Proposed Registration Decision PRD2018-02, Hydrogen Peroxide and Peroxyacetic Acid and OxiDate 2.0
Notice to the reader:
This consultation is now closed.
Pest Management Regulatory Agency
20 February 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-2E-PDF
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 PRD2018-02, Hydrogen Peroxide and Peroxyacetic Acid and OxiDate 2.0 please contact our publications office.
Should you require further information please contact the Pest Management Information Service.
Table of Contents
- Proposed Registration Decision for Hydrogen Peroxide and Peroxyacetic Acid
- What Does Health Canada Consider When Making a Registration Decision?
- What Is Hydrogen Peroxide and Peroxyacetic Acid?
- Health Considerations
- Environmental Considerations
- Value Considerations
- Measures to Minimize Risk
- Next Steps
- Other Information
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 full registration for the sale and use of OxiDate 2.0 Technical and OxiDate 2.0, containing the technical grade active ingredients hydrogen peroxide and peroxyacetic acid, for the suppression or partial suppression of fungal and bacterial diseases on labeled crops grown in greenhouse, field and hydroponic systems, as well as a sanitizer for greenhouse surfaces and equipment.
An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.
This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2018-02, Hydrogen Peroxide and Peroxyacetic Acid and OxiDate 2.0 provides detailed technical information on the human health, environmental and value assessments of OxiDate 2.0 Technical and the end-use product OxiDate 2.0.
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:
- Protecting Your Health and the Environment
- Pesticide Registration Process
- Pesticide Risk Reduction Program
Before making a final registration decision on hydrogen peroxide and peroxyacetic acid, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2018-02, Hydrogen Peroxide and Peroxyacetic Acid and OxiDate 2.0. The PMRA will then publish a Registration Decision on hydrogen peroxide and peroxyacetic acid, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA’s response to these comments.
For more details on the information presented in this Summary, please refer to the Science Evaluation of PRD2018-02.
What Is Hydrogen Peroxide and Peroxyacetic Acid?
Hydrogen peroxide and peroxyacetic acid are the two active ingredients in OxiDate 2.0, a new fungicidal and bactericidal end-use product intended for foliar applications for the suppression or partial suppression of fungal and bacterial disease on various field and greenhouse-grown crops and for cleaning greenhouse surfaces and equipment. These active ingredients are known general biocides with a broad spectrum of activity against fungal and bacterial pathogens.
Can Approved Uses of Hydrogen Peroxide and Peroxyacetic Acid Affect Human Health?
Hydrogen peroxide and peroxyacetic acid are unlikely to affect human health when OxiDate 2.0, containing hydrogen peroxide and peroxyacetic acid, is used according to label directions.
Potential exposure to hydrogen peroxide and peroxyacetic acid may occur when handling and applying the product, 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.
OxiDate 2.0 is expected to be slightly acutely toxic by the oral and dermal routes and moderately acutely toxic by the inhalation route. It is also expected to be corrosive to the eyes and severely irritating to the skin but is not expected to be a skin sensitizer. Consequently, signal words are required to be on the product label highlighting the skin irritation and eye corrosivity hazards.
Residues in Water and Food
Dietary risks from food and water are not of concern
Due to the rapid degradation of hydrogen peroxide and peroxyacetic acid and the low application rate, the residues from treated crops are not expected to be of concern to human health.
It is expected that the uses of hydrogen peroxide and peroxyacetic acid in Canada on food crops for the proposed uses will not pose a risk to any segment of the population, including infants, children, adults and seniors, from consumption of produce from treated crops.
Exposure to hydrogen peroxide and peroxyacetic acid is not expected in drinking water from the proposed uses and therefore, risk due to exposure from drinking water is not anticipated.
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 OxiDate 2.0. The label has necessary mitigation measures to prevent bystander exposure, such as to prevent spray drift from application. To avoid bystander exposure in fields or greenhouses, the end-use product label must state that unprotected persons should be kept out of the area for the duration of the treatment period. Entry or re-entry to the greenhouse is allowed only after thorough ventilation and mists or fog have dissipated and the treated surface has dried. Entry or re-entry to the field is allowed only after the treated surface has dried. Consequently, residential and bystander exposure is not of concern.
Occupational Risks from Handling OxiDate 2.0
Occupational risks are not of concern when OxiDate 2.0 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 (PPE)) and a restricted-entry interval (REI) are on the end-use product label to protect workers before, during and after product application.
