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

This instrument is a Statement of Principles (SOP) made by the Repatriation Medical Authority under subsection 196B(2) of the Veterans' Entitlements Act 1986 (the VEA), setting out the criteria that will, as a minimum, raise a reasonable hypothesis that fibrosing interstitial lung disease (FILD) or death from FILD is related to a person’s relevant service (see s 3, s 5, s 8 and s 9). It commences on 20 September 2021 and repeals the previous Statement of Principles No. 53 of 2013 (s 2, s 4). The SOP applies to claims to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies (s 5).

Mechanically, the SOP does three things. First, it defines the disease scope: FILD is defined as a group of lung diseases characterised by progressive fibrosis of the pulmonary interstitium with or without chronic inflammation, and the instrument expressly excludes a list of specified interstitial lung conditions (s 7(2)). Second, it specifies the kinds of exposures, medical events, treatments and time‑based thresholds that, if established, will satisfy the "factors that must exist" test so that a reasonable hypothesis is raised linking FILD (or death from it) to relevant service (s 9). These factors include quantified smoking histories (pack‑years and latency periods), cumulative exposure thresholds for asbestos (separate thresholds for enclosed and open environments), silica, coal dust, hard metal dust, talc exposure, beryllium, ionising radiation doses, specific toxic gas/fume exposure events, certain drugs and medical treatments (including therapeutic radiation and specific radionuclide therapies), prior acute lung injuries and listed disease states (eg acute respiratory distress syndrome, acute silicosis, paraquat poisoning) (s 9 and Schedule 1). Third, it sets rules about temporal and causal relationships to service: a factor established in the claimant must be related to the person’s relevant service, and specific provisions govern when factors operate as causes of material contribution or aggravation (s 10).

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RMA-Red

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:<br>
<br> <br>Professor Terence Campbell AM<br>Chairperson<br>

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;

(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.

Schedule 1 - Dictionary

Note: See Section 6

1 Definitions

In this instrument:

acute beryllium disease means a rapid onset toxic pneumonitis resulting from inhaling high airborne concentrations of beryllium and characterised by non-cardiogenic pulmonary oedema.

acute respiratory distress syndrome means a clinical syndrome of severe dyspnoea of rapid onset, hypoxaemia and diffuse pulmonary infiltrates leading to respiratory failure.

Note: Examples of events that can cause acute respiratory distress syndrome include infectious pneumonia (including coronavirus disease 2019 (COVID-19)), septicaemia, lung surgery or lung contusion, severe trauma with multiple fractures, inhalational injury (including severe smoke inhalation), burns and pancreatitis.

acute silicosis means a pulmonary disease characterised by basilar filling of alveoli with lipid and proteinaceous exudative material, following exposure to high levels of respirable crystalline silica dust over a short time span.

cumulative equivalent dose means the total dose of ionising radiation received by the particular organ or tissue from external exposure, internal exposure or both, apart from normal background radiation exposure in Australia, calculated in accordance with the methodology set out in Guide to calculation of 'cumulative equivalent dose' for the purpose of applying ionising radiation factors contained in Statements of Principles determined under Part XIA of the Veterans' Entitlements Act 1986 (Cth), Australian Radiation Protection and Nuclear Safety Agency, as in force on 2 August 2017.

Note 1: Examples of circumstances that might lead to exposure to ionising radiation include being present during or subsequent to the testing or use of nuclear weapons, undergoing diagnostic or therapeutic medical procedures involving ionising radiation, and being a member of an aircrew, leading to increased levels of exposure to cosmic radiation.

Note 2: For the purpose of dose reconstruction, dose is calculated as an average over the mass of a specific tissue or organ. If a tissue is exposed to multiple sources of ionising radiation, the various dose estimates for each type of radiation must be combined.

diffuse alveolar haemorrhage means extravasation of blood into the alveoli and interstitium from injury to the pulmonary microcirculation.

Note: Diffuse alveolar haemorrhage can be due to taking vitamin K anticoagulants including warfarin.

exogenous lipoid pneumonitis means inflammation of the pulmonary interstitium due to the aspiration or inhalation of oil-based substances.

fibrosing interstitial lung disease—see subsection 7(2).

hard metal means material composed predominantly of cobalt and tungsten carbide.

inhaling beryllium dust or fumes means:

(a) having a history of exposure to beryllium dust or beryllium fumes, for a cumulative period of at least 240 hours;

(b) having a history of acute beryllium disease; or

(c) clinical evidence of sensitisation to beryllium by positive findings on beryllium lymphocyte proliferation testing of blood or bronchoalveolar lavage fluid.

