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Molinate chemical review

In progress

Molinate (ethyl N, N’-hexamethylenethiolocarbamate) is a pre and post-emergent, systemic thiocarbamate herbicide used exclusively in rice growing for the control of barnyard grasses (Echinochloa spp.) and silver top or brown beetle grass (Diplachne fusca).

Vertical Tabs

Work plan

Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.

Chemicals	Molinate

1. Nomination

Phase status:

Completed

Molinate active constituents, chemical products and labels were nominated for review in 2003 on the basis of risks to human health, including work health and safety.

2. Prioritisation

Phase status:

Completed

3. Scoping and work plan

Phase status:

Completed

The review scope document (2003) is available in the publication archive tab. The scope included assessments for environment and human health, including work health and safety. The work plan was first published on 1 July 2015.

4. Notice of reconsideration

Phase status:

Completed

The notice of reconsideration for active constituents, chemical products and labels for molinate was published in the Gazette on 6 May 2003.

The s 32 notice of reconsideration were given to holders upon commencement of the reconsideration on 30 April 2003.

Additional s 32 notices were sent to holders on 1 July 2015 to include all approved actives and registered products in the review.

An s 33 notice was sent to holders on 15 April 2011 requiring further occupational health and safety data to assess worker safety.

An s 33 notice was sent to holders requesting further water monitoring data (to assess environment risks related to runoff) and exposure study data (to assess worker safety) on 25 September 2015.

5. Assessment

Phase status:

Completed

In June 2004, the Advisory Committee on Chemicals Scheduling reconsidered the scheduling of molinate. The committee included molinate in Schedule 7 of the Standard for the Uniform Scheduling of Medicines and Poisons.

In June 2011, registrants voluntarily amended product labels in a collaborative effort with the APVMA to reduce worker exposure to molinate. Molinate product labels were amended to read ‘For use in closed delivery and supply systems only’.

In June 2013, the APVMA released the toxicological and occupational health and safety assessments for molinate in combination with a targeted consultation with affected industry and state departmental agencies. These assessments did not support the ongoing ground or aerial application of molinate, based on human health concerns.

6. Proposed regulatory decision

Phase status:

Forecasted

In January 2014 the APVMA released the Molinate preliminary review findings report. This proposed the cancellation of all active constituent approvals, all product registrations and all product label approvals on the basis that products containing molinate may have an effect that is harmful to humans and compromise worker safety.

Publication of the proposed regulatory decision is expected in early 2021.

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7. Consultation

Phase status:

Forecasted

The APVMA invited comment on the Molinate Preliminary Review Findings Report from 13 January 2014 to 6 April 2014. Four submissions were received during this period.

8. Final regulatory decision

Phase status:

Forecasted

Following the consultation period, further meetings were held with interested stakeholders.

The labels of products have been amended voluntarily to delete instructions for chemigation and ground application, and to restrict aerial application to methods using Soluble Chemical Water Injection in Rice Techniques (SCWIIRT) only.

Further information has been required from holders to confirm the safety of workers when applying molinate by these aerial SCWIIRT techniques, as well as the safety of aquatic environments that may be exposed to molinate.

Following the close of the public consultation period, and consideration of submissions received, the final regulatory decision will be published. Publication of the final regulatory decision is expected by September 2020.

9. Implementation

Phase status:

Forecasted

The implementation period will begin on the date the final regulatory decision is made.

Publication archive

Type	Title	Publication date
Report	Molinate preliminary review findings	1 January 2014
Report	Occupational health and safety risk assessment of the ground and aerial application of molinate	1 October 2012
Report	Review of the mammalian toxicology and metabolism/toxicokinetics of molinate	1 January 2004
Report	Molinate review scope document	1 May 2003
Gazette	Reconsideration of approvals and registrations related to molinate	6 May 2003