Re-evaluation decision RVD2023-17, 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin and hydroxymethyl-5,5-dimethylhydantoin and its associated end-use products

Pest Management Regulatory Agency
21 December 2023
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2023-17E-PDF (PDF version)

Summary

To obtain a full copy of Re-evaluation Decision RVD2023-17, 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin and hydroxymethyl-5,5-dimethylhydantoin and its associated end-use products please contact our publications office.

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

Table of Contents

• Re-evaluation decision for 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMY) and hydroxymethyl-5,5-dimethylhydantoin (MMY) and associated end-use products
• Re-evaluation decision for DMY and MMY
• Risk mitigation measures
• Implementation of the re-evaluation decision
• Next steps
• Other information
• Appendix I Registered products containing DMY and MMY in Canada

Re-evaluation decision for 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMY) and hydroxymethyl-5,5-dimethylhydantoin (MMY) 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 meet current health and environmental standards and have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies. More details, on the legislative framework, risk assessment and risk management approach, are provided under the Evaluation Approach of the full version of Re-evaluation Decision RVD2023-17, 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin and hydroxymethyl-5,5-dimethylhydantoin and Its Associated End-use Products.

1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMY) and hydroxymethyl-5,5-dimethylhydantoin (MMY) are antimicrobial material preservatives used in a wide variety of products such as liquid detergents, soft soaps, room deodorizers and air fresheners, water-based surfactants, polymer emulsions, protective and decorative coatings, water-based gels for household and industrial products, textiles, water-based adhesives, latex for paper and coatings and water-based inks. Currently registered products containing DMY and MMY can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision, PRVD2022-10,^{Footnote 1} 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin and hydroxymethyl-5,5-dimethylhydantoin and Associated End-use Products, underwent a 90-day consultation period which ended 28 August 2022. PRVD2022-10 proposed that products containing DMY and MMY are acceptable for continued registration in Canada provided that the additional proposed risk mitigation measures are implemented. The proposed risk mitigation measures to protect human health and the environment include requiring a closed transfer system, as well as updated label statements to reflect current standards for personal protective equipment and for paper and paperboard use, and updating label statements to prohibit effluent discharge.
Health Canada received two comments during the consultation period conducted in accordance with section 28 of the Pest Control Products Act. Both comments were in support of the re-evaluation from the registrant of the technical grade active ingredient. The comments did not result in revisions to the risk assessments and did not result in changes to the proposed re-evaluation decision as described in PRVD2022-10. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2022-10.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2022-10; no further information was used in the final re-evaluation decision. Therefore, the complete reference list of all information used in this final re-evaluation decision is set out in PRVD2022-10.

This document (RVD2023-17) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of DMY and MMY, including the required amendments (risk mitigation measures) to protect human health and the environment as well as the label amendments required to bring labels to current standards. All products containing DMY and MMY that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for DMY and MMY

Health Canada has completed the re-evaluation of DMY and MMY. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing DMY and MMY is acceptable. An evaluation of available scientific information found that the uses of DMY and MMY products meets current standards for protection of human health and the environment and have acceptable value when used according to revised conditions of registration which includes new mitigation measures. Label amendments, as summarized below and listed in Appendix II of RVD2023-17, are required.

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 required label amendments including any revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of DMY and MMY, are summarized below. Refer to Appendix II of RVD2023-17 for details.

Human health

To protect human health, the following risk-reduction measures are required:

• To protect workers using end-use products during the manufacturing process:
  • A closed transfer system for commercial-class liquid (solution) products
• To protect workers, updated label statements are required to reflect current standards for personal protective equipment (PPE)
• To protect consumers, label statements are required to reflect current standards for paper and paperboard use

Environment

To protect the environment, the following risk-reduction measures are required:

• An update to the label statement prohibiting effluent discharge

Implementation of the re-evaluation decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides general timelines for implementation of post-market decisions.

Health considerations

When conducting human health risk assessments, risks from exposure to a pesticide are estimated by comparing potential exposures with the most relevant endpoint from toxicology studies, with standard protection factors incorporated to further protect human health, including the most sensitive population. These factors provide an inherent level of protection from exposures that could result in adverse effects to human health. Furthermore, Health Canada applies additional protection factors if warranted by the hazard profile of the pesticide or by the quality and completeness of the underlying data. When risks of concern are identified in the human health exposure scenarios, it does not necessarily mean that exposure will result in adverse effects, but mitigation measures to reduce potential risks would be required in order to support continued registration of the product/use.

Potential and relative health risks are thus considered acceptable during the general 2-year implementation period unless there is evidence from incident reports or other sources of real-world post-market surveillance data suggesting that there are adverse health effects occurring as a result of the use of the product(s) according to the currently approved label/use conditions. Other considerations may include how widely the product is used, the populations potentially exposed to the product and/or other factors.

Taking into consideration these factors, the 2-year implementation timeline for label amendments for DMY/MMY is considered appropriate from a human health perspective.

Environmental considerations

The registered uses of DMY and MMY are considered to be indoor uses and the potential for environmental exposure is considered to be low. Therefore, the risks to the environment are considered to be acceptable under the current conditions of use.

Based on the above, Health Canada has determined that the potential risks to human health and the environment from the use of DMY and MMY under the current conditions of use are considered acceptable during the 24-month time period required to implement the required mitigation measures.

Refer to Appendix I for details on specific products impacted by this decision.

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of this decision document. Accordingly, both registrants and retailers will have up to 24 months from the date publication of RVD2023-17 to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on DMY and MMY and its associated end-use products within 60 days from the date of publication of this Re-evaluation Decision (RVD2023-17). For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-10) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Appendix I Registered products containing DMY and MMY in Canada