APP202097 Reassessment of dichlorvos and its formulations Dr - - PowerPoint PPT Presentation

APP202097

Reassessment of dichlorvos and its formulations

Dr Matthew Allen

Disclaimer

The information contained in this presentation represents the views of the staff of the EPA, and is intended to provide a summary of the background, application and submissions process, and the staff proposals. This presentation should be read in conjunction with the relevant application documentation:

http://www.epa.govt.nz/search-databases/Pages/applications- details.aspx?appID=APP202097

The staff proposals may or may not be supported by the decision-making committee for this application. The decision- making committee can choose to accept, reject or modify the recommendations.

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EPA Project team

Project leads:

Dr Matthew Allen, Dr Aidan Allan

Ecotoxicology and environmental risk assessment:

Dr Valerie Herno

Toxicology and human health risk assessment:

Dr Stuart Creton, Dr Richard Mohan

Kaupapa Kura Taiao:

Bevan Hunter (earlier Manu Graham)

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Outline

Introduction Statutory process Initial assessment and proposals Submissions Amended proposals Key issues

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Introduction

Dichlorvos is an organophosphate insecticide Highly volatile and high toxicity

+ wide-range of uses + effective pest control + short half-life and withholding periods

• current uses lead to high levels of exposure relative

to Acceptable Operator Exposure Level (AOEL)

• fumigant-style exposure pathways

Drivers for reassessing dichlorvos

Overseas reviews resulting in restrictions and/or non- approval of dichlorvos products

US, Europe, Australia

Concerns over human health and environmental exposure

Concerns that the current HSNO controls are insufficient to manage risks

Note, results of overseas regulatory action not the driver

• f the EPA staff proposals. Our proposals have been

shaped by our risk assessment of New Zealand use patterns.

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Overview of statutory process

Milestone Date Grounds for R/A established (RES08004) September 2008 Formal receipt of Application 23 October 2014 Start of submission period 28 October 2014 End of submission period 9 December 2014 Staff Update Report distributed 21 April 2015 Hearing 6-7 May 2015 Anticipated dates for upcoming milestones (subject to change): Consideration (start) 7/8 May 2015 Drafting of decision report May/June 2015 Decided/decision notified Late June 2015

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Information used in risk assessment

Assessment of recommended uses and rates on the product labels Call for information to establish existing use patterns of dichlorvos in New Zealand

Various horticultural and agricultural industry sectors provided info (including off-label uses)

Available toxicological and ecotoxicological information Risk assessment methodologies from overseas regulatory bodies in absence of NZ-specific data

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Key risk assessment results (1)

Most current uses of dichlorvos in New Zealand result in unacceptable exposures to people and the environment Environment:

Only outdoor uses able to be quantitatively assessed Very high risks to aquatic organisms, birds, and beneficial insects Exposures tens-to-thousands of times higher than high risk threshold of the models High risks to soil organisms for some use patterns Insufficient information to assess chronic risks to earthworms, plants and arthropods

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Key risk assessment results (2)

Human health:

Highest risks are to operators/applicators Operator exposures are up to several hundred times higher than acceptable levels, even assuming PPE/RPE is being worn Operator exposures acceptable for small-scale uses with PPE/RPE (e.g. biosecurity, some post-harvest treatments of horticultural produce) Re-entry workers – exposures acceptable assuming PPE/RPE, limiting exposure duration and sufficient ventilation before re-entry Bystanders – indoor uses lead to unacceptable bystander exposures, worst when used in residential settings Bystanders – potentially significant exposures from unintentional emissions from greenhouses

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Examples of bystander concerns

Controls toolbox

Current dichlorvos uses under existing controls lead to unacceptable exposures New controls must be considered Types of controls initially considered

Buffer zones (too large to be quantified, impractical) Maximum handling quantities Maximum application rates, frequencies, minimum spray intervals Prescribed PPE/RPE Restricted entry intervals (REIs) Exclusion zones Signage, notification Approved handler (where not already applied)

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Initial proposals

Revoke approvals for domestic use products

No practical measures to manage exposures High residual risks, no significant benefits identified

Restrict use of other substances, focusing on restricting and reducing exposures to acceptable levels

Considered this could be achieved by restricting access for purposes of biosecurity purposes only

• Small scale
• Restricted access
• Controlled locations

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Assumptions and knowledge gaps (1)

Noted that uncertainties were propagated through the risk assessment due to:

Unique physicochemical properties Gaps in information about dichlorvos exposure Lack of complete eco/toxicological datasets for dichlorvos