Note: acute beryllium disease is also defined in the Schedule 1 - Dictionary.

MRCA means the Military Rehabilitation and Compensation Act 2004.

one pack-year means the amount of tobacco consumed in smoking 20 cigarettes per day for a period of 1 year, or an equivalent amount of tobacco products.

Note 1: An equivalent amount of tobacco products is 7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination of same. For pipe tobacco, cigars or combinations of multiple tobacco types, 1 gram of tobacco is considered to be equal to one cigarette.

Note 2: Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 and multiplying this number by the number of years the person has smoked. For example, smoking 10 cigarettes per day for 10 years is equal to 5 pack-years, and smoking 40 cigarettes per day for 10 years is equal to 20 pack-years.

paraquat means a dipyridilium compound whose dichloride and dimethylsulphate salts are used as contact herbicides.

relevant service means:

(a) operational service under the VEA;

(b) peacekeeping service under the VEA;

(d) British nuclear test defence service under the VEA;

(e) warlike service under the MRCA; or

(f) non-warlike service under the MRCA.

Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.

specified list of drugs means:

(a) amiodarone;

(b) azathioprine;

(d) D-penicillamine;

(e) fluoxetine;

(f) gold salts;

(g) leflunomide;

(h) mTOR inhibitors including everolimus and sirolimus;

(i) methotrexate;

(j) mycophenolate mofetil;

(k) nitrofurantoin;

(l) panitumumab;

(m) rituximab;

(n) sulphasalazine;

(o) tumour necrosis factor alpha antagonists;

(p) tocainide; or

(q) tyrosine kinase inhibitors including afatinib, erlotinib and gefitinib.

specified list of substances means:

(a) cement;

(b) cleaning agents;

(d) dental materials;

(e) diesel engine exhaust;

(f) metals including aluminium, cadmium, indium-tin, iron-oxide and steel;

(g) minerals including mica, sand, silicates and stone;

(h) organic material including from animals and plants;

(i) welding materials; or

(j) wood.

terminal event means the proximate or ultimate cause of death and includes the following:

(a) pneumonia;

(b) respiratory failure;

(d) circulatory failure; or

(e) cessation of brain function.

tropical pulmonary eosinophilia means a disorder which is characterised by pulmonary infiltrations of eosinophils and blood eosinophilia, and is caused by infection with the microfilariae Wuchereria bancrofti, Brugia malayi or Dirofilaria immitis.

VEA means the Veterans' Entitlements Act 1986.

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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:<br>
<br> <br>Professor Terence Campbell AM<br>Chairperson<br>

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

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.

The SOP is organised around a small number of interlocking legal‑medical concepts that determine how claims will be assessed. These are: the definition and scope of the recognised disease; the "reasonable hypothesis" evidentiary threshold; explicitly enumerated causal factors and quantitative thresholds; temporal/latency criteria; differentiation between causation of disease (clinical onset) and material contribution or aggravation (clinical worsening); cross‑reference to other SOPs and definitions; and the procedural reach of the instrument in relation to claims under the VEA and MRCA (see ss 5-11 and Schedule 1).

Definition and scope: s 7(2) sets what is included and what is excluded. The SOP covers fibrosing interstitial lung disease characterised by progressive fibrosis of the pulmonary interstitium, while expressly excluding five named conditions (eg hypersensitivity pneumonitis and bronchiolitis obliterans organising pneumonia). Death from FILD is included when FILD contributed to the terminal event (s 7(3)).

Reasonable hypothesis standard and evidential role: s 8 states the Repatriation Medical Authority’s view that there is sound medical‑scientific evidence that FILD and death from FILD can be related to relevant service. Section 9 then lists the "factors that must exist" , at least one of those factors must be established before a reasonable hypothesis is said to be raised connecting FILD or death from FILD with the circumstances of relevant service. This makes the SOP an objective list of evidentiary triggers rather than a catalogue of exhaustive causes.

Enumerated factors and quantitative thresholds: s 9 contains 51 numbered factors. Many factors are expressed as quantified thresholds: for example pack‑year minima (one example: s 9(1) requires at least 10 pack‑years before clinical onset, commencing at least 5 years prior), cumulative exposure hours (eg asbestos in enclosed space: 1,000 cumulative hours and first inhalation at least 5 years before onset, s 9(2); coal dust: 3,000 cumulative hours and first inhalation at least 5 years before onset, s 9(8)), and dose minima for ionising radiation (cumulative equivalent dose of at least 0.2 sievert to the lung, s 9(13)). Other factors are event‑based with short latency requirements (eg acute toxic gas/fume inhalation causing severe acute lower respiratory damage with persistent symptoms within 1 year, s 9(10)).

