Re-evaluation Note REV2017-07, Re-evaluation Project Plan for Tebufenozide
Pest Management Regulatory Agency
15 March 2017
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2017-7E-PDF (PDF version)
Table of Contents
In Canada, tebufenozide 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.
Tebufenozide is an insecticide registered for control of larval Lepidoptera (in other words, butterflies and moths). It is registered for use on terrestrial and greenhouse food crops, greenhouse and outdoor ornamentals, and for forest and woodlots management. As of 7 January 2017, there are one technical grade product and two end-use products registered for use in Canada.
Under the authority of section 16 of the Pest Control Products Act, the registrant of tebufenozide was notified of the initiation of the re-evaluation of tebufenozide. Following this, the registrant of tebufenozide technical grade active ingredient in Canada indicated its 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 tebufenozide.
Re-evaluation Project Plan
Anticipated Re-evaluation Timeline
The re-evaluation of tebufenozide is defined as a Category 1 as described in DIR2016-04, Management of Pesticides Re-evaluation Policy, which was adopted on 1 December 2016. However, because this re-evaluation was initiated prior to the publication of DIR2016-04, the proposed re-evaluation decision for tebufenozide is anticipated to be published for consultation by February 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 toxicology and dietary exposure. Existing assessments with minor updates are considered to be adequate to support the re-evaluation of tebufenozide for the other aspects of human health assessment.
Environmental Risk Assessment
New assessments will be conducted for environmental fate, water modelling and exposure.
The value of tebufenozide 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 tebufenozide related to toxicology and 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 registrants, to inform the risk assessments.
PMRA documents can be found in the Pesticides and Pest Management section of Health Canada's website at healthcanada.gc.ca/pmra. 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)
Appendix I Data Requirements Under Subsection 19(1) of the Pest Control Products Act for the Re-evaluation of Tebufenozide
|DACO 4.2.9||Acute toxicity|
|DACO 4.5.5||Genotoxicity: In vitro mammalian cell assay|
|DACO 4.5.7||Genotoxicity: In vivo cytogenetics|
|DACO 4.6.3||Acute studies: Acute inhalation - EP|
|DACO 4.8||Other toxicology studies|
|DACO 12.5.4||Foreign reviews of toxicity (if available)|
|DACO 22.214.171.124||Analytical methods: Sediment|
|DACO 126.96.36.199||Analytical methods: Water|
|DACO 188.8.131.52||Analytical methods: Biota|
|DACO 184.108.40.206.2||Biotransformation in soil: Aerobic soil 20-30°C|
|DACO 220.127.116.11||Hive study (including brood)|
|DACO 18.104.22.168||Non-target terrestrial invertebrates: Honey bee|
|DACO 9.3.2||Non-target freshwater invertebrates (Daphnia sp. Acute)|
|DACO 9.3.3||Non-target freshwater invertebrates (Daphnia sp. Chronic)|
|DACO 9.4.5||Non-target marine invertebrates: chronic (mollusk or crustacean)|
|DACO 22.214.171.124||Acute studies: cold water fish (rainbow trout)|
|DACO 126.96.36.199||Sublethal and chronic studies: fish, early life cycle toxicity test|
|DACO 188.8.131.52||Sublethal and chronic studies: fish, life cycle toxicity|
|DACO 9.8.4||Non-target plants: terrestrial vascular plants|
|DACO 9.8.5||Non-target plants: aquatic vascular plants|
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