Proposed Registration Decision PRD2022-02, Sheep Fat, Trico and Trico Garden

Pest Management Regulatory Agency
9 February 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-2E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for sheep fat
• What does Health Canada consider when making a registration decision?
• What is sheep fat?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for sheep fat

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 Sheep Fat Technical, Trico and Trico Garden, containing the technical grade active ingredient sheep fat, as a repellent to deer, elk or moose from trees and shrubs in forestry, grapevines, apple trees and outdoor ornamentals.

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 PRD2022-02, Sheep Fat, Trico and Trico Garden provides detailed technical information on the human health, environmental and value assessments of sheep fat, Trico and Trico Garden.

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:

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

Before making a final registration decision on sheep fat, Trico and Trico Garden, Health Canada’s PMRA will consider any comments received from the public in response to PRD2022-02. Health Canada will then publish a Registration Decision on sheep fat, Trico and Trico Garden, 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 Overview, please refer to the Science Evaluation of PRD2022-02.

What is sheep fat?

Sheep fat is the active ingredient in the commercial class product Trico and the domestic class product Trico Garden. Sheep fat is a new animal repellent that repels deer, elk or moose with a scent and taste that is repulsive to the target animals from trees and shrubs in forestry, grapevines, apple trees and outdoor ornamentals.

Health considerations

Can approved uses of sheep fat affect human health?

Sheep Fat is unlikely to affect human health when it is used according to label directions.

Potential exposure to sheep fat may occur when handling and applying the products Trico and Trico Garden, as well as during typical occupational and residential activities following application. When assessing health risks, two key factors are considered:

• the levels at which no health effects occur and
• the levels to which people may be exposed.

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 for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose at which no effects are observed.

Publicly available toxicology information was submitted on the acute toxicity of the major sheep fat fatty acids as well as surrogate fatty acids. Sheep Fat Technical is considered to be of low acute toxicity by the oral, dermal and inhalation routes, mildly irritating to eye and skin and unlikely to be a dermal sensitizer. While some positive sensitization results from pure constituent fatty acids were reported, Sheep Fat Technical was considered unlikely to be a dermal sensitizer based on an accepted rationale that considered the weight-of-evidence including the history of sheep fat in the human diet and fatty acids in consumer products. However, prolonged or frequently repeated skin contact to sheep fat may cause allergic reactions in some individuals.

The Registrant submitted publicly available information as well as a rationale to waive data requirements for short-term toxicity, developmental toxicity, genotoxicity and various other effects. Sheep fat is produced from fat tissues of sheep and has long been part of the human diet, including the Canadian diet. Sheep fat is a triglyceride that consists predominantly of glycerol with the following fatty acids: palmitic acid, stearic acid and oleic acid as well as smaller amounts of myristic, palmitoleic, heptadecanoic and linoleic acid. Saturated fatty acids are readily metabolized in the body into important components used for energy, signalling, etc., and generally oxidize to carbon dioxide and water.

Based on a weight-of-evidence of the available data for the major components of sheep fat and taking into consideration the history of use of sheep fat in the human diet and fatty acids in consumer products, the low toxicity profile of sheep fat, and the anticipated limited human exposure based on the proposed use patterns, no short-term toxicity, developmental toxicity, genotoxicity, or other adverse effects are anticipated for sheep fat.

The toxicological profiles of Trico and Trico Garden are considered to be similar to the toxicological profile of Sheep Fat Technical.

Residues in water and food

Dietary risks from food and water are acceptable.

Sheep fat has a long history of use in the human diet and is part of the Canadian diet. The proposed use pattern requires that application of Trico and Trico Garden to food crops (apples and grapes) must occur before flowering. In addition, the likelihood of residues of sheep fat in drinking water will be very low. Consequently, health 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 residential and other non-occupational exposure is acceptable.

As Trico is a commercial product for use in forest nurseries and plantations (deciduous and coniferous trees and shrubs), apple orchards, and grapes (new and established plantations), with no residential uses, a residential applicator exposure assessment is not required. In the interest of promoting best management practices and to minimize human exposure from spray drift or from spray residues resulting from drift, a spray drift statement is required for the label.

Trico Garden is for domestic use on outdoor ornamentals (flowers, trees, and shrubs), apple trees, and grapevines. Domestic users handling and applying Trico Garden will be required to wear rubber gloves and protective eyewear. Unprotected persons must remain out of the treated area until sprays have dried. Residential exposure to Trico Garden is therefore expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Occupational risks from handling Trico

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

Workers handling Trico can come into direct contact with sheep fat primarily on the skin, but incidental inhalation or eye exposure is possible, which is expected to be minimal. Sheep fat is not volatile; therefore, inhalation exposure, if any, would occur only if very fine droplets are formed during application and inhaled. For ocular exposure, potential exposure would only be during splashes when mixing/loading or if spray solution goes into the eye during application. To protect workers from exposure to Trico, the proposed label requires workers to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear (goggles or face shield) during mixing, loading, application, clean-up and repair. Health Canada considers this mitigation to be acceptable to protect against potential irritation and sensitization, in some sensitive individuals from prolonged or repeated exposure when handling Trico. In addition, the proposed label requires unprotected persons to remain out of the treated area until sprays have dried, and includes spray advisory statements to minimize spray drift. Health Canada requires further label statements that if early entry is necessary before sprays have dried, workers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear (goggles or face shield).

The occupational risks are acceptable when the precautionary statements on the label are observed.

Environmental considerations

What happens when sheep fat is introduced into the environment?

Environmental risk associated with the use of sheep fat is acceptable.

Sheep fat enters the environment when it is applied as an animal repellent for deer, elk and moose on forestry, apple orchards and grape vineyards. Sheep fat breaks down rapidly in the environment and is not expected to move downward in soil to groundwater. If sheep fat reaches water, it is not expected to mix with water but will be quickly broken down by bacteria. Sheep fat does not exhibit toxicity to terrestrial or aquatic wildlife or plants.

Value considerations

What is the value of Trico and Trico Garden?

Trico and Trico Garden prevents or reduces damage to trees and shrubs in forestry, outdoor ornamentals, apple trees, and grapevines caused by deer, elk or moose.

Deer, elk and moose cause damage to outdoor ornamentals, apple trees, and grapevines throughout the year by feeding and rubbing on plants.

Trico is a commercial class product applied to young trees and shrubs in forestry to prevent or reduce damage caused by deer, elk or moose. It is also used in agriculture to prevent damage to apple trees in orchards and grapevines caused by deer.

Trico Garden is a domestic class product applied to outdoor ornamentals, apple trees and grapevines to prevent damage caused by deer.

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 Sheep Fat Technical, Trico and Trico Garden to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

Standard hazard and precautionary statements are required on the technical grade active ingredient label and the end-use product labels to inform workers and domestic users of the potential for eye and skin irritation as well as the possibility that prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

Workers handling and applying Trico will be required to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear (goggles or face shield).

Domestic users handling and applying Trico Garden will be required to wear rubber gloves and protective eyewear.

For both end-use products, unprotected persons must remain out of the treated area until sprays have dried. If early entry is necessary before sprays have dried for Trico, unprotected persons must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear (goggles or face shield).

To limit bystander exposure, both end-use product labels require drift statements.

Precautionary statements are also required on both end-use product labels to use freshly prepared spray solution for each application and not to contaminate food or bodies of water.

Next steps

Before making a final registration decision on sheep fat, Trico and Trico Garden, Health Canada’s PMRA will consider any comments received from the public in response to PRD2022‑02. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-02. 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 sheep fat, Trico and Trico Garden (based on the Science Evaluation of PRD2022-02). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA’s Reading Room.