{"id":"F2019L00223","name":"Statement of Principles concerning methaemoglobinaemia (Balance of Probabilities) (No. 18 of 2019)","slug":"statement-of-principles-concerning-methaemoglobinaemia-balance-of-probabilities-no-18-of-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439938,"registerId":"F2019L00223-fast-fetch-1775955767897","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Statement of Principles concerning methaemoglobinaemia (Balance of Probabilities) (No. 18 of 2019)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 20.2\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nStatement of Principles\n\nconcerning\n\nMETHAEMOGLOBINAEMIA (Balance of Probabilities)\n\n(No. 18 of 2019)\n\nThe Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n \n\nDated 1 March 2019\n\n \n\n \n\n \n\n \n\n \n\n| The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:
|\n| --- |\n| 
Professor Nicholas Saunders AO
Chairperson
|\n\n\n \n\n \n\n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Repeal\n\n5 Application\n\n6 Definitions\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n8 Basis for determining the factors\n\n9 Factors that must exist\n\n10 Relationship to service\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nSchedule 1 - Dictionary\n\n1 Definitions\n\n \n\n\n\n\n1 Name\n\nThis is the Statement of Principles concerning methaemoglobinaemia (Balance of Probabilities) (No. 18 of 2019).\n\n2 Commencement\n\n This instrument commences on 25 March 2019.\n\n3 Authority\n\nThis instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.\n\n4 Repeal\n\nThe Statement of Principles concerning methaemoglobinaemia No. 48 of 2010 (Federal Register of Legislation No. F2010L01661) made under subsection 196B(3) of the VEA is repealed.\n\n5 Application\n\nThis instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies.\n\n6 Definitions\n\nThe terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.\n\n7 Kind of injury, disease or death to which this Statement of Principles relates\n\n(1) This Statement of Principles is about methaemoglobinaemia and death from methaemoglobinaemia.\n\nMeaning of methaemoglobinaemia\n\n(2) For the purposes of this Statement of Principles, methaemoglobinaemia:\n\n(a) means a greater than normal amount of methaemoglobin in the blood as a result of the oxidation of haem iron to the ferric state, making it less able to bind with oxygen; and\n\n(b) causes clinical manifestations such as cyanosis, headache or fatigue; and\n\n(c) includes the heterozygous form of NADH-methaemoglobin reductase deficiency restricted to red blood cells but excludes other forms of congenital methaemoglobinaemia.\n\n(3) While methaemoglobinaemia attracts ICD‑10‑AM code D74, in applying this Statement of Principles the meaning of methaemoglobinaemia is that given in subsection (2).\n\n(4) For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4.\n\nDeath from methaemoglobinaemia\n\n(5) For the purposes of this Statement of Principles, methaemoglobinaemia, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's methaemoglobinaemia.\n\nNote: terminal event is defined in the Schedule 1 – Dictionary.\n\n8 Basis for determining the factors\n\nOn the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that methaemoglobinaemia and death from methaemoglobinaemia can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.\n\nNote: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.\n\n9 Factors that must exist\n\nAt least one of the following factors must exist before it can be said that, on the balance of probabilities, methaemoglobinaemia or death from methaemoglobinaemia is connected with the circumstances of a person's relevant service:\n\n(1) taking or being treated with a drug that causes oxidation of haemoglobin, within the two days before the clinical onset of methaemoglobinaemia;\n\nNote: Drugs that cause methaemoglobinaemia include, but are not limited to, dapsone; 8‑aminoquinolines such as primaquine or tafenoquine; chloroquine; nitrates such as nitroglycerine; nitrites such as amyl nitrite; local anaesthetics such as benzocaine; and sulphonamide antibiotics.\n\n(2) inhaling, ingesting or having cutaneous contact with a chemical agent that causes oxidation of haemoglobin, within the two days before the clinical onset of methaemoglobinaemia;\n\nNote: Chemicals that cause methaemoglobinaemia include, but are not limited to, aniline and its derivatives (for example, found in dyes); naphthalene (for example, found in mothballs); nitrobenzenes (for example, found in solvents and paints); nitrogen oxide (for example, found in smoke from fires); paraquat (for example, found in herbicides); and chlorates, nitrates and nitrotoluenes (for example, found in explosives).