Proposed Re-evaluation Decision PRVD2015-11, Octhilinone

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The online consultation is now closed.

Pest Management Regulatory Agency
23 December 2015
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2015-11E-PDF (PDF version)

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 Re-evaluation Decision PRVD2015-11, Octhilinone please contact our publications office.

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

Summary

Table of Contents

What Is the Proposed Re-evaluation Decision?

After a re-evaluation of the antimicrobial active ingredient octhilinone, 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 octhilinone for sale and use in Canada.

An evaluation of available scientific information found that most uses of octhilinone products do not present unacceptable risks to human health or the environment when used according to the proposed label directions. The use of octhilinone as a material preservative in coatings (paints and stains) is proposed to be cancelled to address potential risks of concern to human health. As a requirement of the continued registration of remaining octhilinone uses, new risk-reduction measures are proposed for end-use products registered in Canada, including revised label directions.

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

Proposed Re-evaluation Decision PRVD2015-11, Octhilinone is a consultation document that summarizes the science evaluation for octhilinone and presents the reasons for the proposed re-evaluation decision. It also proposes additional risk-reduction measures to further protect human health and the environment.

The information is presented in two parts. The Overview describes the regulatory process and key points of the evaluation, while the Science Evaluation of provides detailed technical information on the assessment of octhilinone.

The PMRA will accept written comments on Proposed Re-evaluation Decision PRVD2015-11, Octhilinone up to 60 days from the date of publication of Proposed Re-evaluation Decision PRVD2015-11, Octhilinone. 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, which is in line with the requirements of the Pest Control Products Act.

For more details on the information presented in this summary, please refer to the Science Evaluation of Proposed Re-evaluation Decision PRVD2015-11, Octhilinone.

What is Octhilinone?

Octhilinone is an antimicrobial active ingredient registered in Canada for use in the preservation of coatings (paints and stains), building materials (for example caulks, sealants, and stucco), wallpaper pastes and adhesives, aqueous emulsions and adhesives, fabric, leather, polymer and vinyl compounds. The commercial end-use products containing octhilinone can be incorporated into materials or solutions to be preserved during the manufacturing process via open pour or a closed mixing/transfer system. For treatment of fabric, it can also be added during laundering operations.

Health Considerations

Can Approved Uses of Octhilinone Affect Human Health?

Octhilinone is unlikely to affect your health when used according to the proposed label directions.

Potential exposure to octhilinone may occur when handling and applying the product or through contact with materials/products containing the product as a preservative. Dietary exposure to octhilinone is not expected based on the currently registered use pattern.

Occupational exposure while handling and applying the product in an industrial setting is not of concern under the proposed conditions of use. Occupational and residential exposures through contact with materials/products (except as a material preservative in coatings (paints and stains)) containing octhilinone are not of concern under the proposed conditions of use. The use as a material preservative in coatings (paints and stains) is proposed for cancellation.

Environmental Considerations

What Happens When Octhilinone Is Introduced Into the Environment?

Octhilinone is unlikely to affect non-target organisms when used according to the proposed label directions.

Octhilinone is not expected to persist in the environment and has a low potential for bioaccumulation in biota. It is highly toxic to aquatic organisms. The use of octhilinone as a material preservative is unlikely to result in a significant environmental exposure. Standard environmental hazard and advisory label statements are proposed to be added to all product labels.

Proposed Measures to Minimize Risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human health and the environment. These directions must be followed by law. As a result of the re-evaluation of octhilinone, the PMRA is proposing further risk-reduction measures outlined below.

Human Health

  • Hazard label statements on the technical grade product label
  • Additional personal protective equipment to protect workers in industrial/manufacturing settings
  • Cancellation of octhilinone use as a material preservative in coatings (paints and stains)
  • Reduction of the maximum application rate in building materials, aqueous emulsions and adhesives, and polymer compounds
  • Prohibition of use in adhesives, polymer and vinyl compounds for food contact materials
  • Prohibition of use in polymer and vinyl compounds for children's toys

Environment

  • Standard environmental hazard and advisory label statements.

Next Steps

During the consultation period, registrants and stakeholder organizations may submit further data that could be used to refine risk assessments, which could result in revised risk-reduction measures. Before making a final re-evaluation decision on octhilinone, the PMRA will consider any comments received from the public in response to Proposed Re-evaluation Decision PRVD2015-11, Octhilinone. A science-based approach will be applied in making a final decision on octhilinone. 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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