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Public notice of final decisions - ACMS#29, ACCS#27, Joint ACMS-ACCS#24, March 2020
Scheduling medicines and poisons
4.2 Polyoxin D zinc salt
4 Final decisions on proposed amendments to the current Poisons Standard under regulation 2ZCZU
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4.2 Final decision in relation to polyoxin D zinc salt
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 polyoxin D zinc salt as follows:
Schedule 5 - 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 polyoxin D zinc salt;
- 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)
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 (SPF, 2018). In particular, I note that:
- The proposed change to the Poisons Standard to include a new entry for Polyoxin D zinc salt, indicates that there are benefits to the agricultural industry from the introduction of this fungicidal active constituent. Polyoxin D is a naturally occurring compound, with fungicidal activity, produced by Streptomyces cacaoi var. asoensis. The target enzyme is fungal chitin synthetase. Polyoxin D is very water soluble so it is formulated as the zinc salt to give longer residence time on plant surfaces. It is proposed for the control of certain fungal diseases in various food crops, however no products containing polyoxin D zinc salt has been proposed for registration at this time. The risks to human health and safety from the active constituent per se have been addressed by the pesticide regulator (APVMA) in it application (52E(1)(a)).
- The purpose and extent for which the substance is to be used has been adequately outlined by Applicant. Products containing polyoxin D zinc salt have been approved for use in Japan (>40 years), other countries in Asia, USA (since 1997), Canada (2017) and New Zealand (2016). These products are registered for use in a range of fruit and vegetable crops, as well as turf and ornamentals (52E(1)(b)).
- Polyoxin D zinc salt preparations have low acute oral, dermal and inhalational toxicity. It is a slight-moderate eye irritant, not a skin irritant but is a weak skin sensitiser in guinea pigs. Mild to no treatment-related effects were observed in the short- and long-term repeat dose toxicity studies with polyoxin D zinc salt preparations in mice, rats, rabbits and dogs at the highest doses tested. Polyoxin D zinc salt preparations did not demonstrate any carcinogenic, developmental or reproductive toxicity, immunotoxicity or neurotoxicity potential. The weight of evidence indicates that polyoxin D zinc salt preparations do not have genotoxic potential (52(E)(1)(c)).
- The toxicity profile of polyoxin D zinc salt is such that it meets the factors for inclusion in Schedule 5 of the Poisons Standard (52(E)(1)(c)).
- At this time, no products have been proposed for registration in Australia. Any future products seeking registration in Australia must first seek authorisation from the APVMA, and will be labelled with an APVMA approved label. This will set out the directions for use and the required label statements, including: first aid instructions; safety directions; precaution/restraint statements; and re-entry or re-handling statements, as well as instructions for safe storage (52(E)(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)).
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.