Proposed Registration Decision PRD2020-02, Stearic Acid and Related Fatty Acids and Rodents Away Odor Free

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Pest Management Regulatory Agency
5 February 2020
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2020-2E-PDF (PDF version)

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain a full copy of Proposed Registration Decision PRD2020-02, Stearic Acid and Related Fatty Acids and Rodents Away Odor Free please contact our publications office.

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

Summary

Table of contents

Proposed registration decision for stearic acid and related fatty acids

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 Stearic Acid and Related Fatty Acids Technical and Rodents Away Odor Free, containing the technical grade active ingredient stearic acid and related fatty acids, for use as a mouse repellent in indoor spaces such as homes and recreational vehicles.

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 PRD2020-02, Stearic Acid and Related Fatty Acids and Rodents Away Odor Free provides detailed technical information on the human health, environmental and value assessments of stearic acid and related fatty acids and Rodents Away Odor Free.

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 stearic acid and related fatty acids and Rodents Away Odor Free, Health Canada’s PMRA will consider any comments received from the public in response to PRD2020-02. Health Canada will then publish a Registration Decision on stearic acid and related fatty acids and Rodents Away Odor Free, 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 PRD2020-02.

What are stearic acid and related fatty acids?

Stearic acid and related fatty acids is the active ingredient in the domestic class rodent repellent product, Rodents Away Odor Free, which reduces the presence and activity of house mice in indoor spaces including modes of transport. It is unknown how stearic acid and related fatty acids reduces the presence and activity of house mice.

Health considerations

Stearic acid and related fatty acids are unlikely to affect human health when it is used according to label directions.

Potential exposure to stearic acid and related fatty acids may occur 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.

Based on available information, the technical grade active ingredient, Stearic Acid and Related Fatty Acids Technical, and the end-use product, Rodents Away Odor Free, were of low acute oral, dermal, and inhalation toxicity, non-irritating to the eyes and skin, and are not dermal sensitizers.

Information from the published scientific literature was assessed for the potential of stearic acid and related fatty acids to cause short-term toxicity, developmental toxicity, and genotoxicity. Stearic acid and related fatty acids are naturally occurring fatty acids. Adverse effects in animals given repeated doses were not observed. There was no indication of prenatal developmental toxicity. There was no evidence that stearic acid and related fatty acids induced mutagenic or genotoxic effects.

Residues in water and food

Dietary risks from food and water are acceptable

Rodents Away Odor Free is not proposed for food or feed uses. In addition, the likelihood of residues of stearic acid and related fatty acids 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.

Rodents Away Odor Free is proposed for use in indoor spaces including modes of transport (for example, homes and recreational vehicles). Residential and non-occupational exposure to Rodents Away Odor Free is expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Occupational risks from handling Rodents Away Odor Free

Occupational risks are acceptable when Rodents Away Odor Free is used according to the label directions, which include protective measures.

Since Rodents Away Odor Free is a domestic product, occupational risks are not applicable.

Environmental Considerations

An environmental assessment was not required for Stearic Acid and Related Fatty Acids Technical and Rodents Away Odor Free as they have no outdoor uses.

Value Considerations

What is the value of Rodents Away Odor Free?

Rodents Away Odor Free is a new domestic class product that reduces the presence and activity of house mice.

Rodents Away Odor Free reduces the presence and activity of house mice, which may reduce damage caused by house mice presence and/or activity.

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 labels of Stearic Acid and Related Fatty Acids Technical and Rodents Away Odor Free to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

The statements, ‘KEEP OUT OF REACH OF CHILDREN’ and ‘Wash thoroughly with soap and water after handling’ are required for the PRECAUTIONS section of the secondary display panel of the end-use product.

Next steps

Before making a final registration decision on stearic acid and related fatty acids and Rodents Away Odor Free, Health Canada’s PMRA will consider any comments received from the public in response to PRD2020-02. Health Canada will accept written comments on PRD2020-02 up to 45 days from the date of this document. Please forward all comments to PMRA 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 stearic acid and related fatty acids and Rodents Away Odor Free (based on the Science Evaluation of PRD2020-02). 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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