\n\n(3) ingesting food or fluid contaminated by excess levels of nitrates or nitrites, within the two days before the clinical onset of methaemoglobinaemia;\n\n(4) being exposed to dialysis fluid contaminated with chloramine or hydrogen peroxide, within the two days before the clinical onset of methaemoglobinaemia;\n\n(5) taking or being treated with a drug that causes oxidation of haemoglobin, within the two days before the clinical worsening of methaemoglobinaemia;\n\nNote: Drugs that cause methaemoglobinaemia include, but are not limited to, dapsone; 8‑aminoquinolines such as primaquine or tafenoquine; chloroquine; nitrates such as nitroglycerine; nitrites such as amyl nitrite; local anaesthetics such as benzocaine; and sulphonamide antibiotics.\n\n(6) inhaling, ingesting or having cutaneous contact with a chemical agent that causes oxidation of haemoglobin, within the two days before the clinical worsening of methaemoglobinaemia;\n\nNote: Chemicals that cause methaemoglobinaemia include, but are not limited to, aniline and its derivatives (for example, found in dyes); naphthalene (for example, found in mothballs); nitrobenzenes (for example, found in solvents and paints); nitrogen oxide (for example, found in smoke from fires); paraquat (for example, found in herbicides); and chlorates, nitrates and nitrotoluenes (for example, found in explosives).\n\n(7) ingesting food or fluid contaminated by excess levels of nitrates or nitrites, within the two days before the clinical worsening of methaemoglobinaemia;\n\n(8) being exposed to dialysis fluid contaminated with chloramine or hydrogen peroxide, within the two days before the clinical worsening of methaemoglobinaemia;\n\n(9) inability to obtain appropriate clinical management for methaemoglobinaemia.\n\n10 Relationship to service\n\n(1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.\n\n(2) The factors set out in subsections 9(5) to 9(9) apply only to material contribution to, or aggravation of, methaemoglobinaemia where the person's methaemoglobinaemia was suffered or contracted before or during (but did not arise out of) the person's relevant service.\n\n11 Factors referring to an injury or disease covered by another Statement of Principles\n\nIn this Statement of Principles:\n\n(1) if a factor referred to in section 9 applies in relation to a person; and\n\n(2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA;\n\nthen the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.\n\n \n\n \n\nSchedule 1 - Dictionary \n\nNote: See Section 6\n\n1 Definitions\n\nIn this instrument:\n\n methaemoglobinaemia—see subsection 7(2).\n\n MRCA means the Military Rehabilitation and Compensation Act 2004.\n\n relevant service means:\n\n(a) eligible war service (other than operational service) under the VEA;\n\n(b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or\n\n(c) peacetime service under the MRCA.\n\nNote: MRCA and VEA are also defined in the Schedule 1 - Dictionary.\n\n terminal event means the proximate or ultimate cause of death and includes the following:\n\n(a) pneumonia;\n\n(b) respiratory failure;\n\n(c) cardiac arrest;\n\n(d) circulatory failure; or\n\n(e) cessation of brain function.\n\n VEA means the Veterans' Entitlements Act 1986.\n\n \n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument updates and clarifies the RMA’s Statement of Principles for methaemoglobinaemia and repeals the 2010 Statement, but it does not materially expand the legal scope of what can be claimed. Changes are primarily definitional and procedural: clarifying the form of congenital methaemoglobinaemia that is included, expressly including death contributed to by methaemoglobinaemia, listing exposures that support causation and structuring factors to cover both clinical onset and clinical worsening (s 7(2), s 7(5), s 9). Those are refinements and elaborations rather than a significant broadening of the instrument’s original purpose (to identify factors that link methaemoglobinaemia to relevant service)."},"complexity_factors":["Short instrument: 11 sections plus a short Schedule (definitions).","Limited number of defined terms (methaemoglobinaemia, MRCA, VEA, relevant service, terminal event) in Schedule 1.","Nine alternative factors in section 9, with duplicated onset/worsening structure (s 9(1)–(9)).","Uniform short timing condition (‘within the two days before clinical onset’ / ‘before clinical worsening’) that applies across most factors — creates conditional logic tied to timing.","Cross‑references to other instruments and statutes: VEA, MRCA, ICD‑10‑AM code, and other Statements of Principles (s 4, 5, 7(4), 11).","A small conditional rule distinguishing when aggravation/material contribution factors apply (s 10(2)).","Repeals a prior Statement (administrative sequencing)."],"plain_english_summary":"**What this instrument does (mechanics)**\n\n- It sets out a Statement of Principles about methaemoglobinaemia (a blood disorder) and death from methaemoglobinaemia for use in claims under the Veterans' Entitlements Act 1986 (VEA) and the Military Rehabilitation and Compensation Act 2004 (MRCA) (see sections 3, 5). The prior Statement (No. 48 of 2010) is repealed (s 4).