Re-evaluation Note REV2019-04, Re-evaluation Project Plan for Florasulam

Pest Management Regulatory Agency
31 January 2019
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2019-4E-PDF (PDF version)

PDF Version (174kb)

Background

In Canada, florasulam is under re-evaluation by Health Canada's Pest Management Regulatory Agency (PMRA). The PMRA re-evaluates registered pesticides to determine whether the use of these products continues to be acceptable in terms of value, human health and the environment according to current standards.

Florasulam is a selective systemic herbicide registered for use in the Prairie provinces and the Peace River region of British Columbia for the control or suppression of weeds on cereals and grass. As of 16 January 2019, a total of 42 products containing florasulam were registered including six technical, two manufacturing concentrate and 34 commercial class end-use products.

Under the authority of section 16 of the Pest Control Products Act, the registrants of florasulam were notified of the initiation of the re-evaluation of florasulam. Following this, the registrants of florasulam technical grade active ingredients in Canada indicated support of all uses included on the labels of end-use products in Canada.

The re-evaluation project plan below outlines the timeline, the anticipated areas of focus for the risk assessments, and the data requirements for the re-evaluation of florasulam.

Re-evaluation Project Plan

Anticipated Re-evaluation Timeline

The re-evaluation of florasulam is defined as a Category 1 as described in Regulatory Directive DIR2016-04, Management of Pesticides Re-evaluation Policy. Currently, a proposed re-evaluation decision for florasulam is anticipated to be published for consultation by January 2020. The re-evaluation timeline may be updated if, during the risk assessment, the PMRA identifies additional areas of focus that should be considered.

Human Health Risk Assessment

New assessments will be conducted for toxicology, dietary exposure and occupational exposure.

Environmental Risk Assessment

New assessments will be conducted for environmental fate, water modelling and environmental exposure.

Value

The value of florasulam will be considered. The viability of alternatives will be examined for certain uses if risks of concern requiring mitigation are identified.

Data Requirements

The PMRA has identified the need for the technical registrants to provide data for florasulam related to health and the environment. Available data have been submitted to the PMRA. A summary of the data call-in is found in the PMRA's Public Registry. For a list of data categories that have been required, see Appendix I. In addition, information regarding the registered use pattern has been requested and received from the registrants, to inform the risk assessments.

Additional Information

PMRA documents can be found in the Pesticides section of Canada.ca. PMRA documents are also available through the Pest Management Information Service:

Phone:

1-800-267-6315 within Canada, or

1-613-736-3799 outside Canada (long distance charges apply)

Fax:

1-613-736-3798

E-mail:

pmra.info-arla@hc-sc.gc.ca

Appendix I Data Required Under Subsection 19(1) of the Pest Control Products Act for the Re-evaluation of Florasulam

DACO	Description
Toxicology
4.5.4	Genotoxicity: Bacterial Reverse Mutation Assay
4.5.7	Genotoxicity: In vivo Cytogenetics
4.5.15	Immunotoxicity
4.8	Other Studies/Data/Reports
Environmental Fate
8.2.1	Summary of Physicochemical Properties
8.2.2.1	Analytical Methodology Soil
8.2.2.3	Analytical Methodology Water
8.2.4.1	Summary of Laboratory Studies of Mobility
8.2.3.3	Phototransformation
8.2.3.4.2	Biotransformation in Soil: Aerobic Soil: 20°-30°C
8.2.3.5.4	Biotransformation in Aquatic Systems: Aerobic Water/Sediment 20°-30°C
8.2.4.2	Adsorption/Desorption
8.3.2	Hydrolysis
8.3.3.3	Aquatic Field Studies of Dissipation/Accumulation
8.6	Other Studies/Data/Reports
Ecotoxicology
9.1	Summary of Environmental Toxicology
9.2.3.1	Earthworms Acute Toxicity
9.2.3.2	Earthworms Chronic Toxicity
9.2.4.1	Bee Adult Acute Contact Toxicity
9.2.4.2	Bee Adult Acute Oral Toxicity
9.2.4.3	Bee Larvae Toxicity
9.2.4.4	Honey Bee Adult Chronic Toxicity
9.2.4.9	Other Pollinator Studies
9.2.5	Predators
9.2.7	Other Terrestrial Invertebrates
9.3.2	Non-Target Freshwater Invertebrates: Daphnia sp. Acute
9.5.2.1	Acute Studies Cold Water Fish (Rainbow Trout)
9.8	Non-Target Plants
9.8.2 9.8.4	Non-Target Plants: Terrestrial Vascular Plants and Fresh Water Algae
9.8.5	Non-Target Plants: Aquatic Vascular Plants
9.9	Other Studies/Data/Reports