This content is current only at the time of printing. This document was printed on 23 November 2014. A current copy is located at http://apvma.gov.au/node/1608
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2,4-dichlorophenoxyacetic acid (2,4-D) Chemical Review - 5. Assessment
Review Process Workflow
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.
Work Plan Information
|Related Chemical||2,4-dichlorophenoxyacetic acid (2,4-D)|
|Reconsideration Assessment Period||N/A|
|Scope||Human health, occupational health and safety, environment|
|Timeframe||1 January 2003|
|Work plan release date|
|Work plan revision date|
Review process phases
|1||Nomination||Completed: 1 January 2003||More information on "1 - Nomination"|
|2||Prioritisation||Completed: 1 January 2003|
|3||Scoping and work plan||Completed: 1 January 2003||More information on "3 - Scoping and work plan"|
|4||Notice of reconsideration||Completed: 1 January 2003||More information on "4 - Notice of reconsideration"|
|5||Assessment||In progress||More information on "5 - Assessment"|
|6||Draft regulatory measure||Forecasted: 1 January 2015|
|7||Consultation||Forecasted: 1 January 2015|
The review of 2,4-D was separated into two parts:
- part 1 contains the environmental risk assessment of high volatile (short-chain) ester forms of 2,4-D, and is now complete
- part 2 contains the toxicological and occupational health and safety assessments for all 2,4-D forms, and the environmental risk assessment of the low and non-volatile forms (acid, salt, and long-chain esters) of 2,4-D.
In October 2005 the APVMA released a label review under s.34A of the Agricultural and Veterinary Medicines Code Act 1994 following reports of crop damage through our Adverse Experience Reporting Program. In consultation with state authorities, the APVMA developed additional instructions to strengthen the existing label warnings in relation to minimising spray drift. All registrants were required to update their product labels by 30 November 2005.
In April 2006 the APVMA released the 2,4-D preliminary review findings report (environment) part 1: 2,4-D high volatile esters, volume 1: review summary. This report identified that high volatile ester (ethyl ester, butyl ester and isobutyl ester) forms of 2,4-D pose an unacceptable risk to the environment. To minimise the risks to the environment, the APVMA proposed cancelling all approvals and registrations relating to the high volatile ester forms of 2,4-D.
In October 2006 the APVMA suspended the registrations and label approvals of 24 products containing high volatile ester forms of 2,4-D and issued new instructions for use to allow further data to be generated by registrants. Use of the suspended products was only approved in accordance with specific instructions detailed in APVMA permit PER13339.
In July 2013 the APVMA published the report Annex to the APVMA's preliminary review findings (environment) part 1: 2,4-D esters volume 1: review summary and advised selected 2,4-D high volatile ester (HVE) registrants and approval holders of our intention to cancel selected registrations and approvals on the basis of unacceptable environmental risks.
On 21 August 2013, the APVMA cancelled selected active constituent approvals, registrations and associated label approvals for 2,4-D HVE. The decision was to:
- cease supply of cancelled 2,4-D HVE active constituent immediately (21 August 2013)
- from 31 August 2013, cease supply of cancelled product manufactured prior to 21 August 2013
- allow users who may have bought these products to use what stocks they have before 31 August 2014, under the same permit instructions (PER14329) that currently apply (that is, for use in the winter window only and under strict usage conditions). After that time, the use of the existing products will be illegal.
The human health, occupational health and safety and environmental assessments of 2,4-D, part 2, are still in progress, and a preliminary review findings report will be released after the assessments are completed. The human health report is expected to be available at the end of 2014.