Proposed Registration Decision PRD2025-07, Fluoxapiprolin and Xivana Prime

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Pest Management Regulatory Agency
12 September 2025
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2025-7E-PDF (PDF version)

Summary

Table of contents

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

Proposed registration decision for fluoxapiprolin

Health Canada’s Pest Management Regulatory Agency (PMRA), pursuant to subsection 28(1) of the Pest Control Products Act, is proposing registration for the sale and use of Fluoxapiprolin 95 TC (the technical grade active ingredient) and Xivana Prime (the end-use product), containing the active ingredient fluoxapiprolin, for the control of late blight on potatoes, and against downy mildew and certain Phytophthora diseases on brassica head and stem vegetables, bulb vegetables, cucurbit vegetables, fruiting vegetables, leafy vegetables, leafy petiole vegetables, grapes and Amur river grapes.

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 products are acceptable.

This summary describes the key points of the evaluation, while the Science evaluation in the full version of Proposed Registration Decision PRD2025-07, Fluoxapiprolin and Xivana Prime provides detailed technical information on the human health, environmental and value assessments of fluoxapiprolin and Xivana Prime.

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’s PMRA 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 fluoxapiprolin and Xivana Prime, Health Canada’s PMRA will consider any written comments received from the public directly related to the proposed decision in PRD2025-07.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on fluoxapiprolin and Xivana Prime, 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 PRD2025-07.

What is fluoxapiprolin?

Fluoxapiprolin is a new conventional fungicide active ingredient for disease management in a wide range of crops grown in Canada.

Health considerations

Can approved uses of fluoxapiprolin affect human health?

Xivana Prime, containing fluoxapiprolin, is unlikely to affect your health when used according to proposed label directions.

Potential exposure to fluoxapiprolin may occur through the diet (food and drinking water) or 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 selected 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 dose levels 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 technical grade active ingredient fluoxapiprolin was of low acute toxicity by the oral, dermal and inhalation routes. Fluoxapiprolin was non-irritating to the eyes and skin and did not cause an allergic skin reaction.

The acute toxicity of the end-use product, Xivana Prime, containing fluoxapiprolin, was low via the oral, dermal and inhalation routes of exposure. It was non-irritating to the eyes and skin. It did cause an allergic skin reaction; consequently, the hazard statement “POTENTIAL SKIN SENSITIZER” is required on the label.

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 fluoxapiprolin to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were effects on the skeleton of developing rats. There was an indication that the young were more sensitive than the adult animal. 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 level at which these effects occurred in animal tests.

Residues in food and drinking water

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

Aggregate acute dietary (food plus drinking water) intake estimate indicated that females 13–49 years are exposed to less than 1% of the acute reference dose (ARfD) for fluoxapiprolin, and therefore is not of health concern.

Aggregate chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 1%of the acceptable daily intake (ADI) for fluoxapiprolin, and therefore are not of health concern.

Aggregate chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 22%of the acceptable daily intake for the metabolite fluoxapiprolin-BDM-pyrazole, and therefore are not of health concern.

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 fluoxapiprolin is used according to the supported label directions, MRLs are being proposed as a result of this assessment (refer to PMRL2025-20, Fluoxapiprolin).

MRLs for fluoxapiprolin determined from the acceptable residue trials conducted throughout Canada and the United States, on potatoes, bulb onions, green onions, leaf lettuce, head lettuce, spinach, mustard greens, broccoli, cauliflower, cabbage, bell peppers, non-bell peppers, tomatoes, cucumbers, summer squash, muskmelons, grapes, celery, and strawberries can be found in the Science evaluation of PRD2025-07.

Occupational risks from handling Xivana Prime

Occupational risks are not of health concern when Xivana Primeis used according to the proposed label directions, which include protective measures.

Workers mixing, loading or applying Xivana Prime, and workers entering recently treated fields can be exposed to fluoxapiprolin residues through direct skin contact and/or through inhalation. Therefore, the label specifies that anyone mixing and loading Xivana Prime and engaging in clean-up and repair activitiesmust wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. For applicators using handheld airblast/mist blowing equipment, chemical-resistant coveralls with a hood over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear must also be worn. For all other application equipment, the applicator must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. The label also requires that workers do not enter or be allowed entry into treated fields 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 risks to these individuals from exposure to Xivana Prime are not of health concern when the end-use product is used according to the proposed label directions.

Risks in residential and other non-occupational environments

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

Residential exposure to Xivana Prime is not expected, as it is not proposed for use in residential areas.