\n\n- It gives a working definition of methaemoglobinaemia: an excess of methaemoglobin in blood from oxidation of the haem iron to the ferric state that reduces oxygen binding, with clinical signs such as cyanosis, headache or fatigue; it expressly includes the heterozygous NADH‑methaemoglobin reductase deficiency limited to red blood cells and excludes other congenital forms (s 7(2)). It also treats death that was contributed to by a person’s methaemoglobinaemia as part of the condition (s 7(5)).\n\n- The Repatriation Medical Authority (RMA) states that, on the available medical‑scientific evidence, it is more probable than not that methaemoglobinaemia (and death from it) can be related to relevant service for veterans/members (the legal standard used by decision makers) (s 8).\n\n- The instrument lists the factual “factors” that, if present, are sufficient for a decision‑maker to say — on the balance of probabilities — that the condition is connected to relevant service. At least one of these must be shown (s 9). The factors are primarily exposures or events occurring within two days before the clinical onset (or before clinical worsening) of methaemoglobinaemia:\n - taking/being treated with drugs that oxidise haemoglobin (examples listed in the notes) (s 9(1), (5));\n - inhaling/ingesting/having skin contact with chemicals that oxidise haemoglobin (examples in notes) (s 9(2), (6));\n - ingesting food or fluid contaminated with excess nitrates/nitrites (s 9(3), (7));\n - exposure to dialysis fluid contaminated with chloramine or hydrogen peroxide (s 9(4), (8));\n - inability to obtain appropriate clinical management for methaemoglobinaemia (s 9(9)).\n\n- Those factors must be related to the person’s “relevant service” (s 10(1)). Separately, the factors in s 9(5)–(9) (relating to clinical worsening or to lack of appropriate management) only apply where the person’s methaemoglobinaemia was suffered or contracted before or during, but did not arise out of, the relevant service — i.e. they can establish material contribution or aggravation (s 10(2)).\n\n- If a listed factor also refers to an injury or disease covered by another Statement of Principles, the rules in that other Statement apply (s 11).\n\n\n**Who is affected**\n\n- Primary: veterans and current/former members of the Australian Defence Force making claims under the VEA or the MRCA where methaemoglobinaemia or death from it is alleged (s 5). Decision‑makers in the Department responsible for entitlements will apply this Statement when assessing causation.\n\n- Secondary: medical practitioners and hospitals preparing clinical records (because the Statement focuses on short exposure windows and clinical onset/worsening), and entities that can supply evidence of exposures (employers, unit logs, pharmacy records).\n\n- Private businesses that produce or supply listed drugs/chemicals are not directly regulated by this instrument; it does not impose safety duties or penalties on them — it only identifies exposures that, if shown, support a causal link to service for compensation purposes.\n\n\n**Why it matters (practical effect)**\n\n- The Statement is an evidentiary tool: if a claimant establishes one of the listed factors and links it to their relevant service, a decision‑maker can accept (on the balance of probabilities) that methaemoglobinaemia is connected with service (s 9, s 10). That can be decisive in entitlement decisions and administrative compensation.\n\n- The instrument narrows the kinds of exposures and the timing that will support a favourable causation finding: most listed exposures must occur within two days before clinical onset or worsening (s 9). This creates a clear, short window for medical and documentary evidence to establish.\n\n\n**Assessment of the instrument’s claimed purpose against implementation costs, incentives and trade‑offs**\n\n- Claimed purpose: the RMA says the medical evidence supports linking methaemoglobinaemia to relevant service on the balance of probabilities (s 8). The instrument implements that by listing factors that, if proved, will usually establish causation.\n\n- Evidence and proof burden: the short two‑day windows (s 9) reduce ambiguity for decision‑makers but increase the evidentiary burden on claimants to establish precise timing of exposure and onset. Where onset timing is unclear, claimants may fail to meet the listed factors even if service‑related exposure plausibly occurred.\n\n- Administrative cost and risk: the instrument directs decision‑makers to apply a defined list of factors. That can reduce case‑by‑case medical debate and speed decisions, but it creates sensitivity to record quality — absent contemporaneous clinical notes or exposure records, legitimate claims may be denied, transferring costs to appeals and medical assessments.