Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides (revised)

1 November 2010
HC Pub: 100543
ISBN: 978-1-100-17016-9 (print version)
ISBN: 978-1-100-17017-6 (PDF version)
Catalogue number: H113-5/2010-17E (print version)
Catalogue number: H113-5/2010-17E -PDF (PDF version)

Executive Summary

Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides is being published to notify registrants, pesticide regulatory officials and the Canadian public that Health Canada's Pest Management Regulatory Agency (PMRA) is requiring additional risk mitigation measures for rodenticide products containing the active ingredients brodifacoum, bromadiolone, bromethalin, chlorophacinone, difethialone, diphacinone, warfarin or zinc phosphide, as part of an overall risk-reduction strategy for rodenticides in Canada. Furthermore, these measures may be applied to new active ingredients and end-use products when risk mitigation measures are required. The regulatory actions outlined in this document do not apply to rodenticide field uses (for example, in crop land, orchards, nurseries, rangeland, landfills, etc.), with the exception of fields open to the public for "pick your own" activities, or to products registered for use as a tracking powder.

Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides summarizes comments made to the PMRA in response to the Re-evaluation Note REV2009-05, Proposed Risk Mitigation Measures for Eight Rodenticides, published on 22 June 2009. Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides also provides the PMRA's responses to the comments received.

Table of Contents

• Executive Summary
• 1.0 Background
• 2.0 Regulatory Action
• 3.0 Implementation of the Regulatory Action
  • 3.1 Timeline for the Implementation of the Regulatory Action
    • 3.1.1 Submissions for Amendments Consistent with the Risk Mitigation Decision
    • 3.1.2 Notice of Intent to Discontinue and Last Date of Sale for Products Not Complying with Risk Mitigation Decision
  • 3.2 Ready-to-Use Bait Stations for Domestic Class Products
  • 3.3 Bait Stations Sold Without Bait
• 4.0 Additional Information

1.0 Background

As part of an overall risk-reduction strategy for rodenticides in Canada, the PMRA has proposed additional mitigation measures for rodenticide products containing brodifacoum, bromadiolone, bromethalin, chlorophacinone, difethialone, diphacinone, warfarin or zinc phosphide, similar to those required by the United States Environmental Protection Agency (USEPA) in their Risk Mitigation Decision for Ten Rodenticides (2008). The proposed mitigation measures for these active ingredients were first presented in consultation document Re-evaluation Note REV2009-05, Proposed Risk Mitigation Measures for Eight Rodenticides.

Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides summarizes the PMRA's risk mitigation decision and the reasons for it. Comments received during the consultation resulted in some changes to the proposed risk mitigation measures as described in REV2009-05. Appendix I of Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides summarizes the comments received during the consultation period and provides the PMRA's response.

2.0 Regulatory Action

The risk mitigation measures for eight rodenticides outlined in Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides apply to products registered for use in or around structures, including the following: in and around residential, commercial, agricultural (such as, feed barns, storage sheds, poultry houses), industrial and public buildings; closed structures, such as garbage dumpsters; sewers. It should be noted that these measures do not apply to products registered solely for "field" uses (for example, in crop land, orchards, nurseries, rangeland, landfills, etc.), with the exception of fields open to the public for "pick your own" activities, or to products registered for use as a tracking powder. The PMRA's regulatory actions are summarized in Appendix II and III of Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides. Appendix IV and V of Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides outline the revised labelling requirements for domestic and commercial class products, respectively.

3.0 Implementation of the Regulatory Action

3.1 Timeline for the Implementation of the Regulatory Action

Appendix VI of Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides provides an overview of timelines and requirements for complying with the risk mitigation decision.

3.1.1 Submissions for Amendments Consistent with the Risk Mitigation Decision

For products for which registrants intend to comply, registrants must submit an application to amend the product labels and package (if applicable) within 90 days of publication of the risk mitigation decision.

