suggest that there is a higher level of risk for the unsupported crops. Topic: Application/ Controls Issue # 32 Use of full PPE for operators is not feasible or enforceable. ERMA Consideration of the practicality of controls and whether they are likely to Response be adhered to is part of the ERMA New Zealand assessment process. Industry has responded by saying the full PPE would be a matter of good practice for products such as those containing endosulfan. Issue # 33 Buffer zone should be 150m - the same as the APVMA ERMA As recommended in the application, ERMA New Zealand believes a 100 m Response buffer zone is appropriate. Issue # 34 Proposed restrictions would not be financially viable for (citrus) industry ERMA The recommendation to prohibit airblast use on citrus is based on a Response significant level of human health and environmental risk. ERMA New Zeealand believes the proposed recommendation is appropriate. Issue # 35 The buffer zone proposal is based on an assessment that omitted to include flooding. ERMA The environmental modelling is mainly concerned with spray drift and run Response off. Flooding has not been considered as this would introduce a significant dilution of the run off. Topic: Human Health Issue #36 Link to human health effects (particularly cancer, reproductive/developmental toxicity and autism. ERMA Many submitters claimed that endosulfan may be the cause of increased Response cancer, particularly breast cancer, rates in New Zealand. A key basis for such claims is the effect endosulfan has on breast cell grown in vitro (outside the body). The key question must be the relevance of such studies to the route and extent of exposure to endosulfan and whether this is sufficient to cause stated effects on human health. Clearly this also relates to whether or not endosulfan is considered a carcinogen (see below). In relation to reproductive and other effects in humans see other responses on endocrine disruption and overseas studies. Issue #37 Concerns about endocrine disruption from endosulfan, and how this aspect is addressed. Endosulfan Reassessment – Update Paper October 2008 Page 13 of 41 ERMA ERMA New Zealand assessed evidence relating to the ability of endosulfan Response to cause endocrine disruption and concluded that the evidence is not strong (as have other overseas authorities). In reaching this conclusion, ERMA New Zealand is not claiming there is no evidence at all of such activity, rather that the balance of the evidence indicated that endosulfan is not substance which acts strongly as an endocrine disrupter. In this context it was commented that this represented a mechanism of action (for reproductive/developmental effects, and target organ toxicity in particular), and that studies did not support a HSNO 6.8 classification. Some submitters interpreted this inappropriately as indicating no action could be taken. ERMA New Zealand has the option of triggering controls aside from classifications and would do so if that that option was considered justifiable. That step was not recommended in the application due to the equivocal nature of evidence in relation to endosulfan, and the fact that other toxicity classifications trigger significant controls. Issue #38 Persistence and presence of endosulfan in our bodies and breast milk. ERMA ERMA New Zealand notes that little information is available on the Response concentrations of endosulfan in the bodies of New Zealanders and human breast milk, and that endosulfan was not included in the Ministry for the Environment's extensive survey of persistent organochlorine chemicals (carried out 1997 - 2000 approximately). ERMA New Zealand notes there is evidence from overseas of the presence of endosulfan in body fat and milk. ERMA New Zealand understands that the levels are far lower than for other chlorinated insecticides (such as DDT and its derivatives) which are far more persistent and bioaccumulative. If a decision is taken to retain food related uses, the residue aspect will be addressed by the NZ Food Safety Authority, since most endosulfan exposure will be from dietary sources. Issue #39 That inadequate consideration has been given to neurotoxicity ERMA ERMA New Zealand notes that one of the mechanisms of toxicity from Response endosulfan is neurotoxicity and that neurotoxic effects typically occur after very high acute exposures. The proposed controls on endosulfan would ensure that such exposures are unlikely. Issue #40 That ERMA New Zealand has incorrectly or selectively used data from particular sources such as ATSDR, in relation to reproductive toxicity, mutagenicity and/or carcinogenicity. ERMA ERMA New Zealand has reviewed the data and attempted to take into Response account the most recent technical reviews. ERMA New Zealand believes that the technical review has taken into account the overall dataset, and applied caution where information is lacking. Issue #41 That inadequate consideration has been given to the need for precaution when addressing uncertainty in the data relating to human health effects. ERMA Where data are uncertain or differ, a ‘weight of evidence’ approach is Response usually taken and this involves judgement about the reliability of different studies (particularly whether they have been performed according to more recent standards). It is important to note that while the HSNO regulations may provide constraints on the classifications that may apply based on data, it is possible to apply additional controls when they are justified under the Act. Issue #42 Inadequate account has been taken of human data from India Endosulfan Reassessment – Update Paper October 2008 Page 14 of 41 ERMA When considering the relevance of studies attributing toxic effects in humans Response to endosulfan, uncertainty is introduced due to other factors to which the population may be exposed, so there may be some uncertainty about whether or not the effects are attributable to endosulfan. ERMA New Zealand noted those concerns and also that the nature of the controls on the use of the substance may be different in New Zealand to those that would have applied or be followed in India. Issue #43 Inadequate account has been taken of higher acute toxicity of endosulfan in female rats. ERMA The HSNO 6.1 acute toxicity classification for endosulfan is primarily Response "driven" by the inhalation classification which is 6.1A. The precise classification is not critical; what is important is the controls that are applied to the substance as a result of the classification. Topic: Residues in Food Issue # 44 It is unethical for ERMA not to report on residues in food as part of its assessment for this review. ERMA As detailed in Section 4 of the application, dietary exposure and risks from Response residues of endosulfan in food are evaluated by the New Zealand Food Safety Authority under the Food Act 1981. Topic: Animals Issue # 45 ERMA has not addressed the issue of contamination of New Zealand's marine mammals despite substantial scientific data on the contamination of marine mammals elsewhere in the world. Evidence from elsewhere in the world should have been used to evaluate the risks to marine mammals. ERMA In the application, ERMA New Zealand discusses the bio Response concentration/bioaccumulation/biomagnification (BMF) processes by which marine mammals might accumulate residues of endosulfan (paras 4.3.29- 4.3.32) and USEPA model biomagnification potential in aquatic ecosystems and conclude that, except for air-respiring marine organisms, such as marine mammals, there is a low potential for biomagnification. BMF for marine mammals are of the order of 22, compared to measured values of 1-7 for beluga and ringed seal (para 4.3.33). There is however, considerable uncertainty around this modelling. ERMA New Zealand was unable to identify any marine mammal effects or residue data from New Zealand waters and none have been submitted as part of this reassessment. ERMA New Zealand was also unable to identify any data relating to concentrations in New Zealand waters. In the absence of such information, it is not possible to determine local environmental concentrations (para 4.3.37), although extrapolating from remote regions in other parts of the world, low