Re-evaluation Decision RVD2021-03, Pyriproxyfen and Its Associated End-use Products

Pest Management Regulatory Agency
26 February 2021
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2021-3E-PDF (PDF version)

Summary

To obtain a full copy of Re-evaluation Decision RVD2021-03, Pyriproxyfen and Its Associated End-use Products please contact our publications office.

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Table of contents

Re-evaluation decision for pyriproxyfen and its associated end-use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Pyriproxyfen is an insect growth regulator that contributes to the management of white flies in greenhouse vegetable and ornamental production, flea control in indoor, non-food areas of structures and management of fleas on cats and dogs. Currently registered products containing pyriproxyfen can be found in the Pesticide Label Search and in Appendix I. The Proposed Re-evaluation Decision PRVD2019-10, Pyriproxyfen and Its Associated End-use ProductsFootnote 1 containing the evaluation of pyriproxyfen and proposed decision, underwent a 90-day consultation period ending on 4 February 2020. PRVD2019-10 proposed that products containing pyriproxyfen are acceptable for continued registration when used according to the proposed conditions of registration, which include new mitigation measures.

No comments were received during the consultation period. Health Incident report information was updated (see Science evaluation update of RVD2021-03), and the outcome of this update did not change the conclusions in PRVD2019-10. Therefore, this final decision is consistent with the proposed re-evaluation decision stated in PRVD2019-10, which also lists all information used as the basis for the re-evaluation decision.

This document (Re-evaluation Decision RVD2021-03, Pyriproxyfen and Its Associated End-use Products) presents the final re-evaluation decisionFootnote 2 for the re-evaluation of pyriproxyfen, including the required amendments (risk mitigation measures) to protect human health and the environment, as well as any label amendments required to bring labels to current standards. All products containing pyriproxyfen that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for pyriproxyfen

Health Canada has completed the re-evaluation of pyriproxyfen. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing pyriproxyfen is acceptable. An evaluation of available scientific information found that uses of pyriproxyfen products meet current standards for protection of human health and the environment and have acceptable value when used according to the revised conditions of registration which includes new mitigation measures. Label amendments, as summarized below and listed in Appendix II of RVD2021-03, are required.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required amendments, including any revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of pyriproxyfen, are summarized below. Refer to Appendix II of RVD2021-03 for details.

Health

Label improvements to meet current standards:

Risk Mitigation:

Environment

Label improvements to meet current standards:

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of RVD2021-03. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of RVD2021-03 to transition to using the newly amended labels, which will be available on the Public Registry.

The majority of spot-on products containing pyriproxyfen were examined separately under the PMRA Guidance Document, Label Improvements for Spot-on Pesticides Used on Companion Animals (published 6 December 2019); registrants were notified of and consented to the label changes prior to publication (September/October 2019). The label amendments for the spot-on products in Appendix 2 of the Guidance Document will be implemented according to the timeline specified in the Guidance. The only exception includes 11 spot-on products containing imidacloprid (outlined in Appendix I, Table 2), which were registered just prior to the publication of the 2019 Guidance Document. Label amendments consistent with the Guidance Document have already been implemented as part of these registration decisions.

Refer to Appendix I, Table 1 for details on specific products impacted by this re-evaluation decision.

Other information

Any person may file a notice of objectionFootnote 3 regarding this decision on pyriproxyfen and its associated end-use products within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service by phone (1-800-267-6315) or by e-mail (hc.pmra-info-arla.sc@canada.ca).

The relevant confidential test data on which the decision is based (as referenced in PRVD2019-10) are available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa). For more information, please contact the PMRA's Pest Management Information Service.

