Proposed Registration Decision PRD2024-02, Spearmint Oil and Biox-M

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Summary

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 PRD2024-02, Spearmint Oil and Biox-M please contact our publications office.

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

Table of contents

Proposed registration decision for Spearmint Oil and Biox-M

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 Spearmint Oil and Biox-M, containing the technical grade active ingredient spearmint oil, to control sprouting in potatoes in indoor air cooled and mechanically cooled storage.

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 PRD2024-02, Spearmint Oil and Biox-M provides detailed technical information on the human health, environmental and value assessments of spearmint oil and Biox-M.

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 acceptableFootnote 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 valueFootnote 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, 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 the Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides section of Canada.ca.

Before making a final registration decision on spearmint oil and Biox-M, Health Canada's PMRA will consider any comments received from the public in response to this consultation document.Footnote 3 Health Canada will then publish a Registration DecisionFootnote 4 on spearmint oil and Biox-M, 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 PRD2024-02.

What is spearmint oil?

Spearmint oil is an essential oil derived from the spearmint plant that can act as a plant growth regulator and can be used to manage sprouting in potatoes in storage. Spearmint oil damages the growing points of the sprouts allowing them to remain in storage for longer periods.

Health considerations

Can approved uses of spearmint oil affect human health?

Spearmint oil is unlikely to affect human health when it is used according to label directions.

Potential exposure to spearmint oil 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 animals, spearmint oil is of low acute toxicity by the oral, dermal, and inhalation routes, minimally irritating to the eyes, non-irritating to the skin, and a dermal sensitizer.

Short-term oral toxicity testing, prenatal developmental toxicity testing, and genotoxicity/mutagenicity testing on spearmint oil were also assessed. Animals given repeated high doses of spearmint oil by gavage exhibited changes in blood, clinical chemistry and organ weight parameters. In pregnant animals, exposure to spearmint oil resulted in decreases in maternal body weight, fetal and placental weights, as well as an increase in skeletal variations in the fetus. There was no indication that the young were more sensitive than the adult animals. Spearmint oil is not considered to be mutagenic or genotoxic.

The end-use product, Biox-M, has the same toxicological profile as Spearmint Oil.

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.

Dietary exposure to spearmint oil may occur through consumption of treated potatoes; however spearmint oil present in Biox-M is not expected to pose a health risk when the end-use product is applied as directed by the label. Similarly, based on the indoor use, the likelihood of spearmint oil 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.

There are no residential uses for Biox-M, as the product will be applied to potatoes stored in commercial storage facilities. Therefore, risk due to residential and bystander exposure is acceptable.

Occupational risks from handling Biox-M

Occupational risks are acceptable when Biox-M is used according to the label directions, which include protective measures.

Due to the closed loading system and automated nature of the applications, occupational exposure during loading and application is not expected. Occupational bystander exposure to spearmint oil is also not expected to occur due to the nature of the application. However, as Biox-M is a commercial-class product, workers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during loading, application, clean-up and repair.

Workers entering the treatment area before the ventilation period is complete could come in direct contact with spearmint oil through inhalation and contact with the skin and eyes. If early entry is necessary, in emergencies only, workers must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and a respirator with a NIOSH-approved organic vapour-removing cartridge with a prefilter approved for pesticides or a NIOSH-approved-canister approved for pesticides.

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

Environmental considerations

An environmental assessment was not required for indoor air cooled and mechanically cooled storage.

Value considerations

What is the value of Biox-M?

The registration of Biox-M will provide growers with a new option for the management of sprouting in stored potatoes and a potential product for use in organic potato production.

Sprouting in potatoes can lead to substantial losses in quality and marketability. Biox-M is applied using thermal fogging techniques to potatoes in storage, which is consistent with current industry practices. Biox-M is effective at controlling sprouting in potatoes when applied as directed.

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 Spearmint Oil and Biox-M to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

The signal words "POTENTIAL SENSITIZER" are required on the principal display panels of the labels for both Spearmint Oil and Biox-M.

Standard hazard and precautionary statements are also required on the end-use product labels.

Workers will be required to wear standard personal protective equipment including a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes.

A restricted-entry interval (REI) is included on the label for Biox-M which specifies that workers are not allowed to enter into the treated area until complete ventilation of the storage facility has occurred with aerosol particles visibly settled.

If early-entry into the treated areas is required for emergencies during application, or prior to ventilation or settling of aerosol fog, workers must wear coveralls over a long-sleeved shirt, long pants, chemical- resistant gloves, socks and shoes, and a respirator with a NIOSH-approved organic vapour-removing cartridge with a prefilter approved for pesticides or a NIOSH-approved-canister approved for pesticides.

Next steps

Before making a final registration decision on spearmint oil and Biox-M, Health Canada's PMRA will consider any written comments received from the public in response to PRD2024-02 up to 45 days from the date of publication (1 March 2024) of PRD2024-02. 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 Spearmint Oil and Biox-M (based on the Science evaluation of PRD2024-02). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.

Footnotes

Footnote 1

"Acceptable risks" as defined by subsection 2(2) of the Pest Control Products Act.

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Footnote 2

"Value" as defined by subsection 2(1) of the Pest Control Products Act: "the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product's (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact."

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Footnote 3

"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.

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Footnote 4

"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.

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