EPA staff reply to submissions made during the hearing

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www.epa.govt.nz

APP201045: Organophosphate and carbamate reassessment

EPA staff reply to submissions made during the hearing

April 2013

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APP201045: Organophosphate and carbamate reassessment EPA staff reply

April 2013

Introduction

The Chief Executive of the Environmental Protection Authority (EPA) lodged an application to reassess organophosphate and carbamate (OPC) based products used for plant protection purposes. The application was notified on 2 November 2012 and open for submissions from 2 November 2012 until 22 January 2013.

Hearings were held in Wellington on 4 March 2013 and in Auckland on 7 March 2013. The appointed decision making committee (the committee) adjourned the hearing on 7 March 2013 to seek additional information and gave submitters until 5 April 2013 to provide it.

This document is the applicant’s reply to points made on the application during and since the hearing.

It is divided into two parts:

1. Response to themes which reoccurred across submissions; and 2. Response to points raised in individual submissions.

This document also refers to the original application lodged by the Chief Executive; the consultation report prepared by EPA staff, and the Evaluation and Review report (EnR) prepared by EPA staff after

consideration of the submissions. The recommendations in this document are made by the EPA staff and supported by the Chief Executive of the Environmental Protection Authority (who initiated the reassessment).

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1. Common themes from the hearing

This section includes the response to the most substantive points raised by multiple submitters. It also provides additional information which submitters requested during the hearing.

1.1. Issues related to timing

We are very grateful both for the submissions received, and the time submitters have taken to help the EPA and the committee to understand the use of these products. EPA staff acknowledge that the size of the application required significant input in terms of resourcing in order to meet the statutory timeframes specified in the Hazardous Substances and New Organisms (HSNO) Act for applications of this type, and thanks submitters for their input.

1.2. Acceptable Daily Intakes (ADI’s)

The acceptable daily intake (ADI) is a value used to assess the human health significance of estimated intakes of pesticides from food. The ADI is derived from toxicological findings and is set to represent the oral intake of a pesticide that a human can consume day after day for a lifetime without adverse effect. ADIs are important because the Ministry for Primary Industries (MPI) Agricultural Compounds and Veterinary

Medicines (ACVM) Group use them to assess dietary pesticide intakes and to establish maximum residue limits (MRL’s) for food crops.

Why EPA has listed the ADI values

This section explains the EPA’s legislative role in setting exposure standards, and sets out why the EPA listed ADIs for use by MPI.

The EPA has the legislative mandate under the HSNO (Class 6, 8, 9) Controls Regulations 2001 to set exposure standards for hazardous substances. This includes setting values for the ACVM Group to use in assessing the human health significance of food residues for pesticide and veterinary medicine active ingredients and setting/listing ADIs.

When processing applications for hazardous substances containing new active ingredients which have not had ADIs established overseas the EPA’s role is determined by HSNO. The role of the EPA in setting ADE and PDE values also applies to substances under reassessment.

The EPA’s role under HSNO (Class 6, 8, 9) Controls Regulations 2001 is to define the following values:

 Acceptable Daily Exposure (ADE) values - a daily exposure to a substance that is not considered to represent a health hazard over a life time of exposure

 Potential Daily Exposure (PDE) values - established to represent various sources of exposure. The EPA has generally set three PDE values:

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o PDEfood, usually 70% of the ADE

o PDEdrinking water, usually 20% of the ADE

o PDE_other, usually 10% of the ADE

After setting the values the EPA advises the ACVM Group of the ADE and PDEs, with particular attention to the PDEfood, as this value is used by ACVM as the ADI.

Selection of ADI’s during this reassessment process

The EPA and ACVM Group had an ongoing dialogue about the fact that some of the ADI values set by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) were outdated prior to our previous reassessments on dichlorvos, diazinon, methamidophos and acephate. Recognising that the EPA’s role is to set exposure parameters, the ACVM Group indicated it would value advice from the EPA on the suitable values for use in dietary risk assessment, pending FAO/WHO revision. ADE and PDE values had not been set for the existing substances when they were transferred to the HSNO Act when HSNO took effect in 1996, and the

reassessment process was seen to provides the opportunity to set them.

EPA staff are acutely aware that the ADIs listed have a flow on effect to the regulatory requirements of the ACVM Group, as the two pieces of legislation they operate under are linked in this way. The EPA staff have reviewed the ADIs and consider the values are appropriate for the reasons given below.

Since the hearing the EPA has been invited to participate in discussions with the ACVM Group, registrants and representatives from the agricultural and horticultural industry on the ACVM reassessment of MRL’s. A meeting was held on 8 April 2013 in Wellington. The ACVM Group have indicated that they will reassess the MRL’s of the substances, and are talking to industry and registrants about the process for how label claims could be deleted or refined.

OPC specific modifications to the exposure setting process

As a result of the reassessment applications for acephate, diazinon, dichlorvos and methamidophos, concern was raised by MPI relating to the use of 70% of the ADE for derivation of the PDEfood, as this effectively results in a New Zealand ADI lower than overseas values. EPA staff agree that it is appropriate to allow 100% of the ADE for the PDEfood in the case of the OPCs, so that the value used would be in line with overseas values.

The EPA consultation listed the proposed ADI, but since these values are being proposed under the HNSO Regulations, these would have been more correctly listed as the ADE or PDEfood. The numbers would be numerically the same, since it has been agreed that the PDEfood is 100% of the ADEs, i.e. ADI = PDEfood = ADE.

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Rationale for the selection of the ADI

The ADIs selected are the same as those used in Australia by the Australian Pesticides and Veterinary Medicine Authority (APVMA), with the exception of acephate, diazinon, methamidophos, and pirimicarb.

These exceptions will be discussed under the following three categories:

 Acephate, diazinon, dichlorvos and methamidophos

 OPCs for which APVMA values were selected (carbaryl, chlorpyrifos, dimethoate, fenamiphos, fenitrothion, maldison, methomyl, oxamyl, phorate, pirimiphos methyl, prothiofos, terbufos)

 Pirimicarb, for which an EFSA value was selected 1. Acephate, diazinon, dichlorvos and methamidophos

The ADIs for these four active ingredients were initially determined from full toxicology data reviews undertaken as part of the original reassessment applications. Submissions were received raising concerns about the proposed ADIs (with the exception of dichlorvos) and the application of the uncertainty factors used to address data gaps in the derivation of the original ADE and PDE values.

