Proposed Registration Decision PRD2022-09, Trichoderma asperellum strain ICC 012, Trichoderma gamsii strain ICC 080, and Foretryx

Pest Management Regulatory Agency
12 August 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-9E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for Trichoderma asperellum strain ICC 012 and Trichoderma gamsii strain ICC 080
• What does Health Canada consider when making a registration decision?
• What are Trichoderma asperellum strain ICC 012 and Trichoderma gamsii strain ICC 080?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for Trichoderma asperellum strain ICC 012 and Trichoderma gamsii strain ICC 080

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 the microbial pest control agents (MCPAs) contained in Trichoderma asperellum ICC 012 Technical, Trichoderma gamsii ICC 080 Technical and Foretryx, containing the technical grade active ingredients Trichoderma asperellum strain ICC 012 and Trichoderma gamsii strain ICC 080, for the suppression and partial suppression of certain fungal diseases on field and greenhouse fruiting vegetables, squash, lettuce, field and greenhouse strawberries, greenhouse ornamentals and cannabis produced commercially indoors.

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 PRD2022-09, Trichoderma asperellum strain ICC 012, Trichoderma gamsii strain ICC 080, and Foretryx provides detailed technical information on the human health, environmental and value assessments of Trichoderma asperellum strain ICC 012, Trichoderma gamsii strain ICC 080 and Foretryx.

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^{Footnote 1} 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^{Footnote 2} 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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program.

Before making a final registration decision on Trichoderma asperellum strain ICC 012, Trichoderma gamsii strain ICC 080 and Foretryx, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-09.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Trichoderma asperellum strain ICC 012, Trichoderma gamsii strain ICC 080 and Foretryx, 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 PRD2022-09.

What are Trichoderma asperellum strain ICC 012 and Trichoderma gamsii strain ICC 080?

Trichoderma is a genus of ubiquitous fungi that colonize rhizosphere soil and plant roots, rotting wood, and dead plant material. It is regarded as one of the most widely distributed of all soil fungi. It is found frequently in all types of natural or agricultural soils, including forest humus layers, and orchards. Some strains are able to parasitize plant pathogenic fungi.

Trichoderma asperellum strain ICC 012and Trichoderma gamsii strain ICC 080 are new active ingredients for disease management on various field and greenhouse crops in Canada. These two active ingredients demonstrate fungicidal properties by competing with plant pathogens for space and nutrients on target crops and may also induce systemic resistance.

Health considerations

Can approved uses of Trichoderma asperellum strain ICC 012 and Trichoderma gamsii strain ICC 080 and Foretryx affect human health?

Trichoderma asperellum strain ICC 012 and Trichoderma gamsii strain ICC 080 are unlikely to affect your health when Foretryx is used according to the label directions.

Potential exposure to T. asperellum strain ICC 012and T. gamsii strain ICC 080may occur when handling and applying Foretryx. When assessing health risks, several key factors are considered:

• the microorganism's biological properties (for example, production of toxic by-products);
• reports of any adverse incidents;
• its potential to cause disease or toxicity as determined in toxicological studies; and
• the level to which people may be exposed relative to exposures already encountered in nature to other isolates of this microorganism.

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.
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 Trichoderma asperellum ICC 012 Technical and Trichoderma gamsiiICC 080 Technical were tested on laboratory animals, there was low toxicity following oral, pulmonary instillation and dermal exposures. Foretryx is minimally irritating to the skin and is non-irritating to the eyes. Furthermore, there was no sign that the microbial pest control agents, T. asperellum strain ICC 012and T. gamsii strain ICC 080, caused any disease.

Residues in water and food

Dietary risks from food and water are acceptable.

Residues of T. asperellum strain ICC 012and T. gamsii strain ICC 080 on treated crops are possible at the time of harvest. Agricultural practices of washing these crops following harvest are expected to reduce the potential for dietary exposure to residues of T. asperellum strain ICC 012and T. gamsii strain ICC 080. Furthermore, no signs of infectivity or toxicity were observed when T. asperellum strain ICC 012and T. gamsii strain ICC 080 were tested on laboratory animals, and significant levels of secondary metabolites are not expected to occur on edible portions of the crops. In addition, the likelihood of T. asperellum strain ICC 012and T. gamsii strain ICC 080 contaminating drinking water is expected to be low as the label has the necessary mitigation measures to limit contamination of drinking water from the proposed uses of Foretryx. Consequently, dietary risks are acceptable.