concentrations would be expected. In the absence of exposure concentrations, risk cannot be evaluated (para 4.3.37). ERMA New Zealand noted the low usage in New Zealand (5-7 tonnes/year approx) compared to global usage decreasing from 13,000 tonnes/year in 2001 and indicated that, given the potential for long-range transport, New Zealand will be affected by global emissions (para 4.3.36). ERMA New Zealand does not have the tools to manage long-range transport (para 4.3.37) and maintains that it is more appropriate for this to be addressed at the international level through the Stockholm and Rotterdam Conventions. Endosulfan Reassessment – Update Paper October 2008 Page 15 of 41 Issue # 46 Concern about the toxicity to aquatic life ERMA Toxicity per se does not indicate a need for stricter controls; it is the Response comparison of toxicity with exposure that triggers the need for risk management. ERMA New Zealand takes the toxicity to aquatic life into account in its risk modelling (paras 4.3.36-4.3.73). The conclusion of this modelling is that there are risks that require management and the introduction of buffer zones was suggested. One submission claimed that the toxicity values used in the aquatic risk modelling (HC5 values) were an order of magnitude higher than a literature report provided by the submitter. ERMA New Zealand used the extensive ANZECC water quality guideline database to derive HC5 values and determines that this provides an adequate reflection of aquatic toxicity. The literature report used the ACQUIRE database. However, there is considerable overlap between the database used in the literature report and that used by ERMA. Both ERMA New Zealand and the authors of the literature report used the same BurrLioz software to calculate the HC5. The reason for the difference in the HC5 values is therefore unclear. The value used by ERMA New Zealand is similar to that used by overseas agencies in their risk assessments. High risk to the aquatic compartment is demonstrated. Issue # 47 Endosulfan toxicity to bees is inconsistent with IPM. The report that bees are removed from glasshouses for 3 days after application of endosulfan is quoted as evidence of the unsuitability of endosulfan in IPM programmes. There is additional evidence not considered by ERMA New Zealand indicating toxicity to a range of other non-target organisms. A submitter claimed that the data used by ERMA NZ to classify endosulfan toxicity to bees (9.4B) should be replaced by a value of 0.8 ug a.i./bee triggering a 9.4A classification. ERMA ERMA New Zealand stressed the lack of clarity about effects on bees with Response high toxicity in the laboratory, but uncertainty as to effects in the field (paras 4.3.88-4.3.91). ERMA New Zealand draws a distinction between glasshouse use, in which bees cannot forage without exposure, and field use in which avoidance behaviour is possible. Field usage showing an absence of effects on bees is reported in para 4.3.88. ERMA New Zealand concluded that endosulfan is toxic to many non-target invertebrates (Appendix B to the application), albeit not all of the specific species identified in submissions. The toxicity value of 0.8 ug a.i./bee was determined from testing an endosulfan formulation. The classification of the formulated product is expressed in terms of ug formulation/bee. In the absence of information on what formulation was tested, the value of 0.8 ug a.i./bee cannot be converted to ug formulation/bee. ERMA New Zealand notes that if the formulation tested had been approved under the HSNO Act (350 g a.i./l) this would trigger a 9.4B classification. Formulation test data are not used to classify active ingredients. Endosulfan Reassessment – Update Paper October 2008 Page 16 of 41 Issue # 48 It is presumed that endosulfan is toxic to frogs and given the global threats to frogs this should have been taken into account. ERMA ERMA New Zealand did not identify information on the toxicity of Response endosulfan to amphibia. Even in the absence of such information, the risk assessment performed for other taxa in the aquatic compartment indicate high risk that will be taken into account in deciding appropriate risk management. Issue # 49 Risk to soil organisms has not taken account of relevant studies. The data used to classify endosulfan indicates 3x greater toxicity to earthworms than other literature available. ERMA ERMA New Zealand concluded that there are risks to earthworms both in Response treated areas and outside them in areas exposed to runoff. This conclusion will be taken into account in decision making, notwithstanding information on risks to other types of soil biota. ERMA New Zealand uses the available information in deriving a classification. In this case it is appropriate to use the value showing greater toxicity to classify endosulfan. Issue # 50 Risks to birds feeding on earthworms are clearly sufficient to prohibit the use of endosulfan on turf, even without a risk assessment. ERMA ERMA New Zealand concurs there is an acute risk to birds feeding on turf, Response albeit feeding on the grass itself, rather than earthworms for which no assessment was made. The risk to birds feeding on earthworms requires information on residues in worms and assumptions about the proportion of worms in the diet. ERMA New Zealand notes that risks to birds feeding in water do not exceed levels of concern other than for birds feeding exclusively on piscivorous fish. Topic: Plant Toxicity Issue # 51 Contrary to the application (para 4.3.87) there are data indicating plant toxicity. Toxic effects on plants include altered permeability of root membranes resulting in coiling of the root radical, inhibition of root growth, stunting of shoots, and burning of the margins and tips of leaves (IPCS 1984). Furthermore, Perez et al (2007) found endosulfan to be genotoxic to the wetland macrophyte Bidens laevis L (bur marigold, beggars tick) at environmentally relevant concentrations. It interacted with the mitotic spindle at concentrations of only 5 ug/l, well below the NOAELs reported for chronic toxicity (0.57, 0.67 mg/kg/day). In microalgae it caused DNA strand breaks at concentrations of only 1 ug/l (Akcha et al 2008). ERMA ERMA New Zealand notes that the effects noted in IPCS (1984) are reported Response to be very isolated effects, 'In normal usage, endosulfan has not been shown to be significantly toxic to plants' and the concentrations causing them (1.5 g/kg and 1 g a.i./l) exceed the concentrations expected to arise from normal use. However, ERMA New Zealand also notes that the concentrations reported to be causing genotoxic effects are lower than the exposure concentrations used in the aquatic risk assessment, indicating a risk to plants. Endosulfan Reassessment – Update Paper October 2008 Page 17 of 41 Topic: Environmental Contamination Issue # 52 The toxicity, persistence, bioaccumulation and long-range transport properties of endosulfan are such that its use is contrary to the principles of the HSNO Act and the Treaty of Waitangi and it should be banned. ERMA The HSNO Act requires substances to be approved and managed on the basis Response of a risk assessment. Toxicity, persistence and bioaccumulation are all taken into account in evaluating the risks. Such risk assessment has been performed in this application and recommendations have been made as to appropriate management of those risks. Under the HSNO Act, properties of persistence, bioaccumulation and toxicity do not per se mean that the risks cannot be managed. Section 8 of the Act requires the Authority, when considering applications, to ‘take into account’ the principles of the Treaty of Waitangi. Of particular relevance is the principle of active protection affirmed by the Court of Appeal in the Lands case (1987). Taking into account the principle of active protection encourages the Authority to consider whether this application provides sufficient evidence to show that the potential benefits of the controlled use of endosulfan continue to outweigh the potential risks and costs to iwi/Māori. As part of its consideration of the application and submissions received, the Authority will consider what controls may be needed to manage risks to the relationship of Māori and