Summary of HS application APP202349 and Submission guidance
Date Submissions Open: 4 November 2016 Date Submissions Close: 16 December 2016
Application number: APP202349
Purpose: To reassess five chlorothalonil-containing formulations used as home-garden fungicides
Applicant: Environmental Protection Authority
Application Lead: Jeane Nicolas
Purpose of this document
On 25 November 2016 the Environmental Protection Authority (EPA) received an application seeking to reassess five chlorothalonil-containing formulations used as home-garden fungicides. This application is being publicly notified to enable the public to comment and to put all relevant information before the Decision makers.
The purpose of this document is to summarise the application and to provide guidance on the submission process.
Application summary
This document is a summary of the information provided in the application only. The EPA staff risk assessment, as described in appendix G from the application, will be completed at a later date using information from the application, submissions and other relevant sources.
The risk assessment results could be revised if more information is provided about the following factors.
Application rates, frequencies and intervals.
Typical application areas and time spent by an operator applying the substance.
Dermal absorption data for the spray, the concentrate, or the active ingredient.
Dislodgable foliar residues (DFR) for treated crops
Foliar half-life of the product
Any studies of operator, re-entry or bystander exposure for persons using chlorothalonil.
Submission process
This document also provides guidance to the submission process. The EPA encourages all submissions.
The submission period for this application will start on 4 November 2016 and will end on 16 December 2016 at 5pm.
In a submission you can provide information, make comments and raise issues. In this way, you contribute to the EPA decision making process on specific applications. We are particularly interested in hearing from you on the following matters:
Adverse effects, especially adverse effects not identified in the application1; and
Positive effects, especially positive effects not identified in the application2.
Further information on the purpose of submissions is available from the EPA website using the link below:
www.epa.govt.nz/about-us/have-your-say.
If you have any questions, you can contact:
The EPA for any question on the application and/or submission process. The Application Lead, Jeane Nicolas, can be contacted by e-mail (Jeane.Nicolas@epa.govt.nz) or by phone (04 474 5423).
1 Adverse effects can include any risks and costs associated with release of the substance.
2 Positive effects can include any benefits associated with release of the substance.
Application summary
1. The Grounds, to reassess the five existing chlorothalonil-containing formulations that are used as home- garden fungicides, were established on the basis of the new information relating to the risks from non- professional use of chlorothalonil containing substances in the home garden, and this is the focus of the present reassessment.
It should be noted that one of the substances included in this reassessment is also used in a professional setting. However, as the Grounds for reassessment were only established for risk from home-use, the risks from professional use have not been assessed in this application.
2. The applicant considers that chlorothalonil-containing fungicide substances should be assigned the following hazard classifications (bold text denotes changes to the current classifications):
Substance name Approval
number Current classification Preliminary classification Suspension concentrate
containing 500 g/L chlorothalonil (Substance B)
HSR000480 6.1E (oral), 6.3B, 6.4A, 6.5B, 6.7B, 6.9A (All), 9.1A, 9.2B, 9.3B3
6.1B (inhalation), 8.3A, 6.5B, 6.7B, 6.9A (oral), 9.1A, 9.2C, 9.3B
Suspension concentrate containing 102 g/L chlorothalonil and 125 g/L thiophanate methyl
HSR000147 6.1E (oral), 6.3B, 8.3A, 6.5B, 6.6B, 6.7B , 6.9A (All), 9.1A, 9.2B, 9.3C4
6.1C (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, 6.9B (oral), 9.1A, 9.2C, 9.3C
Suspension concentrate containing 62.5 g/L chlorothalonil, 9.6 g/L tau- fluvalinate and 62.5 g/L thiophanate methyl
HSR000586 6.1D (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, 6.9B (All), 9.1A, 9.2C, 9.3C
6.1D (inhalation), 8.3A, 6.5B, 6.6B, 6.7B, 6.9B (oral), 6.9B (dermal), 9.1A, 9.2C, 9.3C
Suspension concentrate containing 250 g/L chlorothalonil and 250 g/L thiophanate methyl
HSR000618 6.1B (inhalation), 6.4A, 6.6B, 6.7B, 6.9A (All), 9.1A, 9.2B, 9.3C5
6.1B (inhalation), 6.3B, 8.3A, 6.5B, 6.6B, 6.7B, 6.9A (oral), 9.1A, 9.2C, 9.3C
Tui Disease Eliminator (ready to use)
HSR100872 6.5B, 6.7B, 9.1B 6.5B, 6.7B, 9.1C
Staff note that there is a potential that the composition of these substances may have changed since they were approved. Therefore the EPA requests that all manufacturers of these substances submit
information on their formulations, including details on the source and impurity profile of the active ingredient.
3 Originally classified based on a company Material Safety Data Sheet (MSDS) dated 15/08/03. In 2014, staff requested the provision of an SDS confirming that the classifications are correct for acute inhalation toxicity and skin-& eye corrosion. No information has been received and therefore the proposed revised classification is based on mixture rules.
