Proposed Re-evaluation Decision PRVD2021-03, Florasulam and Its Associated End-use Products

Pest Management Regulatory Agency
25 February 2021
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2021-3E-PDF (PDF version)

Table of contents

• Proposed re-evaluation decision for florasulam and associated end-use products
• Proposed re-evaluation decision for florasulam
• International context
• Next steps
• Additional scientific information

Proposed 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 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, 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 Label Search and in Appendix I of PRVD2021-03.

This document (Proposed Re-evaluation Decision PRVD2021-03, Florasulam and Its Associated End-use Products) presents the proposed re-evaluation decision for florasulam including the proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the science evaluation on which the proposed decision is based. All products containing florasulam that are registered in Canada are subject to this proposed re-evaluation decision. PRVD2021-03 is subject to a 90-day public consultation period,^{Footnote 1} during which the public including the pesticide manufacturers and stakeholders may submit written comments and additional information to PMRA Publications. The final re-evaluation decision will be published after taking into consideration the comments and information received during the consultation period.

Proposed re-evaluation decision for florasulam

Under the authority of the Pest Control Products Act and based on an evaluation of available scientific information, Health Canada is proposing continued registration of florasulam and associated end-use products registered for sale and use in Canada.

With respect to human health, potential risks from dietary (food and drinking water) and occupational exposure were shown to be acceptable when florasulam is used according to the proposed conditions of registration, which includes additional mitigation measures such as personal protective equipment and standard restricted-entry intervals. The cumulative risks from potential co-exposure to florasulam, cloransulam-methyl, flumetsulam, diclosulam, penoxsulam and metosulam through food and drinking water are also acceptable.

The environmental risk assessment found that potential risks to the environment associated with the use of florasulam were shown to be acceptable when used according to proposed conditions of registration, which includes new mitigation measures, such as precautionary statements, and spray buffer zones for the protection of terrestrial and aquatic habitats (up to 3 metres).

Florasulam has value in providing control or suppression of a wide spectrum of annual and perennial broadleaf weeds, including those hard-to-control weeds such as cleavers and wild buckwheat, in cereal crops, grass pastures, and summerfallow.

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 proposed label amendments including any revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of florasulam, are summarized below. Refer to Appendix XI of PRVD2021-03 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 proposed:

• 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.

To protect workers entering treated sites, a restricted-entry interval (REI) of 12 hours is proposed.

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 proposed:

• 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.

International context

As of 10 July 2020, florasulam is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries including the United States, European Union, Australia, Japan, New Zealand, Norway, and Switzerland. No decision by an OECD member country to prohibit all uses of florasulam for health or environmental reasons has been identified.

Next steps

Upon publication of this proposed re-evaluation decision (PRVD2021-03), the public including the registrants and stakeholders are encouraged to submit additional information that could be used to refine risk assessments during the 90-day public consultation period.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document,^{Footnote 2} The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with Health Canada's responses.

Refer to Appendix I of PRVD2021-03 for details on specific products impacted by this proposed decision.

Additional scientific information

The registrant of Pest Control Products Act Reg. No. 26888 is required to provide batch data in order to address the impurities of concern. A notice, pursuant to paragraph 12 of the Pest Control Products Act, which includes details outlining the requirements, will be issued to the registrant.