their culture and traditions with ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga. Issue # 53 The application inadequately addresses fate/distribution in air following volatilisation from plant and soil surfaces. ERMA's quoting of APVMA stating that endosulfan is a regional rather than a global air pollutant is inappropriate. ERMA ERMA New Zealand recognises that endosulfan will volatilise from plant Response and soil surfaces (para 4.3.36 of the application) and that given the long- range movement of endosulfan this will lead to contamination of remote regions of New Zealand. However, as stated in the application, ERMA New Zealand does not have the tools to model the distribution of endosulfan following such volatilisation. The application cites APVMA comment on regional rather than global distribution, but in the same sentence recognises that global distribution does occur. ERMA New Zealand notes that atmospheric transport and any resultant management actions are being discussed at the international level, notably the UNEP POP Review Committee. The Authority will consider proposed international actions as part of its consideration of this reassessment. Issue # 54 ERMA NZ should manage NZ emissions that contribute to global long-range transport, even though these are very small compared to global emissions. Endosulfan Reassessment – Update Paper October 2008 Page 18 of 41 ERMA In the application, ERMA New Zealand stated (paras 4.3.36-4.3.37): Response - the size of New Zealand's use of endosulfan relative to global usage (currently 5-7 tonnes compared to 13000 tonnes worldwide in 2001); - that endosulfan shows a potential to contaminate areas remote from its area of use, but ERMA New Zealand lacks the tools to model atmospheric distribution, particularly at a global scale; - that residues of endosulfan have been detected in remote regions of the globe; - that the assessment of risks from New Zealand usage requires risk management; - that there are discussions ongoing at the international level under the Stockholm and Rotterdam Conventions, that include considering listing of endosulfan as a Persistent Organic Pollutant (POP); - it is ERMA New Zealand's view that global emissions and global contamination is best managed at the international level (Executive Summary). It is noted that if a substance is listed in Schedule 2A to the HSNO Act as a POP it is prohibited from use in New Zealand unless otherwise provided in Schedule 2A. The Authority will take all this information into account when considering this application. The fact that action is being considered at the international level does not preclude the Authority from taking action based on local risks. Issue # 55 Metabolites are also persistent and of toxicological concern ERMA ERMA New Zealand recognises the persistence and effects caused by some Response of the metabolites of endosulfan, particularly endosulfan sulphate. Endosulfan sulphate was explicitly taken into account in modelling aquatic risks (para 4.3.61). There are few data on endosulfan diol ecotoxicity but those that do exist suggest it may be less toxic and it was not included in the risk assessment. Toxicity and ecotoxicity studies implicitly take account of metabolites where their formation occurs during the study. Issue # 56 ERMA has failed to take account of the intrinsic value of ecosystems. ERMA ERMA New Zealand's risk assessment process compares exposure to effects Response and comment is made as to uncertainties in this assessment. The intrinsic value of ecosystems is only taken into account in as much as risks can be evaluated. Contamination per se does not equal a risk. There is always uncertainty around extrapolation from laboratory, single-species toxicity test data to ecosystem effects and contamination with persistent substances poses the potential for chronic effects that may be particularly hard to detect with laboratory testing. The Authority will take such uncertainty into account in reaching its decision. Issue # 57 ERMA New Zealand should have taken account of environmental exposure will occur from glasshouses since when the glasshouses are vented endosulfan will volatilise. ERMA ERMA New Zealand stated in para 3.5.43 of the application that Response environmental exposure arising from glasshouse use would be minimal. This should be qualified since, as the submitter points out, when glasshouses are vented emissions through volatilisation will occur. However, since application rates in glasshouses are the same as those in open fields, and runoff from glasshouse use is much less, the environmental risks inherent in Endosulfan Reassessment – Update Paper October 2008 Page 19 of 41 endosulfan use in glasshouses will be no greater than those assessed in open fields. Issue # 58 Plants bioaccumulate endosulfan ERMA The submitter reports the results of studies showing bioconcentration in Response bulrushes and conifers. The latter study suggests annual removal by US western conifer forests of about 2% of the US usage and suggests other vegetation types may be accumulating even greater amounts. ERMA New Zealand notes that the concentrations reported are very much lower (7.6 mg/kg lipid in fir needles) than those used in the risk assessment of birds eating vegetation (10-500 mg/kg, Appendix F; for comparative purposes lipid content in conifer needles is 1-5%) and would be insufficient to cause toxic effects on birds, but nevertheless this is further evidence of the long-range distribution of endosulfan. Issue #59 ERMA has not used all available bioaccumulation data Submitters provide additional reports of measured residues in aquatic fauna. Having considered the new information presented in submissions ERMA New Zealand remains of the opinion that there is uncertainty regarding the potential for biomagnification, but that modelling indicates its possibility for air-breathing aquatic organisms. Topic: International Reputation Issue # 60 Account must be taken of the impact of continuing to use endosulfan on New Zealand's international reputation. ERMA The Authority will consider risk to international reputation from the point of Response view of New Zealand’s ‘clean green’ image (see paras 4.2.12-4.2.18) and anxiety in society at large over use of the substance, which would include international consumers (see paras 4.2.10-4.2.11). Issue # 61 Potential for loss of markets (associated with loss of clean green image) ERMA The issue of market access has been addressed in the application. Exporters Response are responsible for ensuring that their products do not breach maximum residue limits (MRLs) set by NZFSA. When endosulfan is used in compliance with the strict controls governing its use and MRLs are complied with, there should not be any adverse effects on markets. ERMA New Zealand agrees that in the wider context of international market access, a loss of trust in New Zealand produce could have long term adverse effects. Issue # 62 Export consignments have already been rejected because of failing residue tests (for endosulfan) ERMA Compliance with international market regulations (including MRLs) is the Response responsibility of individual exporters. Such breaches may affect New Zealand's international reputation. Issue # 63 New Zealand wants to maintain its clean green image ERMA ERMA New Zealand agrees with submitters that there is economic value in Response the notion of a 'clean green' image. The Authority makes decisions on a case-by-case basis and takes into account the incremental effect of approvals on international markets as part of the decision process. Issue # 64 While New Zealand continues to use such chemicals (a) it risks losing its clean, green image and/or (b) the notion of a clean green image is an illusion Endosulfan Reassessment – Update Paper October 2008 Page 20 of 41 ERMA The Authority makes decisions based on the weighing up of adverse and Response beneficial effects. The concept of a 'clean green’ image has relevance to effects on the market economy and effects on society and community and is addressed in the application in respect of these areas. Issue # 65 We should be working towards chemical free organic agriculture and away from chemical solutions ERMA The Authority