Re-evaluation Decision RVD2020-02, Folpet and Its Associated End-use Products for Agricultural Uses

Pest Management Regulatory Agency
23 January 2020
ISSN: 1925-1025
Catalogue number: H113-28/2020-2E-PDF

Summary

Table of Contents

• Re-evaluation Decision
• Outcome of Science Evaluation
• Regulatory Decision for Agricultural Products containing Folpet
• Risk Mitigation Measures
• Next Steps
• Other Information
• Appendix I Registered Agricultural Folpet Products in Canada as of 18 June 2019, excluding discontinued products or products with a submission for discontinuation

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 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.

Folpet is a fungicide used on a number of food crops such as apples, crab apples, grapes, strawberries, cranberries, and field vegetables, as well as ornamental crops. This document (RVD2020-02) presents the re-evaluation outcome on these agricultural uses. Currently registered products containing folpet for agricultural uses can be found in the Pesticide Label Search Webpage and in Appendix I.

Folpet is also used as a material preservative in paints and coatings, and vinyl plastics. Health Canada plans to publish a separate document regarding material preservatives for the folpet products. Further details may be found in the published document: Re-evaluation Note REV2018-02, Approach for the Re-evaluation of Pesticides Used as Preservatives in Paints, Coatings and Related Uses.

The regulatory approach for the re-evaluation of folpet for agricultural uses was first presented in the Proposed Re-evaluation Decision PRVD2018-05, Folpet^{Footnote 1} which underwent a 90 day consultation period ending on 12 June 2018. PRVD2018-05 proposed continued registration of folpet products with mitigation measures such as reduced number of applications, longer re-treatment intervals, increased personal protective equipment (PPE), longer restricted entry intervals, updated aquatic buffer zones, and implementing a water soluble bag formulation for wettable powder formulations. In addition, use on cranberry, cut flowers and azalea stem soak was proposed for cancellation.

Health Canada received comments and data/information relating to the health and value assessments. Respondents are listed in Appendix III of RVD2020-02. These comments are summarized in Appendix II of RVD2020-02 along with the responses by Health Canada. These comments and new data/information resulted in revisions to the risk assessments (see Science Evaluation Update of RVD2020-02), and subsequently some changes to the proposed regulatory decision as described in PRVD2018-05. A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2018-05, and further information used in the re-evaluation decision is listed in Appendix VI of RVD2020-02.

This document (RVD2020-02) presents the final regulatory decision^{Footnote 2} for this stage of the re-evaluation of folpet, including the required risk mitigation measures to protect human health and the environment. All products containing folpet that are registered for agricultural uses in Canada are subject to this re-evaluation decision.

Outcome of Science Evaluation

Following the consultation on the proposed re-evaluation decision, Health Canada revised the occupational risk assessment based on the comments and information received. As a result, health risks from the current folpet end-use products have been shown to be acceptable for all agricultural uses when used according to the revised label directions with the new mitigation measures, with the exception of risks associated with apples, crab apples, and cranberries on the wettable powder product. In addition, sufficient data were not available to assess the azalea stem soak use, resulting in its cancellation.

Dietary risks were shown to be acceptable and no comments were received pertaining to the dietary risk assessment.

After a review of the available scientific information, folpet and its associated end use products were found to pose an acceptable risk to the environment when used according to the revised label directions.

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.

Regulatory Decision for Agricultural Products containing Folpet

Health Canada has completed this stage of the re-evaluation of folpet. Under the authority of the Pest Control Products Act, Health Canada has determined that with required amendments, continued registration of products containing folpet is acceptable. An evaluation of available scientific information found that all agricultural uses of folpet meet current standards for protection of human health and the environment when used according to the revised label directions with the exception of the azalea stem soak use. Label amendments, as summarized below and listed in Appendix IV of RVD2020-02, are required. No additional data are required.

Risk Mitigation Measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The revised/updated label statements and mitigation measures required, as a result of the re-evaluation of folpet, are summarized below. Refer to Appendix IV of RVD2020-02 for details.

Human Health

To protect mixers/loaders and applicators:

• Additional personal protective equipment (PPE) for all products is required
• Cancellation of the azalea stem soak use as adequate data to estimate exposure were not available
• For the wettable powder product:
  • Closed cab tractor for airblast application equipment is required
  • Limit on the amount of product handled per day when using groundboom application equipment
  • Cancellation of the following wettable powder uses: apples, crab apples, and cranberries.

To protect workers entering treated agricultural areas:

• Revision or establishment of restricted-entry intervals (REIs) is required;
• A reduction to the maximum number of applications per season is required for greenhouse and outdoor ornamentals grown for cut flower production, and for tomatoes not grown for processing
• Label statements to clarify the acceptable greenhouse uses of folpet are required.

To protect bystanders from spray drift:

• A statement to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift is required.

To ensure potential residues do not occur on crops not registered for use with folpet:

• A rotational plantback interval of 12 months is required for crops not listed for use on folpet labels.

Environment

To protect the environment, the following risk-reduction measures are required:

• Additional precautionary standard label statements for runoff mitigation
• Updated storage statements
• Mitigation statements for aquatic organisms
• Field sprayer and airblast application mitigation statements
• Additional label statement to prohibit aerial application
• Updated buffer zones to mitigate environmental risks

Label improvements to meet current standards:

• Updated discharge of effluent statements
• Updated storage statements

Next Steps

To comply with this decision, the required mitigation measures must be implemented on all affected product labels sold by registrants no later than 24 months after the publication date of this decision document. Refer to Appendix I for details on specific products impacted by this decision.

Other Information

Any person may file a notice of objection^{Footnote 3} regarding this decision on folpet within 60 days from the date of publication of RVD2020-02. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra.info-arla@hc-sc.gc.ca).

The relevant test data on which the decision is based (as referenced in PRVD2018-05 and RVD2020-02) are available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa). For more information, please contact the PMRA's Pest Management Information Service.

Appendix I Registered Agricultural Folpet Products in Canada as of 18 June 2019, excluding discontinued products or products with a submission for discontinuation

Footnotes