As a result of the submissions, the ADI values for acephate, diazinon and methamidiphos were externally peer reviewed by two Australian toxicology experts. The reviews led to the modification of the uncertainty factors to address the need for additional precaution due to the data gaps. This resulted in the original ADIs being adjusted to those currently recommended, which are consistent with values established by overseas regulators.

2. OPCs allocated APVMA values

A complete review of the toxicological and epidemiological information for these active ingredients was not undertaken by EPA staff prior to the selection of the ADIs. This is because the EPA adopted the position with general support from industry that it would carry out a group reassessment. In choosing to carry out the group reassessment it became evident that it would an inefficient use of resources to duplicate work done overseas on the ADIs. As set out in the consultation document, a list of the ADIs established by other regulatory agencies was prepared. EPA staff then selected a suitable ADI for each active based on the listed values. The EPA staff selection gave preference to APVMA ADIs for the following reasons:

 It provides a consistent set of values from one regulator for as many of the values as possible

 APVMA is also undertaking a review programme which includes several of these organophosphates and carbamates

 There are harmonisation advantages in aligning assessments between Australia (APVMA) and New Zealand (EPA and MPI’s ACVM Group), including in relation to the inputs (ADIs) used for the calculation of food MRL values

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 New Zealand and Australian regulatory agencies involved in registration of plant protection products have a close working relationship and a number of registrants have products which are registered in both jurisdictions

3. Pirimicarb

When the APVMA value was not considered appropriate a value was derived from other sources. In this reassessment the APVMA value for pirimicarb was not used as it was very old (1987) and also anomalously low in comparison to more recent values by other regulators. The value selected was the European Food Safety Authority (EFSA) value (2006).

Response to concerns about the selection of ADI values

A number of submitters at the hearing were critical of the EPA staff preference for selection of the APVMA values. EPA staff have therefore reviewed the ADI selections again. For some of these active ingredients the APVMA values are not always the most current values, but we consider the value in aligning with APVMA outweighs any currency issues.

In some cases the APVMA list does not provide complete information on the basis for the ADI derivation, so the appropriateness of the derivation is difficult to evaluate. Without a more thorough assessment of the basis of the ADI the EPA staff based their selection on the following rationale:

 All the values are based on a scientific evaluation, and we remain confident in the appropriateness of the APVMA values, noting that the values used are all in current use in Australia. Some of the other values, particularly in Europe or the USA, are related to active ingredients that are not currently use in those jurisdictions, so that they may be considered obsolete.

 A more thorough review would be of limited value, be time consuming and duplicate overseas reviews (avoiding such duplication is one of the reasons for the group reassessment being undertaken)

In conclusion, the EPA is confident that the listed ADIs are appropriate values for use by MPI.

1.3. The EPA’s risk assessment approach & selection of data

Submitters raised concerns about the EPA’s risk assessment approach. This approach has been designed to be consistent with the legislation and with similar assessments overseas.

Submitters concerns related to the risk assessment itself as well as identified components of it, such as the selection of endpoints.

In relation to the risk assessment itself, HSNO requires the assessment of adverse and positive effects and requires the decision maker to decline an application where the adverse effects outweigh the positive effects or approve it where the positive effects outweigh the adverse effects. EPA staff developed an operational approach to allow comparison of the negative effects and the positive effects.

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The adverse effects on human health have been assessed by comparing predicted or measured exposures of the substances to operators, workers re-entering a recently sprayed area, and bystanders, to the

maximum levels of exposure that are generally not expected to result in harmful effects. The adverse effects on the environment have been assessed by comparing predicted or measured exposures of the substances to wildlife against effect concentrations. Adverse effects are referred to as ‘risks’. The positive effects of OPCs are assessed based on the advantages received by users and the New Zealand economy. The assessment considered the availability of alternative products, and the relative efficacy and cost of the alternative products. The positive effects are referred to as ‘benefits’. The Sustainability Council, Deer Industry New Zealand and Beef + Lamb have challenged the validity of the risk assessment approach. It is worth re-iterating that although EPA staff refer to risks and benefits, HSNO only requires an overall

assessment of whether the positive effects of a substance outweigh the adverse effects. The EPA staff risk assessment has been designed to inform this process and allow the evaluation.

The EPA staff make recommendations based on a risk assessment which broadly follows the methodology below:

 If the risk assessment indicates risks are acceptable then the approvals should be retained

 If additional controls make the risks acceptable, then the approval should be retained with those additional controls.

 If the risks are not acceptable, even with extra controls a risk/benefit analysis is conducted (including an assessment of the likely effecs of the substance being unavailable) and:

o If benefits are greater than the risks the approval is recommended to be retained o If risks are greater than benefits the approval is recommended to be revoked

The EPA staff’s evaluation has been criticised as being too conservative (Deer Industry New Zealand and Beef + Lamb) and not conservative enough (Pesticide Action Network Aotearoa New Zealand). EPA staff are comfortable with the approach taken which is similar to the methodology used by overseas regulators, and is consistent with the legislation.

In relation to components of the risk assessment, Te Rūnanga O Ngāi Tahu and the Waikato Tainui River Trust expressed concern that the EPA had not taken a holistic approach to the assessment of the risks to human health and the environment. They also suggested that the EPA had not selected sufficient endpoints, for example, there was no endpoint for earthworms and for native species. The decision on the endpoints to select for this reassessment was informed by work undertaken by the EPA on the earlier OPC applications for diazinon, dichlorvos, acephate and methamidophos. Further context on the selection of the endpoints is provided in sections 2.7 and 2.10.

Submitters raised concerns about the data provided by the EPA on hospital admissions. For clarity, this was presented for context and background only and was not a factor in any EPA staff recommendations. All recommendations have been based on the published risk assessment not environmental or human health poisoning data.

