Proposed Re-evaluation Decision PRVD2019-07, Thiophanate-Methyl and Its Associated End-use Products

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Pest Management Regulatory Agency
28 June 2019
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2019-7E-PDF (PDF version)

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Table of Contents

Proposed 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. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Thiophanate-methyl is a fungicide that controls a broad spectrum of diseases on a wide variety of crops and use sites in Canada, including greenhouse non-food crops, terrestrial food crops, mushrooms, outdoor ornamentals, turf and seed treatment for food and feed (sweet corn, beans, potato seed pieces). Formulations of commercial end-use products include: wettable powder, dust or powder, wettable powder in water soluble bag, suspension or solution. Thiophanate-methyl can be applied using conventional ground application equipment, by air and as a seed treatment. A full list of products containing thiophanate-methyl can be found in Appendix I of PRVD2019-07 or the online Pesticide Label Search at Canada.ca.

Health Canada published a Proposed Re-evaluation Decision (PRVD2011-07) in 2011 that identified potential risks of concern for human health and the environment and the additional information required to refine the risk assessments. Subsequently in 2012, an update on the re-evaluation of thiophanate-methyl was published (REV2012-14) summarizing the main areas of focus (in other words, toxicology, occupational and dietary assessments including drinking water) that would be updated and the revised data requirements.

Health Canada has since received the required new data/information and has updated the health and environmental risk assessments to incorporate the revised registrant-supported use pattern, revised toxicology reference values and current methods/policy. Extensive comments related to the health and environmental risk assessments received during the consultation were also considered in the updated risk assessments.

This document (Proposed Re-evaluation Decision PRVD2019-07, Thiophanate-Methyl and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of thiophanate-methyl, including the proposed risk mitigation measures to further protect human health and the environment, as well as the science evaluation on which the proposed decision was based. All products containing thiophanate-methyl registered in Canada are subject to this proposed re-evaluation decision. This document (PRVD2019-07) is subject to a 90-day public consultation period, during which the public, including the pesticide manufacturers and stakeholders, may submit written comments and additional information to the PMRA. The final re-evaluation decision will be published, taking into consideration the comments and information received.

Outcome of Science Evaluation

Based on the current use pattern of thiophanate-methyl, human health risks were shown to be acceptable for most uses with proposed risk mitigation measures. For certain other uses, health risks were identified and the cancellation of these uses is proposed.

Thiophanate-methyl and its major transformation product, carbendazim, enter the environment when thiophanate-methyl is used to control fungal pests on a variety of sites. After a review of the available scientific information, the risks of thiophanate-methyl have been shown to be acceptable to the environment when used according to the revised use pattern and label instructions.

Thiophanate-methyl is an important component of pest management programs to control economically important diseases and it is an important rotational fungicide for managing disease resistance in susceptible pathogens, as it is the only Group 1 mode of action registered on several agricultural use sites.

Proposed Regulatory Decision for Thiophanate-methyl

Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, Health Canada is proposing continued registration for uses of thiophanate-methyl that have acceptable risk with mitigation measures. Uses of thiophanate-methyl where risks to human health are not shown to be acceptable are being proposed for cancellation.

Labels of registered pesticide products include specific instructions for use that must be followed by law. Directions include risk-reduction measures to protect human and environmental health. The key risk-reduction measures being proposed to address the potential risks identified as a result of the re-evaluation of thiophanate-methyl are as follows. See details in Appendix XI of PRVD2019-07.

Human Health

Proposed cancellation for the following uses:

Proposed continued registration for the remaining uses with mitigation measures:

Environment

International Context

Thiophanate-methyl is currently acceptable for use in other Organisation for Economic Co-operation and Development member countries, including Norway, Switzerland, Australia, European Union member countries, New Zealand, and the United States.

No decision by an Organisation for Economic Co-operation and Development member country to prohibit all uses of thiophanate-methyl for health or environmental reasons has been identified.

Next Steps

The public, including the registrants and stakeholders, are encouraged to submit comments and/or additional information that could be used to refine risk assessments during the 90-day public consultation periodFootnote 1 upon publication of this proposed re-evaluation decision (PRVD2019-07).

All comments and information received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document,Footnote 2 which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with Health Canada’s responses.

Additional Scientific Information

No additional data are required at this time.

Footnote 1

“Consultation statement” as required by subsection 28(2) of the Pest Control Products Act.

Return to footnote 1 referrer

Footnote 2

“Decision statement” as required by subsection 28(5) of the Pest Control Products Act.

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