Completed
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.
Work Plan
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.
Fenamiphos
1. Nomination
Completed
1. Nomination
Phase status: Completed
Fenamiphos was nominated for review following reports of bird and fish deaths possibly relating to the use of products containing fenamiphos. Additional reports of adverse experiences involved the potential for environmental contamination of groundwater and waterways, particularly due to leaching from the site of application.
2. Prioritisation
Completed
2. Prioritisation
Phase status: Completed
3. Scoping and work plan
Completed
3. Scoping and work plan
Phase status: Completed
In April 2003 the APVMA began a review of fenamiphos because of concerns relating to public health, occupational health and safety, the environment, and residues in food.
4. Notice of reconsideration
Completed
4. Notice of reconsideration
Phase status: Completed
The Notice of Reconsideration was published in NRA Gazette 4, 1 April 2003, with another Notice of Reconsideration published in February 2013, to coincide with the publication of the Preliminary review findings report, including all newly registered products in the fenamiphos review.
5. Assessment
Completed
5. Assessment
Phase status: Completed
In February 2013 the APVMA published the component assessment reports for residues, toxicology, occupational health and safety and the environment.
6. Proposed regulatory decision
Completed
6. Proposed regulatory decision
Phase status: Completed
In February 2013, the APVMA released the Preliminary review findings report. Assessments undertaken for certain components of the fenamiphos review, particularly the environment and residues assessments, identified a basis for which a potential risk may exist (that is, a potentially unacceptable risk to the environment, a potentially unacceptable dietary risk to humans or both).
Insufficient or inadequate data were provided or available to the APVMA to refine its assessment of fenamiphos, or to enable APVMA to conclude that the Agvet tests are satisfied.
7. Consultation
Completed
7. Consultation
Phase status: Completed
A public consultation has been conducted following the publication of the Preliminary review findings report in 2013.
8. Final regulatory decision
Completed
8. Final regulatory decision
Phase status: Completed
Final review findings and regulatory decision for the reconsideration of fenamiphos
The APVMA has reconsidered the approvals, registrations and product labels associated with the nematicide and insecticide fenamiphos. The scope of this review was to assess the toxicological, occupational health and safety, residues and environmental risks associated with the approvals and registrations for fenamiphos.
Assessment of available data concluded that the use of products containing fenamiphos may, in most situations, pose undue risks to the environment and in some situations may pose undue risks to human health (via dietary exposure). The APVMA has taken the following regulatory actions to manage these risks:
- cancellation of one product used on turf
- variation of the label of the fenamiphos granular product to update the safety directions, warnings and restraints and to delete all use patterns except strawberry runners
- variation of the label of the fenamiphos emulsifiable concentrate products to update the safety directions, warnings and restraints and to delete all use patterns except aloe vera planting material and banana planting material
These decisions have taken into consideration:
- the technical assessments of the toxicological, occupational health and safety, residues and environmental risks arising from the use of fenamiphos, which are available from the publications archive
- the eleven submissions to the APVMA received in response to the Preliminary Review Findings of 26 February 2013, which can be found in Appendix B to the Review Findings Report and Regulatory Decision which is available from the publications archive
9. Implementation
Completed
9. Implementation
Phase status: Completed
Phase out period has ended: cancelled products must not be supplied or used
The phase out of cancelled products and varied label approvals has been completed. Further information, including a list of the affected products, is outlined in the APVMA Gazette Notice of 28 July 2015.
All registered products have new labels that meet the review outcomes. These labels have been assigned the label approval number '(product_number)/0715'.
The following product has been cancelled and may not be used or supplied after the below cease use and supply dates:
Product No. | Product name | Registrant | Label approval numbers |
---|---|---|---|
62093 | Barmac Electricur Turf Nematicide | Amgrow Pty Ltd | 62093/0309 |
62093/100182 |
Publication Archive
Type | Title | Publication date |
---|---|---|
Gazette | Reconsideration of active constituents, registrations and label approvals related to fenamiphos | 28 July 2015 |
Report | Fenamiphos review findings report and regulatory decision | 28 July 2015 |
Media release | Chemical regulator considers action on fenamiphos | 26 February 2013 |
Gazette | Reconsideration of approvals and registrations related to fenamiphos | 26 February 2013 |
Report | Fenamiphos preliminary review findings report | February 2013 |
Report | Fenamiphos residues and dietary risk assessment report | February 2013 |
Report | Fenamiphos residues and dietary risk assessment report appendix 1 | September 2012 |
Report | Occupational health and safety assessment of fenamiphos | November 2011 |
Report | Review of the mammalian toxicology and metabolism/toxicokinetics of fenamiphos | October 2008 |
Report | Environmental assessment report of fenamiphos | June 2008 |
Report | The reconsideration of approvals and registrations relating to fenamiphos—review scope document | April 2003 |