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1.4. Health and Safety in Employment (HSE) Act responsibilities when using OPCs

The issue of the Health and Safety in Employment (HSE) Act and cholinesterase monitoring was touched on by various submitters, and it is clear that there is some variation in practice among employers. The principal object of the Health and Safety in Employment (HSE) Act 1992 is to prevent harm to all persons at work, and other persons in, or in the vicinity of, a place of work. Employers and others (e.g. self-employed) have general duties to take all practicable steps to ensure the safety of employees and others¹.

If the hazard is significant (as would most likely be the case using any organophosphate (OP) product), the HSE Act sets out the steps that employers must follow.

• If practicable the hazard must be eliminated (for example, employers must consider if a less hazardous product or an alternative means of pest control could be used instead of an OP).

• If elimination is not practicable, the hazard must be isolated (for example, employers must consider if it is practical to use closed mixing, loading or application systems).

• If it is impracticable to eliminate or isolate the hazard, the employer must minimise the likelihood that employees will be harmed by the hazard (for example, they must provide appropriate Personal Protective Equipment (PPE) to their employees).

Where the hazard cannot be eliminated or isolated, employers must monitor employee’s exposure to the hazard. When using organophosphate plant protection products² it is expected that employers (with employees’ consent) will arrange for monitoring of employees’ cholinesterase levels in accordance with the published guidance³ i.e. S10(2)d HSE Act. This should be done in consultation with a doctor. Before using organophosphates employees should have baseline cholinesterase tests. These tests should be done when a user has had no contact with an organophosphate for at least 30 days according to the Occupational Safety and Health (OSH) guideline, and 60 days according to NZS8409. Establishing a baseline level is important in order to understand any future results.

The monitoring should occur following the periods of peak exposure. The decision about how frequently biological monitoring should occur lies with the employer and would vary depending on the individuals involved and their working circumstances. There is no mandatory number of hours that a user must use OPs for before biological monitoring should occur, and employers must make this decision on a case by case basis. For example, for a new user it would be expected that exposure would be monitored approximately every week during exposure for the first two or three weeks. After this, on the basis of reassuring initial

1 Self-employed people also have duties under the HSE Act. They have a responsibility for their own safety and health while at work.

They must also ensure that their actions do not harm anyone else.

2 It is noted that cholinesterase monitoring is not recommended if users are only using carbamates, as any carbamate-induced cholinesterase depression recovers very quickly

3 Department of Labour, 2000 A guideline to promote best practice with organophosphates.

http://www.osh.dol.govt.nz/order/catalogue/pdf/organophosphate.pdf

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results and evidence of good hygiene practice, monitoring could be less frequent. If at any time during use of organophosphates an employee has concerns about their health they could have another cholinesterase test. The results should be discussed with a doctor and in some instances there may be a need for the worker to have no further exposure to organophosphates for a period of time.

Anecdotal feedback during the OPC reassessment suggested that some employers only carry out baseline cholinesterase testing and do not monitor employee exposure during actual use unless an employee gets ill.

This may not comply with the requirements of the HSE Act (to monitor an employee’s exposure to a hazard which has not been eliminated or isolated).

1.5. Controls

Where the risk assessment has indicated that additional controls are required to remove or reduce a risk, the EPA staff have proposed additional controls to be applied to the substance approvals. These controls are intended to be pragmatic, practical and effective. The proposed controls have been designed to manage particular exposure risks, and without additional controls it is likely that EPA staff would have proposed greater restrictions on approvals or further revocations. A number of submitters provided comments on the following specific controls.

1.5.1. Buffer zones

Submitters including the Nursery and Garden Industry Association, Rural Contractors and Nufarm raised concerns relating to the practicality of buffer zones. The EPA staff modified their position from the consultation report to the E&R and are now recommending that sensitive persons or areas are protected through use of buffer zones (as detailed in NZS8409:2004⁴) or by adherence to an approved code of practice that provides for alternative measures to manage the risks associated with spray drift. EPA staff maintain the view that the risk to aquatic environments and bystanders from spray-drift needs to be mitigated, and that the buffer zone control is the most effective way to do this.

The EPA staff consider buffer zones to be the most appropriate way to control spray drift and has proposed to base its buffer zone controls on the distances specified in NZS8409:2004, in order to provide certainty for and clarity in the substance approvals. Under NZS8409:2004, use of buffer zones is not a specific obligation, whereas the EPA staff are of the opinion that buffer zones should be a requirement for wide-dispersive use of OPC substances, unless alternative drift mitigation measures are implemented via an appropriate spray drift management plan. The EPA staff consider that this plan should be in the form of an approved code of practice, specifically designed to manage spraydrift resulting from use of OPC substances and obligating particular practices to be employed. The EPA staff consider that this code of practice is required in addition to NZS8409:2004, which does not obligate specific risk mitigation strategies to be employed.

NZS8409:2004 has been used as the basis for establishing buffer zones, and provides reduction of distances when shelter belts are used. The EPA staff note that there are other methods that could assist in

4 NZS8409:2004 New Zealand Management of Agrichemicals

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reducing spray drift, and has proposed a mechanism to develop alternative spray drift mitigation plans. EPA staff acknowledge that use of buffer zones may impose inconveniences when undertaking spraying with OPCs, but the intention is to protect sensitive persons and environments.

1.5.2. Incorporation of NZS8409:2004

The EPA manages risks by imposing controls. Many submitters including Rural Contractors and the New Zealand Agrichemical Education Trust raised concerns about the overlapping requirements of HSNO, the RMA and codes of practices. The EPA has a mandate to approve the import and manufacture of hazardous substances and must therefore impose its own controls rather than deferring to the RMA or regional plans, which play a specific role in managing the adverse effects of activities. Adherence to NZS8409:2004 is a requirement for application of pesticides under regional plans, and EPA staff are conscious of ensuring that its proposals are in line with this guidance document. To manage the overlap, details of the relevant sections of NZS8409:2004 have been included in the controls, rather than simply referring to a section or sections.

This should provide clarity about the relevant conditions of use under the controls that apply to a given substance. In some instances, such as use of buffer zones, EPA staff consider that this requirement should be an obligation and have proposed the requirements as controls rather than guidance as detailed in

NZS8409:2004. The EPA staff note the variable nature of the information presented by presenters regarding adherence to NZS8409:2004, and consider that making the key aspects mandatory will assist in driving risk reduction for use of OPCs.

1.5.3. Notification

Several submitters raised concerns over the proposals to notify neighbours about intended application of OPCs. EPA staff consider that the requirements specified in NZS8409:2004 do not provide sufficient notice to adequately inform neighbours and parties who may be adversely affected by application of OPC

substances. Informing neighbours will allow them to take precautions to avoid exposure. Notification requirements vary under different regional plans, and the EPA staff’s proposed notification requirements provide standard requirements for notification of OPC substances. There may be instances however, where a regional requirement is more stringent than the proposed requirements.

Methods of notification were raised by submitters. The EPA staff consider that the notification should be in writing. This would include use of electronic forms, and the use of modern technologies to facilitate this would be encouraged.

1.5.4. Authorised person controls (R-16, R-17)⁵

The information provided by MPI in their written and verbal submission provides strong evidence of benefits for the maintenance of fenamiphos for biosecurity use only. The EPA staff recommend the availability of

5 The Authorised Person controls are intended to maintain an approval for use by an Authorised Person, as designated under section 103 of the Biosecurity Act 1993. Restricting an approval solely for the purpose of biosecurity use under the control of an Authorised Person will allow the substance to be available for biosecurity uses only. Additionally, requirements of certain other controls (such as buffer zones, application rates, notification requirements) do not apply when the substance is being used under the control of an authorised person, providing a level of flexibility required to deal with urgent and previously unknown pest incursions and where the effectiveness of a response could be impacted by those restrictions.

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fenamiphos be retained for the use on infested imported plants with additional controls which should

continue after general availability has been phased out. We recommend that this be done by requiring all use be under the control of an “Authorised Person” under the Biosecurity Act 1993. We have recommended that this control be broadened to all OPCs in this reassessment to ensure their availability for biosecurity use.

Concerns raised about the continued commercial availability of fenamiphos still remain under this recommendation, as it is unlikely that a product would continue to be imported or manufactured into New Zealand solely for the purposes of biosecurity usage. However, EPA staff consider that the risks associated with maintaining the approvals for continued wide-spread usage are too high. Maintaining approvals for these substances to be imported into New Zealand will allow MPI through the Authorised Persons control to secure alternative suppliers of the substances for use in their biosecurity programme (for example, making arrangements to source products from overseas use programmes into New Zealand with provision to return product back into the source programme for use before the product expires). The EPA notes that this would require the overseas substances to be covered by the existing approvals. This would not be setting a precedent. For example, DDVP strips are only available for use in New Zealand by MPI for use in their fruit fly surveillance programme.

1.5.5. Approved handler control to restrict use of OPCs in the home garden

Some submitters (New Zealand Nursery and Garden Industry Association, Bill Brett) challenged the approved handler control recommended by EPA staff. EPA staff maintain the most effective way to achieve the removal of the OPC substances from general use by untrained users is through the approved handler requirement. This would ensure that users have the required level of knowledge and competency to effectively manage the risks of using and disposing these substances especially in areas where vulnerable bystanders are likely to be.

1.5.6. Review clause

Submitters suggested that some of the phase out, for example diazinon, should be a ten year phase out with a pre-programmed review two years prior to the end of the phase-out period. EPA staff do not support a pre- scheduled reassessment. The statutory scheme is to approve or decline the approval under s 29 and allows for any person to establish grounds for, and initiate, a reassessment at any point in time. HSNO allows for any person to seek grounds to initiate a reassessment at any time. EPA staff consider that the reassessment process provides the appropriate regulatory mechanism to allow new information to be used to modify an approval decision, or aspects of a decision.

1.5.7. Submitters recommendations for longer phase-outs

Submitters supported shorter (Pacific Action Network Aotearoa New Zealand) or longer (Market Access Solutionz) phase out periods than those proposed by EPA staff. The phase-outs proposed in the EnR report recognise that continued approval is justified because, for those specified phase out periods, the benefits of these substances to the New Zealand economy outweigh the adverse effects while there are no established alternatives. However, this is a finely balanced decision and the EPA considers that the scale of adverse

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and positive effects will tip the other way with the passage of time if an alternative substance becomes available.

1.5.8. Other recommended controls

The Nursery and Garden Indusrtry Association submitted that the adverse effects of any OPCs can be controlled with appropriate active ingredient concentrations, packaging, more intuitive labelling, advice or restrictions at the point of sale or single use packages.

In respect of concentrations, the EPA can only reassess those substances currently under reassessment, and therefore cannot make any recommendations on active ingredient concentrations.

EPA staff believe that due to the high risks of OPCs, users must be trained and know how to mitigate the risks. This could not be done unless they are properly trained, merely talking to someone with a Growsafe or Approved Handler certificate does not achieve this. This requirement should apply for all use of OPCs, from small scale non-dispersive applications through to wide-dispersive applications.

EPA staff have proposed controls to improve labelling which should lead to increased awareness of risks.

They maintain the most effective way to achieve the removal of the OPC substances from general use by untrained users is through the approved handler requirement as it will ensure that those using the

substances have the required level of knowledge and competency to effectively manage the risk. EPA staff stand by the original recommendation to impose an approved handler control. In the absence of a

demonstration of competency through qualification, the approvals would require restrictions to remove their availability for use by the home garden sector.

The EPA staff’s proposals have detailed specific restrictions surrounding the use of OPC substances, such as maximum use rates. The intention of imposing such controls is to restrict use to the scenarios for which benefits have been demonstrated to outweigh the risks associated with use. Use in excess of the parameters would result in the risks associated with that use not being outweighed by benefits. When this occurs, HSNO requires that thes approvals be revoked. These operational use restrictions provide a cap to the level of risk from use of a substance. The use rates and frequencies are parameters that were used to determine levels of exposure in the EPA’s risk assessment and were based on use parameters provided by industry. The EPA staff have proposed the use parameters that it considers are necessary to manage the exposure arising and to restrict use to those scenarios assessed. The EPA staff stand by their position of proposing use rates and frequencies, and considers such restrictions important risk mitigation tools for use of OPCs. EPA staff agree the submission made by Nufarm that it would be more practical to specify frequencies per crop cycle, rather than per year, and recommend this should apply to any application frequencies that are imposed on OPC approvals.

