Re-evaluation Decision RVD2022-03, Florasulam and its associated end-use products

Pest Management Regulatory Agency
7 April 2022
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2022-3E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for florasulam and associated end-use products
• Re-evaluation decision for florasulam
• Risk mitigation measures
• Next steps
• Other information
• Appendix I - Registered products containing florasulam in Canada

Re-evaluation decision for florasulam 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.

Florasulam is an herbicide registered for use on oats, spring barley, spring wheat (including durum), winter wheat, grasses grown for seed production, grass pastures, and summerfallow in the Prairie provinces and the interior of British Columbia. It is applied using ground equipment to control or suppress annual and perennial broadleaf weeds and is often used tank mixed or co-formulated with other active ingredients. Currently registered products containing florasulam can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2021-03, Florasulam and Its Associated End-use Products^{Footnote 1} containing the evaluation of florasulam and proposed decision, underwent a 90-day consultation period ending on 24 May 2021. PRVD2021-03 proposed that products containing florasulam are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included personal protective equipment and standard restricted-entry intervals.

The only comment received during the consultation period was from a technical grade active ingredient registrant, supporting the proposal and mitigation measures. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2021-03, which lists all data used as the basis for the re-evaluation decision. However, the PRVD reflected the use pattern as of September 2020 and a minor use (i.e., established alfalfa for forage and hay to PCP No. 31259) was registered in December 2020. While this use expansion was not captured in the PRVD, it has been included in the RVD (under Appendix II of the full version of Re-evaluation Decision RVD2022-03, Florasulam and its associated end-use products). Further information on the evaluation of this use can be found in the Evaluation Report located in the Pesticide Product Information Database under Sub. No. 2020-3054.

This document presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of florasulam, including the required amendments (risk mitigation measures) to protect human health and the environment, as well as label amendments required to bring labels to current standards. All products containing florasulam that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for florasulam

Health Canada has completed the re-evaluation of florasulam. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing florasulam is acceptable. An evaluation of available scientific information found that the use of florasulam 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 III of RVD2022-03, 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 amendments, including any updated label statements and mitigation measures, as a result of the re-evaluation of florasulam, are summarized below. Refer to Appendix III of RVD2022-03 for details.

Human health

Risk mitigation:

To protect workers (mixer/loader/applicator) and those entering treated areas, and bystanders the following risk-reduction measures are required:

• Personal protective equipment (PPE) consisting of a long-sleeved shirt and long pants plus chemical-resistant gloves is required to protect mixers/loaders and applicators.
• A standard restricted-entry interval (REI) of 12 hours is required to protect workers entering treated areas.
• The standard drift mitigation statement is required to minimize the potential for spray drift to bystanders.

Environment

Label improvements to meet current standards:

• Updated discharge of effluent statements.
• Updated disposal statements.
• Updated storage statements.

Risk mitigation:

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

• Standard label statements to minimize potential risks resulting from runoff.
• Label statement to inform users of the potential toxic effects of florasulam to non-target terrestrial and aquatic vascular plants.
• Spray buffer zones (up to 3 metres) to protect terrestrial and aquatic habitats.
• Precaution statements on product labels warning of the potential for leaching and groundwater contamination.

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 RVD2022-03. 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 3} regarding this decision on florasulam 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 PRVD2021-03) 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 florasulam in Canada

