Proposed Registration Decision PRD2026-08, GATTEN Fungicide, containing Flutianil

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Health Canada
Healthy Environments and Consumer Safety Branch
Pesticides Regulatory Directorate
30 April 2026
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2026-8E-PDF (PDF version)

Summary

Table of Contents

• Proposed registration decision for flutianil
• What does Health Canada consider when making a registration decision?
• What is flutianil?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Purpose of consultation

Health Canada, pursuant to subsection 28(1) of the Pest Control Products Act, is proposing registration for the sale and use of GATTEN Fungicide, containing the technical grade active ingredient flutianil, to control powdery mildew species on greenhouse vegetables (pepper, eggplant, cucumber and tomato) and greenhouse ornamentals. This evaluation was completed under the User Requested Minor Use Label Expansion program, which is a cooperative program between Agriculture and Agri-Food Canada and Health Canada and includes participation by sponsor groups, manufacturers, and both provincial and federal governments.

Flutianil is a narrow spectrum, conventional fungicide that targets certain species of powdery mildew. Flutianil is classified as a Group U13 fungicide by the Fungicide Resistance Action Committee (FRAC); however, the mode of action of flutianil is not definitively known. It has been observed to disrupt the formation of haustoria, which are structures that initiate powdery mildew infection. It is applied as a foliar spray using broadcast or airblast ground equipment against certain species of powdery mildew on cherries (Crop Subgroup 12-09A), cucurbit vegetables (Crop Group 9) and grapes. For details, see Proposed Registration Decision PRD2021-09, Flutianil and GATTEN, Registration Decision RD2022-03, Flutianil and GATTEN.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of the pest control product is acceptable.

This summary describes the key points of the evaluation, while the full version of Proposed Registration Decision PRD2026-08, GATTEN Fungicide, containing Flutianil provides detailed technical information on the human health, environmental and value assessments of GATTEN Fungicide, containing flutianil.

What does Health Canada consider when making a registration decision?

The primary objective of the Pest Control Products Act is to prevent unacceptable risks to individuals and the environment from the use of pest control products. Health or environmental risk is considered acceptable^{Footnote 1} if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value^{Footnote 2} when used according to the label directions. Conditions of registration may include precautionary measures on the product label to further reduce risk.

To reach its decisions, Health Canada applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children). They also consider the unique characteristics of organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information on how Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and Pest Management portion of Canada.ca.

Before making a final registration decision on GATTEN Fungicide, containing flutianil, Health Canada will consider any written comments received from the public directly related to the proposed decision in this PRD2026-08.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on GATTEN Fungicide, containing flutianil, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada's response to these comments.

For more details on the information presented in this summary, please refer to the Science evaluation of PRD2026-08.

What is flutianil?

Flutianil is a narrow spectrum fungicide that has shown activity towards certain powdery mildew plant pathogens. Application of flutianil as a foliar spray makes it difficult for powdery mildew disease to establish and spread to other plants. Flutianil is used to manage powdery mildew diseases on various labelled fruit,vegetable and ornamental crops.

Health considerations

Can approved uses of flutianil affect human health?

GATTEN, containing flutianil, is unlikely to affect your health when used according to label directions.

Potential exposure to flutianil may occur through the diet (food and drinking water), when handling and applying the end-use product, or when coming into contact with treated surfaces. When assessing health risks, two key factors are considered:

• the levels at which no health effects occur, and
• the levels to which people may be exposed.

The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose level at which no effects are observed. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide products are used according to label directions.

In laboratory animals, the acute toxicity of the technical grade active ingredient flutianil was low via the oral, dermal and inhalation routes of exposure. Flutianil was non-irritating to the eyes and skin. It did not cause an allergic skin reaction.

In laboratory animals, the acute toxicity of the end-use product GATTEN Fungicide was low via the oral, dermal and inhalation routes of exposure. It was moderately irritating to the eyes,mildly irritating to the skin, and caused an allergic skin reaction.

Prior to the initial registration of flutianil, registrant-supplied short- and long-term (lifetime) animal toxicity tests, as well as information from the published scientific literature, were assessed for the potential of flutianil to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. No new toxicology data were received for these proposed new uses. As described in PRD2021-09, the most sensitive endpoints for risk assessment were effects on the liver, delayed bone development and the respiratory tract. There was an indication that the young were more sensitive than the adult animals. The risk assessment protects against the effects noted above and other potential effects by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.

Occupational risks from handling GATTEN Fungicide

Occupational risks are not of concern when GATTEN Fungicide is used according to the proposed label directions, which include protective measures.

Workers mixing, loading or applying GATTEN Fungicide, and workers entering recently treated greenhouses can be exposed to flutianil residues through direct skin contact and through inhalation. Therefore, the label specifies that anyone mixing, loading and applying GATTEN Fungicide must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear (goggles or face shield) during mixing, loading, application, clean-up and repair. Eye, head and respiratory protective equipment are required when applying GATTEN Fungicide above waist height using handheld equipment. The label also requires that workers do not enter or be allowed into treated areas during the restricted-entry interval (REI) of 12 hours. Taking into consideration the label statements, the number of applications and the duration of exposure for handlers and postapplication workers, the health risks to these individuals from exposure to GATTEN Fungicide are not of health concern.