In response to comments from Gourmet Paprika regarding application rate restrictions, the EPA staff assessed the risks of exposure resulting from chlorpyrifos use on blueberries based on a use rate of 750 g / ha, as provided by industry. The EPA staff have proposed a maximum use rate of 1500 g / ha for chlorpyrifos use, which would accommodate the use rate of 750 g / ha.

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The EPA staff have taken into account the time it would take to implement new labelling requirements in their proposed phase-in periods for these requirements. EPA staff acknowledge that it is feasible that users may be in possession of old stock, which does not have updated label information. Given that these requirements are proposed to come into effect two years after the decision is made, the EPA staff consider that on-going use of the substance after this time-frame should be in accordance with the new requirements.

1.6. Approved handler regime

Comments were made during the hearing on the approved handler regime. Requiring persons applying OPC substances to be approved handlers is one way for the EPA to ensure a level of knowledge and competency of those applicators, resulting in a reduction in the levels of exposure and risk.

The EPA is aware of limitations with the approved handler regime. The legislation does not allow the EPA to dictate what is required from approved handler training courses . The EPA approves the test certifiers for a mazimum of 5years and would view any inadequate assessment of approved handlers as of great concern. It is the test certifiers’ responsibility to assess an applicant for the approved handler certification against the regulatory requirements. The EPAs influence is limited to working with test certifiers and working with the Ministry for the Environment (MfE) on the legislation.

The EPA has recently issued a draft test certifier performance standard for consultation which sets out the expectations for the test certifiers issuing an approved handler certificate. The purpose is to improve the quality and consistency of decision making by test certifiers. The EPA expects that this will lead to some improvements in this regime.

Even with the limitations of the scheme, the EPA are still of the view that this condition allows substances to be used by people with a heightened level of knowledge and experience.

1.7. Compliance and enforcement

Submitters, such as the Bay of Plenty Regional Council and Auckland Council raised concerns on the level of compliance with HSNO controls; and with the way that these controls are enforced. Improving the level of compliance with HSNO controls is a priority for the EPA and its Board. Increased funding and resources have been put into the compliance area and is being put toward new initiatives. For example, advisory material produced by the EPA which has been targeted at small and medium businesses to assist them to comply with HSNO controls. Improvements will require a collaborative approach between the Ministry of Business, Innovation and Employment (MBIE), the Ministry for the Environment (MfE), the EPA and industry. That collarboration is progressing well.

The EPA recently made a strong submission to the ‘safety review’ taskforce which is expected to report back to the Minister of Labour in April 2013. The government has also announced the establishment of a

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stand alone HSE agency which was recommended out of the Royal Commission of Inquiry on the Pike River disaster.

The concerns raised by submitters on the broader policy issues will be collected and communicated to MfE to inform any future policy review process.

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2. Submission by submission response

This section addresses the points made in submissions in the order that they were heard.

2.1. Nursery and Garden Industry Association (NGIA)

NGIA expressed opposition to the approved handler requirement discussed in point 1.6 as they supported ongoing use of OPC products by home gardeners.

NGIA supported the on-going use of diazinon granules for grass grub. The EPA staff consider the risks of diazinon granules are too great for continued use in the home garden by home gardneners and do not support this use. This is particularly due to the difficulty managing potential health risks to bystanders (especially young children and pregnant women) in this setting.

EPA staff agree with the submitter that there are many benefits of gardening, however, these benefits are not considered to outweigh the risks of using OPCs in the home garden.

2.2. Rural Contractors New Zealand Incorporated

Rural Contractors support retaining OPCs on the basis of efficacy of the substances and the lack of harm to human health shown to be caused by the substances. They also submitted that the risk of the substances can be safely managed by qualified persons.

EPA staff acknowledged the large benefits associated with the use of OPC’s, and these were reflected in our recommendations, including length of phase out where appropriate.

The EPA staff agree that many of the risks posed by the substances can be managed by appropriately qualified persons which is reflected in the recommendation that OPCs be used by approved handlers. However, there are still residual risks to human health of the substances and that is why it is recommended that some be declined and others phased out over time.

Rural Contractors specifically requested clarification on whether recirculated air in a tractor cab would meet the control for use of Personal Protective Equipment (PPE). The proposed control is written as a performance based control referring to equipment that prevents contact with, or inhalation of, the substance. The submitter would need to ensure that the systems in place in their machine can achieve that outcome. In practice, this would require a properly functioning and maintained ventilation system that provides equivalent or greater respiratory protection than any alternative Respiratory Protective Equipment (RPE) device that would be required to be worn. Vehicle manufacturers should be able to confirm the level of protection that their vehicles provide.

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2.3. New Zealand Agrichemical Education Trust (NZAET)

NZAET supported a focus on good practice to manage risks associated with the use of OPCs, but believes that many of the practices should be the expected standard for all agrichemical compounds classified as hazardous substances. The submitter recommends that the controls for personal protective equipment (PPE) and notification be consistent with those in NZS8409:2004, and that signage indicating use of OPCs is required for both indoor and outdoor use. The submitter also commented on the Approved Handler system. The main points in NZAET’s submission have been addressed in section 1 of this document.

2.4. Beef + Lamb New Zealand and Deer Industry New Zealand

Beef + Lamb and the Deer Industry New Zealand gave a joint submission. They emphasised the importance of the pastoral sector to the New Zealand economy and expressed concerns about the risk assessment approach taken by the EPA, and the work required by industry to provide data on the benefits of the substances. The submitters also recommended that the committee delay its final decision until the UK Committee on Toxicity’s (COT) review of epidemiological evidence on the health effects of chronic exposure to organophosphates is completed.

EPA staff agree that the submitters sectors provide a large economic benefit to New Zealand. This positive impact on the economy has led EPA staff to recommend the longer phase-out periods for some substances widely used in these sectors, as the benefits outweigh the risks of using these substances while no alternatives are available to control grass grub.

Comments on risk assessment approach

The submitters expressed some concerns about the risk assessment approach used by EPA Staff.

