4.1. Final decision in relation to bixlozone

4. Final decisions (without interim decision) made pursuant to regulation 2ZCZU

4.1. Final decision in relation to bixlozone

Final decision

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 bixlozone as follows:

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.

In determining that this matter will be a delegate-only decision, I note that:

• Bixlozone has a very low toxicity profile and the weight of evidence from the toxicological database indicates that it does not appear to present any substantial toxicological hazard for acute, short term or long term exposures. Bixlozone has very low dermal absorption and normal use patterns are unlikely to lead to toxicologically significant systemic exposures. The data indicates that bixlozone has very low toxicity by oral and dermal routes. It is not a skin or eye irritant in rabbits or a skin sensitiser in the local lymph node assay (LLNA) test in mice. Although the inhalational LC₅₀ for bixlozone was >2110 mg/m³, this was the highest technically achievable and there were no deaths or clinical signs of systemic toxicity. Therefore, the inhalational toxicity of bixlozone is considered low to negligible. There is no evidence of neurotoxicity, immunotoxicity, endocrine disruption, genotoxicity, carcinogenicity, effects on reproduction or teratogenicity (52E(1)(a)(c)(f)).
• Bixlozone is intended for the control of certain grasses and broad leaf weeds as an 'incorporated by sowing' (IBS) pre-emergent herbicide for grain crops including barley, canola and wheat. It will be used once per crop, and, even for contract workers, exposure is likely to limited to only a few weeks. The product is intended only for professional use and will not be available to the general public (52E(1)(b)).
• The Applicant has demonstrated that appropriate risk mitigation measures will be put in place for the proposed product containing the substance that may be registered for use in Australia, and that account for the dosage (application rate), formulation, labelling, packaging and presentation of bixlozone. As a result, no additional measures are required in the Poisons Standard. Further use of bixlozone in other pesticide products will be addressed by the pesticide regulator (APVMA) in any future applications to the regulator (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)).

Therefore, based on the information provided in the application, it is considered that bixlozone does not meet the factors for inclusion in the Schedules of the Poisons Standard. Bixlozone should be listed in Appendix B due to low toxicity (Part 1, a; Part 2, 1.1).