Onset versus worsening: the SOP treats clinical onset and clinical worsening separately. Factors 9(1)-9(25) relate to clinical onset; factors 9(26)-9(51) relate to clinical worsening or material contribution/aggravation where the person’s FILD was suffered or contracted before or during (but did not arise out of) relevant service (s 10(2)). The thresholds for onset and worsening may differ (eg smoking: onset requires 10 pack‑years, onset latency 5 years, s 9(1); worsening requires 5 pack‑years and commencement at least 1 year before worsening, s 9(26)).

Definitions and methodological references: Schedule 1 sets technical definitions (one pack‑year, cumulative equivalent dose), lists of drugs and substances, and the ARPANSA Guide reference for dose reconstruction (Schedule 1, cumulative equivalent dose note). For exposures to ionising radiation, the SOP requires the cumulative equivalent dose to be calculated in accordance with the ARPANSA guide as in force on 2 August 2017 (Schedule 1).

Relationship to other SOPs: where a factor refers to another injury or disease for which a separate SOP exists, that other SOP applies (s 11). This creates a structured network of medico‑legal standards and requires cross‑checking when factors invoke conditions governed elsewhere.

Together, these concepts create an SOP that operationalises causation in veterans’ claims by listing specific exposures, quantifying thresholds and applying temporal rules. The document is structured to assist decision‑makers in determining, on a medico‑scientific basis, whether a reasonable hypothesis connects FILD (or death from it) to relevant service.

Primary subjects: veterans, members of Peacekeeping Forces, and members of the Forces under the VEA or MRCA who are making claims that fall under section 120A of the VEA or section 338 of the MRCA are directly affected, because the SOP applies to those claims (s 5). The instrument alters the evidentiary landscape for claimants alleging fibrosing interstitial lung disease or death from it by specifying the factors that will, as a minimum, raise a reasonable hypothesis of service‑connection (s 9).

Decision‑makers and administrators: decision‑makers in the Department of Veterans’ Affairs and medical advisors who apply the VEA and MRCA claim procedures will use this SOP as a medico‑legal standard. The Repatriation Medical Authority made the instrument under s 196B(2) , the Authority sets the medical criteria while the claim processing authorities will apply them to individual claims (s 3).

Medical and scientific experts: physicians, occupational hygienists, radiation dose reconstruction specialists and other experts will be asked to provide evidence mapped to the SOP’s thresholds. Schedule 1 calls for dose calculation in accordance with an ARPANSA guide for ionising radiation exposures, and the SOP identifies specific tests (eg beryllium lymphocyte proliferation testing) and diagnostic entities (eg acute silicosis, acute respiratory distress syndrome) that must be evidenced (Schedule 1; s 9(4), s 9(6), s 9(10) and relevant definitions).

Employers, record-keepers and third‑party witnesses: the SOP operationalises cumulative exposure thresholds expressed as hours (eg asbestos 1,000 or 3,000 hours, silica 1,500 hours, coal dust 3,000 hours, hard metal 120 hours, etc., s 9(2)-9(3), s 9(5), s 9(8), s 9(9)). Consequently, employment records, rosters, contractor logs, safety data sheets, incident reports and industrial hygiene monitoring become evidence critical to supporting claims. Where exposures occurred during peacekeeping, operational, hazardous or nuclear test service, military records and deployment logs will be relevant.

Legal representatives and advisers: lawyers and advocates preparing claims must produce evidence aligned to the SOP’s numeric and temporal thresholds. For worsening claims, s 10(2) imposes the condition that the SOP factors relevant to aggravation apply only where the FILD was suffered or contracted before or during relevant service but did not arise out of that service. This affects the legal strategy for demonstrating material contribution or aggravation rather than primary causation.

Patients and families in death claims: s 7(3) extends the SOP to death from FILD when FILD contributed to a terminal event or condition. For advisors preparing death claims, evidence must tie FILD to the terminal event (as defined in Schedule 1: examples include pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function).

Actuaries, policy and budget units: while the SOP itself does not specify payments or costs, the instrument will influence the flow of accepted claims and thereby affect the financial exposure of veterans’ entitlements schemes. Changes in acceptance rates may shift administrative workloads and fiscal forecasts for agencies administering VEA/MRCA benefits; the SOP’s thresholds may reduce uncertain case-by-case causation assessments but also require expert inputs.

In short, the SOP affects a network of parties: claimants seeking service connection for FILD or death from FILD; decision‑makers applying the VEA/MRCA; treating clinicians and medico‑legal experts; record keepers whose documents establish hours and exposures; and legal advisers structuring claim evidence to match the specified factors and definitions.

