Canada completes the re-evaluation of abamectin and its associated end-use products

Re-evaluation decision for abamectin and associated end-use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they meet current health and environmental standards and have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies. More details, on the legislative framework, risk assessment and risk management approach, are provided under the Evaluation Approach Section of the full version of Re-evaluation Decision RVD2025-04, Abamectin and its associated end-use products.

Abamectin is an acaracide/insecticide registered for use on a wide-range of outdoor field-grown fruit and vegetable crops, outdoor ornamentals, greenhouse vegetables and greenhouse ornamentals for the control or suppression of a variety of agricultural pests such as mites, sawflies, moths, thrips, leafminers, psyllids, aphids and certain beetles. It is also registered for commercial and domestic indoor and/or outdoor structural use to control cockroaches and ants.

Currently registered products containing abamectin can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2023-01, Abamectin and Its Associated End-use Products1 containing the evaluation of abamectin and proposed decision, underwent a 90 day consultation period ending on 29 May 2023. PRVD2023­01 proposed continued registration of abamectin and all associated end-use products provided new risk mitigation measures are put in place. The proposed human health mitigation measures included cancellation of greenhouse ornamentals grown for cut flower production, additional personal protective equipment for agricultural workers, a limit to the amount of abamectin handled per day and restricted-entry intervals for several crops/uses. The proposed environmental mitigation measures included additional precautionary label statements, spray buffer zones, measures to reduce exposures to bees, the use of vegetative filter strips and restriction of the maximum application rate for outdoor uses.

Health Canada received comments (and information) relating to the health, environmental and value assessments. Commenters are listed in Appendix II of RVD2025-04. These comments are summarized in Appendix III of RVD2025-04 along with the responses by Health Canada. These comments and new data/information resulted in revisions to the dietary, occupational and environmental risk assessments and an updated value review (see Science evaluation update in the full version of RVD2025-04), and resulted in changes to the proposed re-evaluation decision as described in PRVD2023-01, such as retaining the use on greenhouse ornamentals grown for cut flowers.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2023-01, and further information used in the re-evaluation decision is listed in Appendix XI of RVD2025-04. Therefore, the complete reference list of all information used in this final re-evaluation decision includes both the information set out in PRVD2023-01 and the information set out in Appendix XI of RVD2025-04.

This summary presents the final re-evaluation decision2 for the re-evaluation of abamectin, including the required amendments (risk mitigation measures) to protect human health and the environment, as well as label amendments required to bring labels to current standards. All products containing abamectin that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for abamectin

Health Canada has completed the re-evaluation of abamectin. Under the authority of the Pest Control Products Act, Health Canada has completed all required evaluations and consultations and has determined that the registration of products containing abamectin is required to be amended, in accordance with paragraph 21(2)(a) of the Pest Control Products Act. An evaluation of available scientific information respecting the health and environmental risks and value of abamectin found that all uses of abamectin products meet current standards for protection of human health and the environment and have acceptable value when used according to the amended conditions of registration which includes new mitigation measures. Label amendments, as summarized and listed in Appendix X of RVD2025-04, are required.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required amendments, including any revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of abamectin, are summarized below. Refer to Appendix X of RVD2025-04 for details.

Human health

The following risk-reduction measures are required for continued registration of abamectin in Canada:

To protect workers entering treated areas from occupational exposure, the following risk-reduction measures are required:

• Restricted-entry intervals were updated for some activities.

The following label improvements are required to meet current standards:

• Updated personal protective equipment label statements as per current labelling standards.

• Updated precautionary statements to minimize exposure at residential sites.

The following label restrictions was added in response to comment from the registrant:

• Prohibit the application of abamectin via handheld airblast/mistblower.

Environment

To protect the environment, the following risk-reduction measures are required for continued registration of abamectin in Canada:

• Label statements to inform users of potential risks to bees, beneficial arthropods, birds, small wild mammals, and aquatic organisms.

• Spray buffer zones to reduce the risk to aquatic habitats from spray drift.

• Label restrictions to reduce the exposure to bees.

• Construction and maintenance of a 10 m wide vegetative filter strip to reduce the risk to aquatic organisms from runoff.

• Reduction of the maximum cumulative application rate to 38.2 g a.i./ha/per year for outdoor uses.

Implementation of the re-evaluation decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides information and general timelines regarding the implementation of post-market decisions, (for example, up to 24-month timeline for label amendments and up to 36-month phase-out timeline for cancelled registrations), and Information Note: update on implementation of post-market decisions provides additional information on phase-out measures for post-market decisions that include cancellations. The post-market decision considers potential health and environmental risks regarding the use of the pest control product, and its value, when establishing the implementation timelines.

The health and environmental considerations for the implementation timeline for this final decision are outlined below.

Health considerations

Risks to human health from exposure to a pesticide are estimated by comparing potential exposures with the most relevant endpoint from toxicology studies, with standard protection factors incorporated to further protect human health, including the most sensitive population. These factors provide an inherent level of protection from exposures that could result in adverse effects to human health. Furthermore, Health Canada applies additional protection factors if warranted by the hazard profile of the pesticide or by the quality and completeness of the underlying data. When risks of concern are identified in the human health exposure scenarios, it does not necessarily mean that exposure will result in adverse effects, but mitigation measures to reduce potential risks would be required.

Potential and relative health risks are considered acceptable during the general 2-year implementation period unless there is evidence from incident reports or other sources of real-world post-market surveillance data suggesting that there are adverse health effects occurring as a result of the use of the product(s) according to the currently approved label/use conditions. Taking into consideration these factors, the general 2-year implementation timeline for label amendments for abamectin is considered appropriate from a human health perspective. Therefore, the required label updates will be implemented within 24 months following the publication of the re-evaluation decision document.

Environmental considerations

Registered labels for products containing abamectin currently include all the precautionary statements that were determined to be required by the environmental assessment for the re-evaluation. Buffer zones were recalculated based on the reduction of the maximum cumulative application rate to 38.2 g a.i./ha and registrant's proposed change of the spray quality size from American Society of Agricultural and Biological Engineers (ASABE) Fine to ASABE Medium spray quality. The revised spray buffer zones are smaller or within the same range as buffer zones currently on product labels. Therefore, the required environmental precautionary statements and mitigative measures on product labels will be protective during the general 2-year implementation timeline for label amendments for pest control products containing abamectin, and environmental risks are considered to be acceptable.

Taking into consideration these factors, the general 2-year implementation timeline for label amendments for pest control products containing abamectin is considered appropriate from a human health and environmental perspective.

Amendment timeframe

Based on the above considerations, the required amendments (mitigation measures and label updates) for pest control products containing abamectin must be implemented within 24-months from the date of this decision document.

Refer to Appendix I for details on specific products impacted by this decision.

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels no later than 24 months after the publication date of this decision document. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection3 regarding this decision on abamectin and its associated end-use products 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 Section of the Canada.ca website (Public Engagement Portal - Public Engagement Forms - Notice of Objection) or contact the PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2023-01 and in Appendix XI of RVD2025-04) are available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the Pest Management Information Service.