Methyl bromide review history and regulatory outcomes

Nomination for review

Methyl bromide is the most potent ozone depleting substance still in use today. In 1991 methyl bromide was identified by the Montreal Protocol on Substances that Deplete the Ozone Layer (the Montreal Protocol) as a chemical that contributes to depletion of the ozone layer. In accordance with the Montreal Protocol, the Australian manufacture and importation of methyl bromide was to have been phased out completely by 1 January 2005. However, the uses of methyl bromide in quarantine pre-shipment (QPS) and as a chemical feedstock are currently exempt from the phase-out under the Montreal Protocol.

The APVMA has not conducted any previous regulatory action regarding methyl bromide as its use in Australia has been regulated by the Australian Government Department of the Environment and Water Resources (formerly the Department of the Environment and Heritage) since 1996.

In September 2005 the APVMA began a review of methyl bromide because of environmental concerns. The review focused on the appropriateness of the warnings and instructions on product labels, particularly in respect of the known environmental concerns with methyl bromide, and Australia’s obligations under the Montreal Protocol.

Preliminary Review Report

In April 2006 the APVMA released the Methyl Bromide Preliminary Review Findings Report. In the preliminary report the APVMA proposed:

• varying product labels with general fumigation uses to delete all uses with the exception of QPS uses and include a recommendation that recapture technology be used where appropriate
• varying product labels that have both soil fumigation and general fumigation uses to delete soil fumigation uses
• cancelling the registration and approvals for methyl bromide products that that only have soil fumigation uses and cannot be varied.

Final review and outcomes

In June 2007 the APVMA released the Methyl Bromide Final Review Report and Regulatory Decision. The APVMA found that use of methyl bromide products in accordance with current label instructions may have an unintended effect that is harmful to the environment

However, the APVMA was satisfied that the labels of all methyl bromide products could be varied in such a way that the continued use of methyl bromide products would not be likely to have an unintended effect that is harmful to the environment.

In June 2007 the APVMA board decided to:

• vary product labels with general fumigation uses to allow such fumigation for QPS and approved Critical Use Exemption (CUE) situations only
• vary product labels with in-field plant-bed/turf soil fumigation and stored soil/compost/hay fumigation uses to allow such use for QPS and approved CUE situations only
• vary product labels with only in-field horticultural-crop soil fumigation uses to allow such use for QPS and approved CUE situations only
• vary all labels to include the direction that recapture is recommended, where feasible
• allow a 24-month phase-out period, consistent with the Montreal Protocol, for stock bearing old labels.

The APVMA will continue a project to see if low-dose variable concentration and time options (flexible CT) is feasible and acceptable to the Australian Quarantine and Inspection Service (AQIS). The APVMA will liaise with any registrant willing to submit an application for flexible CT products to be assessed for approval onto their methyl bromide product label.

The APVMA will also keep a watching brief on developments in recapture technology and liaise with the peak fumigators group, regarding developments in the economics and logistics of its possible implementation as a registration requirement. The APVMA proposes to monitor any changes in the Australian Threshold Limit Value (TLV) for methyl bromide, and any implications this may have on mandatory degassing and/or recapture immediately after fumigation.

For more information please contact the Chemical Review Program on (02) 6210 4749 or by email to chemrev@apvma.gov.au