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

Table of contents

• Re-evaluation decision for thiophanate-methyl and associated end-use products
• Re-evaluation decision for thiophanate-methyl
• Next steps
• Other information
• Appendix I Registered products containing thiophanate-methyl in Canada

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-methyl^{Footnote 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 decision^{Footnote 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:

• Greenhouse tobacco seedlings
• Apples and pears (rate reduced in British Columbia)
• Stone fruit (cherry, nectarine, peach, plum, prune)
• Greenhouse ornamentals grown for cut flowers (soil drench application only)
• Greenhouse non-cut flower ornamentals (foliar and soil drench applications)
• Outdoor roses and outdoor ornamentals (grown for cut flowers and non-cut flowers)
• White button mushrooms (casing and spawn treatment)
• Strawberry, raspberry, low bush blueberry
• White bean, sugarbeet, aspen and poplar (liquid/water soluble package (WSP) formulations only)
• Golf course and sod farm turf (liquid/WSP formulations only)
• Seed treatment of dry beans and sweet corn (liquid/WSP formulations only)
• Potato seed piece treatment (liquid/WSP formulations only)

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:

• Greenhouse ornamentals grown for cut flowers (foliar application)
• All residential turf uses (all formulations)
• Golf courses and sod farms (wettable powder formulation)
• White bean, sugarbeet, aspen and poplar (wettable powder formulation)
• Aerial application (wettable powder formulation)
• Potato seed piece treatment (dust formulation)
• Seed treatment of dry beans and sweet corn (wettable powder formulation – discontinued by the registrant)

Label Amendments:

• To protect mixers/loaders and applicators, additional PPE, engineering controls, and limits on amount of product handled per day or amount of treated potato seed pieces planted per day (liquid and water soluble package formulations).
• To protect workers entering treated areas, revise or establish restricted-entry intervals (REIs), limit number of applications per season, limit applications to greenhouse ornamentals grown for cut flowers to soil drench only, and reduce the maximum application rate for apples and pears in British Columbia (the Eastern Canada rate will become the national maximum application rate).
• Update label with current spray drift precautionary statement to meet current standards.

Environment

Label Amendments:

• Precautionary label statements to inform the user that thiophanate-methyl is toxic to bees, earthworms, birds, small and medium sized mammals, and aquatic organisms.
• Label statements to advise users to restrict application during periods of bloom to evenings for stone fruit and white beans.
• A label statement to inform the user to not discharge thiophanate-methyl-contaminated effluent from greenhouses and mushroom houses into aquatic environments.
• Precautionary label statements informing users of ways to reduce the potential for runoff.
• The use of spray buffer zones to protect non-target aquatic habitats.
• Update label with current standard storage and disposal statements to meet current standards.

Value

• Remove any vague reference such as "apply as needed", or "apply as required". Directions for Use should reflect the use-specific re-application interval, as outlined in Appendix VI of RVD2020-13.

Label improvements to meet current standards:

• Update labels according to Regulatory Directive DIR2013-04, Pesticide Resistance Management Labelling Based on Target Site/Mode of Action.
• Tank mix partners must be clearly indicated, by product name, on the product labels. Specific directions regarding use of the tank mix, or a reference to the tank mix partner label, must be included. Any tank mix claim should be consistent with Section 3.10 (labelled tank mixes) and/or Section 7.11 (unlabelled tank mixes) of DIR2016-02, Notification/Non-notification.

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.

• one (1) year of sale by registrant from the publication date of this decision document, followed by;
• one (1) year of sale by retailer from the last date of sale by registrant, followed by;
• one (1) year of permitted use from the last date of sale by retailer.

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 objection^{Footnote 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 amendments^{Footnote 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-evaluation^{Footnote 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%