3.1.2 Notice of Intent to Discontinue and Last Date of Sale for Products Not Complying with Risk Mitigation Decision

Registrants who do not intend to comply with the risk mitigation decision must notify the PMRA that they intend to discontinue sales of these products. This must be done within 90 days of publication of the risk mitigation decision. The last date of sale by registrants for products not complying with the risk mitigation decision is 31 December 2012.

3.2 Ready-to-Use Bait Stations for Domestic Class Products

The PMRA requires that domestic class products be packaged with one or more tamper-resistant bait stations that meet the conditions of use (indoor versus outdoors), as well as the tamper-resistance indicated by the label:

• The tier 1 to 4 designations are indicators of the resistance of packaging:
  • Tier 1 bait stations are tamper-resistant for children and dogs, and are weather resistant. They can be used indoors or outdoors.
  • Tier 2 bait stations are tamper-resistant for children and dogs. They can only be used indoors.
  • Tier 3 bait stations are tamper-resistant for children only. They can only be used indoors, in locations inaccessible to pets, domestic animals and non-target wildlife.
  • Tier 4 bait stations are non-refillable (one-time use only). They can only be used indoors, in locations inaccessible to children, pets, domestic animals or non-target wildlife. These bait stations are self-certified by the registrants. Please note that the registrants must certify that the bait station is made of a material of sufficient rigidity such that the station is not easily crushed or opened by children younger than 6 years old, not easily chewed by rats/mice and will not release rodenticide bait except for bait removed by target rodents.
• Tier 1 to 3 bait stations may be non-refillable (disposable, one-time-use stations) or refillable (sold with bait refills); however, it should be noted that the label of domestic class products must indicate that the use of a tamper-resistant bait station is mandatory for each placement of rodenticide baits (see Appendix IV).
• It is the registrant's responsibility to test tier 1, 2 and 3 bait stations that are to be sold with domestic class end-use products in Canada for tamper-resistance according to USEPA protocols.
• For domestic class products sold with tier 4 bait stations, a self-certification statement about packaging must be provided to the PMRA.
• The labels of domestic class end-use products must indicate if the bait station included in the packaging can be used indoors and outdoors (tier 1) or indoors only (tier 2, 3 and 4) and must indicate the bait station's ability to isolate bait from children and/or pets (see Appendix IV).
• Bait stations for mouse control are required to accommodate bait placements of between 7 and 28 g of bait. Bait stations for rat control are required to accommodate bait placements of between 113 and 454 g of bait for warfarin, diphacinone or chlorophacinone baits; between 28 and 170 g of bait for bromethalin baits; and between 4 and 9 g of bait for zinc phosphide baits.
• No more than 454 g of bait can be sold with one bait station.
• All bait stations distributed with domestic class rodenticide products must be clearly labelled "WARNING POISON" and bear the skull and crossbones symbol.

3.3 Bait Stations Sold Without Bait

Bait stations that are sold without bait are considered to be application equipment. Therefore, they are not pest control products and not regulated directly by the Pest Control Products Act. However, commercial class rodenticide products registered in Canada must be used in bait stations in certain situations. In such cases, the users of rodenticide baits are responsible for obtaining or constructing bait stations that are appropriate for the use situation (for example, resistant to weather and/or to tampering by children and dogs) and consistent with label requirements. Appendix V of Re-evaluation Note REV2010-17, Risk Mitigation Measures for Eight Rodenticides lists the required label amendments for commercial class products.

4.0 Additional Information

Any person may file a notice of objection regarding this decision on the eight rodenticide active ingredients within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides and Pest Management portion of Health Canada's website Request a Reconsideration of Decision or contact the PMRA's Pest Management Information Service.

PMRA documents can be found on the Pesticides and Pest Management portion of Health Canada's website. PMRA documents are also available through the Pest Management Information Service.

The USEPA documents for rodenticides are available at regulations.gov (Docket ID EPA-HQ-OPP-2006-0955).