Application Form: HS8 Application for whether there are Grounds for a Reassessment of a

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Send by post to: Environmental Protection Authority, Private Bag 63002, Wellington 6140 OR email to: HSApplications@epa.govt.nz

Payment must accompany application; see our fees and charges schedule for details.

Application Form: HS8 Application for whether there are Grounds for a Reassessment of a

Hazardous Substance

under section 62 of the Hazardous Substances and New Organisms Act 1996

REASSESSMENT

Applicant:

Rob Forlong

Chief Executive, Environmental Protection Authority

Date:

27 May 2015

APPLICANT CHECKLIST

Mandatory sections filled out Appendices enclosed

Fees enclosed

Signed and dated

OFFICE USE ONLY

Application code Date received

EPA contact Fees paid $

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Important

1. Before you fill in this application form, please talk to the EPA. We can help you scope and prepare your request.

2. We need all relevant information early on in the process. Quality information up front will speed up the process.

3. Any extra material that does not fit in the form should be clearly labelled and cross-referenced. If there is commercially sensitive information, it should be collated in a separate document.

4. All applicants must sign the form at the end of Part A and enclose the correct application fee. Please check the EPA’s current pricing policy: http://www.epa.govt.nz/about-us/fees/Pages/Hazardous-Substances-fees- schedule.aspx. We are unable to process applications that do not contain the correct fee.

5. Copies of all our application forms are available on our website: http://www.epa.govt.nz.

6. If you have any suggestions for improvements to this form, please contact our operations staff at the address below.

7. You can get more information at any time by telephoning, writing to, or calling in at our Wellington office. One of our staff members will be able to help you.

Environmental Protection Authority Private Bag 63002

Wellington New Zealand

Telephone: 64 4 916 2426 Facsimile: 64 4 914 0433

Email: HSApplications@epa.govt.nz http://www.epa.govt.nz

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1. Applicant details

This should be the organisation or person formally responsible for this application, and be located within New Zealand.

Name: Rob Forlong (Chief Executive, EPA) Address: Private Bag 63002, Wellington 6140 Phone: 04 474 5403

Fax: 04 914 0433

Email: Rob.Forlong@epa.govt.nz Service Address (if different from above):

1.2. Contact’s details (if different from above).

Name: Asela Atapattu

Address: Private Bag 63002, Wellington 6140 Phone: 04 474 5463

Fax: 04 914 0433

Email: Asela.Atapattu@epa.govt.nz

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2. Hazardous substance details

2.1. Name of substance (identify the substance as fully as possible).

If more than one substance is involved – for example, the active ingredient and the products – they should all be listed.

The table below identifies the HNSO approval names and numbers, including the trade names of specific products, where known, for which grounds for reassessment are being sought.

Table 1 Identity of the substance approvals for which grounds for reassessment are being sought HSNO Approval name Known trade name(s) HSNO Approval

number

Hazard

classifications Suspension concentrate

containing 500 g/litre chlorothalonil (Substance B)

Yates Bravo HSR000480 6.1E (oral), 6.3B, 6.4A,

6.5B, 6.7B, 6.9A, 9.1A, 9.2B, 9.3B

Suspension concentrate containing 102 g/litre chlorothalonil and 125 g/litre thiophanate methyl

Yates Greenguard HSR000147 6.1E (oral), 6.3B, 8.3A,

6.5B, 6.6B, 6.7B, 6.9A, 9.1A, 9.2B, 9.3C

Suspension concentrate containing 62.5 g/litre chlorothalonil, 9.6 g/litre tau- fluvalinate and 62.5 g/litre thiophanate methyl

Yates Guardall HSR000586 6.1D (inhalation),

8.3A, 6.5B, 6.6B, 6.7B, 6.9B, 9.1A, 9.2C, 9.3C

Suspension concentrate containing 250 g/litre chlorothalonil and 250 g/litre thiophanate methyl

McGregor’s Black Spot and Fungus Spray

Watkins Fungus and Mildew Spray

Taratek 5F

HSR000618 6.1B (inhalation), 6.4A, 6.6B, 6.7B, 6.9A, 9.1A, 9.2B, 9.3C

Tui Disease Eliminator (ready to use)

Tui Disease Eliminator for Fruit and Veges RTU

HSR100872 6.5B, 6.7B, 9.1B

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2.2. If the substance has been assessed by the authority, list the reference number(s) of the existing approval (from the authority’s register).

If more than one substance is involved, for example, the active ingredient and the products, they should all be listed.

Refer to 2.1

2.3. If the substance is covered by Parts XI to XV, list any reference numbers of registrations, licenses etc under the Explosives Act, Pesticides Act, Toxic Substances Act, Dangerous Goods Act or Animal Remedies Act.

Not applicable

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3. Grounds for reassessment

3.1. Please indicate which category applies.

More than one may be relevant.

Has significant new information relating to the effects of the substance become available?

Yes (go to question 3.2)

Has another substance with similar or improved beneficial effects and reduced adverse effects become available?

Yes (go to question 3.3) Not applicable

Has information showing a significant change of use of the substance become available?

Has information showing a significant change in the quantity of the substance manufactured or imported become available?

Other?

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3.2. Provide details of the significant new information relating to the effects of the substance. (Include the date and some of the information.)

Further information? Yes No

Commercially sensitive information? Yes No

New human health risk assessment for non-professional users

This application seeks to establish whether there are grounds to reassess the substance approvals identified in section 2.1 on the basis of significant new information relating to the effects of the substances when used by non- professional users (such as home gardeners).

