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Public notice of final decisions - ACMS#29, ACCS#27, Joint ACMS-ACCS#24, March 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 selenium
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 selenium as follows:
Schedule 4 - Amend Entry
- for human oral use with a recommended daily dose of more than 300 micrograms; or
- for the treatment of animals except:
- when included in Schedule 6 or 7;
- in solid, slow release bolus preparations
each weighing 100 g or more andcontaining 300 mg or less of selenium per dosage unit;
- in other divided preparations containing 30 micrograms or less of selenium per dosage unit;
- as elemental selenium, in pellets containing 100 g/kg or less of selenium; or
- in feeds containing 1 g/tonne or less of selenium.
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to selenium;
- 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 amendment to the Poisons Standard entry is to exempt from scheduling selenium products used for the treatment of animals that are solid, slow release bolus preparations for ruminants containing 300 mg or less of selenium per dosage unit based on its human health risk. The applicant, APVMA indicated the boluses for sheep are of a smaller size and shape, which reduces the likelihood of regurgitation, and requires administration using a bolus applicator. It would not be physically possible to administer 100 g boluses (required for Schedule 4 exemption) to sheep so the cut-off limit in the SUSMP cannot accommodate for a sheep bolus product. No exposure to public is anticipated following use and the risk is no greater than that of the current approved use as a dietary supplement, for the treatment of animals. The risks have been adequately addressed by the pesticide regulator (APVMA) in its application (52E(1)(a)).
- The purposes and extent for which the substance is to be used has been adequately outlined by Applicant (52E(1)(b)).
- There has been no substantive change in the information available regarding the toxicity of the substance since it was last considered for Scheduling, that would warrant a change to its Scheduling Classification in the Poisons Standard based on the criteria set out in SPF (2018) (52E(1)(c)).The dosage, formulation, labelling, packaging and presentation of the substance from its currently approved uses in animal dietary supplement will change as a result of its proposed use as a dietary supplement, for sheep. The applicant is responsible for ensuring appropriate labelling. The pattern of potential professional exposure is expected to be of short-term duration, with negligible public exposure. As a result, no additional measures are required in the Poisons Standard. Further use of the substance in other veterinary products will be addressed by the pesticide regulator (APVMA) in any future applications to the regulator. The proposed amended entry for the substance in the Poisons Standard will not affect selenium-containing ingredients listed under the ARTG (52E(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)).
- Selenium has been extensively considered by the National Drugs and Poisons Schedule Committee (NDPSC), the Advisory Committee on Medicines Scheduling (ACMS), the Advisory Committee on Chemical's Scheduling (ACCS), and the Delegate. Treatment of animals in solid, slow release bolus preparations each weighing 100 g or more and containing 300 mg or less of selenium per dosage unit have been exempted from scheduling. Amending this to treatment of animals in solid, slow release bolus preparations containing 300 mg or less of selenium per dosage unit has been adequately justified by the applicant (52(E)(1)(f)).
Therefore, 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