Re-evaluation Decision RVD2018-19, Trichoderma harzianum Rifai strain KRL-AG2 and Its Associated End-use Products

Pest Management Regulatory Agency
12 June 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-19E-PDF (PDF version)

(PDF Version 169 K)

Table of Contents

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. 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 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. Currently registered products containing Trichoderma harzianum Rifai strain KRL-AG2 are listed in Appendix I.

This document presents the final regulatory decisionFootnote 1 for the re-evaluation of Trichoderma harzianum Rifai strain KRL-AG2. All pest control products containing Trichoderma harzianum Rifai strain KRL-AG2 that are registered in Canada are subject to this re-evaluation decision. This re-evaluation decision has undergone a 90-day consultation period as the Proposed Re-evaluation Decision PRVD2017-20, Trichoderma harzianum Rifai strain KRL-AG2 and Its Associated End-use Products.Footnote 2

No comments were received during the consultation period. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2017-20, which lists all data used as the basis for the re-evaluation decision.

Regulatory Decision for Trichoderma harzianum Rifai strain KRL-AG2

The PMRA has completed the re-evaluation Trichoderma harzianum Rifai strain KRL-AG2. Under the authority of the Pest Control Products Act, the PMRA is granting continued registration of products containing Trichoderma harzianum Rifai strain KRL-AG2 for sale and use in Canada. An evaluation of available scientific information found that uses of Trichoderma harzianum Rifai strain KRL-AG2 products do not present unacceptable risks to human health or environment when used according to the conditions of registration, including amended label directions. Label amendments, as summarized below and listed in Appendix II, are required for all end-use products. No additional data are requested at this time.

Risk Mitigation Measures

Registered pesticide product labels include specific direction for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law.

The following label amendments are included as part of the re-evaluation.

Health

  • Restricted-entry intervals

Environment

  • Precautionary label statement to minimize the potential for spray drift
  • Environmental label statements

Next Steps

To comply with this decision, the required mitigation measures must be implemented on all products labels sold by registrants no later than 24 months after the publication date of this decision document. Appendix I lists the products containing Trichoderma harzianum Rifai strain KRL-AG2 that are registered under the authority of the Pest Control Products Act.

Other Information

Any person may file a notice of objectionFootnote 3 regarding this decision on Trichoderma harzianum Rifai strain KRL-AG2 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 and Pest Management portion of Canada.ca (Request a Reconsideration of Decision) or contact the PMRA’s Pest Management Information Service.

Appendix I Registered Trichoderma harzianum Rifai strain KRL-AG2 Products in Canada

Table 1    Registered Trichoderma harzianum Rifai strain KRL-AG2 Products in CanadaFootnote 1
Registration Number Marketing Class Registrant Product Name Formulation Type Guarantee

31054

M

Bioworks Inc

Rootshield® plus granules biological fungicide

Granular

TDG: 5.3 × 106
FTR: 1 × 107

27115

C

Bioworks Inc

Rootshield HC biological fungicide wettable powder

Live Organism

FTR: 1 ×107

27116

C

Bioworks Inc

Rootshield granules biological fungicide

Live Organism

FTR: 1 ×107

29890

C

Bioworks Inc

Rootshield® WP - biological fungicide

Live Organism

FTR: 1 × 107

30539

C

Bioworks Inc

Rootshield® plus WP biological fungicide

Live Organism

TDG: 5.3 × 106
FTR: 1 × 107

31989

C

Bioworks Inc

BW240 WP biological fungicide

Live Organism

TDG: 5.3 × 106
FTR: 1 × 107

27114

T

Bioworks Inc

Rootshield technical biological fungicide

Live Organism

FTR: 5 × 108

31103

C

AEF Global Inc

Bora HC

Live Organism

FTR: 1 × 107

31104

C

AEF Global Inc

Bora WP (Wettable Powder)

Live Organism

FTR: 1 × 107

Footnote 1

as of 4 April 2018, excluding discontinued products or products with a submission for discontinuation

Return to footnote 1 referrer

Appendix II  Label Amendments for Products Containing Trichoderma harzianum Rafai strain KRL-AG2

The label amendments presented below do not include all label requirements for individual end-use products, such as first aid statements, disposal statements, precautionary statements and supplementary protective equipment. Information on labels of currently registered products should not be removed unless it contradicts the label statements provided below.
The following label statements are required:

  • The following statement must be included under the RE-ENTRY INTERVAL section for end-use products with indoor and outdoor foliar applications (excluding granular formulations):
  • “DO NOT re-enter or allow re-entry into treated areas for 4 hours or until sprays have dried, unless wearing appropriate personal protective equipment including long-sleeved shirt, long pants, shoes plus socks, and waterproof gloves.”
  • The following statement must be included under the PRECAUTIONS section for all end-use product labels with outdoor uses:
  • “Apply only when the potential for drift to areas of human habitation or areas of human activity such as houses, cottages, schools and recreational areas is minimal. Take into consideration wind speed, wind direction, temperature inversions, application equipment and sprayer settings.”

III)    The following statements must be included under the ENVIRONMENTAL PRECAUTIONS section for all end-use products:

  • “To reduce runoff from treated areas into aquatic habitats, avoid application to areas with a moderate to steep slope, compacted soil, or clay.”
  • “Avoid application when heavy rain is forecast.”
  • “Contamination of aquatic areas as a result of runoff may be reduced by including a vegetative strip between the treated area and the edge of the water body.”

IV)    The following statements must be included under the DIRECTIONS FOR USE section for all end-use products:

  • “DO NOT contaminate irrigation or drinking water supplies or aquatic habitats by cleaning of equipment or disposal of wastes.”

“DO NOT allow effluent or runoff from greenhouses containing this product to enter lakes, streams, ponds or other waters.”

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