Proposed Re-evaluation Decision PRVD2020-05, Folpet and Its Associated End-use Products, Used as a Preservative in Paints and Vinyl Plastics

Pest Management Regulatory Agency
9 July 2020
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2020-5E-PDF (PDF version)

Table of Contents

• Proposed re-evaluation decision
• Outcome of science evaluation
• Proposed regulatory decision for folpet
• International context
• Next steps
• Additional scientific information

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 PRVD2020-05, Folpet and Its Associated End-use Products, Used as a Preservative in Paints and Vinyl Plastics) 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 PRVD2020-05, Folpet and Its Associated End-use Products, Used as a Preservative in Paints and Vinyl Plastics) presents the proposed regulatory decision for the re-evaluation of folpet used as a preservative in paints and vinyl plastics, 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 folpet for use as a preservative in paints and vinyl plastics are subject to this proposed re-evaluation decision. PRVD2020-05 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.

Folpet is a dry-film material preservative used to control bacterial and fungal degradation in solvent-based paints and vinyl plastics (gaskets, roof membranes, exterior vinyl products including artificial leather for outdoor seating, truck covers, industrial tents and outdoor architectural fabrics). All other registered uses of folpet (that is, as a fungicide on food and ornamental crops) were evaluated separately (Proposed Re-evaluation Decision PRVD2018-05, Folpet and Its Associated End-use Products ; Re-evaluation Decision RVD2020-02, Folpet and Its Associated End-use Products for Agricultural Uses).

Outcome of science evaluation

With respect to human health, risks of concern were identified for primary handlers (industrial manufacturers) handling folpet as a material preservative and for secondary handlers (professional and residential) using folpet-treated paint.

Therefore, mitigation measures are proposed for mixing/loading folpet (that is, additional personal protective equipment and a reduction of the amount handled per person per day) and the use of folpet in paint is proposed for cancellation. Exposure from the remaining use as a material preservative in vinyl plastics is unlikely to affect human health when used according to the revised label directions.

Proposed regulatory decision for folpet

Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, Health Canada is proposing that use of folpet as a material preservative in vinyl plastics is acceptable for continued registration in Canada, provided that the proposed risk mitigation measures are in place. The use of folpet as a material preservative in paint has not been shown to be acceptable and is proposed for cancellation.

Human Health

To mitigate risks to secondary handlers (professional and residential):

• Cancel the use of folpet in solvent-based paints.

To mitigate risks to primary handlers (industrial manufacturers) manufacturing vinyl plastics:

• For the commercial-class solid product, require additional protective equipment (chemical-resistant coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear and a respirator) when mixing and loading, together with reducing the amount of active ingredient handled per worker per day to 648 g a.i./person/day.

International context

Folpet is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, the European Union, Mexico and New Zealand. No decision by an OECD-member country to prohibit all uses of folpet 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 period^{Footnote 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 folpet and support refined risk assessment. In addition, stakeholders may consider providing information on risk management options for folpet (for example, additional personal protective equipment (PPE), 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:

• Refined daily amounts of paint manufactured and treated with preservatives in Canada
• Chemical-specific dermal absorption studies conducted with paint formulations