2.1. Helium

On this page: Referred scheduling proposal | Scheduling application |Current scheduling status | Australian regulatory information | International regulations | Substance summary | Section 52(E) criteria of the Therapeutic Goods Act 1989 | Consideration of Scheduling Policy Framework (SPF) criteria | Aversives | Pre-meeting public submissions | Summary of ACCS-ACMS advice to the delegates | Delegate's considerations | Delegate's interim decision

Referred scheduling proposal

An application was submitted by the Australian Competition and Consumer Commission (ACCC) to include helium gas in Schedules 6 and 7, and Appendices E and F in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard. The ACCC proposed that helium gas in pressurised gas canisters or cylinders sold or hired to consumers for household or domestic use must contain an aversive and that the supply of helium gas for commercial and industrial uses would not require an aversive, but its supply would be restricted by scheduling.

Scheduling application

This was a general application. The applicant’s proposed amendments to the Poisons Standard are:

The applicant's reasons for the request are:

• The ACCC makes this proposal having regard to the safety risks associated with the supply of helium as a consumer good and following correspondence from the Victorian Coroner. The Victorian Coroner has requested that the ACCC investigate the supply of helium gas and recommended the restriction of the ease of access to helium gas by the Australian public.
• Helium gas has known potential for misuse. The substance is a simple asphyxiant. Inhalation of helium gas has a high potential for causing harm (including death) at relatively low exposure and without warning of the asphyxiation effect. The substance is colourless, odourless and tasteless. Asphyxiation by this substance occurs very quickly and occurs through the displacement of oxygen by helium in the lungs. This may result in brain damage and death, with rescue being unlikely.
• Asphyxiation by inert gases, including helium, is widely publicised as a certain, quick, simple, painless and non-disfiguring method of suicide.
  • Asphyxiation with helium gas is an increasingly popular method of suicide in Australia since 2000. There have been an estimated 400 suicides using helium gas between 2000 and 2016 (an average of about 24 each year). The number of cases gradually increased between 2000 and 2009, but more than doubled in 2009-10, increasing from 23 to 50 cases each year. The higher number of helium asphyxiation suicides per year has been relatively steady since 2010, at about 45 cases per year.
• Helium gas canisters or cylinders, and other equipment used to commit suicide by this method, are readily available to the public and information about the method is easily found on the internet.
  • According to information in the national coronial database, the main sources of helium used for suicides are party goods suppliers (76 per cent) and industrial gas suppliers (14 per cent).
  • Helium is supplied to Australian householders for the purpose of inflating balloons or similar novelty items. Small non-refillable and disposable helium canisters are available for purchase in retail outlets. In addition, larger helium cylinders are available for hire for the same purpose from party supply stores and some suppliers of industrial gases.
• Adding an aversive to helium gas sold to consumers is expected to reduce its misuse/abuse for suicide. It should also reduce other forms of dangerous misuse, such as 'huffing' and deliberately inhaling the gas from balloons to achieve a squeaky voice effect.
• This proposal does not seek any amendments to Parts 1-3 of the Poisons Standard (Controls and Regulations). However, the ACCC highlights a potential supplementary application to amend the presentation and packaging of the product to require more complex or difficult to use fixings through a change to Parts 1-3 of the Poisons Standard.
• The ACCC is seeking assistance from the bottled gas industry and helium suppliers, regarding potential changes to the valve and nozzle arrangement on helium canisters and cylinders that are sold to or hired by consumers for balloon inflation. These negotiations are aimed at having the bottled gas industry make a voluntary change to the operation of these fittings, so that gas is more difficult for adults and children to get out of the cylinder or canister. This change is considered secondary to the inclusion of an aversive in domestic supplies of helium. If this change requires the amendment of a voluntary standard (for gas cylinders), it is likely to be time-consuming and needs to be driven by the bottled gas industry itself. If imported helium canisters are to be fitted with different fixings, this will require a supplementary application to amend the Poisons Standard, as these products do not appear to be required to comply with Australian Standards.
• As helium gas is currently not scheduled, no First Aid Instructions or Safety Directions are required, due to the general exemption for unscheduled substances.
• The proposed scheduling arrangement will not affect commercial, industrial or medical uses of helium. Helium gas for sale in pre-inflated balloons (e.g. through a party hire business) would not be affected, as this is a commercial use of helium. Helium gas containing an aversive would be freely available for sale or hire by consumers to use in their homes to inflate balloons and similar novelties.

Current scheduling status

Helium gas is not currently scheduled and has not been previously considered for scheduling. Therefore a scheduling history is not available.

Australian regulatory information

According to the Globally Harmonised System (GHS) of classification, helium is a non-flammable non-toxic gas 2.2 and requires the following label:

International regulations

New Zealand and United Kingdom (UK)

The ACCC is aware of some efforts to address the misuse of helium in NZ and the UK. However, no jurisdictions appear to have been able find an appropriate solution or achieve any regulatory change.

