Evaluation Report ERC2014-02, Fluopyram
Pest Management Regulatory Agency
22 August 2014
ISSN: 1911-8082 (PDF version)
Catalogue number: H113-26/2014-2E-PDF (PDF version)
This page is a summary of the Evaluation Report. If you would like more detail, please request the full Evaluation Report.
To obtain an electronic copy of the document, Evaluation Report ERC2014-02, Fluopyram, please contact our publications office.
Should you require further information please contact the Pest Management Information Service.
Table of Contents
- Registration Decision for Compound Fluopyram
- What Does Health Canada Consider When Making a Registration Decision?
- What Is Fluopyram?
- Health Considerations
- Risks in Residential and Other Non-Occupational Environments
- Environmental Considerations
- Value Considerations
- Measures to Minimize Risk
- What Additional Scientific Information Is Being Requested?
- Other Information
Registration Decision for Compound Fluopyram
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 the technical active, Fluopyram Technical Fungicide and end-use products, Luna Privilege containing the technical grade active ingredient fluopyram, Luna Tranquility Fungicide containing the technical grade active ingredients fluopyram and pyrimethanil, and Propulse Fungicide containing the technical grade active ingredients fluopyram and prothioconazole. All three end-use products are used to control several fungal diseases on various horticultural and field crops.
An evaluation of available scientific information found that, under the approved conditions of use, the products have 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 of Evaluation Report ERC2014-02, Fluopyram provides detailed technical information on the human health, environmental and value assessments of fluopyram in Fluopyram Technical Fungicide, Luna Privilege, Luna Tranquility Fungicide and Propulse 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:
What Is Fluopyram?
Fluopyram is a new systemic fungicidal compound present as the lone active ingredient in the new end-use product Luna Privilege. It is also present as one of the two active ingredients in two new pre-mix end-use products, Luna Tranquility Fungicide and Propulse Fungicide. The compound is used as a broad-spectrum fungicide applied as a foliar spray or through drip irrigation systems on various horticultural and field crops. It acts on pathogen cells by inhibiting their normal respiration process.
Can Approved Uses of Fluopyram Affect Human Health?
Products containing fluopyram are unlikely to affect your health when used according to label directions.
Exposure to fluopyram may occur through the diet (food and water), when handling and applying the product or when entering treated sites. 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 pesticide products are used according to label directions.
In laboratory animals, the acute toxicity of fluopyram was low via the oral, dermal and inhalation routes of exposure. Fluopyram was minimally irritating to the eyes and non-irritating to the skin and did not cause an allergic skin reaction.
The acute toxicity of the end-use product Luna Privilege was low via the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eyes and non-irritating to the skin and did not cause an allergic skin reaction. Both end-use products Luna Tranquility Fungicide and Propulse Fungicide were of low acute toxicity via the oral, dermal and inhalation routes of exposure. They were non-irritating to the eyes and skin and did not cause allergic skin reactions.
Health effects in animals given repeated doses of fluopyram included changes in the liver, thyroid and kidneys. Fluopyram did not cause birth defects in animals and there were no effects on the ability to reproduce. When fluopyram was given to pregnant or nursing animals, effects on the developing fetus and juvenile animal (reduced pup and litter weights, body size, spleen and thymus weights, and/or slightly delayed sexual development) were observed at doses that were toxic to the mother, indicating that the young do not appear to be more sensitive to fluopyram than the adult animal. Fluopyram did not selectively target the nervous system, however, temporary non-specific functional effects (decreased motor and locomotor activity) were observed, possibly related to the nervous system. There was no evidence to suggest that fluopyram damaged genetic material. Fluopyram did, however, cause thyroid tumours in mice and liver tumours in rats.
The risk assessment protects against the effects of fluopyram by ensuring that the level of human exposure is well below the lowest dose at which these effects occurred in animal tests.
Residues in Water and Food
Dietary risks from food and water are not of concern.
Aggregate dietary intake estimates (food plus water) revealed that the general population and infants less than one year old, the subpopulation which would ingest the most fluopyram relative to body weight, are expected to be exposed to less than 64% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from fluopyram is not of concern for all population subgroups. The lifetime cancer risk from the use of fluopyram on various crops is considered acceptable, based on a limited three-year application period.
Acute dietary (food and water) estimates for the general population and all population subgroups were less than 10% of the acute reference dose, and are not of health concern. The highest exposed subpopulation was children 1-2 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 fluopyram on potatoes, sugar beets, dry beans and dry peas, watermelon, apples, cherries, strawberries, grapes, almonds, pecans, peanuts, soybeans, wheat, sorghum, corn (field and sweet), canola and cottonseed, as well as trials conducted in Latin America using fluopyram on bananas are acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of Evaluation Report ERC2014-02, Fluopyram.