These included:

 The evidence on benefits has not been given the same effort as that spent on risks. The submitters expressed that the burden for benefits should be with the applicant and not on industry

 The modelling is not sufficient. Where there is a history of use of the substance risk modelling should be secondary to actual observed data

EPA staff accept that there is a lack of detailed information relating to the actual human health and environmental impacts of OPC use in New Zealand. This may be because there are inadequate surveillance systems in place rather than that no risks to human health or the environment exist.

It is very difficult to link chronic human health or environmental risks to use of particular chemicals.

This issue occurs in all other jurisdictions and risk assessment is the main approach used by

regulators who have responsibility for managing risks from chemicals. The risk assessment approach used by the EPA in the OPC assessment is similar to those used by regulators in the European

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Union, Australia, USA and Canada and consequently our conclusions about the risks of these substances are also similar. Therefore, the EPA staff consider that the risk assessment results should be given appropriate weight by the decision makers.

EPA staff also note that just carrying out a risk assessment on new substances being introduced into the market, and not to substances being reassessed could make it more difficult to approve new lower risk substances while older higher risk substances remain in use.

Recommend postponement until post COT review

The submitters contended that the decision-making committee should wait until the findings of the UK COT Review have been released. EPA staff do not support this contention as the scope of the COT review does not include epidemiological evidence relating to all the health effects for which potential associations with organophosphate exposure have been reported. For example, neurodevelopmental effects are excluded from the scope of the COT review. Therefore the outcome of the COT review cannot be expected to provide a definitive answer as to the potential health effects associated with long term exposure to low levels of OPCs.

Substances not being used proposed to be revoked

The submitters oppose the revocation of approvals for some active ingredients and formulations not currently being used in New Zealand because they could have the potential need for them to treat pest incursions in the future. We note this request was not supported by MPI.

The majority of the approvals in question are only for the active ingredients. The revocation of these approvals will in no way affect the potential to gain future approvals for formulations containing these active ingredients. New formulations will require both HSNO and ACVM approval regardless of whether a HSNO approval for the active ingredient already exists.

The active ingredients with these approvals present high risks due to their mode of action, and they are not considered to provide any benefits for New Zealand as they are not being used here. As the risks outweigh the benefits EPA staff continue to recommend revocation of these approvals.

2.5. Ministry for Primary Industries (MPI)

Three groups from MPI submited on the impacts of the reassessment on food residues, pest response and plant importation. The submitter highlighted that sufficient OPC substances must be retained within the toolbox for incursion response and plant import pest treatments. Many of the points relevant to MPI’s submission have been addressed in Part 1 of this document.

Risk modelling concerns regarding exposure while dipping plant material

MPI is concerned that the risk of exposure to fenmiphos while root dipping has been overstated. The risks have been assessed based on the information that was available at the time. The MPI

submission and verbal evidence at the hearing on 4 March 2013 indicated that the assumption of

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exposure duration of 8 hours would be overly conservative. The submission did not indicate what would be a more realistic assumption.

The EPA have reviewed the risk assessment and found that even if exposure duration was

significantly shorter (e.g. 30 minutes) the risk quotient would still be above the level of concern. The high risk quotients are to a large degree determined by the lack of dermal absorption data for fenamiphos and the resulting need to use default values.

2.6. Bill Brett for himself, 13 independent garden centres, Kings Plant Barn and Palmers Garden Centres

Bill Brett presented on behalf of himself and others in Wellington on 4 March 2013. His submission highlighted that he considered many of the controls to be unnecessary, not practical and unlikely to be complied with. He also suggested alternative controls. Controls are discussed in Part 1 of this report.

The submitter highlighted the importance of OPCs to home gardeners particularly as other

insecticides did not have label claims supporting their use on home garden crops. The benefits of use in the home garden are acknowledged. However, we do not consider that they outweigh the risks of using these substances. This has been discussed in more detail in Part 1.

2.7. Waikato Tainui River Trust

Julian Williams spoke in Wellington on behalf of the Waikato Tainui River Trust. The Trust supports the recommendations to revoke substances containing 19 of the OPCs, and retain substances containing 10 of the OPCs as this is in harmony with their long term goal for the Waikato River to be chemical free.

The submitter raised concerns about the risk assessment and supported a more holistic approach to the development and management of biosecurity and pest management. The Trust considers that the EPA should assess the environment as a whole and take into account the long-term risks, costs and benefits.

The submission asserted that there were information gaps within the EPA’s assessment, the

cumulative impact of which is a miscalculation of overall risk due to lack of data. The information gaps are cited below.

A lack of assessment of chronic risks to human health and environment

Sub-chronic risks to human health were assessed. This is line with international practice for the assessment of risks to operators, re-entry workers and bystanders from use of pesticides, as it is not expected that a specific pesticide will be sprayed daily. While a chronic environmental risk

assessment would have provided additional information, further assessment would be unlikely to change the outcomes or the staff recommendations given the high acute environmental risks already identified.

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Lack of assessment of the risks to aquatic environments of OPC’s from runoff and leaching

The decision not to include runoff in this assessment was made because for the vast majority of use scenarios risks from spraydrift alone were significantly above the EPA’s level of concern. Assessing the risks from runoff would have made the assessment more complete but would not have changed the conclusion that these substances pose a risk to the aquatic environment.

A lack of New Zealand specific information, such as the effect of OPCs on taonga species including eels and puha

EPA staff acknowledge that the risks to taonga and native species were not specifically addressed in the consultation document. However, the assessment has been carried out using available data for the most representative and sensitive species in the aquatic and terrestrial environments. This is consistent with international best practise. In general, toxicity data for pesticides are generated for many regulatory authorities around the world and comply with the Organisation for Economic Co- operation and Development (OECD) requirements and test guidelines. This is also the case for the data used in the EPA evaluation of OPCs. The recommended test species in these guidelines are sensitive species that are considered to be representatives for the target species group i.e. fish or birds.

EPA did some analysis of the risks to aquatic organisms from runoff and leaching, plus assessment of potential effects on soil invertebrates, for the original three applications for dichlorvos, diazinon, acephate and methamidophos. This led to the view that it was not necessary to do additional ecotoxicological assessments as the risks we had determined for those substances were already high. For the benefit of submitters, the EPA have attached some of this historical information in appendices. This includes information on the aquatic endpoints used in the risk assessment (Appendix A), the effect of runoff and leaching on some aquatic organisms (Appendix B), and the original ecotoxicological work on the effect of OPCs on soil invertebrates (Appendix C).

