Statement of Principles concerning fibrosing interstitial lung disease (Reasonable Hypothesis) (No. 85 of 2021) (Cth)

Statement of Principles concerning FIBROSING INTERSTITIAL LUNG DISEASE (Reasonable Hypothesis) (No. 85 of 2021) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986.

Dated 20 August 2021

The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of:

Professor Terence Campbell AM Chairperson

Contents 1 Name 2 Commencement 3 Authority 4 Repeal 5 Application 6 Definitions 7 Kind of injury, disease or death to which this Statement of Principles relates 8 Basis for determining the factors 9 Factors that must exist 10 Relationship to service 11 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions

1 Name This is the Statement of Principles concerning fibrosing interstitial lung disease (Reasonable Hypothesis) (No. 85 of 2021). 2 Commencement This instrument commences on 20 September 2021. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning fibrosing interstitial lung disease No. 53 of 2013 (Federal Register of Legislation No. F2013L01640) made under subsections 196B(2) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies. 6 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about fibrosing interstitial lung disease and death from fibrosing interstitial lung disease. Meaning of fibrosing interstitial lung disease (2) For the purposes of this Statement of Principles, fibrosing interstitial lung disease: (a) means a diverse group of lung diseases characterised by progressive fibrosis of the pulmonary interstitium with or without chronic inflammation; and (b) excludes: (i) bronchiolitis obliterans organising pneumonia; (ii) desquamative interstitial pneumonia; (iii) hypersensitivity pneumonitis (also known as extrinsic allergic alveolitis); (iv) pulmonary manifestations of systemic diseases; and (v) respiratory bronchiolitis-associated interstitial lung disease. Note: Clinical features typically include shortness of breath, chronic cough, restrictive pattern on lung function tests and impaired diffusing capacity of the lungs for carbon monoxide. Radiographic imaging reveals variable patterns of interstitial fibrosis. Death from fibrosing interstitial lung disease (3) For the purposes of this Statement of Principles, fibrosing interstitial lung disease, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's fibrosing interstitial lung disease. Note: terminal event is defined in the Schedule 1 - Dictionary. 8 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that fibrosing interstitial lung disease and death from fibrosing interstitial lung disease can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 - Dictionary. 9 Factors that must exist At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting fibrosing interstitial lung disease or death from fibrosing interstitial lung disease with the circumstances of a person's relevant service: (1) having smoked tobacco products: (a) in an amount of at least 10 pack-years before the clinical onset of fibrosing interstitial lung disease; and (b) commencing at least 5 years before the clinical onset of fibrosing interstitial lung disease; Note: one pack-year is defined in the Schedule 1 - Dictionary. (2) inhaling respirable asbestos fibres in an enclosed space, at the time material containing asbestos was being applied, removed, cut, drilled, dislodged or disturbed: (a) for a cumulative period of at least 1,000 hours before the clinical onset of fibrosing interstitial lung disease; and (b) where the first inhalation of asbestos fibres commenced at least 5 years before the clinical onset of fibrosing interstitial lung disease; Note: Disturbance of debris or dust contaminated with asbestos fibres already present in an enclosed space may result in exposure to respirable asbestos fibres. (3) inhaling respirable asbestos fibres in an open environment, at the time material containing asbestos was being applied, removed, cut, drilled, dislodged or disturbed: (a) for a cumulative period of at least 3,000 hours before the clinical onset of fibrosing interstitial lung disease; and (b) where the first inhalation of asbestos fibres commenced at least 5 years before the clinical onset of fibrosing interstitial lung disease; Note: Disturbance of debris or dust contaminated with asbestos fibres already present in an open environment may result in exposure to respirable asbestos fibres. (4) inhaling beryllium dust or fumes before the clinical onset of fibrosing interstitial lung disease; Note: inhaling beryllium dust or fumes is defined in the Schedule 1 - Dictionary. (5) inhaling respirable crystalline silica dust at the