Occupational risks from handling Foretryx

Occupational risks are acceptable when Foretryx is used according to label directions, which include protective measures.

Workers handling Foretryx can come into direct contact with T. asperellum strain ICC 012and T. gamsii strain ICC 080 on the skin, by inhalation, or in the eyes. To protect workers from exposure to Foretryx, the label states that workers must wear personal protective equipment, including waterproof gloves, long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes. The product label includes measures to restrict access to the treated area for 4 hours or until sprays have settled.

Risks in residential and other non-occupational environments

Estimated risk for non-occupational exposure is acceptable.

Foretryx is proposed for commercial use as a drip chemigation in greenhouses and diluted broadcast spray applications at planting to the soil surface in agricultural fields. The product label includes measures to prevent bystander exposure such as reducing spray drift. Residential and non-occupational exposure to Foretryx is therefore expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Environmental considerations

What happens when Trichoderma asperellum strain ICC 012, Trichoderma gamsii strain ICC 080 and Foretryx are introduced into the environment?

Environmental risks are acceptable.

Information on the environmental fate of T. gamsii strain ICC 080 and T. asperellum strain ICC 012 suggests that, as a soil microorganism, they are likely to readily survive after applications of Foretryx to agricultural field crops, but that over time their populations should return to naturally sustainable levels.

There are no published reports of disease associated with natural populations of Trichoderma gamsii or Trichoderma asperellum in birds, wild mammals, fish, terrestrial and aquatic arthropods, terrestrial and aquatic non-arthropod invertebrates, or terrestrial and aquatic plants. Also, the applicant submitted studies designed to examine the effects of T. gamsii strain ICC 080 and T. asperellum strain ICC 012 to bees, earthworms, soil microorganisms, fish, aquatic arthropods, and aquatic plants. No adverse effects were observed in bees, earthworms, soil microorganisms, or fish. There were toxic effects noted in daphnids including reproductive effects for T. gamsii strain ICC 080. There were toxic effects to duckweed from T. gamsii strain ICC 080 and growth inhibition to algae from both strains; however, these effects occurred at levels that exceed estimated exposure levels when Foretryx is used according to the label.

Based on a critical review of data and published scientific literature submitted by the applicant, no significant effects to birds, bees, arthropods, wild mammals, soil microorganisms, fish, or plants are expected when Foretryx is applied according to directions on the label.

Value considerations

What is the value of Foretryx?

Foretryx is a soil-applied fungicide containing two strains of live fungi for the control of soil –borne pathogens. The registration of Foretryx will provide Canadian growers with an alternative fungicide product for use to manage certain diseases on a variety of field and greenhouse crops.
Foretryx is applied to soil as a broadcast spray or via chemigation to suppress or partially suppress certain diseases on various field and greenhouse crop.

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 labels of Foretryx to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures – Human Health

All microorganisms, including T. asperellum strain ICC 012 and T. gamsii strain ICC 080, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of T. asperellum strain ICC 012 and T. gamsii strain ICC 080. In turn, workers handling or applying Foretryx must wear waterproof gloves, a long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes. Furthermore, all unprotected workers are restricted from entering treated areas during application and for 4 hours following application or until sprays have settled.

Key risk-reduction measures – Environment

The Foretryx label will include environmental precaution statements to prohibit aerial application, limit drift, and reduce the potential for contamination of aquatic systems.

Next steps

Before making a final registration decision on Trichoderma asperellum ICC 012 Technical, Trichoderma gamsii ICC 080 Technical and Foretryx, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-09. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-09. 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 ICC 012 Technical, Trichoderma gamsii ICC 080 Technical and Foretryx (based on the Science Evaluation of PRD2022-09). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.