Pest Management Regulatory Agency
19 June 2025
ISSN: 2561-6269 (PDF version)
Catalogue number: H113-17/2025-1E-PDF (PDF version)

Summary

To obtain a full copy of Special Review Decision SRD2025-01, Methyl Bromide and its associated end-use products please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Table of contents

• Special review decision for methyl bromide and associated end-use products
• Special review decision for methyl bromide
• Risk mitigation measures
• Implementation of the special review decision
• Next steps
• Other information
• Appendix I Registered products containing methyl bromide in Canada

Special review decision for methyl bromide and associated end-use products

Under the authority of the Pest Control Products Act, pesticides are regulated by Health Canada's Pest Management Regulatory Agency (PMRA) on behalf of the Minister of Health. The Pest Control Products Act prescribes both the pre-market and post-market assessment (re-evaluations and special reviews) of pesticides to determine the acceptability or continued acceptability of human health and environmental risks, and acceptable value of a pesticide in Canada. Unlike a re-evaluation, a special review is triggered only under certain circumstances, as described in section 17 of the Pest Control Products Act, and the intent of a special review is to address specifically the identified aspect(s) of concern. The special review approach is described in the PMRA Guidance Document: Approach to Special Reviews of Pesticides.

Health Canada evaluates the aspects of concern that prompted the special review in accordance with subsection 18(4) of the Pest Control Products Act. A science-based approach was used for the assessment of the aspect(s) of concern, which includes a risk management approach to address the concerns identified.

Pursuant to subsection 17(2) of the Pest Control Products Act, Health Canada initiated a special review of all registered pest control products containing methyl bromide, based on the European Union's decision to prohibit all uses of methyl bromide. The identified aspects of concern are:

• Potential for risk from occupational exposure.
• Potential for risk to bystanders.

To assess the aspects of concern, Health Canada considered the information that prompted the special review and other relevant information currently available, including information from international regulatory authorities such as the United States Environmental Protection Agency (USEPA).

Methyl bromide is classified as an ozone-depleting substance (ODS) under the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol). Canada is a Party to the Montreal Protocol, and has committed to specific international obligations pertaining to the consumption (import) and use of methyl bromide. The Ozone Depleting Substances and Halocarbon Alternatives Regulations (ODSHAR), established under the authority of the Canadian Environmental Protection Act, 1999, implement Canada's international obligations under the Montreal Protocol, including those for methyl bromide. Under the ODSHAR, the import, export, and certain uses of methyl bromide are prohibited without an authorization issued by Environment and Climate Change Canada (ECCC). This final special review decision will discuss the status of methyl bromide in Canada as a pest control product under the Pest Control Products Act.

Methyl bromide has undergone re-evaluation where aspects related to human health, environment and value were assessed in the Re-evaluation Decision RVD2025-02, Methyl bromide and its associated end-use products.

Methyl bromide is a broad-spectrum fumigant, effective as an insecticide, acaricide, fungicide, animal toxicant, molluscicide, nematicide, and herbicide. Under the Pest Control Products Act, it is registered for general space fumigation of structures (for example, warehouses, grain elevators, food processing plants, restaurants) and enclosed space fumigation (in other words, chamber/vault; vacuum chamber; transport vehicles and gas tight covering (tarpaulin) fumigation) and applied to empty structures or to treat stored food/feed and non-food/non-feed commodities. Methyl bromide is also registered as a pre-plant soil fumigant for ornamental and forest nurseries and tomatoes.

Fumigation with methyl bromide is generally prohibited unless the specific use meets the definition of a quarantine or pre-shipment (QPS) application under the ODSHAR (see Appendix II of Special Review Decision SRD2025-01, Methyl Bromide and Its Associated End-use Products) and the import and export of methyl bromide always requires an authorization issued by ECCC. Additionally, registered uses of a pest control product containing methyl bromide that do not meet the definition of a QPS use, for example, pre-plant soil fumigation uses, also require a critical or emergency use authorization under the ODSHAR issued by ECCC. Any use of a pest control product containing methyl bromide must also be registered under the Pest Control Products Act.

Pre-plant soil fumigation uses of methyl bromide are cancelled in the Re-evaluation Decision of methyl bromide (RVD2025-02). Therefore, the registered pre-plant soil fumigation uses have not been considered as part of the human health assessment in this Special Review Decision. Currently registered pest control products containing methyl bromide can be found in the Pesticide Product Information Database and in Appendix I.

