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Public notice of final decisions - ACMS#29, ACCS#27, Joint ACMS-ACCS#24, March 2020
Scheduling medicines and poisons
4.1 Sodium bromide
4 Final decisions on proposed amendments to the current Poisons Standard under regulation 2ZCZU
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Final decision in relation to sodium bromide
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 sodium bromide as follows:
Schedule 5 - New Entry
SODIUM BROMIDE for therapeutic use.
Index - Amend Entry
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to sodium bromide;
- 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 (e) the potential for abuse 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.
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 sodium bromide in Schedule 5 indicates that there are benefits to public health and safety from its use as an important agent in the control of water-borne pathogens in swimming pools and spas. Sodium bromide is currently listed in Schedule 4 for therapeutic uses. However, sodium bromide is also used in Australia as a sanitiser in swimming pools and spas in combination with other Scheduled chemicals, e.g. sodium dichloroisocyanurate. The proposed change to the Poisons Standard would account for the use of sodium bromide alone as a sanitiser in swimming pools and spas. The risks associated with human exposure to the substance have been adequately addressed by the regulator of pool and spa chemicals (APVMA) (52E(1)(a)).
- The purpose and extent for which the substance is to be used has been adequately outlined by the applicant. The substance is currently used as a sanitiser (ca 150 g/kg) in swimming pools and spas in combination with other chemicals. It is currently available for use alone (>98%) in various OECD countries, including Canada and the USA, as a sanitiser in swimming pools and spas (52E(1)(b)).
- Bromine is a naturally occurring element, found in seawater and volcanic rock. It is present as bromide ions in living organisms and in the environment. On addition of an activator e.g. chlorine, sodium bromide will hydrolyse in water to form hypobromous acid, which is the active disinfectant. Swimming pool bromination is currently endorsed in all Australian jurisdictions as a standard method for residual sanitation (52E(1)(b)).
- Sodium bromide has low acute toxicity by oral, dermal and inhalational routes and is a very slight skin and slight eye irritant but not a skin sensitiser (in the GPMT). Repeat dose toxicity effects on the central nervous system (CNS) and endocrine system have been seen in human studies with sodium bromide, but these effects occurred at high doses compared to normal use and were reversible on cessation of exposure. Evidence indicates that bromide salts are neither genotoxic nor carcinogenic. Utilising an internationally established Health Based Guidance Value from the FAO/WHO Joint Meeting on Pesticide Residues (JMPR), i.e. an Acceptable Daily Intake (ADI) for bromide, the Applicant has determined that the risk of adverse human health effects from exposure to sodium bromide in spa or swimming pool water would be negligible. Furthermore, risks associated with the use of products containing sodium bromide during sanitising procedures, can be adequately managed through warning statements, safety directions and first aid instructions on APVMA approved product labels (52E(1)(c)).
- It is considered that the toxicity profile of sodium bromide is consistent with a Schedule 5 classification (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 sodium bromide. As a result, no additional measures are required in the Poisons Standard (53E(1)(d)).
- There is no information to indicate that the substance could pose a risk to humans from abuse of the substance (52(E)(1)(e)).
- Disinfection by-products (DBPs) are formed when sanitisers/disinfectants react with each other and with organic and inorganic matter in swimming pools and spas. Bathers and/or swimmers may be exposed to sodium bromide dissociation products as well as the activator chemical and disinfection by-products (DBPs) e.g. sodium bromate. The occurrence and type of DBPs depends on a number variables, including the type of pool, type of disinfectants used, disinfectant dosages, bather loads, temperature and pH of the pool/spa water. The applicant noted that the risks from exposure to DBP and other substances were considered to be beyond the scope of the current application, as levels in swimming pool water are a function of the quality of the water and methods of disinfection, as opposed to the substance per se. The potential risks associated with exposure to DBPs including bromate and aquatic pathogens, can be mitigated by adherence to State and Territory guidelines/standards on the use of sodium bromide in swimming pools and spas (52(E)(1)(f)).
- An Acceptable Daily Intake (ADI) value of 1 mg/kg bw/day was established by the FAO/WHO Joint Meeting on Pesticide Residues (JMPR) (1998) for bromide (Br-). This was based on a 12-week oral human study using sodium bromide where no neurophysiological or endocrinological effects were observed at the highest tested dose of 9 mg Br-/kg bw/day (equivalent to 11.6 mg/kg bw/day sodium bromide), using a 10 fold safety factor (52(E)(1)(f)).
- Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.
Date of effect of the decision
1 October 2020