Re-evaluation Decision RVD2020-13, Thiophanate-methyl and Its Associated End-use Products

Pest Management Regulatory Agency
3 December 2020
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2020-13-PDF (PDF version)

Summary

To obtain a full copy of Re-evaluation Decision RVD2020-13, Thiophanate-methyl and Its Associated End-use Products please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Table of contents

Re-evaluation decision for thiophanate-methyl and associated end-use products

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

Thiophanate-methyl is a systemic fungicide, registered for use on greenhouse non-food crops, terrestrial food crops, mushrooms, outdoor ornamentals, turf, and seed treatment for food and feed (sweet corn, dry beans, and potato seed pieces). Currently registered products containing thiophanate-methyl can be found in the Pesticide Label Search and in Appendix I of RVD2020-13.

Health Canada published a Re-evaluation Note REV2007-12, Preliminary Risk and Value Assessments of Thiophanate-Methyl and a Proposed Re-evaluation Decision PRVD2011-07, Thiophanate-methyl which identified potential risks of concern for human health and the environment, and the additional information required to refine the risk assessments. In addition, an update on the re-evaluation of thiophanate-methyl was published (REV2012-14) summarizing the main areas of focus that would be updated and the revised data requirements. The subsequent Proposed Re-evaluation Decision PRVD2019-07, Thiophanate-methylFootnote 1 containing the evaluation of thiophanate-methyl and proposed decision, underwent a 90-day consultation period ending on 26 September 2019. PRVD2019-07 proposed continued registration of thiophanate-methyl products with mitigation measures such as increased personal protective equipment (PPE), longer restricted-entry intervals (REIs), and limiting the number of applications per season and the amount handled per day to protect human health; and buffer zones and label statements to protect the environment. For uses where risks were not shown to be acceptable, cancellation of these uses was proposed.

Health Canada received comments and additional information relating to the health, environmental and value assessments. Commenters are listed in Appendix II of RVD2020-13. These comments are summarized in Appendix III of RVD2020-13 along with the responses by Health Canada. These comments and new data/information resulted in revisions to the health and environmental risk assessments (see Science evaluation update of RVD2020-13), and resulted in changes to the proposed re-evaluation decision as described in PRVD2019-07, in other words, continued registration were shown to be acceptable for more uses, provided additional mitigation measures are implemented.

A reference list of information used as the basis for the proposed re-evaluation decision is included in REV2007-12, PRVD2011-07, PRVD2019-07, and further information used in the re-evaluation decision is listed in Appendix VII of RVD2020-13. Therefore, the complete reference list of all information used in this final re-evaluation decision includes the information set out in the References section of the aforementioned documents herein.

This document (Re-evaluation Decision RVD2020-13, Thiophanate-methyl and Its Associated End-use Products) presents the final re-evaluation decisionFootnote 2 for the re-evaluation of thiophanate-methyl, including the required amendments (risk mitigation measures) to protect human health and the environment, and any label amendments required to bring labels to current standards. All products containing thiophanate-methyl that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for thiophanate-methyl

Health Canada has completed the re-evaluation of thiophanate-methyl. Taking into consideration the comments and new data/information provided during the consultation of PRVD2019-07, the occupational and residential health assessments were revised. Risks were not shown to be acceptable for some uses, even when additional mitigation measures were considered, thus these uses are cancelled; they are listed in the risk mitigation measures section below. Risks were shown to be acceptable when mitigations measures were considered for the following crops:

Revised environmental risk assessment included adjustment to the spray buffer zones and other mitigation measures to account for the cancellation of the higher application rate on apples and pears and a new chronic amphibian endpoint. Environmental risks were shown to be acceptable for all uses of thiophanate-methyl and its associated end-use products when revised label directions and mitigation measures are followed.

An evaluation of available scientific information found that most uses of thiophanate-methyl products meet current standards for protection of human health and environment and have value, when used according to the revised conditions of registration, which includes new mitigation measures and cancellation of the uses that did not show acceptable risks. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing thiophanate-methyl is acceptable, when used according to revised conditions of registration.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required amendments, including updated label statements and mitigation measures, as a result of the re-evaluation of thiophanate-methyl, are summarized below. Refer to Appendix VI or RVD2020-13 for details.

Human health

Cancellation of the following uses:

Label Amendments:

Environment

Label Amendments:

Value

Label improvements to meet current standards:

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of RVD2020-13. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of RVD2020-13 to transition to using the newly amended labels, which will be available on the Public Registry.

Products that are cancelled will be phased out following the implementation timeline outlined below.

Refer to Appendix I of RVD2020-20 for details on specific products impacted by this decision.

Other information

Any person may file a notice of objectionFootnote 3 regarding this decision on thiophanate-methyl and its associated end-use products within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service by phone (1-800-267-6315) or by e-mail (hc.pmra-info-arla.sc@canada.ca).

The relevant confidential test data on which the decision is based are available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa). For more information, please contact the PMRA's Pest Management Information Service.

Appendix I Registered products containing thiophanate-methyl in Canada

Table 1 Registered products containing thiophanate-methyl in Canada requiring label amendmentsFootnote 1
Registration number Marketing classFootnote 2 Registrant Product name Formulation type Active ingredient
12279 C Nippon Soda Company Ltd. Senator 70WP 1 Fungicide Wettable powder TPM: 70%
25343 C Nippon Soda Company Ltd. Senator 70WP Fungicide Wettable powder TPM: 70%
27297 C Nippon Soda Company Ltd. Senator 70 WP WSB1 Fungicide Water soluble bag TPM: 70%
31761 C Belchim Crop Protection Canada Inc. TPM Flowable 25% Undyed Liquid Fungicide Seed Treatment Solution TPM: 296.5 g/L
31784 C Nippon Soda Company Ltd. Thiophanate-Methyl 500 SC Fungicide Suspension TPM: 500 g/L
32093 C Nippon Soda Company Ltd. Cercobin Fungicide Suspension TPM: 500 g/L
32096 C Nippon Soda Company Ltd. Senator 50 SC Fungicide Suspension TPM: 500 g/L
32097 C Nippon Soda Company Ltd. Renovo Fungicide Suspension TPM: 500 g/L
27539 MC Nippon Soda Company Ltd. Senator 70WP MUP Systemic Fungicide Wettable powder TPM: 70%
32291 MC Nippon Soda Company Ltd. Thiophanate-Methyl 500 SC MUP Suspension TPM: 500 g/L
22710 T Nippon Soda Company Ltd. Thiophanate-Methyl Technical Wettable powder TPM: 98.3%
Table 2 Products containing thiophanate-methyl cancelled as a result of re-evaluationFootnote 1
Registration Number Marketing ClassFootnote 2 Registrant Product Name Formulation Type Active Ingredient
14599 C Nippon Soda Company Ltd. Senator PSPT 1 Potato Seed Piece Treatment Dust TPM: 10%
26236 C Nippon Soda Company Ltd. Senator PSPT Potato Seed Piece Treatment Dust TPM: 10%
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