Registration Decision RD2019-05, Clothianidin and associated end-use products

Pest Management Regulatory Agency
11 April 2019
ISSN: 1925-0940 (PDF version)
Catalogue number: H113-25/2019-5E-PDF (PDF version)

Table of Contents

• Conditions of Registration
• Registration Decision Statement for Clothianidin
• Implementation of Mitigation Measures Required to Protect Pollinators
• Other Information
• Appendix I - Comments and Responses

Conditions of Registration

The conditions of registration previously outlined in section 12 notices for the end-use products listed in Table 1 have been fulfilled. Refer to PRD2017-17, Clothianidin, for more details on the conditions of registrations.

Registration Decision Statement^{Footnote 1} for Clothianidin

Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is granting a three-year registration for the sale and use of the end-use products listed in Table 1, containing the technical grade active ingredient clothianidin for use as seed treatments, foliar and soil applications. This decision is consistent with the Proposed Registration Decision, PRD2017-17, which contains a detailed evaluation of the information submitted in support of this registration. See Appendix I for a summary of comments received during the consultation on PRD2017-17, as well as Health Canada’s response to these comments.

An evaluation of available scientific information – as set out in PRD2017-17, in PRVD2017-23, Clothianidin and Its Associated End-Use Products: Pollinator Re-evaluation, and in RVD2019-05, Clothianidin and Its Associated End-use Products: Pollinator Re-evaluation – 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. Labels will be amended following the re-evaluation implementation schedule described under the next section.

Implementation of Mitigation Measures Required to Protect Pollinators

The additional risk mitigation measures described in the final decision document, RVD2019-05, will be implemented over a 24-month period. The risks identified are not considered imminent because they are not expected to cause irreversible harm over this period. Potential effects include sublethal effects on colonies or solitary bees, but affected pollinator populations are expected to recover following implementation of the additional restrictions which will reduce exposure. Moreover, recovery is expected because risks to pollinators are geographically limited to areas where these products are applied and areas adjacent to application sites. The presence of unaffected solitary bees, bumble bees, and honey bees in areas where products are not being used will further facilitate recovery since unaffected bees in the environment can move back into areas where effects may have occurred. Overall, risk to pollinators is acceptable over the time period required to implement the mitigation measures.

As a result of this decision, growers will be required to change their pest management practices.  Pesticides have extensive and precise instructions and often require specialized application and safety equipment and training. This transition period will allow for an orderly and safe implementation of these new restrictions, and should reduce the risk of product misuse or the improper disposal of products as users switch to alternatives, where required. This approach is consistent with Health Canada’s current policy and practice with respect to phase out of uses as a result of a re-evaluation (Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review) and with the practice of other international regulators.

A small subset of uses were found to lack alternatives for the management of a serious pest (the invasive brown marmorated stink bug) on a very few crops present in limited geographical areas of Canada. As a result, the implementation of the re-evaluation decision for these uses will be delayed for an additional year to allow growers to find pest management solutions. During this period, the overall exposure to pollinators will be significantly reduced through both removal of uses to control other pests on these crops and other crops that pose a risk to bees, as well as through implementation of additional restrictions in application timing, which will further reduce pollinator exposure. The risks to pollinators are therefore considered acceptable for an additional year for this small subset of uses.

The risk-reduction measures and other conditions of registration applicable to the end-use products listed in Table 1 are described in RVD2019-05. For more details, refer to RVD2019-05. After this registration decision is issued, these products will also be subject to the final outcome of the special review currently ongoing.

Other Information

The relevant test data on which the decision is based (as referenced in PRD2017-17) are available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa). For more information, please contact the PMRA’s Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra.info-arla@hc-sc.gc.ca).

Appendix I - Comments and Responses

1. Comments suggesting an immediate phase-out of the products instead of the proposed three-year registration.
   

   Response

   Health Canada acknowledges the comments requesting an immediate ban or cancellation of neonicotinoids, and also shares in the concern for pollinator health and agrees with the importance of pollinators to food production.

   For the pollinator re-evaluation of clothianidin, Health Canada has concluded that continued registration of products containing this active ingredient is acceptable with required amendments; however, certain uses are cancelled to address potential risk of concern to pollinators. The overall exposure to pollinators will be significantly reduced through both removal of many uses that pose a risk to bees and through implementation of additional restrictions in application timing that will further reduce pollinator exposure. As stated earlier, a two year period to allow for the implementation of the additional risk mitigation measures required to protect pollinators is considered acceptable. The risks identified are not considered imminent because they are not expected to cause irreversible harm over the phase-out period.

   The risks to pollinators are also acceptable for one additional year for uses having critical pest management needs (for brown marmorated stink bug control). During this period, the overall exposure to pollinators will be significantly reduced through both removal of uses to control other pests on these crops and other crops that pose a risk to bees, as well as through implementation of additional restrictions in application timing thereby further reducing pollinator exposure.

2. A comment was received disagreeing with the consultation taking place under the authority of subsection 28(1)(c) of the Pest Control Products Act rather than 28(1)(a) “given that data are being evaluated on a prior conditional and thus incomplete registration”.

   Response

   Before any of the conditional registrations were granted, the risk was determined to be acceptable, based on the data evaluated. The conditional registration status of these products was not considered to be an incomplete registration; each conditional registration was a final registration decision based on a finding of acceptable risk made in accordance with section 8 of the Pest Control Products Act.

   Under 28(1)(a) of the Pest Control Products Act, a public consultation is required when there is a new active ingredient being proposed for registration, or where the registration or amendment of the registration may result in significantly increased health or environmental risks. All of the clothianidin products were either initially granted registration before the current Pest Control Products Act existed (that is, before 28 June 2006) or were previously consulted on as major new uses under 28(1)(a) of the Pest Control Products Act. As such, neither of the criteria under 28(1)(a) applies to the proposed registration decisions for these products that have recently been the subject of consultation. Given the public interest in all of these neonicotinoid conditional registrations, Health Canada made a decision to consult the public on the most recent proposal in respect of all products in Table 1, and did so under 28(1)(c) of the Pest Control Products Act.