Statement of Principles concerning SOFT TISSUE SARCOMA (Balance of Probabilities) (No. 77 of 2023) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986. Dated 25 August 2023. 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 soft tissue sarcoma (Balance of Probabilities) (No. 77 of 2023). 2 Commencement This instrument commences on 26 September 2023. 3 Authority This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning soft tissue sarcoma No. 6 of 2015 (Federal Register of Legislation No. F2014L01818) made under subsections 196B(3) and (8) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004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 soft tissue sarcoma and death from soft tissue sarcoma. Meaning of soft tissue sarcoma (2) For the purposes of this Statement of Principles, soft tissue sarcoma: (a) means a malignant neoplasm of soft connective tissue including fibrous, fat, muscle (cardiac, skeletal muscle and smooth muscle), tendon, nerve sheath, vascular, histiocytic and synovial tissue; and (b) includes: (i) non-articular cartilage sarcoma; (ii) synovial sarcoma; (iii) malignant mast cell tumour (mast cell sarcoma); (iv) dendritic cell sarcoma including interdigitating (dendritic cell) sarcoma, Langerhans cell sarcoma, and sarcoma of follicular dendritic cells; (v) histiocytic sarcoma (malignant histiocytosis); (vi) malignant odontogenic tumours; (vii) atypical fibroxanthoma; and (viii) Mullerian adenosarcoma; and (c) excludes: (i) carcinosarcoma (malignant mesodermal mixed tumour or malignant mixed Mullerian tumour); (ii) Kaposi sarcoma; (iii) malignant neoplasm of the bone and articular cartilage (osteosarcoma and chondrosarcoma); (iv) malignant neoplasm of the cerebral meninges; (v) mesothelioma; (vi) leukaemia; (vii) non-Hodgkin lymphoma, and Hodgkin lymphoma; (viii) myeloma and malignant plasma cell neoplasms; (ix) primary myelofibrosis; and (x) myeloid sarcoma and granulocytic sarcoma. Note: Some of the names of soft tissue sarcoma include liposarcoma, fibrosarcoma, angiosarcoma, leiomyosarcoma, rhabdomyosarcoma, extraskeletal chondrosarcoma, and synovial sarcoma. (3) While soft tissue sarcoma attracts ICD‑10‑AM codes C22.3, C22.4, C32.3, C48, C49, C54.2, C96.2, C96.4, or C96.8, in applying this Statement of Principles the meaning of soft tissue sarcoma is that given in subsection (2). (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. Death from soft tissue sarcoma (5) For the purposes of this Statement of Principles, soft tissue sarcoma, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's soft tissue sarcoma. Note: terminal event is defined in the Schedule 1 – Dictionary. 8 Basis for determining the factors On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that soft tissue sarcoma and death from soft tissue sarcoma can be related to relevant service rendered by veterans 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 exist before it can be said that, on the balance of probabilities, soft tissue sarcoma or death from soft tissue sarcoma is connected with the circumstances of a person's relevant service: (1) inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD) for a cumulative period of at least 500 hours, at least 5 years before the clinical onset of soft tissue sarcoma; Note: inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD) is defined in the Schedule 1 – Dictionary. (2) undergoing a course of therapeutic radiation for cancer, where the affected region was in the field of radiation, at least 5 years before the clinical onset of soft tissue sarcoma; (3) having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the affected region, at least 5 years before the clinical onset of soft tissue sarcoma; Note: cumulative equivalent dose is defined in the Schedule 1 - Dictionary. (4) for angiosarcoma only, having received a cumulative equivalent dose of at least 0.5 sievert of ionising radiation to the affected region at least 2 years before the clinical onset of soft tissue sarcoma; Note: cumulative equivalent dose and angiosarcoma are defined in the Schedule 1 - Dictionary. (5) for hepatic angiosarcoma only, having received ionising radiation to the liver from internal deposition of thorium dioxide (Thorotrast), at least 5 years before the clinical onset of soft tissue sarcoma; Note: cumulative equivalent dose and angiosarcoma are defined in the Schedule 1 - Dictionary. (6) for hepatic angiosarcoma only, inhaling a cumulative dose of at least 200 ppm-years of gaseous vinyl chloride, at least five years before the clinical onset of soft tissue sarcoma; Note: ppm-years and angiosarcoma are defined in the Schedule 1 - Dictionary. (7) being treated with an immunosuppressive drug resulting in substantial suppression of immune responses to prevent transplant rejection before the clinical onset of soft tissue sarcoma; (8) for leiomyosarcoma and Epstein Barr virus associated smooth muscle tumours, being infected with human immunodeficiency virus before the clinical onset of soft tissue sarcoma; (9) for angiosarcoma only, having persistent chronic lymphoedema of the affected region for at least 6 months before the clinical onset of soft tissue sarcoma; Note: angiosarcoma is defined in the Schedule 1 - Dictionary. (10) for uterine sarcoma only, being obese for a period of at least 5 years within the 20 years before the clinical onset of soft tissue sarcoma; Note: being obese is defined in the Schedule 1 - Dictionary. (11) for angiosarcoma only, having an arteriovenous fistula at the site of the angiosarcoma at least 5 years before the clinical onset of soft tissue sarcoma; Note: angiosarcoma is defined in the Schedule 1 - Dictionary. (12) for angiosarcoma only, having a vascular graft at the site of the angiosarcoma at least 5 years before the clinical onset of soft tissue sarcoma; Note: angiosarcoma is defined in the Schedule 1 - Dictionary. (13) for endometrial stromal sarcoma only, having endometriosis before the clinical onset of soft tissue sarcoma, where the soft tissue sarcoma has arisen in close proximity to the endometriosis; (14) inability to obtain appropriate clinical management for soft tissue sarcoma before the clinical worsening of soft tissue sarcoma. 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 factor set out in subsection 9(14) applies only to material contribution to, or aggravation of, soft tissue sarcoma where the person's soft tissue sarcoma 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(3) 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: angiosarcoma means angiosarcoma, lymphangiosarcoma or haemangiosarcoma. being obese means having a Body Mass Index (BMI) of 30 or greater where BMI means W/H2 where: (a) W is the person's weight in kilograms; and (b) H is the person's height in metres. 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. inhaling, ingesting or having cutaneous contact with a chemical agent contaminated by 2,3,7,8-tetrachlorodibenzo-para-dioxin (TCDD) means: (a) decanting or spraying; (b) cleaning or maintaining equipment used to apply; (c) being sprayed with; (d) handling or sawing timber treated with; (e) being in an environment shrouded in dust from timber treated with; or (f) using cutting oils contaminated with; one of the following chemicals: (a) 2,4,5-trichlorophenoxyacetic acid; (b) 2,4,5-trichlorophenoxypropionic acid; (c) 2,4,5-trichlorophenol; (d) 2-(2,4,5-trichlorophenoxy)-ethyl 2,2-dichloropropionate; (e) o,o-dimethyl-o-(2,4,5-trichlorophenyl)-phosphorothioate; (f) pentachlorophenol; (g) 2,3,4,6-tetrachlorophenol; (h) 2,4,6-trichlorophenol; (i) 1,3,4-trichloro-2-(4-nitrophenoxy)benzene; (j) 2,4-dichloro-1-(4-nitrophenoxy)benzene; or (k) 2,4-dichloro-1-(3-methoxy-4-nitrophenoxy)benzene. MRCA means the Military Rehabilitation and Compensation Act 2004. ppm-years means parts per million multiplied by years of exposure. relevant service means: (a) eligible war service (other than operational service) under the VEA; (b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or (c) peacetime service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. soft tissue sarcoma—see subsection 7(2). terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986.