Re-evaluation Decision RVD2023-11, Nucleopolyhedrovirus for Douglas-Fir Tussock Moth and Neodiprion abietis Nucleopolyhedrovirus, and Their Associated End-use Products

• Pest Management Regulatory Agency
• 6 June 2023
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2023-11E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for Nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus, and their associated end-use products
• Re-evaluation decision for Nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus
• Risk mitigation measures
• Next steps
• Other information
• Appendix I Registered products containing Nucleopolyhedrovirus for Douglas-fir tussock moth or Neodiprion abietis nucleopolyhedrovirus in Canada

Re-evaluation decision for Nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus, and their associated end-use products

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

Nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus are naturally occurring baculoviruses, registered in Canada for use as microbial pest control agents. Nucleopolyhedrovirus for Douglas-fir tussock moth is used for the control of Douglas-fir tussock moth and the suppression of white marked tussock moth on forest trees, in woodlands, along rights-of-way, in tree nurseries, in seed orchards, and in areas that are less than half a hectare with high-value trees or ornamental trees. Neodiprion abietis nucleopolyhedrovirus is used for the management of balsam fir sawfly larvae (Neodiprion abietis) in forestry sites and on field-grown conifers, including Christmas trees. Currently registered products containing nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus can be found in the Pesticide Product Information Database and in Appendix I.

The Proposed Re-evaluation Decision PRVD2022-20, Nucleopolyhedrovirus for Douglas-Fir Tussock Moth and Neodiprion abietis Nucleopolyhedrovirus and Their Associated End-use Products^{Footnote 1} containing the evaluation of nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus underwent a 90-day consultation period ending on 24 January 2023. PRVD2022-20 proposed continued registration of nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus products for sale and use in Canada, with label updates to meet current labelling standards (Appendix II and III of RVD2023-11).

No comments were received during the consultation period. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2022-20, which lists all information used as the basis for the re-evaluation decision.

This summary presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus, including the label updates required to meet the current labelling standards. All products containing nucleopolyhedroviruses for Douglas-fir tussock moth or Neodiprion abietis nucleopolyhedroviruses that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for Nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus

Health Canada has completed the re-evaluation of nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing nucleopolyhedroviruses for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedroviruses are acceptable with the label updates (Appendix II and III of RVD2023-11). An evaluation of available scientific information found that uses of nucleopolyhedroviruses for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedroviruses products meet current standards for protection of human health and the environment and have acceptable value with the label updates (Appendix II and III of RVD2023-11).

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 updated label statements, as a result of the re-evaluation of nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus, are summarized below. Refer to Appendix II and III of RVD2023-11 for details.

Label improvements to meet current standards - Human health:

• Update to standard label statements (wording related to personal protective equipment, first aid, spray drift, directions for use and the addition of a re-entry interval).

Label improvements to meet current standards – Environment:

• Updates to standard label statements (wording related to disposal).

Next steps

To comply with this decision, the required label amendments must be implemented on all product labels no later than 24 months after the publication date of this decision document. 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 this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on nucleopolyhedrovirus for Douglas-fir tussock moth and Neodiprion abietis nucleopolyhedrovirus and its associated end-use products within 60 days from the date of publication of RVD2023-11. 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 Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-20) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Appendix I Registered products containing Nucleopolyhedrovirus for Douglas-fir tussock moth or Neodiprion abietis nucleopolyhedrovirus in Canada

Table 1 Registered products containing Nucleopolyhedrovirus for Douglas-fir tussock moth requiring (label) amendments^{Table 1 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Guarantee
17786	R	Natural Resources Canada (FPM)	Virtuss Nucleopolyhedrovirus Biological Insecticide	Wettable Powder	2.5% (Contains at least 1 × 1010 Polyhedral Inclusion Bodies (PIBs) of Orgyia pseudotsugata nucleopolyhedrovirus per gram)
19293	R	Natural Resources Canada (FPM)	Tm Biocontrol-1 Nucleopolyhedrovirus Biological Insecticide	Wettable Granules	Contains at least 7.05 × 109 PIBs per gram
20290	T	Natural Resources Canada (FPM)	Tm Biocontrol-1 Nuclear Polyhedrosis Virus Biological Insecticide	Wettable Powder	3.5% (Contains at least 70 million activity units per gram)
29106	T	Natural Resources Canada (FPM)	Virtuss Technical Active Nucleopolyhedrovirus Biological Insecticide	Wettable Powder	2.5% (Contains at least 1 × 1010 PIBs of Orgyia pseudotsugata nucleopolyhedrovirus per gram)
T = Technical; R= restricted Natural Resources Canada (FPM) = Natural Resources Canada, Great Lakes Forestry Centre

Table 2 Registered products containing Neodiprion abietis nucleopolyhedrovirus requiring (label) amendments^{Table 2 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Guarantee
28303	T	Natural Resources Canada (CDQ)	Abietiv Technical	Suspension	4 × 109 PIBs per milliliter
28304	R	Natural Resources Canada (CDQ)	Abietiv Flowable Biological Insecticide	Suspension	4 × 109 PIBs per milliliter
T = Technical; R= restricted Natural Resources Canada (CDQ) = Natural Resources Canada, Canadian Forest Service-Atlantic Forestry Centre