2.8. Sustainability Council of New Zealand

The Sustainability Council raised concerns with the overall process under the HSNO Act and suggested different approaches to reassessing substances. The submitter considered that the decision making committee should take on board the precautionary principle and section 7 of the HSNO Act. The Sustainability Council also criticised the speed at which the reassessment has been carried out, but supported the group reassessment process.

The broader policy implications of the Sustainability Council’s submission will be provided to MfE to inform any future HSNO Act policy changes. This includes the suggestion that overseas decisions could be used to automatically updated HSNO approvals in the future. However under the current legislation it is the EPA’s view that this would be contrary to the purpose of the HSNO Act as the EPA could be seen to be divesting its responsibility under HSNO. Further, our unique environement and

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sometimes use of these substances may mean that overseas findings are not always relevant without some interpretation of them for the New Zealand market. The Sustainability Council also made comments on the EPA’s risk assessment which have been discussed in Part 1.

2.9. Federated Farmers

Federated Famers submitted via telephone. Federated farmers raised concerns about the lack of alternatives for the control of pests and the time required to research and develop them. Federated Farmers also submitted on a possible review close to the end of the recommended phase-out periods if there is still a lack of alternatives at this time; and on ADI’s. These are both discussed in Part 1 of this reply, and we reiterate that any person can seek to establish grounds to initiate a reassessment of a substance at any time.

2.10. Te Rūnanga O Ngāi Tahu

Te Rūnanga O Ngāi Tahu raised concerns about some of the areas that had not been assessed, such as chronic risks to the environment, and emphasised that the EPA should consider the environment as a whole with particular emphasis on mahinga kai. The submitter also recommended additional label warnings, signage requirements and education for Māori on risks of OPCs for kai gathered in areas adjoining sprayed areas.

The submitter was generally supportive of the recommendations to revoke substances containing 19 of the OPC substances, and retain substances containing 10 of the OPC substances.

Risks of OPC substances to human health from food gathering

Concerns were expressed by Te Rūnanga O Ngāi Tahu Tahu about the lack of any assessment of potential exposures to OPCs from the consumption of traditional foods, in particular, watercress, puha, eels and other aquatic species that may be contaminated from use of these substances.

EPA staff acknowledge that no assessment has been undertaken of these potential sources of exposure. Data are not available for OPC residues that would be present on aquatic or other plants or in fish species to enable an assessment of the likely exposures.

Some of the controls proposed by EPA staff to address other human health and ecotoxicity risks would also assist in reducing the likely exposure levels of some of these food sources, particularly the aquatic species. Users are unlikely to apply these products when rain is expected, and product labels contain the statement that the substances are not to be applied “into or onto” water. While this manages risks from spraydrift it does not address the potential run off of OPCs and their residues into the aquatic ecosystem. Other proposed controls, such as maximum application rates and buffer zones, will also reduce the likelihood of OPCs getting into the aquatic ecosystems from which

traditional foods are collected. The contamination of terrestrial plants is not directly impacted by these controls which act to restrict application directly onto or spraydrift reaching the waterways.

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Risks of OPC substances to the environment

In the OPC consultation document the EPA did not specifically consider the risks to native species in New Zealand and the chronic risks to aquatic and terrestrial organisms. Te Rūnanga O Ngāi Tahu and other submitters have pointed out that these risks should be addressed and consider the lack of these assessments a significant data gap. In their view these risks should be addressed before a decision can be made.

Other submitters mentioned that the EPA should take a more holistic whole ecosystem approach in the assessment.

EPA staff acknowledge that the risks to native species were not specifically addressed in the consultation document. However, the assessment has been carried out using available data for representative and sensitive species in the aquatic and terrestrial environments. This is consistent with international best practise. In general, toxicity data for pesticides are generated for many regulatory authorities around the world and comply with the Organisation for Economic Co-operation and Development (OECD) requirements and test guidelines. This is also the case for the data used in the EPA evaluation of OPCs. The recommended test species in these guidelines are sensitive species that are considered to be representative of the target species group i.e. fish or birds.

Information on the risks of OPC substances to native species is not currently available to the EPA, and very limited data are available on the risks to native species of pesticides in general. The EPA invited interested parties to provide data in order to refine the risk assessment and did not receive additional information on native species.

Research to determine whether there are differences in sensitivity to pesticides between test species and native species would be valuable. Such a model would be very useful and would potentially help to determine the risks to native species in future evaluations, without requiring additional testing of native species.

EPA staff assessed the acute risks to the aquatic environment and to birds and bees as

representatives of the terrestrial environment. For the vast majority of use scenarios the risks of the substances were significantly above the EPA’s level of concern, however in some cases the benefits of these substances were considered to be greater.

Although a risk assessment on native species and a chronic environmental risk assessment would have provided additional data, further assessment would be unlikely to change the outcomes or the EPA staff recommendations given the high risks already identified in the acute risk assessment. Any decision on whether to retain or revoke approvals for OPCs must take into account the high

environmental risks.

EPA staff recommend including a chronic risk assessment in future assessments. In addition, if data on native species are available this information should also be taken into account.

Submitters also mentioned that the EPA took a restrictive approach by assessing the aquatic

environment, birds and bees separately instead of taking a holistic whole ecosystem approach. While

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it would be preferable to take a more holistic approach, long term and complex field studies would need to be carried out in order to do so. It is not common practice to execute such studies due to their complexity, and the significance of the results is difficult to interpret. The approach of the EPA is consistent with international best practice.

EPA staff are interested in exploring options for taking a more holistic approach in future and would be happy to discuss possibilities to do so. However, for this review, EPA staff have already identified high risks to the environment from use of OPCs and this conclusion would not change with further analysis.

Runoff

Several submitters have pointed out that the EPA has underestimated the risks to the aquatic environment as we have assessed the risk of spray drift but not of runoff. This is correct and EPA staff explained this in the consultation document. For ease of reference, we have outlined why we made this decision below.

