Proposed Registration Decision PRD2016-18, Tea Tree Oil

 

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Pest Management Regulatory Agency
27 July 2016
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2016-18E-PDF (PDF version)

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain a full copy of Proposed Registration Decision PRD2016-18, Tea Tree Oil please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Summary

Table of Contents

Proposed Registration Decision for Tea Tree Oil

Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing full registration for the sale and use of Tea Tree Oil Technical and Timorex Gold, containing the technical grade active ingredient tea tree oil, to control powdery mildew on greenhouse pepper, tomato, cucumber and grape, suppress powdery mildew on strawberry, suppress downy mildew on grape and greenhouse cucumber, and suppress late blight on greenhouse tomato.

Tea Tree Oil Technical (Registration Number 30909) and Timorex Gold (Registration Number 30910) are conditionally registered in Canada. The detailed review for Tea Tree Oil Technical and Timorex Gold can be found in Evaluation Report ERC2014-01, Tea Tree Oil. Since the original applications, amendments have been made to the Timorex Gold label to add field peppers, blueberries, raspberries, and potatoes. The current applications were submitted to convert Tea Tree Oil Technical and Timorex Gold from conditional registration to full registration.

An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2016-18, Tea Tree Oil provides detailed technical information on the human health, environmental and value assessments of Tea Tree Oil Technical and Timorex Gold.

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 tea tree oil, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-18, Tea Tree Oil. The PMRA will then publish a Registration Decision on tea tree oil, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA’s response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of Proposed Registration Decision PRD2016-18, Tea Tree Oil.

What Is Tea Tree Oil?

Tea tree oil is an extract from a cultivated tree native to Australia, New Zealand and Southeast Asia. It contains several organic compounds with anti-fungal properties and will control or suppress certain fungal diseases present in Canada when applied in the end-use product, Timorex Gold.

Health Considerations

Can Approved Uses of Tea Tree Oil Affect Human Health?

Tea Tree Oil is unlikely to affect human health when used according to label directions.

Potential exposure to tea tree oil may occur through the diet (food and water) or when handing and applying the end-use product, Timorex Gold. When assessing health risks, two key factors are considered:

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

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

Tea tree oil is slightly acutely toxic via the oral route and of low acute toxicity via the dermal and inhalation routes. It is a severe eye and skin irritant, and is considered to be a skin sensitizer. Although tea tree oil has low acute inhalation toxicity, because of its eye and skin irritancy, it is considered to be a potential respiratory irritant if inhaled. Consequently, appropriate hazard signal words are required on the label.

The end-use product, Timorex Gold, has low acute toxicity via the oral, dermal, and inhalation routes of exposure. It is moderately irritating to the eyes and skin and is considered to be a skin sensitizer. Because of its eye and skin irritancy, it is considered to be a potential respiratory irritant if inhaled. Based on these characteristics, appropriate hazard signal words are required on the label.

Animal toxicity tests provided, as well as information from the published scientific literature, were assessed for the potential of tea tree oil to cause short-term toxicity, developmental effects, genotoxicity, and various other effects. Tea tree oil was determined to not be genotoxic, and there was no indication that the young were more sensitive than the adult animal. The risk assessment protects against these, and any other potential effects, by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.

Residues in Water and Food

Dietary risks from food and water are not of concern.

Dietary risks from food and drinking water are not expected to be of concern given the low toxicity and dietary and drinking water exposures to tea tree oil. The major components of tea tree oil (monoterpenes, sesquiterpenes, and related alcohols) are volatile, and after application, tea tree oil is expected to substantially volatilize with low residence times on plants and soil. In submitted residue trials, the levels of tea tree oil components on treated crops were less than the limit of quantification 48 hours after the application of Timorex Gold. Accordingly, the pre-harvest interval of two days for the end-use product is expected to further encourage the dissipation of any tea tree oil residues prior to harvesting treated crops. In addition, based on information from the United States Food and Drug Administration, consumers are already exposed to low levels of tea tree oil components as they are approved for use as food flavouring substances, in sanitizing solutions for food-processing equipment, and in coatings on food contact surfaces. Consequently, the specification of a maximum residue limit for tea tree oil under the Pest Control Products Act is not required. Because tea tree oil and its components are volatile, have low water solubility, have low residence times in environmental media, and the end-use product has label directions against application to water or contaminating water when cleaning equipment, there is not likely to be any significant contamination of ground or surface water sources of drinking water.

Risks in Residential and Other Non-Occupational Environments

Non-occupational risks from bystander exposure are not of concern.

Risks to bystanders from commercial applications of Timorex Gold are not expected to be of concern due to the low toxicity of tea tree oil and the low potential for bystander exposure when the end-use product is applied according to label directions.

Occupational Risks from Handling Tea Tree Oil

Occupational risks are not of concern when used according to label directions.

