Re-evaluation Decision RVD2023-12, Chondrostereum purpureum strain PFC2139 and Its Associated End-use Products

• Pest Management Regulatory Agency
• 06 July 2023
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2023-12E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for Chondrostereum purpureum strain PFC2139 and associated end use products
• Re-evaluation decision for Chondrostereum purpureum strain PFC2139
• Risk mitigation measures
• Next steps
• Other information
• Appendix I - Registered products containing Chondrostereum purpureum strain PFC2139 in Canada

Re-evaluation decision for Chondrostereum purpureum strain PFC2139 and 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 safety 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 current risk management approaches and policies.

Chondrostereum purpureum strain PFC2139 is a naturally occurring biological herbicide registered for use in Canada for inhibiting resprouting and regrowth from cut stumps of certain deciduous trees in rights-of-way and for forest vegetation management. Chondrostereum purpureum strain PFC2139 is a native, fungus that is commonly distributed across Canada. The fungus is not host specific and has a wide host range with a preference for broad-leaved trees. Currently registered products containing Chondrostereum purpureum strain PFC2139 can be found in the Pesticide Product Information Database and in Appendix I.

The Proposed Re-evaluation Decision PRVD2022-03, Chondrostereum purpureum strain PFC2139 and Its Associated End-use Products^{Footnote 1} containing the evaluation of Chondrostereum purpureum strain PFC2139 and proposed decision, underwent a 90-day consultation period ending on 20 June 2022. PRVD2022-03 proposed continued registration of Chondrostereum purpureum strain PFC2139 products in Canada, with the proposed updates to label directions and precautions to reflect the current labelling standards and improve clarity.

Health Canada received one comment relating to a product name. Commenter is listed in Appendix II of Re-evaluation Decision RVD2023-12, Chondrostereum purpureum strain PFC2139 and Its Associated End-use Products. The comment is summarized in Appendix III of RVD2023-12 along with the response by Health Canada. The comment did not result in revisions to the value assessment and did not result in changes to the proposed re-evaluation decision as described in PRVD2022-03. A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2022-03.

This summary presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of Chondrostereum purpureum strain PFC2139, including the required label updates required to bring labels to current standards and improve clarity. All products containing Chondrostereum purpureum strain PFC2139 that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for Chondrostereum purpureum strain PFC2139

Health Canada has completed the re-evaluation of Chondrostereum purpureum strain PFC2139. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing Chondrostereum purpureum strain PFC2139 is acceptable. An evaluation of available scientific information found that the use of Chondrostereum purpureum strain PFC2139 products meet current standards for protection of human health and the environment and have acceptable value when used according to revised conditions of registration which includes label updates.

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 Chondrostereum purpureum strain PFC2139, are summarized below. Refer to Appendix IV of RVD2023-12 for details.

Human Health

Label updates to meet current standards:

• Update to standard label statements (wording related to first aid and disposal).

Environment

Label updates to meet current standards:

• Updates to standard label statements (use restrictions, environmental precautions and disposal).

Next steps

To comply with this decision, the required amendments (label updates) 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 Chondrostereum purpureum strain PFC2139 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 PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-03) 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 Chondrostereum purpureum strain PFC2139 in Canada

Table 1 Products containing Chondrostereum purpureum strain PFC2139 requiring (label) amendments^{Table 1 Footnote 1}

Registration number	Class	Registrant	Product name	Formulation type	Active ingredient (%)
27822	T	Danstar Ferment AG.	CP-PFC2139	Dust or powder	CPO 105 to 107 CFU/kg
29292	T	Danstar Ferment AG.	PT-PFC2139	Wettable powder	CPO 1 × 107 to 5 × 108 CFU/kg
27823	C	Danstar Ferment AG.	Chontrol™ Paste	Paste	CPO 105 to 107 CFU/kg
29293	C	Danstar Ferment AG.	Lalcide Chondro	Paste	CPO 105 to 107 CFU/kg
T = Technical grade active ingredient, C = Commercial CPO = Chondrostereum purpureum strain PFC2139, CFU = colony-forming unit