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Notice of final decisions to amend (or not amend) the current Poisons Standard, November 2020
Scheduling medicines and poisons
4 Final decisions on proposed amendments to the current Poisons Standard under regulation 2ZCZU
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4.4 Final decision in relation to fluazaindolizine
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 Fluazaindolizine as follows:
Schedule 5 - New entry
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 fluazaindolizine;
- 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;
- 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 amendment to the Poisons Standard entry is to include a new entry for fluazaindolizine in Schedule 6, and for preparations containing 50 per cent or less fluazaindolizine in Schedule 5, based upon benefits to the agricultural industry from the introduction of this new nematicidal active constituent. The risks to human health and safety from fluazaindolizine have been addressed by the pesticide regulator (APVMA) in its application that concluded that the human health risk posed by the product is acceptable according to the criteria stipulated in Section 5A of the Agricultural and Veterinary Chemicals Code Act (1994) 52E(1)(a)(b)).
- The applicant provided data for a product containing 500 g/L of the active constituent fluazaindolizine, which indicated that the toxicity profile was consistent with a Schedule 5 entry, i.e. low acute toxicity by the oral (LD50 >2000 mg/kg bw), dermal (LD50 >5000 mg/kg bw) and inhalational (LC50 >5100 mg/m3) routes. The product was a slight eye and skin irritant and was not a skin sensitiser. The skin and eye irritation potential of this product can be adequately managed with safety directions. Overall, the substance was found to be non-carcinogenic, non-genotoxic and did not exhibit any developmental or reproductive toxicities (52E(1)(c)(d)).
- I find that the risks to human health and safety from exposure to fluazaindolizine at a concentration of 50% or less, during use, re-entering treated areas or handling treated material, and the general public coming into contact with the product have been adequately qualified in the APVMA's Human Health Risk Assessment (HHRA) technical report (52E(1)(a)).
- Products containing 50% or less fluazaindolizine, are intended only for professional use, and will not be available to the general public. Therefore, the potential for misuse or abuse of the substance as contained in the proposed products is limited. The substance has no established therapeutic value in humans that would indicate that there is a risk of dependency, abuse, misuse or diversion into illicit use (52E(1)(e)).
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 February 2021