There is a potential for dermal and inhalation occupational exposures to tea tree oil during mixing, loading, application, clean-ups, and repairs when using Timorex Gold. There is a similar potential for exposure if workers enter treated areas before sprays have dried. To minimize such exposure, the label for Timorex Gold includes precautionary, personal protective equipment, and hygiene statements, as well as a four-hour restricted-entry interval (REI) and a requirement for greenhouse vents to be open and fans operational during the REI. Taking into consideration the precautionary measures, label statements, and the REI, occupational risks from tea tree oil are not expected to be of concern.

Environmental Considerations

What Happens When Tea Tree Oil Is Introduced Into the Environment?

When Tea Tree Oil Technical and Timorex Gold are used according to label instructions, tea tree oil is not expected to pose risks of concern to the environment.

Tea Tree Oil Technical and its related end-use product, Timorex Gold, will enter the environment when applied as a fungicide, using field and airblast sprayers, on various field and greenhouse crops. It can enter soil directly at the time of application and it can enter aquatic environments directly through spray drift or via run-off from the treated field. Tea tree oil is composed of several chemicals that evaporate easily at normal temperatures and are all expected to be found in air within the first 24 hours after application of Timorex Gold. These chemicals are quickly broken down and are, therefore, expected to be short-lived in the environment (soil, air and water) and are not expected to be found in groundwater. Direct contact with the spray or drifting spray droplets may, however, be possible for certain non-target organisms for a short period of time after application of Timorex Gold. Tea tree oil is toxic to aquatic organisms and beneficial arthropods; therefore, based on the assessment of the potential risk to these organisms from short-term exposure, label statements regarding these hazards and risk mitigation measures are required.

Value Considerations

What Is the Value of Timorex Gold?

Timorex Gold is a non-conventional fungicide that can be used in both conventional and organic production systems.

Timorex Gold has demonstrated effectiveness in controlling or suppressing powdery mildew, downy mildew, and late blight on registered crops. The inclusion of tea tree oil in a conventional spray program could reduce the reliance on chemical fungicides. Timorex Gold also provides a non-conventional option for organic production. The multi-site mode of action of tea tree oil reduces the potential for resistance development.

Measures to Minimize Risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measur

The key risk-reduction measures being proposed on the label of Timorex Gold to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The label for the technical grade active ingredient includes the hazard signal words, “CAUTION POISON”, “DANGER – EYE IRRITANT”, “DANGER – SKIN IRRITANT”, and “POTENTIAL SKIN SENSITIZER”. Additional precautionary statements include “Harmful if swallowed. Severely irritating to the eyes, skin and respiratory tract. DO NOT get in eyes, on skin or clothing, or inhale sprays, mists or vapours. Potential skin sensitizer.”

The label for the commercial end-use product also includes hazard signal words and precautionary statements to identify the hazards and minimize human health risks. The following hazard signal words are included on the label for Timorex Gold: “WARNING - EYE IRRITANT”, “WARNING – SKIN IRRITANT”, and “POTENTIAL SKIN SENSITIZER”, and the following precautionary statements are included on the label: “Causes eye, skin, and mucous membrane irritation. DO NOT get in eyes, on skin or clothing, or inhale sprays, mists or vapours.” and “Potential skin sensitizer.”

To prevent skin, eye, and respiratory tract occupational exposures and risks from tea tree oil, the label for Timorex Gold contains the following personal protective equipment (PPE) statements: “Workers potentially exposed to the product through mixing, loading, applying, and clean-up and repair activities must wear chemical-resistant goggles or a face shield, an appropriate NIOSH-approved respirator, a long-sleeved shirt and long pants, chemical-resistant gloves and shoes plus socks. Follow manufacturer’s instructions for cleaning/maintaining PPE. If no such instructions are available for wa

Risks from potential occupational exposures to tea tree oil are further mitigated by occupational hygiene statements on the label for Timorex Gold including “Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. Remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. Remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.”

“A restricted-entry interval (REI) of 4 hours must be observed following application. Do not enter or allow worker entry into treated areas during the REI.”, “For greenhouse applications, vents should be opened and ventilation fans should be operational during the REI.”, and “Treated crops should not be harvested until a pre-harvest interval (PHI) of two days has passed.” are additional risk mitigation measures that are included in the application directions on the label for the end-use product.

To avoid inadvertent bystander exposure during application, the Timorex Gold label includes the statements, “Keep unprotected persons out of the areas of the greenhouse to be treated for the duration of the treatment and the restricted-entry interval (REI).”, “Do not apply to field crops when bystanders are in the vicinity of the fields to be treated.”, and “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.”

Environment

Label statements indicating toxicity to aquatic organisms and beneficial arthropods are required. To minimize potential risks to aquatic organisms, buffer zone label statements for the protection of aquatic environments are also required.

Next Steps

Before making a final registration decision on tea tree oil, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-18, Tea Tree Oil. The PMRA will accept written comments on PRD2016-18, Tea Tree Oil up to 45 days from the date of publication of PRD2016-18. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency’s response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on tea tree oil (based on the Science Evaluation of PRD2016-18, Tea Tree Oil). In addition, the test data referenced in PRD2016-18 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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