4 Originally classified based on information supplied by registrant, appears to mainly be based on the company MSDS provided for Yates Bravo.
5 Originally classified based on product data for the product Taratek 5F, which uses the same approval number as McGregor’s Black Spot and Fungus Spray and Watkins Fungus and Mildew Spray. A read across justification is needed to decide if studies provided on Taratek 5F are applicable to these other products..
3. The non confidential part of the application is available from the EPA website using the link below:
http://www.epa.govt.nz/search-databases/Pages/applications-details.aspx?appID=APP202349
Adverse and beneficial effects
4. The following is a summary of the applicant’s overall evaluation of the risk associated with release of the substance:
Receptor Level of adverse effect Comment
Human health
The result of the quantitative human health risk assessment showed the risks to operators, bystanders, and the person re- entering the treated area, are greater than the level of concern for spray application for all products
Environmental
The result of the qualitative environmental risk assessment shows the environmental risks from the use of chlorothalonil product in a domestic setting is low.
Māori and relationship to environment
Chlorothanlonil presents
significant potential risk to Māori in terms of adversely affecting taha hauora, including vulnerable groups such as tamariki (children) and kaumātua (the elderly).
Chlorothalonil raises concerns around how potential harm to taha hauora may manifest in relation to whānau environments and lifestyle contexts. This substance may potentially affect all four cultural health dimensions of taha hauora. The availability of
chlorothalonil may not engender an overall net benefit for
kaitiakitanga
For greater detail, please refer to the application form.
5. The following is a summary of the applicant’s overall evaluation of the benefits associated with release of the substance: Chlorothalonil is a broad spectrum, contact, and protectant fungicide with long residual activity and is considered to be at low risk for resistance due to its mode of action. However, while resistance management is of critical importance in commercial use of plant protection products it is of limited relevance for home use where resistance is less of an issue. While there are properties of chlorothalonil products that are considered to be beneficial in terms of practicality and broad spectrum control, limited market usage suggests that there is no particular dependency on chlorothalonil and that alternative pest control options are being used.
Please let us know whether you consider that there are additional adverse effects that we should be aware of or additional information related to the described effects.
When identifying adverse effects it is important that you provide us with reasons as to:
What other adverse effects are likely to be caused by using chlorothalonil-containing fungicide substances used as home-garden fungicides
How likely these adverse effects are and their potential scale
How you think the adverse effects could happen (i.e. the series of events that would have to happen for the adverse effects to occur)
Options and proposals for managing the adverse effects, and
Any uncertainty you have on the scope of the information we will use to assess the adverse effects.
Please let us know whether you consider that there are additional positive/beneficial effects that we should be aware of or additional information related to the described effects.
When identifying positive/beneficial effects, it is important that you provide us with information on:
Other positive effects likely to be caused by using chlorothalonil-containing fungicide substances used as home-garden fungicides
How likely these positive/beneficial effects are and their potential scale
How you think the positive/beneficial effects could happen (i.e. the series of events that would have to happen for the positive/beneficial effects to occur)
Options and proposals for ensuring the positive/beneficial effects occur, and
Any uncertainty you have on the scope of the information used to assess the positive/beneficial effects.
Other information
If there is other information you wish us to be aware of, please also include this in your submission.
Making a submission
What is a submission?
We encourage anyone to make a submission, regardless of how much detail you are able to put in to it. In your submission, you can also request a hearing if you would like to strengthen your views in person before the Decision-Making Committee. Further information on submissions for a hazardous substance application is available from the EPA website using the link below:
http://www.epa.govt.nz/about-us/have-your-say/Pages/what-is-submission.aspx
Submissions are publically available and will be displayed on the application web page after submissions close. If you have confidential information you wish to provide, please contact the Application Lead, Jeane Nicolas, by e-mail (Jeane.Nicolas@epa.govt.nz) or by phone (04 474 5423).
How to make a submission?
The EPA website provides guidance on how to make a submission. This is preferably done via the EPA submission form but may be sent as a letter or email to the EPA. This information and the submission form can be accessed from the EPA website using the link below:
http://www.epa.govt.nz/about-us/have-your-say/Pages/make-submission.aspx
What happens after you make a submission?
When the submission period closes, all submissions will be summarised and made available to the Decision- Making Committee together with the EPA Staff Report.
You are entitled to bring witnesses who may speak to your submission at a hearing. If you choose this option, you should provide the EPA with a list of the witnesses, their areas of expertise, and the elements of the submission or application they will talk to.
You are also entitled to speak at the hearing in one of the three official languages of New Zealand: English, Māori or New Zealand Sign Language. Please advise the Application Lead at least two weeks prior the hearing in order for the EPA to organise for an interpreter. The Application Lead, Jeane Nicolas, can be contacted by e-mail (Jeane.Nicolas@epa.govt.nz) or by phone (04 474 5423).
At least two weeks prior to the hearing, both the applicant and submitter(s) need to provide the EPA with copies of any information they intend to present at the hearing.
A decision will be made by the Decision-Making Committee at the end of the consideration period. This will be made public on the EPA website.
