Proposed Re-evaluation Decision PRVD2018-05, Folpet and Its Associated End-use Products
This consultation is now closed.
Pest Management Regulatory Agency
14 March 2018
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2018-5E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Folpet
- Human Health
- International Regulatory Context
- Next Steps
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. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.
Folpet is a fungicide used on a number of food and ornamental crops and as a material preservative in vinyl plastics. Folpet is also used as a material preservative in paints and coatings, however, these uses are not included in this re-evaluation. The PMRA plans to publish a document in the future to provide a broader examination of material preservatives for paints and coatings.
This document (Proposed Re-evaluation Decision PRVD2018-05, Folpet and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of folpet, including proposed risk mitigation measures to further protect human health and the environment, as well as the science evaluation on which the proposed decision was based. All products containing folpet registered in Canada are subject to this proposed re-evaluation decision. PRVD2018-05 is subject to a 90-day public consultation period, during which the public, including manufacturers and stakeholders, may submit written comments and additional information to the PMRA Publications Section . The final re-evaluation decision will be published taking into consideration any comments and information received.
Outcome of Science Evaluation
Folpet is a broad-spectrum, contact protectant fungicide used in several important crops and as a material preservative.
As a material preservative, folpet is registered for use in paints and coatings and in vinyl plastics. The material preservative use of folpet in paints and coatings will be re-evaluated at a later date.
The primary uses of folpet-treated vinyl plastics are in the manufacture of window gaskets for homes and cars, vinyl flooring backing, outdoor upholstery (seats for boats), coatings applied to tents, exterior vinyl products, awnings and roof membranes. Use of folpet for treating vinyl plastics is proposed for cancellation due to risks of concern for workers manufacturing these vinyl plastics.
As an agricultural fungicide, folpet is a valuable pest management tool and contributes to integrated pest management programs on several important crops, including apples, grapes and strawberries, due to its multi-site mode of action and low risk for resistance development.
The use of folpet on cranberries and cut flowers did not meet current standards for the protection of human health. Therefore these uses are proposed for cancellation. For the azalea stem soak use, there was insufficient data to conduct a health risk assessment. Hence, this use is also proposed for removal.
For remaining agricultural uses, health and environmental standards are met when used according to the revised label directions proposed in PRVD2018-05.
Folpet can enter soil and surface water when used as a fungicide. Folpet may pose risks of concern to certain aquatic organisms and small mammals; therefore, preventative measures to reduce risk to these organisms are proposed. To protect non-target organisms from spray drift, updated aquatic buffer zones are proposed.
Proposed Regulatory Decision for Folpet
Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, some uses of folpet do not meet standards for human health protection and, are therefore, proposed for removal. These include use as a material preservative in vinyl plastics, use on cranberries and cut flowers, and as an azalea stem soak.
Remaining agricultural uses of folpet are considered acceptable for continued registration with the implementation of the mitigation measures summarized below. For details of proposed label changes, see Appendix XIII of PRVD2018-05.
To protect mixer/loader/applicators:
- Require that the wettable powder agricultural product be packaged in water soluble packages.
- Require additional protective equipment when mixing/loading and applying.
- Remove the stem soak use from commercial labels.
- Cancel the soluble powder product for the manufacture of treated plastics.
To protect workers entering treated sites:
- Revise or establish restricted entry intervals (REIs) for some crops.
- Require restrictions on number of applications allowed per season for some crops.
- Require label statements to clarify the acceptable greenhouse uses of folpet.
- Remove crop uses with agronomically unfeasible REIs (cranberry and cut flower (field and greenhouse)).
To protect bystanders from spray drift:
- Require a statement to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.
To protect consumers from potential residues in, or on, food:
- A rotational plantback interval of 12 months for crops not registered for use with folpet.
Residue definition for enforcement:
- The residue of folpet in all commodities is currently expressed as folpet per se for enforcement and dietary risk assessment purposes. It is proposed that the residue definition be amended to include the phthalimide metabolite, expressed as folpet.
To protect aquatic habitats, the following measures are proposed:
- Advisory statements to inform users that folpet is toxic to non-target organisms including small mammals, aquatic invertebrates, fish, algae and frogs.
- Spray buffer zones to protect aquatic habitats from drift.
- Advisory statements to inform users of conditions that may result in run-off and leaching.
- A statement advising that transformation products could potentially reach groundwater, particularly in areas where soils are permeable and/or the depth to the water table is shallow.
Though not proposed as a requirement, certain additional information may allow for the refinement of occupational and residential exposure risk assessment. This could potentially reduce restrictions and mitigation measures proposed in PRVD2018-05, and may allow uses to be maintained which are proposed for removal. These data include, but are not limited to the following:
- Dermal absorption study (such as rat in vivo, triple pack of rat in vivo and rat/human in vitro studies);
- Exposure study for workers handling solid formulations in industrial settings;
- Dislodgeable foliar residue studies conducted under conditions relevant to the Canadian climate and use pattern;
- Postapplication worker exposure studies following application of folpet and performing activities that are relevant to Canadian climate and agricultural practices.
International Regulatory Context
Folpet is currently acceptable for use in other OECD member countries, including the United States.
Before finalizing a re-evaluation decision for folpet, the PMRA will consider any comments received during this consultation. A Re-evaluation Decision document will be published which will include a summary of comments received and the PMRA’s responses, as well as any revisions to this proposed re-evaluation decision.
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