The SOP itself prescribes medical‑evidentiary standards rather than statutory duties and rights in the classic sense. Practically, it imposes obligations and creates entitlements in the administrative decision process by identifying what evidence will, as a minimum, raise a reasonable hypothesis that FILD or death from FILD is connected to relevant service. The key operational duties and rights derived from the instrument are:

Duty on decision‑makers to apply the SOP: decision‑makers handling VEA/MRCA claims must apply the SOP when considering whether a reasonable hypothesis exists. Section 9 sets the factors that must exist as a minimum before a reasonable hypothesis is found. Section 11 requires application of other SOPs where a factor references an injury or disease governed by another SOP.

Requirement to relate factors to relevant service: s 10(1) expressly requires that the existence in a person of any factor referred to in s 9 must be related to the person’s relevant service. That means the decision is not simply a mechanical finding that an exposure occurred; there must be a nexus between the established factor and the service (s 10(1)). Evidence must therefore connect the exposure or event to service circumstances.

Differentiated application for aggravation/worsening: s 10(2) imposes a narrower application for factors listed in s 9(26)-9(51), which are limited to establishing material contribution to, or aggravation of, FILD where the disease was suffered or contracted before or during (but did not arise out of) relevant service. This gives rise to a duty on applicants to establish the temporal sequencing of disease in relation to service for worsening claims.

Evidentiary duty on applicants/representatives: the SOP’s thresholds make clear what evidence applicants should provide to meet a minimum test. For example, to satisfy s 9(1) an applicant must demonstrate at least 10 pack‑years of smoking with commencement at least five years before clinical onset. For ionising radiation (s 9(13)), applicants (and decision‑makers) must rely on cumulative equivalent dose calculated in accordance with the ARPANSA guide specified in Schedule 1. For beryllium exposure, Schedule 1 specifies alternative ways of meeting the inhalation threshold , documentation of at least 240 hours' exposure, history of acute beryllium disease, or positive beryllium lymphocyte proliferation testing.

Right to have other SOPs applied where relevant: s 11 preserves the right of a claimant to have factors that refer to other injuries or diseases assessed under the separate SOP for that condition. Where a factor in this SOP invokes another disease for which there is a SOP, that SOP’s factors apply according to its terms.

No penalties prescribed: the instrument contains no punitive provisions, fines, or enforcement mechanisms. Its legal force operates through its role in administrative decision‑making under the VEA and MRCA; it is not itself a source of criminal or civil liability outside the claims process.

Procedural implications: because the SOP provides objective thresholds, applicants and agents have a duty to assemble documentation (medical records, exposure logs, employment history, prescription records, radiation dose data, test results) aligned to the enumerated factors. Decision‑makers have a corresponding duty to assess whether those factual elements are present and whether they are related to relevant service per s 10(1).

In sum, the SOP creates a set of rights and expectations in the claims process: claimants have a right to have specified factors considered and to have related factors governed by other SOPs applied; decision‑makers have a duty to apply the SOP and to ensure that established factors are related to relevant service before finding a reasonable hypothesis.

The Statement of Principles does not create offences, civil penalties or an independent enforcement mechanism. It is an administrative medico‑legal instrument intended to guide the assessment of claims under the Veterans' Entitlements Act 1986 and the Military Rehabilitation and Compensation Act 2004 (see s 5 and s 3). There are no sections in the instrument that impose pecuniary penalties, criminal sanctions, inspection powers, compliance orders, or administrative fines. Consequently, "enforcement" in the ordinary regulatory sense is not within the SOP; the instrument functions as a binding administrative criterion for adjudicators applying ss 120A (VEA) and 338 (MRCA) within those Acts.

Operational enforcement: the practical effect is that decision‑makers will accept a reasonable hypothesis of service connection for FILD or death from FILD if at least one of the factors in s 9 is established and related to relevant service (s 9 and s 10(1)). Conversely, failure to establish any of the specified factors, or failure to show a nexus to relevant service, gives administrative decision‑makers grounds to reject a service‑connection argument on the basis that a reasonable hypothesis has not been raised. That outcome impacts entitlement decisions under the VEA/MRCA, which carry statutory consequences for pension, medical and rehabilitation benefits under those Acts , but those statutory entitlement consequences are created by the VEA and MRCA, not this SOP.

Evidence standards and procedural contestability: the SOP sets minimum factors that will raise a reasonable hypothesis. It does not prescribe the exclusive types of admissible evidence, nor does it fix evidentiary weight; those matters remain within the decision‑maker’s procedural framework under the VEA or MRCA. Applicants can provide supporting evidence (medical reports, occupational history, radiation dose reconstructions, laboratory testing) to meet the factors; decision‑makers may request further evidence or expert opinion. Disagreement can be challenged through the statutory review and appeal processes available under the VEA or MRCA, but the SOP itself does not set those review routes , they reside in the parent Acts.

