Re-evaluation Note REV2019-03, Re-evaluation Project Plan for Triticonazole

Pest Management Regulatory Agency
31 January 2019
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2019-3E-PDF (PDF version)

(PDF version)

Background

In Canada, triticonazole 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.

Triticonazole is a systemic fungicide registered for control or suppression diseases on cereals, corn and turf. As of 16 January 2019, 11 products containing triticonazole were registered in Canada including one technical grade active ingredient, two manufacturing concentrate and eight commercial class end use products.

Under the authority of section 16 of the Pest Control Products Act, the registrants of triticonazole were notified of the initiation of the re-evaluation of triticonazole. Following this, the registrants of triticonazole 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 triticonazole.

Re-evaluation Project Plan

Anticipated Re-evaluation Timeline

The re-evaluation of triticonazole is defined as a Category 1 as described in Regulatory Directive DIR2016-04, Management of Pesticides Re-evaluation Policy. However, because this re-evaluation was initiated prior to the publication of DIR2016-04, the proposed re-evaluation decision for triticonazole is anticipated to be published for consultation by July 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, occupational exposure and residential exposure.

Environmental Risk Assessment

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

Value

The value of triticonazole 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 triticonazole 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: 1-800-267-631 within Canada, or
1-613-736-3799 outside Canada (long distance charges apply)

Fax: 1-613-736-3798
E-mail: hc.pmra.info-arla.sc@canada.ca

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

I Chemistry

DACO Description
Chemistry
2.13.4 Impurities of Human Health or Environmental Concern
Human Health
4.2.3 Acute Inhalation
4.2.6 Dermal Sensitization
4.5.1 An Acute Oral
4.5.4 Genotoxicity: Bacterial Reverse Mutation Assay
4.5.14 Developmental Neurotoxicity
4.8 Other Studies/Data/Reports
5.9 Dislodgeable Residues
Environmental Fate and Ecotoxicology
8.2.2.1 Analytical Methodology Soil
8.2.2.4 Analytical methodology (parent compound and transformation products).
8.2.3.3.2 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
8.2.3.5.6 Anaerobic Sediment/Water 20°-30°C
9.2.3.1 Earthworms: Acute Toxicity
9.2.4.1 Bees/Pollinators: acute contact
9.2.4.2 Bees/Pollinators: acute oral
9.2.4.3 Bees/Pollinators: bee larvae toxicity
9.2.4.4 Bees/Pollinators: bee adult chronic toxicity
9.3.2 Non-Target Freshwater Invertebrates: Daphnia sp. Acute
9.3.3 Daphnia sp. Chronic (Life-Cycle)
9.4.2 Non-Target Marine Invertebrates Acute (Crustacean)
9.4.8 Bioconcentration/Depuration (Bivalve or Crustacean)
9.5.2.2 Warm Water Fish (bluegill sunfish)
9.5.2.4 Marine/Estuarine Fish
9.5.3.1 Fish, Early Life Cycle Toxicity Test
9.5.3.2 Fish, Life Cycle Toxicity Test
9.8.2 Fresh Water Algae
9.8.4 Terrestrial Vascular Plants
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