Proposed Registration Decision PRD2025-09, Isofetamid 400SC Fungicide, containing Isofetamid

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

Summary

Table of contents

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

Proposed registration decision for isofetamid

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 Isofetamid 400SC Fungicide, containing the technical grade active ingredient isofetamid, to control botrytis grey mould (Botrytis cinerea) on 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's Pest Management Regulatory Agency and includes participation by sponsors group, manufacturers, and both provincial and federal governments.

Isofetamid 400SC Fungicide is currently registered to control various fungal diseases on a wide variety of crops under use-site category numbers 13, 14 and 30. For details, see Proposed Registration Decision PRD2014-19, Isofetamid, and Registration Decision RD2016-19, Isofetamid.

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 PRD2025-09, Isofetamid 400SC Fungicide, containing Isofetamid provides detailed technical information on the human health, environmental and value assessments of Isofetamid 400SC Fungicide, containing isofetamid.

What does Health Canada consider when making a registration decision?

The key 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, the 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 the Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and pest management portion of the Canada.ca website.

Before making a final registration decision on Isofetamid 400SC Fungicide, containing isofetamid, Health Canada's PMRA will consider any written comments received from the public directly related to the proposed decision in this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Isofetamid 400SC Fungicide, containing isofetamid, 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 PRD2025-09.

What is isofetamid?

Isofetamid is a member of the succinate-dehydrogenase inhibitor group of fungicides which affect fungal respiration. Isofetamid 400SC is applied via foliar applications to control or suppress various pathogens on certain crops.

Health considerations

Can approved uses of isofetamid affect human health?

Isofetamid 400SC Fungicide, containing isofetamid, is unlikely to affect your health when used according to label directions.

Potential exposure to isofetamid may occur through the diet (food and drinking water), when handling and applying the product or when in 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 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 technical grade active ingredient isofetamid was of low acute toxicity by the oral, dermal and inhalation routes. It was non-irritating to skin, minimally irritating to eyes and did not cause an allergic skin reaction.
The acute toxicity of the end-use product Isofetamid 400SC Fungicide was low via the oral, dermal and inhalation routes of exposure. It was non-irritating to eyes and skin and did not cause an allergic skin reaction.

Prior to the initial registration of isofetamid, 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 isofetamid to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. As described in PRD2014-19, the most sensitive endpoints for risk assessment were effects on the liver and on the developing cardiovascular system. There was no evidence of increased sensitivity of the young compared to 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 level at which these effects occurred in animal tests.

Risks in residential and other non-occupational environments

Non-occupational risks are not of concern when used according to label directions.

There are no risks in residential and other non-occupational environments as Isofetamid 400SC will only be applied in commercial greenhouses. Furthermore, exposure to treated ornamental plants that are subsequently purchased at retail locations is considered negligible.

Occupational risks from handling Isofetamid 400SC Fungicide

Occupational risks are not of concern when Isofetamid 400SC Fungicide is used according to the proposed label directions, which include protective measures.

Workers mixing, loading or applying Isofetamid 400SC Fungicide, and workers entering recently treated areas can come in direct contact with isofetamid residues on the skin and through inhalation. Therefore, the label specifies that anyone mixing, loading and applying Isofetamid 400SC Fungicide must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. 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 Isofetamid 400SC Fungicide are not of health concern.

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

Environmental considerations

What happens when isofetamid is introduced into the environment?

When used according to label directions, the environmental risks associated with the major new use of isofetamid and its associated end-use product, Isofetamid 400SC Fungicide, on greenhouse ornamental plants are acceptable.

The environmental impact of the use of isofetamid as a foliar treatment against various Botrytis and Sclerotinia diseases on grape, lettuce (head and leaf), rapeseed (Crop Subgroup 20A), low growing berry (Crop Subgroup 13-07G), and turfgrass on golf courses and sod farm was evaluated in Proposed Registration Decision PRD2014-19, Isofetamid, and Registration Decision RD2016-19, Isofetamid. Isofetamid is toxic to aquatic organisms, birds and small wild mammals. Risk mitigation measures for these organisms are present on the registered label of Isofetamid 400SC Fungicide.

After a scientific review of the available information, the PMRA has concluded that the environmental risks associated with the major new use of isofetamid against Botrytis cinerea (Botrytis grey mould) on greenhouse ornamental plants are acceptable when Isofetamid 400SC Fungicide is used according to label directions.

Value considerations

What is the value of Isofetamid 400SC Fungicide?

Isofetamid is the active ingredient in Isofetamid 400SC Fungicide. Isofetamid 400SC Fungicide provides control of botrytis grey mould (Botrytis cinerea) on greenhouse ornamentals. The registration of Isofetamid 400SC Fungicide for this use will provide greenhouse ornamental growers with an alternative product for use to manage botrytis grey mould.

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 Isofetamid 400SC Fungicide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

To reduce the potential of workers coming into direct contact with isofetamid on the skin or through inhalation, workers mixing, loading and applying Isofetamid 400SC Fungicideand performing cleaning and repair activities must wear 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 areas during the REI of 12 hours.

Key risk-reduction measures - Environment

Label statement prohibiting the discharge of greenhouse releases, effluent or runoff to water.

Next steps

Before making a final registration decision on Isofetamid 400SC Fungicide, containing isofetamid, 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 this consultation document up to 45 days from the date of publication (26 September 2025) of this document. 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 the Health Canada makes its registration decision, it will publish a Registration Decision on Isofetamid 400SC Fungicide, containing isofetamid, (based on the Science evaluation of PRD2025-09). In addition, the test data referenced in this consultation document 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.