Proposed Registration Decision PRD2018-06, Pydiflumetofen, A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide, and A21461 Fungicide
Notice to the reader:
This consultation is now closed.
Pest Management Regulatory Agency
6 April 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-6E-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 PRD2018-06, Pydiflumetofen, A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide, and A21461 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 Pydiflumetofen
- What Does Health Canada Consider When Making a Registration Decision?
- What Is Pydiflumetofen?
- Health Considerations
- Environmental Considerations
- Value Considerations
- Measures to Minimize Risk
- Next Steps
- Other Information
Proposed Registration Decision for Pydiflumetofen
Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing registration for the sale and use of Pydiflumetofen Technical, A19649 Fungicide and A19649TO Fungicide, containing the technical grade active ingredient Pydiflumetofen to manage certain important diseases on both major and minor crops in Canada. Also being registered are A20259 Fungicide containing pydiflumetofen and difenoconazole, A20560 Fungicide containing pydiflumetofen and fludioxonil, and A21461 Fungicide containing pydiflumetofen, azoxystrobin and propiconazole to manage certain diseases on several crops. A19649TO Fungicide is also proposed for use on turf and golf courses in Canada.
A number of these pydiflumetofen end-use products are formulated with the active ingredients fludioxonil, difenoconazole, azoxystrobin and propiconazole. These active ingredients are currently registered for the proposed uses in Canada and there are no major new uses for any of these active ingredients.
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 PRD2018-06, Pydiflumetofen, A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide, and A21461 Fungicide provides detailed technical information on the human health, environmental and value assessments of Pydiflumetofen Technical, A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide and A21461 Fungicide.
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 human health 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 Pydiflumetofen, the PMRA will consider any comments received from the public in response to PRD2018-06. The PMRA will then publish a Registration Decision on Pydiflumetofen, 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 PRD2018-06.
What Is Pydiflumetofen?
Pydiflumetofen is a conventional fungicide active ingredient that works by inhibiting respiration in susceptible fungi. It controls or suppresses economically important diseases of field crops, fruit crops, vegetable crops, ornamentals, turf and golf courses.
Can Approved Uses of Pydiflumetofen Affect Human Health?
Products containing pydiflumetofen are unlikely to affect your health when used according to label directions.
Potential exposure to pydiflumetofen may occur through the diet (food and water), when handling and applying the end-use products, or when entering an area that has been treated with these products. 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.
In laboratory animals, the technical grade active ingredient pydiflumetofen was of low acute toxicity via the oral, dermal and inhalation routes. It was minimally irritating to the eyes and non-irritating to the skin. It did not cause an allergic skin reaction. Based on these findings, hazard statements for acute toxicity are not required on the label.
The three end-use products, A19649TO Fungicide, A20259 Fungicide, and A20560 Fungicide, were all of low acute toxicity via the oral, dermal and inhalation routes. They were non-irritating to the skin and eyes and did not cause allergic skin reactions. The end-use product A19649 Fungicide had a similar acute toxicity profile, except that it was minimally irritating to the eyes. Based on these findings, hazard statements for acute toxicity are not required on the product labels.
The end-use product A21461 Fungicide was of moderate acute toxicity via the oral route and of low acute toxicity via the dermal and inhalation routes. It was moderately irritating to the eyes, minimally irritating to the skin, and did not cause an allergic skin reaction. Based on these findings, the signal word and hazard statements “POISON” and “WARNING – EYE IRRITANT” are required on the product label.
Short-term and long-term (lifetime) animal toxicity tests were assessed for the potential of pydiflumetofen to cause neurotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, genetic damage, and various other effects. The most sensitive endpoints used for risk assessment were effects on body weight, liver, activity level, and behaviour. There was no evidence that pydiflumetofen damaged genetic material; however, it did cause liver tumours in mice. There was some evidence that the young animal was more sensitive to pydiflumetofen 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 drinking water are not of health concern.
Aggregate dietary intake estimates (food plus drinking water) revealed that the general population and children 1-2 years old, the subpopulation that would ingest the most pydiflumetofen relative to body weight, are expected to be exposed to less than 30% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from pydiflumetofen is not of health concern for all population subgroups.
Pydiflumetofen is not carcinogenic; therefore, a cancer dietary risk assessment is not required.
Acute dietary (food plus drinking water) intake estimates for the general population and all population subgroups were less than 9% of the acute reference dose, and are not of health concern. The highest exposed subpopulation was children 3-5 years old.
The Food and Drugs Act prohibits the sale of adulterated food, that is, food containing a pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs are established for Food and Drugs Act purposes through the evaluation of scientific data under the Pest Control Products Act. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.
Residue trials conducted throughout Canada and the United States using pydiflumetofen on various crops are acceptable. The proposed MRLs for this active ingredient can be found in the Science Evaluation of PRD2018-06.
Risks in Residential and Other Non-Occupational Environments
Residential risks are not of concern when pydiflumetofen is used according to the proposed label directions and restricted-entry intervals are observed.
Adults, youth and children golfing can come into direct contact with A19649TO Fungicide residues from treated turf. Therefore, the label requires that individuals do not re-enter treated golf courses until sprays have dried. Taking into consideration the label statements, number of applications and the duration of exposure, risks to individuals golfing are not a concern.
