Proposed Registration Decision PRD2020-03, Trichoderma asperellum strain T34, Asperello T34 Biocontrol

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Pest Management Regulatory Agency
17 February 2020
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2020-3E-PDF (PDF version)

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To obtain a full copy of Proposed Registration Decision PRD2020-03, Trichoderma asperellum strain T34, Asperello T34 Biocontrol please contact our publications office.

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Summary

Table of Contents

Proposed registration decision for Trichoderma asperellum strain T34

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is proposing registration for the sale and use of T34 Biocontrol Technical, and Asperello T34 Biocontrol, containing the technical grade active ingredient Trichoderma asperellum strain T34 to be used against certain fungal diseases on greenhouse ornamentals, cannabis produced commercially indoors and greenhouse vegetables.

Trichoderma asperellum strain T34 is currently registered to suppress fusarium wilt on greenhouse ornamentals. For details, see Proposed Registration Decision PRD2011-21, Trichoderma asperellum strain T34, and Registration Decision RD2013-19, Trichoderma asperellum strain T34.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of the pest control products are acceptable.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2020-03, Trichoderma asperellum strain T34, Asperello T34 Biocontrol provides detailed technical information on the human health, environmental and value assessments of Trichoderma asperellum strain T34 and Asperello T34 Biocontrol.

What does Health Canada consider when making a registration decision?

The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides.

For more information please refer to the following:

Before making a final registration decision on Trichoderma asperellum strain T34 and Asperello T34 Biocontrol, Health Canada's PMRA will consider any comments received from the public in response to PRD2020-03. Health Canada will then publish a Registration Decision on Trichoderma asperellum strain T34 and Asperello T34 Biocontrol, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada's response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2020-03.

What is Trichoderma asperellum strain T34?

Trichoderma asperellum strain T34 is the active ingredient in the product Asperello T34 Biocontrol, a biological fungicide to be used against certain fungal diseases on greenhouse ornamentals, cannabis produced commercially indoors and greenhouse vegetables. It has multiple modes of action to protect plants from disease infection.

Health considerations

Can approved uses of Trichoderma asperellum strain T34 affect human health?

Trichoderma asperellum strain T34 is unlikely to affect your health when Asperello T34 Biocontrol is used according to the label directions.

Potential exposure to Trichoderma asperellum strain T34 may occur through the diet (food and water) or when handling and applying Asperello T34 Biocontrol. When assessing health risks, several key factors are considered:

The levels used to assess risks are established to protect the most sensitive human population (for example children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses that are determined as having no health risks of concern are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from large doses of exposure to a microorganism and identify any pathogenicity, infectivity and toxicity concerns. When Asperello T34 Biocontrol was tested on laboratory animals, there was low toxicity following oral, inhalation, and pulmonary exposures, there was no toxicity or irritation following dermal exposure, and there were no signs that it caused any disease.

Residues in water and food

Dietary risks from food and water are acceptable.

Residues of Trichoderma asperellum strain T34 on treated food crops are possible at the time of harvest. However, populations of Trichoderma spp. on crops measured after application of the end-use product are low and decline over time. As well, no secondary metabolites of toxicological significance are detectable in the formulated product or in the edible parts of crops treated with the end use product. While Trichoderma asperellum and other related Trichoderma species are abundant in nature, no cases involving foodborne illness have been reported. Moreover, no signs of infectivity and low toxicity were observed when Asperello T34 Biocontrol was tested on laboratory animals. In addition, the likelihood of residues of Trichoderma asperellum strain T34 contaminating drinking water supplies from the proposed application of Asperello T34 Biocontrol on greenhouse food crops and cannabis grown commercially indoors is low. Consequently, dietary risks are acceptable for all segments of the population, including infants, children, adults and seniors.

Risks in residential and other non-occupational environments

Estimated risk for non-occupational exposure is acceptable.