makes decisions on applications made either for new Response substances or for the reassessment of existing substances. The Authority makes decisions on a case-by-case basis and while the consideration of the availability of alternatives is part of the assessment (in terms of the 'with' and 'without' scenarios, the Authority must weigh up the adverse and positive effects and will not promote one production system over and above another. Issue #66 It is internationally embarrassing that New Zealand still uses this toxic chemical on our food and sports fields. The use of highly toxic, persistent, and bioaccumulative chemicals needs to be phased out rapidly if we are to maintain our international reputation. ERMA The option of an immediate ban or a phase out over a period of time for Response some or all of the current uses of endosulfan is available to the Authority when it considers this application. Topic: ERMA Issue # 67 The continued use of endosulfan is not consistent with ERMA's stated intent of aligning with government priorities - “growing globally competitive firms, environmental sustainability”, "safe communities” and "better health for all” ERMA The HSNO Act requires the Authority to make decisions based on weighing Response up of adverse and positive effects. Government priorities are taken into account in the identification and assessment of effects. Issue # 68 ERMA's reputation is at risk if endosulfan is allowed to be continued to be used. ERMA ERMA New Zealand makes decisions on a case-by-case basis on the Response information available to it. ERMA New Zealand applies the decision making criteria in the Act and the Methodology on a consistent basis. Issue # 69 ERMA is not representing the public interest in allowing the continued use of endosulfan ERMA The Authority will make the decision as to whether the benefits (positive Response effects) outweigh the risks and costs (adverse effects). In making this decision the Authority will consider all the potential effects of endosulfan including effects on the environment, effects on human health and safety, effects on Maori cultural and spiritual values, effects on society and community and effects on the market economy. Topic: Further Queries Issue # 70 A number of points were raised that were not directly relevant to the endosulfan reassessment (recycling of light bulbs, concerns about the chemical load on society) ERMA Not relevant to this application. Response Issue # 71 What can be done to prevent the import of foodstuffs containing endosulfan residues? Endosulfan Reassessment – Update Paper October 2008 Page 21 of 41 ERMA As stated above, setting of MRLs is the responsibility of the NZFSA under Response the 1981 Food Act and are outside the remit of this reassessment which is restricted to the lifecycle of endosulfan and its formulations in New Zealand. Issue # 72 This endosulfan review highlights that to be sustainable, New Zealand should be moving to organic agriculture. ERMA This is a reassessment of endosulfan. While consideration is given to Response alternatives to the use of endosulfan, its scope does not extend to a consideration of the merits of organic versus non-organic production systems. Topic: Quantities Issue # 73 It is acknowledged that quantities of endosulfan used in New Zealand are reducing partly as a result of market pressures. Some submitters feel this demonstrates there is no longer a need to use endosulfan here and indicate restrictions imposed on use overseas. ERMA ERMA New Zealand has discussed many of these points in the application Response (see Executive Summary, paras 3.5.19, 3.5.22-3.5.35). ERMA New Zealand is of the view that reducing use, the closure of some export markets, and the existence of alternatives are factors that will inform a decision, but they do not in themselves mean there is no justification for continuing use since there may be uses for which endosulfan is needed and there may be issues around the use of alternatives. Issue # 74 A submitter claimed that use of endosulfan increased 40x between 1998 and 2004. ERMA The origin of this claim is unknown. ERMA New Zealand considers that Response information on use in New Zealand indicating a reduction in use in recent years (see para 3.5.19) is relevant to the Authority’s consideration of this application. Topic: Importation Issue # 76 ERMA has not taken note of the impact on the environment and human health in the countries where endosulfan is manufactured ERMA The submitter is correct. ERMA has not specifically considered the country Response of origin of endosulfan formulations imported into New Zealand. For pragmatic reasons this is the practice followed by ERMA New Zealand in its risk assessments. Topic: IPM Issue # 77 Comments in favour or use of endosulfan in IPM ERMA Points raised by submitters in support of the use of endosulfan in IPM are Response already included in the application (see paras 4.2.19-4.2.36) Issue # 78 Reasons for a decline in the use of endosulfan on particular crops ERMA Both brassica growers and the submitter claim that endosulfan use on Response brassicas has reduced in recent years due to IPM. The submitter claims that endosulfan use is therefore not necessary on brassicas, while the growers claim they need it for when IPM fails (para 3.5.26). Issue # 79 Submitters challenged whether endosulfan is compatible with IPM, particularly in glasshouses, because of its toxicity to non-target organisms and claimed that the development of resistance is an issue Endosulfan Reassessment – Update Paper October 2008 Page 22 of 41 ERMA ERMA New Zealand's application reports laboratory toxicity to a range of Response non-target organisms but adds that there is uncertainty as to whether toxic effects occur in the field (see paras 4.3.89, 4.3.91, 4.3.271 Table B4, Table B5). Toxicity to other species has been highlighted in other references provided as part of submissions. ERMA New Zealand notes that behavioural effects (avoidance) that may protect non-target organisms in the field, are less likely to occur in glasshouses. As part of the submissions additional information was referenced indicating that resistance to endosulfan has been reported in a range of species. This reference is to a University of Michigan website. The site provides names of pest species, crop and other host plants, but no other details. This information suggests that the claim from Makhteshim included in the application, that 'only a few cases of temporary insect resistance have been reported' may be wrong. Topic: Maori Issues Issue # 80 ERMA has failed to consult with Maori. ERMA concluded that the use of endosulfan is not consistent with the principle of active protection regarding the principles of the Treaty of Waitangi, as affirmed by the Lands case (1987), but have then ignored this in their proposed decision. ERMA The application outlines the extent of consultation undertaken before the Response application was publicly notified. The submission process allows all interested parties, including Maori, to submit information on the application. The Maori Party has indicated that it would like to see endosulfan banned. A report received from the Maori advisory committee to the Authority, Nga Kaihautu Tikanga Taiao, (see Appendix B of this paper) indicates a preference for banning or phasing out endosulfan. These views will be taken into account by the Authority when it considers this application. Topic: Public Awareness Issue # 81 ERMA approval of a substance will be interpreted as meaning the product is 'safe', leading to a lack of consideration of alternatives and local risks. The submitter quoted an example, 'when I was contacted about a school that was using this product on its playing fields. There was no understanding on the part of the school Principal or trustees who fielded the parental complaints that this chemical was known to be highly toxic, persistent and bioaccumulative, and that the health risk to the children who would shortly be playing on these fields was an appropriate matter of concern. There was no appreciation of the greater vulnerability of their children because they had not considered the fact that children are not small adults' Endosulfan Reassessment – Update Paper October 2008 Page 23 of 41 ERMA ERMA New Zealand's evaluation of the risks associated with the use of a Response product assumes that the controls on that substance are in place, i.e. that it will not be misused as would be assumed by an 'approval = safe' mindset. It is the convention for regulatory risk assessments that misuse cannot be modelled. Regarding the example given in the submission, ERMA New Zealand did model risks to bystanders, but did not look at the specific example of children exposed to endosulfan treated turf. ERMA New Zealand concluded that risks to adults from exposure to treated turf were high (para 4.3.244), and commented that these could be reduced by watering-in (not included in ERMA New Zealand's modelling, although recommended). The application also stated it did not have sufficient information to determine if this would sufficiently reduce the risk (para 4.3.246). Risks to children from exposure to treated turf would be expected to be greater than risks to adults. The Methodology requires the Authority to invite comment on the “cost- effective” application of controls to achieve a specified level of risk management and that some submitters have indicated that the controls proposed in relation to turf use may not be practical. In the light of these comments, ERMA New Zealand considers that there may be valid concerns about the practicality of these controls and notes that the Authority may conclude that these recommendations are no longer appropriate. ERMA New Zealand did look at risks to children (and operators) from other uses and identified high risks as a result of airblast applications and as a consequence recommended that airblast application to citrus be prohibited (see page 13 of the application). Topic: Testing Issue # 82 Laboratory testing provides only an indication of effects that may occur in the field but does not take into account interactions including the impact of differing environmental conditions. ERMA It is correct that laboratory testing of toxicity provides only an indication of Response likely effects in the field. However, these tests are designed to maximise exposure and so provide a worst-case scenario with regard to the impact of environmental conditions. Greater realism may be achieved through field studies (see para 4.3.88 for example). Single-species laboratory tests (and nearly all laboratory tests are single-species) do not determine species interactions. Field study data give some indication of such interactions. This is the best information that is available for risk assessment and the approach taken by ERMA New Zealand is the conventional approach to such risk assessment. Topic: Accident Issue # 83 Risks from accidents are not highly improbable and it should not be assumed that the first people on the scene are likely to be trained personnel. Endosulfan Reassessment – Update Paper October 2008 Page 24 of 41 ERMA The application (para 4.3.115) states that the likelihood of accidents is highly Response improbable (which by ERMA New Zealand’s definition, means almost certainly not occurring but cannot be ruled out). This should have said that the risks to human health from accidents during importation, transportation or storage are highly improbable, such risks being a consequence of the probability of the accident occurring and human exposure being sufficient to cause an effect. ERMA New Zealand maintains that the first response is likely to be from trained personnel, which the submitter says should not be assumed. ERMA New Zealand has only assumed it to be so in that it has said it is 'likely'. Topic: New Zealand Incident Data Issue # 84 Lack of incidents data does not necessarily mean lack of incidents. ERMA ERMA New Zealand agrees that lack of incident data can either be due to a lack Response of incidents or a lack of reporting, and this is stated in para 4.2.8 of the application. Endosulfan Reassessment – Update Paper October 2008 Page 25 of 41 Section Three – Conclusions 3.1 The Authority’s decision on the future use of endosulfan in New Zealand will be based on its consideration of: the application; all submissions and further information received since the application was publicly notified; and information provided at the hearing. 3.2 The Authority is required under the Act, to consider whether or not the positive effects (benefits) of using endosulfan outweigh the negative effects (risks and costs) of its use - after taking account of all safety precautions that might be imposed and the likely effects of the substance being unavailable. 3.3 If the benefits outweigh the risks and costs, the Authority may approve the continued use of endosulfan in New Zealand for some or all of its current uses (possibly with stricter controls or with further restrictions on use). If the benefits do not outweigh the risks or costs then the Authority may decide to prohibit endosulfan or some or all of its uses. 3.4 In the application, ERMA New Zealand noted that some uses (aerial, domestic and airblast application) were of particular concern and recommended they be prohibited. No additional information has been submitted which suggests that ERMA New Zealand's risk/benefit analysis was incorrect in this respect. Although no timeframe for prohibiting these uses was discussed in the application, ERMA New Zealand recommends that approval for these uses is revoked with either immediate effect or a very short phase out period. It is noted that this will effectively prohibit the use of endosulfan on citrus. 3.5 As regards other uses on other crops, ERMA New Zealand notes that a phase out over a period of time is an option open to the Authority and further notes Horticulture New Zealand’s proposal for a phase out over a five year period. However, if the Authority does consider that the approvals should be phased out over time, ERMA New Zealand recommends that a tighter risk management regime (incorporating the controls set out in the table below) should be adopted during the phase out period. 3.6 In relation to use of endosulfan on turf, this is an ‘off label’ use and so there are no current set application rates. The recommendations in the application proposed a number of new controls to manage the risks associated with endosulfan use for turf management, namely limiting it to one annual treatment followed immediately by watering in, with a 48 hour “stand down” period in the case of use at “ground contact” sports fields and public parks where children may play. ERMA New Zealand notes the requirement in the Methodology (clause 35(b)) to invite comment on the “cost- effective” application of controls to achieve a specified level of risk management and that some submitters have indicated that these proposed controls may not be practical. In the light of these comments, ERMA New Zealand considers that there may be valid concerns about the practicality of these controls and notes that the Authority may conclude that these recommendations are no longer appropriate. If so, the Authority Endosulfan Reassessment – Update Paper October 2008 Page 26 of 41 may decide to prohibit use on turf outright or phase it out over a period of time. If it decides that the latter route is the most appropriate, ERMA New Zealand recommends that a tighter risk management regime incorporating the controls set out in the table below should be adopted during the phase out period. 3.7 In summary, should the Authority choose to allow the continued use of endosulfan then we would recommend that the controls set out in the table below be adopted. We also recommend that these controls should be adopted during any phase out period should the Authority choose to prohibit the substance. Recommended controls Rationale Nature When Immediately The REI values are based on a review of values The following Restricted Entry applied in various overseas jurisdictions where Intervals (REIs) should be endosulfan is still used (USA, Australia and imposed for all uses, where Canada). The values have not been based on personal protective equipment quantitative modelling using New Zealand (PPE) is not used when re- label rates but by the application of the most entering: relevant REI (which were from the USA). 