Proposed Registration Decision PRD2025-02, Pelargonic acid and Beloukha Herbicide

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Pest Management Regulatory Agency
3 March 2025
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2025-2E-PDF (PDF version)

Summary

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

Table of contents

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

Proposed registration decision for pelargonic acid

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 Pelargonic Acid Technical and Beloukha Herbicide, belonging to Belchim Crop Protection Canada Inc., containing the active ingredient pelargonic acid, to control or suppress weeds in greenhouse-grown cucumber, tomato, pepper and lettuce, in greenhouse-grown ornamentals (bedding plants, flowering and non-flowering plants) and around outdoor woody and herbaceous ornamentals, including container-, field-, and liner-grown plants, plants in landscape plantings, landscape trees, nursery trees, shrubs, Christmas trees, and forest and commercial trees.

Pelargonic acid is currently registered to provide burndown, spot, and inter-row weed control in fruit, vegetable and field crops, desiccant and pre-harvest weed management in potato and cereal crops, sucker control in grapes and tree fruits, and control of weeds and mosses in non-crop areas. For details, see Proposed Registration Decision PRD2019-15, Pelargonic Acid, Beloukha Herbicide and Beloukha Agricultural Herbicide, and Registration Decision RD2020-03, Pelargonic Acid, Beloukha Herbicide and Beloukha Agricultural Herbicide.

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 PRD2025-02, Pelargonic acid and Beloukha Herbicide provides detailed technical information on the human health, environmental and value assessments of Pelargonic acid and Beloukha Herbicide.

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 their 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’s PMRA 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 pelargonic acid and Beloukha Herbicide, Health Canada’s PMRA will consider any written comments received from the public in response to PRD2025-02.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on pelargonic acid and Beloukha Herbicide, 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 Section of PRD2025-02.

What is pelargonic acid?

Pelargonic acid is a non-selective, contact fatty acid herbicide that causes cellular membrane disruption in green plant tissue. This leads to cell collapse, followed by tissue dehydration and necrosis.

Health considerations

Can approved uses of pelargonic acid affect human health?

Pelargonic acid is unlikely to affect human health when used according to the label directions.

Potential exposure to pelargonic acid may occur through the diet (food and drinking water) or when handling and applying Beloukha Herbicide. When assessing health risks, several 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 resulting from varying levels of exposure to a chemical and identify dose levels at which no effects are observed.

In laboratory animal studies, the technical grade active ingredient, Pelargonic Acid Technical, was of low toxicity via oral and dermal routes, and slightly acutely toxic by the inhalation route. It was severely irritating to the skin and eyes, and was a dermal sensitizer.

In laboratory animal studies, the end-use product, Beloukha Herbicide, was of low toxicity via oral and dermal routes and slightly acutely toxic by the inhalation route. It was mildly irritating to the skin, moderately irritating the eyes, and was not a dermal sensitizer.

Animal toxicity tests as well as information from the published scientific literature were assessed for the potential of pelargonic acid to cause short-term toxicity, developmental toxicity, genotoxicity and various other effects. Pelargonic acid is a medium chain fatty acid. Fatty acids are used by the body as a primary nutrient, following a metabolic pathway that is well described. The short-term toxicity for pelargonic acid was characterized as low, and there is a low level of concern for sensitivity of the young. The mutagenic potential of pelargonic acid was considered to be of no concern, based on a weight of evidence of the data. The risk assessment further protects against these findings noted above as well as any other potential effects by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.

Residues in food and drinking water

Dietary risks from food and drinking water are acceptable.

Beloukha Herbicide is already approved for use on various food crops. Application of Beloukha Herbicide is directed to weeds around food and non-food crops. Edible food commodities are not directly sprayed, but residues of pelargonic acid on food crops are possible at the time of harvest. Furthermore, the likelihood of residues of pelargonic acid in drinking water is low. As the oral toxicity of this active ingredient is low, dietary risks 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.

Beloukha Herbicide is currently registered for use as a non-selective herbicide to control unwanted vegetation around food and non-food agricultural field crops, as well as non-agricultural sites, such as around trees and shrubs in parks, rights-of-way, and building structures. It is also used as a desiccant in wheat, barley, oats and potatoes, and for sucker control in grapes, pome fruit and stone fruit. Beloukha Herbicide is proposed for use to control/suppress weeds, grasses, and mosses on greenhouse floors and under benches, around outdoor ornamentals, as well as in Christmas tree nurseries. The product label includes mitigation measures to prevent bystander and residential exposure, such as reducing spray drift, and restricting access to the treated area until sprays have dried.

Residential and non-occupational exposure to Beloukha Herbicide is therefore 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 Beloukha Herbicide

Occupational risks are acceptable when Beloukha Herbicide is used according to label directions, which include protective measures.

