Completed
Work Plan
1. Nomination
Completed
1. Nomination
Phase status: Completed
On 1 November 1994 the APVMA (then the NRA) invited the public to nominate active constituents, chemical products or labels for consideration for review. Of the 600 chemical nominations, 80 were included in the priority candidate review list published in the Gazette on 2 May 1995, including 2,4-D active constituents, chemical products and labels.
2. Prioritisation
Completed
2. Prioritisation
Phase status: Completed
3. Scoping and work plan
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 human health, including work health and safety, and environment. The work plan was first published on 1 July 2015.
4. Notice of reconsideration
Completed
4. Notice of reconsideration
Phase status: Completed
The s 32 notice of reconsideration was given to holders on 10 June 2003.
The notice of reconsideration was published in the Gazette on 2 May 1995 and again on 1 July 2003.
Additional s 32 notices were sent to holders on 1 July 2015, to include all approved actives and registered products in the review.
On 23 September 2013, s 33 notices were sent to holders of active constituent approvals requesting results of experiments to determine the levels of dioxins as impurities present in approved 2,4-D active constituents.
5. Assessment
Completed
5. Assessment
Phase status: Completed
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.
On 24 October 2019, the APVMA published the 2,4-D Review Technical Report.
Due to reported incidents of spray drift damage attributed to 2,4-D, in accordance with s 45B of the Code, on 4 October 2018 and 1 October 2019 the decision was made to suspend product labels because the APVMA concluded that the labels may not meet the labelling criteria.
The suspension decision gave effect to permits PER87451 (in effect from 1 October 2019 until the end of 30 September 2020) and PER87174 (in effect from 4 October 2018 through 2 October 2019) to allow persons to possess, have custody of, supply, and use affected products.
6. Proposed regulatory decision
Completed
6. Proposed regulatory decision
Phase status: Completed
On 24 October 2019 the APVMA published the proposed regulatory decisions for 2,4-D.
7. Consultation
Completed
7. Consultation
Phase status: Completed
The public consultation on the proposed regulatory decisions (outlined in the Special Gazette of 24 October 2019) ran from 24 October 2019 to 31 January 2020.
8. Final regulatory decision
Completed
8. Final regulatory decision
Phase status: Completed
On 3 September 2020, the APVMA published the 2,4-D final review technical report and the final regulatory decisions in respect to the review.
Model labels are available for holders to see the changes relevant to their product group.
9. Implementation
Completed
9. Implementation
Phase status: Completed
The 12-month implementation period for the final regulatory decisions ended on 3 September 2021.