Re-evaluation Note REV2017-26, Re-evaluation Project Plan for Flucarbazone
Table of Contents
In Canada, flucarbazone 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.
Flucarbazone is an agricultural herbicide used on wheat. As of 29 August 2017, there were one technical product and nine end-use products containing flucarbazone registered in Canada.
Under the authority of section 16 of the Pest Control Products Act, all registrants of flucarbazone products were notified of the initiation of the re-evaluation of flucarbazone. Following this, the registrant of the flucarbazone technical grade active ingredient 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 flucarbazone.
Re-evaluation Project Plan
Anticipated Re-evaluation Timeline
The re-evaluation of flucarbazone 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 flucarbazone is anticipated to be published for consultation by April 2019. 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 dietary exposure. Existing assessments with minor updates are considered to be adequate to support the re-evaluation of flucarbazone for the other aspects of human health assessment.
Environmental Risk Assessment
New assessments will be conducted for environmental fate, water modelling, as well as the environmental risk assessment for terrestrial and aquatic non-target organisms.
The value of flucarbazone will be considered. The viability of alternatives will be examined for certain uses if risks of concern requiring mitigation are identified.
The PMRA has identified the need for the technical registrant to provide data for flucarbazone related to toxicology and the environment. Relevant data/studies have been requested from the technical registrant. 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 from the registrant, to inform the risk assessments.
Phone: 1-800-267-6315 within Canada, or 1-613-736-3799 outside Canada (long distance charges apply)
Appendix I Data Required Under Subsection 19(1) of the Pest Control Products Act for the Re-evaluation of Flucarbazone
I. Toxicology Data
- DACO 4.3.6 Inhalation study with rats
II. Environmental Data
- CODO 18.104.22.168 Toxicité pour les abeilles au stade larvaire
- CODO 22.214.171.124 Toxicité chronique pour les abeilles au stade adulte
- CODO 9.2.5 Prédateurs
- CODO 9.2.6 Parasites
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