Administrative consequences for non‑compliance with thresholds: a claimant who cannot document the required exposure thresholds or medical history specified in s 9 risks having the claim not satisfy the reasonable hypothesis test. That is a practical enforcement mechanism: the SOP’s thresholds operate as a gate for administrative acceptance. Section 10(1)’s requirement that factors must be related to relevant service is an additional gateway.

No investigatory powers: the instrument does not grant investigatory powers to the Repatriation Medical Authority or other agencies for the purpose of enforcing compliance. Any investigative or record‑gathering actions must therefore be undertaken under the authority of the VEA/MRCA or other relevant statutory powers, not under this SOP.

In short, enforcement is procedural and administrative: the SOP shapes entitlement outcomes by defining the medico‑scientific triggers for a reasonable hypothesis of service connection, but it does not itself create penalties or statutory enforcement mechanisms.

The SOP is made under subsection 196B(2) of the Veterans' Entitlements Act 1986 and is expressly applied to claims under section 120A of the VEA and section 338 of the Military Rehabilitation and Compensation Act 2004 (MRCA) (s 3; s 5). It therefore functions within the statutory architecture of the VEA and MRCA. Its legal effect is to set a medico‑scientific standard that must be considered by decision‑makers applying the statutory tests for service connection and material contribution/aggravation in those Acts.

Reference to ARPANSA methodology and cross‑agency content: the Schedule 1 definition of cumulative equivalent dose requires calculation "in accordance with the methodology set out in Guide to calculation of 'cumulative equivalent dose' for the purpose of applying ionising radiation factors contained in Statements of Principles determined under Part XIA of the Veterans' Entitlements Act 1986 (Cth), Australian Radiation Protection and Nuclear Safety Agency, as in force on 2 August 2017" (Schedule 1). That ties the SOP to an external technical guide maintained by the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). Decision‑makers and experts reconstructing radiation exposures must therefore apply that ARPANSA methodology, integrating a non‑statutory technical standard into the administrative determination under the VEA/MRCA.

Interaction with other SOPs: s 11 requires that where a factor in this SOP refers to an injury or disease for which a separate SOP has been determined under s 196B(2) of the VEA, the factors in that other SOP apply according to its terms. Practically, this creates a tiered interaction: a factor may invoke another disease (for example, a specified disease that itself has a SOP) and the adjudication must follow the separate SOP’s provisions. This prevents inconsistent application of medico‑scientific criteria across related conditions and requires cross‑reference during determinations.

Parent Acts and appeal mechanisms: while the SOP provides the medical criteria, the statutory rights, obligations and appeal mechanisms remain those in the VEA or MRCA. The SOP does not vary statutory entitlements or procedural rights in those Acts; instead it informs a factual determination under them. Any contestation of an entitlement decision that turns on application of the SOP will be resolved through the review and appeal mechanisms available under the VEA/MRCA, rather than within the SOP itself.

Administrative record-keeping and evidence laws: because the SOP relies on exposure histories, occupational records, medical tests and dose reconstructions, evidence admissibility and privacy considerations continue to be governed by applicable evidence rules, privacy laws, and record disclosure regimes. The SOP does not alter those general legal frameworks but interacts with them operationally , e.g. obtaining pre‑service or in‑service records to meet cumulative hours thresholds may require searches under archival and record‑disclosure rules and may be affected by statutory retention periods.

No displacement of common law: the SOP is administrative and statutory in character. It does not purport to displace any common law tort or contractual rights that claimants or third parties might have. The instrument is focused on entitlement determinations under the VEA and MRCA rather than on civil liability.

Replaced prior SOP: s 4 repeals Statement of Principles No. 53 of 2013. That repeal interacts with prior determinations by replacing the medical criteria previously used for FILD claims under the VEA. Determinations and entitlements made under the previous SOP may be revisited or assessed under the new criteria where relevant procedural rules allow.

Overall, the SOP sits within a matrix of legislated entitlement provisions (VEA/MRCA), technical guides (ARPANSA), and other SOPs. It supplies the medical thresholds and definitions which must be applied by decision‑makers operating under the VEA and MRCA, and it requires inter‑instrument coordination where factors invoke other stated diseases.

