Proposed Re-evaluation Decision PRVD2024-02, Natamycin and Its Associated End-use Products

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Pest Management Regulatory Agency
6 March 2024
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2024-2E-PDF (PDF version)

Summary

Table of contents

• Proposed re-evaluation decision
• Next steps
• Other information
• Additional scientific information

Proposed re-evaluation decision

Under the Pest Control Products Act, all registered pesticides must be re-evaluated regularly 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 data and information from various sources such as information from pesticide manufacturers, incident reports, and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods, risk management approaches and policies to all re-evaluations.

This document (Proposed Re-evaluation Decision PRVD2024-02, Natamycin and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of natamycin, including any proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the science evaluation on which the proposed decision is based.

Natamycin is registered to suppress dry bubble disease in mushroom production facilities. It is also registered for use as a preservative for samples of milk used in analytical testing laboratories. Currently registered products containing natamycin are listed in Appendix I of the full version of PRVD2024-02.

Natamycin, also known as pimaricin, is a naturally-occurring antimycotic substance, produced by the soil bacterium Streptomyces natalensis, Streptomyces lydicus, and Streptomyces chattanoogensis. Natamycin prevents the germination of fungal spores. It is an important tool for mushroom growers to control integrated dry bubble disease management. It is also important to the dairy industry to preserve milk samples in analytical testing laboratories. Natamycin is also a food preservative that is approved and used in more than 150 countries around the world. Based on the current use pattern, natamycin has value in providing a pest management solution, and the potential risks to human health (dietary, occupational, and bystander) and the environment (aquatic and terrestrial organisms) are considered to be acceptable when products containing natamycin are used according to proposed label updates.

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law. The key risk-reduction measures being proposed for natamycin to address the potential risks identified in this re-evaluation are as follows:

• Updates to precautionary and first aid statements
• Updates to storage and disposal statements
• Resistance management statement for mushroom use

Refer to Appendix II of PRVD2024-02 for all proposed label updates.

Under the authority of the Pest Control Products Act and based on an evaluation of currently available scientific information, products containing natamycin (Appendix I of PRVD2024-02) are being proposed for continued registration in Canada, with the proposed updates to label directions (Appendix II of PRVD2024-02).

All products containing natamycin registered in Canada are subject to this proposed re-evaluation decision. This document is subject to a public consultation^{Footnote 1}, during which written comments and additional information may be submitted to PMRA Publications. The final re-evaluation decision will be published taking into consideration the comments and information received during the consultation period.

Next steps

The public, including the registrants and stakeholders, are encouraged to submit written comments and additional information during the 90-day public consultation period upon publication of this proposed re-evaluation decision.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document^{Footnote 2}, which could result in revised risk mitigation measures. 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 with Health Canada's responses.

Other information

When Health Canada makes its re-evaluation decision, it will publish a Re-evaluation Decision on natamycin (based on the Science Evaluation of PRVD2024-02). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room.

Additional scientific information

Additional scientific data are not required at this time.

Footnotes