In 2014 EPA staff received an application that sought approval to import or manufacture a new substance

containing chlorothalonil, that was intended for use as a fungicide and to be sold and marketed to home gardeners (EPA application APP202057). For this application EPA staff conducted a quantitative human health risk

assessment to estimate the likely exposure of people to chlorothalonil when the substance was used in home garden environments. The risk assessment took into account information about the human toxicity of chlorothalonil and the proposed use pattern of the substance, and then used models to predict the exposures to people (users and bystanders).

The results of the quantitative human health risk assessment identified that there would be significant risks to users and bystanders from the use of the chlorothalonil-containing substance in home garden settings.

Key findings of the risk assessment for APP202057 were that:

 It was not valid to assume that home gardeners would wear appropriate levels of Personal Protective Equipment (PPE). Many may be unaware of the potential health consequences of not protecting themselves against exposures to certain substances, and some may assume that if a substance is truly dangerous it would not be available for home garden use.

 Exposure modelling estimated that users’ exposures to chlorothalonil would exceed acceptable levels by 166%.

 Exposure modelling estimated that toddlers re-entering a treated area shortly after treatment would exceed acceptable exposure levels by almost 600%.

 Given the intended market and use environment, it was not feasible to manage user and bystander risks through the application of controls such as requiring specific PPE or imposing restricted entry intervals.

 There was significant uncertainty around the dermal absorption potential of the active ingredient. In particular there was no available data to determine the influence that the product formulation would have on the extent to which the active ingredient would be absorbed through the skin. This compounded uncertainties around the levels of exposure and subsequent risk to users and bystanders.

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 Additional hazards of the substance, such as eye corrosivity (8.3A) and suspected carcinogenicity (6.7B), were also of concern given the intended users and expectation that adequate PPE would not necessarily be worn.

The Decision-making Committee for application APP202057 accepted the staff’s risk assessment and the assumption that it was unlikely that non-professional users (home gardeners) would wear appropriate PPE. The Committee considered that the significant risks identified to users and bystanders in the risk assessment could not be mitigated through the application of reasonable or effective controls on the substance. The benefits of approving the substance were not considered to outweigh the identified risks. Accordingly the application (APP202057) to import or manufacture the new chlorothalonil-containing substance for use by home gardeners was declined.

Chlorothalonil-containing substances and home-use

The EPA is aware that there are a number of chlorothalonil-containing fungicide products currently marketed and sold to home gardeners in New Zealand. The HSNO approvals and trade names (where known) of these products are listed in Table 2, below.

Table 2. Identity of chlorothalonil-containing fungicide products currently marketed and sold to home gardeners Known trade name(s) HSNO Approval

number

HSNO Approval name ACVM registration number

Yates Bravo HSR000480 Suspension concentrate

containing 500 g/L chlorothalonil (Substance B)

P002945

Yates Greenguard HSR000147 Suspension concentrate containing 102 g/L chlorothalonil and 125 g/L thiophanate methyl

P004469

Yates Guardall HSR000586 Suspension concentrate

containing 62.5 g/L chlorothalonil, 9.6 g/L tau-fluvalinate and 62.5 g/L thiophanate methyl

P004666

McGregor’s Black Spot and Fungus Spray;

Watkins Fungus and Mildew Spray

HSR000618¹ Suspension concentrate containing 250 g/L chlorothalonil and 250 g/L thiophanate methyl

P005865

P005851

Tui Disease Eliminator for Fruit and Veges RTU

HSR100872 Tui Disease Eliminator (ready to use)²

P008984

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EPA staff consider that the human health risk assessment conducted for EPA application APP202057, which identified high risks to non-professional users and bystanders, is likely to be highly relevant to the substances listed in Table 2. This position is based on the similarities of the use patterns and application rates, the assumption that in many cases no PPE (or insufficiently protective PPE) will be used, and the anticipated exposures to chlorothalonil.

Accordingly, the EPA holds concerns that the substances identified in Table 2 may not be appropriate to be used by non-professionals or in home garden settings.

Should grounds for reassessment for these approvals be established, the EPA will seek to undertake a reassessment of these substance approvals. That process would involve presentation of an updated risk

assessment and submissions would be sought on the EPA’s proposals to either modify the existing controls on the approvals, or to revoke the approvals altogether.

Further available information on the home-use risk assessment

Further information about the risk assessment from EPA application APP202057, and the Committee’s subsequent decision to decline approval of a new home-use chlorothalonil substance can be found at the links given below.

EPA staff Evaluation and Review (E&R) Report for APP202057:

http://www.epa.govt.nz/search-

databases/HSNO%20Application%20Register%20Documents/APP202057_APP202057_EandR_%20FINAL.pdf

Errata to E&R report for APP202057:

databases/HSNO%20Application%20Register%20Documents/APP202057_APP202057%20Errata%20document%

20to%20E%20and%20R.pdf

Decision Document for APP202057:

databases/HSNO%20Application%20Register%20Documents/APP202057_APP202057%20Decision.pdf

3.3. Provide details of the information relating to the effects of the new substance (include the date and some of the information). The beneficial and adverse effects of the new substance should be compared with those of the substance.

Not applicable to the current application

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information on how this change has come about).

3.5. Provide details of the significant change in the quantity of the substance manufactured or imported.

3.6. Provide details of other reasons requesting a reassessment.

3.7. Provide any other information relevant to the request for reassessment.

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4. Declaration

27 May 2015 Signature of applicant or person Date

authorised on behalf of applicant

Name: Rob Forlong Chief Executive

Environmental Protection Authority