The instrument itself contains limited explicit amendment history within the text provided. Key temporal facts in the instrument are: the SOP is dated 20 August 2021 (prefatory material), it commences on 20 September 2021 (s 2), and it expressly repeals the prior Statement of Principles concerning fibrosing interstitial lung disease No. 53 of 2013 (s 4). The Repatriation Medical Authority affixed its Common Seal to the instrument on the date shown (prefatory text).

The repeal provision (s 4) shows a single, express amendment act: the 2021 SOP supersedes the 2013 SOP and replaces it as the controlling Statement of Principles for FILD under Part XIA of the VEA. The instrument does not list amendments to itself or prior amending instruments; the textual record given contains only the new SOP and the repeal of the 2013 instrument. There are no further schedules of amendments or transitional provisions included in the provided text.

References to external documents that affect application: Schedule 1 refers to the ARPANSA Guide "as in force on 2 August 2017" for calculating cumulative equivalent dose for ionising radiation factors. That is an external document with its own amendment history; the SOP fixes the ARPANSA guide as it stood on that date. Any subsequent changes to the ARPANSA guide after 2 August 2017 would not alter the SOP’s defined methodology unless the SOP is itself amended.

No retrospective amendment clause: the instrument does not include express transitional or retrospective application clauses besides the commencement date. It applies from its commencement date to claims to which the specified sections of the VEA and MRCA apply (s 2, s 5). For claims that arose under the previous SOP, the repeal means future determinations will be governed by the 2021 SOP unless other statutory transitional arrangements in the VEA or administrative practice provide otherwise; those transitional rules are not contained in this instrument.

No amending history embedded: the instrument does not list previous variations of the 2013 SOP other than its repeal. It also does not show internal amendments (eg insertion/deletion dates) beyond the standard instrument metadata.

Practical consequence for practitioners: when relying on SOP factors that reference external methodologies or other SOPs, practitioners must ensure they use the versions specified in the instrument (eg ARPANSA guide as at 2 August 2017) and be aware that the 2013 SOP has been removed from the statute book by this instrument (s 4). Any legal or evidentiary strategies based on the prior SOP should be reviewed in light of the 2021 document.

The text supplied contains no case law citations, no references to judicial review or litigation outcomes, and no recorded disputes about the 2021 Statement of Principles. The instrument itself does not record litigation history. It is an administrative determination made by the Repatriation Medical Authority under s 196B(2) of the VEA and functions as a medico‑scientific standard for decision‑makers rather than a litigated statutory provision.

Implications for practitioners: absence of litigation history in the source text means there are no authority quotes or judicial constructions of the 2021 SOP provided in this instrument. Where disputes arise about the application of the SOP , for example, the interpretation of cumulative hours thresholds, the meaning of "related to the relevant service" (s 10(1)), or the application of the ARPANSA cumulative equivalent dose methodology , those disputes would be resolved in the context of the VEA/MRCA administrative appeals and any judicial review proceedings, using the parent statutes and standard administrative law principles. The SOP does not itself provide precedent.

Where factors refer to other diseases governed by separate SOPs (s 11), litigation involving those other SOPs may be relevant in future disputes; however, no such cross‑references to litigation are made in this document.

Recommended practitioner action in the absence of settled litigation: because the SOP sets out precise thresholds and cross‑references external technical guidance, legal advisers and medical experts preparing or defending claims should anticipate contestation on factual evidence, on the application of definitions in Schedule 1 (eg the ARPANSA guide for radiation doses, the definition of one pack‑year, the inhalation of beryllium dust or fumes specification), and on nexus to relevant service per s 10(1). Any administrative or judicial contention will take place against the SOP’s terms, but the instrument contains no recorded litigation history to guide interpretation.

In short, the SOP contains no litigation history within its text; practitioners must therefore rely on the SOP’s plain language and applicable statutory review mechanisms under the VEA and MRCA to address any disputes that arise.

This SOP contains numerous technical thresholds and cross‑references that can trap an unaware practitioner or claimant if not carefully navigated. Key "gotchas" observable from the text include:

