Proposed Registration Decision PRD2019-15, Pelargonic Acid, Beloukha Herbicide and Beloukha Agricultural Herbicide

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Pest Management Regulatory Agency
4 December 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-15E-PDF (PDF version)

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To obtain a full copy of Proposed Registration Decision PRD2019-15, Pelargonic Acid Beloukha Herbicide and Beloukha Agricultural Herbicide please contact our publications office.

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Summary

Table of Contents

Proposed Registration Decision for Pelargonic Acid

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 Pelargonic Acid Technical, Beloukha Herbicide and Beloukha Agricultural Herbicide, containing the technical grade active ingredient pelargonic acid, 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 unwanted weeds and mosses in non-crop areas.

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 PRD2019-15, Pelargonic, Acid Beloukha Herbicide and Beloukha Agricultural Herbicide provides detailed technical information on the human health, environmental and value assessments of pelargonic acid, Beloukha Herbicide and Beloukha Agricultural 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 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 pelargonic acid, Beloukha Herbicide and Beloukha Agricultural Herbicide, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-15. Health Canada will then publish a Registration Decision on pelargonic acid, Beloukha Herbicide and Beloukha Agricultural 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 of PRD2019-15.

What Is Pelargonic Acid?

Pelargonic acid is a non-selective contact herbicide that inhibits plant growth by disrupting cell membranes resulting in leakage of cell contents, which leads to plant death. Pelargonic acid does not translocate in the plant nor does it have any residual activity in the soil.

Health Considerations

Can Approved Uses of Pelargonic Acid Affect Human Health?

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

Potential exposure to pelargonic acid 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 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 animal studies, the technical grade active ingredient, pelargonic acid was of low toxicity via the 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 animals, the end-use products, Beloukha Herbicide and Beloukha Agricultural Herbicide, were of low toxicity via the oral and dermal routes. They were mildly irritating to the skin, moderately irritating to the eyes, and were not considered dermal sensitizers. Both products are considered to be slightly acutely toxic by the inhalation route.

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 animal. 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 Water and Food

Dietary risks from food and water are acceptable.

Applications of Beloukha Herbicide and Beloukha Agricultural Herbicide are directed to weeds in and around food and non-food crops or directly to cereal crops before harvest. Therefore, residues of pelargonic acid on food crops are possible at the time of harvest; however, toxicity to this active ingredient is low. In addition, the likelihood of residues of pelargonic acid in drinking water will be low. Consequently, health risks are acceptable for all segments of the population, including infants, children, adults and seniors.

Risk in Residential and Other Non-Occupational Environments

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

Beloukha Herbicide and Beloukha Agricultural Herbicide are proposed for use on agricultural fields and non-crop land areas. 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 Beloukha Herbicide and Beloukha Agricultural Herbicide is therefore expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Occupational Risks From Handling Beloukha Herbicide and Beloukha Agricultural Herbicide

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

Workers handling Beloukha Herbicide and Beloukha Agricultural Herbicide can come into direct contact with pelargonic acid primarily on the skin and eyes. To protect workers from exposure to Beloukha Herbicide and Beloukha Agricultural Herbicide, the label states that mixers, loaders, and applicators must wear chemical-resistant gloves, goggles or face shield, long-sleeved shirt, long pants, socks and shoes. Individuals must remain out of the treated area until the sprays have dried. If re-entry is necessary before the sprays have dried, workers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks, shoes, and protective eyewear (goggles or face shield).

Environmental Considerations

What Happens When Pelargonic Acid Is Introduced Into the Environment?

After a scientific review of the available information, PMRA has concluded that environmental risks associated with the proposed uses of pelargonic acid and associated end-use products are acceptable when used according to the proposed label directions.

Pelargonic acid can enter the environment when Beloukha Herbicide or Beloukha Agricultural Herbicide are used to control weeds in fruit, vegetable, and non-crop land, for cereal and potato desiccation, and for grape and fruit tree sucker control. Fatty acids, including pelargonic acid, are natural components in the environment and are produced by both plants and animals. Pelargonic acid is not persistent and is quickly broken down by microorganisms in the environment. Pelargonic acid is not expected to move through soil to groundwater. Fatty acids, including pelargonic acid, are a significant part of the normal diet of birds, mammals and invertebrates, and are readily metabolized by animals. As such, pelargonic acid is not expected to accumulate in organisms.

Non-target species may be exposed to pelargonic acid through direct contact with spray or spray drift, contact with sprayed surfaces or from ingestion of contaminated food. The use of pelargonic acid as an herbicide may affect beneficial arthropods, and non-target terrestrial plants. Label statements to inform users of the toxicity to non-target organisms and buffer zones to reduce exposure to terrestrial habitats will be required to mitigate these risks. When pelargonic acid 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 Beloukha Herbicide and Beloukha Agricultural Herbicide?

Beloukha Herbicide and Beloukha Agricultural Herbicide are non-conventional and non-selective contact herbicides for control of weeds, mosses, suckers and crop desiccation.

Both Beloukha Herbicide and Beloukha Agricultural Herbicide are formulated with pelargonic acid. They 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.

Management of undesired plant growth is critical in crop production as well as in non-cropland. Beloukha Herbicide and Beloukha Agricultural Herbicide provide additional options for weed, moss and sucker control, as harvest aids, and for herbicide resistance management in many crops and in non-cropland areas.

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 Beloukha Herbicide and Beloukha Agricultural Herbicide to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The signal words “DANGER-SKIN AND EYE IRRITANT”, “CAUTION-POISON” and “POTENTIAL SKIN SENSITIZER” are required on the principal display panel of the label for Pelargonic Acid Technical. Additionally, the signal words “WARNING – SKIN AND EYE IRRITANT” and “CAUTION POISON” are required on the principal display panels for Beloukha Herbicide and Beloukha Agricultural Herbicide. Standard hazard and precautionary statements are also required on the Technical grade active ingredient and end-use product labels to inform workers of the hazard irritation potential of the active ingredient to the skin and eyes and the respiratory tract. Workers handling Beloukha Herbicide and Beloukha Agricultural Herbicide will be required to wear standard personal protective equipment including chemical-resistant gloves, goggles or face shield, long-sleeved shirt, long pants, shoes and socks.

Individuals are restricted from re-entering treated areas until the sprays have dried. If re-entry is necessary before the sprays have dried, workers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks, shoes, and protective eyewear (goggles or face shield).

Environment

Next Steps

Before making a final registration decision on pelargonic acid and Beloukha Herbicide and Beloukha Agricultural Herbicide, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-15. Health Canada will accept written comments on PRD2019-15 up to 45 days from the date of its publication. 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 pelargonic acid, Beloukha Herbicide and Beloukha Agricultural Herbicide (based on the Science Evaluation of PRD2019-15). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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