Proposed Re-evaluation Decision PRVD2020-04, Ziram and Its Associated End-use Products, Used as a Preservative in Adhesives

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Pest Management Regulatory Agency
9 July 2020
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2020-4E-PDF (PDF version)

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Table of Contents

Proposed re-evaluation decision

Under the authority of 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. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

This document (Proposed Re-evaluation Decision PRVD2020-04, Ziram and Its Associated End-use Products, Used as a Preservative in Adhesives) forms part of a re-evaluation assessment of several active ingredients used as preservatives in paints, coatings and related uses. As per Re-evaluation Note REV2018-02, Approach for the Re-Evaluation of Pesticides Used as Preservatives in Paints, Coatings and Related Uses , the paint-related uses of sodium omadine, chlorothalonil, dazomet, folpet and ziram were evaluated separately from other uses and relied on data provided by the registrants and the Antimicrobial Exposure Assessment Task Force II (AEATF II). This approach was adopted in order to obtain and review paint-related studies, have risk assessments more reflective of current and realistic exposure scenarios and to allow for a consistent approach to the risk assessment and risk management for these uses. Paint studies/data were also used as surrogates for the assessment of building materials and adhesives.

This document (Proposed Re-evaluation Decision PRVD2020-04, Ziram and Its Associated End-use Products, Used as a Preservative in Adhesives) presents the proposed regulatory decision for the re-evaluation of ziram, used as a preservative in adhesives, including the proposed risk mitigation measures to further protect human health , as well as the science evaluation on which the proposed decision was based. All products registered in Canada containing ziram for use as a preservative in adhesives are subject to this proposed re-evaluation decision. PRVD2020-04 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 Health Canada . The final re-evaluation decision will be published taking into consideration the comments and information received.

Ziram is an “in-can” material preservative used to control bacterial and fungal degradation of dry starch and synthetic latex adhesives. The only other registered use of ziram, as a protectant fungicide in agriculture, was evaluated separately (Re-evaluation Decision RVD 2018-39, Ziram and Its Associated End-use Products for Agricultural Uses ); all registered agricultural uses in Canada were cancelled. Therefore, all remaining registered products in Canada are solely for use as material preservatives in adhesives (Appendix I of PRVD2020-04).

Outcome of science evaluation

With respect to human health, when using ziram as a material preservative risks of concern were identified for occupational workers (mixing/loading the end-use product and handling the impregnated dry starch and latex adhesives) and residential handlers; risks were not shown to be acceptable when used according to label directions. Therefore, cancellation of material preservative uses of ziram in adhesives is proposed.

Proposed regulatory decision for ziram

Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, the registration of products containing ziram for use as a material preservative in Canada is proposed for cancellation. In accordance with PRVD2016-06 and RVD2018-39, all agricultural uses of ziram have been cancelled and all maximum residue limits (MRLs) will be revoked (Proposed Maximum Residue Limit PMRL2019-08, Ferbam, Thiram and Ziram). Therefore, cancellation of the material preservative use will also result in cancellation of all remaining registered ziram products.

International context

Ziram is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, the European Union (agricultural use only) and Australia. No decision by an OECD-member country to prohibit all uses of this active for health or environmental reasons has been identified.

Next steps

The public, including the registrants and stakeholders, are encouraged to submit additional information that could be used to refine the risk assessment during the 90-day public consultation periodFootnote 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 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.

Additional scientific information

No additional scientific data are being requested. However, during the consultation period, the registrants and other stakeholders may consider submitting the following information that may address uncertainties in the available information database of ziram and support refined risk assessment. In addition, stakeholders may consider providing information on risk management options for ziram (for example, additional personal protective equipment, engineering controls).

The evaluation of any additional data would be based on the scientific merit and relevance to the risk assessment. While additional data may reduce uncertainty in the risk assessment, continued registration of any uses would be based on the acceptability of risk assessed using a science-based approach.

Additional detailed use description information and other data/information that may allow further refinement of the risk assessment:

Footnote 1

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

Return to footnote 1 referrer

Footnote 2

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

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