• Australia New Zealand Industrial Gas Association (ANZIGA) members have provided informal advice that approaches considered in NZ and the UK have included the use of 'Heliox' (79% helium + 21% oxygen) as an inflation gas for balloons and the inclusion of aversives. The NZ Ministry of Business, Innovation & Employment consulted their local gas industry about the 'Heliox' approach in March-April 2016.
• Advice from ANZIGA is that in NZ there was concern about flammability issues with balloons inflated with 'Heliox', especially as helium is likely to leach from a balloon faster than oxygen, leaving the highly flammable oxygen in the balloon.

United States of America (USA)

According to Title 21: Food and Drugs:

• Part 582.1355, helium is “generally recognised as safe when used in accordance with good manufacturing or feeding practice”.
• Part 184—direct food substances affirmed as generally recognized as safe, helium must be of purity suitable for its intended use and when used in food, helium has no limitations other than current good manufacturing practice.
• Part 201 Labelling, a warning statement must be included on medical gas canisters containing helium indicating that the administration of the gas or gas combination may be hazardous or contraindicated; and that the gas or gas combination should only be used by of under the supervision of a licenced practitioner who is experienced in the use and administration and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration.

European Union

The hazard classification and labelling of helium is 'Warning' in the EU:

Substance summary

Helium gas is a simple asphyxiant that is insoluble in body tissues.

Table 2.1.1: Chemical information of Helium

Property	Helium
CAS number	7440-59-7
Chemical structure	He
Chemical name	Helium
Atomic weight	Ar (He) = 4.003
Colour	Colourless
Odour	Odourless
Taste	Tasteless
Reactivity	Inert (Noble) gas
Flammability and explosivity	Not combustible; If heated in a sealed vessel, may expand to rupture container

Acute toxicity

Lethal doses or concentrations not established.

Skin irritation

Not an eye or skin irritant and non-corrosive.

Sensitization

No sensitisation effects.

Repeat-dose toxicity

N/A

Carcinogenicity and genotoxicity

Not mutagenic, carcinogenic or a teratogen.

Reproduction and developmental toxicity

Not a reproductive toxicant.

Commercial and industrial uses:

• Manufacture of various materials (e.g. semi-conducting materials, optical glass fibres);
• Inert gas shield in gas-tungsten arc welding (GTAW);
• In gas mixtures in Geiger counters, lasers;
• In breathing gas mixtures for commercial deep diving or technical diving e.g. in 'Heliox' or 'Trimix';
• Creation of an inert atmosphere for growth of crystals and in supersonic wind tunnels;
• Coolant in high-temperature nuclear reactors;
• Inert gas diluent;
• Carrier gas in gas-liquid and gas-solid chromatography; and
• Lifting gas in airships or dirigible balloons.

Medical uses:

• Supportive treatment in patients with respiratory obstruction (in combination with other gases);
• Liquid cryogen in MRI machines; and
• Rare use in gas mixtures for lung inflation during airway surgery or as a diluent in certain anaesthetic gas mixtures.

Domestic uses:

• Inflation of 'floating' party or decorative balloons and novelty items.

Misuses:

• Squeaky or cartoon voice 'party trick';
• Possible short term euphoric 'high' through deliberate inhalation ('huffing'); and
• Suicide.

Section 52(E) criteria of the Therapeutic Goods Act 1989

(a) Risks and benefits associated with the use of a substance

Social benefit of continued domestic supply of helium:

• Helium gas in a domestic or household setting is legitimately used for inflation of balloons or similar novelty items, such as 'air swimmers'. These balloons are used as decorations, for amusement and as gifts. The balloons are generally made of light mylar or 'foil'. The balloons float in air due to the weight of the helium and the balloon being less than the air that it displaces. Normal thin rubber balloons can also be inflated with helium gas, but they are heavier and deflate much faster than mylar balloons.
• Domestic use of helium gas in balloons as decoration or as a gift has social benefit, but could be considered non-essential. This type of benefit is difficult to quantify or value.
• This application proposes the addition of an aversive to helium gas canisters or cylinders sold or hired for domestic use. The use of the gas by householders for balloon inflation is not affected by the addition of an aversive to the helium gas canister/cylinder, so this social benefit continues.

