Proposed Registration Decision PRD2018-21, Hydrogen peroxide; Peroxyacetic acid; AdvaCare D

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This consultation is now closed.

Pest Management Regulatory Agency
3 December 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-21E-PDF (PDF version)

This page is a summary of the consultation document. 

To obtain a full copy of Proposed Registration Decision PRD2018-21, Hydrogen peroxide; Peroxyacetic acid; AdvaCare D 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 Hydrogen Peroxide and Peroxyacetic Acid

Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing registration for the sale and use of Hydrogen Peroxide and PAA 11/15% and AdvaCare D, containing the technical grade active ingredients hydrogen peroxide and peroxyacetic acid (PAA), as a commercial and industrial laundry sanitizer.

The active ingredients are currently registered in Canada. Hydrogen peroxide is an algaecide, bactericide, fungicide, slimicide, sanitizer and acaricide, with uses in aquaculture, agriculture, industry and as a hard and soft surface sanitizer. For details, please see Proposed Re-evaluation Decision PRVD2017-12, Hydrogen Peroxide and Its Associated End-use Products, and Re-evaluation Decision RVD2018-09, Hydrogen Peroxide and Its Associated End-use Products. Peroxyacetic acid is a slimicide co-formulated with hydrogen peroxide for the control of algal, bacterial, fungal and yeast growth in pulp and paper mills; it also controls bacterial growth in recirculating cooling water systems and sewage, wastewater effluents in treatment plants, and on-shore oil and gas field well operations. For details, please see Proposed Re-evaluation Decision PRVD2017-13, Peroxyacetic acid and Its Associated End-use Products, and Re-evaluation Decision RVD2018-10, Peroxyacetic acid and Its Associated End-use Products.

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 product are acceptable.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2018-21, Hydrogen peroxide; Peroxyacetic acid; AdvaCare D section provides detailed technical information on the human health, environmental and value assessments of hydrogen peroxide, peroxyacetic acid, and AdvaCare D.

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 Pest Control Products 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 hydrogen peroxide, peroxyacetic acid, and AdvaCare D, Health Canada’s PMRA will consider any comments received from the public in response to PRD2018-21. Health Canada will then publish a Registration Decision on hydrogen peroxide, peroxyacetic acid, and AdvaCare D, 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 PRD2018-21.

What Are Hydrogen Peroxide and Peroxyacetic Acid?

Hydrogen peroxide and peroxyacetic acid are the two active ingredients in AdvaCare D, a new sanitizer end-use product intended for application to soiled laundry from institutions such as hospitals and long-term care facilities to kill bacteria and viruses. These active ingredients kill microorganisms by oxidizing cellular components such as lipids, proteins and nucleic acids.

Health Considerations

Can Approved Uses of Hydrogen Peroxide and Peroxyacetic Acid Affect Human Health?

Hydrogen peroxide and peroxyacetic acid are unlikely to affect your health when AdvaCare D is used according to label directions.

Potential exposure to hydrogen peroxide and peroxyacetic acid may occur when handling and using AdvaCare D, but dietary (food and water) exposure is unlikely. When assessing health risks, two key factors are considered: the levels where 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 (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 available information on hydrogen peroxide and peroxyacetic acid was assessed for their potential to cause acute and short-term toxicity, developmental effects, genotoxicity, and various other effects. Due to the rapid degradation of hydrogen peroxide and peroxyacetic acid to water and oxygen, there is no concern for carcinogenicity, developmental or other long-term effects. Due to the corrosive nature of these chemicals, the hazard posed by the product containing these active ingredients is mostly of an acute nature.

AdvaCare D is expected to be highly acutely toxic by the oral, dermal, and inhalation routes and is corrosive to eyes and skin, but is not likely to be a skin sensitizer. Consequently, signal words are required on the product label highlighting the hazards associated with corrosivity of the end-use product.

Residues in Water and Food

Dietary risks from food and water are not of concern.

There are no food or feed uses proposed for AdvaCare D; therefore, there is no dietary exposure to residues of hydrogen peroxide and peroxyacetic acid.

Exposure to hydrogen peroxide and peroxyacetic acid is not expected in drinking water from the proposed use; therefore, there is no drinking water exposure concern.

Risks in Residential and Other Non-Occupational Environments

Estimated risk for residential and other non-occupational exposure is not of concern.

There are no residential uses for AdvaCare D. Given the nature of the proposed use, there is no bystander exposure. Consequently, residential and bystander exposure are not of concern.

Occupational Risks From Handling AdvaCare D

Occupational risks are not of concern when AdvaCare D is used according to the label directions, which include protective measures.

For the assessment of occupational exposure and risks, emphasis has been placed on hydrogen peroxide and peroxyacetic acid’s potential for acute toxicity from the corrosive nature of these active ingredients.

Standard precautionary statements (for example, wearing of personal protective equipment) are present on the end-use product label to protect workers during handling of the product.

Environmental Considerations

An environmental assessment was not required for this evaluation based on the use pattern.

Value Considerations

What Is the Value of AdvaCare D?

AdvaCare D is used to kill bacteria and viruses in soiled laundry.

Laundry sanitizers are important for commercial operations that clean laundry from hotels or institutions such as hospitals and long-term care facilities. Heavy-duty laundering is required for items such as towels and bed sheets that are used by multiple people over a short time. The laundry sanitizer is used to ensure bacteria and viruses are killed to prevent pathogens from cross-contamination. Laundering with detergent alone can reduce the bacteria present on fabric, but does not achieve the level of control provided by a sanitizer. There are several laundry sanitizers currently registered, but all of these are based on one active ingredient, sodium hypochlorite. AdvaCare D will add alternative active ingredients for this use.

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 Hydrogen Peroxide and PAA 11/15%, and AdvaCare D to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The hazard signal words “DANGER–POISON and CORROSIVE TO EYES AND SKIN” are required on the principal display panels of the labels of Hydrogen Peroxide and PAA 11/15% and the end-use product AdvaCare D.

The requirements of personal protective equipment on the end-use product AdvaCare D label include protective eyewear (goggles, face shield, or safety glasses), protective clothing, and rubber gloves when handling.

Next Steps

Before making a final registration decision on hydrogen peroxide, peroxyacetic acid, and AdvaCare D, Health Canada’s PMRA will consider any comments received from the public in response to PRD2018-21. Health Canada will accept written comments on PRD2018-21 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 the Health Canada makes its registration decision, it will publish a Registration Decision on hydrogen peroxide, peroxyacetic acid, and AdvaCare D (based on the Science Evaluation of PRD2018-21). In addition, the relevant test data referenced in PRD2018-21 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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