time material containing respirable crystalline silica dust was being produced, excavated, drilled, cut, ground or polished, or used in construction, manufacturing, cleaning or blasting: (a) for a cumulative period of at least 1,500 hours before the clinical onset of fibrosing interstitial lung disease; and (b) the first inhalation of respirable crystalline silica dust commenced at least 1 year before the clinical onset of fibrosing interstitial lung disease; (6) having acute silicosis within the 6 months before the clinical onset of fibrosing interstitial lung disease; Note: acute silicosis is defined in the Schedule 1 - Dictionary. (7) inhaling or intravenously injecting a talc-containing compound or mixture, on more days than not, for a period of at least 2 years, before the clinical onset of fibrosing interstitial lung disease; (8) inhaling respirable coal dust while engaged in the mining or transport of coal: (a) for a cumulative period of at least 3,000 hours before the clinical onset of fibrosing interstitial lung disease; and (b) where the first inhalation of respirable coal dust occurred at least 5 years before the clinical onset of fibrosing interstitial lung disease; (9) inhaling respirable dust generated from hard metal or diamond-cobalt, while engaged in the manufacture, utilisation or maintenance of tools composed of hard metal or diamond-cobalt, for a cumulative period of at least 120 hours before the clinical onset of fibrosing interstitial lung disease; Note: hard metal is defined in the Schedule 1 - Dictionary. (10) inhaling a toxic gas or fumes resulting in: (a) signs and symptoms of severe acute lower respiratory damage requiring medical attention within 48 hours after exposure; and (b) the persistence of respiratory signs and symptoms for at least 1 week after exposure, within the 1 year before the clinical onset of fibrosing interstitial lung disease; Note: Types of toxic gases or fumes include anhydrous ammonia fumes, smoke, oxides of sulphur, oxides of nitrogen, chlorine, phosgene, humidifier detergents, perfluoroisobutylene (may be released in fires of military vehicles containing Teflon) and zinc chloride smoke from smoke bombs. (11) having paraquat poisoning within the 6 months before the clinical onset of fibrosing interstitial lung disease; Note: paraquat is defined in the Schedule 1 - Dictionary. (12) inhaling mustard gas within the 20 years before the clinical onset of fibrosing interstitial lung disease; (13) having received a cumulative equivalent dose of at least 0.2 sievert of ionising radiation to the lung at least 6 months before the clinical onset of fibrosing interstitial lung disease; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (14) undergoing a course of therapeutic radiation for cancer, where the affected lung was in the field of radiation, at least 6 months before the clinical onset of fibrosing interstitial lung disease; (15) having received iodine-131 (radioactive iodine) as therapy for widespread pulmonary metastases from a malignant neoplasm of the thyroid, at least 6 months before the clinical onset of fibrosing interstitial lung disease; (16) having received yttrium-90 microspheres as therapy for primary or metastatic liver tumours, at least 3 months before the clinical onset of fibrosing interstitial lung disease; (17) having acute respiratory distress syndrome within the 6 months before the clinical onset of fibrosing interstitial lung disease; Note: acute respiratory distress syndrome is defined in the Schedule 1 - Dictionary. (18) being treated with a cytotoxic agent for a malignant neoplasm or in association with haematopoietic stem cell transplantation, before the clinical onset of fibrosing interstitial lung disease; (19) taking a drug from the specified list of drugs within the 6 months before the clinical onset of fibrosing interstitial lung disease; Note: specified list of drugs is defined in the Schedule 1 - Dictionary. (20) having chronic or recurrent diffuse alveolar haemorrhage before the clinical onset of fibrosing interstitial lung disease; Note: diffuse alveolar haemorrhage is defined in the Schedule 1 - Dictionary. (21) having exogenous lipoid pneumonitis at the time of the clinical onset of fibrosing interstitial lung disease; Note: exogenous lipoid pneumonitis is defined in the Schedule 1 - Dictionary. (22) having tropical pulmonary eosinophilia for at least the 6 months before the clinical onset of fibrosing interstitial lung disease; Note: tropical pulmonary eosinophilia is defined in the Schedule 1 - Dictionary. (23) inhaling a vapour, gas, dust or fumes produced by a substance from the specified