Risks of continued domestic supply of helium

• Uses of helium in the domestic or household setting other than for balloon inflation are considered misuses and are dangerous to health. These misuses involve the deliberate inhalation of helium for suicide, 'huffing' and a squeaky voice party trick.
• As a simple asphyxiant, inhalation of helium can result in rapid hypoxia or death. Death may be deliberate (suicide) or accidental (as a result of over-inhalation) while 'huffing' or trying to achieve a squeaky voice for fun. Symptoms of hypoxia can include light-headedness or dizziness, which can also result in falls and injuries.
• Information about the demographic of people who commit suicide using helium asphyxiation was not included in the data provided by the NCIS. The literature does not closely define the type of person that may choose to commit suicide by this method, but they are likely to include vulnerable consumers. Some researchers have suggested that mental illness is a commonality, but this is not likely to be unique to people who consider helium asphyxiation, as opposed to other methods of suicide. Some researchers have identified features of people choosing to commit suicide by helium asphyxiation. People committing suicide by helium asphyxiation were more likely to be younger (Howard et al., 2011, Gunnell et al., 2015a, Chang et al., 2016), more affluent (Gunnell et al., 2015a), have a psychiatric disorder (Howard et al., 2011), have financial problems (Chang et al., 2016) and a history of substance abuse (Howard et al., 2011). These characteristics are not inconsistent with the details of cases that the ACCC has been alerted to by the Victorian Coroner.
• The literature indicates that helium asphyxiation suicides are often preceded by a period of research on the internet (Gunnell et al., 2015a, Chang et al., 2016). Gunnell et al., (2015b) did not find a generalised increase in internet searching for information about helium for suicide (2004-2014), but increased searching was documented following news coverage of helium suicides by celebrities. Around one third of links from Google searches for "suicide" mentioned helium (Gunnell et al., 2015b).
• This application proposes that domestic users of helium should only be able to access helium gas that contains an aversive. This will not reduce the social utility of helium gas in the domestic or household setting, but it may reduce the misuse of the gas in this setting.

(b) The purposes for which a substance is to be used and the extent of use of that substance

Domestic and household use:

• Helium gas is widely and properly used in a domestic or household setting for the inflation of party balloons and similar novelty items e.g. 'air swimmers'. Consumers may purchase balloons pre-inflated with helium from commercial outlets, such as party supplies stores or party hire businesses. Consumers can also purchase or hire kits that allow them to inflate the balloons themselves. It is unknown how long helium gas cylinders have been available to the public.
• Helium balloon inflation kits can be purchased without restriction from retail stores. Helium balloon inflation kits for sale or hire to consumers always include a helium gas canister with fittings. Helium canisters are small non-refillable and disposable. Most kits also include a selection of balloons and trimmings; some require a consumer to separately purchase balloons for use with the canister.

Commercial and industrial use:

• Helium gas has a range of commercial and industrial uses, including in gas tungsten-arc welding (GTAW), manufacturing and in certain medical/scientific equipment. Helium is used in commercial deep diving and technical diving in combination with oxygen ('Heliox') and sometimes also nitrogen ('Trimix'). It is used very rarely in medical or surgical practice, and this is generally in combination with other gases.
• This application is intended to prevent the supply of helium without an aversive to consumers. It is not intended to affect the supply of helium gas to existing commercial or industrial users and proposes that helium for commercial or industrial use continues to be supplied without an aversive.
• Party supplies stores and party hire outlets would continue to sell balloons inflated to order with helium from cylinders without an aversive, but would not be permitted to sell or hire helium gas cylinders or balloon inflation kits to consumers without an aversive.

(c) Toxicity and safety of the substance

Helium gas is non-toxic. It is a colourless, odourless and tasteless gas and is a simple asphyxiant.

Simple asphyxiants:

• The normal level of oxygen in fresh air is about 21 per cent. Oxygen concentrations below 16 per cent are dangerous to human health. Early signs of oxygen deprivation include dizziness and light-headedness. With continued exposure to a low-oxygen atmosphere, unconsciousness follows very quickly. Oxygen concentrations below 10 per cent cause rapid brain damage. Oxygen levels below 6 per cent cause unconsciousness in less than one minute (1-2 breaths), followed by death a few minutes later.
• Simple asphyxiants displace oxygen in the lungs, causing reduced alveolar partial pressure of oxygen and, as a consequence, hypoxemia. Other gases classified as simple asphyxiants include argon, nitrogen, carbon dioxide, sulfur hexafluoride, hydrogen sulphide and gaseous hydrocarbons such as methane, ethane, propane and butane.
• Because helium is a simple asphyxiant, there are no occupational exposure limits established for the gas in Australia or overseas. Essential use of helium in the workplace requires engineering controls and personal protective equipment to ensure an adequate oxygen supply to the worker. All Safety Data Sheets (SDSs) for helium gas note the potential for rapid asphyxiation from exposure to helium.
• The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) requires labelling of gases under pressure with standard pictograms and hazard statements (Pictogram GHS04 and 'Contains gas under pressure; may explode if heated.').
• A Safety Advice Bulletin^[48] published by the Australia New Zealand Industrial Gas Association notes that "The 'fun' to be found in the squeaky voice helium trick is far from funny when people, often youngsters, die trying this. It does not take many breaths of helium to fall unconscious and die this way."

