Proposed Registration Decision PRD2022-11, Fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide

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Pest Management Regulatory Agency
29 August 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-11E-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.

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Table of contents

Proposed registration decision for Fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide

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 Fenazaquin Technical, Magister SC Miticide/Fungicide, and Magus SC Miticide, containing the technical grade active ingredient fenazaquin, to control certain mites, psylla, whitefly, and powdery mildew on a variety of crops and ornamental plants.

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 PRD2022-11, Fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide provides detailed technical information on the human health, environmental and value assessments of fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide.

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 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 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 fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-11.Footnote 3 Health Canada will then publish a Registration DecisionFootnote 4 on fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide, 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 PRD2022-11.

What is Fenazaquin?

Fenazaquin is a conventional chemical miticide, insecticide and fungicide that acts by disrupting energy production within the cells of certain mites, insects and fungi. It is the active ingredient in the commercial class products Magister SC Miticide/Fungicide and Magus SC Miticide, which provide control of the target mite, insect and fungal pests on a variety of food crops as well as indoor and outdoor ornamental plants.

Health considerations

Can approved uses of Fenazaquin affect human health?

Magister SC Miticide/Fungicide and Magus SC Miticide, containing Fenazaquin, are unlikely to affect human health when used according to proposed label directions.

Potential exposure to fenazaquin may occur through the diet (food and drinking water), when handling and applying the end-use products, or when coming into contact with treated surfaces. When assessing health risks, two key factors are considered:

The dose levels used to assess risks are selected 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 level at which no effects are observed. The health effects noted in animals occur at dose levels 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, technical-grade active ingredient, fenazaquin, was of high acute toxicity by the oral route and was considered to potentially cause an allergic skin reaction; consequently, the signal word "DANGER" and hazard statements "POISON" and "POTENTIAL SKIN SENSITIZER" are required on the label. It was of low acute toxicity by the dermal route, of slight acute toxicity by inhalation exposure, minimally irritating to the eyes, and non-irritating to the skin.

The end-use products Magister SC Miticide/Fungicide and Magus SC Miticide were of high acute toxicity by the oral route, mildly irritating to the eyes, and moderately irritating to the skin in laboratory animals; consequently, the signal word "DANGER" and hazard statements "POISON" and "EYE AND SKIN IRRITANT" are required on the labels. Both products were of low acute toxicity by the dermal route and of slight acute toxicity by inhalation exposure, and neither caused an allergic skin reaction.

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 fenazaquin to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoint for risk assessment was reduced survival of the young. An increase in adrenocortical tumors in female hamsters could not clearly be attributed to treatment with fenazaquin. There was no evidence of increased sensitivity of the young 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 level at which these effects occurred in animal tests.

Residues in water and food

Dietary risks from food and water are acceptable.

Aggregate acute dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 58% of the acute reference dose, and therefore are not of health concern.

Aggregate chronic (non-cancer and cancer) dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 10% of the acceptable daily intake, and therefore are not of health concern.

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. Given that dietary risks from the consumption of foods are shown to be acceptable when fenazaquin is used according to the supported label directions, MRLs are being proposed as a result of this assessment

MRLs for fenazaquin determined from the acceptable residue trials conducted throughout the United States, including regions representative of Canada, on fruiting vegetables (pepper, tomato), cucurbit vegetables (cantaloupe, cucumber, zucchini), pome fruits (apple, pear), stone fruits (peach, cherry, plum), caneberries (raspberry), bushberries (blueberry), vine climbing small fruits (grape), low growing berries (strawberry) and citrus fruits (lemon, lime, grapefruit) can be found in the Science Evaluation of PRD2022-11.

