ARCHIVED - Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane

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Pest Management Regulatory Agency
30 April 2014
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2014-2E-PDF (PDF version)

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Dimethoxane
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Summary

Table of Contents

What Is the Proposed Re-evaluation Decision?

After a re-evaluation of the material preservative dimethoxane, Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act and  Regulations, is proposing continued registration of products containing dimethoxane for sale and use in Canada.

An evaluation of available scientific information found that products containing dimethoxane do not present unacceptable risks to human health or the environment when used according to the revised label directions. As a condition of the continued registration of dimethoxane uses, new risk-reduction measures are proposed to be included on the label of the product. Additional data are also required as a result of this re-evaluation.

Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane is a consultation document that summarizes the science evaluation for dimethoxane and presents the reasons for the proposed re-evaluation decision. It also proposes additional risk-reduction measures to further protect human health and environment.

This proposal affects the end-use products containing dimethoxane registered in Canada. Once the final re-evaluation decision is made, the registrants will be instructed on how to address any new requirements.

The information in Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane is presented in two parts. This Summary describes the regulatory process and key points of the evaluation, while the Science Evaluation of Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane provides detailed technical information on the assessment of dimethoxane.

The PMRA will accept written comments on Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane up to 45 days from the date of publication of this document. Please forward all comments to Publications.

What Does Health Canada Consider When Making a Re-evaluation Decision?

The PMRA's pesticide re-evaluation program considers potential risks, as well as value, of pesticide products to ensure they meet modern standards established to protect human health and the environment. Regulatory Directive DIR2012-02, Re-evaluation Program Cyclical Re-evaluation, presents the details of the cyclical re-evaluation approach.

Dimethoxane is registered in the United States as a material preservative. The  United States Environmental Protection Agency (USEPA) completed a Reregistration Eligibility Decision in 1996. In June 2011, the USEPA published the final workplan for dimethoxane. The Canadian use pattern is encompassed by the American use pattern, and hence, the PMRA used the USEPA documents as a basis for the re-evaluation of dimethoxane.

For more details on the information presented in this Summary, please refer to the Science Evaluation of Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane.

What is Dimethoxane?

Dimethoxane is a material preservative that is used in adhesives, dyestuffs, emulsions, gums, inks, latex, polyvinyl acetate, silicone, textile auxiliaries and thickeners. It can be either applied by the open-pouring method or via a closed delivery system.

Health Considerations

Can Approved Uses of Dimethoxane Affect Human Health?

Dimethoxane is unlikely to affect your health when used according to the revised label directions.

People could be exposed to dimethoxane by working as a mixer/loader in industrial settings and through contact with products containing materials treated with dimethoxane. The PMRA considers two key factors when assessing health risks: the levels at which no health effects occur and the levels to which people may be exposed. The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). Only uses for which exposure is well below levels that cause no effects in animal testing are considered acceptable for continued registration.

The PMRA concluded that the registration of dimethoxane is acceptable provided that additional mitigation measures are implemented (Appendix IV of Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane).

Environmental Considerations

What Happens When Dimethoxane Is Introduced Into the Environment?

Dimethoxane is unlikely to affect non-target organisms when used according to the revised label directions.

Given the currently registered use pattern under the Pest Control Products Act, and the environmental fate data indicating a rapid degradation of dimethoxane in water, the potential for environmental exposure is considered to be minimal. The PMRA concluded that dimethoxane is unlikely to cause harm to the environment. Standard environmental advisory label statements to minimize surface water contamination are proposed.

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. As a result of the re-evaluation of dimethoxane, the PMRA is proposing further risk-reduction measures for product labels (Appendix IV of Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane).

Human Health

  • A statement prohibiting the use of this active ingredient in the production of materials that will come into contact with food
  • A hazard label statement addressing skin sensitization potential
  • Personal protective equipment to protect workers in industrial settings

Environment

  • Standard environmental statements to minimize surface water contamination

A submission to implement label revisions will be required within 90 days of finalization of the re-evaluation decision.

What Additional Scientific Information Is Required?

Data are required as a condition of continued registration under Section 12 of the Pest Control Products Act. The registrant of this active ingredient must provide these data or an acceptable scientific rationale to the PMRA within the timeline specified in the decision letter. Appendix I lists all data requirements.

Next Steps

Before making a final re-evaluation decision on dimethoxane, the PMRA will consider all comments received from the public in response to Proposed Re-evaluation Decision PRVD2014-02, Dimethoxane. The PMRA will then publish a Re-evaluation Decision that will include the decision, the reasons for it, a summary of comments received on the proposed decision and the PMRA's response to these comments.

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