Evaluation Report ERC2011-08, Fluopicolide

This content was archived on June 24, 2013.

Pest Management Regulatory Agency
21 November 2011
ISSN: 1911-8082 (PDF version)
Catalogue number: H113-26/2011-8E-PDF (PDF version)

Summary

Table of Contents

• Registration Decision for Fluopicolide
• What Does Health Canada Consider When Making a Registration Decision?
• What Is Fluopicolide?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• What Additional Scientific Information Is Being Requested?
• Other Information

Registration Decision for Fluopicolide

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act and  Regulations, has granted conditional registration for the sale and use of Fluopicolide Technical, Fluopicolide 4 SC Fungicide and Presidio^TM Fungicide, containing the technical grade active ingredient fluopicolide, to control important fungal diseases on vegetable crops and outdoor ornamentals (bedding plants and cut flowers).

Fluopicolide Technical and V-10161 4 SC Fungicide, an end-use product similar to Fluopicolide 4 SC Fungicide and Presidio^TM Fungicide, were previously reviewed by the PMRA in support of a request to establish import maximum residue limits (MRLs) for the active ingredient fluopicolide. The detailed review for fluopicolide can be found in the Evaluation Report for the original import MRL application (Application Number 2007-4677), located within the PMRA Public Registry on the Health Canada website.

An evaluation of available scientific information found that, under the approved conditions of use, the products has value and do not present an unacceptable risk to human health or the environment.

Although the risks and value have been found acceptable when all risk reduction measures are followed, the applicant must submit additional scientific information as a condition of registration.

This Summary describes the key points of the evaluation, while the Science Evaluation provides detailed technical information on the human health, environmental and value assessments of Fluopicolide Technical, Fluopicolide 4 SC Fungicide and Presidio^TM 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 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 (for example, those most sensitive to environmental contaminants). 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 PMRA regulates pesticides, the assessment process and risk-reduction programs, please refer to the following:

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

What Is Fluopicolide?

Fluopicolide is the active ingredient present in the end-use products Presidio^TM Fungicide and Fluopicolide 4 SC Fungicide which belongs to a new chemical class (Group 43). Fluopicolide causes rapid destabilization of fungal cell structures. It is a systemic and protectant fungicide applied as a foliar or a drench treatment that is used to control some important diseases on plants.

Health Considerations

Can Approved Uses of Fluopicolide Affect Human Health?

Fluopicolide is unlikely to affect your health when used according to label directions.

Potential exposure to fluopicolide may occur through the diet (food and water) or when handling and applying the product. 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). 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 fluopicolide products are used according to label directions.

The toxicity of fluopicolide and its associated end-use product, V-10161 4 SC Fungicide, were evaluated previously for the purpose of setting the import maximum residue levels (MRL). The present document discusses the data submitted in support of the domestic registration, namely the non-oral acute toxicity studies and short-term dermal exposure study, and sets the toxicological endpoints for occupational exposure risk assessment. For an evaluation of acute, short term, chronic/oncogenicity, reproductive, developmental, metabolism, and genotoxicity studies for fluopicolide, please refer to the Evaluation Report for the original import MRL application (Application Number 2007-4677) found within the PMRA Public Registry on the Health Canada website.

The end-use products Fluopicolide 4 SC Fungicide and Presidio^TM Fungicide are toxicologically equivalent to V-10161 4 SC Fungicide. Fluopicolide is of low acute toxicity by oral, dermal and inhalation routes in the rat. It is non irritating to the skin and minimally irritating to the eyes of rabbits and it is not a dermal sensitizer in guinea pigs. Consequently, no signal words are required on the label. The end-use product V-10161 4 SC Fungicide is of low acute toxicity by the oral and dermal routes of exposure and is slightly toxic by the inhalation route in the rat. It is minimally irritating to the skin and mildly irritating to the eyes of rabbits. V-10161 4 SC Fungicide is not a dermal sensitizer in guinea pigs. The signal words "CAUTION POISON - EYE IRRITANT" are required on the label for the end-use products.

No treatment-related toxicity was observed in rats after repeated exposure with high dose levels of fluopicolide via the dermal route.