Due to these uncertainties there is potential the calculated risk quotients (RQs) may underestimate risk in some areas Application highlighted areas where further information could help revise risk assessment and staff proposals

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Assumptions and knowledge gaps (2)

Air quality monitoring

Semi-automatic spraying methods in greenhouses Demonstrating compliance with WES (protection of workers)

Types of PPE/RPE assumed to be worn, and the level of protection offered What measures are used to protect or ensure safety of bystanders? Higher tier studies

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Submissions

Number of submissions / submitters

Received 13 Broadly supportive of application proposals 5 Broadly oppose application proposals 2 Did not indicate support or opposition to proposals 6 Wishing to be heard 7

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Key submission themes

Benefits had been underestimated Dichlorvos use is critical to many horticulture sectors No record of adverse effects from dichlorvos (non-domestic use) Lack of data for native species Risks from contamination of traditionally gathered food

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Staff risk assessment too conservative No assessment of use in grain silos or for treating grain Would REIs apply to treated produce? Caution against constantly removing active ingredients from the toolbox Clarity of proposed controls Concerns over bystander welfare

Actions from submissions (1)

NZIER report into costs and benefits of use of dichlorvos

Gives independent evaluation of worst case scenario to industry (i.e. cost of complete withdrawal of dichlorvos from the market)

Risk assessment for dichlorvos use to treat grain and in grain storage facilities

Similar conclusions to non-greenhouse use Operator and bystander risks require management

Shift focus from allowing biosecurity and post-harvest treatment to ‘small-scale’ usage (regardless of sector)

e.g. allows ‘small-scale’ use in greenhouses, on outdoor crops etc that would not have been permitted under the initial proposals

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Small vs. large scale use

“Small-scale” is intended to include

spot-treatments using targeted application equipment indoor and outdoor applications small structure treatments (e.g. containers) the application of small quantities of dichlorvos (i.e. limited by an individual’s maximum handling quantity) non-wide-dispersive applications.

“Large-scale indoor use” refers to

large, whole facility or building treatments (e.g. greenhouses, warehouses) wide-dispersive applications larger volumes of dichlorvos being handled and applied (i.e. > maximum handling quantity).

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Actions from submissions (2)

Consideration of what controls would be required to allow large-scale indoor use

E.g. indoor application of volumes required to treat entire commercial greenhouses, industrial warehouses etc Worker safety (operators and re-entry workers) could be managed by requiring full automated application methods only (opposed by industry in submissions) and REIs Primary residual concern is exposure of bystanders Requirement to obtain a permission under s95A

Major concern is the complexity of an expanded and conditional controls regime

Complexity  non-compliance  people put at risk

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Actions from submissions (3)

Specific questions or requests for clarification about the risk assessment

Specifically addressed in Appendix A of Staff Update Report

Consideration of whether information provided in submissions allows significant revision of risk assessment and proposals

No information allowed substantive changes to the overall staff proposals

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Key amendments to staff proposals

Use of dichlorvos substances restricted to small-scale use (initial proposal was to restrict to biosecurity and limited post-harvest use) Revised control proposals now prevent use of dichlorvos substances in “sensitive areas” Propose maximum application rate control for indoor applications (0.05 g / m3) Reduced REIs for non-greenhouse use (from 96 to 48 hours) Propose implementation of s66 disposal requirements for the substances proposed for revocation

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Overview of final staff proposals

Retain approval for dichlorvos (active ingredient), with revised HSNO classification, revised default controls Retain approvals for 3 dichlorvos substances (HSR000211, HSR000212, HSR000213):

Revised controls Restricted to small-scale use Use in sensitive areas prohibited

Revoke approvals for domestic-use products (HSR000207, HSR000209)

Require disposal of unsold stocks within 6 months

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Key issues (1)

Scientific and technical uncertainty

In the absence of key information we have had to make assumptions in our risk assessment The HSNO Act requires exercise of a precautionary approach when there is scientific or technical uncertainty related to adverse effects We have highlighted where key assumptions are made due to information gaps No information has been forthcoming to allow us to substantively change the risk assessment or proposals

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Key issues (2)

Is the controls regime required for large-scale indoor uses too complex to be efficient and effective?

Complexity may lead to intentional or unintentional non- compliance Non-compliance will put further people at risk

REI requirements for treated produce storage locations

Measurements of dichlorvos air concentrations will be required to reduce REI for treated produce storage locations Is there sufficient knowledge to make these controls work?

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Key issues (3)

With controls in place to manage risks, are the residual benefits of the substance sufficient to approve the application?

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