Proposed Re-evaluation Decision PRVD2019-07, Thiophanate-Methyl and Its Associated End-use Products
Notice to the reader:
The online consultation is now closed.
Pest Management Regulatory Agency
28 June 2019
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2019-7E-PDF (PDF version)
If you would like to comment, please request the full consultation document.
To obtain a full copy of Proposed Re-evaluation Decision PRVD2019-07, 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
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Thiophanate-methyl
- International Context
- Next Steps
- Additional Scientific Information
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.
Proposed cancellation for the following uses:
- Aerial application using wettable powder products.
- Wettable powder products on all turf uses, white bean, sugarbeet, aspen and poplar.
- All turf uses except on golf courses and sod farms for the liquid and water-soluble packaging products.
- Greenhouse tobacco seedlings (foliar spray and foliar drench applications).
- Greenhouse cut flowers (foliar application).
- Outdoor cut flowers.
- Apples and pears in British Columbia due to the high application rate (this use in Eastern Canada has acceptable risks due to the lower application rate).
- Peach, nectarine, plum, prune, cherry.
- Commercial seed treatment of bean seeds using wettable powder products.
- On-farm dry application to bean seeds using wettable powder products.
- Potato seed piece treatment for all product formulations.
Proposed continued registration for the remaining uses with mitigation measures:
- To protect mixers/loaders and applicators, additional personal protective equipment (PPE), engineering controls, and limits on amount of product handled per day.
- To protect workers entering treated areas, revise or establish restricted-entry intervals (REIs), limit number of applications per season, limit greenhouse cut flower applications to soil drench only.
- 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 avoid application during periods of bloom for crops that are attractive to pollinators.
- 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.
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.
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.
- For the use on apples and pears, Health Canada is seeking comments from British Columbia stakeholders on the agronomic feasibility to adopt the Eastern Canada use pattern (lower rate of thiophanate-methyl in tank-mix with captan), as the higher rates in British Columbia are proposed for cancellation.
- For the uses where changes to the use pattern are proposed as mitigation measures, Health Canada is asking stakeholders if these measures are considered to be agronomically feasible for the management of the pest in the production of the crop across Canada. Stakeholders are asked to provide comment regarding the feasibility of the proposed new buffer zones, including those for aerial application and turf.
Report a problem or mistake on this page
- Date modified: