Proposed Registration Decision PRD2019-03, Ammonium Salt of Fatty Acid, EMERION W 36 SL and AXXE Broad Spectrum Herbicide

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Pest Management Regulatory Agency
17 April 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-3E-PDF

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Summary

Table of Contents

Proposed Registration Decision for Ammonium Salt of Fatty Acid

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing registration for the sale and use of EMERION W 36 SL and AXXE Broad Spectrum Herbicide, containing the technical grade active ingredient ammonium salt of fatty acid, for control or burndown of weeds and grasses on food and feed crops and pastures.

Ammonium salt of fatty acid is currently registered for the control or burndown of weeds and grasses on ornamentals, turf, landscapes, non-crop areas on farmsteads, interiorscapes and greenhouses. For details, see the Proposed Registration Decision PRD2008-12, Ammonium Soap of Fatty Acid, PRD2017-04 Ammonium Salt of Fatty Acid and the Registration Decision RD2017-09, Ammonium Salt of Fatty Acid.

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 PRD2019-03, Ammonium Salt of Fatty Acid, EMERION W 36 SL and AXXE Broad Spectrum Herbicide provides detailed technical information on the human health, environmental and value assessments of ammonium salt of fatty acid, EMERION W 36 SL and AXXE Broad Spectrum 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 Pest Control Products 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 ammonium salt of fatty acid, EMERION W 36 SL and AXXE Broad Spectrum Herbicide, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-03. Health Canada will then publish a Registration Decision on ammonium salt of fatty acid, EMERION W 36 SL and AXXE Broad Spectrum 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 PRD2019-03.

What Is Ammonium Salt of Fatty Acid?

Ammonium salt of fatty acid is a contact herbicide for control or suppression of weeds and liverworts. It is a non-selective herbicide that penetrates plant cell walls to disrupt plant growth.

Health Considerations

Can Approved Uses of Ammonium Salt of Fatty Acid Affect Human Health?

Ammonium Salt of Fatty Acid is unlikely to affect human health when it is used according to label directions.

Potential exposure to ammonium salt of fatty acid may occur when mixing, loading, and/or applying the product, as well as during clean-up and repair activities. 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 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 where no effects are observed.

In laboratory animals, and based on publicly available information, the technical grade active ingredient, EMERION W 36 SL, containing ammonium salt of fatty acid, is of low acute toxicity, mildly to moderately irritating to the skin, moderately irritating to the eyes, and is not a dermal sensitizer.

Based on laboratory animal studies and publicly available information, the end-use product, AXXE Broad Spectrum Herbicide, is of low acute toxicity, mildly to moderately irritating to the skin, moderately irritating to the eyes, and is not a dermal sensitizer.

Registrant-supplied waiver rationales, based on publicly available information, were assessed for the potential of ammonium salt of fatty acid to cause mutagenicity, genotoxicity, carcinogenicity, prenatal developmental toxicity, and reproductive toxicity. The available information suggests that ammonium salt of fatty acid is not expected to cause these.

Residues in Water and Food

Dietary risks from food and water are acceptable.

AXXE Broad Spectrum Herbicide is not to be applied directly on the crop. In addition, ammonium salt of fatty acid is of low toxicity, has a half-life of less than one day in both soil and water, and salts of fatty acid have a history of use as food additives, thus the dietary risk from food and drinking water is not a concern.

There is reasonable certainty that no harmful effects will result from dietary exposure to residues of ammonium salt of fatty acid from the proposed use around food crops in greenhouses, in the general population and potentially sensitive subpopulations, including infants and children.

Risks in Residential and Other Non-Occupational Environments

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

Risk from residential and non-occupational exposure to individuals coming in contact with AXXE Broad Spectrum Herbicide, containing the active ingredient ammonium salt of fatty acid, during application is acceptable when AXXE Broad Spectrum Herbicide is used according to label directions.

Occupational Risks from Handling AXXE Broad Spectrum Herbicide

Occupational risks are acceptable when AXXE Broad Spectrum Herbicide is used according to the label directions, which include protective measures.

Risk from occupational exposure to individuals handling AXXE Broad Spectrum Herbicide is acceptable when the product is used according to label directions. Precautionary and hygiene statements on the product label aimed at mitigating worker exposure are considered adequate to protect individuals from a potential risk due to occupational exposure.

Post-application activities, such as scouting treated areas, may result in the exposure of workers re-entering areas treated with AXXE Broad Spectrum Herbicide. The risk due to exposure is acceptable when re-entry into a treated area is restricted until dry.

Risk from bystander exposure is acceptable when the product is used according to label directions.

Environmental Considerations

What Happens When Ammonium Salt of Fatty Acid Is Introduced Into the Environment?

AXXE Broad Spectrum Herbicide, containing ammonium salt of fatty acid, is not expected to pose risks of concern to the environment when used according to label instructions.

Ammonium salt of fatty acid may enter the environment when AXXE Broad Spectrum Herbicide is used to control weeds around ornamental plants, turf, landscapes, interiorscapes, greenhouses, food crops, feed crops and other non-crop areas on farmsteads. The active ingredient ammonium salt of fatty acid is soluble in water and can enter the atmosphere. In air, it would break down very quickly or would be removed by rain. Ammonium salt of fatty acid is not expected to move through soil. Fatty acids are natural components in soil and water in the environment, and ammonium salt of fatty acid will be broken down quickly in soil and water by microorganisms. Build-up in the environment and long-term effects on plants and animals are not expected. Ammonium salt of fatty acid is also not expected to move through soil to groundwater.

Non-target terrestrial plants may be damaged by contact with ammonium salt of fatty acid at high enough concentrations. However, the label includes requirements to prevent contact with desirable plants, including grass. When used according to label directions, ammonium salt of fatty acid is not expected to pose risks of concern to non-target terrestrial and aquatic plants.

Value Considerations

What Is the Value of AXXE Broad Spectrum Herbicide?

AXXE Broad Spectrum formulated with the active ingredient ammonium salt of fatty acid provides control or suppression of weeds and liverworts in several use sites.

Application of AXXE Broad Spectrum Herbicide at a 5% active ingredient concentration to the point of run-off or 325-765 L/ha based on weed height and density provides control or suppression of numerous weeds, such as crabgrass, pigweeds, amaranth, and carpetweed, and liverworts.

The registration of AXXE Broad Spectrum provides an alternative non-conventional herbicide option for weed and liverwort management in food and field crops and pastures.

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 AXXE Broad Spectrum Herbicide to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The personal protective equipment for all mixing, loading, and/or application, as well as clean-up and repair activities required on the end-use product label includes a long-sleeved shirt, long pants, shoes, socks, chemical-resistant gloves, and goggles or a face shield. Personnel should also avoid inhaling spray mists. Care must be taken to avoid bystander exposure from drift during application and entry into treated areas is not permitted until dry.

Environment
A precautionary label statement indicating the phytoxicity to non-target terrestrial plants is required. A precautionary label statement to reduce the potential for runoff of ammonium salt of fatty acid to adjacent aquatic habitats, for sites with characteristics that may be conducive to runoff and when heavy rain is forecasted, is required. In addition, label instructions will include requirements to prevent contact with desirable plants, including grass.

Next Steps

Before making a final registration decision on ammonium salt of fatty acid, EMERION W 36 SL and AXXE Broad Spectrum Herbicide, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-03. Health Canada will accept written comments on PRD2019-03 up to 45 days from the date of its publication. 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 ammonium salt of fatty acid, EMERION W 36 SL and AXXE Broad Spectrum Herbicide (based on the Science Evaluation of PRD2019-03). 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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