Proposed Registration Decision PRD2024-11, Copper (Metallic), Intelligent Sink Trap

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Pest Management Regulatory Agency
19 December 2024
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2024-11E-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 PRD2024-11, Copper (Metallic), Intelligent Sink Trap please contact our publications office.

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

Table of contents

Proposed registration decision for copper (metallic)

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 Intelligent Sink Trap, containing the technical grade active ingredient copper (metallic), to control the growth and disinfection of viruses inside a sink trap.

Copper (metallic) was first registered in 2004 and is registered as a broad-spectrum fungicide, algaecide, aquatic herbicide, molluscicide, and antimicrobial for use on indoor surfaces and materials. For details, see Proposed Re-evaluation Decision PRVD2009-04, Copper Pesticides, and Re-evaluation Decision RVD2010-05, Copper Pesticides.

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 PRD2024-11, Copper (Metallic), Intelligent Sink Trap provides detailed technical information on the human health, environmental and value assessments of copper (metallic) and Intelligent Sink Trap.

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, the 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 and Pest Management portion of Canada.ca.

Before making a final registration decision on copper (metallic) and Intelligent Sink Trap, Health Canada’s PMRA will consider any written comments received from the public in response PRD2024-11.Footnote 3 Health Canada will then publish a Registration DecisionFootnote 4 on copper (metallic) and Intelligent Sink Trap, 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 PRD2024-11.

What is copper (metallic)?

Copper is a naturally occurring, ubiquitous element in the environment. Copper is found in water and air and occurs naturally in various foods including organ meats, seafood, beans, nuts, and whole grains. In most foods, copper is bound to macromolecules rather than remaining as a free ion. For many animals, copper is essential for the homeostasis of life. The role of copper in maintaining normal health both in humans and animals has been recognized for many years.

Copper-containing pesticides are formulated using various forms of copper, which ultimately dissociates into the cupric ion, the active component. There are a number of pesticidal active ingredients containing copper registered in Canada. These include pesticides that are used in agriculture, such as cuprous oxide, copper sulfate pentahydrate, copper oxychloride, copper hydroxide and copper sulphate. There are also pesticides that have only antimicrobial uses, such as copper naphthenate, copper 8-quinolinolate, copper (metallic) and cupric oxide. In PRVD2009-04 Proposed Re-evaluation Decision, Copper Pesticides, copper (metallic) is referred to as “metallic copper” or as “metallic copper powder”.

Copper is a metal that has well-known antimicrobial properties, although modes of action in viruses are debated. One commonly considered method is that copper generates reactive oxygen species (ROS), which increases oxidative stress. It is also thought that copper ions can bind to and interact with DNA. Both of these modes of action disrupt the viral genome.

Health considerations

Can approved uses of copper (metallic) affect human health?

Copper (metallic) is unlikely to affect human health when used according to label directions.

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. 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.

The end-use product, Intelligent Sink Trap, is a copper (metallic) ion generating device. Potential exposure to copper (metallic) may occur when handling the device. In laboratory animals, copper (metallic) was of slight acute toxicity via the oral route, low acute toxicity via the dermal route, moderate acute toxicity via the inhalation route, moderately irritating to the eye, mildly irritating to the skin and not a dermal sensitizer.

Copper is a naturally occurring metal that is present in many foods and in drinking water. Copper is also an essential element in maintaining normal health in humans, with adverse effects more likely to result from copper deficiency rather than excess.

There was no evidence of copper being carcinogenic or resulting in any other systemic toxicity in animals having normal copper homoeostasis. Available studies in animals generally indicate that the main concern for reproductive and developmental effects is associated with copper deficiency rather than excess.

Residues in drinking water and food

Dietary risks from food and drinking water are acceptable.

The Intelligent Sink Trap, is not proposed for food or feed uses. Dietary exposure, including drinking water, is not expected from the proposed use of copper (metallic) to reduce viruses in standing water. 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.

Professionals install the device under a sink, replacing the existing sink trap in hospitals, retirement homes, hotels, sport facilities, public washrooms, and restaurants. Based on the proposed use pattern, residents and the general public are not expected to have contact with metallic copper or copper ions generated by the device. Consequently, the health risk to residents and the general public is acceptable.

Occupational risks from handling Intelligent Sink Trap

Occupational risks are acceptable when Intelligent Sink Trap is used according to the label directions, which include protective measures.

After professionals install Intelligent Sink Trap under the sink, the device is controlled remotely. Workers do not come in contact with the device during normal operation. Precautionary statements on the label are considered adequate to protect individuals from occupational exposure.

The health risks to workers are acceptable when the precautionary statements on the label are observed.

Environmental considerations

What happens when copper ions generated from copper (metallic), in Intelligent Sink Trap are introduced into the environment?

Copper ions generated from metallic copper in the device, Intelligent Sink Trap, are used to disinfect standing water that collects in commercial sink traps. Disinfected sink trap water is expected to be released to aquatic environments via waste water. Metallic copper is a natural and ubiquitous element in the environment. The use of Intelligent Sink Trap is not expected to significantly contribute to the concentrations of copper in the environment relative to industrial sources (such as metal mining, pulp and paper mills, waste water from electric power generation) or piping and plumbing fixtures, and naturally occurring sources. Therefore, the environmental risks associated with the proposed use of Intelligent Sink Trap are acceptable.

Value considerations

What is the value of intelligent sink trap?

Intelligent Sink Trap is a copper ion-generating device capable of reducing viruses within the waste water that collects in sink traps.

The standing water which collects in sink traps can be contaminated with viruses. Aerosolized sink trap water may cause contamination of the surfaces surrounding the sink. The registration of Intelligent Sink Trap will offer a novel method of treating viruses in sink traps. When water stops running into the trap, a specific amount of copper ions are generated inside the standing waste water within the trap in order to reduce viruses.

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 Intelligent Sink Trap to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

To limit exposure, a label statement is required informing users not to separate the device from plumbing during normal operations.

Key risk-reduction measures - Environment

None.

Next steps

Before making a final registration decision on copper (metallic) and Intelligent Sink Trap, Health Canada’s PMRA will consider any written comments received from the public in response to PRD2024-11 up to 45 days from the date of publication (19 December 2024) of PRD2024-11. 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 copper (metallic) and Intelligent Sink Trap (based on the Science evaluation of PRD2024-11). 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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