Occupational risks from handling Magister SC Miticide/Fungicide and Magus SC Miticide

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

Workers mixing, loading or applying Magister SC Miticide/Fungicide or Magus SC Miticide, and workers entering recently treated fields, nurseries, non-cropland areas and ornamental plant greenhouses can be exposed to fenazaquin residues through direct skin contact or through inhalation. Therefore, the label specifies that anyone mixing, loading and applying Magister SC Miticide/Fungicide or Magus SC Miticide must wear coveralls over a long-sleeved shirt and long pants, chemical-resistant gloves, protective eyewear (goggles or faceshield), socks and chemical-resistant footwear. Additionally, workers applying with open-cab airblast equipment must wear chemical-resistant headgear. Greenhouse workers and workers using mechanically-pressurized handguns must wear chemical-resistant coveralls instead of coveralls and a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides, or a NIOSH-approved canister approved for pesticides. For berries and orchard crops, a restriction on the amount handled per day of up to 12 L is required when using mechanically-pressurized handguns.

The label also requires that workers do not enter treated fields up to a maximum of 22 days (depending on the crop or use and associated postapplication activity) after application. The restricted-entry intervals (REIs) for greenhouse vegetables, and for indoor/greenhouse and outdoor ornamental cut flowers were not considered agronomically feasible; therefore, these uses are not supported.

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 fenazaquin are not of health concern when the end-use products are used according to the proposed label directions.

Risks in residential and other non-occupational environments

Health risks in residential and other non-occupational environments are not of health concern when Magister SC Miticide/Fungicide or Magus SC Miticide is used according to the proposed label directions and REIs are observed.

Residential exposure to fenazaquin during pick-your-own berries and orchard fruit activities, and from contact with treated ornamental plants and trees in residential, recreational, commercial, industrial and public areas are not of health concern when the end-use products are used according to the proposed label directions.

Health risks to bystanders

Bystander risks are not of health concern when Magister SC Miticide/Fungicide or Magus SC Miticide is used according to the proposed label directions for ornamental plants and trees and orchard trees in rights-of-way, easements and recreational areas and the public use of treated areas is allowed only when the sprays have dried. For interiorscapes or plantscapes in buildings, since Magister SC Miticide/Fungicide or Magus SC Miticide can only be applied when occupants and/or bystanders are not present, no health risks of concern are expected. In addition, a standard label statement to protect against drift during application is on the label. Therefore, health risks to bystanders from the other exposure scenarios are also not of concern.

Environmental considerations

What happens when Fenazaquin is introduced into the environment?

When fenazaquin and its end-use products are used according to label directions, the risks to the environment are acceptable.

Fenazaquin can enter the environment when its end-use products are applied as a foliar spray to control fungal diseases and insect and mite pests on various outdoor and greenhouse plants. Fenazaquin on plant surfaces is not expected to travel into plant tissues. Fenazaquin is not expected to be found in air. On land, fenazaquin may persist for months, but fenazaquin and its breakdown products have low potential to carry over to the next growing season and are not expected to move through the soil and reach groundwater. In water bodies, fenazaquin moves quickly into sediments and may persist for months. Fenazaquin is not expected to build up in aquatic organisms.

Use restrictions and hazard statements on end-use product labels are required to reduce risks to bees, other beneficial arthropods and aquatic organisms. When used according to label directions, fenazaquin and its breakdown products pose acceptable risk to terrestrial and aquatic organisms.

Value considerations

What is the value of Magister SC Miticide/Fungicide and Magus SC Miticide?

Magister SC Miticide/Fungicide and Magus SC Miticide provide a new active ingredient, and in most cases a new mode of action, for control of important mite and insect pests of food crops and ornamental plants, and for control of powdery mildew diseases of food crops.

Magister SC Miticide/Fungicide provides control of certain mites, including spider mites, and powdery mildew on a variety of terrestrial food crops, pear psylla on pear, spider mites on indoor and outdoor ornamental plants, and sweetpotato whitefly on indoor ornamentals. Magus SC Miticide provides control of certain spider mites on indoor and outdoor ornamental plants and sweetpotato whitefly on indoor ornamentals. These products provide a new active ingredient for all of their uses and a new mode of action for most of their uses, which will aid in the management of resistance to pest control products already registered for those uses.

