4.3. Final decision in relation to metcamifen

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

4.3. Final decision in relation to metcamifen

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 metcamifen as follows:

Date of effect of the decision

1 February 2020.

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 change to the Poisons Standard to include a new entry for metcamifen, indicates there are benefits to the agricultural industry from the introduction of this new seed safener, to protect grain and other seeds from the phytotoxic effects of S-metalochlor herbicides. Risks associated with human exposure to the substance have been adequately addressed by the pesticide regulator (APVMA) in its application (52E(1)(a)).
• The purpose and extent for which the substance is to be used has been adequately outlined by the Applicant (52E(1)(b)). This includes the intention of metcamifen to protect grain or forage sorghum seed from the phytotoxic effects of S-metalochlor herbicides. Metcamifen will be applied once to seed, either prior to storage and sale, or on-farm prior to sowing. The product is intended only for professional use, and will not be available to the general public. The proposed use is related only to broad acre farming.
• The data indicates that metcamifen has very low toxicity across the toxicological database and does not appear to present any substantial toxicological hazard. Metcamifen has very low acute toxicity by oral, dermal and inhalational routes. It is not a skin irritant or sensitiser but causes a slight eye irritation in rabbits. Metcamifen was not genotoxic in a battery of in vivo and in vitro assays and was not considered carcinogenic in lifetime studies in mice and rats. Metcamifen was not a reproductive or developmental toxicant in rats but caused an increased incidence of skeletal and cartilage variations in rabbits that was slightly outside the historical control range for these variations. Metcamifen was considered to pose a negligible risk of developmental toxicity in humans. The potential for skin irritation due to metcamifen can be managed with appropriate safety directions on the label of the proposed product (52E(1)(c)).
• 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 the substance. 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 (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 Health Based Guidance Values will be established for the substance that will protect consumers from residues of the substances in food (52E(1)(f)).

Therefore, based on the information provided in the application, I have considered that metcamifen does not meet the factors for inclusion in the Schedules of the Poisons Standard. Metcamifen should be listed in Appendix B due to low toxicity (Part 1a; Part 2, 1). The proposed amendment was not referred to an expert advisory committee.