Proposed Registration Decision PRD2022-14, Florylpicoxamid, GF-3840 Fungicide and GF-4017 Fungicide

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Pest Management Regulatory Agency
3 November 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-14E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for florylpicoxamid
• What does Health Canada consider when making a registration decision?
• What is florylpicoxamid?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information
• Footnotes

Proposed registration decision for florylpicoxamid

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 XDE-659 Technical Fungicide, GF-3840 Fungicide and GF-4017 Fungicide, containing the technical grade active ingredient florylpicoxamid, to manage certain diseases of wheat, sugar beet, canola, lentil, and turfgrass.

The proposed end-use product GF-4017 Fungicide is a coformulation of florylpicoxamid with the registered active ingredient pyraclostrobin, and does not represent any expansion of use of pyraclostrobin. For details regarding the registration of pyraclostrobin, see Proposed Registration Decisions PRD2008-04, Pyraclostrobin, Insignia EG Fungicide, Headline EC and PRD2011-15, Pyraclostrobin Seed Treatment, and Registration Decision RD2012-07, Pyraclostrobin Seed Treatment.

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 PRD2022-14, Florylpicoxamid, GF-3840 Fungicide and GF-4017 Fungicide provides detailed technical information on the human health, environmental and value assessments of florylpicoxamid, GF-3840 Fungicide and GF-4017 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 people and the environment from the use of pest control products. Health or environmental risk is considered acceptable^{Footnote 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 value^{Footnote 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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program.

Before making a final registration decision on florylpicoxamid, GF-3840 Fungicide and GF-4017 Fungicide, Health Canada’s PMRA will consider any comments received from the public in response to this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on florylpicoxamid, GF-3840 Fungicide and GF-4017 Fungicide, 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 PRD2022-14.

What is florylpicoxamid?

Florylpicoxamid is a conventional fungicide active ingredient that can be used to manage certain diseases of wheat, sugar beet, canola, lentil, and turfgrass. This product provides growers with a unique mode of action fungicide for disease management.

Health considerations

Can approved uses of florylpicoxamid affect human health?

GF-3840 Fungicide and GF-4017 Fungicide, containing florylpicoxamid, are unlikely to affect your health when used according to proposed label directions.

Potential exposure to florylpicoxamid may occur through the diet (food and drinking water), when handling and applying the end-use products, or when entering an area that has been treated with the products. When assessing health risks, two key factors are considered: the levels at which no health effects occur and the levels to which people may be exposed. 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, the technical grade active ingredient florylpicoxamid was of low acute toxicity by the oral, dermal and inhalation routes. It was non-irritating to the eyes and skin, and did not cause an allergic skin reaction.

The acute toxicity of the end-use product GF-3840 containing florylpicoxamid was low via the oral, dermal and inhalation routes of exposure. It was minimally irritating to the skin and did not cause an allergic skin reaction. GF-3840 was mildly irritating to the eyes; consequently, the signal word and hazard statement “CAUTION – EYE IRRITANT” are required on the label.

The end-use product GF-4017 containing florylpicoxamid and pyraclostrobin was of low acute toxicity via the dermal and inhalation routes of exposure, and did not cause an allergic skin reaction. It was moderately toxic via the oral route and mildly irritating to the eyes and skin. Consequently, the signal word “WARNING” and hazard statements “POISON” and – “EYE AND SKIN IRRITANT” are required on the label.

Registrant-supplied short- and long-term (lifetime) animal toxicity tests were assessed for the potential of florylpicoxamid to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. There was no evidence of tumourigenicity. The most sensitive endpoints for risk assessment were abortions and delayed puberty. Although there were serious effects observed in the young (delayed puberty and abortions), 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.

Occupational risks from handling GF-3840 and GF-4017 Fungicides

Occupational risks are not of health concern when GF-3840 and GF-4017 Fungicides are used according to the proposed label directions, which include protective measures.

Workers mixing, loading or applying GF-3840 or GF-4017 Fungicides, and workers entering recently treated fields of wheat, canola, lentils, sugar beets and turf can be exposed to florylpicoxamid residues through direct skin contact or through inhalation. Therefore, the label specifies that anyone mixing, loading and applying GF-3840 or GF-4017 Fungicidesmust wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear. The labels also requires that workers do not enter or be allowed into treated fields and sod farms during the restricted-entry interval (REI) of 12 hours, and for golf course entry is permitted once sprays have dried. 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 GF-3840 and GF-4017 Fungicides are not of health concern when the end-use product is used according to the proposed label directions.

GF-4017 Fungicide is formulated with pyraclostrobin. Pyraclostrobin is already registered for the proposed use in Canada.

Health risks in residential and other non-occupational environments

Risks in residential and other non-occupational environments are not of health concern when GF-3840 Fungicide is used according to the proposed label directions and REIs are observed.

