Proposed Special Review Decision PSRD2024-01, Proposed special review decision of methyl bromide and its associated end-use products

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Pest Management Regulatory Agency
28 March 2024
ISSN: 2561-636 (PDF version)
Catalogue number: H113-30/2024-1E-PDF (PDF version)

Summary

Table of contents

• Proposed special review decision for methyl bromide and associated end-use products
• Proposed special review decision for methyl bromide
• Risk mitigation measures
• Next steps
• Other information

Proposed 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. More details on the legislative framework are provided under the section of Legislative Framework of this document.

Health Canada evaluates the aspect(s) of concern that prompted the special review in accordance with subsection 18(4) of the Pest Control Products Act. The internationally accepted science-based approach is used for the assessment of the aspect(s) of concern, similar to all other scientific assessments (for example, new product registrations, re-evaluations). This step includes both risk (or value, if applicable) assessment and risk management to address the concerns identified. Health Canada's approach to risk and value assessment as well as risk management is outlined in the Framework for Risk Assessment and Risk Management of Pest Control Products.^{Footnote 1}

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.

Methyl bromide is classified as an ozone-depleting substance (ODS) under the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol). This proposed special review decision will discuss the status of methyl bromide in Canada as a pest control product under the Pest Control Products Act.

Pursuant to subsection 18(4) of the Pest Control Products Act, Health Canada has evaluated the aspects of concern that prompted the special review of pest control products containing methyl bromide, which are relevant to human health. This proposed special review decision includes the outcome of the assessment of the aspects of concern.

Methyl bromide is also under re-evaluation where aspects related to human health, environment and value are discussed in the Proposed Re-evaluation Decision PRVD2024-03, 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. It is registered as a general space fumigation of structures (for example, warehouses, grain elevators, food processing plants, restaurants), enclosed space fumigation (in other words, chamber/vault; vacuum chamber; 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. All currently registered products containing methyl bromide have been considered in this special review. Currently registered pest control products containing methyl bromide can be found in the Pesticide Product Information Database and in Appendix I of the full version of the Proposed Special Review Decision PSRD2024-01, Special Review Decision of Methyl Bromide and Its Associated End-use Products.

Methyl bromide is classified as an ODS under the 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 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 (in other words, as feedstock and analytical standards). Pre-plant and soil fumigation uses of methyl bromide do not meet the criteria for an exemption under the Montreal Protocol (in other words, not a QPS, CUE or emergency use), and are proposed for cancellation in the Proposed Re-evaluation Decision of methyl bromide (PRVD2024-03). Therefore, the registered pre-plant and soil fumigation uses have not been considered as part of the human health assessment in this Proposed Special Review Decision.

This proposed special review decision is a consultation document.^{Footnote 2} 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.

Proposed special review decision for methyl bromide

Under the authority of the Pest Control Products Act and based on an evaluation of available relevant scientific information related to the aspects of concern for human health, 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

The assessment of the aspects of concern from this special review indicate that risks to human health for the above uses of methyl bromide are considered to be acceptable provided that proposed label amendments are implemented.

The proposed additional mitigation measures are summarized below, and details are outlined in Appendices III and IV of PSRD2024-01.

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 special review of methyl bromide, are summarized below. Refer to Appendices III and IV of PSRD2024-01 for details.

Human health

Implementation of the mitigation summarized below and in Appendices III and IV of PSRD2024-01 is proposed. Additional revisions to the methyl bromide labels are also proposed to meet the current labelling standards.

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.
• Additionally, 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.

Next steps

Health Canada will accept written comments on this proposal up to 90 days from the date of publication of this document. Before making a special review decision on methyl bromide, the comments received during the consultation period will be taken into consideration in preparation of the special review decision document.^{Footnote 3} A science-based approach will be applied in making a final decision on methyl bromide. Health Canada will then publish a special review decision document, which will include the decision, the reasons for it, a summary of the comments received on the proposed decision, and Health Canada's response to these comments.

Other information

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