Proposed Registration Decision PRD2018-01, Quinoxyfen
Notice to the reader:
This consultation is now closed.
Pest Management Regulatory Agency
5 January 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-1E-PDF (PDF version)
UPDATE: As of 15 February 2018, the consultation period has been extended. Interested parties are encouraged to provide comments and suggestions by 26 February 2018.
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 PRD2018-01, Quinoxyfen please contact our publications office.
Should you require further information please contact the Pest Management Information Service.
Table of Contents
- Proposed Registration Decision for Quinoxyfen
- What Does Health Canada Consider When Making a Registration Decision?
- What Is Quinoxyfen?
- Health Considerations
- Environmental Considerations
- Value Considerations
- Measures to Minimize Risk
- Next Steps
- Other Information
Proposed Registration Decision for Quinoxyfen
Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing cancellation of the registration of Quinoxyfen Technical Fungicide and Quintec Fungicide, containing the technical grade active ingredient quinoxyfen, to control or suppress powdery mildew on several fruit and vegetable crops.
Quinoxyfen Technical Fungicide (Registration Number 29754) and Quintec Fungicide (Registration Number 29755) are conditionally registered in Canada. The detailed review for Quinoxyfen Technical Fungicide and Quintec Fungicide can be found in Evaluation Report ERC2013-02, Quinoxyfen.
At the time of the original registration, the evaluation of the scientific information demonstrated that Quintec Fungicide had value and that human health and environmental risk was acceptable. However, additional information was required to address uncertainties with regard to the chronic risk to aquatic organisms and the bioaccumulation potential of the major transformation product of quinoxyfen: 2-oxo-quinoxyfen. As such, a conditional registration was granted. The current applications were submitted to address the required information and to convert Quinoxyfen Technical Fungicide and Quintec Fungicide from conditional registration to full registration.
The evaluation of the additional environmental information found that quinoxyfen meets the criteria for Track 1 substances under the Toxic Substances Management Policy (TSMP). The PMRA's implementation of the TSMP is outlined in Regulatory Directive DIR99-03, The Pest Management Regulatory Agency's Strategy for Implementing the Toxic Substances Management Policy. This directive describes how Track 1 substances are managed by the PMRA, and calls for the virtual elimination of Track 1 substances. For use of Quintec Fungicide to control or suppress powdery mildew on several fruits and vegetables, as well as use on hops, specific risk mitigation measures are required, which include buffer zones to minimize risk related to spray drift. Therefore, registration of the use of Quintec Fungicide is granted for a phase-out period of three years beginning 1 July 2018 until 30 June 2021.
This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2018-01, Quinoxyfen provides detailed technical information on the human health, environmental and value assessments of Quinoxyfen Technical Fungicide and Quintec 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. 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 quinoxyfen, the PMRA will consider any comments received from the public in response to PRD2018-01. The PMRA will then publish a Registration Decision on quinoxyfen, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA's response to these comments.
For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2018-01.
What Is Quinoxyfen?
Quinoxyfen is a fungicide that controls or suppresses powdery mildew on stone fruits, grapes, strawberry, melon, squash, lettuce and hops.
Can Approved Uses of Quinoxyfen Affect Human Health?
Quintec Fungicide, containing quinoxyfen, is unlikely to affect your health when used according to label directions.
Potential exposure to quinoxyfen 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). 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-containing products are used according to label directions.
In laboratory animals, the technical active ingredient, quinoxyfen, was of low acute toxicity via the oral, dermal and inhalation routes of exposure, and non-irritating to the skin. Quinoxyfen was mildly irritating to the eyes; therefore, the signal word and hazard statement "CAUTION – EYE IRRITANT" are required on the label. Quinoxyfen caused an allergic skin reaction; consequently, the signal words "POTENTIAL SKIN SENSITIZER" are required on the label.
The end use product, Quintec Fungicide, was of low toxicity via oral, dermal or inhalation routes of exposure, and was minimally irritating to the eyes and slightly irritating to the skin. It did not cause an allergic skin reaction. Consequently, no hazard signal words are required on the label.
Registrant-supplied short-term and long-term (lifetime) animal toxicity tests were assessed for the potential of quinoxyfen to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints used for risk assessment included abortions, anemia and effects on body weight and the liver in adult animals. There was no indication that the young animal was more sensitive than the adult animal. The risk assessment protects against these effects 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 children one to two years old, the subpopulation which would ingest the most quinoxyfen relative to body weight, are expected to be exposed to less than 9% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from quinoxyfen is not of health concern for all segments of the population. Quinoxyfen is not carcinogenic; therefore, a chronic cancer dietary exposure assessment is not required.
Animal studies revealed no acute health effects. A single dose of quinoxyfen is not likely to cause acute health effects in the general population (including infants and children). An acute reference dose was not established, therefore, an acute dietary intake estimate is not required.
