Re-evaluation Decision RVD2018-11, Chlorothalonil and Its Associated End-use Products for Agricultural and Turf Uses

Pest Management Regulatory Agency
10 May 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-11E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation Decision
• Regulatory Decision for Chlorothalonil
• Next Steps
• Other Information
• Appendix I - Registered Chlorothalonil Products for Use in Agriculture and Turf as of January 2018

Re-evaluation Decision

Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Chlorothalonil is a contact and protectant fungicide with a multi-site mode of action. It controls a broad range of fungal diseases on a large number of field and orchard crops, conifers, greenhouse vegetables, greenhouse and outdoor ornamentals and turf. In agriculture, chlorothalonil is applied by both aerial and ground application equipment. This document (Re-evaluation Decision RVD2018-11, Chlorothalonil and Its Associated End-use Products for Agricultural and Turf Uses) will focus on agricultural and turf uses. Currently registered products containing chlorothalonil are listed in Appendix I.

Chlorothalonil is also used as a material preservative in paint; however, the PMRA plans to publish a separate document in the future examining the material preservative use of chlorothalonil. Further details may be found in the published document: (Re-evaluation Note REV2018-02, Approach for the Re-evaluation of Pesticides Used as Preservatives in Paints, Coatings and Related Uses).

The regulatory approach for the re-evaluation of chlorothalonil was first presented in Proposed Re-evaluation Decision PRVD2011-14, Chlorothalonil. The amended proposed re-evaluation decision was presented in Re-evaluation Note, REV2016-06, Chlorothalonil Amendment to the Proposed Re-evaluation Decision.^{Footnote 1}

Comments received during the consultation process were taken into consideration. These comments and new data/information resulted in revisions to some parts of the risk assessments (see the Science Evaluation Update of RVD2018-11) and subsequently in some changes to the proposed regulatory decision as described in PRVD2011-14 and REV2016-06. Appendix II of RVD2018-11 summarizes comments received during consultation periods and provides the PMRA's response.

RVD2018-11 presents the re-evaluation decision^{Footnote 2}  describing this stage of the PMRA's regulatory process for the re-evaluation of chlorothalonil and summarizes the Agency's decision and the reasons for it. A reference list for all data used as the basis for the re-evaluation decision is included in RVD2018-11, as well as in PRVD2011-14 and REV2016-06.

Regulatory Decision for Chlorothalonil

The PMRA has completed the re-evaluation of chlorothalonil. Under the authority of the Pest Control Products Act, the PMRA has determined that continued registration of products containing chlorothalonil is acceptable. An evaluation of available scientific information found that most uses of chlorothalonil products meet current standards for protection of human health or the environment when used according to the conditions of registration, which include required amendments to label directions. Certain uses of chlorothalonil will be cancelled to address potential risks of concern for human health. Risk mitigation measures, as summarized below as well as outlined in Appendix III of RVD2018-11, are required for all end-use products.

Risk Mitigation Measures

Registered pesticide product labels include specific instructions for use. Directions include risk reduction measures to protect human health and the environment. These directions must be followed by law. The key risk-reduction measures required are summarized below. Refer to Appendix III of RVD2018-11 for details.

Human Health

• Cancellation of uses on greenhouse cut flowers, greenhouse pachysandra, and field grown roses (for cut flowers)
• All chlorothalonil products currently registered as dry flowable or water dispersible granules must be packaged in water soluble packaging.
• Additional measures to mitigate exposure of mixers/loaders/applicators, including personal protection equipment and/or engineering controls.
• Additional measures to mitigate exposure of postapplication workers, including reduced number of applications and restricted-entry intervals
• Additional label statements to clarify use directions.
• Standard precautionary label statement to mitigate a potential drift into residential areas

Environment

• Revised buffer zones
• Requirement for a vegetative filter strip

International Context

Chlorothalonil is currently acceptable for use in member countries from the Organisation for Economic Co-operation and Development (OECD), including the United States, Australia and member states of the European Union. No decision by an OECD member country to prohibit all uses of chlorothalonil for health or environmental reasons has been identified at this time. Chlorothalonil is under registration review at the United States Environmental Protection Agency (USEPA).

Next Steps

To comply with this decision, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Appendix I lists the products containing chlorothalonil that are registered under the authority of the Pest Control Products Act.

Please note that water soluble packaging is required for all chlorothalonil products registered as dry flowable or water dispersible granules. Should registrants of these specific products wish to keep their chlorothalonil registration, an application to register a new product in water soluble packaging is required as soon as possible so that the new formulation will be approved and available for sale no later than 24 months after the publication date of RVD2018-11. Additional label requirements are outlined in Appendix III of RVD2018-11.

Other Information

Any person may file a notice of objection^{Footnote 3}  regarding this decision on chlorothalonil within 60 days from the date of publication of this re-evaluation decision (RVD2018-11). For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides and Pest Management section of Canada.ca (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service.

Appendix I Registered Chlorothalonil Products for Use in Agriculture and Turf as of January 2018