Table 1 Products containing Florasulam requiring (label) amendments^{Table 1 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation typeTable 1 Footnote 2	Active ingredient (%, g/L)Table 1 Footnote 3
26888	Technical Grade Active Ingredient	Corteva Agriscience Canada Company	DE-570 Technical Herbicide	SO	FRA: 99.2%
30610		Adama Agricultural Solutions Canada Ltd.	ADAMA Florasulam Technical		FRA: 99.0%
30830		FMC of Canada Ltd.	FMC Florasulam Technical Herbicide		FRA: 99.35%
32664		NewAgco Inc.	NewAgco Florasulam Technical Herbicide		FRA: 98.44%
33121		Zhejiang Zhongshan Chemical Industry Group Co., Ltd.	Zhongshan Florasulam Technical 98%		FRA: 98.43%
33243		Sharda CropChem Ltd.	Sharda Florasulam Technical		FRA: 99.01%
33877		Albaugh, Llc.	ALBAUGH FLORASULAM Technical Herbicide		FRA: 98.34%
34074		Farmer's Business Network Canada, Inc.	FBN Florasulam Technical		FRA: 98.3%
33352	Commercial	Corteva Agriscience Canada Company	GF-1374 Herbicide	EC	FRA: 2.5 g/L; DPI: 80.0 g/L; FLR: 100 g/L
32099			Stellar™ XL Herbicide		FRA: 2.5 g/L; FLR: 100 g/L; MAE: 350 g/L
29286			GF-184 Herbicide	SU	FRA: 2.5 g/L; FLR: 100 g/L
28804			Frontline™ XL Herbicide		FRA: 4.0 g/L; MAE: 280 g/L
33289			GF-2257 Herbicide		FRA: 5.0 g/L; FLR: 100 g/L
33440			Tridem™ B Herbicide
33455			Avenza™ A Herbicide
26891			Florasulam Suspension Concentrate Herbicide		FRA: 50.0 g/L
27031			Spectrum™ A Herbicide
29651			PrePass™ XC A Herbicide
30060			Frontline™ 2,4-D XC A Herbicide
31519			ReadySet SC Herbicide
31547			PREP II Herbicide
31304			Paradigm™ PRE Herbicide	WG	FRA: 20.0%; HXM: 20.0%
33803			Exhilarate™ A Herbicide
34180			Cirpreme™ A Herbicide
30162			GF-1352 Herbicide		FRA: 25.0%
30416			PrePass™ 250 WG Herbicide
31038			Florasulam II Herbicide
31204			Florasulam WDG Herbicide
31259			PrePass™ FLEX Herbicide
31405			Korrex™ A Herbicide
33936		Syngenta Canada Inc.	STEEL Herbicide	EC	FRA: 2.5 g/L; FLR: 100 g/L
29138			BROADBAND®Herbicide		FRA: 7.73 g/L; PRN: 92.7 g/L
31646		Adama Agricultural Solutions Canada Ltd.	Outshine	SU	FRA: 2.5 g/L; FLR: 100 g/L
30814			Florasulam 50 SC Herbicide		FRA: 50.0 g/L
30831			PRIORITY®Herbicide
30857			Florasulam NC
31252		FMC of Canada Ltd.	SPITFIRE®50 SC Herbicide
32758			CHA 5373 Herbicide	WG	FRA: 20.0; MEX: 30.0%
31325		NewAgco Inc.	MPower Florasulam Herbicide	SU	FRA: 50.0 g/L
33003			BATTLEFRONT®Herbicide
31671		Winfield United Canada Ulc.	FirstPass™ Herbicide
31687		Loveland Products Canada Inc.	Blitz™ Herbicide
33273		Arysta LifeScience North America, Llc.	INFERNO®TRIO Herbicide	EC	FRA: 50 g/L; CAE: 175 g/L; FLS: 141 g/L
33431		Ciech Sarzyna S.A.	Florin Herbicide	SU	FRA: 50.0 g/L
33610		Sharda CropChem Ltd.	Flora Herbicide	SN	FRA: 50.0 g/L
33657		UPL AgroSolutions Canada Inc.	Akito™ Herbicide	EC	FRA: 2.5 g/L; DPI: 80.0 g/L; FLR: 100 g/L
33717		Nufarm Agriculture Inc.	ThunderHawk™ B Herbicide	SU	FRA: 50.0 g/L
34186		Farmer's Business Network Canada, Inc.	FBN Florasulam 50 SC
Table 1 Footnote 1 As of 4 November 2021, excluding discontinued products or products with a submission for discontinuation. Table 1 Return to footnote 1 referrer Table 1 Footnote 2 EC = emulsifiable concentrate; SN = solution; SO = solid; SU = suspension; WG = wettable granules. Table 1 Return to footnote 2 referrer Table 1 Footnote 3 FRA = florasulam; CAE = carfentrazone-ethyl; DPI = clopyralid; FLR = fluroxypyr-meptyl; FLS = flucarbazone (present as flucarbazone-sodium); HXM = halauxifen-methyl; MAE = MCPA (present as esters); MEX = tribenuron methyl; PRN = pinoxaden. Table 1 Return to footnote 3 referrer

Table 2 Products containing florasulam that do not require (label) amendments^{Table 2 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation typeTable 2 Footnote 2	Active ingredient (%, g/L)Table 2 Footnote 3
26889	Manufacturing Concentrate	Corteva Agriscience Canada Company	EF-1343 Manufacturing Concentrate	SU	FRA: 4.84%
26890			EF-1440 Manufacturing Concentrate		FRA: 45.0%
Table 2 Footnote 1 As of 4 November 2021, excluding discontinued products or products with a submission for discontinuation. Table 2 Return to footnote 1 referrer Table 2 Footnote 2 SU = suspension Table 2 Return to footnote 2 referrer Table 2 Footnote 3 FRA = florasulam Table 2 Return to footnote 3 referrer