Onset versus worsening: the SOP separates clinical onset (factors 9(1)-9(25)) from clinical worsening/material contribution/aggravation (factors 9(26)-9(51)). s 10(2) narrows the operation of the latter group to cases in which the disease was suffered or contracted before or during (but did not arise out of) the person’s relevant service. Failure to establish that temporal sequencing will preclude use of those aggravation factors.
Different numeric thresholds and latencies: some exposures require cumulative hours and minimum latency before clinical onset (eg asbestos in an enclosed space requires at least 1,000 cumulative hours before clinical onset and first inhalation at least 5 years before onset, s 9(2)); open environment asbestos requires 3,000 hours and first inhalation at least 5 years before onset, s 9(3). Practitioners must match the exposure environment to the relevant sub‑paragraph, or risk misapplying the threshold.
Cessation windows for some exposures: for several factors involving exposure to listed substances or smoke from fire (eg s 9(23)-9(25) and s 9(48)-9(50)), if the exposure ceased before onset or worsening then the onset/worsening must have occurred within 20 years of cessation. Claims where exposure ceased more than 20 years before onset/worsening will not meet those factors.
Quantifying pack‑years: Schedule 1 defines one pack‑year and gives conversion for pipe tobacco, cigars and smoking tobacco weight. The conversion rules (1 gram = one cigarette; 7,300 grams equivalent to one pack‑year) are granular and can alter whether a claimant meets the 5 or 10 pack‑year thresholds (s 9(1) and s 9(26), and Schedule 1). Accurate calculation and documentary evidence are essential.
Beryllium criteria have alternatives: "inhaling beryllium dust or fumes" can be evidenced by either a history of exposure for at least 240 hours, a history of acute beryllium disease, or clinical evidence of sensitisation by positive beryllium lymphocyte proliferation testing (Schedule 1). The multiple pathways create both flexibility and complexity: different evidentiary routes have different practical collection needs.
Radiation dose reconstruction technicality: s 9(13), s 9(37) and Schedule 1 require cumulative equivalent dose calculation in accordance with the ARPANSA Guide as at 2 August 2017. Practitioners must use the specified methodology; use of a different calculation method risks rejection.
Drugs list specificity and narrow window: the "specified list of drugs" in Schedule 1 must have been taken within 6 months before clinical onset or worsening (s 9(19), s 9(43)). The list is specific and includes agents from amiodarone to tyrosine kinase inhibitors. If prescription records fall outside the six‑month window, the factor will not be satisfied.
Acute event timing constraints: for toxic gas/fume exposure to qualify (s 9(10) and s 9(34)), signs and symptoms must have required medical attention within 48 hours and persisted at least a week, and in the 1 year before clinical onset/worsening. Failure to demonstrate prompt medical attention or persistent symptoms will undermine that factor.
The "inability to obtain appropriate clinical management" factor (s 9(51)) is open‑ended. It could be relevant in cases where lack of treatment materially contributed to worsening, but the SOP provides no definition of "appropriate clinical management." This may be contested and requires detailed contemporaneous medical records and expert opinion.
Cross‑application trap: s 11 requires that if a factor refers to another disease covered by a separate SOP, that SOP applies. Practitioners must therefore identify when a factor invokes another SOP and ensure compliance with that other instrument’s terms. Failure to do so may result in overlooked requirements or inconsistent evidence.
Repeal of the 2013 SOP: s 4 repeals the previous SOP. Cases assessed under the old SOP may need review if ongoing determinations rely on the new criteria; practitioners should check whether transitional rules or existing determinations are affected by the repeal as applied in practice.
Death claims require linkage to terminal events: s 7(3) includes death from FILD where the disease contributed to a terminal event. The Schedule defines "terminal event" with examples. Practitioners must link FILD to the death by medical evidence; a death certificate alone that lists a terminal event may not be sufficient without showing contribution by FILD.
Evidence of occupational hours: many exposures are measured in cumulative hours (1,000; 1,500; 3,000; 5,000; 10,000 hours etc.). Older service records, informal contracting arrangements, or non‑standard shift patterns may make it difficult to produce precise cumulative hours. The absence of documentary precision can be determinative.

These "gotchas" are concrete evidentiary and interpretive traps that follow from the instrument’s heavy reliance on quantified exposures, temporal thresholds, specific definitions and cross‑references. Practitioners must align fact collection and expert opinion to the SOP’s exact language.

Preparing a claim that aligns with this SOP requires a methodical evidence strategy targeted at the specific factors and definitions set out in the instrument. Below are practical steps and document types that claimants, lawyers and medical advisors should assemble, mapped to the SOP’s requirements:

