Azinphos-methyl Chemical Review

In 1994 azinphos-methyl was nominated for review as part of the Existing Chemicals Review Program. Azinphos-methyl was nominated due to concerns about its toxicity and associated potential risks to the public, occupational health and safety and the environment. There were related concerns about residues and possible impacts on Australian trade.

In 2006 the APVMA released the Azinphos-methyl preliminary review findings report. The APVMA’s key preliminary findings were that azinphos-methyl residues in apricots and kiwi fruit might pose a potential risk to consumers; that the use of azinphos-methyl products in some situations might pose a potential risk to the environment; and that the mixing and loading of some products might pose a potential risk to users of the products.

To reduce any risks associated with using azinphos-methyl, the APVMA proposed ceasing the chemical’s uses on some crops, modifying product containers, and including new warnings and safety directions on product labels.

During the period of public consultation, several submissions were received regarding ceasing the use of azinphos-methyl on apricots, the need for a 100 metre buffer zone and the proposed limitation to two sprays per season. In response, the APVMA conducted revised assessments. As the use of azinphos-methyl on apricots was not found to adversely affect human health, the assessment resulted in support for the continued use of azinphos-methyl on apricots. Its use on kiwifruit and citrus was not supported. In addition, restraint statements were revised to further minimise potential aquatic, environmental and bee exposure to azinphos-methyl. These changes have been outlined in the Azinphos-methyl review findings report (released July 2011). The key findings from this report are as follows:

• Ongoing approval of azinphos-methyl active is supported.
• Amendments to label particulars are proposed.
• Ongoing registration of products containing azinphos-methyl is supported at this time, pending further consideration with regard to the APVMA spray drift operating principles.

Registrants have voluntarily amended product labels in line with the current review findings and in response to information provided by the APVMA. The APVMA has decided to accept the registrants’ voluntary label amendments, as they address the concerns identified as reasons to review azinphos-methyl registration and approvals.

In accepting the voluntary label changes, the APVMA recognises that the label statements relating to spray drift were derived from methodology developed prior to 2006, and do not reflect the current spray drift operating principles. Products containing azinphos-methyl will therefore be listed as a priority for spray drift review. The APVMA is continuing to work with its external advisory agencies on a framework for spray drift. As a result, the priority list of chemicals (including azinphos-methyl) for spray drift label review is an indicative list which is likely to change with time as we formulate our spray drift assessment framework.

Given that there is regulatory action for azinphos-methyl in overseas countries, the APVMA will examine overseas regulatory reports for any additional information or studies that might be relevant for the continued registration and approval of azinphos-methyl in Australia.

In March 2015, the APVMA concluded the review of azinphos-methyl and published the Azinphos-methyl Review Regulatory Decisions Report. The APVMA determined that azinphos-methyl can continue to be used in Australia. The comprehensive risk assessment conducted on Australian-registered products and use patterns concluded that the use of azinphos-methyl in Australia poses lower occupational health and safety, and environmental risks than the uses that were approved in Europe, USA or Canada.

As foreshadowed in July 2011, before concluding the review, the APVMA in collaboration with the Office of Chemical Safety (OCS) and the Department of the Environment reviewed the basis of the regulatory decisions made by regulators in USA, Canada, New Zealand and Europe. It concluded that the regulatory reports prepared in relation to these overseas regulatory decisions contain no new information that would warrant a revision of the APVMA’s Review Findings Report published in 2011. Further details can be found in the APVMA report Azinphos-methyl Review: Regulatory Decisions Report.

In finalising the review, the APVMA updated the product labels to bring them in line with the current First Aid and Safety Directions Handbook and added a restraint statement prohibiting the use of hand-held sprayers to protect workers.