Re-evaluation Decision RVD2023-03, Flucarbazone (present as flucarbazone-sodium) and Its Associated End-use Products

• Pest Management Regulatory Agency
• 9 February 2023
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2023-3E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for flucarbazone (present as flucarbazone-sodium) and associated end-use products
• Re-evaluation decision for flucarbazone
• Risk mitigation measures
• Next steps
• Other information
• Appendix I - Registered products containing flucarbazone in Canada

Re-evaluation decision for flucarbazone (present as flucarbazone-sodium) and associated end-use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they meet current health and environmental standards and have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Flucarbazone (present as flucarbazone-sodium) is a selective herbicide used on wheat (spring, durum and winter) in Alberta, Manitoba, Saskatchewan, and Peace River region of British Columbia. It is used to control certain annual grasses and broadleaf weeds. Flucarbazone products are formulated as wettable granules, suspension or emulsifiable concentrate and can be applied using ground or aerial equipment. Currently registered products containing flucarbazone can be found in the Pesticide Product Information Database and in Appendix I.

This document (Re-evaluation Decision RVD2023-03, Flucarbazone (present as flucarbazone-sodium) and Its Associated End-use Products) presents the final re-evaluation decision for the re-evaluation of flucarbazone, including the required risk mitigation measures to protect human health and the environment, as well as label amendments required to bring labels to current standards. All pest control products containing flucarbazone that are registered in Canada are subject to this re-evaluation decision.

Prior to finalizing this decision, Health Canada published the Proposed Re-evaluation Decision, PRVD2022-02, Flucarbazone (present as flucarbazone-sodium) and Associated End-Use Products, for a 90-day consultation period which ended 25 April 2022. PRVD2022-02 proposed that products containing flucarbazone are acceptable for continued registration in Canada provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included updated restricted-entry interval (REI), adding the standard drift mitigation label statement, updating the personal protective equipment (PPE) label statements to reflect current standards, precautionary leaching label statements, and spray buffer zones.

No comments were received during the consultation period. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2022-02, which lists all information used as the basis for the re-evaluation decision.

A reference list of data used as the basis for the re-evaluation decision is included in PRVD2022-02.

Re-evaluation decision for flucarbazone

Health Canada has completed the re-evaluation of flucarbazone. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing flucarbazone is acceptable. An evaluation of available scientific information found that the uses of flucarbazone products meets current standards for protection of human health and the environment and have acceptable value when used according to revised conditions of registration which includes new mitigation measures. Label amendments, as summarized below and listed in Appendix II of RVD2023-03, 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 required label amendments including any revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of flucarbazone, are summarized below. Refer to Appendix II of RVD2023-03 for details.

Human health

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

• To protect workers during mixing, loading and applying and postapplication exposure:
  • Mixers/loaders and applicators - Protective clothing and personal protective equipment (PPE) requirements consisting of a long-sleeved shirt and long pants plus chemical-resistant gloves, socks and shoes.
  • Re-entry workers - A standard restricted-entry interval (REI) of 12 hours.
• To protect bystanders from agriculture application exposure, add standard spray drift statement.

Environment

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

• Precautionary leaching label statements.
• Terrestrial and freshwater aquatic buffer zones to mitigate risk from drift.

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of this decision document. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection^{Footnote 1} regarding this decision on flucarbazone and its associated end-use products 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 the Canada.ca website (Request a Reconsideration of Decision) or contact Health Canada's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-02) are available for public inspection, upon application, in Health Canada's Reading Room. For more information, please contact Health Canada's Pest Management Information Service.

Appendix I Registered products containing flucarbazone in Canada

Table 1 Products containing flucarbazone requiring label amendments^{Table 1 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Guarantee
26447	Commercial	Arysta LifeScience North America, LLC	Everest 70 WDG Herbicide	Wettable granules	66%
26448			Everest Solupak 70 DF	Wettable granules in water-soluble packets	66%
29500			Pre-Pare Herbicide	Wettable granules	66%
30342			Everest 2.0 Herbicide	Suspension	397.33 g/LTable 1 Footnote 2
30580			ARY 0548-019 Herbicide		36.3 g/L (+ 200 g/L fluroxypyr)
30663			Inferno Duo	Wettable granules	45% (+ 23.9% tribenuron methyl)
32602			Everest 3.0 Herbicide	Suspension	200 g/L
33258			Everest 3.0 AG Herbicide	Suspension	200 g/L
33273			Inferno Trio Herbicide	Emulsifiable Concentrate or Emulsion	141 g/L (+50 g/L florasulam + 175 g/L carfentrazone-ehtyl)
33372			Batalium Suspension Concentrate Herbicide	Suspension	20.4 g/L (+ 241 g/L MCPA ester + 90.5 g/L fluroxypyr + 241 g/L bromoxynil)
33370		New Agco Inc.	Mpower Himalaya Herbicide	Wettable granules	66%
32941		Syngenta Canada Inc.	Sierra® 3.0 Herbicide	Suspension	200 g/L
33538			Sierra® 3.0 AG Herbicide	Suspension	200 g/L
26446	Technical Grade Active Ingredient	Arysta LifeScience North America, LLC	Everest Technical Herbicide	Solid	89.20%
33333		New Agco Inc.	Newagco Flucarbazone Technical	Solid	93.20%
34110		Albaugh LLC	Flucarbazone Technical Herbicide	Solid	91.2%