Proposed Re-evaluation Decision PRVD2018-04, Ethyl Alcohol and Its Associated End-use Products
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Pest Management Regulatory Agency
31 January 2018
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2018-4E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Ethyl Alcohol
- International Context
- Next Steps
- Additional Scientific Information
Proposed Re-evaluation Decision
Under the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.
Ethyl alcohol is registered as a disinfectant and sanitizer. It is registered for domestic use as a sanitizer of hard non-porous surfaces and fabrics. It is also registered for commercial use as a disinfectant of maple sap tapping equipment (bits and spouts). Beside the pesticide uses, ethyl alcohol is widely used in consumer and pharmaceutical products such as food additives and cosmetics.
Proposed Re-evaluation Decision PRVD2018-04, Ethyl Alcohol and Its Associated End-use Products presents the proposed regulatory decision for the re-evaluation of ethyl alcohol including the proposed updates to the label directions to further protect human health and the environment, as well as the science evaluation on which the proposed decision was based. All products containing ethyl alcohol (as a disinfectant and sanitizer) registered as a pesticide in Canada are subject to this proposed re-evaluation decision. Proposed Re-evaluation Decision PRVD2018-04, Ethyl Alcohol and Its Associated End-use Products is subject to a 90-day public consultation period, during which the public including the pesticide manufacturers and stakeholders may submit written comments and additional information to the PMRA. The final re-evaluation decision will be published taking into consideration the comments and information received.
Outcome of Science Evaluation
Ethyl alcohol has value as a sanitizer of hard non-porous surfaces (for example, empty garbage cans, bathroom surfaces), fabrics, and as a disinfectant of maple sap tapping equipment (bits and spouts).
Ethyl alcohol has a long history of use in consumer and pharmaceutical products. With respect to human health, ethyl alcohol is of low acute toxicity profile. It is mildly irritating to the eyes, minimally irritating to the skin, and is not anticipated to be a dermal sensitizer. It is poorly absorbed via skin and well absorbed by inhalation. Ethyl alcohol is not categorized as a carcinogen and it is not expected to be genotoxic.
Exposure to workers using ethyl alcohol for disinfection of maple sap tapping equipment (bits and spouts) is not expected to be of concern under the current label directions (for example, use is limited to outdoor use, and requires personal protective equipment). Exposure to individuals using ethyl alcohol for general surface and fabric sanitization is also not expected to be of concern under the current conditions of use. Based on the current use pattern of ethyl alcohol, the residential, bystanders and dietary exposures (food + water) are expected to be minimal and not of concern.
Ethyl alcohol is used in a localized manner (tapping bits and spouts disinfection, surface and fabric sanitization). When products containing ethyl alcohol is used in accordance with the current label directions, risks of concern to non-target terrestrial and aquatic organisms are not expected.
Proposed Regulatory Decision for Ethyl Alcohol
Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, Health Canada is proposing that pesticide products containing ethyl alcohol are acceptable for continued registration for use and sale in Canada, provided that the proposed updates to label directions are in place.
Registered pesticide product labels include specific instructions for use. Directions include risk mitigation measures to protect human health and the environment that must be followed by law. As a result of the re-evaluation of ethyl alcohol, no additional risk mitigation measures are proposed by the PMRA. To meet current labelling standards, minor label updates (disposal) are proposed (Appendix II of Proposed Re-evaluation Decision PRVD2018-04, Ethyl Alcohol and Its Associated End-use Products):
Ethyl alcohol is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, European Union, and Australia. As of 24 August 2017, no decision by an OECD member country to prohibit all uses of ethyl alcohol for health or environmental reasons has been identified.
The public including the registrants and stakeholders are encouraged to submit comments during the 90-day public consultation period Footnote 1 upon publication of this proposed re-evaluation decision.
All comments received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document. Footnote 2 The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with PMRA's responses.
Additional Scientific Information
No additional data are required.
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