Proposed Registration Decision PRD2017-17, Clothianidin

Pest Management Regulatory Agency
19 December 2017
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2017-17E-PDF (PDF version)

Summary

Table of Contents

• Background
• List of Data Previously Required as Conditions of Registration under Section 12
• Proposed Registration Decisions for Clothianidin
• What Does Health Canada Consider When Making a Registration Decision?
• Summary of Risk Mitigation Measures
• Conclusion
• Next Steps

Background

Clothianidin Technical Insecticide (Reg. No. 27445) is fully registered in Canada for structural uses as a crack and crevice or spot treatment for control of cockroaches, both indoors and on the exterior of structures. For further details see the Proposed Registration Decision PRD2016-04, Clothianidin and Registration Decision RD2016-13, Clothianidin. Other uses of Clothianidin Technical Insecticide, and its associated end-use products (listed in Table 1), are conditionally registered in Canada for use as seed treatments, foliar and soil applications. Additional information to assess the potential risk to pollinators for these uses was required under section 12 of the Pest Control Products Act as a condition of registration. Also under section 12, information on the movement of clothianidin into water was required for products with foliar and soil applications. The required additional information for these end-use products has been received and reviewed under applications to fulfill the conditions of registration.

A re-evaluation of clothianidin was announced in 2012 (Re-evaluation Note REV2012-02, Re-evaluation of Neonicotinoid Insecticides). This re-evaluation was initiated to assess the potential risk to pollinators in light of international updates to the pollinator risk assessment framework, including information requirements. Data received from the registrants, including those that were required to fulfill the conditions of registration under section 12, as well as data obtained from published literature, were considered in the re-evaluation assessment.

Health Canada has completed an assessment of pollinator risk for clothianidin. A Proposed Re-evaluation Decision was published in PRVD2017-23, Clothianidin and Its Associated End-Use Products: Pollinator Re-Evaluation. This document (PRVD2017-23) summarizes the science evaluation with regards to the potential risks posed by clothianidin to pollinators in Canada, as well as proposes strategies to reduce the risks to these pollinators.

This Proposed Registration Decision (PRD2017-17) document is consistent with the pollinator re-evaluation outcome. The final re-evaluation outcome will be reflected in the final registration decision for clothianidin technical active ingredient, and the end-use products listed in Table 1.

Table 1 Conditionally registered end-use products containing clothianidin included in this consultation.

Product Name	Registration Number
Sepresto 75 WS	30972
Clothianidin Insecticide	29384
Arena 50 WDG Insecticide	29383
Clutch 50 WDG Insecticide	29382
Poncho 600 FS Seed Treatment Insecticide	27453
Titan Insecticide	27449
Prosper FL Flowable Insecticide and Fungicide Seed Treatment	27564
Nipsit Inside 600 Insecticide	28975
Prosper T 200 Flowable Insecticide and Fungicide Seed Treatment	29158
Prosper FX Flowable Insecticide and Fungicide Seed Treatment	29159
Emesto Quantum	30362
Prosper Evergol	30363
Nipsit Suite Canola Seed Protectant	31355
Nipsit Suite Cereals of Seed Protectant	31357

For the four following end-use products; Sepresto 75 WS, Clothianidin Insecticide, Arena 50 WDG Insecticide, and Clutch 50 WDG Insecticide, and in respect of Use-Site Categories 13, 14 and 30 for Clothianidin Technical Insecticide, Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Pest Control Products Regulations, has extended the validity period of the registrations of these products until 31 December  2019. This extension was granted under 14(7) of the former Pest Control Products Regulations, to carry out a consultation under 28(1)(c) of the Pest Control Products Act, on the proposed registration decisions in respect of these products. The PMRA considers it in the public interest to consult on the proposed registration decisions in light of, and in response to the growing public interest in the registration status of the neonicotinoid insecticides.

For the remaining 10 end-use products listed in Table 1, and in respect of Use-Site Categories 10 and 11 for Clothianidin Technical Insecticide, the validity period of the registrations of these products has been automatically extended until 31 December 2019 by operation of subsection 14(6) of the former Pest Control Products Regulations. This provision extends the validity period of a conditional registration for two years upon receipt of an application complying with the requirements of the notice delivered under section 12 of the Pest Control Products Act.

List of Data Previously Required as Conditions of Registration under Section 12

Below is listed the additional information to assess the potential risk to pollinators which was previously required under section 12 of the Pest Control Products Act as a condition of registration.

• DACO: 9.2.4.1
  • Title: Acute contact toxicity
  • Details:  Available studies including those using end-use product formulations, dust from treated seed, or other species. Test material: active ingredient and major relevant transformation products, and/or end-use product.
• DACO: 9.2.4.2
  • Title: Acute oral toxicity
  • Details:  Available studies including those using end-use product formulations, dust from treated seed, or other species. Test material: active ingredient and major relevant transformation products, and/or end-use product.
• DACO: 9.2.4.3
  • Title: Honeybee larvae toxicity
  • Details:  Toxicity of clothianidin and its relevant transformation products to honeybee larvae; including those studies requested by the US EPA (United States Environmental Protection Agency) and CalDPR (California Department of Pesticide Regulation). Test material: active ingredient and major relevant transformation products, and/or end-use product.
• DACO: 9.2.4.3
  • Title: Chronic adult honey study
  • Details:  Chronic toxicity of clothianidin and relevant transformation products to adult honeybee; including those studies requested by the US EPA and CalDPR. Test material: active ingredient and major relevant transformation products, and/or end-use product.
• DACO: 9.2.4.3
  • Title: Semi-field / field study for pollinators
  • Details:  Semi-field and/or Field hive studies from various use patterns (e.g. soil application, foliar application (pre-bloom, during bloom, succeeding crops, etc.), seed treatment; including those studies requested by US EPA and CalDPR. Test material: end-use product.
• DACO: 9.9 (8.5)
  • Title: Residue study for pollinators
  • Details:  Residues of clothianidin and its major transformation products in pollen and/or nectar resulting from various use patterns (e.g. soil application, foliar application, seed treatment, including succeeding crops, etc.); including those studies requested by the US EPA and CalDPR. Test material: end-use product.
• DACO: 9.9
  • Title: Information on dust generated from treated seed (including residues and/or effects)
  • Details:  Information/studies to address the potential exposure/effects of dust generated from treated seeds. Test material: end-use product/active ingredient.
• DACO: 9.9
  • Title: Other pollinator studies/data/reports
  • Details:  Monitoring data (of exposure and/or effects). Test material: end-use product.
• DACO: 9.9
  • Title: Information on other exposure routes (including residues and/or effects)
  • Details:  Information/studies to address the potential exposure/effects of guttation water on bees. Test material: end-use product/active ingredient.