48 hours for all crops or Some values have been lengthened slightly activities not listed below: from what was initially proposed in the application to reflect US recommendations. 3 days for sweetpotato; 4 days for brassicas (broccoli, cabbage, cauliflower, brussels sprouts), mustard, radish, turnip; 6 days for blueberries; 17 days for sweetcorn; 4 days for glasshouse Glasshouse REI based on the US EPA and Cal use; EPA values 10 days for “pick your own” activities (for Members of the public may be more vulnerable members of the public). than workers. Immediately High level of risks to the aquatic environment A 100 metre no-spray buffer zone and to soil fauna. will be required for all uses around waterbodies and the edges In the absence of evidence suggesting that a of treated crops smaller buffer zone would be effective, ERMA New Zealand proposes a 100 metre buffer zone on the basis of overseas analyses of the effectiveness of buffer zones. Immediately ERMA New Zealand raised the possibility of A maximum application rate for reducing application rates or frequency in the permitted turf use of 0.7 kg a.i/ha application for reassessment in order to reduce and one (1) application per operator human health and environmental risks. season) NZSTI advised that the 2.1 kg a.i./ha referred to in the application for turf is higher than is in Endosulfan Reassessment – Update Paper October 2008 Page 27 of 41 fact the case and that the maximum rate should be 0.7 kg a.i./ha. This means that the excessive operator exposure risk from application on turf can be reduced to the extent necessary, although this still requires the use of full PPE during application. No submissions were received suggesting alternative application rates or frequencies for other uses. Since ERMA New Zealand has received no information on which to base changes to use patterns to reduce risks consistent with the efficacy of use and achieving of benefits, the original use patterns have been use in this assessment for other uses. Immediately Operator exposure estimates have The following personal protective demonstrated that the health risk from mixing, equipment (PPE) requirements loading and application of endosulfan are should be stipulated on the label relatively high and only become acceptable for for different types of application the operator using “full” PPE. Therefore it is and at different stages of the recommended that the stated PPE be stipulated lifecycle (mixing/loading; on the label. application) and PPE should also be stipulated for re-entry prior to expiry of the relevant REI: Mixing/loading Coveralls or long sleeved shirt and long pants Chemical resistant gloves, apron and footwear Protective eye wear (may be combined with respirator) Appropriate respiratory protection for spray mist* Application# Coveralls or long sleeved shirt and long pants Chemical resistant gloves, apron and footwear Protective eye wear (may be combined with respirator) Appropriate respiratory protection for spray mist * * A combination mist/organic vapour respirator is required for operations involving Substance A and Substance D, due to the higher toxicity of the solvent in these formulations. # In the case of application using Endosulfan Reassessment – Update Paper October 2008 Page 28 of 41 an enclosed cab, the PPE needed for the driver during application may be varied appropriately. Early re-entry: PPE should also be worn by people entering crops before the expiry of the relevant REI. (This will not apply to ’pick your own activities” for which no early entry is permitted.) The required PPE is: Coveralls or long sleeved shirt and long pants; Chemical resistant gloves, apron and footwear; Protective eye wear (may be combined with respirator); Appropriate respiratory protection for spray mist.* * A combination mist/organic vapour respirator is required for operations involving Substance A and Substance D, due to the higher toxicity of the solvent in these formulations. Endosulfan Reassessment – Update Paper October 2008 Page 29 of 41 The following classification Immediately They are technically warranted and provide changes should be made: clearer information to users. for all formulations, replace 6.1C overall acute toxicity classification with 6.1A based on inhalation toxicity; replace the current 6.3B classification on Substance D with a 6.3A classification; remove the 6.8B classification applied to Thionex Insecticide Solvesso formulation; replace the current 9.2C classification on endosulfan and all its formulations with a 9.2A classification. Assign an approval number to the Immediately As set out in the application. Thionex Insecticide Solvesso formulation Immediately As set out in the application. Change the packing group assigned to endosulfan and all formulations containing endosulfan from PG I to PG II. Endosulfan Reassessment – Update Paper October 2008 Page 30 of 41 Appendix A – Summary of additional aquatic exposure modelling Background The application for reassessment of endosulfan was publicly notified on 27 June 2008. One of the areas of high risk identified by ERMA New Zealand during the preparation of this application was the potential for effects on aquatic biota. ERMA New Zealand flagged uncertainty about this conclusion because of the methods used to estimate the concentration of endosulfan in surface water. The methods and areas of uncertainty were: A Tier I analysis using the GENEEC2 model. This model estimates the concentration of endosulfan in a static water body 1 ha in size, 2 m deep, receiving the runoff and spray drift from a 10 ha area immediately adjacent to it. The GENEEC2 model is an intrinsically conservative model with uncertainty inherent in its output. Higher tier modelling performed by USEPA using the PRZM/EXAMS models (USEPA, 2007). This modelling used US use scenarios, US weather and soil characteristics. Higher tier modelling performed by Ramanarayanan et al (1999) and submitted by Makhteshim Chemical Works (MCW) using the PRZM/EXAMS models and application scenarios applicable to the US. These analyses differed from those of USEPA primarily in their use of lower estimates of spray drift. The GENEEC2 modelling estimate of concentrations in the receiving water were similar to those of USEPA, but higher than those of Ramanarayanan et al (1999), although all analyses estimated risks requiring management. However, it was not apparent to what extent the PRZM output might have been affected by the use of US application scenarios. ERMA New Zealand therefore asked MCW to perform another PRZM/EXAMS analysis using inputs applicable to New Zealand. This work was contracted by MCW to AMEC Earth & Environmental and a report was received by ERMA New Zealand on 2 July 2008 (Schupner & Mackay, 2008). The AMEC report did use New Zealand application scenarios, but did not use New Zealand soil and weather parameters. Consequently, ERMA New Zealand contracted HortResearch to evaluate the AMEC report and run another model, SPASMO, using New Zealand soil and weather data. SPASMO is a leaching model that was extended for this work by incorporation of the runoff routine within the CREAMS model. These models were run using New Zealand soil and weather information. A report on this work was received by ERMA New Zealand on 26 August 2008 (Müller et al, 2008). The following comprises a summary of the reports from AMEC and HortResearch and comments on how these additional analyses affect the conclusions for aquatic risk reached by ERMA New Zealand in its application. Schupner & Mackay (2008) As with the USEPA (2007) and Ramanarayanan et al (1999) analyses, this is another application of the PRZM/EXAMS model estimating the concentration in a 1 ha, 2 m deep pond adjacent to a 10 ha field. The major difference in Schupner & Mackay’s analysis is that use patterns reflect New Zealand application rates, frequency and scenario (ground boom) Endosulfan Reassessment – Update Paper October 2008 Page 31 of 41 and the analysis was performed assuming there was no no-spray (buffer) zone around the field. Drift was assumed to be 0.5% for each of the scenarios modelled. Some of the inputs into this analysis used parameters applicable to the US, for example rainfall, and soil parameters and degradation rates. It