Proposed Registration Decision PRD2020-10, Inpyrfluxam, Excalia Fungicide and Zeltera Fungicide

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Pest Management Regulatory Agency
23 June 2020
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2020-9E-PDF (PDF version)

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain a full copy of Proposed Registration Decision PRD2020-10, Inpyrfluxam, Excalia Fungicide and Zeltera Fungicide please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Summary

Table of Contents

Proposed registration decision for inpyrfluxam

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is proposing registration for the sale and use of Inpyrfluxam Technical, Excalia Fungicide and Zeltera Fungicide, containing the technical grade active ingredient inpyrfluxam, to be applied foliarly and as a seed treatment on various crops. 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 of Proposed Registration Decision PRD2020-10, Inpyrfluxam, Excalia Fungicide and Zeltera Fungicide provides detailed technical information on the human health, environmental and value assessments of inpyrfluxam, Excalia Fungicide and Zeltera Fungicide.

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 people and the environment from the use of pest control products. Health or environmental risk is considered acceptable 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 when used according to the label directions. Conditions of registration may include special 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) as well as 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 please refer to the following:

Before making a final registration decision on inpyrfluxam, Excalia Fungicide and Zeltera Fungicide, Health Canada's PMRA will consider any comments received from the public in response to PRD2020-10. Health Canada will then publish a Registration Decision on inpyrfluxam, Excalia Fungicide and Zeltera Fungicide, 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 PRD2020-10.

What is inpyrfluxam?

Inpyrfluxam is a new conventional fungicide active ingredient that inhibits an enzyme involved in energy production in some fungi. It controls or suppresses economically important diseases of apple and field crops.

Health considerations

Can approved uses of inpyrfluxam affect human health?

Excalia Fungicide and Zeltera Fungicide, containing inpyrfluxam, are unlikely to affect your health when used according to proposed label directions.

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

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 dose levels more than 100-times higher (and often much higher) than to which humans are normally exposed when pesticide products are used according to label directions.

In laboratory animals, the technical grade active ingredient inpyrfluxam was of high acute toxicity by the oral route of exposure; consequently, the signal word and hazard statement “DANGER – POISON” are required on the label. It was of low acute toxicity dermally and through inhalation exposure. Inpyrfluxam was minimally irritating to the eyes and non-irritating to the skin, and did not cause an allergic skin reaction.

The acute toxicity of the end-use products Excalia Fungicide and Zeltera Fungicide containing inpyrfluxam was moderate via the oral route of exposure; consequently, the signal word and hazard statement “WARNING – POISON” are required on the labels. They were of low acute toxicity via the dermal and inhalation routes of exposure. They were non-irritating to the eyes and skin and did not cause allergic skin reactions.

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 inpyrfluxam 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 liver and adrenal glands. 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.

Residues in water and food

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

Aggregate acute dietary (food plus drinking water) intake estimates for the general population and all population subgroups are expected to be less than 17% of the acute reference dose, and are not of health concern. Infants are the subpopulation expected to be subject to the highest exposure relative to body weight.

Aggregate chronic dietary (food plus drinking water) intake estimates for the general population and all population subgroups are expected to be less than or equal to 35%of the acceptable daily intake, and are not of health concern. Infants are the subpopulation expected to be subject to the highest exposure relative to body weight.

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. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.

MRLs for inpyrfluxam determined from the acceptable residue trials conducted throughout Canada and the United States on apples, canola, corn, peanuts, rice, sorghum, soybeans, and sugar beets can be found in the Science Evaluation of this consultation document.

Occupational risks from handling Excalia Fungicide

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

Farmers and custom applicators who mix, load or apply Excalia Fungicide, as well as orchard or field workers entering freshly treated areas, may come in direct contact with inpyrfluxam residues on the skin and through inhalation. Therefore, the label of Excalia Fungicide specifies that users must wear a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair, unless specified otherwise. Gloves are not required during application within a closed-cab tractor. For application using handheld airblast/mistblower, workers must wear chemical-resistant coveralls with a chemical-resistant hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks, chemical-resistant footwear and a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides or a NIOSH-approved canister approved for pesticides.

The label also requires that workers do not enter treated areas for 12 hours after application, and standard label statements to protect against drift during application are present on the label. Taking into consideration these label statements, the application timing, the number of applications and the duration of exposure for handlers and workers, health risks to these individuals are not of concern.

Occupational risks from handling Zeltera Fungicide

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

Workers treating seeds with Zeltera Fungicide in commercial facilities, with commercial mobile systems, or in on-farm settings, as well as workers planting or handling treated seeds, may come into direct contact with inpyrfluxam residues on the skin and through inhalation.

Therefore, the label of Zeltera Fungicide specifies that commercial handlers (including facility workers and mobile treaters) must use a closed-transfer system only, including closed mixing, loading, calibrating and closed treatment equipment, and must wear coveralls over a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes during mixing, loading, treating, calibrating, bagging, sewing, stacking and cleaning.

