Re-evaluation Decision RVD2025-02, Methyl bromide and its associated end-use products

Pest Management Regulatory Agency
19 June 2025
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2025-2E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for methyl bromide and associated end-use products
• Re-evaluation decision for methyl bromide
• Risk mitigation measures
• Implementation of the re-evaluation decision
• Health considerations
• Value considerations
• Amendment and cancellation timeframes
• Next steps
• Other information
• Appendix I  Registered products containing methyl bromide in Canada1

Re-evaluation decision for methyl bromide 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.

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 re-evaluation decision will discuss the status of methyl bromide in Canada as a pest control product under the Pest Control Products Act.

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 the full version of Re-evaluation Decision RVD2025-02, 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 an 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.

Currently registered products containing methyl bromide can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2024-03, Proposed Re-evaluation Decision for Methyl Bromide and Its Associated End-use Products^{Footnote 1} containing the evaluation of methyl bromide and proposed decision, underwent a 90-day consultation period ending on 26 June 2024.

Health Canada received comments but they did not relate to the health, environmental or value assessments. Commenters are listed in Appendix III of RVD2025-02. These comments are summarized in Appendix IV of RVD2025-02 along with the responses by Health Canada. These comments did not result in revisions to the risk assessments, and did not result in changes to the proposed re-evaluation decision as described in PRVD2024-03.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2024-03; no further information was used in the final re-evaluation decision. Therefore, the complete reference list of all information used in this final re-evaluation decision is set out in PRVD2024-03.

This document (RVD2025-02) presents the final re-evaluation decision^{Footnote 2} for the re-evaluation of methyl bromide, including the required 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 methyl bromide that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for methyl bromide

Health Canada has completed the re-evaluation of methyl bromide. 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 methyl bromide is required to be amended, in accordance with paragraph 21(2)(a) of the Pest Control Products Act. An evaluation of available scientific information for methyl bromide found that certain uses of methyl bromide products meet current standards for protection of human health and the environment and has acceptable value when used according to the amended conditions of registration which includes new mitigation measures. Label amendments, as summarized below and listed in Appendix V and VI of RVD2025-02, are required. However, the registration is required to be amended to cancel pre-plant soil fumigation uses of methyl bromide since the registered uses do not meet the criteria for a QPS application under the ODSHAR, and it is no longer used as a pre-plant soil fumigant for the uses found on the currently registered label of Terr-O-Gas 67 pre-plant soil fumigant (Reg. No. 13477) (in other words, ornamental and forest nurseries, and tomatoes).

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 methyl bromide, are summarized below. Refer to Appendix V and VI of RVD2025-02 for details.

Value

• Label amendments to use directions for clarity and consistency, including improved instructions for monitoring temperature and methyl bromide concentrations during treatment; and development of a “Fumigant Usage Form” to improve record keeping.
• Cancellation of pre-plant soil fumigation uses of methyl bromide and the registration of the associated product, Terr-O-Gas 67 pre-plant soil fumigant (Reg. No. 13477).

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.

Environment

• Additional and updated precautionary statements to bring labels up to current standard.

Other label updates

• Emphasis that the registered methyl bromide product is to be used for control of pests for quarantine and pre-shipment fumigation only as defined under ODSHAR.
• Clarification of a critical use and an emergency use including the scenarios in which they are permitted under the ODSHAR.

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, (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 and the value considerations for the cancellation 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 RVD2025-02.

Value considerations

It was determined that pre-plant soil fumigation uses cannot meet the definition of a QPS application under the ODSHAR. Additionally, information from stakeholders indicated that methyl bromide is no longer used as a pre-plant soil fumigant for the registered uses found on the label in Canada (in other words, ornamental and forest nurseries and tomatoes). On this basis, the end-use product Terr-O-Gas 67 Preplant Soil Fumigant (Reg. No. 13477; 67.0% methyl bromide; only registered for pre-plant soil fumigations) will be cancelled immediately under the authority of paragraph subsection 21(2)(b) of the Pest Control Products Act as of the date of the RVD2025-02 with no phase-out period. No manufacture, importation, possession, handling, storage, distribution, sale and use is permitted after the re-evaluation decision date as per paragraph 21(5)(a) of the Pest Control Products Act. For the cancelled uses, the following possible alternative fumigants were identified: chloropicrin, metam-potassium, metam-sodium, and Oriental mustard seed meal.

Amendment and cancellation timeframes

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 RVD2025-02. In addition, certain registrations of pest control products containing methyl bromide are cancelled as of the date of RVD2025-02.

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 RVD2025-02. Accordingly, both registrants and retailers will have up to 24 months from the date of this RVD2025-02 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 RVD2025-02 to transition to using the newly amended labels, which will be available on the Public Registry - Canada.ca.

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

The registration of the product Terr-O-Gas 67 pre-plant soil fumigant (Reg. No. 13477) is cancelled and expires as of the date of this decision and is no longer authorised for sale or use as of the date of RVD2025-02. 

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 PRVD2024-03) are available for public inspection, upon application, in PMRA’s Reading Room. For more information, please contact Health Canada’s Pest Management Information Service.

Appendix I Registered products containing methyl bromide in Canada

Table 1 Products containing methyl bromide requiring (label) amendments^{Table 1 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient (%, g/L)
9564	Restricted	Lanxess Corporation	METH-O-GAS Space Fumigant	Liquid	MBR 100%
18613	Technical Grade Active Ingredient	Lanxess Corporation	Methyl Bromide	Liquid	MBR 99.96%
Table 1 Footnote 1 as of 21 January 2025, excluding discontinued products or products with a submission for discontinuation Table 1 Return to footnote 1 referrer

Table 2      Products containing methyl bromide cancelled as a result of re-evaluation^{Table 2 Footnote 1}

Registration number	Marketing class	Registrant	Product name	Formulation type	Active ingredient (%, g/L)
13477	Restricted	Lanxess Corporation	TERR-O-GAS 67 Preplant Soil Fumigant	Liquid	MBR 67%, CPN 32.7%
MBR = Methyl Bromide, CPN = Chloropicrin Table 2 Footnote 1 as of 21 January 2025, excluding discontinued products or products with a submission for discontinuation Table 2 Return to footnote 1 referrer

Footnotes