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.
Should you require further information please contact the Pest Management Information Service.
Table of contents
- Re-evaluation decision for pyriproxyfen and its associated end-use products
- Re-evaluation decision for pyriproxyfen
- Risk mitigation measures
- Next steps
- Other information
- Appendix I - Registered products containing pyriproxyfen in Canada
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:
- Updated label statements for personal protective equipment
- Label statements to address the following:
- Prohibit application of recycled greenhouse water to outdoor food crops
- Prevent contamination of food and food surfaces during indoor applications
- Clarifying and/or ensuring consistency regarding use directions and precautionary statements
- Label amendments as per PMRA Guidance Document, Label Improvements for Spot-on Pesticides Used on Companion Animals (2019)
Risk Mitigation:
- Addition of personal protective equipment for products used to control fleas in indoor environments
- Prohibition of application using handheld mist blower or handheld fogging equipment due to lack of data to assess occupational exposure,
Environment
Label improvements to meet current standards:
- Standard label statements to inform users of the potential toxic effects of pyriproxyfen to aquatic organisms.
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
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% |
|||
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.
- Footnote 2
-
"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.
- Footnote 3
-
As per subsection 35(1) of the Pest Control Products Act
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