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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)

This work plan has been prepared to fulfill new legislative requirements intended to improve the transparency and predictability of chemical review decisions. Work plans for all current chemical reviews have been prepared in accordance with subsection 31(2) of the Agvet Code and set out the remaining work to be completed and the maximum legislative timeframe by which a decision must be made. The timeframes have been calculated according to the formula specified in Section 78B of the Agricultural and Veterinary Chemicals Code Regulations 1995. The APVMA will update these work plans at least yearly or as necessary.

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Work plan

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

Chemicals	Molinate
Nomination Reason	Environment Human health Occupational health and safety

1. Nomination

Phase status:

Completed

In May 2003, the APVMA began a review of molinate because of toxicological, occupational health and safety and environmental concerns.

2. Prioritisation

Phase status:

Completed

3. Scoping and work plan

Phase status:

Completed

As part of the nomination the APVMA released the Molinate review scope document. This scope document outlines the information needed to conduct a comprehensive scientific assessment of molinate.

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4. Notice of reconsideration

Phase status:

Completed

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. Draft regulatory measure

Phase status:

Completed

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.

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7. Consultation

Phase status:

Completed

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. 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. This information is expected by early to mid-2016.

Any additional information submitted by holders or stakeholders will be assessed by the APVMA prior to finalisation of the review.

9. Implementation

Phase status:

Forecasted

Publication archive

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