3.2 Triticonazole

3 Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #29, November 2020)

3.2 Interim decision in relation to triticonazole

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to triticonazole.

Materials considered

In making this interim decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to triticonazole;
• The 124 public submissions, which included no written submissions, received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Meeting of the Advisory Committee on Chemicals Scheduling (ACCS #29);
• 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 (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.

Summary of ACCS advice to the Delegate

The Committee recommended that the current scheduling for triticonazole remains appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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 (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

1. the risks and benefits of the use of a substance:
   • Risks
     • The toxicity of the substance
   • Benefit
     • Triticonazole is used to control fungal diseases in turf.
   • the purposes for which a substance is to be used and the extent of use of a substance:
     • Fungicide used for the control of various fungal diseases in turf.
     • Could be used up to 500 L in first two years of registration.
     • Note: not currently intended for use in the home garden, by removing it from scheduling, there is a potential for similar products to become more attractive or marketed towards household users.
   • the toxicity of a substance:
     • Acute dermal toxicity > 2000 mg/kg bw.
     • Acute inhalational toxicity >1400 mg/m³.
   • the dosage, formulation, labelling, packaging and presentation of a substance:
     • The amendment would see the commercial fungicide product no longer carrying the label 'CAUTION' but all other aspects of labelling required by APVMA would remain.
     • Label specifies safety, warnings and first aid information.
     • Packaging to be in 1-20L HDPE containers.
   • any other matters considered necessary to protect public health:
     • A separate submission was considered to exempt azoxystrobin at a 10% cut-off. Acceptance of both proposals would result in a new product containing 10% azoxystrobin and 20% triticonazole being unscheduled.

Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to retain the scheduling of triticonazole in the current Poisons Standard. This decision is to not exempt triticonazole from scheduling when suspension concentrate preparations contain triticonazole at a concentration of 20% or less. The reasons for my interim decision are set out below.

The toxicology data for triticonazole remains consistent with the Scheduling Factors for inclusion in Schedule 5, having acute dermal and inhalational toxicity (SPF, 2018). I find that the applicant has presented no compelling evidence to support the safety and reduced toxicity of preparations containing of 20% or less triticonazole. Care should be taken in the use of products containing this substance to minimise exposure and I am concerned that the exemption of products at this cut-off, would remove the necessary label of 'CAUTION' from products containing ≤20% triticonazole.

I note no written public submissions were received in response to this application to amend the current Poisons Standard with regards to triticonazole.

With insufficient evidence of reduced toxicity and safety of products containing 20% or less triticonazole, I am unable to support the down scheduling of this substance.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.