Re-evaluation Decision RVD2019-10, N-Octyl bicycloheptene dicarboximide (MGK-264) and Its Associated End-use Products

Pest Management Regulatory Agency
26 August 2019
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2019-10E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation Decision
• Outcome of Revised Science Evaluation
• Regulatory Decision for N-Octyl bicycloheptene dicarboximide (MGK-264)
• Risk Mitigation Measures
• Next Steps
• Other Information

Re-evaluation Decision

Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

N-Octyl bicycloheptene dicarboximide (MGK-264) is an insecticide synergist that is always co-formulated with one or more active ingredients belonging to synthetic pyrethroids and pyrethrins. It enhances the pesticide properties of other insecticides. MGK-264, is registered for a wide spectrum of insect pests in stored food and feed, structures, companion animals, human habitat and recreational areas, human skin, clothing and proximal sites, and residential outdoors. Domestic-class products are applied using pressurized spray cans, roll-ons, pet shampoos and pump sprayers. Commercial-class products are applied using foggers, ultra-low volume equipment, pressurized sprayers and automated aerosol dispensers. Information on registered products containing MGK-264 in Canada can be accessed through Health Canada's pesticide label search;^{Footnote 1} there are 154 registered products as of 11 March 2019.

The regulatory approach for the re-evaluation of MGK-264 was first presented in the Proposed Re-evaluation Decision PRVD2017-15, N-Octyl bicycloheptene dicarboximide (MGK-264) and its associated end-use products, which underwent a 90-day consultation period ending on 28 December 2017.^{Footnote 2} PRVD2017-15 proposed the cancellation of dust products, aerosol products for use as a metered-release space spray and space spray uses for aerosol products. The use of MGK-264 on livestock for food production was not supported by the technical registrant and will be cancelled. Additionally, changes to the limits of the maximum active ingredient concentration for aerosol products, limits to the rate for liquid formulations, prohibition of the use of handheld foggers/mistblowers and ultra-low-volume aerosol generators/mechanical aerosol generator, changes to the re-entry intervals, addition of personal protective equipment, and changes to label statements to protect mixer/loader/applicators, bystanders and consumers were proposed.

Health Canada received comments relating to the health risk assessments. These comments are summarized in Appendix I of Re-evaluation Decision RVD2019-10, N-Octyl bicycloheptene dicarboximide (MGK-264) and Its Associated End-use Products along with the responses by Health Canada. These comments and new data/information resulted in revisions to the risk assessments (see Science Evaluation Update section of RVD2019-10), and subsequently, in changes to the proposed regulatory decision as described in PRVD2017-15. A reference list of data used as the basis for the proposed re-evaluation decision is included in PRVD2017-15, and further data used in the re-evaluation decision is listed in Appendix V of RVD2019-10.

This document (RVD2019-10) presents the final regulatory decision^{Footnote 3} for the re-evaluation of MGK-264, including the required risk mitigation measures to protect human health and the environment. All products containing MGK-264 that are registered in Canada are subject to this re-evaluation decision.

Outcome of Revised Science Evaluation

Following the consultation on the proposed re-evaluation decision, Health Canada revised the occupational and residential risk assessments based on additional data submitted. For most registered uses of MGK-264 health risks are acceptable when used according to the revised label directions, which incorporate additional mitigation measures. The use of certain domestic-class products will be cancelled in order to protect human health. The environmental risks associated with the use of MGK-264 and its related end-use products are acceptable when products are used according to the revised label directions.

Regulatory Decision for N-Octyl bicycloheptene dicarboximide (MGK-264)

Health Canada has completed the re-evaluation of MGK-264. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of most products containing MGK-264 is acceptable. An evaluation of available scientific information found that most uses of MGK-264 products meet current standards for protection of human health and the environment when used according to revised label directions which include new mitigation measures. Certain uses of MGK-264 are cancelled to address potential risks of concern to human health. Label amendments, as summarized below and listed in Appendix II of RVD2019-10, are required for all remaining end-use products. No additional data are requested.

Risk Mitigation Measures

Registered pesticide product labels include specific directions for use. Directions include risk reduction measures to protect human and environmental health and must be followed by law. The key risk-reduction measures required, as a result of the re-evaluation of MGK-264, are summarized below. Refer to Appendix II of RVD2019-10 for details.

Human Health

To protect homeowners and those entering treated residential and commercial areas, the following measures are required:

For domestic-class products:

• Cancellation of dust products.
• Cancellation of pressurized products^{Footnote 4} for use as a metered-release space spray.
• Limit the maximum concentration of MGK-264 to 0.4% for aerosol products registered for indoor treatment of fleas, ticks, and carpet beetles; products with a maximum concentration of MGK-264 greater than 0.4% will be cancelled.
• Label directions must include precautionary statements, as well as definitions of application methods, as indicated in PRO2018-04, unless similar or more restrictive information is already present.

For commercial-class products:

• Limit the maximum space spray application rate to 0.055 g a.i./m3 for liquid formulations used in certain residential areas (dwellings such as houses, apartments, or in guest rooms of hotels and motels).
• Limit the maximum concentration of MGK-264 to 3.35% for metered-release pressurized products; products with a maximum concentration of MGK-264 greater than 3.35% will be cancelled.
• Prohibit the use of metered-release pressurized products in areas where children may be present for more than four hours per day.
• Entry into treated sites in both residential and commercial areas following an indoor space spray application must not occur until two hours after application of a liquid commercial-class product, or 15 minutes after application of a pressurized commercial-class product. The commercial applicator is responsible for notifying workers, the homeowner, and others of the re-entry period requirement.
• Label directions must include precautionary statements, as well as definitions of application methods, as indicated in PRO2018-04, unless similar or more restrictive information is already present.

To protect mixer/loader/applicators, the following measures are required:

• Additional personal protective equipment when mixing, loading or applying by truck-mounted sprayers or handheld equipment.
• Limit the amount of MGK-264 handled per day when using a mechanically-pressurized handheld sprayer for fog, aerosol, or mist applications.
• Additional protective equipment when entering areas treated with a space spray, prior to ventilation.

To protect bystanders from spray drift, the following measures are required:

• Statement to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift in non-target areas.

To protect consumers from potential residues in or on food, the following measures are required:

• Statements to prohibit the use of commercial-class products on livestock intended for food production.
• Statements on all labels to prevent contamination of food.

Environment

• No additional environmental risk mitigation measures are required.

Next Steps

To comply with this decision, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document (RVD2019-10). The registered products containing MGK-264 that are subject to this decision can be found through Health Canada's pesticide label search database. Products that are cancelled will be phased out following the implementation timeline outlined below:

• One (1) year of sale by registrant from the publication date of this decision document, followed by
• One (1) year of sale by retailer from the last date of sale by registrant, followed by
• One (1) year of permitted use from the last date of sale by retailer.

Other Information

Any person may file a notice of objection^{Footnote 5} regarding this decision on MGK-264 within 60 days from the date of publication of RVD2019-10. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact Health Canada's Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra.info-arla@hc-sc.gc.ca)

The relevant test data on which the decision is based (as referenced in PRVD2017-15) 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.