Proposed Registration Decision PRD2013-06, Garlic Powder

Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Pest Management Regulatory Agency
12 April 2013
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2013-6E-PDF (PDF version)

Summary

Table of Contents

• Proposed Registration Decision for Garlic Powder
• What Does Health Canada Consider When Making a Registration Decision?
• What Is Garlic Powder?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• Next Steps
• Other Information

Proposed Registration Decision for Garlic Powder

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 Garlic Powder Technical and Influence WP, containing the technical grade active ingredient garlic powder, to suppress seed rot, pre-emergence damping-off and root rot on greenhouse peppers and greenhouse ornamentals.

Garlic Powder Technical (Registration Number 29666) is fully registered in Canada to suppress powdery mildew on greenhouse food crops (cucumbers and tomatoes) and grape, as well as scab on apple, crabapple and pear. The detailed review for garlic powder can be found in Proposed Regulatory Decisions PRD2010-11, Garlic Powder and PRD2012-22, Garlic Powder, as well as in Registration Decisions RD2010-11, Garlic Powder and RD2013-02, Garlic Powder. Use on greenhouse ornamentals represents a major new use for the active ingredient garlic powder.

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 PRD2013-06, Garlic Powder provides detailed technical information on the human health, environmental and value assessments of Garlic Powder Technical and Influence WP.

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 (for example, those most sensitive to environmental contaminants). 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 garlic powder, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2013-06, Garlic Powder. The PMRA will then publish a Registration Decision on garlic powder, 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 PRD2013-06, Garlic Powder.

What Is Garlic Powder?

Garlic powder is the active ingredient in the end-use product Influence WP, a wettable powder formulation. This fungicide is used to suppress powdery mildew and seedling diseases on certain greenhouse crops and ornamentals.

Health Considerations

Can Approved Uses of Garlic Powder Affect Human Health?

Garlic powder is unlikely to affect human health when used according to label directions.

Exposure to garlic powdermay occur when handling and applying the product. 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.

The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

The technical grade active ingredient, garlic powder,is of low acute toxicity by the oral and dermal routes and is slightly irritating to eyes and skin. Due to the irritative nature of garlic, inhalation exposure may cause throat irritation. There is potential for skin sensitization to occur when skin is repeatedly exposed to the garlic powder. Therefore, cautionary statements alerting users to this sensitization concern are required on product labels.

Inhalation and dermal exposures are likely for occupational workers and commercial applicators. Anyone entering the sprayed areas before the spray is dried may be exposed dermally. Therefore, appropriate precautionary statements and a restricted entry statement are required on the Influence WP label to mitigate such exposure concerns.

Based on garlic's long history of consumption as a food and in natural health products, there is little indication of short- or long-term toxic effects from exposure to garlic powder from the use of the commercial end-use product.

Residues in Water and Food

Dietary risks from food and water are not of concern.

The use of Influence WP for greenhouse non-food crops as a fungicide to be applied to greenhouse ornamentals should not result in additional exposure to sources of food or drinking water beyond currently registered food uses. In addition, the new crop, greenhouse peppers is being added to the Influence WP label.

Garlic is used for culinary purposes world-wide and is also consumed for its medicinal values. Garlic powder is rapidly degraded in the environment, so exposure from residues in water and from treated food commodities is likely to be minimal. Therefore, these new uses of garlic powder are not expected to result in dietary risk from consuming food or drinking water.

Occupational Risks From Handling Influence WP

Occupational risks are not of concern when Influence WP is used according to label directions, which include protective measures.

Occupational exposure to individuals mixing, loading or applying Influence WP is not expected to result in unacceptable risk when the product is used according to label directions.

Precautionary and hygiene statements on the label are considered adequate to protect individuals from any unnecessary risk due to occupational exposure.

Environmental Considerations

What Happens When Garlic Powder Technical is Introduced Into the Environment?

Garlic Powder Technical is not persistent and the proposed use is not expected to pose a risk to non-target terrestrial or aquatic organisms.

Garlic Powder Technical is derived from a naturally-occurring food commodity (garlic bulb). Allyl sulfides are volatile and, as such, volatilization is expected to be an important route of dissipation for this technical active in the environment. Allyl sulfides are expected to degrade in air by reaction with hydroxyl radicals. The environmental exposure from the use of garlic powder is expected to be minimal for the proposed use in greenhouses for ornamentals and pepper.

Garlic powder is non-toxic to honey bees and birds and is slightly toxic to fish and aquatic invertebrates on an acute basis. Garlic Powder Technical poses negligible risk to non-target terrestrial or aquatic organisms from this proposed use.

Value Considerations

What Is the Value of Influence WP?

Influence WP is a non-conventional fungicide that provides suppression of seed rot, pre-emergence damping-off and root rot on greenhouse peppers and greenhouse ornamentals.

Influence WP represents an alternative mode of action to conventional fungicides and poses a low risk of resistance development.

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 Influence WP to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

On the label for Influence WP, the following statement should be included "Individuals who are sensitive or allergic to garlic should avoid handling the product."

Next Steps

Before making a final registration decision on garlic powder, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2013-06, Garlic Powder. The PMRA will accept written comments on Proposed Registration Decision PRD2013-06, Garlic Powder up to 45 days from the date of publication of Proposed Registration Decision PRD2013-06, Garlic Powder. 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 garlic powder (based on the Science Evaluation of Proposed Registration Decision PRD2013-06, Garlic Powder). 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).