Asperello T34 Biocontrol is proposed for use in greenhouses only. Consequently, it is unlikely that the general public will be exposed to Trichoderma asperellum strain T34. Even in the event of exposure, risk to residents and the general population is acceptable since Asperello T34 Biocontrol is of low toxicity and there were no signs that it caused any disease in studies on laboratory animals.

Occupational risks from handling Asperello T34 Biocontrol

Occupational risks are not of concern when Asperello T34 Biocontrol is used according to label directions, which include protective measures.

Workers handling Asperello T34 Biocontrol can come into direct contact with Trichoderma asperellum strain T34 on the skin, by inhalation, or in the eyes. To protect workers from exposure to Asperello T34 Biocontrol, the label states that mixers, loaders, and applicators must wear personal protective equipment, including waterproof gloves, long-sleeved shirt, long pants, goggles, socks with shoes, and NIOSH-approved particulate filtering facepiece respirator. A restricted-entry interval of 4 hours, or until dusts have settled or sprays have dried is required. If re-entry into treated areas is necessary during the restricted-entry interval, workers must wear waterproof gloves, long-sleeved shirt, long pants, goggles, socks with shoes, and NIOSH-approved particulate filtering facepiece respirator.

Environmental considerations

What happens when Trichoderma asperellum strain T34 is introduced into the environment?

Environmental risks are acceptable.

Asperello T34 Biocontrol is an end use product that is currently registered for use on greenhouse ornamentals and is not registered for outdoor uses. The proposed use expansions of Asperello T34 Biocontrol to greenhouse food crops and cannabis grown commercially indoors are not expected to result in sustained increases of Trichoderma asperellum strain T34 in terrestrial and aquatic environments beyond natural background levels.

Based on a critical review of data provided and information from public sources conducted during the initial registration of Asperello T34 Biocontrol, no significant effects to birds, wild mammals, fish, aquatic insects, earthworms, soil microorganisms, mushrooms, or horticultural crops are expected when Asperello T34 Biocontrol is applied according to directions on the label. Also, minimal exposure to non-target organisms is anticipated from the proposed use of Asperello T34 Biocontrol in greenhouses.

Value Considerations

What is the value of T34 Biocontrol?

Trichoderma asperellum strain T34 suppresses or partially suppresses listed diseases on greenhouse ornamentals, cannabis produced commercially indoors and greenhouse vegetable crops.

Asperello T34 Biocontrol is a biological fungicide that will provide an alternative disease management product for use on these crops. This product may contribute to resistance reduction for conventional fungicides as well as provide organic growers with an additional tool for disease management.

Measures to Minimize Risk

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 on the label of T34 Biocontrol Technical and Asperello T34 Biocontrol to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

All microorganisms, including Trichoderma asperellum strain T34, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of Trichoderma asperellum strain T34. In turn, workers handling or applying Asperello T34 Biocontrol must wear waterproof gloves, long-sleeved shirt, long pants, socks with shoes, and a NIOSH-approved particulate filtering facepiece respirator.

A restricted-entry interval of 4 hours or until sprays have dried or dusts have settled is required for Asperello T34 Biocontrol. If re-entry into treated areas is required during the restricted-entry interval, workers must waterproof gloves, long-sleeved shirt, long pants, goggles, socks with shoes, and NIOSH-approved particulate filtering facepiece respirator.

Environment

The end use product label includes environmental precaution statements that reduce contamination of aquatic systems from the use of Asperello T34 Biocontrol.

Next Steps

Before making a final registration decision on Trichoderma asperellum strain T34 and Asperello T34 Biocontrol, Health Canada's PMRA will consider any comments received from the public in response to PRD2020-03. Health Canada will accept written comments on PRD2020-03 up to 45 days from the date of publication of this document. Please forward all comments to Publications. Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada's response to these comments.

Other Information

When the Health Canada makes its registration decision, it will publish a Registration Decision on Trichoderma asperellum strain T34 and Asperello T34 Biocontrol (based on the Science Evaluation of PRD2020-03). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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