Adults, youth and children golfing can come into direct contact with florylpicoxamid 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, the number of applications and the duration of exposure, the risks to individuals golfing from exposure to GF-3840 Fungicide are not of health concern when the end-use product is used according to the proposed label directions.

Health risks to bystanders

Bystander risks are not of health concern when GF-3840 and GF-4017 Fungicides are used according to the proposed label directions and spray drift restrictions are observed.

A standard label statement to protect against drift during application is 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.

Residues in water and food

Dietary risks from food and drinking water are not of health concern.

Studies in laboratory animals showed no acute health effects. Consequently, a single dose of florylpicoxamid is not likely to cause acute health effects in the general population (including infants and children).

Aggregate chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 74%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 florylpicoxamid is used according to the supported label directions, MRLs are being proposed as a result of this assessment (refer to PMRL2022-19, Florylpicoxamid).

MRLs for florylpicoxamid determined from the acceptable residue trials conducted throughout Canada and the United States on canola, dry beans and peas, sugar beets, and wheat can be found in the Science evaluation section of this document.
One of the proposed end-use products, GF-4170 Fungicide, is also formulated with the active ingredient pyraclostrobin. This co-active ingredient is already registered for these uses in Canada, and residues in treated commodities will be covered under the existing pyraclostrobin MRLs.

Aggregate health risks

When golf courses are treated with GF-3840 Fungicide, there is potential for individuals to be exposed to florylpicoxamid concurrently via the dermal route while golfing and the oral route while eating treated food commodities. As such, aggregation of dermal and dietary exposure was assessed and no health risks of concern were identified.

Environmental considerations

What happens when florylpicoxamid is introduced into the environment?

When used according to label directions, environmental risks associated with florylpicoxamid and its associated end-use products are acceptable.

Florylpicoxamid enters the environment when GF-3840 Fungicide and GF-4017 Fungicide are used to control diseases in labelled crops. Florylpicoxamid is quickly broken down into several transformation products, one of which is X12485649. X12485649 has a similar structure to florylpicoxamid but takes much longer to break down in the environment.

Transformation products of florylpicoxamid may move through soil to reach groundwater. They may also move off the treatment area in runoff to reach surface water. Florylpicoxamid and its transformation products are not expected to be found in the air, travel long distances in the atmosphere or accumulate in the tissue of animals.

Florylpicoxamid and X12485649 may cause adverse effects to aquatic organisms, beneficial arthropods and non-target terrestrial plants if they are exposed to high enough concentrations. Risk mitigation measures (described below) are required to reduce these risks. After a scientific review of the available information, the PMRA has concluded that the environmental risks from the proposed uses of florylpicoxamid are acceptable when used according to the label directions.

Value considerations

What is the value of GF-3840 Fungicide and GF-4017 Fungicide?

GF-3840 Fungicide contains florylpicoxamid as the active ingredient while GF-4017 Fungicide contains both florylpicoxamid and the registered active ingredient, pyraclostrobin. The registration of these products will provide Canadian growers and turf managers with a unique mode of action fungicide to manage important fungal diseases in wheat, sugar beet, canola, lentil, and turfgrass, while reducing the risk of resistance development by causal pathogens.

GF-3840 Fungicide is applied to foliage of wheat to control septoria leaf spot, to sugar beet to control cercospora leaf spot, to canola to suppress black leg and sclerotinia stem rot, and to turf grass on sod farms and golf courses to control dollar spot. GF-4017 Fungicide is applied to canola to suppress blackleg and to lentil to control anthracnose.

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 XDE-659 Technical Fungicide, GF-3840 Fungicide and GF-4017 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 florylpicoxamidthrough direct skin contact or inhalation of sprays, workers mixing, loading and applying GF-3840 and GF-4017 Fungicidesand performing cleaning and repair activities must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear. Additionally, standard label statements to protect against drift during application are on the label. The label also requires that workers do not enter or be allowed entry into treated fields and sod farms during the REI of 12 hours and not to enter into treated golf courses until the sprays have dried.
• The following label statement is required for GF-3840 Fungicide:
  • An 8-day restriction for foraging and cutting of hay for wheat is required.

Key risk-reduction measures - Environment

• Precautionary label statements to inform users of:
  • Toxicity to aquatic organisms.
  • Toxicity to non-target terrestrial plants and beneficial arthropods (for GF-3840 Fungicide only).
  • The potential for leaching of florylpicoxamid residues to groundwater.
• Spray buffer zones of up to 50 metres to protect sensitive non-target aquatic and terrestrial habitats.
• Standard runoff label statements to reduce risk to aquatic organisms from runoff.

Next steps

Before making a final registration decision on florylpicoxamid, GF-3840 Fungicide and GF-4017 Fungicide, Health Canada’s PMRA will consider any comments received from the public in response to PRD2022-14. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-14. 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 florylpicoxamid, GF-3840 Fungicide and GF-4017 Fungicide (based on the Science evaluation of PRD2022-14). 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