Map the clinical event first: determine whether the claim concerns clinical onset, clinical worsening/aggravation, or death contributed to by FILD (see s 7(2)-(3) and the delineation at s 9). That determines which factor subset (9(1)-9(25) or 9(26)-9(51)) applies and whether s 10(2) constraints on aggravation apply.
Smoking history , quantify pack‑years: collect medical notes, GP records, statements and employment health records documenting tobacco usage. Calculate pack‑years per Schedule 1: number of cigarettes per day divided by 20, multiplied by years smoked. Convert non‑cigarette tobacco (pipe, cigars, loose) using Schedule 1 equivalence. For onset claims use the 10 pack‑year threshold with commencement at least 5 years before onset (s 9(1)); for worsening use the 5 pack‑year threshold with commencement at least 1 year before worsening (s 9(26)).
Occupational exposure hours , document duties and time: for factors expressed in cumulative hours (eg asbestos, silica, coal dust, hard metal, specified substances and smoke) gather rosters, timesheets, contractor agreements, task logs, trade histories, witness statements and any industrial hygiene records quantifying exposure duration. Differentiate enclosed versus open environments (asbestos thresholds differ: 1,000 hours enclosed, 3,000 hours open, s 9(2)-9(3)). For exposures that have ceased, check the 20‑year window in applicable factors (s 9(23)-9(25), s 9(48)-9(50)).
Provide event‑based medical evidence: for acute exposure events (eg toxic gases/fumes requiring medical attention within 48 hours and persistent symptoms for a week, s 9(10) and s 9(34)) obtain contemporaneous emergency department, hospital and GP notes showing timing, diagnosis, treatment and persisting symptoms. For acute silicosis, acute respiratory distress syndrome, paraquat poisoning and diffuse alveolar haemorrhage, obtain specialist reports and diagnostic test results (Schedule 1; s 9(6), s 9(11), s 9(17), s 9(20), s 9(30), s 9(35), s 9(41)).
Radiation and radionuclide treatments: for ionising radiation exposure claims, obtain radiotherapy records, dosimetry records and any relevant service exposure records. Commission a cumulative equivalent dose reconstruction in accordance with the ARPANSA guide specified in Schedule 1. For therapeutic radiation where affected lung was in the field (s 9(14), s 9(38)), collect treatment plans, fractions, dose per fraction and field maps. For iodine‑131 or yttrium‑90 microspheres therapies, supply oncological treatment records (s 9(15), s 9(16), s 9(39), s 9(40)).
Drug exposures and medical therapies: for specified drugs in Schedule 1 (eg amiodarone, methotrexate, nitrofurantoin, tyrosine kinase inhibitors), supply prescription records, pharmacy dispensing documentation and hospital medication charts showing intake within the six‑month window before onset or worsening (s 9(19), s 9(43)).
Specific testing for beryllium sensitisation: for suspected beryllium exposures, supply occupational exposure histories documenting at least 240 cumulative hours, any record of acute beryllium disease, and results of beryllium lymphocyte proliferation testing (blood or bronchoalveolar lavage) where performed (Schedule 1, inhaling beryllium dust or fumes).
Demonstrate disease chronology for worsening: for aggravation claims under s 10(2) establish that FILD was suffered or contracted before or during service but did not arise out of it. That requires historical medical records demonstrating disease presence prior to or during service and contemporaneous or retrospective opinions linking service exposures to material contribution to worsening.
Death claims , link FILD to terminal event: where the claim concerns death from FILD (s 7(3)), obtain the death certificate, hospital records, autopsy reports if available, and treating physician opinions that FILD contributed to the terminal event (see Schedule 1 definition of terminal event).
Cross‑reference other SOPs where applicable: if any factor refers to an injury/disease governed by another SOP, identify that SOP and ensure evidence satisfies its terms per s 11.
Use expert opinion to bridge gaps: where documentary proof of cumulative hours is incomplete, employ occupational hygienists, former supervisors and co‑worker statements to reconstruct exposure. For dose reconstruction or complex pathogenesis opinions, commission appropriately qualified experts to apply the ARPANSA methodology or to opine on causation, latency and contribution.
Address the "inability to obtain appropriate clinical management" factor carefully: s 9(51) is open‑ended. If relying on it, prepare detailed evidence showing attempts to obtain care, reasons for inability, and expert opinion on how lack of treatment materially contributed to worsening.
Procedural and administrative follow‑through: ensure consent and privacy releases for service and medical records, and submit contemporaneous statements and supporting documents in the format required by the claims processing agency. Anticipate requests for further information and be ready to obtain supplementary expert reports.
Anticipate definitional specificity: adhere strictly to Schedule 1 definitions. For example, when asserting an inhalation of respirable crystalline silica dust, show the activity (production, excavation, drilling, cutting, grinding, polishing, construction use, manufacturing, cleaning, blasting) and cumulative hours (s 9(5), s 9(29)).
Where records are absent, document reasonable efforts: if older records are missing, provide sworn statements, service logs, pay records or corroborative testimony that reconstructs exposure. Explain why records are not available and how alternative evidence supports the claimed factor.

Following these steps aligns evidence with the SOP’s language and thresholds. The SOP demands quantitative and temporal precision, so claims preparation should prioritise obtaining and documenting exact exposure durations, medical timing, test results and treatment details referenced by the instrument.

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

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