list of substances, or smoke from fire, in an enclosed space: (a) for a cumulative period of at least 5,000 hours before the clinical onset of fibrosing interstitial lung disease; and (b) if that exposure has ceased before the clinical onset of fibrosing interstitial lung disease, then that onset occurred within 20 years of cessation; Note: specified list of substances is defined in the Schedule 1 - Dictionary. (24) inhaling a vapour, gas, dust or fumes produced by a substance from the specified list of substances, or smoke from fire, in an open environment: (a) for a cumulative period of at least 10,000 hours before the clinical onset of fibrosing interstitial lung disease; and (b) if that exposure has ceased before the clinical onset of fibrosing interstitial lung disease, then that onset occurred within 20 years of cessation; Note: specified list of substances is defined in the Schedule 1 - Dictionary. (25) inhaling smoke from the combustion of wood, charcoal, coal or other biomass or fossil fuel, in an enclosed space: (a) for a cumulative period of at least 5,000 hours before the clinical onset of fibrosing interstitial lung disease; and (b) if that exposure has ceased before the clinical onset of fibrosing interstitial lung disease, then that onset occurred within 20 years of cessation; (26) having smoked tobacco products: (a) in an amount of at least 5 pack-years before the clinical worsening of fibrosing interstitial lung disease; and (b) commencing at least 1 year before the clinical worsening of fibrosing interstitial lung disease; Note: one pack-year is defined in the Schedule 1 - Dictionary. (27) inhaling respirable asbestos fibres at the time material containing asbestos was being applied, removed, cut, drilled, dislodged or disturbed: (a) for a cumulative period of at least 1,000 hours before the clinical worsening of fibrosing interstitial lung disease; and (b) within the 2 years before the clinical worsening of fibrosing interstitial lung disease; Note: Disturbance of debris or dust contaminated with asbestos fibres already present in an enclosed space or an open environment may result in exposure to respirable asbestos fibres. (28) inhaling beryllium dust or fumes before the clinical worsening of fibrosing interstitial lung disease; Note: inhaling beryllium dust or fumes is defined in the Schedule 1 - Dictionary. (29) inhaling respirable crystalline silica dust at the time material containing respirable crystalline silica dust was being produced, excavated, drilled, cut, ground or polished, or used in construction, manufacturing, cleaning or blasting: (a) for a cumulative period of at least 1,500 hours before the clinical worsening of fibrosing interstitial lung disease; and (b) the first inhalation of respirable crystalline silica dust commenced at least 1 year before the clinical worsening of fibrosing interstitial lung disease; (30) having acute silicosis within the 6 months before the clinical worsening of fibrosing interstitial lung disease; Note: acute silicosis is defined in the Schedule 1 - Dictionary. (31) inhaling or intravenously injecting a talc-containing compound or mixture, on more days than not, for a period of at least 2 years, before the clinical worsening of fibrosing interstitial lung disease; (32) inhaling respirable coal dust while engaged in the mining or transport of coal: (a) for a cumulative period of at least 3,000 hours before the clinical worsening of fibrosing interstitial lung disease; and (b) where the first inhalation of respirable coal dust occurred at least 5 years before the clinical worsening of fibrosing interstitial lung disease; (33) inhaling respirable dust generated from hard metal or diamond-cobalt, while engaged in the manufacture, utilisation or maintenance of tools composed of hard metal or diamond-cobalt, for a cumulative period of at least 120 hours before the clinical worsening of fibrosing interstitial lung disease; Note: hard metal is defined in the Schedule 1 - Dictionary. (34) inhaling a toxic gas or fumes resulting in: (a) signs and symptoms of severe acute lower respiratory damage requiring medical attention within 48 hours after exposure; and (b) the persistence of respiratory signs and symptoms for at least 1 week after exposure, within the 1 year before the clinical worsening of fibrosing interstitial lung disease; Note: Types of toxic gases or fumes include anhydrous ammonia fumes, smoke, oxides of sulphur, oxides of nitrogen, chlorine, phosgene, humidifier detergents, perfluoroisobutylene (may be released in fires of military vehicles containing Teflon) and zinc chloride smoke from smoke bombs. (35) having