Omethoate proposed regulatory decisions report

The APVMA is reconsidering the approvals, registrations and product labels associated with the insecticide and miticide, omethoate. The scope of this review was to assess the toxicological, occupational health and safety, residues and dietary exposure and trade risks associated with the approvals and registrations for omethoate.

The APVMA invites comment on the Omethoate proposed regulatory decisions report from 4 May 2016 to 4 August 2016.

The APVMA has assessed the available information and concluded that the use of omethoate according to its current instructions for use does not meet the safety criteria listed in sections 5A of the Agvet Codes for continued registration and approval.

The APVMA is proposing to vary the label approvals of the most recent label approval for all products containing omethoate.

Once the label variations have been completed, the APVMA is proposing to affirm the active constituent approvals of omethoate, the registrations of products and the varied label approvals of products containing omethoate.

The proposed label variations include:

• deletion of all horticultural, pasture, grain legume, cereal and home garden uses, that may result in residues of omethoate on edible crops
• retention of the use of omethoate on ornamental plants
• retention of the use of omethoate as a barrier spray against red-legged earth mite around broad-acre crops
• amendments to the safety directions and first aid instructions for all product labels
• addition of re-entry intervals to protect workers re-entering treated areas.

Invitation for submissions

The APVMA invites persons and organisations to submit their comments and suggestions on these proposed decisions. Further information is available in the Omethoate proposed regulatory decision report and the associated technical assessments.

All submissions will be assessed by the APVMA prior to finalisation of the reconsideration and publication of the final regulatory decision report.

Preparing your comments for submission

When making your comments:

• clearly identify the issue and clearly state your point of view
• give reasons for your comments, supporting them, if possible, with relevant information and indicating the source of the information you have used
• suggest to the APVMA any alternative solution you may have for the issue.

Please structure your comments in point form, referring each point to the relevant section in the report.

All submissions to the APVMA will be acknowledged in writing via email or by post.

When making a submission please include:

• contact name
• company or group name (if relevant)
• postal address
• email address (if available)
• the date you made the submission.

Note that all submissions received are subject to the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes.  All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially. (A full definition of ‘confidential commercial information’ is contained in the Agvet Code).

THE CLOSING DATE FOR SUBMISSIONS IS COB 4 AUGUST 2016

Submissions can be sent to:

Director, Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON  ACT  2604
Telephone: +61 2 6210 4749

Fax: +61 2 6210 4776
Email: chemicalreview@apvma.gov.au
Website: www.apvma.gov.au