Proposed Registration Decision PRD2019-09, Mefentrifluconazole and related end-use products

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Pest Management Regulatory Agency
2 August 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-9E-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 PRD2019-09, Mefentrifluconazole and related end-use products 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 Mefentrifluconazole

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 Revysol Fungicide Technical, BAS 752 RC, Belyan, Cevya, Lenvyor, Maxtima, and Relenya, containing the technical grade active ingredient mefentrifluconazole, to control various fungal pests in field crops, fruits, specialty crops and golf course turf.

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 PRD2019-09 Mefentrifluconazole and related end-use products provides detailed technical information on the human health, environmental and value assessments of mefentrifluconazole and related end-use products.

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 mefentrifluconazole and related end-use products, Health Canada’s PMRA will consider any comments received from the public in response to this PRD2019-09. Health Canada will then publish a Registration Decision on mefentrifluconazole and related end-use products, 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 PRD2019-09.

What Is Mefentrifluconazole?

Mefentrifluconazole is a new conventional active ingredient for disease management in certain field crops, fruits, specialty crops and golf course turf. It inhibits spore germination, mycelial growth, and sporulation of the fungus on the leaf surface. Mefentrifluconazole is a systemic and selective fungicide.

Health Considerations

Can Approved Uses of Mefentrifluconazole Affect Human Health?

The end-use products, Lenvyor, Cevya, Maxtima, Relenya, Belyan and BAS 752 RC, containing mefentrifluconazole are unlikely to affect your health when used according to label directions.

Potential exposure to mefentrifluconazole may occur through the diet (food and water) or when handling and applying the end-use products. When assessing health risks, two key factors are considered:

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 mefentrifluconazole was of low acute toxicity by the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eyes and non-irritating to the skin. It caused an allergic skin reaction; consequently, the hazard statement “POTENTIAL SKIN SENSITIZER” is required on the label.

The acute toxicity of the end-use product Lenvyor was low via the oral, dermal and inhalation routes of exposure. It was moderately irritating to the skin and eyes, and in the absence of an appropriate dermal sensitization study, Lenvyor was assumed to cause an allergic skin reaction; consequently, the signal word and hazard statements “WARNING – EYE AND SKIN IRRITANT – POTENTIAL SKIN SENSITIZER” are required on the label.

The acute toxicity of the end-use products Cevya, Maxtima and Relenya was low via the oral, dermal and inhalation routes of exposure. The end-use products were non-irritating to the skin and eyes. In the absence of an appropriate dermal sensitization study, Cevya, Maxtima and Relenya were assumed to cause an allergic skin reaction; consequently, the hazard statement “POTENTIAL SKIN SENSITIZER” is required on each of the labels.

The acute toxicity of the end-use product Belyan was low via the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eyes and did not cause an allergic skin reaction. Belyan was mildly irritating to the skin; consequently, the signal word and hazard statement “CAUTION – SKIN IRRITANT” are required on the label.

The acute toxicity of the end-use product BAS 752 RC was low via the oral, dermal and inhalation routes of exposure. It was slightly irritating to the skin and minimally irritating to the eyes. BAS 752 RC did not cause an allergic skin reaction.

Registrant-supplied short- and long-term (lifetime) animal toxicity tests were assessed for the potential of mefentrifluconazole to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were effects on hematology parameters, the liver and kidneys and activity level. There was no evidence of increased sensitivity of the young to mefentrifluconazole compared to adult animals. The risk assessment protects against the effects noted above and 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 acute dietary (food plus drinking water) intake estimates for the general population and all population subgroups were less than 6% of the acute reference dose, and are not of health concern. The highest exposed subpopulation was children 1-2 years old.

Aggregate chronic dietary (food plus drinking water) intake estimates indicated that the general population and children 1-2 years old, the subpopulation which would ingest the most mefentrifluconazole relative to body weight, are expected to be exposed to less than 12% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from mefentrifluconazole is not of health concern for all population subgroups.

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 mefentrifluconazole on potatoes, sugar beets, legume vegetables, citrus fruits, pome fruits, stone fruits, grapes, tree nuts, cereals, canola and peanuts are acceptable. The MRLs for this active ingredient can be found in the Science Evaluation section of this document.

A number of these mefentrifluconazole products are also formulated with the active ingredients fluxapyroxad and pyraclostrobin. These co-active ingredients are already registered for these uses in Canada, and residues in treated commodities will be covered under the existing MRLs for each active ingredient.

Occupational Risks from Handling BAS 752 RC, Belyan, Cevya and Lenvyor

Occupational risks are not of concern when BAS 752 RC, Belyan, Cevya and Lenvyor are used according to the proposed label directions, which include protective measures.