(d) Dosage, formulation, labelling, packaging and presentation of a substance

Formulation:

• The ACCC proposes that all helium gas canisters or cylinders sold or hired to consumers for domestic or household use i.e. for inflation of balloons, should include an aversive. This will reduce the attractiveness of the gas as a suicide agent and should also deter many people attempting suicide from completing the act.
• It is not proposed to require an aversive to be added to helium gas sold for commercial or industrial purposes. Party supply stores (commercial use) could continue to sell pre-inflated helium balloons using helium without an aversive.
• The inclusion of an aversive in helium sold to consumers will also reduce the likelihood of accidental deaths from inhalation of helium from canisters or cylinders and from balloons that the consumer has inflated themselves.
• Some other gaseous products have included aversives to discourage the inhalation (or 'huffing') of the propellants in these products. Examples include gaseous cleaners for electronics, computers and photographic equipment.

Packaging and presentation:

• Helium gas canisters in balloon inflation kits are purposefully designed to be very simple to use (see image below). A balloon is attached to a nozzle and a valve is opened to allow gas to flow from the canister. The nozzle is pressed down or lifted upwards, causing the gas to flow under pressure from the canister into the balloon. To stop the flow of gas, the pressure on the nozzle is released.
• Figure 2.1.1: Simple valve and nozzle fixings on helium balloon canister
• Separate to this scheduling proposal, the ACCC is consulting with the bottled gas industry about possible amendments to the simple valve and nozzle presentation on helium canisters available to the public. The aim is to alter the presentation of the canister to make the gas more difficult to remove from the canister. Changes may include the need to repeatedly depress a part to keep the gas flowing. These changes will mean that someone impaired with alcohol or other drugs e.g. sedatives, will be less able to complete the suicide act and will also stop the flow of gas once the user is unconscious. These changes may also reduce the likelihood of children being able to release helium from the canister, given that these products are in the home.
• The ACCC notes that imported helium canisters do not appear to be subject to Australian Standards, so the presentation of these products may need to be regulated through an amendment to the Poisons Standard. This will require a supplementary application to amend the Poisons Standard.

(e) Potential for misuse/abuse of the substance

Suicide:

• The ACCC requested data from the National Coronial Information System (NCIS) on the frequency of use of helium gas for suicide from 1 July 2000 to 31 December 2016. Additional information was extracted from case notes in relation to state/territory location of the suicide, whether the helium canister or cylinder was purchased or hired (where known) and the source of the helium (where known). The NCIS data was expressly provided for the purpose of the ACCC making an application to the ACCS to amend the Poisons Standard.
• Trends in suicide by helium asphyxiation

  

  • No suicides by helium asphyxiation were recorded in the NCIS for 2000. Actual or extrapolated^[49]annual numbers of helium suicides in Australia for each year from 2000 to 2016 are shown in the figure below.
  • There have been an estimated 400 suicides using helium gas between 2000 and 2016 (an average of about 24 each year). The number of cases gradually increased between 2000 and 2009, but more than doubled in 2009-10, increasing from 23 to 50 cases each year. The higher number of helium asphyxiation suicides per year has been relatively steady since 2010, at about 45 cases per year (figure below).
  • Figure 2.1.2: Annual Australian suicides using helium asphyxiation
  • The NCIS data is consistent with Australian and overseas studies of the rates of helium asphyxiation suicide. Increasing helium asphyxiation rates since the early 2000s have been documented in Australia and Sweden (Austin et al., 2011), Hong Kong (Chang et al., 2016), the Netherlands (van den Hondel et al., 2016) and the USA (Hassamal et al., 2015; Azrael et al., 2016).
  • The NCIS data was examined for geographical trends by calculating a rate of helium asphyxiation suicide for each state and territory over the period 2000 to 2016 (Table below).
  • In over 70 per cent of investigated cases, the source of helium used to commit suicide is unknown. Seventy six per cent of known sources of helium are party goods suppliers (73 cases), followed by 14 per cent from industrial gas suppliers (13 cases). Other minor sources include online, voluntary euthanasia organisations and suppliers of goods for building, lighting, agriculture, diving and pumping.
  • The method of acquiring helium cylinders and canisters (where known) was split roughly evenly between purchasing and hiring.
• Attractiveness of helium as a suicide agent
  • Asphyxiation with inert gases, including helium, is widely publicised as certain, simple, quick, painless and non-disfiguring. The materials required are all familiar to everyone and freely available without any restriction, age limits or cooling off periods.
  • Information about how to commit suicide using these materials is accessible on the internet, videos and in publications. 'Right to die' advocates have promoted the right to voluntary euthanasia ("self-deliverance") in terminally ill patients and otherwise healthy elderly people. Voluntary euthanasia using various drugs, devices and asphyxiants is publicised through books, documentaries, meetings and the internet. Several books describing the use of these methods are banned in Australia.
  • Austin et al., (2011) quotes Dr Richard McDonald speaking at the 13th National Hemlock Biennial Conference in San Diego USA in 2003: '…we have had a shift to techniques using plastic bags and helium. That, remarkably, has become an acceptable method of hastening death… It is a very speedy process and has never failed in our program.'
  • Suicide by helium asphyxiation is not easily detectable through standard physical, pathological or toxicological examination after death, which is attractive to some people considering suicide. Suicide by helium asphyxiation leaves an intact corpse without disfiguration. Typically, helium suicide is detected only through the presence of equipment at the scene or, in rare cases, by ligature marks where a plastic bag fastened on the neck has been removed. If equipment is removed before an investigation of the death, the cause of death may not be classified as a suicide by helium asphyxiation. This could occur in the case of an assisted suicide or by loved ones wishing to avoid a finding of death by suicide due to social stigma or cultural concerns. This indicates that the documented frequency of suicide by helium is likely to be an underestimate. In addition, given the illegality of assisted suicide, a method that leaves little or no evidence once equipment is removed may be ideal for a pre-arranged suicide.