This document (SRD2025-01) presents the final regulatory decision^{Footnote 1} for the special review of methyl bromide. Pest control products containing methyl bromide that are registered in Canada as a general space and commodity fumigant are subject to this special review decision. Prior to finalizing this decision, Health Canada published the Proposed Special Review Decision PSRD2024-01, Proposed Special Review Decision for Methyl Bromide and Its Associated End-use Products,^{Footnote 2} which underwent a 90-day public consultation period ending on 26 June 2024.

Comments were received during the public consultation period conducted in accordance with section 28 of the Pest Control Products Act. Commenters are listed in Appendix III of SRD2025-01. These comments are summarized in Appendix IV of SRD2025-01 with the responses from Health Canada. These comments were not relevant to the health assessment and did not result in a change to the proposed special review decision as described in PSRD2024-01.

A reference list of information used as the basis for the proposed special review decision is included in PSRD2024-01. No further information was used in the final special review decision. Therefore, the complete reference list of all information used in this final special review decision is set out in PSRD2024-01.

Special review decision for methyl bromide

Health Canada has completed the special review for methyl bromide. Under the authority of the Pest Control Products Act, Health Canada has determined that the registration of products containing methyl bromide is required to be amended, in accordance with paragraph 21(2)(a) of the Pest Control Products Act. The assessments of the aspects of concern from this special review indicated that the risks to human health for the following uses of methyl bromide are acceptable when used according to the amended conditions of registration which includes new risk mitigation measures, as summarized below and listed in Appendix V and VI of SRD2025-01:

• general space fumigant, enclosed space fumigant and gas tight (tarpaulin) fumigant to treat empty structures or stored food/feed and non-food/non-feed commodities listed on the label

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 special review of methyl bromide, are summarized below. Refer to Appendix V and VI of SRD2025-01 for details.

Human health

To protect human health, the following risk-reduction measures are required:

• Updated personal protective equipment (PPE) statements to bring the product labels up to current standards.
• Reduction of methyl bromide exposure limit from 3.0 ppm to 1.0 ppm.
• New respiratory protection requirements based on the results of real-time air monitoring and/or anticipated maximum entry times in the fumigation site.
• As part of the requirements for restricted-class products and fumigants:
  • All employees of facilities or agricultural establishments using methyl bromide who are present during methyl bromide use must complete mandatory annual site- and product-specific training before fumigation is conducted.
• Fumigation management plans (FMPs) must be completed prior to each fumigation application.

To protect the general public and bystanders, the following risk-reduction measures are required for methyl bromide:

• Buffer zones during treatment of commodities or structures and when they are being aerated.
• As part of the updates to all commodity fumigant labels:
  • New air monitoring and distribution of fumigation information for all "difficult to evacuate sites" located within an estimated 16 meters beyond the perimeter of the treatment and aeration buffer zones.
  • Updated placarding statements for treatment areas and buffer zone perimeters.
  • Updated statements indicating that this product is NOT to be used in residential structures or public food service facilities (such as public restaurants). Residential structures include, but are not limited to, homes, garages, schools, restaurants, hotels/motels, public buildings or other structures where the general public including children may potentially be exposed.

Implementation of the special review 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, (in other words, 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 considerations for the implementation timeline for this final decision are outlined below.

Health considerations

Potential and relative health risks are considered acceptable during the general 24-month 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 24-month implementation timeline for label amendments for methyl bromide is considered appropriate from a human health perspective. Therefore, the required label updates will be implemented within 24 months following the publication of the special review decision document.

Amendment timeframe

Based on the above considerations, the required amendments (mitigation measures and label updates) for pest control products containing methyl bromide must be implemented within 24 months from the date of SRD2025-01.

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on the label of METH-O-GAS Space Fumigant (Reg No. 9564) no later than 24 months after the publication date of SRD2025-01. Accordingly, both registrants and retailers will have up to 24 months from the date of SRD2025-01 to transition to selling the product with the newly amended label. Similarly, users will also have the same 24-month period from the date of SRD2025-01 to transition to using the newly amended label, which will be available on the Public Registry.

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

Other information

Any person may file a notice of objection^{Footnote 3} regarding this decision on methyl bromide 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 PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PSRD2024-01) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Appendix I Registered products containing methyl bromide in Canada