Proposed Registration Decision PRD2024-04, Extract of Swinglea glutinosa and EcoSwing Botanical Fungicide

Pest Management Regulatory Agency
12 April 2024
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2024-4E-PDF (PDF version)

Summary

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

Table of contents

• Proposed Registration Decision for Extract of Swinglea glutinosa
• What does Health Canada consider when making a registration decision?
• What is Extract of Swinglea glutinosa?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for Extract of Swinglea glutinosa

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 EcoSwing Technical and EcoSwing Botanical Fungicide, containing the technical grade active ingredient Extract of Swinglea glutinosa, for the control, suppression or partial suppression of common fungal diseases that reduce harvest quality and yields of these crops and fungicide resistance management on field-grown blueberry, certain pome fruits, stone fruits, berries and small fruits, cucurbit vegetables and greenhouse-grown berries and small fruits, cucurbit vegetables, stone fruits and ornamentals.

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 PRD2024-04, Extract of Swinglea glutinosa and EcoSwing Botanical Fungicide provides detailed technical information on the human health, environmental and value assessments of Extract of Swinglea glutinosa and EcoSwing Botanical 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 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 Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides section of the Canada.ca website.

Before making a final registration decision on Extract of Swinglea glutinosa and EcoSwing Botanical Fungicide, Health Canada’s PMRA will consider any written comments received from the public in response to this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Extract of Swinglea glutinosa and EcoSwing Botanical 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 the full version of PRD2024-04.

What is Extract of Swinglea glutinosa?

Extract of Swinglea glutinosa is a nonconventional contact biofungicide with a unique mode of action. It is derived from the leaves of the tropical citrus tree Tabog (Swinglea glutinosa), which is used for food and medicinal purposes. Itacts at multiple sites in fungal pathogens to disrupt cellular integrity, leading to cell leakage, inhibition of fungal growth and the induction of plant defences.

Health considerations

Can approved uses of Extract of Swinglea glutinosa affect human health?

Extract of Swinglea glutinosa is unlikely to affect human health when it is used according to label directions.

Potential exposure to Extract of Swinglea glutinosa may occur through the diet (food and water) or when handling and applying the product. When assessing health risks, two key factors are considered:

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

The 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 where no effects are observed.

In laboratory animals, Extract of Swinglea glutinosa is of low acute toxicity by the oral, dermal, and inhalation routes of exposure, non-irritating to the eyes and skin, and not a dermal sensitizer.

Short-term oral toxicity testing, prenatal developmental toxicity testing, genotoxicity/mutagenicity, and phototoxicity testing on Extract of Swinglea glutinosa were also assessed. There were no treatment related findings when animals received multiple doses of Extract of Swinglea glutinosa. There was no indication that the young were more sensitive than the adult animal. Extract of Swinglea glutinosa is not considered to be mutagenic or genotoxic and is not phototoxic.

The end-use product, EcoSwing Botanical Fungicide, is of low acute toxicity by the oral, dermal, and inhalation routes of exposure, mildly irritating to the eye, non-irritating to the skin, and not a dermal sensitizer.

The risk assessment protects against the findings noted above as well as any other potential effects by ensuring that the level of human exposure is well below the lowest dose at which these effects occur in animal studies.

Residues in water and food

Dietary risks from food and water are acceptable.

Residues of Extract of Swinglea glutinosa on treated crops are possible at the time of harvest. Due to its low toxicity profile, and the rapid biodegradation postapplication, dietary exposure to Extract of Swinglea glutinosa present in EcoSwing Botanical Fungicide is not expected to pose a health risk when the end-use product is applied as directed by the label. Similarly, the likelihood of Extract of Swinglea glutinosa residues in drinking water will be low. Consequently, health risks from dietary exposure are acceptable for all segments of the population, including infants, children, adults and seniors.

Risks in residential and other non-occupational environments

Estimated risk for residential and other non-occupational exposure is acceptable.