Deliberate inhalation of helium gas for a squeaky voice effect:

• It is common for both adults and children to inhale gas from helium balloons at parties to achieve the squeaky/cartoon voice effect. Because this party trick is so common and sounds funny, helium gas has a reputation as being a 'harmless' and 'fun' gas to inhale.
• This squeaky voice effect is due to the lower density of helium (compared to nitrogen, the main component of air). Sound travels faster through the helium in the vocal tract, altering the timbre of the voice and making it sound squeakier.
• People inhaling deeply from a balloon of helium gas may experience dizziness or light-headedness. This may result in falls and injuries.
• Another method of inhaling helium is directly from the cylinder or canister. This is extremely dangerous as the gas under pressure may rupture the lungs or cause an air embolism. Contact with liquid helium or helium directly from a pressurised cylinder or canister may also cause an injury similar to severe frost bite in the mouth, throat and lungs, which can be fatal.

Deliberate inhalation of helium gas for short term ‘high’:

• In a 2012 study of at-risk adolescents, Whitt et al., (2012) reported that 11.5 per cent of the 723 study subjects had inhaled helium gas with the intention of getting 'high' – a practice known as 'huffing'. In this study, over a third of the users claimed to have experienced a 'high' from this activity. Although helium does not have any psychoactive effects, users may experience light-headedness, dizziness or euphoria caused by short-term oxygen deprivation. These symptoms can result in falls or other accidents, leading to injury.

(f) Any other matter that may be relevant to the scheduling of a substance

The bottled gas industry:

• The dominant companies in Australian gas production are made up by two companies (10.2 per cent market share), with smaller companies making up the remainder. The contribution of helium sales to the industrial bottled gas producers' profit is unknown. Australian producers are required to comply with Australian Standards relating to bottled gas.
• There are also a large number of disposable non-refillable helium canisters or balloon inflation kits imported into Australia. These products are freely sold in party supply shops and discount department stores. These products are not required to comply with Australian Standards.
• The bottled gas industry is subject to several regulatory frameworks. Aspects of the bottled gas industry are regulated by the dangerous goods transportation legislation, the industrial chemical framework, as chemicals used in workplaces and with links to the gas appliance safety system.
• There are many voluntary Australian Standards that apply to bottled gas, including:
  • AS 2030.1-2009 Gas cylinders general requirement
  • AS 2473.2:2015 Valves for compressed gas cylinders. Outlet connections (threaded) and stem (inlet) threads
  • AS 4332-2004 (R2016) and AS 4332-2004/ (R2016)Amdt1-2005 The storage and handling of gases in cylinders
  • AS 3840.1-1998(R2016) Pressure regulators for use with medical gases. Pressure regulators and pressure regulators with flow-metering devices
  • AS 4484:2016 Gas cylinders for industrial, scientific, medical and refrigerant use - Labelling and colour coding
• Several additional AS, AS/NZ and ISO Standards apply to medical gases and the construction of gas cylinders.
• 70.  The bottled gas industry is aware of the dangers of inhaling helium (ANZIGA representatives, pers comm). In 2014, bottled gas companies ELGAS and BOC launched a safety advertisement warning of the danger of inhaling helium: Inhaling gas from helium balloons no laughing matter, it can kill.

