Re-evaluation Decision RVD2019-08, Fosetyl-aluminum and Its Associated End-use Products

Pest Management Regulatory Agency
14 June 2019
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2019-8E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation Decision
• Outcome of Science Evaluation
• Regulatory Decision for Fosetyl-aluminum
• Risk Mitigation Measures
• Next Steps
• Other Information
• Appendix I - Registered Fosetyl-aluminum Products in Canada

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.

Fosetyl-aluminum is a systemic fungicide used to manage various diseases on a wide range of agricultural crops, ornamentals and turf. Fosetyl-aluminum is applied as a soil drench treatment and foliar spray by conventional ground application equipment. Currently registered products containing fosetyl-aluminum are listed in Appendix I.

The regulatory approach for the re-evaluation of fosetyl-aluminum was first presented in the Proposed Re-evaluation Decision PRVD2017-19, Fosetyl-aluminum and Its Associated End-use Products which underwent a 90-day consultation period ending on period ending on 29 January 2018^{Footnote 1}. PRVD2017-19 proposed no products for cancellation, however a number of uses and methods of application were proposed for cancellation due to occupational postapplication risks of concern. It was proposed to: prohibit use on cut flowers; increase restricted-entry intervals (REI) for apples, blackberries, highbush blueberries, red/black raspberries, grapes, brassica leafy vegetables, onions, spinach, and ornamental plants; and, prohibit drench applications to bedding plants.

Health Canada received comments relating to the health and value assessments. These comments are summarized in Appendix II of RVD2019-08 along with the responses by Health Canada. These comments and new data/information resulted in revisions to the risk assessments (see Science Evaluation Update section of RVD2019-08), and subsequently, in changes to the proposed regulatory decision as described in PRVD2017-19. A reference list of data used as the basis for the proposed re-evaluation decision is included in PRVD2017-19, and further data used in the re-evaluation decision is listed in Appendix VI of RVD2019-08.

Outcome of Science Evaluation

Following the consultation on the proposed re-evaluation decision, Health Canada revised the occupational risk assessment based on the comments received relating to the use of fosetyl-aluminum on bedding plants, and greenhouse and outdoor cut flowers. Health risks from fosetyl-aluminum and its associated end-use products have been shown to be acceptable for all uses of fosetyl-aluminum when used according to the revised label directions. The environmental risks associated with the use of fosetyl-aluminum and its related end-use products are acceptable when used according to the revised label directions, which include advisory statements and spray buffer zones.

Regulatory Decision for Fosetyl-aluminum

Health Canada has completed the re-evaluation of fosetyl-aluminum. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing fosetyl-aluminum is acceptable. An evaluation of available scientific information found that uses of fosetyl-aluminum products meet current standards for protection of human health and the environment when used according to revised label directions. Label amendments, as summarized below and listed in Appendix V of RVD2019-08, are required for all technical and end-use products. No additional data are requested.

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. As a result of the re-evaluation of fosetyl-aluminum, Health Canada is requiring further risk-reduction measures in addition to those already identified on fosetyl-aluminum product labels. The key risk-reduction measures are summarized below. Refer to Appendix V of RVD2019-08 for details.

Human Health

• Label statements will be added to clarify that products are not to be used on residential lawns, gardens, playing fields, cemeteries, and school grounds.
• To protect mixers/loaders and applicators, additional personal protective equipment (PPE), increased minimum spray volumes, and limits on amount of product handled per day are required.
• To protect workers entering treated sites, revision or establishment of REIs, changes to the maximum number of applications per season and minimum re-treatment interval, and limiting application to soil drench only for some crops, are required.
• The use of foliar application on greenhouse ornamentals grown for cut flowers will be cancelled and prohibited on the labels.

Environment

• Standard hazard statements to inform users of the potential toxic effects to certain beneficial insects, small wild animals and aquatic organisms, as well as drift reduction measures are required.

Next Steps

To comply with this decision, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Appendix I lists the products containing fosetyl-aluminum that are registered under the authority of the Pest Control Products Act.

Other Information

Any person may file a notice of objection^{Footnote 2} regarding this decision on fosetyl-aluminum within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of Canada.ca (Request a Reconsideration of Decision) or contact Health Canada’s Pest Management Information Service.
The relevant test data on which the decision is based (as referenced in PRVD2017-19) are available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa). For more information, please contact the Health Canada’s Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra.info-arla@hc-sc.gc.ca).

Appendix I Registered Fosetyl-aluminum Products in Canada

Table 1 Registered Fosetyl-aluminum Products in Canada^{Table 1 Footnote 1}

Registration Number	Marketing Class	Registrant	Product Name	Formulation Type	Guarantee
24563	Technical	Bayer CropScience	Fosetyl-aluminum Technical	Dust or Powder	97%
24458	Commercial	Bayer CropScience	Aliette WDG Systemic Fungicide	Wettable Granules	80%
24564	Commercial	Bayer CropScience	Aliette Wettable Powder Systemic Fungicide	Wettable Powder	80%
27557	Commercial	Bayer CropScience	Chipco Aliette Ornamental Fungicide	Wettable Granules	80%
27688	Commercial	Bayer CropScience	Aliette Systemic Fungicide Water Dispersible Granule	Wettable Granules	80%
28299	Commercial	Bayer CropScience	Chipco Aliette Signature Fungicide	Wettable Granules	80%
32800	Commercial	Bayer CropScience	Signature XTRA Stressgard	Wettable Granules	60%
Table 1 Footnote 1 as of 25 March 2019, excluding discontinued products or products with a submission for discontinuation Return to Table 1 footnote 1 referrer