For on-farm workers, the label of Zeltera Fungicide indicates that an open or closed transfer system can be used, and they must wear a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes during mixing, loading, treating, calibrating, clean-up, repair and any other activities involving handling treated seeds. Planters of treated seeds must also wear a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes. Open- or closed-cab tractors can be used while planting, and gloves are not required within a closed-cab tractor.
Taking into consideration these label statements, the number of applications and the duration of exposure for handlers and workers, health risks to these individuals are not of concern.

Risks in residential and other non-occupational environments

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

Adults, youth and children, while pruning or maintaining apple trees, may come into direct contact with inpyrfluxam residues on foliage when apple trees in residential areas are treated with Excalia Fungicide by commercial applicators. However, when taking into consideration the label statements, the early application timing (in other words, no later than petal fall), the number of applications and the duration of exposure, health risks to these individuals are not of concern.

Non-occupational exposure in pick-your-own fruit scenarios in treated orchards are also not of health concern as the level of inpyrfluxam residues on foliage is expected to be negligible at the time of normal harvest in the fall when compared to the early timing of application in the spring.

Health risks to bystanders

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

A standard label statement to protect against drift during application is on both labels. Therefore, health risks to bystanders are not of concern.

Environmental considerations

What happens when inpyrfluxam is introduced into the environment?

When used according to label directions, the risks associated with the use of inpyrfluxam are acceptable from the viewpoint of environmental protection.

When inpyrfluxam is used as a foliar application or seed treatment to control fungal diseases, it can remain in the soil for months or years, depending on the soil type and conditions. Inpyrfluxam can move through the soil and, therefore, may reach groundwater. It may also move off the treatment area to reach surface waters such as ponds, streams and rivers. Transformation products of inpyrfluxam may move through soil more readily than the parent. Once in water, inpyrfluxam is expected to remain for a long period of time. Inpyrfluxam is not expected to be found in air, or travel long distances in the atmosphere from the location it is applied. Inpyrfluxam is not expected to accumulate in plant or animal tissue.

Inpyrfluxam does not present a risk to terrestrial invertebrates, bees, beneficial arthropods, aquatic invertebrates (including sediment dwelling invertebrates), algae and vascular aquatic plants. Inpyrfluxam may present a risk to birds, wild mammals and non-target plants adjacent to treated fields. In bodies of water, inpyrfluxam may present a risk to fish and amphibians. To minimize exposure to sensitive non-target species, spray buffer zones are required. In addition, precautionary statements and best management practices are required on the label. When inpyrfluxam is used in accordance with the label and the required precautions, the resulting environmental risk is considered to be acceptable.

Value considerations

What is the value of Excalia Fungicide and Zeltera Fungicide?

Inpyrfluxam is the active ingredient in Excalia Fungicide and Zeltera Fungicide. The registration of these products will provide Canadian growers with a new option to manage important fungal diseases in several crops.

Excalia Fungicide is applied as a foliar spray to control or suppress various diseases of apple corn, soybean and sugar beet. Zeltera Fungicide is applied as a seed treatment to control or suppress certain seed and seedling diseases in particular cereal crops, corn, legume vegetables, soybean, rapeseed, including canola, and sugar beet, as well as sudden death syndrome in soybean and blackleg in canola.

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 Inpyrfluxam Technical, Excalia Fungicide and Zeltera Fungicide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

Because there is concern with users coming into direct contact with inpyrfluxam residues on the skin or through inhalation of spray mists, the label of Excalia Fungicide specifies that users must wear a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair, unless specified otherwise. Gloves are not required during application within a closed-cab tractor. For application using handheld airblast/mistblower, workers must wear chemical-resistant coveralls with a chemical-resistant hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks, chemical-resistant footwear and a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides or a NIOSH-approved canister approved for pesticides. The label also requires that workers do not enter treated areas for 12 hours after application, and standard label statements to protect against drift during application are present on the label.

The label of Zeltera Fungicide specifies that commercial handlers (including facility workers and mobile treaters) must use a closed-transfer system only, including closed mixing, loading, calibrating and closed treatment equipment, and must wear coveralls over a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes during mixing, loading, treating, calibrating, bagging, sewing, stacking and cleaning.

For on-farm workers, the label of Zeltera Fungicide indicates that an open or closed transfer system can be used, and they must wear a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes during mixing, loading, treating, calibrating, clean-up, repair and any other activities involving handling treated seeds. Planters of treated seeds must also wear a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes. Open- or closed-cab tractors can be used while planting, and gloves are not required within a closed-cab tractor.

Furthermore, a standard label statement to protect against drift during application is present on the label.

Environment

To protect the environment, the following proposed risk mitigation measures are required:

Next steps

Before making a final registration decision on inpyrfluxam, Excalia Fungicide and Zeltera Fungicide, Health Canada's PMRA will consider any comments received from the public in response to PRD2020-10. Health Canada will accept written comments on PRD2020-10 up to 45 days from the date of its publication. 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 Publications. 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 inpyrfluxam, Excalia Fungicide and Zeltera Fungicide (based on the Science Evaluation of PRD2020-10). In addition, the test data referenced in PRD2020-10 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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