Risks in residential and other non-occupational environments

Risks in residential and other non-occupational environments are not of concern when GATTEN Fungicide is used according to the proposed label directions.

GATTEN Fungicide is not a domestic-class product and is not intended for residential use. As there is no potential exposure to homeowners mixing, loading, and applying flutianil, a residential risk assessment was not required. Furthermore, exposure to flutianil residues on treated ornamental plants that are subsequently purchased at retail locations is considered negligible.

Health risks to bystanders

Bystander risks are not of health concern when GATTEN Fungicide is used according to the proposed label directions and spray drift restrictions are observed.

Bystander exposure is considered negligible since application is limited to a greenhouse environment where there is no potential for drift. Therefore, bystander exposure and risk are not of health concern.

Aggregate health risks from dietary and residential exposures

Aggregate risks from exposures to flutianil are not of health concern when GATTEN Fungicide is used according to the proposed label directions.

GATTEN Fungicide is a commercial-class product and therefore no residential use is expected. Exposure to flutianil when individuals come into contact with treated greenhouse ornamental plants purchased from retail locations is expected to be negligible. As such, the aggregate assessment for flutianil considered only food and drinking water exposure. Chronic dietary exposure to flutianil from food and drinking water were considered in the determination of aggregate risks. The aggregate risks to adults and children are not of health concern when the end-use product is used according to the label directions.

Residues in food and drinking water

Dietary risks from food and drinking water are not of health concern.

Studies in laboratory animals showed no acute health effects. Consequently, a single dose of flutianil is not likely to cause acute health effects in the general population (including infants and children). Therefore, an acute risk assessment was not necessary.

Aggregate chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 3%of the acceptable daily intake, and therefore are not of health concern.

There was no evidence of tumorigenicity and, therefore, a cancer risk assessment was not necessary.

The Food and Drugs Act prohibits the sale of adulterated food, that is, food containing a pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs are established for Food and Drugs Act purposes through the evaluation of scientific data under the Pest Control Products Act. Given that dietary risks from the consumption of foods are shown to be acceptable when flutianil is used according to the supported label directions, MRLs are being proposed as a result of this assessment (refer to Appendix II of PRD2026-08).

MRLs for flutianil determined from the acceptable residue trials conducted throughout Canada and the United States on greenhouse vegetables can be found in the Science evaluation of PRD2026-08.

Environmental considerations

What happens when flutianil is introduced into the environment?

When GATTEN Fungicide is used according to label directions, the environmental risk associated with the new uses are acceptable.

The properties and environmental characterization of flutianil have been previously reviewed and reported in PRD2021-09 and RD2022-03.

Exposure to non-target organisms in the environment is expected to be minimal from greenhouse uses of pesticide products. Exposure may occur to pollinators and beneficial arthropods if used in managed greenhouse production. A risk assessment considering the proposed application rates determined negligible risks to these organisms is expected.

Value considerations

What is the value of GATTEN Fungicide?

GATTEN Fungicide contains a fungicide with a new mode of action to manage powdery mildew on greenhouse pepper, eggplant, tomato, cucumber and ornamental crops and delay the development of fungicide resistance.

The greenhouse environment is favourable to powdery mildew disease, which can result in severe outbreaks. Many greenhouse food and ornamental crops are susceptible. Because powdery mildew has been observed to rapidly develop resistance, multiple fungicide modes of action are needed for sustained disease management. GATTEN Fungicide provides a new mode of action that has been shown to control or suppress a broad range of powdery mildew species on pepper, eggplant, tomato, cucumber, and ornamental crops.

Measures to minimize risk

Labels of registered pesticide products 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 being proposed on the label of GATTEN Fungicide, containing flutianil to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

To reduce the potential exposure of workers to flutianil through direct contact or inhalation of sprays, workers mixing, loading and applying GATTEN Fungicideand performing cleaning and repair activities must wear long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear (goggles or face shield). Eye, head and respiratory protective equipment are required when applying GATTEN Fungicide above waist height using handheld equipment. The label also requires that workers do not enter or be allowed entry into treated areas during the REI of 12 hours.

Key risk-reduction measures - Environment

A label statement prohibiting the discharge of effluent or runoff containing flutianil from greenhouses to water is required.

Next steps

Before making a final registration decision on GATTEN Fungicide, containing flutianil, Health Canada will consider any written comments received from the public that are directly related to this proposed decision, such as comments directed to the Science evaluation, in response to PRD2026-08 up to 45 days from the date of publication (by 14 June 2026) of PRD2026-08. Please forward all comments to Pesticides Regulatory Directorate's Publications, through the Public Engagement Portal (Public Engagement Portal forms – Consultation Comment). Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada's response to these comments.

Other information

When Health Canada makes its registration decision, it will publish a Registration Decision on GATTEN Fungicide, containing flutianil (based on the Science evaluation of PRD2026-08). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the Pesticides Regulatory Directorate's Reading Room. For more information or if you have questions, please contact the Pest Management Information Service.