4.2. Final decision in relation to thymol
4. Final decisions (without interim decision) made pursuant to regulation 2ZCZU
4.2. Final decision in relation to thymol
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 thymol as follows:
Schedule 6 - Amend Entry
THYMOL when packed and labelled for
the control of Varroa mites in bee hives .
Date of effect of the decision
1 February 2020.
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 and that I have taken into consideration the matters outlined under 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (SPF, 2018).
I have decided to amend the current Poisons Standard in the manner set out in the application.
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 SPF, 2018. In particular, I note that:
- The proposed change to the Poisons Standard entry for thymol, from its limited indication for the 'control of Varroa mites in bee hives' to the more expansive indication for the 'use as a pesticide', indicates potential benefits to the agricultural industry from the broader use of the substance as a pesticide while also noting that there may be risks from the increase in exposure to humans using or coming into contact with this substance. These risks have been adequately addressed by the pesticide regulator (APVMA) in its application (52E(1)(a)). The product is intended for professional use only and is not intended for application to areas accessible to the general public. Bystander risk is possible due to spray drift. I note that adherence to good agricultural practice will minimise potential risks.
- The purposes and extent for which the substance is to be used has been adequately outlined by the Applicant (52E(1)(b)). I have taken into account the broader uses of thymol other than in connection with Varroa mites in bee hives, of particular note, that it is currently used for therapeutic uses in humans. I find that my decision would not affect such use in humans because the wording the applicant has proposed and that I have agreed to is limited to use in pesticides.
- 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 Schedule 6 in the Poisons Standard based on the criteria set out in the SPF (2018) under the scheduling factors for Schedule 6 substances (52E(1)(c)).
- The dosage (application use), formulation, labelling, packaging and presentation of the substance will change as a result of its broader use in pesticide products containing this substance. However, the Applicant has demonstrated that appropriate risk mitigation measures will be put in place should the proposed product containing the substance be registered for use in Australia. As a result, no additional measures are required in the Poisons Standard. Further use of the substance in other pesticide 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 thymol-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 (52E(1)(e)).
- National and International Health Based Guidance Values have been or will be established for the substance that will protect consumers from residues of the substances in food (52E(1)(f)). I have considered that the public may also be exposed in the diet from ingestion of product residues, however, I note that maximum residue limits (MRLs) are set by the applicant to protect consumers from exposure to residue levels above the Acceptable Daily Intakes (ADI). The applicant has determined that human health risk posed by the products is acceptable according to the criteria stipulated in Section 5A of the Agricultural and Veterinary Chemicals Code Act (1994) and made recommendations for personal protective equipment. I find these matters relevant in the interest of protecting public health.