Proposed Re-evaluation Decision PRVD2024-03, Methyl bromide and its associated end-use products

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Pest Management Regulatory Agency
28 March 2024
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2024-3E-PDF (PDF version)

Summary

Table of contents

• Proposed re-evaluation decision for methyl bromide and associated end-use products
• Proposed re-evaluation decision for methyl bromide
• Risk mitigation measures
• International context
• Next steps
• Other information
• Additional scientific information

Proposed 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 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. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Methyl bromide is a broad-spectrum fumigant, effective as an insecticide, acaricide, fungicide, animal toxicant, molluscicide, nematicide, and herbicide. It is registered as a general space fumigation of structures (for example, warehouses, grain elevators, food processing plants, restaurants), enclosed space fumigation (i.e., chamber/vault; vacuum chamber; containers; and transport vehicles and gas tight covering (tarpaulin) fumigation). For these uses, it may be applied to empty structures or used to treat stored food/feed and non-food/non-feed commodities as listed on the label. It is also registered as a pre-plant soil fumigant for ornamental plants, forest nurseries and tomatoes. Currently registered products containing methyl bromide can be found in the Pesticide Product Information Database and in Appendix I of the full version of Proposed Re-evaluation Decision PRVD 2024-03, Methyl Bromide and its associated end-use products.

Methyl bromide is classified as an ozone-depleting substance (ODS) under the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol). Parties to the Montreal Protocol, including Canada, agreed to the reduction and phase-out of methyl bromide. Quarantine and pre-shipment applications (QPS), critical use exemptions (CUE) and emergency uses of methyl bromide, as defined under the Montreal Protocol as outlined in the Ozone-depleting Substances and Halocarbon Alternatives Regulations (ODSHAR) under the Canadian Environmental Protection Act, 1999 (CEPA), are exempt from phase-out (see Appendix II of PRVD2024-03 for definitions).

Since 1 January 2005, the manufacture, import and export of methyl bromide has been prohibited in Canada, except for QPS, CUE, emergency uses, and non-pesticidal uses (i.e., as feedstock and analytical standards). This proposed 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 also under special review pursuant to subsection 17(2) of the Pest Control Products Act, where aspects of concern related to human health, are discussed in the Proposed Special Review Decision PSRD2024-01, Methyl bromide and its associated end-use products. The aspects of concern for the special review are:

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

This document (PRVD2024-03) presents the proposed re-evaluation decision for methyl bromide, including the proposed label amendments (risk mitigation measures) to protect human health and the environment. For the human health assessment, Health Canada considered information from other regulatory agencies, such as the United States Environmental Protection Agency (USEPA).

Health Canada routinely relies on foreign reviews and decisions, including decisions and mitigation measures implemented by the USEPA, to contribute to the assessment of Canadian pest control products. All products containing methyl bromide that are registered in Canada are subject to this proposed re-evaluation decision.

This proposed re-evaluation decision is a consultation document.^{Footnote 1} Health Canada will accept written comments on this proposal up to 90 days from the date of publication of this document. Please forward any comments to Publications. The final re-evaluation decision will be published after taking into consideration the comments and information received during the consultation period of this document).

Proposed re-evaluation decision for methyl bromide

Methyl bromide and its end-use products and uses have acceptable value as a 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 as listed on the label.

The following use of methyl bromide is proposed for cancellation since the value was not shown to be acceptable because these uses do not meet the criteria for an exemption under the Montreal Protocol (in other words, not a QPS, CUE or emergency use) and is no longer used as a pre-plant soil fumigant for the crops registered on the label:

• pre-plant soil fumigation

With the proposed risk mitigation measures and label amendments, potential risks to human health are considered to be acceptable for methyl bromide and its end-use products when used as a general space fumigant, enclosed space fumigant, and gas tight (tarpaulin) fumigant to treat empty structures or stored food/feed and non-food/feed commodities, as specified on the label. Proposed mitigation and label amendments related to human health are summarized below and in Appendices III and IV of PRVD2024-03.

Potential risks to the environment were shown to be acceptable for methyl bromide and its end-use products when used according to the proposed conditions of registration as a general space fumigant, enclosed space fumigant, and gas tight (tarpaulin) fumigant to treat empty structures or stored food/feed and non-food/feed commodities, as specified on the label.

Under the authority of the Pest Control Products Act and based on an evaluation of available scientific information, Health Canada is proposing continued registration of the following uses of methyl bromide that fall within the definition of QPS uses under the Montreal Protocol:

• 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 proposed label 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 Appendices III and IV of PRVD2024-03 for details. Additional revisions to the methyl bromide labels are also proposed to meet the current labelling standards.

Value

• Label amendments to use directions for clarity and consistency are proposed, 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 associated product, Terr-O-Gas 67 pre-plant soil fumigant (Reg. No. 13477) is proposed.

Human health

For the human health assessment, Health Canada considered information from other regulatory agencies. Health Canada routinely relies on foreign reviews and decisions, including decisions and mitigation measures implemented by the USEPA, to contribute to the assessment of Canadian pest control products.

Evaluation of the USEPA regulatory decisions for methyl bromide supports the continued acceptability of potential human health risks with implementation of the proposed mitigation outlined below and in Appendices III and IV of PRVD2024-03.

To protect workers from occupational exposure, the following risk-reduction measures are proposed for methyl bromide:

• Updated personal protective equipment (PPE) statements to bring the product labels up to current standards.
• Reduction of methyl bromide exposure limit from 3 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 mandatory training requirements for restricted-class products and fumigants, training must be completed annually by all employees working in the fumigation facility.
• 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 proposed 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 16 meters of the treatment and aeration buffer zone perimeters.
  • 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 and as specified on the label.
• The definitions of a Critical Use Exemption (CUE) and emergency use are to be outlined, along with a description of the scenarios in which they are permitted under the Montreal Protocol.

International context

Methyl bromide is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, Japan, Australia, New Zealand, and Mexico.

Methyl bromide is not approved for use in the European Union (EU), United Kingdom and Switzerland.

Next steps

Upon publication of this proposed re-evaluation decision, the public, including the registrants and stakeholders are encouraged to submit written comments during the 90-day public consultation period.

Health Canada will accept written comments on this proposal up to 90 days from the date of publication of this document. Before making a re-evaluation decision on methyl bromide, the comments received during the consultation period will be taken into consideration in preparation of re-evaluation decision document. A science-based approach will be applied in making a final decision on methyl bromide. Health Canada will then publish a final re-evaluation decision document, which will include the decision,^{Footnote 2} the reasons for it, a summary of comments received on the proposed re-evaluation decision, and Health Canada's response to these comments.

Refer to Appendix I of PRVD2024-03 for details on specific products impacted by this proposed decision.

Other information

The relevant confidential test data on which the proposed decision is based (see References section of PRVD2024-03) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Additional scientific information

Additional scientific data are not required at this time.