International approaches to prevention of helium misuse

• The ACCC is aware of some efforts to address the misuse of helium in New Zealand and the UK. However, no jurisdictions appear to have been able find an appropriate solution or achieve regulatory change.
• ANZIGA members have provided informal advice that approaches considered in New Zealand and the UK have included the use of 'Heliox' (79% helium + 21% oxygen) as an inflation gas for balloons and the inclusion of aversives. The New Zealand Ministry of Business, Innovation & Employment consulted their local gas industry about the 'Heliox' approach in March-April 2016.
• Advice from ANZIGA is that in New Zealand there was concern about flammability issues with balloons inflated with 'Heliox', especially as helium is likely to leach from a balloon faster than oxygen, leaving the highly flammable oxygen in the balloon.
• The ACCC is continuing to investigate the outcomes of the New Zealand and UK proposals and consultations.

Data gaps

• The ACCC has been unable to find information about the feasibility of the addition of an aversive to helium gas. Some aerosol "compressed air" products used for cleaning electronic and photographic equipment contain an aversive to prevent 'huffing' of the product. However, no information is available about the identity or concentration of the aversive in these products. The ACCC is aware that progress of this proposal will require information from the bottled gas industry and this is being sought.
• In addition, the ACCC has not been able to find information about the extent of the aversion effect that would be required to prevent inhalation of helium when supplied containing an aversive. The bottled gas industry may have conducted but not published the relevant research.

Consideration of Scheduling Policy Framework (SPF) criteria

The public health policy framework includes a system for safe access to chemicals and safe use of these chemicals through the chemical scheduling arrangements, including any necessary restrictions on supply and requirement of appropriate labelling. Chemical scheduling considerations include:

• the chemical's toxicity;
• purpose and need for access;
• potential for abuse or misuse;
• safe use practice, packaging and labelling; and
• the need for any specialist knowledge or equipment for the safe and effective use of the chemical.

Schedule 9: Prohibited substances

• The substance is not included in United Nations Conventions on narcotic drugs or psychotropic substances.
• The substance does not require restriction to use in medical and scientific research. The substance has a long history of legitimate and safe use in domestic, commercial, industrial and medical situations.
• The substance does not present a risk of dependency or abuse.
• The substance is legitimately supplied for household/domestic use for the inflation of balloons. The substance presents some risk of misuse (suicide). The misuse is not extensive and does not warrant stringent controls on supply from Schedule 9, given the social benefit from the legitimate use of the substance for inflation of balloons.

Schedule 9 is not suitable.

Schedule 7: Dangerous Poison

• Helium is non-toxic.
• Helium is of a high health hazard and may cause death if inhaled.
• Special precautions are required in the manufacturing, handling and use of helium. An atmosphere containing sufficient oxygen to sustain life must be maintained at all times, as helium is a simple asphyxiant. There are no workplace exposure standards for helium and the Hazardous Chemical Information System (HCIS ) notes that it is an asphyxiant.
• Helium has a high potential for causing harm at relatively low exposure and without warning of the asphyxiation effect. The substance is colourless, odourless and tasteless. Asphyxiation by this substance occurs very quickly and rescue is unlikely.

Suitable when the substance is used in a commercial or industrial setting and adequate safety precautions and training are in place.

The ACCC notes that application of Appendix J to Schedule 7 may add further controls for commercial and industrial suppliers and users of helium gas. However, adoption of Appendix J varies between States and Territories and there is currently no reason to expect that supplies of helium without an aversive would be illicitly supplied to consumers.

Schedule 6: Poison

• The substance is non-toxic.
• The substance is an asphyxiant.
• The proposal is for the substance to be required to include an aversive when supplied for household or domestic use. The aversive e.g. mercaptan, will have an aversion effect.
• Apart from the risk of asphyxiation, the substance does not present a health hazard. The inclusion of an aversive should reduce the risk of asphyxiation through deliberate inhalation.
• Foreseeable harm to users is not likely to be reduced by distinctive packaging, strong label warnings or extensive safety directions. Inhalation of the substance causing fatalities is normally deliberate.
• Changes to the packaging and presentation of the substance (specifically the simple nozzle/valve arrangement), with or without an aversive, may make the substance less accessible to both adults and children. This may reduce fatalities due to deliberate inhalation of the substance.
• Without an added aversive, the substance has a high potential to cause harm at low exposure. With an added aversive the potential for causing harm is reduced (through aversion), but not eliminated.

Suitable when the substance has an added aversive and is supplied for household or domestic use.

Schedule 5: Caution

The proposal is for the substance to be required to include an aversive when supplied for household or domestic use. The aversive e.g. a mercaptan, will have an aversion effect.

• The substance is non-toxic and is not corrosive or sensitising.
• The substance is an asphyxiant. An asphyxiant is not a low health hazard, even with the addition of an aversive. The substance with an aversive may still be inhaled in sufficient quantity to cause a fatality.
• The substance is an asphyxiant. Adverse effects from sustained inhalation are not minor as fatality is likely. Very short term exposure is likely to have minor adverse effects, including dizziness, light-headedness and potential injuries from falls.
• Risk of injury from normal handling, storage and use could be mitigated through labelling and appropriate packaging. Labelling and packaging will not reduce misuse or attempted misuse of the substance if an aversive is not included. Inclusion of an aversive and appropriate labelling may reduce attempted misuse of the substance.
• Without an added aversive, the substance has a high potential to cause harm at low exposure. With an added aversive the potential for causing harm is reduced (through aversion), but not eliminated.