Farmers and custom applicators who mix, load or apply BAS 752 RC, Belyan, Cevya or Lenvyor as well as workers entering freshly treated fields can come in direct contact with mefentrifluconazole residues on the skin. Therefore, the labels for BAS 752 RC, Belyan and Cevya specify that users wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. The label of Lenvyor specifies that users wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. In addition, the labels for Belyan and Lenvyor also specify that users wear protective eyewear during mixing and loading.

Furthermore, the labels for BAS 752 RC, Belyan and Lenvyor require that workers do not enter treated fields for 12 hours after application. For Cevya, it is required that workers do not enter treated fields for 12 hours after application for all activities, except for cane turning and girdling of table grapes where workers must respect a 35-day restricted-entry interval.

Standard label statements to protect against drift during application are present on the labels. Taking into consideration these label statements, the number of applications and the duration of exposure for handlers and workers, health risks to these individuals are not a concern.

Occupational Risks from Handling Maxtima

Occupational risks are not of concern when Maxtima is used according to the proposed label directions, which include protective measures.

Farmers and custom applicators who mix, load or apply Maxtima as well as workers entering freshly treated golf course turf can come in direct contact with mefentrifluconazole residues on the skin. Therefore, the label for Maxtima specifies that users wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. The restricted-entry interval on commercial golf courses treated with Maxtima is “until sprays have dried”.

Taking into consideration these label statements, the number of applications and the duration of exposure for handlers, workers and golfers, health risks to these individuals are not a concern.

Occupational Risks from Handling Relenya

Occupational risks are not of concern when Relenya is used according to the proposed label directions, which include protective measures.

Workers treating seed with Relenya in commercial facilities, by commercial mobile systems or on-farm, and workers planting treated seed can come into direct contact with mefentrifluconazole residues on the skin and through inhalation.

The Relenya label specifies that workers mixing, loading, applying, bagging, stacking and sewing bags of treated seed and involved in handling treated seed in commercial seed treating facilities or on-farm, must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks and a NIOSH-approved N95 (minimum) filtering facepiece respirator (dust mask) that is properly fit tested.

In addition, workers cleaning-up or maintaining and repairing seed treatment equipment must wear chemical-resistant coveralls in commercial seed treatment facilities, or coveralls on-farm, over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear and a NIOSH-approved N95 (minimum) filtering facepiece respirator (dust mask) that is properly fit tested.

Workers loading and planting treated seed must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks and a NIOSH-approved N95 (minimum) filtering facepiece respirator (dust mask) that is properly fit tested. Closed transfer systems must be used in commercial seed treatment facilities and closed-cab tractors must be used while planting.

Taking into consideration these label statements, the number of applications and the duration of exposure for handlers and workers, health risks to these individuals are not a concern.

Health Risks to Bystanders

For bystanders, exposure is expected to be less than that for workers. Therefore, health risks to bystanders are not of concern.

Risks in Residential and Other Non-Occupational Environments

Risks in residential and other non-occupational environments are not of concern when mefentrifluconazole is used according to the proposed label directions and restricted-entry intervals are observed.

Adults, youth and children while golfing can come into direct contact with mefentrifluconazole residues from treated turf. Therefore, the label requires that individuals do not 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.

Residential exposure in pick-your-own fruit scenarios in treated orchards and residential areas are not of health concern.

Environmental Considerations

What Happens When Mefentrifluconazole Is Introduced Into the Environment?

When mefentrifluconazole is used according to the label directions, the risks to the environment have been determined to be acceptable.

Mefentrifluconazole enters the environment when applied to control or suppress fungal pests on certain vegetable and fruit crops, treated seeds, and golf course turf. In the presence of sunlight, mefentrifluconazole can break down in the upper layers of clear water bodies and form breakdown products M750F005, M750F006, and M750F007. When mefentrifluconazole enters aquatic environments it is expected to move to the sediments and it can also break down to M750F001. Mefentrifluconazole is not expected to move into the air from water or moist soils and it is not expected to travel long distances from where it was applied. Mefentrifluconazole residues can carry-over into the next growing season. Mefentrifluconazole is not expected to move through soil and reach groundwater. Mefentrifluconazole is a systemic fungicide, and therefore, residues may move through plants, in addition to residues being present on leaves and flowers. Mefentrifluconazole is not likely to accumulate in tissues of organisms.

Mefentrifluconazole does not present a risk of concern to wild mammals, birds, beneficial insects, pollinators, earthworms, marine fish, or aquatic plants. When used according to labelled application rates, mefentrifluconazole may pose risks to freshwater fish, freshwater and marine invertebrates, amphibians, and terrestrial plants. Mitigation measures, including spray buffer zones and precautionary label statements, are required to reduce exposure to these organisms. When mefentrifluconazole is used according to the label and the required risk reduction measures are applied, the environmental risks are considered acceptable.