Fluopicolide is not genotoxic and is not likely to pose a carcinogenic risk to humans. There was no indication that fluopicolide caused damage to the nervous system and there were no effects on reproduction. The first signs of toxicity in animals given daily doses of fluopicolide over long periods of time were decreases in body weight and body weight gain and changes to the kidney, liver and adrenal glands. When fluopicolide was given to pregnant animals, malformations (rats) and abortions (rabbits) were observed at doses that were also toxic to the dams. Due to the nature of these endpoints and their potential implications on the health of the foetus, extra protective factors were applied during the risk assessment to further reduce the allowable level of human exposure to fluopicolide.

The risk assessment was conducted to ensure that the level of human exposure is well below the lowest dose at which these effects occurred in animal tests. The dose levels used to assess risks are established to protect the most sensitive human population (for example, children, nursing mothers and women of child bearing age). Only those uses for which exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Residues in Water and Food

Dietary risks from water and food are not of concern

Aggregate dietary intake estimates (food plus water) revealed that the general population and infants, the subpopulation which would ingest the most fluopicolide relative to body weight, are expected to be exposed to less than 36.1% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from fluopicolide is not of concern for all population sub groups.

The acute aggregate (food and water) dietary intake estimate for women aged 13-49 years was 15.44% of the reference dose, which is not a 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 (PCPA). Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.

Residue trials conducted primarily in the United States using fluopicolide on root vegetables (Crop Subgroup 1A), leaves of root and tuber vegetables (Crop Group 2), bulb vegetables (Crop Group 3-07), leafy vegetables (Crop Group 4), brassica head and stem vegetables (Crop Subgroup 5A), cucurbit vegetables (Crop Group 9), fruiting vegetables (Crop Group 8-09), grapes, and potatoes were acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of this Evaluation Report and in the Evaluation Report for Application Number 2007-4677.

Risks in Residential Environments

Postapplication risks for adults and youth contacting ornamental plants treated with Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide are not of concern.

There is potential for dermal exposure to adults and youth through contact with transferable residues following commercial application of fluopicolide on treated ornamentals in residential areas. Residential postapplication exposure to ornamental plants is not expected to be significant for children and toddlers.

Postapplication risk estimates for adults and youth contacting treated ornamental plants are acceptable. Therefore, contact with the foliage of treated ornamentals is acceptable once residues have dried.

Occupational Risks From Handling Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide

Occupational risks are not of concern when Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide is used according to the proposed label directions, which include protective measures.

Farmers, custom applicators, or ornamental nursery operators who mix, load or apply Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide as well as field workers re-entering treated fields and nurseries can come in direct contact with fluopicolide residues on the skin. Therefore, the label specifies that anyone mixing/loading and applying Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide must wear a long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes. The label also requires that workers do not enter treated fields or other treated sites for one to 16 days after application for specific activities in some crops. For all other uses, a restricted-entry interval (REI) of 12 hours is specified. Taking into consideration these label statements, the number of applications and the expectation of the exposure period for handlers and workers, the risk to workers handling Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide is 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.

Environmental Considerations

What Happens When Fluopicolide Is Introduced Into the Environment?

Fluopicolide poses a potential risk to aquatic organisms, therefore additional risk reduction measures need to be observed.

When fluopicolide is released into the environment some of it can be found in soil and surface water. In the terrestrial environment, fluopicolide is expected to be persistent and residues may carryover into the following growing season. Fluopicolide is shown to bind weakly to soils, however, there is evidence that adsorption to soil may increase over time as the product is used. The major transformation product, 2,6-dichlorobenzamide (BAM), is expected to be mobile in soils. Both fluopicolide and BAM are expected to leach through soil and have the potential to reach groundwater.

In aquatic environments, fluopicolide is expected to be persistent and to partition from the water phase to the sediment; the major transformation product BAM has been shown to partition mainly into the water phase. Fluopicolide residues are not expected in the air because of its low volatility and it has a low potential for bioaccumulation in biota. The transformation product BAM is not expected to be a concern to terrestrial and aquatic life.

Fluopicolide may pose a risk to aquatic organisms. In order to minimize the potential exposure of aquatic organisms to fluopicolide, an unsprayed area (spray buffer zone) is needed between the sprayer and downwind sensitive habitats. The width of these spray buffer zones is specified on the product label.