is uncertain how relevant these are to New Zealand. ERMA New Zealand has calculated summary statistics (minimum, maximum and average), from this report for citrus, for pasture and for the other crops combined (see Table 1 below). The results of this analysis show concentrations in the receiving water similar to those estimated by Ramanarayanan et al (1999). ERMA New Zealand notes that although the percentage drift used in Schupner & Mackay (2008) is higher than that used by Rananarayanan et al (1999), it is still lower than used by USEPA (2007) in their PRZM/EXAMS analysis or ERMA New Zealand in its Tier I GENEEC2 analysis. While it is not explicitly stated in Schupner & Mackay (2008), ERMA New Zealand assumes that the figure of 0.5% applies to drift as a percentage of the total amount applied to the 10 ha field, whereas the figure of 5% used by USEPA (2007) applies to drift as a percentage of the application rate. ERMA New Zealand notes that APVMA (2008) express drift as a fraction of the field rate. ERMA New Zealand also notes that it is not evident from Schupner & Mackay (2008) what values were input/derived for volatilisation and subsequent contamination of water bodies. Müller et al (2008) In this report, an integrated SPASMO/CREAMS model was used to estimate leaching and runoff from 6 crops (citrus, pasture (turf), boysenberry, onion, strawberry, potato), in 6 regions (Northland, Bay of Plenty, Waikato, Hawkes Bay, Manawatu, Canterbury) and 5 or 6 sites per region (representing a range of drainage and soil organic carbon content). The model assumes application to, and runoff from, a 1 ha area. Spray drift was assumed to be negligible. Climate data from 34 years of recording were used to estimate concentration probability distributions for leaching and runoff. It was found that: Losses through leaching were minimal. The effect of region and soil type was comparatively minor. The effect of crop type had the greatest impact on runoff. The authors stress the importance of spray date in relation to the development of the crop, as crops develop and vegetation cover increases, runoff decreases. ERMA New Zealand has calculated summary statistics (minimum, maximum and average), for citrus, for pasture and for the other crops combined (see Table 1 below). The results of this analysis are not directly comparable to those of the other analyses, because the output is concentration in runoff (leaching losses were negligible) while the other analyses estimate concentrations in a receiving water taking account of fate processes in the water body. In addition, runoff from a 1 ha treated area is assumed, where the other analyses use runoff from a 10 ha area. To extrapolate from the losses in runoff to concentration in a receiving water can be done using a dilution factor; conventionally a factor of 10 is used. However, the Müller et al (2008) analyses show that although the concentration in runoff is relatively constant (varies by less than a factor of 10), the runoff volume varies between sites by a factor of approximately 700 and hence the total amount in runoff varies considerably. Endosulfan Reassessment – Update Paper October 2008 Page 32 of 41 Dilution in a receiving water is therefore likely to be very variable. In addition, dilution is only one factor reducing the concentration of endosulfan in a receiving water; other fate processes such as degradation and sorption will also have an impact. The results of the Müller et al (2008) analysis indicate concentrations in runoff that are similar to those estimated in receiving waters by ERMA New Zealand using GENEEC2 and by the USEPA using PRZM/EXAMS. However, although dilution, sorption and degradation will lead to a lower concentration in receiving water compared to that in runoff, this cannot be taken as evidence that use of New Zealand specific parameters leads to lower concentrations in receiving waters, because the Müller et al (2008) analyses do not take account of other routes of input such as spray drift and volatilisation/redeposition. Consequences for conclusions of high risk in the aquatic environment ERMA New Zealand’s conclusion on risks to the aquatic environment, as reported in the notified application, was that there is a high risk to aquatic organisms. The information received by ERMA New Zealand since notification provides additional modelling pertinent to freshwater exposure. No additional information has been received requiring a reconsideration of the aquatic toxicity of endosulfan. ERMA New Zealand’s conclusions are: Schupner & Mackay (2008) used New Zealand use scenarios, but US soil and weather data. The concentration in the receiving water from this analysis was similar to that estimated by Ramanararyanan et al (1999) which used the same model but input US use scenarios and US soil and weather data. ERMA New Zealand notes that spray drift of 0.5% was assumed in both these analyses and it is not clear what contribution volatilisation from soil and plant surfaces and redeposition in water makes to the aquatic concentration. On the basis of both Schupner & Mackay (2008) and Ramanarayanan et al (1999), ERMA New Zealand identifies a high risk to aquatic organisms and recommends that risk management is required. Müller et al (2008) used New Zealand use scenarios and New Zealand soil and weather data. Their analysis only looked at input to a receiving water from runoff; fate in that receiving water was not modelled and drift and volatilisation/redeposition were assumed to be zero. The data show that the total endosulfan runoff varies greatly between sites, but making broad assumptions as to fate in receiving waters, spray drift and volatilisation/redeposition input, there is no evidence that use of New Zealand soil and weather data leads to a lesser concentration in receiving waters than is calculated by the other analyses. The conclusion of high aquatic risk is therefore unaffected by this new information. No additional information has been received by ERMA New Zealand relating regarding the extent to which buffer zones might reduce aquatic exposure. The conclusion reached in the application that buffer zones can reduce exposure, remains a truism. In the application, ERMA New Zealand proposed adoption of a buffer zone of 100 m based on overseas analysis of the effectiveness of buffer zones. ERMA New Zealand has no additional information by which to evaluate this proposal. References APVMA (2008) Endosulfan Reassessment – Update Paper October 2008 Page 33 of 41 How the APVMA determines the size of protective no-spray zones. http://www.apvma.gov.au/users/spraydrift/no_spray_zones.pdf Müller K, Green S, Deurer M, Vogeler I and Clothier BE (2008) Endosulfan: Review of AMEC’s surface water exposure assessment report and alternative risk assessment with SPASMO HortResearch report 26553 Ramanarayanan et al (1999) Ramanarayanan, T.; Fischer, R.; Allen, R. (1999). Endosulfan (AE F002671): Tier II Surface Water Exposure Assessment and Comparison to Aquatic Toxicity End-Points. AgrEvo USA Company. Report. BJ99E514 Schupner JK and Mackay C (2008) Endosulfan Tier II surface water exposure assessment using PRZM/EXAMS AMEC Earth & Environmental Report 76861-06-26-08 USEPA (2007) Addendum to the Ecological Risk Assessment for Endosulfan. Memorandum to Special Review and Reregistration Branch. October 31. EPA-HQ-OPP-2002-0262-0063. http://www.regulations.gov Endosulfan Reassessment – Update Paper October 2008 Page 34 of 41 Table 1 Summary of modelling and conclusions Model Application Soil/ Application Buffer Drift Runoff EEC Reference scenario weather (%) conc'n (µg/l) (µg/l) Equipment Rate # Date Runoff Drift Drift Peak 21 day 60 day 90 day (kg a.i./ha) GENEEC2 NZ Generic Boom 0.7 4 - None None 1.2 - 13 8.9 4.8 3.4 ERMA (label) application 2.1 1 0.8 - 10 6.7 3.6 2.6 (turf) Airblast 1.3 2 None None 9.7 - 1.2 11 6 4.3 (citrus) ) PRZM/ US US Aerial 1.1 3 15, 22, None None 5 - 12 5.5 3.9 EXAMS (tomato, 29 Sep USEPA (2007 strawberry) 1.1 15, 22, 23 9.3 6.8 (strawberry) 29 Jan PRZM/ US US Boom 1.1 3 1 Apr, None 91 m 0.19 - 0.23 0.064 ‐ 0.03 Ramanarayanan EXAMS (cantaloupe) 8 May, et al (1999) 15 June 1.2 1 1-Apr 0.15 0.013 0.003 (cantaloupe) Airblast 1.7 1 1-May None 31 m 0.03 - 0.33 0.08 