EcoSwing Botanical Fungicide is proposed as a commercial fungicide and there are no residential uses proposed. The product is proposed for use on field and greenhouse food crops, berries and small fruits, pome fruits, cucurbit vegetables and stone fruits, as well as greenhouse ornamentals. The product labels will include measures to prevent bystander exposure such as reducing spray drift, and restricting access to the treated area until sprays have dried. Residential and non-occupational exposure to EcoSwing Botanical Fungicide is expected to be low when label directions are observed. Consequently, the health risk to residents and the general public is acceptable.

Occupational risks from handling EcoSwing Botanical Fungicide

Occupational risks are acceptable when EcoSwing Botanical Fungicide is used according to the label directions, which include protective measures.

Workers handling EcoSwing Botanical Fungicide can come into direct contact with Extract of Swinglea glutinosa on the skin or by inhalation during mixing, loading, application, clean-up and repair.

To protect workers from exposure to EcoSwing Botanical Fungicide, the labels require workers to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. Gloves are not required during application within a closed cab. In addition, workers will be required to wear protective eyewear (goggles or face shield) during open cab airblast application.

A restricted-entry interval of 4 hours, or until sprays have dried, is prescribed for all uses. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate personal protective equipment (PPE) as specified by the method of application.

The health risks to workers are acceptable when the precautionary statements on the label are observed.

Environmental considerations

What happens when Extract of Swinglea glutinosa is introduced into the environment?

When used according to label directions, environmental risks associated with Extract of Swinglea glutinosa and its associated end-use product, EcoSwing Botanical Fungicide, are acceptable.

Extract of Swinglea glutinosa would enter the environment when its end-use product, EcoSwing Botanical Fungicide, is used to control diseases in labelled crops. Extract of Swinglea glutinosa is derived from the leaves of a subtropical tree in the Rutaceae family commonly known as tabog. It is a natural substance that is very soluble in water and is expected to rapidly biodegrade in the environment. As such, accumulation in the environment is not expected.

Extract of Swinglea glutinosa is classified as practically non-toxic to non-target organisms. After a scientific review of the available information, the PMRA has concluded that the environmental risks from the proposed uses of Extract of Swinglea glutinosa are acceptable when EcoSwing Botanical Fungicide is used according to the label directions.

Value considerations

What is the value of EcoSwing Botanical Fungicide?

EcoSwing Botanical Fungicide, containing Extract of Swinglea glutinosa at a concentration of 82.0%, is a nonconventional contact commercial biofungicide that attacks targeted fungal pathogens at multiple sites.

Multi-site fungicides with unique modes of action are important elements in a fungicide resistance management strategy. For this reason, the registration of EcoSwing Botanical Fungicide will provide growers of field-grown pome fruit crops, field- and greenhouse-grown Berries and Small Fruits (CG13-07), Cucurbit Vegetables (CG9) and Stone Fruit (CG12-09) crops and greenhouse-grown ornamental crops with a product that may be used to combat several common diseases and possibly delay the development of fungicide resistance to single-site fungicides. Use of this product may also help to reduce reliance on conventional chemical alternatives. A similar fungicide product has been registered in the US since July 2018 and is listed for organic use.

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 EcoSwing Technical and EcoSwing Botanical Fungicide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

The hazard signal words “CAUTION – EYE IRRITANT” are required on the principal display panel of the EcoSwing Botanical Fungicide label. Standard precautionary statements are also required on the labels to inform of the potential to cause eye irritation and to avoid contact with eyes.

Workers are required to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. Gloves are not required during application within a closed cab. In addition, workers will be required to wear protective eyewear (goggles or face shield) during open cab airblast application.

There will be a restricted-entry interval of 4 hours, or until sprays have dried. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate PPE as specified for the method of application.

To limit bystander exposure, the end-use product label requires a drift statement.

Key risk-reduction measures - Environment

None, beyond what is already identified on the label.

Next steps

Before making a final registration decision on Extract of Swinglea glutinosa and EcoSwing Botanical Fungicide, Health Canada’s PMRA will consider any written comments received from the public in response to PRD2024-04 up to 45 days from the date of publication (12 April 2024) of PRD2024-04. 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 Extract of Swinglea glutinosa and EcoSwing Botanical Fungicide (based on the Science evaluation of PRD2024-04). 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 Pest Management Information Service