Value Considerations

What Is the Value of Fluopicolide 4 SC Fungicide and Presidio^TM Fungicide?

Fluopicolide, the active ingredient in Fluopicolide 4 SC Fungicide and Presidio^TM Fungicide, controls or suppresses economically important diseases on vegetable crops and outdoor ornamentals (bedding plants and cut flowers).

Presidio^TM Fungicide and Fluopicolide 4 SC Fungicide are products formulated as a foliar or a drench treatment against important diseases on vegetable crops and outdoor ornamentals (bedding plants and cut flowers). Presidio^TM Fungicide and Fluopicolide 4 SC Fungicide are active against selective pathogens affecting the reproduction cycle with systemic and curative properties, and offers an additional tool for disease and resistance management, particularly for the control of downy mildew on various vegetable crops as well as late blight on potato and tomato. Presidio^TM Fungicide and Fluopicolide 4 SC Fungicide are most effective when applied in a regularly scheduled spray program and are to be used as a tank-mix with other registered fungicides with a different mode of action.

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 Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide 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 fluopicolide on the skin, anyone mixing, loading, applying, and involved in clean-up or repair activities with Fluopicolide 4 SC Fungicide or Presidio^TM Fungicide must wear the recommended personal protective equipment (PPE). In addition, standard label statements to protect against drift during application are included on the label. The label also requires REIs of 8 days for hand pruning, thinning, tying and leaf pulling in grapes, 16 days for cane turning and girdling in table grapes, and 1 day for hand pruning and irrigation in Brassica vegetables. A 12-hour REI is required for all other re entry activities.

Environment

Precautionary statements and spray buffer zones for non-target aquatic habitats are required as a result of the environmental risk assessment. To reduce the potential for runoff of fluopicolide to adjacent aquatic habitats precautionary statements for sites with characteristics that may be conducive to runoff and when heavy rain is forecasted are required. Fluopicolide residues could have a high leaching potential, therefore, a label statement is required advising that use may result in contamination of groundwater, particularly in areas where soils are permeable and/or the depth to the water table is shallow. Fluopicolide is persistent and may carryover into the following growing season, therefore a label statement is required advising that products containing fluopicolide should not be used in areas treated during the previous season.

What Additional Scientific Information Is Being Requested?

Although the risks and value have been found acceptable when all risk-reduction measures are followed, the applicant must submit additional scientific information as a condition of registration. More details are presented in the Science Evaluation section of this Evaluation Report or in the Section 12 Notice associated with these conditional registrations. The applicant must submit the following information within the time frames indicated.

All required trials should be submitted within three years from the time of conditional registration being granted.

Chemistry

Analytical data from at least five batches of technical grade active ingredient representing full-scale production.

Human Health

Data are required demonstrating the stability of fluopiciolide derived residues during the maximum storage intervals used during some of the crops field trials (35 months for broccoli, 40 months for cabbage, 38 months for celery and spinach, 41 months for bulb onions, 38 months for green onions, 47 months for carrots, 45 months for radish roots and tops, and 40 months for sugar beet roots and tops) and field crop rotation trial study (fluopicolide, BAM and PCA residues in/on wheat forage and PCA residues in/on wheat straw for 24 months).

Value

The following small-scale field or greenhouse trials are required for the disease claims within the conditional registration:

• Three trials on downy mildew of brassica (head and stem) vegetables and brassica root vegetables (cabbage, radish and/or turnip);
• Two trials on phytophthora blight/crown rot of cucurbit vegetables (pumpkin or/and eggplant);
• Two trials infected by Phytophthora ramorum and P. parasitica on outdoor ornamentals.

Other Information

As these conditional registrations relate to a decision on which the public must be consulted, the PMRA will publish a consultation document when there is a proposed decision on applications to convert the conditional registrations to full registrations or on applications to renew the conditional registrations, whichever occurs first.

The test data cited in this Evaluation Report (for example. the test data relevant in supporting the registration decision) will be made available for public inspection when the decision is made to convert the conditional registrations to full registrations or to renew the conditional registrations (following public consultation). If more information is required, please contact the PMRA's Pest Management Information Service.