Proposed Registration Decision PRD2019-08, Hop Beta Acids (Present as Potassium Salts), HopGuard Liquid, HopGuard II

Notice to the reader:

This consultation is now closed.

Pest Management Regulatory Agency
2 August 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-8E-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 PRD2019-08, Hop Beta Acids (Present as Potassium Salts), HopGuard Liquid, HopGuard II 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 Hop Beta Acids (Present as Potassium Salts)

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 Potassium Beta Resin, a manufacturing concentrate HopGuard Liquid and the end-use product HopGuard II, containing the technical grade active ingredient hop beta acids (present as potassium salts), to control varroa mites in honeybee hives.

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 PRD2019-08, Hop Beta Acids (Present as Potassium Salts), HopGuard Liquid, HopGuard II provides detailed technical information on the human health, environmental and value assessments of hop beta acids (present as potassium salts), HopGuard Liquid and HopGuard II.

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 hop beta acids (present as potassium salts), HopGuard Liquid and HopGuard II, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-08. Health Canada will then publish a Registration Decision on hop beta acids (present as potassium salts), HopGuard Liquid and HopGuard II, 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 PRD2019-08.

What Is Hop Beta Acids (Present as Potassium Salts)?

Hop beta acids (present as potassium salts) are naturally occurring weak organic acids produced by hop plants (Humulus lupulus L.). Hop beta acids (present as potassium salts) are the active ingredient used to formulate HopGuard II, which is used for control of varroa mites in honeybee hives. HopGuard II consists of strips impregnated with hop beta acids (present as potassium salts) which are placed in the brood chamber of bee hives by hanging the strips over hive frames. The mode of action of hop beta acids (present as potassium salts) in killing varroa mite is likely from physical damage to mites leading to death.

Health Considerations

Can Approved Uses of Hop Beta Acids (present as potassium salts) Affect Human Health?

Hop beta acids (present as potassium salts) is unlikely to affect human health when it is used according to label directions.

Potential exposure to hop beta acids (present as potassium salts) may occur when handling and applying the product. When assessing health risks, two 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 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 where no effects are observed.

In laboratory animal studies, and based on publicly available information, the technical grade active ingredient, Potassium Beta Resin, containing hop beta acids (present as potassium salts), is slightly acutely toxic via the oral route and extremely irritating to the eyes. The manufacturing concentrate, HopGuard Liquid, and the end-use product, HopGuard II, were also considered to be of slight acute oral toxicity and extremely irritating to the eyes.

Requests to waive acute oral, dermal, and inhalation toxicity, skin irritation, and dermal sensitization testing for Potassium Beta Resin, HopGuard Liquid, and HopGuard II, as well as short-term toxicity, prenatal developmental toxicity, and genotoxicity testing of Potassium Beta Resin were accepted in lieu of actual test data. Hop beta acids (present as potassium salts) is not expected to cause adverse health effects when used according to label instructions.

Residues in Water and Food

Dietary risks from food and water are acceptable.

Dietary exposure to hop beta acids (present as potassium salts) to humans is unlikely since application of HopGuard II is limited to brood chambers and not honey supers. Also, users are not to collect honey or wax from the treated brood chambers. It is expected that the proposed use of hop beta acids (present as potassium salts) will not pose a risk to any segment of the population, including infants, children, adults and seniors, from consumption of honey and wax from treated beehives.

Exposure to hop beta acids (present as potassium salts) from drinking water will be negligible. Consequently, the dietary risk from drinking water is acceptable.

Risks in Residential and Other Non-Occupational Environments

Estimated risk for residential and other non-occupational exposure is acceptable.

Residential exposure to individuals coming in contact with hop beta acids (present as potassium salts) during application is not expected. Thus, the risk is considered to be acceptable when HopGuard II is used according to label directions.

Bystander exposure is not expected due to the direct application to beehives. Consequently, the risk to bystanders is acceptable.

Occupational Risks From Handling HopGuard II

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

To protect workers from exposure to HopGuard II, the label states that applicators must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear. The occupational risks are acceptable when the precautionary statements on the label are observed.

Environmental Considerations

An environmental assessment was not required for this evaluation based on the use pattern of HopGuard II.

Value Considerations

What Is the Value of HopGuard II?

HopGuard II provides control of varroa mites, the most important pest of honeybees, and offers users a new active ingredient for use against this pest.

Varroa mites are the most important parasitic pest of honeybees, and have a severe economic impact on the Canadian beekeeping industry. Significant varroa mite infestation in a honeybee colony will cause the loss of the infested colony. Based on the mode of action of HopGuard II, varroa mites are not expected to develop resistance, which is a problem with some other varroa mite control products.

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 Potassium Beta Resin, HopGuard Liquid and HopGuard II to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

The signal words "CAUTION POISON" and "DANGER - CORROSIVE TO EYES" are required on the principal display panels of the labels for Potassium Beta Resin, HopGuard Liquid, and HopGuard II.

Standard hazard and precautionary statements are also required on the HopGuard II label to inform workers of the acute oral toxicity and eye irritation of the product. Workers handling packages, as well as the individual strips, of HopGuard II will be required to wear standard personal protective equipment including long-sleeved shirt, long pants, chemical-resistant gloves, shoes with socks, and goggles or face shield.

A restricted-entry interval is not required for HopGuard II.

Next Steps

Before making a final registration decision on hop beta acids (present as potassium salts), HopGuard Liquid and HopGuard II, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-08. Health Canada will accept written comments on PRD2019-08 up to 45 days from the date of its publication.

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 hop beta acids (present as potassium salts), HopGuard Liquid and HopGuard II (based on the Science Evaluation of PRD2019-08). In addition, the test data referenced in PRD2019-08 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: