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Scheduling delegate's final decisions: ACCS/ACMS, June 2013
Scheduling medicines and poisons
Part B: New chemical entities - poisons
The Office of Chemical Safety (OCS) has evaluated the data provided in support of an application for the approval of a new microbial feed additive product, namely Megasphaera elsdenii, intended to aid in the transition from roughage to grain rations for beef cattle, dairy cattle and sheep to manage bloat.
The OCS recommended that Megasphaera elsdenii be included in Appendix B. The applicant was provided a copy of the evaluation report and agreed with the proposed schedule listing.
The delegate considered this application and made a delegate-only decision. The Advisory Committee on Chemicals Scheduling (ACCS) was not consulted.
Megasphaera elsdenii is not specifically scheduled and is not captured by any entry in the Standard for the Uniform Scheduling of Medicines and Poisons.
The delegate considered the following in regards to this proposal:
- the evaluation report (not publicly available);
- section 52E of the Therapeutic Goods Act 1989;
- scheduling factors18; and
- other relevant information.
Delegates' final decision
The delegate has made a final decision to include Megasphaera elsdenii Strain 41125 in Appendix B of the Standard for the Uniform Scheduling of Medicines and Poisons, with an implementation date of 1 September 2013.
The delegate considers that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are (b) purpose and the extent of use and (c) toxicity.
The delegate considers that the reasons for the final decision comprise of the following:
- It has a generally low toxicity profile.
- Has no demonstrated pathogenicity or toxicity.
- The bacterium is naturally occurring in human and animal gut flora.
- The overall toxicity profile is consistent with several other direct-fed microbial substances based on bacteria commonly found in animals and humans.
Appendix B Part 3 - New entry
|Substance||Date of entry||Reason for listing||Area of use|
|Megasphaera Elsdenii Strain 41125||Sep 2013||a||2.4|