Proposed Re-evaluation Decision PRVD2019-08, Streptomyces strain K61 and Its Associated End-use Product
Pest Management Regulatory Agency
25 July 2019
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2019-8E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Streptomyces strain K61
- International Context
- Next Steps
- Additional Scientific Information
Proposed Re-evaluation Decision
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 current health and environmental safety standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports, and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies to all re-evaluations.
Streptomyces strain K61 is a bacterium that is used as a microbial pest control agent for the suppression of damping-off, root and crown rot, and wilt in various greenhouse ornamentals, vegetables, and herbs caused by common pathogenic fungi. The commercial end-use product is formulated as a wettable powder and is applied as a water suspension directly to the root zone/growing media of greenhouse plants. It can also be used as a seed treatment and is applied as a powder directly to seeds.
This document (Proposed Re-evaluation Decision PRVD2019-08, Streptomyces strain K61 and Its Associated End-use Product) presents the proposed regulatory decision for the re-evaluation of Streptomyces strain K61 and includes the proposed label updates, as well as the science evaluation on which the proposed decision was based. All products containing Streptomyces strain K61 registered as a fungicide in Canada are subject to this proposed re-evaluation decision. This document (PRVD2019-08) is subject to a 90-day public consultation period, during which the public, including the pesticide manufacturers and stakeholders, may submit written comments and additional information to the PMRA. The final re-evaluation decision will be published taking into consideration the comments and information received.
Outcome of Science Evaluation
Streptomyces strain K61 has value in providing an additional disease management option for greenhouse vegetables and ornamentals.
Streptomyces strain K61 is a widely distributed and naturally occurring soil bacterium. Previous human exposure to natural populations of it and other soilborne species of Streptomyces are expected, and Streptomyces strain K61 has a long history of use with no known reports of adverse effects. When Streptomyces strain K61 was tested on laboratory animals, there were no signs that it caused any adverse disease, but it was considered to be toxic when inhaled.
With respect to human health, Streptomyces strain K61 has a low toxicity and infectivity profile. When the current label directions are followed, occupational and residential exposures to Streptomyces strain K61 are expected to be minimal and potential occupational and residential risk is considered to be acceptable for all populations. Likewise, with current label directions, food and drinking water residues of Streptomyces strain K61 are expected to be minimal. Combined with a long history of dietary exposure from natural populations and the low toxicity and infectivity profile of Streptomyces strain K61, the potential dietary risk (from food and drinking water) is considered to be acceptable for all populations.
Streptomyces strain K61 is not expected to be pathogenic or toxic to non-target organisms, and based on the current conditions of use in greenhouses, environmental exposure to Streptomyces strain K61 is expected to be minimal. As such, the potential risk to non-target organisms (aquatic and terrestrial) from the use of Streptomyces strain K61 is considered to be acceptable under the current conditions of use.
No additional information is required. No additional risk mitigation measures are proposed. However, updated label statements are proposed for further clarity and to meet the current labelling standards (Appendix II of PRVD2019-08).
Proposed Regulatory Decision for Streptomyces strain K61
Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, Health Canada is proposing that products containing Streptomyces strain K61 are acceptable for continued registration for use and sale in Canada.
Registered pesticide product labels include specific instructions for use. Directions include risk mitigation measures to protect human health and the environment that must be followed by law. As a result of the re-evaluation of Streptomyces strain K61, no additional risk mitigation measures are proposed by the PMRA. To meet current labelling standards, the following label updates and clarifications are proposed (Refer to the details in Appendix II of PRVD2019-08):
- Clarification for use in greenhouses only;
- Updated personal protective equipment label statement;
- Updated warning label statements; and
- Restricted-entry interval label statement.
Streptomyces strain K61 is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the European Union, the United States, and Switzerland.
No decision by an OECD-member country to prohibit all uses of this microbial for health or environmental reasons has been identified.
The public, including the registrants and stakeholders, are encouraged to submit comments during the 90-day public consultation periodFootnote 1 upon publication of PRVD2019-08.
All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision document.Footnote 2 The re-evaluation decision document will include the final re-evaluation decision, the reasons for it, and a summary of comments received on the proposed re-evaluation decision along with the PMRA's responses.
Additional Scientific Information
No additional data are required.
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