Proposed Registration Decision PRD2022-18, Ipflufenoquin and Kinoprol 20 SC

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Pest Management Regulatory Agency
23 December 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-18E-PDF (PDF version)

Summary

Table of contents

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

Proposed registration decision for ipflufenoquin

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 Kinoprol Technical and Kinoprol 20 SC, containing the technical grade active ingredient ipflufenoquin, for control or suppression of pome fruit diseases.

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 PRD2022-18, Ipflufenoquin and Kinoprol 20 SC provides detailed technical information on the human health, environmental and value assessments of ipflufenoquin and Kinoprol 20 SC.

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^{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 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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program.

Before making a final registration decision on ipflufenoquin and Kinoprol 20 SC, Health Canada's PMRA will consider any comments received from the public in response to this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on ipflufenoquin and Kinoprol 20 SC, 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 PRD2022-18.

What is ipflufenoquin?

Ipflufenoquin is new fungicide with a unique mode of action for control or suppression of pome fruit diseases. Ipflufenoquin is quickly absorbed into plant tissue and has the ability to move within the plant between the upper and lower leaf surfaces.

Health considerations

Can approved uses of ipflufenoquin affect human health?

Kinoprol 20 SC, containing ipflufenoquin, is unlikely to affect your health when used according to proposed label directions.

Potential exposure to ipflufenoquin may occur through the diet (food and drinking water), when handling and applying the end-use products, or when entering an area that has been treated with the product. 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 ipflufenoquin was of low acute toxicity by the oral, dermal, and inhalation routes. It was non-irritating to the eyes and skin. It did not cause an allergic skin reaction.

The acute toxicity of the end-use product Kinoprol 20 SC, containing ipflufenoquin, was low via the oral and dermal routes of exposure. Kinoprol 20 SC was of slight toxicity via the inhalation route of exposure; consequently, the signal word and hazard statement "CAUTION – POISON" are required on the label. It was non-irritating to the eyes and skin and did not cause an allergic skin reaction.

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 ipflufenoquin to cause neurotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were effects on motor activity and body weight. 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 indicated that the general population and all population subgroups are exposed to less than 1% of the acute reference dose, 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 1%of the acceptable daily intake, 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 ipflufenoquin is used according to the supported label directions, MRLs are being proposed as a result of this assessment (refer to PMRL2022-24, Ipflufenoquin).

MRLs for ipflufenoquin determined from the acceptable residue trials conducted throughout Canada and the United States on various crops can be found in the Science Evaluation of PRD2022-18.

Occupational risks from handling Kinoprol 20 SC herbicide

Occupational risks are not of health concern when Kinoprol 20 SCis used according to the proposed label directions, which include protective measures.

Workers mixing, loading or applying Kinoprol 20 SC, and workers entering recently treated pome fruit orchards can be exposed to ipflufenoquin residues through direct skin contact or through inhalation. Therefore, the label specifies that anyone mixing, loading and applying Kinoprol 20 SC must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. Chemical-resistant gloves are not required during application within a closed cab. The label also requires that workers do not enter or allowed into treated areas during the restricted-entry interval (REI) of 12 hours. Taking into consideration the label statements, the application rate, the number of applications and the duration of exposure for handlers and postapplication workers, the risks to these individuals are not of health concern when the end-use product is used according to the proposed label directions.

Health risks in residential and other non-occupational environments

Risks in residential and other non-occupational environments are not of health concern when Kinoprol 20 SCis used according to the proposed label directions and restricted-entry intervals (REIs) are observed.

Adults, youth and children involved in postapplication activities, such as pruning and hand harvesting, may come in direct contact with ipflufenoquin residues on the skin when pome fruit trees in residential areas are treated with Kinoprol 20 SC by commercial applicators. Taking into consideration the label statements, the application rate, the number of applications and the duration of exposure, the risks to homeowners and their family are not of health concern once the sprays have dried when the end-use product is used according to the proposed label directions.

Non-occupational exposure during pick-your-own fruit activities in treated orchards and residential areas are also not of health concern when the end-use product is used according to the proposed label directions.

Aggregate health risks

When pome fruit trees in residential settings or pick-your-own facilities are treated with Kinoprol 20 SC, there is potential for individuals to be exposed to ipflufenoquin via the dermal and oral routes of exposure concurrently. Based on the toxicological assessment, aggregation of dermal and dietary exposure is not required. For ipflufenoquin, the aggregate assessment consisted of combining food and drinking water exposure only.

Health risks to bystanders

Bystander risks are not of health concern when Kinoprol 20 SCis 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 ipflufenoquin is introduced into the environment?

When ipflufenoquin is used according to the label directions, the risks to the environment are acceptable.

When ipflufenoquin is applied as a foliar spray to control powdery mildew and scab on pome fruit (for example, apples and pears), it will bind to the soil where up to half of the applied amount may remain for more than 2 years depending on soil type and environmental conditions.

Ipflufenoquin will not move from the treatment area into the air and therefore is not expected to move to non-treated sites via air. Ipflufenoquin may move downward in the soil, and, therefore, may reach groundwater. It has low potential to move from the treatment area to surface waters such as ponds, streams and rivers. If it does enter water, ipflufenoquin will move to the sediment where up to half of it may remain for more than a year and a half, depending on sediment type and conditions. Ipflufenoquin is not expected to accumulate in plant or animal tissues.

When ipflufenoquin is used in accordance with the label directions and the required precautions, the risk to terrestrial invertebrates, birds, wild mammals, bees, beneficial arthropods, terrestrial plants, aquatic invertebrates (including sediment-dwelling invertebrates), amphibians, fish, algae and vascular aquatic plants from the use of ipflufenoquin were determined to be acceptable without the requirement of additional risk mitigation measures.

Value considerations

What is the value of Kinoprol 20 SC fungicide?

Kinoprol 20 SC fungicide offers pome fruit growers a new mode of action fungicide to manage economically important diseases.

Kinoprol 20 SC Fungicide will contribute to disease management in pome fruit orchards with effective reduction of powdery mildew and scab. The new mode of action will help manage the development of resistance to fungicides currently registered for use against these diseases.

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 Kinoprol Technical and Kinoprol 20 SC 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 ipflufenoquin through direct skin contact or inhalation of sprays, workers mixing, loading and applying Kinoprol 20 SCand performing cleaning and repair activities must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. Additionally, a standard label statement to protect against drift during application is on the label. The label also requires that workers do not enter or be allowed entry into treated agricultural fields during the REI of 12 hours. Furthermore, standard label statements to restrict the use of handheld airblast, misters and foggers is present on the label.

Key risk-reduction measures - Environment

Precautionary statements are required to inform users of the potential of ipflufenoquin to reach groundwater.

Next steps

Before making a final registration decision on ipflufenoquin and Kinoprol 20 SC, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-18. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-18. 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 the Health Canada makes its registration decision, it will publish a Registration Decision on ipflufenoquin and Kinoprol 20 SC (based on the Science Evaluation of PRD2022-18). 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, please contact the PMRA's Pest Management Information Service.