Suitable when the substance has an added aversive and is supplied for household or domestic use.

Appendix B: Exempt from scheduling

Not suitable as helium gas meets factors for Schedule 7 (DANGEROUS POISON) for industrial and commercial uses of helium and Schedule 6 (POISON) or Schedule 5 (CAUTION) for domestic and household use when an aversive is included to prevent deliberate inhalation that results in fatalities.

Consideration of the Scheduling Factors indicates that helium (with an aversive) for household or domestic use could be included in either Schedule 6 or Schedule 5 of the Poisons Standard. The ACCC recommends that the substance is included in Schedule 6, given the rapidity of the asphyxiation effect, even if an aversive is included.

Aversives

Mercaptans

Mercaptans (thiols) are organosulfur compounds that contain a carbon-bonded sulfhydryl group:

Figure 2.1.3: Chemical structure of mercaptans, where R can be an alkane, alkene or other carbon-containing moiety.

Table 2.1.2: Properties of the mercaptans (Committee on Acute Exposures Guideline (2013)

Mercaptan	Descriptors	Acute Exposure Guideline Levels (AEGL[50]) for 10 minute exposure	Acute Exposure Guideline Levels (AEGL ) for 10 minute exposure Odour intensity or awareness (LOA[51]) detection thresholds and descriptors	4 hour inhalation LC50 (ppm) (rats/mice)
methyl mercaptan CH4S	Strong odour, garlic-like, rotten cabbage, bad breath	AEGL-1 = no recommendation AEGL-2 = 40 ppm (80 mg/m3) AEGL-3 = 120 ppm (240 mg/m3)	LOA = 0.0019 ppm Detection threshold = 0.041 ppm Strong intensity = 110 ppm	675 / 1667
ethyl mercaptanC2H6S	Penetrating, persistent odour, garlic/leek-like, skunk-like, decaying cabbage	AEGL-1 = 1 ppm (2.5 mg/m3) AEGL-2 = 150 ppm (380 mg/m3) AEGL-3 = 450 ppm (1100 mg/m3)	LOA = 1.4 x 10-4 ppm Detection threshold = 2.6-9.7 x 10-4 ppm Strong = 21-97 ppm	4420 / 2770
phenyl mercaptanC2H6S	Disagreeable, penetrating and repulsive odour, garlic-like	AEGL-1 = no recommendation AEGL-2 = 1 ppm (4.5 mg/m3) AEGL-3 = 3 ppm (14 mg/m3)	Detection threshold = 0.00025 ppm Strong = 38 ppm	33 / 28
tert-mercaptanC2H6S	Disagreeable	AEGL-1 = no recommendation AEGL-2 = 0.77 ppm (4.6 mg/m3) AEGL-3 = 2.3 ppm (14 mg/m3)	-	51 / 47 (both males only)

Many mercaptans have strong odours and are dominant contributors to repulsive smells including garlic, rotten eggs, rotten cabbage, skunk spray and certain chemical faults in wines etc. Mercaptans (generally methyl mercaptan and ethyl mercaptan) and sulfides are added to natural gas supplies and other odourless gases so that consumers can be aware of the gas.

Inhalational toxicity levels and ability of people to detect mercaptans vary. Phenyl mercaptan and tert-octyl mercaptan are both highly toxic than the lower molecular weight mercaptans, methyl mercaptan and ethyl mercaptan. Compared to methyl mercaptan, ethyl mercaptan has lower inhalational toxicity in rats and mice as well as a lower detection threshold.

Ethyl mercaptan appears to be the most suitable mercaptan candidate for inclusion in helium gas as an aversive.

The ACCC requests the Scheduling Delegate commission expert advice about the suitability of the mercaptans (and potentially other aversives) as suitable candidates for inclusion in helium gas for consumer or domestic use.

Pre-meeting public submissions

Eight (8) public submissions were received for helium, one (1) in support and seven (7) opposed.

Main points in support:

• Data from the National Coronial Information System (NCIS) shows an increase in deaths with helium listed as the cause of death. All of these deaths were intentional suicides in individuals ranging in age from 16 years to 94 years.
• Availability of helium for purchase online in large quantities makes this an attractive, easy, relatively inexpensive and very efficient method of suicide.
• Online resources supporting euthanasia run workshops and sell adaptors to facilitate the use of helium for asphyxiation.
• Additionally, the inclusion of an aversive in canisters of helium being sold or hired to consumers should make exposure to excessive quantities of helium more difficult and unpleasant.