What Happens When Hydrogen Peroxide and Peroxyacetic Acid Are Introduced Into the Environment?
Hydrogen peroxide and peroxyacetic acid are not expected to pose risks of concern to the environment when used according to label instructions.
Hydrogen peroxide and peroxyacetic acid, the active ingredients in OxiDate 2.0, will enter the environment when used as a foliar-treatment fungicide and antimicrobial on agricultural field crops and in greenhouses. Hydrogen peroxide and peroxyacetic acid mix readily in water and are expected to break down rapidly to water, acetic acid and oxygen. Hydrogen peroxide and peroxyacetic acid do not remain in soil for a long time because they are broken down by soil bacteria. The movement of hydrogen peroxide and peroxyacetic acid in the environment is expected to be minimal due to their very short half-lives in natural soils. Hydrogen peroxide and peroxyacetic acid are not expected to be found in air and are not expected to move through the soil into groundwater. Hydrogen peroxide and peroxyacetic acid will not accumulate in animals.
Hydrogen peroxide and peroxyacetic acid are not expected to pose risks of concern to earthworms, birds or small wild mammals. Under controlled laboratory conditions, hydrogen peroxide and peroxyacetic acid can be toxic to fish, aquatic invertebrates, amphibians and algae. Hydrogen peroxide and peroxyacetic acid may affect sensitive plants that are not pests if concentrations are high enough. Risk reduction measures are required to mitigate the exposure and potential risks to aquatic organisms, terrestrial plants, bees and other beneficial arthropods. When hydrogen peroxide and peroxyacetic acid are used in accordance with the label statements, and the required measures to reduce adverse effects are applied, risks of concern to the environment are not expected.
What Is the Value of OxiDate 2.0?
OxiDate 2.0 provides an alternative product that will potentially reduce the need for conventional fungicides under low disease pressure.
OxiDate 2.0 is a product applied as a foliar spray or in hydroponic systems to suppress or partially suppress fungal and bacterial diseases of various crops grown under field and greenhouse conditions. OxiDate 2.0 will help address a need expressed by growers for a greater diversity in non-conventional alternatives to manage diseases. This also represents a first registration for the management of slip-skin maceration disorder in sweet cherry. In addition, the product can be used as an effective sanitizer to clean greenhouse surfaces and equipment.
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 OxiDate 2.0 to address the potential risks identified in this assessment are as follows.
Key Risk-Reduction Measures
The OxiDate 2.0 label must include the signal words “WARNING –POISON. DANGER– CORROSIVE TO EYES, DANGER SKIN IRRITANT”.
The label requires workers to wear personal protective equipment (PPE), including goggles or a face shield, coveralls over long-sleeved shirt and long pants, boots, chemical resistant gloves and NIOSH approved respiratory protection during mixing loading and applications, clean–up and repair activities. An REI of “4 hours or until sprays are dry” is also required to minimize exposure of workers. When applied as a mist or fog in greenhouses, the greenhouses must be thoroughly ventilated afterwards before workers are allowed to enter. If early entry into areas treated with OxiDate 2.0 is necessary, the above-mentioned PPE is required.
For outdoor uses, standard drift statements are required on the OxiDate 2.0 label to minimize bystander exposure: “Apply only when the potential for drift to areas of human habitation or areas of human activity such as houses, cottages, schools and recreational areas is minimal. Take into consideration wind speed, wind direction, temperature inversions, application equipment and sprayer settings.”
The following label amendments are required:
- Label statements informing users of the toxicity to plants and aquatic organisms are required.
- Label statement informing users of possible toxicity to bees and other beneficials when exposed to direct contact with the end-use product.
- Spray buffer zones are required for the protection of terrestrial and aquatic habitats.
- Label statements, informing users that effluent from greenhouses containing hydrogen peroxide and peroxyacetic acid should not be allowed to enter the environment, are also required.
Before making a final registration decision on hydrogen peroxide and peroxyacetic acid and OxiDate 2.0, the PMRA will consider any comments received from the public in response to PRD2018-02. The PMRA will accept written comments on PRD2018-02 up to 45 days from the date of publication. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency’s response to these comments.
When the PMRA makes its registration decision, it will publish a Registration Decision on hydrogen peroxide and peroxyacetic acid and OxiDate 2.0 (based on the Science Evaluation of this PRD2018-02). In addition, the test data referenced in PRD2018-02 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).
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