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 Fenazaquin Technical, Miticide/Fungicide, and Magus SC Miticide 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 fenazaquin through direct skin contact or inhalation of sprays, workers mixing, loading and applying Magister SC Miticide/Fungicide or Magus SC Miticide and performing cleaning and repair activities must wear coveralls over a long-sleeved shirt and long pants, chemical-resistant gloves, protective eyewear (goggles or faceshield), socks and chemical-resistant footwear. Additionally, workers applying with open-cab airblast equipment must wear chemical-resistant headgear. Greenhouse workers and workers using mechanically-pressurized handguns must wear chemical-resistant coveralls instead of coveralls when applying to indoor plants and plantscapes and to outdoor ornamental plants and trees, and a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides, or a NIOSH-approved canister approved for pesticides when applying to berries and orchard crops. For berries and orchard crops, a restriction on the amount handled per day of up to 12 L is required when using mechanically-pressurized handguns.

Risks to workers are not of health concern when Magister SC Miticide/Fungicide or Magus SC Miticide is used according to the proposed label directions and REIs are observed. In addition, standard label statements to protect against drift during application are found on each product label.

Table 1 Restricted-entry interval and/or Preharvest interval
Crop Postapplication activity Restricted-entry interval (REI) and/or Preharvest interval (PHI)

Bushberry (Subgroup 13-07B) and Caneberry (Subgroup 13-07A)

Harvesting

7 days

Hand set irrigation

2 days

All other activities

12 hours

Low Growing Berry Subgroup 13-07G

Harvesting

1 day

Hand set irrigation

2 days

All other activities

12 hours

Fruiting Vegetables

Harvesting;

Hand set irrigation

3 days

All other activities

12 hours

Cucurbit Vegetables

Harvesting

3 days

Hand set irrigation

6 days

All other activities

12 hours

Small Fruit Vine Climbing (Subgroup 13-07F)

Hand harvesting of grapes

15 days

Mechanical harvesting of grapes and hand harvesting of all vine climbing berries

7 days

Girdling of table grapes

22 days

Tying and training

15 days for grapes

2 days for other vine climbing berries

Thinning fruit by hand

7 days

Hand set irrigation

3 days

All other activities

12 hours

Pome Fruit and Stone Fruit

Harvesting

10 days

Thinning fruit by hand

17 days

Scouting, hand pruning and training

1 day

All other activities

12 hours

Outdoor ornamental plants; Established outdoor ornamental landscape plantings;

Ornamental plants in rights-of-way and other easements; Ornamental plants in recreational sites (such as campgrounds, golf courses, parks, athletic fields)

Hand set irrigation

1 day

All other activities

12 hours

Greenhouse ornamental plants; Shade house plants; Indoor plants, and Interiorscapes

All activities

12 hours

Health Canada is seeking comments from stakeholders on the agronomic feasibility of the 10-day restricted-entry interval (REI) for hand harvesting stone fruits, 17-day REI for hand thinning pome and stone fruits, and the 22- and 15-day REI for girdling and training grapes, respectively, in addition to any other proposed REIs.

Key risk-reduction measures – Environment

Next steps

Before making a final registration decision on fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-11. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-11. 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 the Health Canada makes its registration decision, it will publish a Registration Decision on fenazaquin, Magister SC Miticide/Fungicide, and Magus SC Miticide (based on the Science Evaluation of PRD2022-11). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.

Footnotes

Footnote 1

"Acceptable risks" as defined by subsection 2(2) of the Pest Control Products Act.

Return to footnote 1 referrer

Footnote 2

"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."

Return to footnote 2 referrer

Footnote 3

"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.

Return to footnote 3 referrer

Footnote 4

"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.

Return to footnote 4 referrer

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