Proposed Registration Decision PRD2016-04, Clothianidin
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The online consultation is now closed.
Pest Management Regulatory Agency
12 February 2016
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2016-4E-PDF (PDF version)
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Table of Contents
Registration Decision for Clothianidin Technical Insecticide
Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing full registration for the sale and use of Clothianidin Technical Insecticide and MaxForce IMPACT Cockroach Bait Gel, containing the technical grade active ingredient clothianidin, as an insecticide product which is applied as a major new use for crack and crevice or spot treatment for control of cockroaches both indoors and on the exterior of structures.
An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.
This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2016-04, Clothianidin provides detailed technical information on the human health, environmental and value assessments of Clothianidin Technical Insecticide and MaxForce IMPACT Cockroach Bait Gel.
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:
Before making a final registration decision on clothianidin, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-04, Clothianidin. The PMRA will then publish a Registration Decision on clothianidin, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRAs response to these comments.
For more details on the information presented in this Summary, please refer to the Science Evaluation of Proposed Registration Decision PRD2016-04, Clothianidin.
What Is Clothianidin?
Clothianidin is the active ingredient contained in the commercial-class insecticide Maxforce IMPACT Cockroach Bait Gel. Clothianidin is a member of the neonicotinoid group of insecticides, which act on the insect nervous system by exhibiting agonistic activity on the insects nicotinic acetylcholine receptors. Maxforce IMPACT Cockroach Bait Gel is a ready-to-use 1.0% clothianidin gel-bait insecticide product which is applied as a crack and crevice or spot treatment for control of cockroaches in structures. Environmental exposure from exterior structural use of the cockroach bait products is expected to be low as applications are limited to cracks and crevices or expansion joints around windows and doors, under stairways and other areas adjacent to homes or structures where cockroaches harbour and in areas not easily accessible to children, pets and other non-target organisms. No environmental exposure is expected from interior use of the cockroach bait products.
Can Approved Uses of Clothianidin Affect Human Health?
Maxforce IMPACT Cockroach Bait Gel is unlikely to affect your health when used according to label directions.
Potential exposure to clothianidin may occur when handling and applying the product or when entering an area that has been treated with 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 populations (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-containing products are used according to label directions.
In laboratory animals, the technical grade active ingredient clothianidin was of high acute toxicity via the oral route of exposure. Consequently, the hazard signal words DANGER POISON are required on the product label. Clothianidin was of low acute toxicity via the dermal and inhalation routes of exposure, was non-irritating to the eyes and skin, and did not produce an allergic skin reaction.
The end-use product Maxforce IMPACT Cockroach Bait Gel, containing clothianidin, was of low acute toxicity by the oral and dermal routes of exposure, was non-irritating to the eyes and skin, and did not cause an allergic skin reaction. It is not considered to pose an acute inhalation hazard due to its viscous gel formulation. Based on these findings, no acute hazard labelling is required.
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 clothianidin to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints used for risk assessment included effects on the nervous system, reduced survival and delayed sexual maturation in the developing young. There was an indication that the young were more sensitive than the adult animal. The risk assessment protects against these and any other potential effects by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.
Risks in Residential and Other Non-Occupational Environments
Estimated risk for non-occupational exposure is not of concern when used according to label directions.
The commercial class product, MaxForce IMPACT Cockroach Bait Gel, must only be placed in areas inaccessible to children, pets, and non-target organisms, and must only be applied by individuals holding an appropriate pesticide applicator certificate or license recognized by the provincial/territorial pesticide regulatory agency where the application occurs. Application within food handling establishments is limited to crack and crevice treatment only.
Exposure to individuals residing in treated areas is not expected to result in unacceptable risk when the end-use product is used according to label directions.
Occupational Risks From Handling MaxForce IMPACT Cockroach Bait Gel
Occupational risks are not of concern when MaxForce IMPACT Cockroach Bait Gel is applied with the ready-to-use syringe and used according to the label directions, which include protective measures.
As exposure is considered to be negligible when the product is used according to label directions, a risk assessment was not conducted for individuals handling and re-entering areas treated with MaxForce IMPACT Cockroach Bait Gel.
Pesticide applicators applying MaxForce IMPACT Cockroach Bait Gel can come in direct contact with clothianidin on the skin. Therefore the label will specify that anyone applying MaxForce IMPACT Cockroach Bait Gel must wear a long-sleeved shirt, long pants, socks, shoes and chemical-resistant gloves during application and clean-up activities.
Given the product is to be applied as a crack and crevice and spot treatment in locations which are accessible only to cockroaches, there is little potential for exposure to workers re-entering treated areas.
What Happens When Clothianidin Is Introduced Into the Environment?
When used according to label directions, clothianidin is not expected to pose an unacceptable risk to the environment.
Terrestrial or aquatic environments are not expected to be exposed when clothianidin is used as an interior cockroach bait. When clothianidin is used on exterior structures as a cockroach bait, there is limited potential for terrestrial or aquatic environments to be exposed as applications are limited to cracks and crevices or expansion joints around windows and doors, porches, screens, eaves, sills, patios, garages, under stairways and other areas adjacent to homes or structures where cockroaches harbor and in areas not easily accessible to children, pets and other non-target organisms. As environmental exposure is expected to be limited for cockroach bait applications, the risk to terrestrial and aquatic organisms is expected be negligible.
What Is the Value of MaxForce IMPACT Cockroach Bait Gel?
Maxforce IMPACT Cockroach Bait Gel has value for controlling cockroaches in structures.
Cockroaches are amongst the most common and difficult to control pests found in structures in Canada, and are both a nuisance pest and a public health concern as they can spread bacteria and pose significant health risk to allergy and asthma sufferers. Maxforce IMPACT Cockroach Bait Gel has value as it incorporates a new bait formulation and provides another active ingredient for control of this pest. Cockroaches are known to have developed resistance to many different insecticide active ingredients and have been known to develop aversion to baits after repeated exposure to the same formulation. Additional bait formulations and active ingredients are needed for control of cockroaches since cockroaches have developed resistance to many older active ingredients and some registered products or uses are proposed for phase-out.
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 MaxForce IMPACT Cockroach Bait Gel to address the potential risks identified in this assessment are as follows.
Key Risk-Reduction Measures
To avoid direct applicator contact with clothianidin, the commercial applicators of MaxForce IMPACT Cockroach Bait Gel must wear a long-sleeved shirt, long pants, socks, shoes and chemical-resistant gloves during application and clean-up activities.
Postapplication exposure to clothianidin following application of the commercial class product, MaxForce IMPACT Cockroach Bait Gel, is minimized by limiting application to crack and crevice and spot treatments in areas inaccessible to children and only crack and crevice application in food handling establishments.
When used according to label directions, clothianidin is not expected to pose an unacceptable risk to the environment.
Before making a final registration decision on clothianidin, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-04, Clothianidin. The PMRA will accept written comments on PRD2016-04, Clothianidin up to 45 days from the date of publication of PRD2016-04. 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 Agencys response to these comments.
When the PMRA makes its registration decision, it will publish a Registration Decision on clothianidin (based on the Science Evaluation of PRD2016-04, Clothianidin). In addition, the test data referenced in PRD2016-04 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).
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