The decision not to include runoff in this assessment was made because for the vast majority of use scenarios risks from spraydrift alone were significantly above the EPA’s level of concern. The risks from runoff would have made the assessment more complete but would not have changed the conclusion that these substances pose a risk to the aquatic environment.

A key factor in reaching the decision not to include the assessment of runoff was work done on the previous reassessment applications for diazinon (ERMA200398), acephate and methamidophos (ERMA200399) along with a new application for a product containing fenamiphos (ERMA200090).

These were supported by an aquatic risk assessment using the model GENEEC2 which included the impacts of both runoff and spraydrift. The results of these risk assessments are in Appendix B, and indicate that Risk Quotient (RQ) values are significantly above the EPA’s level of concern. This is why it is reasonable to assume that adding runoff to the spraydrift risks for the other active ingredients would only increase the risks further.

In the diazinon application there was also an assessment of the downwind buffer zones that would be needed in order to protect the aquatic environment from spraydrift alone. This assessment concluded that downwind buffer zones necessary to reduce the RQ values to below the level of concern would be so large that they would be impractical. Including the impacts of runoff would mean that these risks would be even larger. The EPA has proposed controls to assist mitigation of these risks.

The high RQ values are primarily caused by the very high toxicity of these active ingredients to the aquatic environment. The EPA staff agree with Te Rūnanga O Ngāi Tahu that, should the decision making committee decide to approve these substances, there will be risks to the aquatic environment which will need to be mitigated by appropriate controls.

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Risks of OPC’s to the soil environment

In the OPC consultation document the EPA did not consider the risks to the soil environment (earthworms). Several submitters have pointed out that these risks should be addressed before a decision can be made.

EPA staff acknowledge that the risks to the soil environment were not addressed in the consultation document. However, EPA staff performed a risk assessment for the aquatic environment and assessed the risks to birds and bees. For the vast majority of use scenarios of the substances these risks were significantly above the EPA’s level of concern. Adding the risks to earthworms would have aided completeness but would not have changed the conclusion that these substances pose a risk to the aquatic and terrestrial environment.

The previous reassessment applications for diazinon (ERMA200398), acephate and methamidophos (ERMA200399) along with a new application for a product containing fenamiphos (ERMA200090) all included a risk assessment for earthworms. The results of these risk assessments are in Appendix C.

They show that diazinon may cause adverse effects in the treatment area when 5 kg ai/ha is applied.

However, outside the treatment area it is unlikely that diazinon will cause significant acute adverse effects. The results for acephate and its degradation product methamidophos suggest that it is unlikely that these substances will cause significant acute adverse effects to earthworms. After an application with fenamiphos the acute risk to earthworms in the treatment area is above the level of concern, and outside the treatment area is below the level of concern.

EPA staff also considered the proposed classification of the substances. Carbaryl is ecotoxic to the soil environment (9.2A). The substances chlorpyrifos, diazinon, dichlorvos, dimethoate, maldison, methamidophos, methomyl, and phorate are ecotoxic (9.2B). Terbufos is harmful (9.2C) to the soil environment. The substances, fenamiphos, fenitrothion, oxamyl and pirimiphos-methyl are slightly harmful (9.2D). Acephate, pirimicarb and prothiofos are not classified due to a lack of data.

Given the results for the four substances that were assessed and the toxicity classification of the OPCs for the soil environment EPA staff consider that the substances can cause significant adverse effects to earthworms within the treatment area. However, in general the toxicity to aquatic

invertebrates and to bees is higher than to earthworms. Therefore, the possible adverse effects to earthworms will not change the overall conclusion that the OPCs pose a risk to the aquatic and terrestrial environments.

Recommended signage control

Te Rūnanga O Ngāi Tahu made specific reference to using signage to indicate where OPC

substances have been used, so that persons gathering food from locations near OPC treated areas are aware that OPCs have been used nearby. EPA staff have recommended a similar control before, however, the circumstance of use of OPCs is different to other applications where it has been imposed. For example, aquatic herbicides usage (directly applied into water sources from which food plants are sourced) or 1080 usage (use in areas where the public has access). In the case of OPCs, the effects of pesticide usage beyond the application area are managed by other controls and

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regulations such as not applying substances within specified distances of an aquatic environment.

EPA staff consider that there are practicalities associated with use of signage that would prove difficult, such as location of placement of signs and the duration that the signs should remain in place.

2.11. DuPont

The committee decided to accept the late submission lodged by DuPont, and heard from Greg Mitchell via teleconference during the Auckland hearing on 7 March 2013.

DuPont provided data relating to the human health risk assessments for methomyl and oxamyl, and on the risks to birds for both of these active ingredients. The Staff analysis has been circulated to submitters, and submitters have until 26 April to comment on it.

Based on the new information relating to human health, EPA staff are recommending that the proposed re-entry interval of 48 hours for methomyl could be reduced to 24 hours for outdoor application of methomyl using boom, aerial or knapsack equipment at rates of less than 300 g/ha.

Staff also note that there will be negligible risks to re-entry workers for oxamyl when applied directly to the soil when used in carrot production before crop foliage has developed. However the new

information did not change the re-entry risks for other applications of oxamyl so the REI requirements previously recommended would still apply in these cases.

The bird data indicate that the risk to birds from the use of methomyl on strawberries would be low rather than medium as previously estimated. However, this does not have an impact on the overall recommendations for methomyl. For oxamyl, the data provided indicate that if the use of oxamyl is restricted to application in the furrow while sowing the carrots and the furrow is covered with untreated soil immediately after application, the risks to birds can be considered as low.

2.12. Nufarm

The Nufarm submission largely focused on the practicality of controls. These have been addressed in Part 1 of this reply.

2.13. Gourmet Paprika

The submitter explained how OPC’s were used and explained the importance of the substances to the capsicum exporting business.

The submitter specifically supports dichlorvos. EPA staff note that the only use of dichlorvos being assessed by this committee is the biosecurity strips. This is because other formulations containing dichlorvos are also used for non plant protection purposes. They will be considered as part of the subsequent reassessment of other uses of OPCs.

EPA staff reply to submissions made during the hearing

APP201045: Organophosphate and carbamate reassessment