paraquat poisoning within the 6 months before the clinical worsening of fibrosing interstitial lung disease; Note: paraquat is defined in the Schedule 1 - Dictionary. (36) inhaling mustard gas within the 20 years before the clinical worsening of fibrosing interstitial lung disease; (37) having received a cumulative equivalent dose of at least 0.2 sievert of ionising radiation to the lung at least 6 months before the clinical worsening of fibrosing interstitial lung disease; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (38) undergoing a course of therapeutic radiation for cancer, where the affected lung was in the field of radiation, at least 6 months before the clinical worsening of fibrosing interstitial lung disease; (39) having received iodine-131 (radioactive iodine) as therapy for widespread pulmonary metastases from a malignant neoplasm of the thyroid, at least 6 months before the clinical worsening of fibrosing interstitial lung disease; (40) having received yttrium-90 microspheres as therapy for primary or metastatic liver tumours, at least 3 months before the clinical worsening of fibrosing interstitial lung disease; (41) having acute respiratory distress syndrome within the 6 months before the clinical worsening of fibrosing interstitial lung disease; Note: acute respiratory distress syndrome is defined in the Schedule 1 - Dictionary. (42) being treated with a cytotoxic agent for a malignant neoplasm or in association with haematopoietic stem cell transplantation, before the clinical worsening of fibrosing interstitial lung disease; (43) taking a drug from the specified list of drugs within the 6 months before the clinical worsening of fibrosing interstitial lung disease; Note: specified list of drugs is defined in the Schedule 1 - Dictionary. (44) having chronic or recurrent diffuse alveolar haemorrhage before the clinical worsening of fibrosing interstitial lung disease; Note: diffuse alveolar haemorrhage is defined in the Schedule 1 - Dictionary. (45) having exogenous lipoid pneumonitis at the time of the clinical worsening of fibrosing interstitial lung disease; Note: exogenous lipoid pneumonitis is defined in the Schedule 1 - Dictionary. (46) having tropical pulmonary eosinophilia for at least the 6 months before the clinical worsening of fibrosing interstitial lung disease; Note: tropical pulmonary eosinophilia is defined in the Schedule 1 - Dictionary. (47) having gastro-oesophageal reflux disease for at least the 5 years before the clinical worsening of fibrosing interstitial lung disease; (48) inhaling a vapour, gas, dust or fumes produced by a substance from the specified list of substances, or smoke from fire, in an enclosed space: (a) for a cumulative period of at least 5,000 hours before the clinical worsening of fibrosing interstitial lung disease; and (b) if that exposure has ceased before the clinical worsening of fibrosing interstitial lung disease, then that worsening occurred within 20 years of cessation; Note: specified list of substances is defined in the Schedule 1 - Dictionary. (49) inhaling a vapour, gas, dust or fumes produced by a substance from the specified list of substances, or smoke from fire, in an open environment: (a) for a cumulative period of at least 10,000 hours before the clinical worsening of fibrosing interstitial lung disease; and (b) if that exposure has ceased before the clinical worsening of fibrosing interstitial lung disease, then that worsening occurred within 20 years of cessation; Note: specified list of substances is defined in the Schedule 1 - Dictionary. (50) inhaling smoke from the combustion of wood, charcoal, coal or other biomass or fossil fuel, in an enclosed space: (a) for a cumulative period of at least 5,000 hours before the clinical worsening of fibrosing interstitial lung disease; and (b) if that exposure has ceased before the clinical worsening of fibrosing interstitial lung disease, then that worsening occurred within 20 years of cessation; (51) inability to obtain appropriate clinical management for fibrosing interstitial lung disease. 10 Relationship to service (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. (2) The factors set out in subsections 9(26) to 9(51) apply only to material contribution to, or aggravation of, fibrosing interstitial lung disease where the person's fibrosing interstitial lung disease was suffered or contracted before or during (but did not arise out of) the person's relevant service. 11 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 9 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA; then 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.