Re-evaluation Note REV2017-05, Re-evaluation Project Plan for Pyriproxyfen

Pest Management Regulatory Agency
15 March 2017
ISSN: 1925-0649 (PDF version)
Catalogue number: H113-5/2017-5E-PDF (PDF version)

Table of Contents

• Background
• Re-evaluation Project Plan
• Data Requirements
• Additional Information
• Appendix I Data Required Under Subsection 19(1) of the Pest Control Products Act for the Re-evaluation of Pyriproxyfen

Background

In Canada, pyriproxyfen is under re-evaluation by Health Canada’s Pest Management Regulatory Agency (PMRA). 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.

Pyriproxyfen is an insect and mite growth regulator. It is registered in Canada for the control of a variety of insect and mite pests in greenhouse food and non-food crops, various indoor structures and furniture as well as on companion animals (dogs and cats). As of 4 January 2017, there are one technical grade product, three manufacturing concentrates, two commercial products and 32 domestic class end-use products containing pyriproxyfen registered in Canada.

Under the authority of section 16 of the Pest Control Products Act, all registrants of pyriproxyfen were notified of the initiation of the re-evaluation of pyriproxyfen. Following this, the registrant of pyriproxyfen technical grade active ingredient in Canada indicated support of all uses included on the labels of commercial and domestic class 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 pyriproxyfen.

Re-evaluation Project Plan

Anticipated Re-evaluation Timeline

The re-evaluation of pyriproxyfen is defined as a Category1 as described in Regulatory Directive 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 pyriproxyfen is anticipated to be published for consultation by July 2019. The re-evaluation timeline may be updated if, during the risk assessment, PMRA identifies additional areas of focus that should be considered.

Human Health Risk Assessment

Existing assessments with minor updates are considered to be adequate to support the re-evaluation of pyriproxyfen for most review areas.

Environmental Risk Assessment

Existing assessments with minor updates are considered to be adequate to support the re-evaluation of pyriproxyfen for most review areas.

Value

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

Data Requirements

DPMRA has identified the need for the technical registrant to provide data for pyriproxyfen related to chemistry and toxicology. Relevant data/studies have been requested from the technical registrant. A summary of the data call-in is found in PMRA’s Public Registry, found online at Pesticide Product Information Database. 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.

Additional Information

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)
Fax: 1-613-736-3798
E-mail: pmra.infoserv@hc-sc.gc.ca

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

1. Chemistry Data
   • 2.13.4 Impurities of Toxicological Concern
2. Toxicology Data
   • 4.2.1   Acute Oral
   • 4.2.3   Acute Inhalation
   • 4.2.4   Primary Eye Irritation
   • 4.2.5   Primary Dermal Irritation
   • 4.2.6   Dermal Sensitization
   • 4.3.3   Short-term Oral (28-day)
   • 4.3.5   Short-term Dermal (21/28-day)
   • 4.3.8   Other Short-term Studies
   • 4.4.3   Oncogenicity (rodent species 2)
   • 4.4.4   Combined Chronic/Oncogenicity (rodent)
   • 4.4.5   Other Long-term Studies
   • 4.5.12 Acute Neurotoxicity (rat)
   • 4.5.13 90-day Neurotoxicity (rat)
   • 4.5.2   Prenatal Developmental Toxicity (rodent)
   • 4.5.3   Prenatal Developmental Toxicity (non-rodent)
   • 4.5.4   Genotoxicity: Bacterial Reverse Mutation Assay
     4.5.9   Metabolism/Toxicokinetics in Mammals (laboratory animals)
   • 4.8     Other Studies/Data/Reports