Risks in Residential and Other Non-Occupational Environments
Residential risks are not of concern when products containing fluopyram are used according to the label directions.
Occupational Risks from Handling Luna Privilege, Propulse Fungicide and Luna Tranquility Fungicide
Occupational risks are not of concern when products containing fluopyram are used according to the label directions, which include protective measures.
Farmers and custom applicators who mix, load or apply fluopyram as well as field workers re-entering freshly treated fields can come in direct contact with fluopyram residues on the skin. Therefore, the labels specify that anyone mixing/loading and applying products containing fluopyram must wear a long-sleeved shirt, long pants, shoes plus socks, and chemical resistant gloves. The label also requires that workers do not enter treated fields for 12 hours after application. Taking into consideration these label statements, the number of applications and the expectation of the exposure period 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 Fluopyram Is Introduced Into the Environment?
When fluopyram is applied as a fungicide on field crops, some of it finds its way into soil and water. In soils, it is persistent and has a potential for long-term accumulation and residue carry over to the following crop season. Fluopyram is stable to hydrolysis, photolysis, aerobic and anaerobic biotransformation in soils and does not form major transformation products in soils under Canadian field use conditions. Fluopyram is moderately mobile in soils and has a potential to leach and contaminate the groundwater depending on the soil type and location. None of the minor transformation products, however, have a potential to leach and contaminate groundwater. Fluopyram has a low potential for bioconcentration/bioaccumulation in organisms.
In the aquatic environment, fluopyram is persistent under aerobic and anaerobic conditions and partitions significantly from water to sediment. It does not form any major transformation products in water or sediment phases. Photolysis is not an important route of transformation in the aquatic environment. Several minor transformation products were detected due to photolysis under laboratory conditions in natural water of which one was identified as fluopyram-lactam.
Fluopyram has a low potential for volatilization and, therefore, not expected to result in long range transport in the atmosphere.
Fluopyram presents a negligible risk to soil organisms, bees, beneficial arthropods, freshwater and marine fish, invertebrates, algae and aquatic plants. Fluopyram, however, may pose a risk to non-target terrestrial plants from spray drift (Luna Privilege only), and to amphibians due to runoff and spray drift. In order to minimize the potential risk, no-spray buffer zones between the treated area and downwind sensitive terrestrial and aquatic habitats are required. A bird toxicity label statement is also required as a precaution.
What Is the Value of Luna Privilege, Luna Tranquility Fungicide and Propulse Fungicide?
Luna Privilege, Luna Tranquility Fungicide and Propulse Fungicide are fungicides effective in the control of major economic diseases of various horticultural and field crops.
Luna Privilege, Luna Tranquility Fungicide and Propulse Fungicide provide effective solutions for the management of major economic diseases such as powdery mildew, moulds, blights and other foliar diseases on a range of crops including potato, dry bean, chickpeas, lentils, apple, cherry, wine grape, strawberry, peanut, watermelon and almond. The combinations of different modes of action in Luna Tranquility Fungicide and Propulse Fungicide are of value in reducing the risk of resistance development and by increasing the spectrum of disease protection.
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 on the label of Luna Privilege, Luna Tranquility Fungicide, and Propulse 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 fluopyram residues on the skin or through inhalation of spray mist, anyone mixing, loading and applying products containing fluopyram must wear a long-sleeved shirt, long pants, shoes plus socks, and chemical resistant gloves. In addition, standard label statements to protect against drift during application were added to the label.
Based on the risk identified to off-target sensitive habitats, buffer zones of 1 to 15 m are required to protect amphibians and terrestrial habitats. In addition, standard label statements were added to the labels to protect wild birds, aquatic organisms and non-target terrestrial plants.
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 the Science Evaluation of Evaluation Report ERC2014-02, Fluopyram or in the Section 12 Notice associated with these conditional registrations. The applicant must submit the following information within the time frames indicated.
- Short-term mode of action studies to address the observed tumours. The goal of these studies is to further clarify the two proposed cancer modes of action.
- Inter-Laboratory Analytical Methodology Validation - An independent laboratory validation of Method GM-001-P07-01 for the determination of fluopyram residues in plant matrices is required to fulfill the data requirement for an acceptable enforcement method in plant matrices.
- Field Accumulation Studies - A full set of field rotational crop data are required for canola, soybean and cereals (wheat, barley and corn, both field and sweet).
- One field trial to confirm the efficacy of Luna Privilege against powdery mildew on standard sized cherry trees.
- One field trial to confirm efficacy of Luna Privilege against late leaf spot on peanuts.
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 Science Evaluation of Evaluation Report ERC2014-02, Fluopyram (that is, 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 by phone (1-800-267-6315) or by e-mail (email@example.com).
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