Appendix I - Registered products containing pyriproxyfen in Canada

Table 1 Registered products containing pyriproxyfen in Canada requiring label amendmentsTable 1 footnote 1
Registration number Marketing class Registrant Product name Formulation type Active ingredient
25105 Technical grade active Ingredient Sumitomo Chemical Company Ltd. Sumilary Technical Grade Solid Pyriproxyfen 98.7%
25489 Manufacturing concentrate McLaughlin Gormley King Company Nylar 50% Concentrate Solution Pyriproxyfen 50%
27545 Rolf C. HAGEN Inc. Permethrin Nylar Squeeze on Manufacturing Blen Solution Pyriproxyfen 1.9% Permethrin 45%
27705 Etofenprox Nylar Squeeze on Manufacturing Blend Pyriproxyfen 2.2% Etofenprox 55%
25490 Commercial McLaughlin Gormley King Company Nyguard IGR Concentrate Emulsifiable Concentrate Pyriproxyfen 10%
28414 VALENT Canada Inc. Distance Emulsifiable Concentrate Pyriproxyfen 103 g/L
31119 Domestic HARTZ Canada Inc. Hartz Ultraguard Plus Flea and Tick Home Spray Solution Pyriproxyfen 0.015%
D-phenothrin 0.40% Piperonyl butoxide 1%
25491 Domestic McLaughlin Gormley King Company Nylar Pressurized Spray 2618 Pressurized product Pyriproxyfen 0.015%
D-phenothrin 0.30% Tetramethrin 0.40%
31941 Domestic Neogen Corporation Prozap Pet Guard Igr Flea Spray Pressurized product Pyriproxyfen 0.015%
D-phenothrin 0.30% Tetramethrin 0.40%
26179 Domestic Premier Tech Ltd. C-I-L Flea Killer Surface Spray Pressurized product Pyriproxyfen 0.015%
D-phenothrin 0.300% Tetramethrin 0.400%
26502 Domestic Rolf C. HAGEN Inc. Sergeant's Pretect Household Flea Spray Pressurized product Pyriproxyfen 0.015%
D-phenothrin 0.3% Tetramethrin 0.4%
31647 Sentry Household Flea Spray Pyriproxyfen 0.015%
D-phenothrin 0.30% Tetramethrin 0.40%
Table 2 List of spot-on pyriproxyfen products used on companion animalsTable 2 footnote 1
Registration number Marketing class Registrant Product name Formulation type Active ingredient
Subject to PMRA Guidance Document, Label Improvements for Spot-on Pesticides Used on Companion Animals (2019)
27581 Domestic Elanco Canada Limited Advantage II Small Dog Solution Pyriproxyfen 0.46% Imidacloprid 9.1%
27582 Advantage II Large Dog
27583 Advantage II Medium Dog
27584 Advantage II Extra Large Dog
27585 Advantage II Small Cat/Rabbit/Ferret
27586 Advantage II Large Cat
29777 Advantix II Small Dog Pyriproxyfen 0.44%
Permethrin 44%
Imidacloprid 8.8%
29778 Advantix II Medium Dog
29779 Advantix II Extra Large Dog
29780 Advantix II Large Dog
31517 Advantage II Kittens Pyriproxyfen 0.46% Imidacloprid 9.1%
28113 Domestic Rolf C. HAGEN Inc. Sergeant's Pretect Squeeze-On Flea, Tick and Mosquito Control for Dogs (up to 15 kg)   Liquid Pyriproxyfen 1.9% Permethrin 45%
28280 Sergeant's Pretect Squeeze-On Flea, Tick and Mosquito Control for Dogs (over 30 kg) Solution
28281 Sergeant's Pretect Squeeze-On Flea, Tick and Mosquito Control for Dogs (15-30 kg)
28610 Sergeant's Pre Tect Squeeze-On Flea Control for Cats and Kittens Pyriproxyfen 2.2%
31608 Sentry Flea Squeeze-On for Cats and Kittens
31609 Sentry Flea, Tick and Mosquito Squeeze-On for Dogs (15 to 30 kg) Pyriproxyfen 1.9% Permethrin 45%
31610 Sentry Flea, Tick and Mosquito Squeeze-On for Dogs (over 30 kg)
31611 Sentry Flea, Tick and Mosquito Squeeze-On for Dogs (up to 15 kg)
Label amendments consistent with PMRA Guidance Document, Label Improvements for Spot-on Pesticides Used on Companion Animals (2019) were previously implemented for the following products as part of these registration decisions:
33738 Domestic Evergreen Animal Health, LLC. Evergreen II Spot On for Extra Large Dogs Solution Pyriproxyfen 0.36%
Permethrin 35.6%
Imidacloprid 7.12%
33739 Evergreen II Spot On for Large Dogs
33740 Evergreen II Spot On for Medium Large Dogs
33741 Evergreen II Spot On for Small Dogs
33789 Parapet K9 Praventa 360 for Extra Large Dogs
33790 Parapet K9 Praventa 360 for Large Dogs
33791 Parapet K9 Praventa 360 for Extra Medium Dogs
33792 Parapet K9 Praventa 360 for Small Dogs
33419 Domestic Vetech Laboratories Inc., DBA Ceva Animal Health Vectra 3D for Dogs Weighing 25.1 to 43 kg Solution Pyriproxyfen 0.44%
Dinotefuran 4.95% Permethrin 36.08%
33420 Vectra 3D for Dogs and Puppies over 7 Weeks of Age Weighing 9.1 To 25 kg
33421 Vectra 3D for Dogs and Puppies over 7 Weeks of Age Weighing 4.6 To 9.0 kg

Footnotes

Footnote 1

"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.

Return to footnote 1 referrer

Footnote 2

"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.

Return to footnote 2 referrer

Footnote 3

As per subsection 35(1) of the Pest Control Products Act

Return to footnote 3 referrer

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