Value Considerations

What Is the Value of Lenvyor, Cevya, Maxtima, Relenya, BAS 752 RC and Belyan?

Lenvyor, Cevya, Maxtima and Relenya

Mefentrifluconazole is the active ingredient in Lenvyor, Cevya, Maxtima and Relenya. The registration of these products will provide Canadian growers with a new mode of action to manage important fungal diseases on the crops and plants specified on these product labels.

Lenvyor, Cevya, Maxtima and Relenya contain mefentrifluconazole as their sole active ingredient. Lenvyor, applied as a foliar spray, is effective against certain economically important diseases in corn (field, pop, sweet, seed), Crop Subgroup 6C (dried shelled pea and bean subgroup, except soybeans), soybeans, sugar beet, peanuts, potatoes, canola, rapeseed, mustard, flax and wheat (all types). Cevya, applied as a foliar spray, is effective against certain economically important diseases in grapes, peanuts, potatoes, sugar beet, Crop Group 11-09 (pome fruits), Crop Group 12-09 (stone fruits) and tree nuts. Maxtima, applied as a foliar spray, is effective against certain important diseases in golf course turf. Relenya, applied as a seed treatment, is effective against certain important diseases in canola, corn, Crop Subgroup 6C, soybean and wheat.

BAS 752 RC

Mefentrifluconazole and fluxapyroxad, the active ingredients in BAS 752 RC, control or suppress certain fungal diseases on canola, rapeseed, flax, dry pea, lentil, chickpea, fababean and potato.

BAS 752 RC, formulated as a foliar treatment, is effective against certain fungal diseases in canola, rapeseed, flax, dry pea, lentil, chickpea, fababean and potato.

Belyan

Mefentrifluconazole, pyraclostrobin and fluxapyroxad, the active ingredients in Belyan, control or suppress certain fungal diseases on canola, rapeseed, mustard, flax, Crop Subgroup 6C, potato, soybean and wheat (all types).

Belyan, formulated as a foliar treatment, is effective against certain fungal diseases in canola, rapeseed, mustard, flax, Crop Subgroup 6C, potato, soybean and wheat (all types).

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 labels of BAS 752 RC, Belyan, Cevya, Lenvyor, Maxtima, and Relenya to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

Because there is a concern with users coming into direct contact with mefentrifluconazole on the skin or through inhalation of spray mists, the labels for BAS 752 RC, Belyan, Cevya and Maxtima specify that users wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. The label of Lenvyor specifies that users wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. In addition, the labels for Belyan and Lenvyor also specify that users wear protective eyewear during mixing and loading. Furthermore, standard label statements to protect against drift during application are present.

The labels for BAS 752 RC, Belyan and Lenvyor also require that workers do not enter treated fields for 12 hours after application. For Cevya, it is required that workers do not enter treated fields for 12 hours after application for all activities, except for cane turning and girdling activity in treated vineyards of table grapes where workers do not enter for 35 days after application. For the Maxtima label, the restricted-entry interval on treated commercial golf courses is “until sprays have dried”.

The label for Relenya specifies that workers mixing, loading, applying, bagging, stacking and sewing bags of treated seed or any other activities involving handling treated seed in commercial or on-farm seed treating facilities, must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks and a NIOSH-approved N95 (minimum) filtering facepiece respirator (dust mask) that is properly fit tested. In addition, workers cleaning-up or maintaining and repairing seed treatment equipment must wear chemical-resistant coveralls in commercial seed treatment facilities and coveralls during on-farm seed treatment, over a long-sleeved shirt, long pants, chemical-resistant gloves, socks and chemical-resistant footwear and a NIOSH-approved N95 (minimum) filtering facepiece respirator (dust mask) that is properly fit tested. Workers loading and planting treated seed must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks and a NIOSH-approved N95 (minimum) filtering facepiece respirator (dust mask) that is properly fit tested. In addition, closed transfer systems must be used in commercial seed treatment facilities and closed-cab tractors must be used while planting.

Taking into consideration these label statements, the number of applications and the duration of exposure for handlers, workers and golfers, health risks to these individuals are not a concern.

Next Steps

Before making a final registration decision on mefentrifluconazole and related end-use products, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-09. Health Canada will accept written comments on PRD2019-09 up to 45 days from the date of its publication. 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. 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 Health Canada makes its registration decision, it will publish a Registration Decision on Revysol Fungicide Technical, containing the new active ingredient mefentrifluconazole, and on the associated end-use products BAS 752 RC, Belyan, Cevya, Lenvyor, Maxtima, and Relenya (based on the Science Evaluation section of PRD2019-09). 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).

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