Proposed Registration Decision PRD2022-16, Ozone Generating Device lotus PRO

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Pest Management Regulatory Agency
2 December 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-16E-PDF (PDF version)

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 PRD2022-16, Ozone Generating Device lotus PRO please contact our publications office.

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

Table of contents

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

Proposed registration decision for lotus PRO

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 the ozone generating device lotus PRO, which infuses filtered water with up to 1.7 ppm ozone to create stabilized aqueous ozone for use as a sanitizer and disinfectant on a hard, non-porous surfaces in commercial and industrial areas.

Currently, ozone generators are registered as a molluscide to control zebra mussels in cooling water in power generating stations, see Proposed Registration Decision PRD2008-14, Hankin Ozone Generator, and Registration Decision RD2008-12, Hankin Ozone Generator.

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 PRD2022-16, Ozone Generating Device lotus PRO provides detailed technical information on the human health, environmental and value assessments of lotus PRO.

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 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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program.

Before making a final registration decision on the ozone generating device lotus PRO, 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 Decision^{Footnote 4} on lotus PRO, 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 PRD2022-16.

What is ozone?

Ozone is a gas made of three oxygen atoms (O3). Ozone can kill bacteria and fungi by causing physical damage to their cell walls, proteins, and DNA. Ozone can be infused into water to create an effective liquid antimicrobial solution.

Health considerations

Can approved uses of ozone and lotus PRO affect human health?

Lotus PRO is unlikely to affect human health when it is used according to label directions.

Potential exposure to ozone from stabilized aqueous ozone generated by lotus PRO may occur when dispensing the stabilized aqueous ozone to fill cleaning equipment, such as spray bottles, spray mops or mop buckets, or during application, and postapplication cleaning activities. When assessing health risks, two key factors are considered:

• the levels at which 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 (in other words, 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.

The lotus PRO device generates stabilized aqueous ozone (SAO), which is ozone trapped in filtered water at low levels (maximum of 1.7 ppm). Local off-gassing of SAO results in low levels of airborne ozone.

Publicly available toxicology information was used to assess risks from exposure to ozone and ozonated water. Considering this information and the safe use of ozonated water for various applications, including dermatological use and use as a hand sanitizer (at levels up to 4 ppm) with no reported adverse effects, stabilized aqueous ozone is considered to be non-irritating and not sensitizing to skin. Due to the low levels of ozone in the stabilized aqueous ozone, it is not likely to be toxic by the oral, dermal, and inhalation routes, nor irritating to the eyes or respiratory tract. No short-term toxicity of stabilized aqueous ozone is anticipated from the proposed use.

Residues in water and food

Dietary risks from food and water are acceptable.

There is no direct food use proposed for the lotus PRO device under the Pest Control Products Act as stabilized aqueous ozone (SAO) is proposed for use as a surface sanitizer.

Dietary exposure to ozone residues are expected to be negligible due to the low concentration of ozone in the stabilized aqueous ozone, the high reactivity and relatively short half-life of ozone in water, the short (5–15 minute) contact sanitization time, the requirement for lotus PRO and stabilized aqueous ozone to be used in well-ventilated areas, and the fact that all treated surfaces are hard and non-porous in nature and must be thoroughly dried prior to contact with food.

Stabilized aqueous ozone is not for drinking. When the device is used as directed by the label, the likelihood of ozone contaminating surface or groundwater is low and therefore not a health concern. Consequently, health risks from dietary exposure are acceptable.

The use of lotus Pro in commercial food preparation facilities is exempted from the Pest Control Products Act under paragraph 3(1)(c) of the Pest Control Product Regulations. However it is supported by a letter of acceptance from the Canadian Food Inspection Agency, a letter of no objection from Health Canada's Bureau of Chemical Safety, and provincial letters of acceptance. Therefore, the use will be permitted to appear on the pest control product label.

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 this device; therefore, residential bystanders are not expected to come into contact with the stabilized aqueous ozone or airborne ozone. Therefore, risk due to residential and bystander exposure is acceptable.

Occupational risks from handling lotus PRO

Occupational risks are acceptable when lotus PRO is used according to the directions on the label and operator's manual, which include protective measures.

Workers using lotus PRO can come into direct contact with stabilized aqueous ozone on the skin while filling cleaning equipment, or during the sanitization process, and postapplication clean-up to remove SAO from treated surfaces. Workers can be exposed through direct skin contact with stabilized aqueous ozone or by inhalation of airborne ozone during handling and spraying of stabilized aqueous ozone and from spray drift. Minimal eye exposure to splashes or spray drift is also possible.

Provincial occupational exposure limits for airborne ozone include an average limit of 0.1 ppm and a short-term exposure limit of 0.3 ppm.

The design of the device with engineering and other design controls limit exposure of ozone to levels below regulated occupational exposure limits. Therefore, occupational risks are acceptable when the directions for use and precautionary statements on the label and operating manual are observed.

Health risks to occupational bystanders

Occupational bystander risks are not of health concern when lotus PRO is used according to directions on the label and operator's manual.

Occupational bystander exposure is expected to be low as generated SAO and airborne ozone from local off-gassing of SAO are not likely to exceed natural background levels of ozone. Therefore, risk due to occupation bystander exposure is acceptable.

Environmental considerations

As the use of lotus PRO and stabilized aqueous ozone is proposed for indoor use an environmental assessment was not required.

Value considerations

What is the value of the lotus PRO?

The lotus PRO generates stabilized aqueous ozone (SAO) from filtered tap water, which can be used to kill potentially harmful bacteria and fungi on hard non-porous surfaces.

The registration of the lotus PRO device will give commercial facilities the ability to create aqueous ozone, an effective hard surface sanitizer, on demand. Aqueous ozone produced by the lotus PRO is effective in killing bacteria and fungi.

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 lotus PRO to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

Standard precautionary statements appear on the end-use product label to avoid contact with eye and breathing spray mist.

To limit occupational and bystander exposure, the end-use product label and operating manual require a drift statement and direction for use statement that lotus PRO and stabilized aqueous ozone are to be used only in well-ventilated areas.

To mitigate dietary exposure to residues of the stabilized aqueous ozone, the end-use product label and operating manual require a statement to avoid contamination of food during application and storage.

The maximum concentration of ozone in in the stabilized aqueous ozone is included on the label.

Next steps

Before making a final registration decision on the ozone generating device, lotus PRO, Health Canada's PMRA will consider any comments received from the public in response to this PRD2022-16. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-16.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 the ozone generating device, lotus PRO (based on the Science Evaluation of PRD2022-16). 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.