Proposed Registration Decision PRD2017-18, Thiamethoxam

Pest Management Regulatory Agency
19 December 2017
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2017-18E-PDF (PDF version)

Summary

Table of Contents

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

Background

Thiamethoxam Technical (Reg. No. 26665) is fully registered in Canada for use in gel bait insecticides for ant control. Other uses of Thiamethoxam Technical, and its associated end-use products (see list 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. 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 thiamethoxam 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 thiamethoxam. A Proposed Re-evaluation Decision has been published in PRVD2017-24, Thiamethoxam and Its Associated End-use Products: Pollinator Re-Evaluation. This document (PRVD2017-24) summarizes the science evaluation with regards to the potential risks posed by thiamethoxam to pollinators in Canada, as well as proposes strategies to reduce the risks to these pollinators.

This Proposed Registration Decision (PRD2017-18) is consistent with the pollinator re-evaluation outcome. The final re-evaluation outcome will be reflected in the final registration decision for the thiamethoxam technical active ingredient, and the end-use products listed in Table 1.

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 the products set out in Table 1 until 31 December 2019. This extension is also applicable to the Use-Site Category 10 for Thiamethoxam Technical (Reg. No. 26665). This extension was granted under 14(7) of the former Pest Control Products Regulations, to carry out the 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.

List of Data Previously Required as a Condition 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: 8.5
  • Title: Fate of thiamethoxam and the transformation product clothianidin in plants, including concentrations in nectar and pollen.
  • Details: A study conducted at the highest registered rate, which determines the concentration of thiamethoxam and clothianidin in nectar and pollen of plants (plant fate study).

Proposed Registration Decision for Thiamethoxam

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 end-use products listed in Table 1. This three-year registration proposal is also applicable to Use-Site Category 10 of Thiamethoxam Technical (Reg. No. 26665). 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 PRVD2017-24 and in PRD2017-18 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 recommended.

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 risk are 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 thiamethoxam, the PMRA will consider any comments received from the public in response to PRD2017-18. The PMRA will then publish a Registration Decision on thiamethoxam, 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 thiamethoxam, further risk mitigation measures for product labels are being proposed.

Measures to Protect Pollinators for seed treatment products, as found in PRVD2017-24, Thiamethoxam and Its Associated End-use Products: Pollinator Re-Evaluation

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

• Seed treatment of cereal and legume crops.

The risk-reduction measures 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. Refer to PRVD2017-24.

Conclusion

The conditions of registration relating to the submission of additional information required under section 12 of the Pest Control Products Act for Use-Site Category 10 of Thiamethoxam Technical, and its associated end-use products listed in Table 1, have been met. To address potential risks to pollinators, amendments to the registrations of thiamethoxam 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 Use-Site Category 10 of Thiamethoxam Technical (Reg. No. 26665), and for the sale and use of the end-use products listed in Table 1. An evaluation of available scientific information as set out in PRVD2017-24 and in PRD2017-18 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.

Next Steps

Before making a final registration decision on thiamethoxam, the PMRA will consider any comments received from the public in response to this PRD2017-18. The PMRA will accept written comments up to 90 days from the date of publication. The PMRA will then publish a Registration Decision on thiamethoxam, 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.