0.033 (apple) PRZM/ NZ US Boom 0.7 1 5-Jan None None 0.5 - Min 0.17 Min 0.04 Min 0.04 Min 0.04 Schupner & EXAMS (potatoes, Max Max Max Max Mackay (2008) onions, 0.51 0.22 0.21 0.21 strawberries, Avg Avg Avg Avg boysenberries) 0.36 0.14 0.13 0.13 Endosulfan Reassessment – Update Paper October 2008 Page 35 of 41 Model Application Soil/ Application Buffer Drift Runoff EEC Reference scenario weather (%) conc'n (µg/l) (µg/l) Equipment Rate # Date Runoff Drift Drift Peak 21 day 60 day 90 day (kg a.i./ha) 2 5, 15 None None Min 0.28 Min 0.08 Min 0.07 Min 0.07 Jan Max 1.0 Max Max Max Avg 0.42 0.41 0.41 0.72 Avg Avg Avg 0.26 0.26 0.26 4 5, 15, None None Min 0.44 Min 0.13 Min 0.12 Min 0.12 25 Jan, Max 1.8 Max Max Max 4 Feb Avg 1.2 0.78 0.76 0.76 Avg Avg Avg 0.48 0.47 0.46 Airblast 1.3 1 5-Jan None None 0.5 - 0.26 0.022 0.018 0.017 (citrus) 2 5, 15 None None 0.5 - 0.27 0.043 0.036 0.034 Jan Boom 2.1 1 5-Jan None None 0.5 - 0.42 0.04 0.034 0.032 (turf) SPASMO NZ NZ Not 0.7 1 5-Jan None None 0 Min ‐ ‐ ‐ ‐ Mueller et al specified (Boysenberry, 4.1 2008 (but drift onion, Max assumed to strawberry, 21.7 be potato) Avg negligible) 10.3 2.1 Min ‐ ‐ ‐ ‐ (pasture) 13.4 Max 23.1 Avg 17 1.3 Min ‐ ‐ ‐ ‐ (citrus) 26.9 Max 43.9 Avg 34.8 Endosulfan Reassessment – Update Paper October 2008 Page 36 of 41 Appendix B – Preliminary recommendations included in the application The recommendations set out below are preliminary only. An important part of the reassessment process is public submissions on the application. These public submissions are likely to have an effect on the final outcome of the reassessment. On the basis of its evaluation of whether the risks associated with the use of endosulfan in New Zealand outweigh the benefits, ERMA New Zealand proposes the following preliminary recommendations to ensure that practices are safe for people and the environment: 1. That the use of endosulfan be prohibited for: aerial and domestic use of the substance on the basis that these are not uses to which it is currently put (and the relevant risks have not been assessed as part of this application); and airblast application for citrus on the basis that risks to operators and bystanders are currently assessed as very high. 2. That use on turf be restricted to one annual treatment, followed immediately by watering in, with no use of the treated area in the case of “ground contact” sports use and public parks where children may play, for a period of at least 48 hours following treatment (noting, however, that the operator exposures are high even with full PPE, so the feasibility of a lower application rate needs to be explored). 3. That the following Restricted Entry Intervals (REIs) be imposed for other uses, where PPE is not used when re-entering: 48 hours for all crops not listed below; 3 days for sweetpotato, mustard, radish, turnip; 4 days for brassicas (broccoli, cabbage, cauliflower, brussels sprouts); 6 days for blueberries; 10 days for sweetcorn. In respect of the issue of REIs, ERMA New Zealand notes that: although re-entry restrictions can be specified on New Zealand labels under HSNO regulations, the clearer, more prescriptive approach recommended above is in line with requirements introduced by overseas agencies; consideration will need to be given to an appropriate REI for greenhouse use; consideration will need to be given to longer REIs in the case of ‘pick your own’ berry orchards to take account of the exposure of pickers; and REIs may not be necessary in respect of post-application turf maintenance activities (for example, mowing/rolling) unless the work involves direct exposure. 4. That a no-spray buffer zone around waterbodies and the edges of treated crops be introduced due to high level of risks to the aquatic environment and to soil fauna Endosulfan Reassessment – Update Paper October 2008 Page 37 of 41 (ERMA New Zealand currently considers a 100 m buffer zone may be appropriate on the basis of overseas’ analyses of the effectiveness of buffer zones). 5. That reduced (maximum) application rates (kg a.i./ha per application/season) and/or limits on the number of applications (for example, per season) be introduced for some uses in order to lower the risks to the environment and people (noting the measures of this type proposed by some overseas agencies). 6. That suitable PPE be stipulated for different types of application and at different stages of the lifecycle (mixing/loading; application). Finally, if the Authority’s overall evaluation favours retention of some or all of the endosulfan approvals, ERMA New Zealand recommends the following classification changes: for all formulations, replace 6.1C overall acute toxicity classification with 6.1A based on inhalation toxicity; replace the current 6.3B classification on Substance D with a 6.3A classification; remove the 6.8B classification applied to Thionex Insecticide Solvesso formulation; replace the current 9.2C classification on endosulfan and all its formulations with a 9.2A classification; assign an approval number to the Thionex Insecticide Solvesso formulation; change the packing group assigned to endosulfan and all formulations containing endosulfan from PG I to PG II. Endosulfan Reassessment – Update Paper October 2008 Page 38 of 41 Appendix C – NGĀ KAIHAUTŪ TIKANGA TAIAO REPORT NGĀ KAIHAUTŪ TIKANGA TAIAO REPORT Application for Reassessment of a Hazardous Substance under section 63 of the Hazardous Substances and New Organisms Act 1996 Application Code: HRC07003 Name of substance: endosulfan and formulations containing endosulfan Endosulfan Reassessment – Update Paper October 2008 Page 39 of 41 13 September 2008 NGA KAIHAUTU TIKANGA TAIAO REPORT Introduction Kia ora koutou. My name is Glenice Paine. I am a currently the Tumuaki of Ngā Kaihautū Tikanga Taiao (Nga Kaihautu). I whakapapa to Te Atiawa and Ngai Tahu iwi. My background is in the resource management and conservation fields. I am here today to present a report on behalf of Ngā Kaihautū regarding the Chief Executive Initiated Reassessment of endosulfan and formulations containing endosulfan (HRC07003). The role of Ngā Kaihautū is to provide advice and assistance, from a Māori perspective, to the Environmental Risk Management Authority (ERMA New Zealand). As part of that role, Ngā Kaihautū has considered this reassessment application under Section 63 of the Hazardous Substances and New Organisms Act (HSNO) 1996. Nga Kaihautu supports and endorses ERMA New Zealand action in deciding to reassess endosulfan and formulations containing endosulfan. As a result of many interactions with iwi/Maori nationally, Nga Kaihautu is aware that there is a pervading view that iwi/Maori do not support, in most circumstances, the widespread use of poisons per se. Although this application has been publicly notified, it is understood that no specific iwi/Maori consultation has occurred in relation to this reassessment. Subsequently, as outlined in the Evaluation & Review (E&R) report, there is insufficient information on any benefits that may acrue to iwi/Maori through the continued use of endosulfan and its formulations. In the absence of good robust information on any benefits that are specific to iwi/Maori, Nga Kaihautu believes that the adverse effects to iwi/Maori outweigh any perceived benefits. Accordingly, Nga Kaihautu would recommend that the use of endosulfan and formulations containing endosulfan should be prohibited. The adverse effects on people, the environment and native flora and fauna are set out in the E&R report, and from a Nga Kaihautu perspective, these adverse effects outweigh the stated benefits. If endosulfan (and formulations containing endosulfan) is not prohibited, then Nga Kaihautu would recommend an appropriate ‘phase out’ period. It is believed 3 – 5 years is reasonable. RECOMMENDATIONS Ngā Kaihautu Recommends the use of endosulfan and formulations containing endosulfan should be prohibited in the first instance, or The use of endosulfan and formulations containing endosulfan should be phased out over a period of 3 - 5 years. Endosulfan Reassessment – Update Paper October 2008 Page 40 of 41 Appendix D - Council Survey from NZ Sports Turf Institute Submission Endosulfan Reassessment – Update Paper October 2008 Page 41 of 41