Molinate chemical review

Molinate was nominated for review by the Health Department following the US EPA publication of its preliminary findings for molinate. This US EPA report noted the potential reproductive toxicity, neurotoxicity and suspected carcinogenicity of molinate – 7 June 2002.

Molinate was prioritised for review following consultation with Commonwealth and state agencies responsible for the environment and human health – June 2002 to March 2003.

Remaining Scope: WHS and environment.

s 32(1) notices were sent to holders on 30 April 2003 (data due 18 July 2003).

s 32(2) notices were sent to states and territories and the Gazette was published on 6 May 2003.

An additional s 32(1) notice was sent to holders on 1 July 2015 to include all registered products in the review.

Additional s 32 notices were sent to holders on 26 May 2021 to include all approved labels in the review.

2011 requirement notices (s 33) notices

s 33 notices were sent to holders on 15 April 2011 requiring further WHS data.

Reports published prior to 2015

Occupational Health and Safety assessment – Published in June 2013

Toxicology assessment – Published in June 2013.

Preliminary Review Findings – Published 10 January 2014

2014 requirement notices (s 33) notices and proposed suspension (s34P)

s 33 notices requiring worker exposure data were issued to holders on 15 December 2014.

s 34P notices proposing to suspend product registrations and label approvals were issued to holders on 15 December 2014.

The s 33 and s 34P notices were withdrawn on 17 April 2015.

Voluntary label variations

Label approvals were varied with the consent of the holders on 22 July and 9 Sept 2015 respectively, to remove ground boom and dry bay application methods.

2015 Requirement notices (s 33) notices

Notices requiring additional worker exposure (WHS) and aquatic monitoring (Environment) data were sent to holders on 25 September 2015.

Aquatic monitoring data was submitted on 4 April 2016.

An extension was granted for the worker exposure studies due to drought – the data was submitted on 16 February 2017.

Additional data was provided on 21 May 2018.

2018 Requirement notices (s 33) notices

Notices requiring additional information about details of excipients for consideration of scheduling and safety directions were sent to the holders on 6 April 2018.

Responses were received on 9 and 20 April 2018 respectively.

2021 – final Review Technical Report

The final Review Technical Report on the reconsideration of molinate was published on 11 October 2021.

2022 – final regulatory decision

The final regulatory decision on the reconsideration of molinate was published on 25 February 2022.

2014 proposed regulatory decision

The APVMA issued s 34 notices to holders proposing to cancel all active constituent approvals, product registrations and label approvals. Additional products and labels have since been included in the reconsideration.

2021 proposed regulatory decision

The proposed regulatory decision was published in an APVMA Special Gazette on 11 October 2021. Submissions on the proposed decision closed on 11 January 2022.

The proposed regulatory decision was published in an APVMA Special Gazette on 11 October 2021. Public consultation on the proposed decision closed on 11 January 2022.

The final regulatory decision was published in an APVMA Special Gazette on 25 February 2022. Labels for molinate products have been varied as a result of the decision. Products bearing previously approved labels must not be supplied after 26 February 2024.

On 25 February 2022 the APVMA affirmed molinate active constituent approvals and varied and affirmed molinate product registrations and label approvals. The APVMA determined that products bearing previous labels were able to be supplied for 2 years from the date of the final regulatory decision, under section 81(3) of the Agvet Code.

Products bearing the following label approval numbers may no longer be supplied.