Proposed Registration Decision PRD2019-06, Chlorine Generating Devices, Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400

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Pest Management Regulatory Agency
4 July 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-6E-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 PRD2019-06, Chlorine Generating Devices, Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 please contact our publications office.

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Summary

Table of Contents

Proposed Registration Decision for the chlorine generating devices Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400

Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the the Pest Control Products Act, is proposing registration for the sale and use of Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400. These devices use potassium chloride as a precursor to generate free available chlorine, which can be used to control biofilm and plant pathogens within greenhouse irrigation lines.

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 PRD2019-06, Chlorine Generating Devices, Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 provides detailed technical information on the human health and value assessments of Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400.

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 Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-06. Health Canada will then publish a Registration Decision on Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400, 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 PRD2019-06.

What Are Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400?

Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 are chlorine-generating devices used to control biofilm and plant pathogens within greenhouse irrigation lines. They generate free available chlorine in the forms of chlorine, hypochlorous acid, and hypochlorite by electrolysis of chloride, using potassium chloride as a precursor. The process is similar to the operating principle for chlorine generating devices for salt water pools and spas. There are three models of Chlorinsitu II proposed for registration, models 24, 200 and 400, that all operate on the same principle, but have different outputs of free available chlorine and can treat different volumes of irrigation water.

Health Considerations

Can Approved Uses of Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 Affect Human Health?

Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 are unlikely to affect human health when they are used according to label directions.

Potential exposure to free available chlorine and electrolytic by-products generated by Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 may occur through the diet (food and water) or when working in a greenhouse where the free available chlorine is produced and stored. 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. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide-containing products are used according to label directions.

The end-use products are devices that generate free available chlorine as disinfectants in greenhouse irrigation lines. The free available chlorine circulates in the irrigation systems at levels between 1-4 mg/L. Health Canada recommends that drinking water distribution systems maintain an operational range of free chlorine residual between a detectable level and 5 mg/L.

Residues in Water and Food

Dietary risks from food and water are acceptable.

Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 generate free available chlorine that circulates at low concentrations (1–4 mg/L) in greenhouse irrigation water. Health Canada (2009) suggests that drinking water distribution systems in Canada maintain an operational range of free chlorine residual between a detectable level and 5 mg/L and indicates that chlorine and hypochlorite salts are not expected to accumulate or bioconcentrate in the food chain due to their water solubility and high reactivity. It is anticipated that health risks of concern from the consumption of food commodities that have been watered with irrigation water treated with free available chlorine 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 these devices. Residential bystanders are not expected to come into contact with circulating free available chlorine. Therefore, risk due to residential and bystander exposure is acceptable.

Occupational Risks From Handling Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400

Occupational risks are acceptable when Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 are used according to the label directions, which include protective measures.

During loading, individuals can come into direct contact with potassium chloride but worker exposure is not expected to result in health risks of concern. Due to the closed and automated nature of the devices, no applicator exposure is expected. Maintaining the device in a state of good repair and using high quality (≥99% purity) potassium chloride should prevent build-up of ions on the electrolytic electrodes of the device. In turn, this should eliminate the need for any cleaning of the device with strong acids that could damage the electrodes and result in the release of metals into the electro-chemically activated water. Occupational bystander exposure to free available chlorine and additional by-products generated by the device(s) are also not expected to occur due to the nature of the application. Precautionary and engineering statements on the label and operation manual are considered adequate to protect individuals from occupational exposure.

In the event of a faulty system where high concentrations of free available chlorine are released, the Precautions section of the secondary display panel will state that workers must wear coveralls over a long-sleeved shirt, long pants, socks and chemical-resistant footwear, chemical-resistant gloves, goggles, 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. This precautionary statement is also included in the operation manual.

Exposure from postapplication activities is expected to be low, and not of concern.

Environmental Considerations

An environmental assessment was not required for Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 as they have no outdoor uses, nor will treated greenhouse irrigation waters come into contact with surface or groundwater.

Value Considerations

What Is the Value of Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400?

These devices, by generating chlorine, offer a valuable option for the treatment of greenhouse irrigation water.

Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 generate chlorine, which is effective at controlling bacteria that can form biofilms within irrigation lines and reduce the flow of water to greenhouse plants. Water is a valuable resource and many greenhouses re-use the water from their drip and floor or table flood irrigation systems. This practice can increase the risk of transferring plant pathogens to the crops. Chlorine, added at levels similar to those in swimming pools, is an effective means of controlling plant pathogens and significantly reducing their numbers within the irrigation water delivered to the greenhouse crops. Furthermore, as a precursor to chlorine generation, potassium chloride is used, which is an important fertilizer component.

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 and in the operation manuals of Chlorinsitu II 24, Chlorinsitu II 200, and Chlorinsitu II 400 to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Electrolytic chlorine generators require precautionary labelling due to the fact that they generate hydrogen which is highly flammable and explosive. The signal words “WARNING – Operating Chlorinsitu II (24, 200 or 400) without water flow through the cell can cause a build-up of flammable gases which can result in FIRE OR EXPLOSION” are required on the principal display panels of the labels for Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400.

A Precautions section is to be added to the secondary display panel with the statement “In the event of a faulty system where high concentrations of free available chlorine are released, workers must wear coveralls over a long-sleeved shirt, long pants, socks and chemical-resistant footwear, chemical-resistant gloves, goggles, 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 Directions of Use section of the secondary display panel will include the statement “Hydrogen produced during the electrolysis process must be discharged to the outside atmosphere via a closed system.”

Labels on replacement hypo cells for Chlorinsitu II devices will require the following text on the principal display panels “Read the Label and Operation Manual of the chlorine generating device Chlorinsitu II (24, 200 or 400) before using.”

Next Steps

Before making a final registration decision on Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-06. Health Canada will accept written comments on PRD2019-06 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 Health Canada makes its registration decision, it will publish a Registration Decision on Chlorinsitu II 24, Chlorinsitu II 200 and Chlorinsitu II 400 (based on the Science Evaluation of PRD2019-05). 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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