Health risks to bystanders

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

A standard label statement to protect against drift during application is on the label. Therefore, health risks to bystanders are not of concern when the end-use product is used according to the proposed label directions.

Environmental considerations

What happens when fluoxapiprolin is introduced into the environment?

When fluoxapiprolin is used according to the label directions, the risks to the environment have been determined to be acceptable.

Fluoxapiprolin enters the environment when applied as a foliar spray to control or suppress certain oomycete diseases for various crops. Fluoxapiprolin is non-persistent to moderately persistent in aerobic soils and persistent in anaerobic soils. Fluoxapiprolin adsorbs strongly to soils and is not expected to move through the soil and reach groundwater. In water bodies, fluoxapiprolin will move quickly to sediments where it is slightly persistent under aerobic conditions and moderately persistent under anaerobic conditions. Fluoxapiprolin is not expected to carry over to the next growing season. Fluoxapiprolin is a systemic fungicide; when applied as a spray, fluoxapiprolin can be absorbed and transported inside the plant. Fluoxapiprolin is not expected to be found in the air or to travel long distances from where it is applied. Fluoxapiprolin is not expected to build up in the tissues of organisms.

When used according to the label directions, fluoxapiprolin and its transformation products pose acceptable risk to non-target organisms, including small wild mammals, birds, beneficial insects including bees, earthworms, terrestrial and aquatic plants, amphibians, and freshwater and marine algae, fish, and invertebrates.

Value considerations

What is the value of Xivana Prime?

The registration of Xivana Prime will provide Canadian growers with a new mode of action fungicide to manage economically important and difficult-to-control diseases on the crops listed on the Xivana Prime label and is expected to contribute to resistance management.

Xivana Prime contains fluoxapiprolin as its sole active ingredient. It is effective against downy mildew and certain Phytophthora diseases when applied using ground application to brassica head and stem vegetables (Crop Group 5-13), bulb vegetables (Crop Group 3-07), cucurbit vegetables (Crop Group 9), fruiting vegetables (Crop Group 8-09), leafy vegetables (Crop Group 4-13), leafy petiole vegetables (Crop Subgroup 22B), and grape and Amur river grape. It is also effective against late blight on potato when applied using either ground or aerial application.

Measures to minimize risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.

The key risk-reduction measures being proposed on the label of Fluoxapiprolin 95 TC and Xivana Prime 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 fluoxapiprolinthrough direct skin contact and inhalation of sprays, workers mixing, loading and applying Xivana Prime and performing cleaning and repair activities must wear the personal protective equipment (PPE) presented below.

The required personal protective equipment for Xivana Prime

Application equipment	Personal protective equipment
	Mixer/Loader/Clean-up and repair	Applicator
Handheld airblast/mistblowerTable 1 Footnote 1	Long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes.	Chemical-resistant coveralls with a chemical-resistant hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear.
All other application equipmentTable 1 Footnote 1	Long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes.	Long-sleeved shirt, long pants, chemical-resistant gloves,Table 1 Footnote 2 socks and shoes.
Table 1 Footnote 1 For handheld equipment, wear eye, head and respiratory protection when applying above waist height, including overhead. Table 1 Return to footnote 1 referrer Table 1 Footnote 2 Gloves are not required for application within a closed cab and/or cockpit. Table 1 Return to footnote 2 referrer

The label also requires that workers do not enter or be allowed entry into treated fields during the REI of 12 hours. Risks to workers are not of health concern when Xivana Prime is used according to the proposed label directions and the restricted-entry interval is observed. Furthermore, a standard label statement to protect against drift during application is present on the label.

Key risk-reduction measures - Environment

Standard best management practice statements will be included on the label to minimize risk.

Next steps

Before making a final registration decision on fluoxapiprolin and Xivana Prime, Health Canada’s PMRA 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 PRD2025-07 up to 30 days from the date of publication (12 September 2025) of this document. If more time is required to provide comments, a request for an extension of up to 15 days can be made before the end of the original 30-day consultation period. Please note that, to comply with Canada's international trade obligations, consultation on the proposed MRLs will also be conducted internationally via a notification to the World Trade Organization. Please forward all comments to PMRA Publications, through the Public Engagement Portal (Public Engagement 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 fluoxapiprolin and Xivana Prime (based on the Science evaluation of PRD2025-07). In addition, the test data referenced in PRD2025-07 will be available for public inspection, upon application, in the PMRA’s Reading Room. For more information or if you have questions, please contact the PMRA’s Pest Management Information Service.

Footnotes