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 quinoxyfen on cantaloupes, cherries, grapes, hops, lettuce, peaches, plums, strawberries and winter squash were acceptable. The MRLs for this active ingredient can be found using the Maximum Residue Limit Database on the Maximum Residue Limits for Pesticides webpage.
Occupational Risks From Handling Quintec Fungicide
Occupational risks are not of concern when Quintec Fungicide is used according to the label directions, which include protective measures.
Farmers and custom applicators who mix, load or apply Quintec Fungicide, as well as field workers re-entering freshly treated fields can come in direct contact with Quintec Fungicide residues on the skin. Therefore, the label specifies that anyone mixing/loading and applying Quintec Fungicide must wear a long sleeved shirt, long pants, shoes plus socks and chemical resistant gloves. As an extra precaution, workers that handle the concentrated product are advised to wear coveralls, chemical resistant gloves, goggles and rubber boots. 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, the risk to these individuals 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.
What Happens When Quinoxyfen Is Introduced into the Environment?
Quinoxyfen meets the Government of Canada's criteria for a Track 1 substance under the TSMP, which means that quinoxyfen is toxic, takes a long time to break down and accumulates in living organisms. Because of these environmental concerns, it is proposed that the registered use of quinoxyfen on field crops be cancelled by 30 June 2021. Interim risk reduction measures are proposed to further minimize environmental exposure during the phase-out period.
Quinoxyfen can enter into the environment when applied as a fungicide to field crops.
In the environment, quinoxyfen can be broken down slowly by bacteria. It binds strongly to soil particles, making it unlikely to move downward in the soil and reach groundwater. Quinoxyfen is expected to build-up in the environment and accumulate in the tissues of organisms. Quinoxyfen is not expected to be found in air and is not expected to move long distances in the atmosphere.
In the terrestrial environment, quinoxyfen does not pose a risk to birds, small mammals, plants, earthworms, bees and beneficial arthropods. Precautionary label statements pertaining to terrestrial organisms can be removed from the current product label.
In the aquatic environment, quinoxyfen may pose a risk to aquatic invertebrates, fish, plants, algae and amphibians. Spray buffer zones are required to protect aquatic biota from spray drift.
The information considered in ERC2013-02 showed that the persistence characteristics of quinoxyfen were both above and below the cut-off values for Track 1 substances under the TSMP. The PMRA considered additional environmental information to examine the accumulation of quinoxyfen by fish and to further characterize the behaviour of quinoxyfen and risks to the environment. The PMRA also considered other environmental information reviewed by the European Commission (2016). New information collected when considered with the older information, shows that quinoxyfen persists in the environment and has the potential to accumulate in the tissues of organisms through various routes of exposures. Characteristics such as persistence, accumulation in animal tissues and effects indicate that quinoxyfen may be of concern from exposure to the environment over a long period of time.
Based on the available environmental information, the PMRA concluded that quinoxyfen meets the Government of Canada's criteria for a Track 1 substance under the TSMP. These criteria are also outlined in the Persistence and Bioaccumulation Regulations (SOR/2000-107) which are used to define persistent or bioaccumulative under sections of the Canadian Environmental Protection Act (CEPA, 1999). Under TSMP, substances meeting these criteria (Track 1) are persistent, bioaccumulative, toxic and primarily the result of human activity. Track 1 substances are targeted for virtual elimination from the environment, but may be registered for a limited time in exceptional circumstances. Quinoxyfen meets all four criteria of a Track 1 substance as per the Toxic Substances Management Policy of the Government of Canada.
What Is the Value of Quintec Fungicide?
The active ingredient in Quintec Fungicide, quinoxyfen, is the only active ingredient from its mode of action group that is registered to control or suppress powdery mildew on stone fruits, grapes, strawberry, melon, squash, lettuce and hops.
Quintec Fungicide is an effective tool for the control or suppression of an important disease, powdery mildew, on several fruits and vegetables. Quintec Fungicide has a unique and highly specific mode of action to control or suppress powdery mildew species that may have become resistant to other types of fungicides.
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 Quintec Fungicide to address the potential risks identified in this assessment are as follows.
Key Risk-Reduction Measures
Quinoxyfen Fungicide was mildly irritating to the eyes; therefore, the signal word and hazard statement "CAUTION – EYE IRRITANT" are required on the label. Quinoxyfen caused an allergic skin reaction; consequently, the signal words "POTENTIAL SKIN SENSITIZER" are required on the label.
No hazard signal words are required on the Quintec Fungicide label.
Spray buffer zones are required to protect aquatic biota.
Precautionary label statements pertaining to terrestrial organisms can be removed from the current product labels.
Before making a final registration decision on quinoxyfen, the PMRA will consider any comments received from the public in response to PRD2018-01. The PMRA will accept written comments on PRD2018-01 up to 45 days from the date of publication of PRD2018-01. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency's response to these comments.
When the PMRA makes its registration decision, it will publish a Registration Decision on quinoxyfen (based on the Science Evaluation of PRD2018-01). In addition, the test data referenced in PRD2018-01 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).
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