Proposed Registration Decision PRD2024-10, Fluopyram, Luna Privilege Greenhouse Fungicide
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The online consultation is now closed.
Pest Management Regulatory Agency
16 December 2024
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2024-10E-PDF (PDF version)
Summary
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 PRD2024-10, Fluopyram, Luna Privilege Greenhouse Fungicide please contact our publications office.
Should you require further information please contact the Pest Management Information Service.
Table of contents
- Proposed registration decision for Luna Privilege Greenhouse Fungicide
- What does Health Canada consider when making a registration decision?
- What is fluopyram?
- Health considerations
- Environmental considerations
- Value considerations
- Measures to minimize risk
- Next steps
- Other information
Proposed registration decision for Luna Privilege Greenhouse Fungicide
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 Luna Privilege Greenhouse Fungicide, containing the technical grade active ingredient fluopyram, to control powdery mildew (Erysiphe spp. and Podosphaera spp.) and botrytis blight (Botrytis spp.) on greenhouse grown ornamentals and outdoor ornamentals. This evaluation was completed under the User Requested Minor Use Label Expansion program, which is a cooperative program between Agriculture and Agri-Food Canada and Health Canada's Pest Management Regulatory Agency and includes participation by sponsor groups, manufacturers, and both provincial and federal governments.
Fluopyram is currently registered for use on greenhouse food crops (in other words, tomatoes, peppers/eggplants, cucumbers, lettuce), turfgrass, soybean seeds; horticultural and field crops. For details, refer to the Evaluation Report (ERC), Proposed Registration Decisions (PRD) and Registration Decisions (RD): ERC2014-02, Fluopyram, PRD2016-05, Fluopyram, PRD2016-11, Fluopyram, RD2016-15, Fluopyram, and RD2016-25, Fluopyram.
An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of Luna Privilege Greenhouse Fungicide, containing fluopyram, are acceptable.
This summary describes the key points of the evaluation, while the Science Evaluation of the full version of Proposed Registration Decision PRD2024-10, Fluopyram, Luna Privilege Greenhouse Fungicide provides detailed technical information on the human health, environmental and value assessments of Luna Privilege Greenhouse Fungicide, containing fluopyram on greenhouse grown ornamentals and outdoor ornamentals.
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 individuals and the environment from the use of pest control products. Health or environmental risk is considered acceptableFootnote 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 valueFootnote 2 when used according to the label directions. Conditions of registration may include 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). They also consider the unique characteristics of 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 on how the Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and Pest Management portion of Canada.ca.
Before making a final registration decision on Luna Privilege Greenhouse Fungicide, containing fluopyram, Health Canada's PMRA will consider any written comments received from the public in response to PRD2024-10.Footnote 3 Health Canada will then publish a Registration DecisionFootnote 4 on Luna Privilege Greenhouse Fungicide, containing fluopyram, 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 PRD2024-10.
What is fluopyram?
Fluopyram is a member of the succinate-dehydrogenase inhibitors (SDHI) fungicides and is the active ingredient in Luna Privilege Greenhouse Fungicide. Luna Privilege Greenhouse Fungicide is applied via foliar, drip or drench applications for the management of various fungal diseases on various crops.
Health considerations
Can approved uses of fluopyram affect human health?
Products containing fluopyram are unlikely to affect your health when used according to label directions.
Exposure to fluopyram may occur through the diet (food and water), when handling and applying the end-use product, or when entering treated sites. 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). 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. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide products are used according to label directions.
As described in PRD2016-05, the acute toxicity of the technical grade active ingredient fluopyram was low via the oral, dermal and inhalation routes of exposure in laboratory animals. Fluopyram was minimally irritating to the eyes and non-irritating to the skin and did not cause an allergic skin reaction.
Based on the results of studies in laboratory animals that supported the registration of Luna Privilege (identical to Luna Privilege Greenhouse Fungicide), as summarized in PRD2016-05, the acute toxicity of the end-use product Luna Privilege was low via the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eyes and non-irritating to the skin and did not cause an allergic skin reaction.
Prior to the initial registration of fluopyram, registrant-supplied short- and long-term (lifetime) animal toxicity tests, as well as information from the published scientific literature, were assessed for the potential of fluopyram to cause neurotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. No new toxicology data were received for these proposed new uses. As described in PRD2016-05 and ERC2014-02, the most sensitive endpoints used for risk assessment were decreased activity and effects on the liver, thyroid and kidneys. There were no indications that the young were more sensitive to fluopyram than the adult animal. Fluopyram caused liver tumours in rats and thyroid tumours in mice at high dose levels. The risk assessment protects against these and any other potential effects by ensuring that the level of human exposure is well below the lowest dose at which these effects occurred in animal tests.
Occupational risks from handling Luna Privilege Greenhouse Fungicide
Occupational risks are not of health concern when Luna Privilege Greenhouse Fungicideis used according to the proposed label directions, which include protective measures.