Workers handling Beloukha Herbicide can come into direct contact with pelargonic acid primarily via dermal, inhalation and ocular exposure. To protect workers from exposure to Beloukha Herbicide, the label requires workers to wear personal protective equipment (PPE), including a long-sleeved shirt and long pants, chemical-resistant gloves, shoes plus socks and protective eyewear during mixing, loading, application, clean-up and repair. The product label includes measures to restrict access to the treated area until sprays have dried.

The occupational risks are acceptable when the precautionary statements on the label are observed.

Environmental considerations

What happens when pelargonic acid is introduced into the environment?

When used according to label directions, the environmental risks associated with the major new uses of pelargonic acid and its associated end-use product, Beloukha Herbicide, on Christmas trees, forest trees, nursery trees, outdoor ornamentals, greenhouse ornamentals and greenhouse vegetables are acceptable.

The environmental impact of the use of pelargonic acid in field crops was evaluated in Proposed Registration Decision PRD2019-15, Pelargonic Acid, Beloukha Herbicide and Beloukha Agricultural Herbicide, and Registration Decision RD2020-03, Pelargonic Acid, Beloukha Herbicide and Beloukha Agricultural Herbicide. Pelargonic acid is toxic to beneficial arthropods, and non-target terrestrial plants. Risk mitigation measures for these organisms are present on the registered label of Beloukha Herbicide.

Pelargonic acid is a naturally occurring fatty acid that is produced by both plants and animals, and is rapidly degraded by microorganisms. It is an essential part of healthy animal diets and is readily metabolized. As such, it is not expected to accumulate in organisms. Pelargonic acid metabolizes to CO2 and water. When label directions are followed, the major new uses of Beloukha Herbicide are not expected to increase risks to non-target organisms. This is because, although there is an increase in the maximum yearly application rate, there is no increased environmental exposure of non-target organisms compared to previously registered uses due to the rapid degradation of pelargonic acid in the environment.

The use of pelargonic acid in greenhouses could result in adverse effects to beneficial insects used in greenhouse production. A label statement to inform users to avoid application of pelargonic acid when beneficial insects are in the treatment area is required.

After a scientific review of the available information, Health Canada’s PMRA has concluded that the environmental risks associated with the major new uses of pelargonic acid in Christmas trees, forest trees, nursery trees, outdoor ornamentals, greenhouse ornamentals and greenhouse vegetables are acceptable when Beloukha Herbicide is used according to label directions.

Value considerations

What is the value of Beloukha Herbicide?

Beloukha Herbicide is applied in greenhouses in which cucumber, tomato, pepper, lettuce, and greenhouse-grown ornamentals (bedding plants, flowering and non-flowering plants) are grown, and around outdoor woody and herbaceous ornamentals, including container-, field-, and liner-grown plants, plants in landscape plantings, landscape trees, nursery trees, and shrubs, Christmas trees, and forest and commercial trees, for non-selective weed management.

Beloukha Herbicide is a non-conventional herbicide that will serve as an alternative weed management product option for use around these crops. This product can be expected to reduce the risk of resistance development to conventional herbicides based on its non-selective contact mode of action that results in desiccation of plant tissue.

Measures to minimize risk

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

The key risk-reduction measures being proposed on the labels of Pelargonic Acid Technical and Beloukha Herbicide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

Based on the proposed use expansion to greenhouse floors and under benches, around outdoor ornamentals, as well as in Christmas tree nurseries, no additional risk-reduction measures are necessary.

The principal display panel of Pelargonic Acid Technical includes the signal words “DANGER – SKIN AND EYE IRRITANT”, “CAUTION – POISON” and “POTENTIAL SENSITIZER”. The signal words “WARNING – SKIN AND EYE IRRITANT” and “CAUTION – POISON” appear on the principal display panel for Beloukha Herbicide.

Workers handling or applying Beloukha Herbicide as a foliar application outdoors or in greenhouses must wear a long-sleeved shirt and long pants, chemical-resistant gloves, shoes plus socks and protective eyewear. Furthermore, when applied as a foliar treatment, all unprotected workers are restricted from entering treated areas during application and until sprays have dried.

Key risk-reduction measures - Environment

The following new risk mitigation measures are required:

Greenhouse uses:

• Label statement to inform users to avoid application of pelargonic acid when beneficial arthropods used in greenhouse production are in the treatment area.
• Label statement prohibiting the discharge of greenhouse releases, effluent or runoff to water.

Next steps

Before making a final registration decision on pelargonic acid and Beloukha Herbicide, Health Canada’s PMRA will consider any written comments received from the public in response to PRD2025-02 document up to 45 days from the date of publication (by the 17 April 2025) of PRD2025-02. 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’s PMRA makes their registration decision, a Registration Decision on pelargonic acid and Beloukha Herbicide (based on the Science evaluation of PRD2025-02) will be published. 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.

Footnotes