Proposed Re-evaluation Decision PRVD2022-16, Dodecylguanidine Hydrochloride and Its Associated End-use Products

Pest Management Regulatory Agency
27 July 2022
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2022-16E-PDF (PDF version)

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Table of contents

Proposed re-evaluation decision for dodecylguanidine hydrochloride and associated end use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Dodecylguanidine hydrochloride is registered in Canada to control slime-forming bacteria and other microorganisms that form problematic biofilms on the surfaces of equipment in contact with process waters in pulp and paper mills, cooling towers, and air washers. Dodecylguanidine hydrochloride is a non-oxidizing alternative in biofilm control and acts as a surfactant to break up biofilm then kills isolated bacteria via membrane disruption. Dodecylguanidine hydrochloride is found in co-formulation with n-alkyl dimethyl benzyl ammonium chloride or methylene bisthiocyanate in currently registered products. Currently registered products containing dodecylguanidine hydrochloride can be found in the Pesticide Product Information Database and in Appendix I of the full version of Proposed Re-evaluation Decision PRVD2022-16, Dodecylguanidine Hydrochloride and Its Associated End-use Products. Appendix II of PRVD2022-16 lists all uses for which dodecylguanidine hydrochloride is presently registered.

This document (PRVD2022-16) presents the proposed re-evaluation decision for dodecylguanidine hydrochloride, including the proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the science evaluation on which the proposed decision is based. All products containing dodecylguanidine hydrochloride that are registered in Canada are subject to this proposed re-evaluation decision. This document is subject to a 90-day public consultation period,Footnote 1 during which the public (including the pesticide manufacturers and stakeholders) may submit written comments and additional information to PMRA Publications. The final re-evaluation decision will be published after taking into consideration the comments and information received during the consultation period.

Proposed re-evaluation decision for dodecylguanidine hydrochloride

Under the authority of the Pest Control Products Act and based on an evaluation of available scientific information, Health Canada is proposing continued registration of dodecylguanidine hydrochloride and associated end-use products registered for sale and use in Canada.

Dodecylguanidine hydrochloride has value as a slimicide for pulp and paper mills, cooling towers, and air washers. With respect to human health and the environment, risks were shown to be acceptable when dodecylguanidine hydrochloride is used according to proposed conditions of registration, which includes new mitigation measures, as identified below.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The proposed label amendments, including any revised/updated label statements and/or mitigation measures as a result of the re-evaluation of dodecylguanidine hydrochloride, are summarized below. Refer to Appendix VI of PRVD2022-16 for details.

Human health

As a result of the re-evaluation of dodecylguanidine hydrochloride, the PMRA is proposing further risk-reduction measures in addition to those already present on dodecylguanidine hydrochloride product labels. Additional revisions to the dodecylguanidine hydrochloride labels are also proposed to meet the current labelling standards.
To reduce potential exposure to occupational workers using dodecylguanidine hydrochloride in industrial or manufacturing settings and for label improvement, the following revisions to the product labels are proposed:

Environment

To minimize the exposure to the environment, the following label updates are proposed:

International context

Dodecylguanidine hydrochloride is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States and Mexico. As of 3 March 2022, no decision by an OECD member country to prohibit all uses of dodecylguanidine hydrochloride for health or environmental reasons has been identified.

Next steps

Upon publication of this proposed re-evaluation decision the public, including the registrants and stakeholders, are encouraged to submit additional information that could be used to refine risk assessments during the 90-day public consultation period.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document,2 which could result in revised risk mitigation measures. 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 Health Canada's responses.

Refer to Appendix I of PRVD2022-16 for details on specific products impacted by this proposed decision.

Other information

The relevant confidential test data on which the proposed decision is based (as referenced in PRVD2022-16) are available for public inspection, upon application, in Health Canada's Reading Room. For more information, please contact Health Canada's Pest Management Information Service.

Additional scientific information

No additional scientific data are required at this time.

"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.

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"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.

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