Proposed Re-evaluation Decision PRVD2017-20, Trichoderma harzianum Rifai strain KRL-AG2 and Its Associated End-use Products

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Pest Management Regulatory Agency
17 November 2017
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2017-20E-PDF (PDF version)

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Table of Contents

Proposed Re-evaluation Decision

Under 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. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Trichoderma harzianum Rifai strain KRL-AG2 is a fungus that protects plants from disease-causing fungal pathogens. Trichoderma harzianum Rifai strain KRL-AG2 is a biological fungicide registered for the suppression of root and foliar diseases on greenhouse crops, outdoor nursery plants and agricultural field crops. It can be applied as a soil drench, bulb dip, seed treatment, and as a ground foliar spray.

This document (Proposed Re-evaluation Decision PRVD2017-20, Trichoderma harzianum Rifai strain KRL-AG2 and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of Trichoderma harzianum Rifai strain KRL-AG2 including the proposed risk mitigation measures to further protect human health and the environment, as well as the science evaluation on which the proposed decision was based. All products containing Trichoderma harzianum Rifai strain KRL-AG2 registered in Canada are subject to this proposed re-evaluation decision. Proposed Re-evaluation Decision PRVD2017-20, Trichoderma harzianum Rifai strain KRL-AG2 and Its Associated End-use Products 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 Publications Section. The final re-evaluation decision will be published taking into consideration the comments and information received.

Outcome of Science Evaluation

Trichoderma harzianum Rifai strain KRL-AG2 represents an additional disease management tool that can reduce the reliance on chemical fungicides for greenhouse, nursery and agricultural field crops. Due to its broad mode of action, Trichoderma harzianum Rifai strain KRL-AG2 is not prone to the development of resistance and, thus, can be used as a resistance management tool in a disease management program.

Potential exposure to Trichoderma harzianum Rifai strain KRL-AG2 may occur when handling and applying, or when ingesting treated produce. When spores of Trichoderma harzianum Rifai strain KRL-AG2 were tested on laboratory animals, there were no signs that it caused any significant toxicity or disease. While secondary metabolites of toxicological significance (peptaibols) have been shown to be produced by certain naturally occurring strains of Trichoderma harzianum (including strain KRL-AG2), its use is not expected to result in a sustained increase in levels of these peptaibols beyond the naturally occurring background levels of those produced by native Trichoderma harzianum strains. These metabolites are expected to be short-lived in the environment once produced. As well, the likelihood of residues of Trichoderma harzianum Rifai strain KRL-AG2 contaminating drinking water supplies resulting from applications as a pesticide is considered to be low. Based on the above, dietary risks from food and water are not of concern under the current conditions of use.

There are no domestic-class products containing Trichoderma harzianum Rifai strain KRL-AG2, nor is it expected that the commercial products would be applied in residential areas.  Even in the event of exposure, no risks of concern to bystanders are expected when the products are applied according to label directions since there were no signs of disease or toxicity noted with this microorganism.

Occupational exposures of workers mixing, loading and applying the end-use products, as well as to workers re-entering treated sites, are not expected to result in risks of concern when Trichoderma harzianum Rifai strain KRL-AG2 is used according to the label directions. However, to meet the current standard, updates to the restricted-entry interval section of the labels are proposed.

Overall, Trichoderma harzianum Rifai strain KRL-AG2 is unlikely to affect human health when used according to the label directions.

Trichoderma species are ubiquitous soil-dwellers, inhabiting soil, rotting wood and vegetable matter in virtually all terrestrial environments. Trichoderma harzianum Rifai strain KRL-AG2 and its metabolites (peptaibols) are not expected to pose risks of concern to the environment when used according to the label directions.

Proposed Regulatory Decision for Trichoderma harzianum Rifai strain KRL-AG2

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 Trichoderma harzianum Rifai strain KRL-AG2 are considered acceptable for continued registration for the sale and use 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 Trichoderma harzianum Rifai strain KRL-AG2, no additional risk mitigation measures are proposed by the PMRA.

To meet the current labelling standard the following label updates are proposed (Refer to the details in Appendix I of Proposed Re-evaluation Decision PRVD2017-20, Trichoderma harzianum Rifai strain KRL-AG2 and Its Associated End-use Products):

  • Restricted-entry intervals
  • Precautionary label statement to minimize the potential for spray drift.
  • Environmental label statements

International Context

Trichoderma harzianum Rifai strain KRL-AG2 is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including Australia, the European Union, and the United States. As of 21 July 2017, no decision by an OECD member country to prohibit all uses of this microbial for health or environmental reasons has been identified.

Next Steps

The public including the registrants and stakeholders are encouraged to submit comments during the 90-day public consultation period upon publication of this PRVD2017-20.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision document. 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 the PMRA’s responses.

Additional Scientific Information

No additional data are required.

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