Chemical name: 6,9-Methano-2,4,3-benzodioxathiepin, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-, 3-oxide

Final regulatory action has been taken for the category: Pesticide, Industrial

Final regulatory action: The chemical is Banned

Use or uses prohibited by the final regulatory action:

All approvals for the import and manufacture of endosulfan and endosulfan containing formulations, for all uses, have been revoked. Specifically, the approvals for endosulfan (active ingredient) and for emulsifiable concentrate formulations containing 350 g/litre endosulfan (trade name products: Thiodan, Flavylan 350EC, Thionex 350EC, Endo 350EC) have been revoked.

All uses of endosulfan and endosulfan formulations have thus been prohibited.

All uses of endosulfan and endosulfan products are now prohibited (ie. no approvals remain for any use of endosulfan products). However, there were no previous industrial uses recorded.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

On 15 December 2008, the Environmental Risk Management Authority of New Zealand, under the Hazardous Substances and New Organisms Act 1996, announced the revocation of all approvals for the import, manufacture or use of endosulfan and endosulfan products. The ban (including on use) took effect from 16 January 2009 and all existing stocks must be disposed of by 16 January 2010.

This revocation of approvals followed a reassessment carried out under the provisions of section 63 of the HSNO Act, which included a determination that the environmental and human health risks associated with the use of the products outweighed the benefits obtained from its use.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

Human health risks were determined for a number of use patterns and exposure scenarios. Therese included exposure of pesticide operators to spray, occupational post-application and re-entry worker exposures, bystander and residential exposures, exposure to treated sports field turf. This risk assessment is detailed in Ref. 2, paras 4.3.113 - 4.3.247 pages 96-135. The conclusions of the risk assessment were as follows:

·Endosulfan has high acute oral and inhalation toxicity; but is less toxic via the dermal route due to relatively incomplete absorption. Neurotoxicity is the primary effect observed both acutely and chronically in both humans and animals,

·Endosulfan has not been proven to be mutagenic, carcinogenic, or a reproductive or developmental toxicant

·ERMA New Zealand has set an AOEL = 0.0192 mg/kg/day and, confirmed the ADI = 0.006 mg/kg bw/day.

·No New Zealand exposure data for endosulfan are available for mixers, loaders, applicators, re-entry workers, bystanders or residents, so estimates of exposure have been modelled where possible.

·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. The required PPE includes gloves during mixing and loading; gloves, visor, hood, overalls and boots during application.

·Risks to operators involved in mixing and loading within glasshouses are acceptable provided adequate PPE is uses. Risks top workers within glasshouses have not been separately modelled but are assumed to be unacceptable. For that reason, application should be by remote automated systems.

·Risks to operators for turf and citrus applications even if full PPE (including resporatory protection) is used are high. This is due to the application rates being higher than for the current label uses for both turf and citrus and the different application method for citrus only.

·Risks to workers re-entering areas treated in accordance with label uses, including glasshouse use, indicate that risks are 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. However, risks to bystanders and residents from air-blast applications in citrus are estimated as unacceptable high at current application rates and procedures.

·Risks to sports people from use of endosulfan on treated turf are acceptable if application is in accordance with the current standard practices involving watering in and one annual treatment and an appropriate REI is appliedad (in the case of "ground contract" sports such as rugby, football of hockey and for public parks where children may play).

Further details relating to the human health risk assessment are contained in Appendix G of Ref. 2

Expected effect of the final regulatory action in relation to human health:

Complete risk reduction as there will be no remaining uses of endosulfan products.

Summary of known hazards and risks to the environment:

Environmental risks were determined in the following areas:

Aquatic risk assessment (Ref. 2, paras 4.3.36, pages 77 - 88)

Tier I modelling indicated high acute and chronic risks to freshwater fish and invertebrates (paras 4.3.64 - 4.3.65)

An analysis of overseas Tier II modelling and evaluation of the results in respect to New Zealand use patterns is presented in Apprendix D of Ref. 2

Terrestrial risk assessment - plants, terrestrial invertebrates (including soil invertebrates, honey bees and other invertebrates), soil micro-organisms, and birds (paras 4.3.74 - 4.3.110, pages 88-96, Ref. 2)

The conclusions of the environmental risk assessment undertaken as part of the ERMA, New Zealand reassessment of endosulfan were as follows (paras 4.3.111 - 4.2.112, Ref. 2):

·There is a high acute and chronic risk to aquatic species (fish and invertebrates) from all current uses of endosulfan in New Zealand. This conclusion is based on lower sensitivity environmental exposure modelling.

·Exposure of non-target areas, including the aquatic environment, can be reduced by the use of butter zones. Such buffer zones would need to be substantial, possibly extending over 100 metres.

·Three is a risk to earthworms when endosulfan is used in accordance with label uses. Runoff from use could lead to risks to earthworms and soil arthropods outside the application area. Endosulfan is used to control earthworm populations under specific circumstances including use on sports fields and grass areas at airports.

·Laboratory data suggests 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 is no indication of risks to plants

·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. Using a conservative model there is some risk to large water birds which feed exclusively on piscivorous fish.

·No assessment can be made of the risk to marine mammals (seals, dolphins) due to an absence of New Zealand-based data.

Further details relating to the environmental risk assessment are contained in Appendices E and F of Ref. 2

Expected effect of the final regulatory action in relation to the environment:

Complete risk reduction as there will be no remaining uses of endosulfan products.

Date of entry into force of the final regulatory action: 16/01/2009

(all remaining stocks must be disposed of (not by use) by 16 January 2010.