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.
In October 2018, the APVMA suspended the label approvals of all products (216 in total) containing 2,4-D and issued new instructions targeted to reduce spray drift occurrences and damage to sensitive off target crops for the 2018–19 summer spray season. These label changes were implemented in spring 2018 as an immediate priority, rather than waiting to implement all of the proposed label changes at the completion of the review. Continued use MUST BE in accordance with the instructions appearing on the earlier approved label attached to the product container combined with the instructions detailed in APVMA permit PER87174 and APVMA special Gazette 4 October 2018.
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.
Chemical Reviews (reconsiderations) are dynamic and our work plans must be flexible to consider:
- new scientific information
- our response to emerging issues that may need regulatory action to address.
The 2,4-D work plan has been reviewed and updated in line with the legislation and associated regulations. We have received additional assessment data from approval and registration holders since the review started on 1 July 2015, so the modular assessment levels in this work plan have been adjusted.
The 2,4-D review scope and work plan has been adjusted to include a toxicology level 3.2 assessment (previously a level 3.3) and environment level 7.1 assessment (previously a level 7.3). The recalculated timeframe for the 2,4-D review is 43 months. We expect the review findings and proposed recommendations to be available for public comment in the third quarter 2018.