Occupational Risks From Handling Pydiflumetofen
Occupational risks are not of concern when pydiflumetofen is used according to the label directions, which include protective measures.
Farmers and custom applicators who mix, load or apply A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide and A21461 Fungicide as well as field workers re-entering freshly treated fields, nurseries and greenhouses can come in direct contact with pydiflumetofen residues on the skin. Therefore, the labels specify that a long-sleeved shirt, long pants, chemical resistant gloves, shoes and socks must be worn. Additionally, goggles are required for mixing and loading of A21461 Fungicide. The labels also require that workers do not enter treated fields for 12 hours after application, except for golf courses where re-entry is permitted once sprays have dried. For girdling or turning of grapes, the restricted-entry interval (REI) is 1 day. Taking into consideration these label statements, the number of applications and the duration of exposure for handlers and workers, risks to these individuals are not a concern.
For bystanders, exposure is expected to be much less than that for workers and is considered negligible. Therefore, health risks to bystanders are not of concern.
What Happens When Pydiflumetofen Is Introduced into the Environment?
When used according to label directions, pydiflumetofen is not expected to pose risks of concern to the environment.
Pydiflumetofen can enter land and water habitats through spray drift and runoff when used as a foliar spray for control of a number of fungal diseases on a variety of crops, turf and golf courses. Pydiflumetofen does not dissolve readily in water and has low potential to enter the atmosphere from soil and water surfaces and be transported long distances. In soil, it does not break down easily in the presence of moisture, light and soil microorganisms and, thus, can remain there for a long time. In the aquatic environment, pydiflumetofen resides primarily in the sediment and breaks down in the presence of microorganisms to form the transformation product SYN545547. Because pyflumetofen remains in soil for a long time it can be carried down through the soil profile and has a potential to reach groundwater. Pydiflumetofen also has a potential to run off fields and enter adjacent water ditches, ponds and other water bodies. Pyflumetofen is not expected to accumulate in fish tissues.
When used according to the label directions, pydiflumetofen does not present a risk to earthworms, pollinators and other beneficial arthropods, birds, wild mammals, fresh water algae, aquatic vascular plants, freshwater invertebrates, marine fish, marine algae and crustaceans. However, exposure to pydiflumetofen may affect non-target terrestrial plants, freshwater fish and amphibians. To protect non-target plants, freshwater fish and amphibians from spray drift, spray buffer zones up to 15 meters are required. To protect freshwater amphibians from the potential exposure from runoff, label statements informing users how to reduce runoff will be required. Additional precautionary label statements will be required to inform users of carryover and leaching potential, as well as the toxicity of pydiflumetofen to aquatic organisms.
What Is the Value of A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide and A21461 Fungicide?
Products containing pydiflumetofen provide a new mode of action fungicide to manage certain diseases on several crops as well as turf and golf courses. As it is a new mode of action, it will help reduce the development of resistance in susceptible fungal pathogens.
The registration of these products addresses grower identified disease priorities on minor crops. Co-formulated products provide multiple modes of action which help delay the development of resistance in target fungi and simultaneously manage diseases that co-occur. These products provide disease reduction at a commercially expected level and help maintain the quality of marketed grains and produce, ornamental crops, and golf courses and sod turf.
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 A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide and A21461 Fungicide to address the potential risks identified in this assessment are as follows.
Key Risk-Reduction Measures
Because there is a concern with users coming into direct contact with pydiflumetofen on the skin or through inhalation of spray mists, anyone mixing, loading and applying pydiflumetofen and performing cleaning and repair activities must wear a long-sleeved shirt, long pants, chemical resistant gloves, shoes plus socks and goggles. Additionally, airblast applicators applying A19649TO must wear chemical-resistant headgear, while mixers/loaders of A21461 Fungicide must wear goggles or a face shield. Furthermore, standard label statements to protect against drift during application are present on the label.
To mitigate potential exposure of aquatic organisms to pydiflumetofen through spray drift, spray buffer zones of 1–15 metres are to be specified on the product labels.
To mitigate the potential effects of pydiflumetofen on non-target terrestrial plants, spray buffer zones of 1–15 metres are to be specified on the product labels.
Standard label statements are required to inform users of the toxicity of pydiflumetofen to aquatic organisms and non-target terrestrial plants.
To minimize the potential of pydiflumetofen to be carried-over to the following growing season, a label statement is required to inform users that pydiflumetofen-containing products should not be applied in consecutive years.
Standard statements are required to inform users of conditions that may favour runoff.
Precautionary label statements are required to inform users of conditions where pydiflumetofen may be prone to leaching.
Before making a final registration decision on Pydiflumetofen, A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide, and A21461 Fungicide, the PMRA will consider any comments received from the public in response to PRD2018-06. The PMRA will accept written comments on this proposal up to 45 days from the date of publication of PRD2018-06. Please note that, to comply with Canada’s international trade obligations, consultation on the proposed MRLs will also be conducted internationally via a notification to the World Trade Organization. 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.
When the PMRA makes its registration decision, it will publish a Registration Decision on Pydiflumetofen A19649 Fungicide, A19649TO Fungicide, A20259 Fungicide, A20560 Fungicide, and A21461 Fungicide, (based on the Science Evaluation of PRD2018-06). In addition, the test data referenced in PRD2018-06 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).
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