Main points opposed:

• The occupational work health and safety of people who work with helium regularly and of the general public who might inhale the new gas mixture is of great concern. Rupture of a balloon filled with helium, or the leaching of helium and aversive through the latex membrane of a balloon would allow the undesirable release of the aversive into the work, home and event areas and may result in future medical issues.
• There are many uses of helium that are essential for society, for example in MRI scanners.
• Helium is only dangerous if deliberately misused.
• The inclusion of an aversive would be impractical with positive environmental policies. These policies outline the proper disposal of helium balloons, which includes popping the balloon prior to disposal. Popping a balloon with such an aversive would be unpleasant and would therefore reduce the implementation of environmentally conscience disposal practices.
• The use of an aversive has further been discussed by international authorities and organisations to some length but has never been implemented as the use of an aversive could potentially endanger or destroy the balloon industry.
• The imposition of Schedule 7 requirements on helium will make small business operation very costly.
• Helium does not meet the criteria for scheduling as outlined in the Scheduling Policy Framework.
• The release of helium or other asphyxiant gases straight from its packaging is not the path taken to commit suicide. It is the additional intentional and conscious step by the end user to restrict their atmosphere through a piped direct application method (regulator, tubing and face mask) that is used to displace oxygen. Helium, when used as intended, either for industrial or medical uses, poses little risk to the user.
• There is the potential for all oxygen displacing gases to be inappropriately used. Inert gases such as nitrogen, argon and carbon dioxide have similar asphyxiation hazards. The scheduling of one substance is unlikely to solve the problem, but will shift the focus to another.

The public submissions will be made available on the TGA website.

Summary of ACCS-ACMS advice to the delegates

The committee recommended that helium does not require scheduling.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

1. the risks and benefits of the use of a substance:

• The benefits of helium are that it has many legitimate uses, most of which are non-balloon uses, e.g. industrial, scientific and medical uses.
• The risks for helium do not exist unless it is deliberately inhaled (resulting in oxygen deprivation, leading to asphyxiation); helium is otherwise safe.

• the purposes for which a substance is to be used and the extent of use of a substance:

• Helium has a small number of therapeutic uses as part of gas mixtures.
• Helium has commercial, industrial and medical uses.
• A small amount of helium is also used in domestic situations, primarily for balloons and similar items.

• the toxicity of a substance:

• Helium is an inert, non-toxic gas.
• Correct and legitimate use of helium does not meet the scheduling criteria (SPF 2015).

• the dosage, formulation, labelling, packaging and presentation of a substance:

• Nil.

• the potential for abuse of a substance:

• Helium may be deliberately misused for the purpose of causing asphyxiation but use does not result in dependence or addiction.

• any other matters that the Secretary considers necessary to protect public health

• The addition of an aversive may make the gas more dangerous and the evidence that this would lead to aversion is not there.
• The ACCC should continue to work with the helium industry to reduce risks such as the proposal to modify valves and nozzles for cylinders that increase the difficulty of completing the suicide act. These changes will also reduce the likelihood of children being able to release helium from a canister.

Delegate's considerations

The delegate considered the following in regards to this proposal:

• Scheduling proposal
• ACMS advice
• Public submissions received
• Section 52E of the Therapeutic Goods Act 1989
• Scheduling Policy Framework (SPF 2015)

Delegate's interim decision

The delegate’s interim decision is not to schedule helium.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: (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; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the interim decision are the following:

1. the risks and benefits of the use of a substance:

• The benefits of helium are that it has many legitimate uses, most of which are non-balloon uses, e.g. industrial, scientific and medical uses.
• The risks for helium do not exist unless it is deliberately inhaled (resulting in oxygen deprivation, leading to asphyxiation); helium is otherwise safe.

• the purposes for which a substance is to be used and the extent of use of a substance:

• Helium has a small number of therapeutic uses as part of gas mixtures.
• Helium has commercial, industrial and medical uses.
• A small amount of helium is also used in domestic situations, primarily for balloons and similar items.

• the toxicity of a substance:

• Helium is an inert, non-toxic gas.
• Correct and legitimate use of helium does not meet the scheduling criteria (SPF 2015).

• the dosage, formulation, labelling, packaging and presentation of a substance:

• Nil.

• the potential for abuse of a substance:

• Helium may be deliberately misused for the purpose of causing asphyxiation but use does not result in dependence or addiction.

• any other matters that the Secretary considers necessary to protect public health>

• The addition of an aversive may make the gas more dangerous and the evidence that this would lead to aversion is not there.
• The ACCC should continue to work with the helium industry to reduce risks such as the proposal to modify valves and nozzles for cylinders that increase the difficulty of completing the suicide act. These changes will also reduce the likelihood of children being able to release helium from a canister.

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