Workers mixing, loading or applying Luna Privilege Greenhouse Fungicide, and workers entering recently treated nurseries and greenhouses can be exposed to fluopyram residues through direct skin contact or through inhalation. Therefore, the label specifies that anyone mixing, loading and applying Luna Privilege Greenhouse Fungicidemust wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. In addition, eye, head and respiratory protective equipment are required when applying above the waist using handheld equipment. Users are not allowed to apply the product using handheld airblast mistblowers and fogging equipment. The label also requires that workers do not enter or be allowed into treated areas during the restricted-entry interval (REI) of 12 hours. Taking into consideration the label statements, the number of applications and the duration of exposure for handlers and postapplication workers, the risks to these individuals from exposure to Luna Privilege Greenhouse Fungicide are not of health concern when the end-use product is used according to the label directions.
Health risks in residential and other non-occupational environments
There are no risks in residential and other non-occupational environments as the product will only be applied in commercial nurseries and greenhouses.
A standard label statement to prohibit the use of Luna Privilege Greenhouse Fungicide in residential areas is required on the label. Furthermore, exposure to treated ornamental plants that are subsequently purchased at retail locations is considered negligible.
Health risks to bystanders
Bystander risks are not of health concern when Luna Privilege Greenhouse Fungicide is used according to the proposed label directions and spray drift restrictions are observed.
A standard label statement to protect against drift during application is required on the label. Therefore, health risks to bystanders are not of concern when the end-use product is used according to the proposed label directions.
Environmental considerations
What happens when fluopyram is introduced into the environment?
When used according to label directions, environmental risks associated with the use of fluopyram and its associated end-use product, Luna Privilege Greenhouse Fungicide, are acceptable.
The environmental risk of fluopyram was assessed in ERC2014-02, Fluopyram, PRD2016-05, Fluopyram, PRD2016-11, Fluopyram, RD2016-15, Fluopyram and RD2016-25, Fluopyram. These risk assessments considered the same application rates, application methods, and similar use patterns, as those in the present submissions.
It was determined that fluopyram may pose a risk to birds, and non-target terrestrial plants from spray drift, and to amphibians due to runoff and spray drift. In order to minimize the potential risk, spray buffer zones are required between the treated area and downwind edge of sensitive terrestrial and aquatic habitats. Precautionary hazard statements were also required on associated end-use product labels to inform users that fluopyram is toxic to non-target aquatic organisms, terrestrial plants, and birds. For outdoor uses, precautionary hazards statement on the potential for fluopyram to leach and carry over to the following season were required on end-use products. For greenhouse uses, label directions were required to prevent greenhouse effluent containing fluopyram from entering aquatic systems.
After a review of the information in the current submissions, the PMRA has concluded that the environmental risks associated with the major new uses of fluopyram on greenhouse and outdoor ornamentals is acceptable when used according to the label directions.
Value considerations
What is the value of Luna Privilege Greenhouse Fungicide?
Fluopyram is the active ingredient in Luna Privilege Greenhouse Fungicide. It provides disease management against botrytis blight and powdery mildew on outdoor and greenhouse grown ornamentals, including roses.
Botrytis blight and powdery mildew are major concerns for producers of ornamental plants under either field or greenhouse conditions as any signs of infection may render their product unmarketable. Luna Privilege Greenhouse Fungicide, applied to foliage according to label directions is expected to provide effective disease management against botrytis blight and powdery mildew on ornamentals and, specifically, powdery mildew on roses. The registration of Luna Privilege Greenhouse Fungicide for these uses will provide producers of ornamental plants, including roses, with an additional product option to manage major diseases in crops that have characteristically low economic tolerance for any signs of fungal infection.
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 Luna Privilege Greenhouse Fungicide to address the potential risks identified in this assessment are as follows.
Key risk-reduction measures - Human health
To reduce the potential exposure of workers to fluopyramthrough direct skin contact or inhalation, workers mixing, loading and applying Luna Privilege Greenhouse Fungicideand performing cleaning and repair activities must wear a long-sleeved shirt, long pants, chemical resistant gloves, socks and shoes. Workers applying above the waist using handheld equipment are required to wear eye, head and respiratory protective equipment. The label also requires that workers do not enter or be allowed entry into treated areas during the REI of 12 hours. Furthermore, standard label statements to prohibit the use of this product in residential areas and to protect against drift during application are required on the label. A label statement to prohibit the use of handheld airblast, misters, and foggers during application is present on the label.
Key risk-reduction measures - Environment
No additional risk mitigation measures are required on the Luna Privilege Greenhouse Fungicide label to address environmental risks from greenhouse uses. However, as outdoor uses are new to the label, the following risk reduction measures are required to minimize potential risks from field sprayer and airblast applications:
- Precautionary hazard statements on the label to protect non-target aquatic organisms, terrestrial plants, and birds.
- Spray buffer zones of 1 to 2 m are required for the protection of non-target aquatic and terrestrial organisms.
Next steps
Before making a final registration decision on Luna Privilege Greenhouse Fungicide, containing fluopyram, Health Canada's PMRA will consider any written comments received from the public in response to PRD2024-10 up to 45 days from the date of publication (16 December 2024) of this document (PRD2024-10). 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 Luna Privilege Greenhouse Fungicide, containing fluopyram (based on the Science evaluation Section of PRD2024-10). In addition, the test data referenced in PRD2024-10 will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the Pest Management Information Service.
Footnotes
- Footnote 1
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"Acceptable risks" as defined by subsection 2(2) of the Pest Control Products Act.
- Footnote 2
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"Value" as defined by subsection 2(1) of the Pest Control Products Act: "the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product's (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact."
- Footnote 3
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"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.
- Footnote 4
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"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.
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