Proposed Re-evaluation Decision PRVD2020-03, Sodium Omadine and its associated end-use products, used as a preservative in paints, coatings and related uses

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Pest Management Regulatory Agency
9 July 2020
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2020-3E-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 PRVD2020-03, Sodium Omadine and Its Associated End-use Products, Used as a Preservative in Paints, Coatings and Related Uses) 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.

This document (Proposed Re-evaluation Decision PRVD2020-03, Sodium Omadine and Its Associated End-use Products, Used as a Preservative in Paints, Coatings and Related Uses) presents the proposed regulatory decision for the re-evaluation of sodium omadine, used as a preservative in paints, coatings and related uses, 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 sodium omadine for use as a preservative in paints, coatings and related uses are subject to this proposed re-evaluation decision. PRVD2020-03 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.

Sodium omadine is used as an “in-can” preservative of latex emulsions used in adhesives, caulks, patching compounds, sealants, paints and grouts against bacterial and fungal contamination and spoilage. All other registered uses of sodium omadine (that is, the preservation of aqueous based metalworking, cutting, cooling and lubrication fluids and fluid concentrates; and gypsum wallboards) were evaluated separately (Re-evaluation Decision RVD2018-06, Sodium Omadine and Its Associated End-use Product).

Outcome of science evaluation

With respect to human health, risks of concern were identified for primary handlers (industrial manufacturers) handling sodium omadine as a material preservative and for secondary handlers (professional and residential) using sodium omadine treated products. Therefore, mitigation measures for primary handlers (that is, closed transfer system) and secondary handlers (that is, rate reductions for all uses) are proposed.

Proposed regulatory decision for sodium omadine

Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, Health Canada is proposing that products containing sodium omadine used as a material preservative are acceptable for continued registration in Canada, provided that the proposed risk mitigation measures are in place.

Human health

To mitigate risks to primary handlers (mixers/loaders) manufacturing latex paints and building materials (caulks, sealants, grouts, patching compounds and adhesives):

To mitigate risks to secondary handlers (professional and residential) applying latex paints using a brush and roller or an airless sprayer:

To mitigate risks to secondary handlers (professional and residential) applying building materials (caulks, sealants, grouts, patching compounds and adhesives) using a brush and roller:

Rate reductions for all paint-related uses have been proposed in order to mitigate risks. The current label rate calls for a dosage of up to 1600 ppm of product to inhibit bacterial growth in latex emulsions; equivalent to up to 0.648 g a.i./kg latex emulsion. ValueFootnote 1 information is required to confirm the acceptability of the proposed rate reductions for sodium omadine in paint (0.058 g a.i./kg) and building materials (0.224 g a.i./kg for caulks and sealants; 0.196 g a.i./kg for all other building materials). If value information is not received or if information does not demonstrate value, all paint and paint-related uses will be cancelled.

International context

Sodium omadine is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States and Mexico. No decision by an OECD-member country to prohibit all uses of sodium omadine 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 risk assessments during the 90-day public consultation periodFootnote 2 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 3 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

Risks were not shown to be acceptable for sodium omadine used as a material preservative in paint and paint-related products (that is, building materials) at the current label rate; therefore, a rate reduction is proposed for all paint and paint-related uses. Value information is required for the proposed rate reductions for all paint and paint-related uses in order to maintain registration of sodium omadine products; failure to provide information or to demonstrate value of the proposed rate reductions will result in cancellation of sodium omadine products used as material preservatives in paint and paint-related products.

Additionally, 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 sodium omadine and support refined risk assessment. In addition, stakeholders may consider providing information on risk management options for sodium omadine (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 that may allow further refinement of the risk assessment:

Footnote 1

As defined in the Pest Control Products Act, value, in respect of a pest control product, means the product’s actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product’s (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact.

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Footnote 2

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

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Footnote 3

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

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