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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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4.5 Final decision in relation to florylpicoxamid
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 florylpicoxamid as follows:
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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 florylpicoxamid;
- 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; (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)
The proposed amendment was not referred to an expert advisory committee. In not referring this matter to either the ACCS or the Joint ACCS-ACMS, I am satisfied that sufficient information has been provided by the Applicant for me to exercise my delegation.
In determining that this matter will be a delegate-only decision, I note that:
- Florylpicoxamid is a pesticide used in emulsifiable concentrate formulations for the treatment of wheat and bananas. Products containing florylpicoxamid are intended only for professional use, and will not be available to the general public. 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)(a)(b)(e)).
- The APVMA has 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)).
- Products containing florylpicoxamid (100g/L) have shown a very low toxicity profile with the weight of evidence from the toxicological database indicating that it does not appear to present any substantial risk from acute, short term or long term exposure. The data indicate that florylpicoxamid has very low toxicity by oral, dermal and inhalation routes. It is a slight eye irritant in rabbits, but is not a skin irritant, or skin sensitiser in the local lymph node assay (LLNA) test in mice. There is no evidence of neurotoxicity, immunotoxicity, endocrine disruption, genotoxicity, carcinogenicity, effects on reproduction or teratogenicity (52E(1)(a)(c)(f)).
- The applicant has demonstrated that appropriate risk mitigation measures will be put in place for use of a registered product in Australia, accounting for the dosage (application rate), formulation, labelling, packaging and presentation of florylpicoxamid. As a result, no additional measures are required in the Poisons Standard. Further use of florylpicoxamid in other pesticide products will be addressed by the pesticide regulator (APVMA) in any future applications to the regulator (52E(1)(d)).
Therefore, based on the information provided in the application, it is considered that florylpicoxamid does not meet the factors for inclusion in the Schedules of the Poisons Standard. Florylpicoxamid should be listed in Appendix B due to its low toxicity (Part 1, a; Part 2, 1.1).
Date of effect of the decision
1 February 2021