\n\n- Incentives for clinical practice: because inability to obtain appropriate clinical management is an explicit factor (s 9(9)), claimants may rely on systemic failures in treatment as a basis for compensation. That creates an informational and adjudicative demand for evidence about availability and adequacy of care during/after service.\n\n- Effects on private enterprise and competition: the instrument does not regulate or penalise producers/suppliers of listed drugs/chemicals. It may, indirectly, increase demand for good record‑keeping from suppliers and employers but imposes no statutory compliance duties on them.\n\n- Concentrated benefits and diffuse costs: benefits from a favourable application of the Statement are concentrated (individual claimants who can prove exposures). Costs of awards fall on the Commonwealth’s compensation system and are diffuse across taxpayers/administration. The Statement does not create new payment rules; it only affects causation findings.\n\n\n**Key trade‑offs and implementation risks**\n\n- Trade‑off between precision and flexibility: the instrument’s precise factor list and short timing window promote predictable decision‑making but reduce flexibility to account for atypical presentations or longer latency (s 9).\n\n- Diagnostic and evidentiary risk: methaemoglobinaemia’s clinical onset and worsening can be variable; linking those clinical events to specific exposures within two days may be medically difficult in some cases, producing contested claims and potential appeals (s 9, s 10).\n\n- Interaction with other Statements: where a factor overlaps with another Statement of Principles, that other Statement controls (s 11). Claimants and decision‑makers must therefore check multiple instruments, which can produce complexity in individual cases.\n\n\n**Practical points for claimants and their advisers**\n\n- Focus evidence-gathering on the timing of exposure and the clinical onset/worsening (medical notes, pharmacy or prescribing records, workplace exposure logs) because most factors require proof of exposure within two days before onset/worsening (s 9).\n\n- If a claimant’s issue is lack of appropriate clinical management, gather contemporaneous treatment records and evidence about availability of care (s 9(9)).\n\n- Check whether any listed exposure is also covered by another Statement of Principles and, if so, apply that Statement’s terms (s 11).\n\n\n(References in parentheses are to the relevant sections of the Statement of Principles.)"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument maintains the standard, narrow scope of Repatriation Medical Authority Statements of Principles. It defines one specific medical condition, sets out the causal factors required for compensation eligibility, and operates within the established statutory framework of the VEA and MRCA. No expansion beyond typical SOP parameters."},"complexity_factors":["Short, focused instrument (11 sections plus brief dictionary)","Only 5 defined terms in Schedule 1","Clear, enumerated list of 9 factors with minimal cross-referencing","Some duplication: factors 1-4 and 5-8 are nearly identical pairs (onset vs. worsening)","Single external reference to ICD-10-AM coding system with specific edition citation","Conditional logic limited to simple temporal requirement ('within the two days') and one aggravation clause in section 10(2)","No nested exceptions or complex definitional chains"],"plain_english_summary":"This instrument sets the medical test for whether veterans or current/former Defence members can get compensation for methaemoglobinaemia, using a \"balance of probabilities\" standard and replacing a 2010 version. It requires evidence that exposure (certain drugs, chemicals, contaminated food/water, dialysis fluid) or lack of timely treatment occurred within two days before symptoms. It functions as a strict medical gatekeeper that can bar claims that don’t meet these narrow criteria."}},"importantCases":[],"_links":{"self":"/api/acts/statement-of-principles-concerning-methaemoglobinaemia-balance-of-probabilities-no-18-of-2019","history":"/api/acts/statement-of-principles-concerning-methaemoglobinaemia-balance-of-probabilities-no-18-of-2019/history","analysis":"/api/acts/statement-of-principles-concerning-methaemoglobinaemia-balance-of-probabilities-no-18-of-2019/analysis","conflicts":"/api/acts/statement-of-principles-concerning-methaemoglobinaemia-balance-of-probabilities-no-18-of-2019/conflicts","importantCases":"/api/acts/statement-of-principles-concerning-methaemoglobinaemia-balance-of-probabilities-no-18-of-2019/important-cases","documents":"/api/acts/statement-of-principles-concerning-methaemoglobinaemia-balance-of-probabilities-no-18-of-2019/documents"}}