In addition to the requirements listed above, the additional requirement below was also identified under section 12 for these products: Clothianidin Insecticide (Reg. No. 29384), Arena 50 WDG Insecticide (Reg. No.29383), and Clutch 50 WDG Insecticide, (Reg. No. 29382).

• DACO: 8.3.2.3
  • Title: Other Terrestrial field dissipation study
  • Details: Laboratory studies indicate that Clothianidin may be classified as having a medium to high mobility in soil. However, no adequate terrestrial field dissipation studies were submitted to validate these observations. Note that the available lysimeter studies have been conducted with seed treatment formulations and, therefore, a Lysimeter study conducted in coarse textured soil with a WDG formulation is required.

Proposed Registration Decisions for Clothianidin

1) Sepresto 75 WS (Reg. No. 30972)

Sepresto 75 WS contains the active ingredients clothianidin and imidacloprid, and is conditionally registered based on conditions of registration (section 12 data) for the clothianidin component of the product. The proposed decision in this document is to remove the section 12 conditions of registration for the clothianidin component of Sepresto 75 WS, previously established with regards to pollinators.

A proposed decision resulting from the re-evaluation of Imidacloprid (PRVD2016-20, Imidacloprid) was published for public consultation in 2016 and proposed a phase-out of all outdoor agricultural, ornamental, turf, and tree uses (except tree injection uses) and greenhouse uses of imidacloprid.

The continued registration of Sepresto 75 WS is implicated by this re-evaluation proposal, and as a result, is currently proposed for phase-out. Therefore, the continued registration of Sepresto 75 WS will be subject to the outcomes of the final re-evaluation decisions pertaining to clothianidin and imidacloprid.

2) Other End-use Products Listed in Table 1 and Clothianidin Technical Insecticide

Health Canada’s PMRA, under the authority of section 8 of the Pest Control Products Act, is proposing a three-year registration for the sale and use of the technical grade active ingredient clothianidin and the end-use products listed in Table 1. This consultation is carried out under 28(1)(c) of the Pest Control Products Act, and as such is not subject to section 35(1) of the Pest Control Products Act.

An evaluation of available scientific information as set out in PRVD2017-23, and in PRD2017-17 document 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, provided that labels of registered products are amended as required.

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 individuals and the environment from the use of pest control products. Health and environmental risks are considered acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from the 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 clothianidin, the PMRA will consider any comments received from the public in response to PRD2017-17. 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 PMRA’s response to these comments.

Summary of Risk Mitigation Measures

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. As a result of the pollinator re-evaluation of clothianidin, further risk mitigation measures for product labels are being proposed.

Measures to Protect Pollinators as found in PRVD2017-23, Clothianidin and Its Associated End-use Products: Pollinator Re-Evaluation

Certain crops are highly attractive to bees when their flowers are in bloom. Since large numbers of bees are attracted to these crops when they are in bloom and based on an assessment of the risks to bees, the application of pesticides containing clothianidin can lead to effects that may impact the survival of bee colonies or solitary bee species.

In order to protect pollinators, Health Canada is proposing to phase out the following uses of clothianidin:

• Foliar application to orchard trees and strawberries, and
• Foliar application to municipal, industrial and residential turf sites.

In order to protect pollinators, Health Canada is proposing the following change to the conditions of use of clothianidin:

• Reduce maximum number of foliar applications to cucurbit vegetables to one per season.

To minimize bee exposure to dust during planting of treated seed, additional label statements are proposed for the following use:

• Seed treatment of cereal crops.

The risk-reduction measures described above and other conditions of registration being proposed as a result of the re-evaluation review of the risk to pollinators will apply to the end-use products listed in Table 1. For more details, refer to PRVD2017-23.

Conclusion

The conditions of registration relating to the submission of additional information required under section 12 of the Pest Control Products Act for clothianidin and its associated end-use products have been met. To address potential risks to pollinators, amendments to the registrations of clothianidin products have been proposed.

Health Canada’s PMRA, under the authority of section 8 of the Pest Control Products Act, is proposing a three year registration for the sale and use of Clothianidin Technical Insecticide (Reg. No. 27445) and the end-use products listed in Table 1 - excluding Sepresto 75 WS, which is proposed for phase-out. An evaluation of available scientific information as set out in PRVD2017-23 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.

In addition, the continued registration of Sepresto 75WS is subject to the final outcome of the re-evaluation of imidacloprid.

Next Steps

Before making a final registration decision on clothianidin, the PMRA will consider any comments received from the public in response to PRD2017-17. The PMRA will accept written comments up to 90 days from the date of publication. 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 PMRA’s response to these comments.