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Public notice of final decisions - ACMS#29, ACCS#27, Joint ACMS-ACCS#24, March 2020
Scheduling medicines and poisons
4.5 Fomesafen sodium
4 Final decisions on proposed amendments to the current Poisons Standard under regulation 2ZCZU
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4.5 Final decision in relation to fomesafen sodium
Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to fomesafen sodium as follows:
Schedule 6 - New Entry
Index - New Entry
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to fomesafen sodium;
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- The Scheduling handbook: Guidance for amending the Poisons Standard.
Reasons for the final decision (including findings on material questions of fact)
In determining, that this matter will be a delegate-only decision I have taken into account the information provided in the application from the Applicant (APVMA), and the matters outlined under Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (2018). In particular, I note that:
- The proposed change to the Poisons Standard to include a new entry for fomesafen sodium indicates that there are benefits to the agricultural industry from the introduction of this new herbicide for the control of broad leaf weeds in various food crops. The risks associated with human exposure to the substance have been adequately addressed by the pesticide regulator (APVMA) (52E(1)(a)).
- The purposes and extent for which the substance is to be used has been adequately outlined by the applicant (52E(1)(b)).
- Fomesafen sodium is a new substance (active constituent) which is not currently scheduled in the SUSMP. Fomesafen sodium has low acute toxicity by oral, dermal and inhalational routes, is not a skin sensitiser but is a slight to moderate skin irritant and a severe eye irritant. The substance is not a developmental or reproductive toxin, is not genotoxic in a battery of in vivo and in vitro assays and did not produce carcinogenic effects of human relevance in life-time studies in mice and rats (52E(1)(c)).
- The proposed product containing 240 g/L of fomesafen sodium, has low acute toxicity by the oral, dermal and inhalational routes, is a slight skin and severe eye irritant but is not a skin sensitiser (52E(1)(c)).
- The toxicity profile of fomesafen sodium is such that it meets the factors for inclusion in Schedule 6 of the SUSMP. The toxicity profile of the proposed product is also consistent with a Schedule 6 signal heading and consequently no cut off to Schedule 5 or exemption is supported on the basis of the currently available data (52E(1)(c)).
- The parent substance, fomesafen acid, is less of an irritant than the sodium salt (at most a slight skin irritant and slight eye irritant) and has similarly low acute oral, dermal and inhalational toxicity based on the data provided in the application. Although the fomesafen acid may be consistent with a Schedule 5 entry there is no application for use in an agricultural product of the acid as such (52E(1)(c)).
- The applicant has demonstrated that appropriate risk mitigation measures will be put in place for the proposed product containing the substance that may be registered for use in Australia, and that account for the dosage (application rate), formulation, labelling, packaging and presentation of fomesafen sodium. As a result, no additional measures are required in the Poisons Standard. Further use of fomesafen sodium in other pesticide products will be addressed by the pesticide regulator (APVMA) in any future applications to the regulator (53E(1)(d)).
- There is no information to indicate that the substance could pose a risk to humans from abuse of the substance (52(E)(1)(e)).
- National Health Based Guidance Values will be established for the substance that will protect consumers from residues of the substances in food (52(E)(1)(f)).
Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.
Date of effect of the decision
1 October 2020